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Monday, June 9
 

1:00pm EDT

12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration
Monday June 9, 2025 1:00pm - 4:00pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-25-501-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account My Events.

This Short Course will be offered virtually – Join from anywhere! This short course will provide an overview of the current use of real-world data (RWD) and real-world evidence (RWE) for evidence generation in major markets, with a primary focus on regulatory use and how it can inform clinical development planning. Following the major points from recently released guidance documents from around the world, the course will explain how the fitness of evidence from RWD are assessed for any use case, key elements of design and analysis, and the current status for when real-world studies will be sufficient to meet regulatory evidence requirements. Specifically, the course will discuss (a) the evolving regulatory landscape; (b) the evolution of RWD, how to utilize it, and when RWD is fit-for-purpose; (c) the evolution from safety evaluation to label extensions; and (d) how to ensure design transparency and data feasibility when proposing external comparator arms. The course will feature interactive elements such as polling questions, and participants are encouraged to present their own scenarios for open discussion.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals involved in or interested in learning about real-world evidence, real-world data, epidemiology, clinical research, regulatory and technology development.

Learning Objectives

  • Discuss how regulators are using RWE for regulatory decision support and how RWD and RWE are being used to inform clinical development planning
  • Describe the concept of RWD being “fit-for-purpose” including the importance of relevant data and methodologic rigor
  • Identify how RWE can be assembled and integrated to generate a compelling message


Speakers
avatar for Jaclyn Bosco

Jaclyn Bosco

Vice President & General Manager, Global Head of Epidemiology & Database Studies, IQVIA, United States
Dr. Jaclyn Bosco Global Head of Epidemiology & Database Studies in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated... Read More →
avatar for Linda Kalilani

Linda Kalilani

Senior Director and Head of Oncology Epidemiology, GlaxoSmithKline, United States
Linda Kalilani is Senior Director & Head of Oncology Epidemiology at GlaxoSmithKline. She has worked as an epidemiologist in the pharmaceutical industry for over 10 years. She has led the development of cross-functional real-world evidence strategies, has extensive experience leading... Read More →
avatar for Tara MacCannell

Tara MacCannell

Global Head and Executive Director, RWE, Vertex Pharmaceuticals, United States
Tara MacCannell, PhD MSc, is the Global Head and Executive Director of Real World Evidence at Vertex Pharmaceuticals. In her role, Tara leads the RWE function with a team of epidemiologists responsible for the strategy and execution of observational studies in support of early development... Read More →
avatar for Rachel Sobel

Rachel Sobel

Vice President, Head of Pharmacoepidemiology & Risk Management Ctr of Excellence, Regeneron Pharmaceuticals Inc., United States
Dr. Sobel has over 24 years of experience in epidemiology, risk management, and registries. She is currently Head of Pharmacoepidemiology at Regeneron in Global Patient Safety and has held roles of increasing responsibility at Pfizer Inc and UBC, a CRO. She has extensive experience... Read More →
Monday June 9, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Tutorial |   09: Regulatory, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Tuesday, June 10
 

9:30am EDT

21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol
Tuesday June 10, 2025 9:30am - 12:30pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.50 Application UAN: 0286-0000-25-502-L04-P; CME 2.50; IACET 2.50; RN 2.50

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account My Events.

This Short Course will be offered virtually – Join from anywhere!In this short course, participants will gain hands-on experience in applying Risk-Based Quality Management (RBQM) principles, grounded in the Quality by Design (QbD) framework, to real-world clinical trial scenarios. Working in small groups, participants will analyze a three-page real-life study synopsis, using guidance from ICH E6(R2/R3), to identify critical data, critical processes, and potential risks. Following an instructor-led introduction to key concepts like risk scoring and mitigation strategies, participants will identify and prioritize risks, create actionable risk statements, develop mitigation plans, define Key Risk Indicators (KRIs), and establish Quality Tolerance Limits (QTLs).With feedback from expert instructors, participants will refine their critical thinking and learn how to distinguish key data and processes in clinical trials. This approach emphasizes practical relevance, equipping attendees with tools to apply RBQM and QbD principles to their own protocols immediately. Through collaborative group work and actionable insights, attendees will leave with a clear understanding of how to embed ICH E6(R3)-aligned QbD strategies into their risk management practices.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals involved in or interested in clinical research, particularly risk managers, project managers, study managers, clinical data managers, statisticians, lead monitors, auditors, and those involved in risk-based quality management and risk-based monitoring activities.

Learning Objectives

  • Identify critical data and critical processes, determine the risks and define a risk statement
  • Evaluate the risks regarding likelihood, impact and detectability, and define suitable mitigation actions, KRIs and QTLs
  • Evaluate compliance with ICH E6 R2/R3 and increase the potential for study success


Speakers
avatar for Julien Nunes Goncalves

Julien Nunes Goncalves

Head of Growth, Cyntegrity, South Africa
A research scientist by training, Julien has almost a decade of experience in the pre-clinical and clinical research fields, where he leverages his scientific foundation to meet the unique challenges that existing at the junction of marketing, sales, and clinical science. Julien applies... Read More →
avatar for Johann Proeve

Johann Proeve

Chief Scientific Officer, Cyntegrity, Germany
Dr. Johann Proeve is the Chief Scientific Officer at Cyntegrity. Johann has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Data Management at Bayer Healthcare.? Awarded one of the 2018 MCC Champions by the Metrics Champion... Read More →
Tuesday June 10, 2025 9:30am - 12:30pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Tutorial |   08: RD-Quality-Compliance, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-503-L04-P; CME 2.75; IACET 2.75; PDU 2.75 PMI 2166LKA26P; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere!This short course provides a focused, in-depth exploration of how established project management frameworks, tools, and best practices can be applied specifically to the drug development process. Participants will begin by examining a range of methodologies—such as Agile, Waterfall, and hybrid approaches—to understand which strategies work best for managing the multifaceted challenges of clinical trials. Through guided instruction, attendees will learn how to adapt these methodologies to meet stringent regulatory requirements, handle complex demands, and maintain stringent quality standards. In addition to foundational methodologies, this course delves into practical tools and templates that streamline project planning, risk management, and communication. These tools help teams navigate the intricate timelines associated with bringing a drug to market, enabling participants to anticipate and mitigate risks before they become obstacles. By learning to identify common bottlenecks and implement effective contingency plans, attendees can keep projects on schedule and budget, ensuring that new therapies reach patients faster. A central component of the course focuses on enhancing cross-functional collaboration. Participants will learn strategies to improve communication among scientific, clinical, regulatory, and operational teams, ensuring that everyone shares a common understanding of project goals and responsibilities. This improved alignment not only accelerates decision-making but also fosters a more cohesive and productive working environment. To reinforce these concepts, the course provides real-world examples and case studies to give participants hands-on experience in applying project management principles, evaluating risk, adjusting timelines, and coordinating team efforts in real-world scenarios. In addition, advanced tools and techniques are introduced, equipping learners with cutting-edge resources that support informed decision-making and efficiency throughout the drug development lifecycle. By the end of this program, participants will have gained a practical, customizable toolkit they can immediately apply in their daily work. Participants will emerge with greater confidence in managing complex drug development and clinical research projects, ultimately improving trial outcomes and accelerating the delivery of innovative therapies to the patients who need them. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals working in or interested in drug development who seek to improve their project management knowledge and skillset. Roles that would benefit from this course include project managers, clinical research associates, data managers, regulatory specialists, and clinical operations staff, amongst others, who aim to streamline processes and deliver projects on time and on budget to accelerate the development of new therapies.

Learning Objectives

  • Identify key project management methodologies and tools to improve efficiency in drug development
  • Discuss drug development timelines by learning strategies to manage risks, streamline timelines, and overcome bottlenecks
  • Apply Cross-Functional Collaboration to ensure smoother project execution and faster delivery of therapies


Speakers
avatar for Melody Keel

Melody Keel

Founder, CEO and Consultant, The Research Associate Group, Inc., United States
Melody Keel is a transformative clinical operations strategist and Founder/CEO of The Research Associate Group, pioneering a people-first approach to clinical trial excellence. With nearly two decades of experience across rare diseases, oncology, and CNS, she developed the proprietary... Read More →
avatar for Jess Thompson

Jess Thompson

Founder, CEO, Clinical Research Pro, United States
Jess Thompson brings over 15 years of clinical research experience across labs, sites, CROs, and pharma. She founded Clinical Research Pro to empower professionals through education, development, and career growth. Under her leadership, Clinical Research Pro fosters a supportive community... Read More →
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Tutorial |   07: ProjectManagement-StrategicPlanning, Tutorial |   12: ProfDevelopment, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Tutorial
 
Wednesday, June 11
 

9:30am EDT

31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations
Wednesday June 11, 2025 9:30am - 12:30pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.50 Application UAN: 0286-0000-25-504-L04-P; CME 2.50; IACET 2.50; RN 2.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! Cell and Gene Therapies (CGTs) are a rapidly expanding area in the pharmaceutical sector, offering the potential to address serious unmet medical needs in many indications. Yet some of the conceptual frameworks in this field differ dramatically from those of traditional pharmaceutical medicines, specifically with regard to CMC, Non-clinical and Clinical requirements and Health Authority expectations. This short course will help those who have pharmaceutical sector experience but are newcomers to the CGT field ‘get into the right frame of mind’ to think about CGT development. Participants will be introduced to requirements for each of the major disciplines for regulatory submissions: CMC, Non-clinical and Clinical. The course will also explain the rationale behind the CMC approach to CGT manufacture and basic CMC regulatory expectations for CGT products, including process and product characterization, comparability and process validation. Biological mechanisms for CGTs will also be discussed, with a focus on how mechanistic understanding can inform the design of in vitro and animal studies to provide non-clinical evidence of safety and efficacy. Key principles for clinical development of CGTs will be presented, with an emphasis on clinical study design elements that are critical for Health Authority evaluation of benefit-risk. Case studies of recent FDA approvals will be showcased to highlight key clinical considerations and changes in the regulatory environment for CGTs. The course features ex-Health Authority Regulators presenters who have a combined 20 years of experience at the FDA and EMA. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals involved in or interested in gaining an understanding of the basics of cell and gene therapy development, including regulatory personnel, clinical operations personnel, researchers and investigators, medical writers, and commercial specialists.

Learning Objectives

  • Demonstrate why cell and gene therapies (CGT) require a different and very specialized regulatory approach compared to small molecules and biologics
  • Develop knowledge of CGT-specific considerations and requirements for CMC, Non-Clinical, and Clinical development
  • Analyze important regulatory considerations for CGT development programs


Speakers
avatar for Christiane Niederlaender

Christiane Niederlaender

Vice President, Technical, Parexel International, United Kingdom
Christiane is a member of Parexel’s Cell and Gene Therapy Center of Excellence. As VP technical for CMC, her focus is on manufacturing consideration for advanced therapies of all types, including genetically modified cells and viral vectors. Christiane has spent over 12 years in... Read More →
avatar for Luman Wing

Luman Wing

Consultant, Nonclinical, Management Consultants, United States
With over 25 years of experience in pharmaceutical R&D, Luman is a regulatory nonclinical expert specializing in small molecules, biologics, cell and gene therapies, and medical devices. A primary author of over 20 INDs and 5 NDAs/BLAs, Luman has led regulatory strategies, nonclinical... Read More →
avatar for Steve Winitsky

Steve Winitsky

Senior Vice President, Technical, Parexel International, United States
In his current position as Senior Vice President, Technical for Regulatory Strategy at Parexel International, Dr. Winitsky is a member of the Cell and Gene Therapy Center of Excellence. He provides clinical regulatory support to clients for all phases of product development for cell... Read More →
Wednesday June 11, 2025 9:30am - 12:30pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Tutorial |   09: Regulatory, Tutorial |   10: RegCMC-Product Quality, Tutorial |   20: Short-Courses, Tutorial

1:00pm EDT

32P: Introduction to Artificial intelligence (AI) Ethics, Regulations and Governance for Life Sciences
Wednesday June 11, 2025 1:00pm - 4:00pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-25-505-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! This short course will provide an overview of major regulations and regulatory frameworks of major world health authorities around the use of Artificial intelligence (AI)/GenAI in the life sciences industry. It will cover the ethical, legal, and practical aspects of AI implementation, focusing on compliance with current and emerging regulations. It will introduce concepts of the AI Risk Management Framework (RMF) by National Institute of Standards and Technology and explore how they can be extended to AI governance within the life sciences industry. It will provide some ideas on how to implement AI governance processes for the implementation of projects and ongoing maintenance. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals involved in the drug development and commercialization space (business as well as IT) who are interested in understanding the fast-growing discipline of AI regulations and governance frameworks, especially when AI/GenAI tools are being increasingly evaluated, prototyped and implemented in the life sciences industry.

Learning Objectives

  • Discuss key regulations and regulatory frameworks around the use of AI in the life sciences industry
  • Describe the business impact and compliance requirements for AI applications in drug development and commercialization
  • Identify strategies to establish AI governance and compliance processes in the implementation of capabilities and ongoing maintenance


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States
Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management... Read More →
avatar for Cary Smithson

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Wednesday June 11, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Tutorial |   20: Short-Courses, Tutorial
 
Thursday, June 12
 

9:30am EDT

41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
Thursday June 12, 2025 9:30am - 12:30pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.50 Application UAN: 0286-0000-25-506-L04-P; CME 2.50; IACET 2.50; RN 2.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! Statistical methods are a powerful tool used in clinical trials to assess whether the data support evidence of a treatment effect. It is therefore key that the results of any statistical analysis are interpreted correctly. However, understanding and interpreting statistical results can be challenging for non-statisticians. In this short course, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts to be covered include commonly seen hypothesis test, survival analyses, regression modelling, mixed models for repeated measures (MMRM), and adjusting for multiplicity. Important concepts such as p-values will be explained fully. Idealized examples as well as examples from publicly posted FDA reviews and results on clinicaltrials.gov will be used. Group discussions using example outputs (including examples from FDA reviews) will give participants the opportunity to apply their learning by critically evaluating statistical analysis approaches and interpreting statistical results, thus giving participants the tools necessary to effectively communicate with their colleagues involved in drug development. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals involved in or interested in clinical trials who want to understand how to interpret the results of common statistical analyses and have more effective communications with their statistical team members.

Learning Objectives

  • Determine why certain statistical analyses are applied to specific outcomes
  • Evaluate statistical summaries and extract the important information
  • Interpret the statistical results using easily understandable language


Speakers
avatar for Stephen Corson

Stephen Corson

Associate Director, Statistics and Technical Solutions, Phastar, United Kingdom
I am a Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of Mathematics... Read More →
Thursday June 12, 2025 9:30am - 12:30pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

42P: Regulatory Strategy Development for Complex Devices and Combination Products
Thursday June 12, 2025 1:00pm - 4:00pm EDT
Virtual
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-507-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. Implementation of a strategy includes the compilation of the plans and/or documents pertaining to strategic partnerships, intellectual property (IP) initiatives, product development approaches, quality management systems (QMS) optimizations, and regulatory submission plans into the integrated regulatory strategy for the complete “asset” as the traditional “ways of working” and/or processes will be challenged when developing an innovative combination product. This short course will explore key challenges and opportunities, offering practical exercises and a structured framework for success. It will focus on mitigating regulatory risk(s) in submissions timeliness and addressing issues such as excessive queries from health authorities, additional testing needs, and delays that impact time to market. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Entry/Intermediate professionals in quality, product development, and risk management who are suppliers/CDMOs or patent attorneys.

Learning Objectives

  • Analyze the latest regulatory expectations and challenges for complex devices and combination products
  • Explain potential future innovation platforms
  • Identify opportunities to integrate regulatory strategies across functional areas including risk management activities and content between Sponsors, Suppliers and CDMOs


Speakers
CD

Carolyn Dorgan

Director, Technical Service, Sutton's Creek, United States
Carolyn Dorgan has 15+ years experience in the medical device and combination product industries, including seven years at the US Food and Drug Administration (FDA) leading the Infusion Devices team. She currently serves as one of the Directors of Technical Services at Suttons Creek... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
avatar for Jerzy Wojcik

Jerzy Wojcik

VP, Regulatory & Quality Services, EdgeOne Medical, United States
Jerzy Wojcik is VP of Quality and Regulatory Affairs Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory affairs. His expertise includes identification and execution of regulatory activities across all stages of product development... Read More →
Thursday June 12, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Tutorial |   09: Regulatory, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Sunday, June 15
 

12:30pm EDT

Registration
Sunday June 15, 2025 12:30pm - 6:00pm EDT
TBD
Component Type: Session



Sunday June 15, 2025 12:30pm - 6:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking-Opportunities, Session

6:00pm EDT

Inspire Awards
Sunday June 15, 2025 6:00pm - 7:30pm EDT
Planet Word
Join Us In Celebrating
The Inspire Awards recognize the trailblazers whose passion, innovation, and influence are paving the way toward better, more accessible healthcare for all. These honorees embody the spirit of collaboration, purpose, and progress that drives the DIA community forward.

Join us in celebrating the visionaries whose contributions are not only advancing the frontiers of healthcare—but also inspiring a global movement toward innovation, equity, and a healthier future.

Your Registration Includes Access to the Exclusive Networking Event!

Add to Cart
Sunday June 15, 2025 6:00pm - 7:30pm EDT
Planet Word 925 13th St. NW Washington, D.C. 20005
  19: Networking-Opportunities

7:00pm EDT

DIA Annual Meeting Welcoming Reception - Planet Word
Sunday June 15, 2025 7:00pm - 9:00pm EDT
Planet Word
Join us for a truly unforgettable evening at Planet Word, recently ranked by USA Today as one of Washington D.C.’s most unusual and inspiring museums. Set in a beautifully restored historic schoolhouse, Planet Word combines stunning architecture with interactive exhibits that celebrate the power of language—and it's the perfect backdrop for high-impact networking before the DIA Global Annual Meeting begins.

Why You Should Attend:
  • Two-Hour Hosted Bar & Curated Bites: Sip, savor, and socialize with a premium selection of drinks and delicious food—all included.
  • Elite Networking: Connect with fellow industry leaders, innovators, and rising stars in an intimate setting designed for meaningful conversation.
  • A Museum Like No Other: Explore immersive exhibits like the Speaking Willow and the magical Library filled with books that talk—yes, really!

Limited Capacity: This event is designed to be high-touch and high-value. Spots are limited and will fill quickly.
Don’t miss this chance to connect, spark ideas, and experience one of D.C.'s most talked-about venues.

Cost: $100, must be registered for DIA Global Annual Meeting to attend.

Add to Cart

Sunday June 15, 2025 7:00pm - 9:00pm EDT
Planet Word 925 13th St. NW Washington, D.C. 20005
  19: Networking-Opportunities
 
Monday, June 16
 

7:00am EDT

Coffee and Light Refreshments
Monday June 16, 2025 7:00am - 8:00am EDT
Ballroom Foyer 3rd Floor
Component Type: Social Event



Monday June 16, 2025 7:00am - 8:00am EDT
Ballroom Foyer 3rd Floor Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

8:00am EDT

#100: Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact
Monday June 16, 2025 8:00am - 10:00am EDT
Ballroom
Component Type: Forum

Start your day with a powerful and inspiring session that brings together visionary leaders, groundbreaking science, and real-world patient experiences. DIA President and CEO Marwan Fathallah sets the stage, followed by a moving personal story from Jimi Olaghere, who shares his extraordinary journey from a sickle cell diagnosis to conquering Mt. Kilimanjaro. Dive into the future of innovative treatments with a keynote on Type 1 Diabetes breakthroughs by renowned researcher Douglas Melton. The session concludes with a dynamic multi-stakeholder panel, where top regulators, researchers, and industry leaders explore how global collaboration can accelerate patient-centered innovation and derisk product development.

Learning Objectives

Describe how patient experiences and personal journeys can inform and inspire innovative approaches to drug development and healthcare solutions; Analyze the scientific and regulatory challenges associated with developing innovative treatments for chronic and rare diseases, such as Type 1 Diabetes and Sickle Cell Anemia; Identify collaborative strategies that enable multi-stakeholder partnerships to derisk medical product development and accelerate patient access to innovative therapies.

Chair

Marwan Fathallah, MBA, MSc

Speaker

Panelist
Emer Cooke, MBA, MSc

Panelist
Sudip Parikh, PhD

The Patient Experience
Jimi Olaghere

The Future of Innovative Treatments
Doug Melton, PhD

Panelist
Martin Makary, MD, MPH

Panelist
Lawrence Tallon


Speakers
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
avatar for Marwan Fathallah

Marwan Fathallah

President & Chief Executive Officer, DIA, United States
Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho... Read More →
avatar for Martin Makary

Martin Makary

Commissioner, FDA, United States
avatar for Doug Melton

Doug Melton

Distinguished Research Fellow, Vertex, United States
avatar for Jimi Olaghere

Jimi Olaghere

Patient Advocate, United States
Jimi Olaghere is a CasGevy recipient who has developed a keen interest in the advancements of Cell and Gene therapies, since his transformative participation in the groundbreaking clinical trial. He is passionate about the positive impact these therapies can have on patients in need... Read More →
avatar for Sudip Parikh

Sudip Parikh

Chief Executive Officer and Executive Publisher, Science Journals, United States
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency, United Kingdom
Monday June 16, 2025 8:00am - 10:00am EDT
Ballroom Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  00: Plenary, Forum

10:00am EDT

Coffee Break
Monday June 16, 2025 10:00am - 11:00am EDT
EH
Component Type: Social Event



Monday June 16, 2025 10:00am - 11:00am EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

10:15am EDT

#101 IT: IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 1
Component Type: Session

We will explore how AI can enhance clinical trials resulting in increased efficiency and precision. Hear from representatives from IQVIA and NVIDIA to 1)Gain insights into how AI will transform workflows in clinical trials, and 2) Explore “what if” scenarios that can help sponsors review different eligibility criteria and parameters to determine what may impact recruitment goals and quantify each option. Join us to discuss how AI will pave the way for more efficient and effective drug development.

Speaker

Speaker
Raja Shankar, MS

Speaker
Raghav Mani


Speakers
avatar for Raghav Mani

Raghav Mani

Director of Digital Health Products,, NVIDIA, United States
Raghav Mani is the Director of Digital Health, focused on building products and platforms for providers, payors and pharma. Prior to NVIDIA, Raghav worked at Epic, where he led different product and engineering teams including their Deep Learning team and their patient engagement... Read More →
avatar for Raghav Mani

Raghav Mani

Director of Digital Health Products, NVIDIA, United States
Raghav Mani is the Director of Digital Health, focused on building products and platforms for providers, payors and pharma. Prior to NVIDIA, Raghav worked at Epic, where he led different product and engineering teams including their Deep Learning team and their patient engagement... Read More →
avatar for Raja Shankar

Raja Shankar

Vice President, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:15am EDT

#102 IT: Lokavant, Inc Innovation Theater: Uncertainty Drives Innovation - Four Use Cases of AI-Powered Study Forecasting
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 3
Component Type: Session

The clinical trial landscape is shifting—uncertainty, complexity, and cost pressures demand a smarter path forward. In this session, Lokavant CEO Rohit Nambisan shares how sponsors and CROs use AI-powered study forecasting to move from reactive to proactive planning. Learn how real-time, scenario-based modeling helps teams reduce risk, optimize timelines, and forecast with confidence.

Speaker

Speaker
Rohit Nambisan


Speakers
avatar for Rohit Nambisan

Rohit Nambisan

CEO, Lokavant, Inc., United States
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:15am EDT

#103 IT: OM1 Innovation Theater: Real-World Evidence Generation in a Demanding Era
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 2
Component Type: Session

As the demand for faster, more agile, and cost-effective evidence generation grows, traditional observational studies are showing their limitations—slow site activation, burdensome operations, and limited scalability. This session explores how automation and AI are modernizing approaches to real-world observational programs. Join us to discover how leading life sciences are using AI-powered real-world data solutions to streamline prospective studies, post-marketing commitments, and regulatory-required evidence generation. Learn how these technologies enable long-term, scalable, and diverse patient engagement while meeting the rigorous demands of regulatory authorities and supporting product differentiation in real-world settings.

Speaker

Speaker
Eric Schrock


Speakers
avatar for Eric Schrock

Eric Schrock

Chief Technology Officer, OM1, United States
Eric Schrock is Chief Technology Officer and Head of Evidence Generation Solutions at OM1, where he leads a diverse technology team spanning product engineering, data engineering, product management, information security, and IT. He is responsible for shaping and driving OM1's digital... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:00am EDT

#104: A Regulator's View on the Future Vision for Pharmacovigilance
Monday June 16, 2025 11:00am - 12:00pm EDT
207A
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-510-L04-P; CME 1.00; RN 1.00

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Chair

Sarah Vaughan

Speaker

Panelist
Monica Munoz, PharmD, PhD


Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
avatar for Monica Munoz

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

11:00am EDT

#105: Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-511-L04-P; CME 1.00; RN 1.00

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Chair

Tae Hyun Jung, PhD

Speaker

Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD

Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD


Speakers
avatar for Tae Hyun Jung

Tae Hyun Jung

Senior Statistical Reviewer, CDER, FDA, United States
Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases... Read More →
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Digital Biomarkers, Verily, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers at Verily, where she leads the research and evidence generation for digital measures and AI/ML capabilities. She oversees the development, validation, and implementation of the technology in internal and external clinical... Read More →
avatar for Tarik Yardibi

Tarik Yardibi

Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Tarik Yardibi is the Director of Sensing and Measurement at Takeda Pharmaceuticals, operating within the Digital Health Sciences department at Takeda R&D. As a digital health and data science technical leader, Tarik has contributed extensively across both medical device and pharmaceutical... Read More →
avatar for Vadim Zipunnikov

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Vadim Zipunnikov is an Associate Professor of Biostatistics at Johns Hopkins Bloomberg School of Public Health and co-leads the Wearable and Implantable Technology (WIT) group. His research focuses on developing statistical methods for analyzing digital health data from wearables... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

11:00am EDT

#106: Real-World Evidence: First Choice or Last Resort?
Monday June 16, 2025 11:00am - 12:00pm EDT
207B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-512-L04-P; CME 1.00; RN 1.00

Opportunities and challenges for using RWE from the perspective of drug development, regulatory considerations, health technology assessments, clinician and patients will be discussed, including new collaborations between regulators and HTA.

Learning Objectives

Describe how RWE is being used through the medicinal product lifecycle by showing relevant examples; Evaluate the utility of RWE for benchmarking disease progress and/or to use as an external comparator; Explain the extent to which HTA and regulators collaborate on RW requirements.

Chair

Nancy Dreyer, PhD, MPH, FISPE

Speaker

RWE for Clinical Decision Support
Richard Gliklich, MD

Opportunities and Challenges in Using RWE from the Perspective of Drug Development
Brian Bradbury, DrSc, MA

How Regulators are Collaborating with Payers: Update on EMA-HTA Pilot Work
Patrice Verpillat, DrMed, MD, PhD, MPH


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Brian Bradbury

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States
Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise... Read More →
avatar for Richard Gliklich

Richard Gliklich

Founder & Chief Executive Officer, OM1, United States
Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

11:00am EDT

#107: From Approval to Access: Integrating Patient Insights into Coverage Decisions
Monday June 16, 2025 11:00am - 12:00pm EDT
202A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-513-L04-P; CME 1.00; RN 1.00

Despite advances, patient engagement (PE) in post-approval access decisions remains limited, complex, and unclear. This session examines how patients can offer value-based insights and explores pathways to strengthen PE in product access decisions.

Learning Objectives

Identify existing opportunities to incorporate patient input into access determinations; Recognize patient-contributed information and data that could broaden the evidentiary base for CMS and other payers; Discuss the resources and frameworks needed for CMS to systematically and scientifically engage with patient communities.

Chair

June Cha, PhD, MPH

Speaker

Vital Voices from Patients in Access Determination
June Cha, PhD, MPH

Patients Engaging with CMS: Opportunities, challenges, and lessons learned
Kristi Martin, MA, MPA

Patient Perspectives: Are They Missing from Commercial Payer Drug Coverage Policies?
James Chambers, PhD, MPharm, MSc

How Breakthrough T1D has Engaged CMS
Campbell Hutton, MPH


Speakers
avatar for June Cha

June Cha

Policy Director, FasterCures, Milken Institute, United States
June Cha is a policy director at FasterCures, Milken Institute Health. She brings decades of experience in infectious diseases research, non-profit, multilateral, and bilateral organizations, government, and the pharmaceutical industry, where she has focused on US and global health... Read More →
avatar for James Chambers

James Chambers

Professor, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, United States
James Chambers is a Professor at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies. His research focuses on insurance coverage of medical technology and the role of cost-effectiveness in U.S. health care.
avatar for Campbell Hutton

Campbell Hutton

Senior Vice President, Global Advocacy, Breakthrough T1D, United States
Campbell Hutton, is Senior Vice President, Global Advocacy at Breakthrough T1D, a non-profit organization whose mission is to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D) and its complications. In her role she oversees the regulatory affairs... Read More →
avatar for Kristi Martin

Kristi Martin

Director, Camber Collective, United States
Kristi Martin is a seasoned health policy expert with over 20 years of experience in the public sector, private sector, and philanthropy. She is currently a Director at Camber Collective, a strategy consulting firm known for its analytic rigor and human-centered approach. Kristi began... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

11:00am EDT

#109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Monday June 16, 2025 11:00am - 12:00pm EDT
152AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-515-L04-P; CME 1.00; RN 1.00

This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies

Learning Objectives

Describe the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.

Chair

Mandy Kaur Budwal-Jagait, MSc

Speaker

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Kavita C. Dada, PharmD, RAC

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Adil Nashed

Panelist
Peter Twomey, MA, MPharm

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Reina Hayashi


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Kavita Dada

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
Captain Kavita Dada, Pharm.D., RAC, is the Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at FDA's Center for Drug Evaluation and Research. With over 20 years of regulatory experience, she leads initiatives to modernize... Read More →
RH

Reina Hayashi

Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reina Hayashi currently serves as an inspector of the Office of Non-clinical and Clinical Compliance in the Pharmaceuticals and Medical Devices Agency (PMDA).
avatar for Adil Nashed

Adil Nashed

Drug Specialist, Health Canada, Canada
Adil Nashed graduated as a Veterinarian from University of Khartoum, Sudan.He successfully completed his Veterinary Internship in Vienna, Austria under the supervision of the University of Vienna. Adil also holds a post graduate diploma in Homeopathic Medicine and Science from the... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum |   02: ClinTrials-Ops, Forum

11:00am EDT

#110: Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
151B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-516-L04-P; CME 1.00; RN 1.00

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno

EMA Perspective
Andrew Thomson, PhD, MA, MS

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Kevin Bugin, PhD, MS, RAC


Speakers
avatar for Thomas Bognanno

Thomas Bognanno

Patient Representative, Alliance Practice, United States
Founder and Partner of Alliance Practice LLC, a firm dedicated to supporting select organizations in the trauma-informed care sector. Before retirement in 2023, Bognanno served as the Chief Executive Officer of Creating Healthier Communities for 17 years. Before that, he served as... Read More →
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer Inc, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs for small molecules and biologics. Her diverse experience... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

11:00am EDT

#111: Project Orbis: Six Years Later
Monday June 16, 2025 11:00am - 12:00pm EDT
147AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-517-L04-P; CME 1.00; RN 1.00

In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.

Learning Objectives

Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative and explain how sponsors can benefit from participating in Project Orbis.

Chair

Sema Hashemi, MSc

Speaker

Panelist - Australia
Sarah Golding, MD

Panelist - Brazil
Marcelo Moreira, MS

Panelist - Canada
Melissa Hunt, MSc

Panelist - Israel
Michal Hirsh-Vexberg, PharmD

Panelist - Switzerland
Ulrich Peter Rohr, DrMed

Panelist - United States
R. Angelo De Claro, MD

Panelist - United States
Dianne Spillman


Speakers
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Sarah Golding

Sarah Golding

Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation, Therapeutics Goods Administration, Australia
Dr. Sarah Golding is dual qualified; both as a medical doctor and a biomedical scientist with honours in biochemistry and molecular biology. Her 12 years' experience at Australia's Therapeutic Goods Administration (TGA) include 9 years in the clinical review and approval of oncology... Read More →
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
MH

Michal Hirsh-Vexberg

Head of the Pharmaceuticals Registration Department, Medical Technology, Health, Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department at the Medical Technologies, Health Innovation, Information, and Research Directorate, Israel Ministry of Health. In charge of several units evaluating non-clinical and clinical data as part of MA applications and post-approval variations... Read More →
avatar for Melissa Hunt

Melissa Hunt

Director, Health Canada, Canada
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →
avatar for Marcelo Moreira

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
avatar for Ulrich Rohr

Ulrich Rohr

Unit Head Clinical Review Hematology & Oncology, Swissmedic, Switzerland
avatar for Dianne Spillman

Dianne Spillman

Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
Dianne Spillman is the Associate Director for Global and Regulatory Outreach in the FDA's Oncology Center of Excellence (OCE). She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government service spans over 30 years, with the majority in FDA... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

11:00am EDT

#112: Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-518-L04-P; CME 1.00; RN 1.00

Among the largest areas of concern with the Inflation Reduction Act (IRA) are potential unintended consequences to pharmaceutical innovation. This forum will convene industry experts to explore the impact of and potential adjustments to the IRA.

Learning Objectives

Discuss the unintended consequences of the IRA on innovation; Examine potential legislative solutions.

Chair

Sarah Martin, PhD, MS

Speaker

Panelist
Gregory Daniel, PhD, MPH

Industry Perspective
Ryan Gough

The Impacts of the Inflation Reduction Act on Biopharmaceutical Investment Decisions
Richard Xie, PhD

Early Signals of IRA Impact: Theoretical and Observed Unintended Consequences
Julie Ann Patterson, PharmD, PhD


Speakers
avatar for Gregory Daniel

Gregory Daniel

Global Head of Public Policy, Global Corporate Affairs, Eli Lilly and Company, United States
Gregory Daniel, PhD, MPH, is the Global Head of Public Policy at Eli Lilly & Company in Washington, D.C. Greg is also on the board of directors for the Innovation in Value Initiative (IVI), adjunct associate professor at the UNC Eshelman School of Pharmacy, and Visiting Expert at... Read More →
RG

Ryan Gough

Partner, Senior Vice President, Public Affairs, Woodberry Associates and PACH, United States
avatar for Sarah Martin

Sarah Martin

Senior Director - Global Regulatory Policy (Oncology), Eli Lilly & Co., United States
Sarah currently serves as senior director of global regulatory policy for oncology at Lilly. She previously served as senior director of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America (PhRMA) where she led their regulatory advocacy efforts... Read More →
avatar for Julie Patterson

Julie Patterson

Senior Director of Research, National Pharmaceutical Council, United States
Julie Patterson, PharmD, PhD, is Senior Director of Research and Director of the NPC Enterprise Lab at the National Pharmaceutical Council. She designs and conducts policy-relevant research related to sustainable access to innovative biopharmaceuticals, often focusing on incentives... Read More →
avatar for Richard Xie

Richard Xie

Senior Health Economist, RA Capital Management, United States
Richard Xie has over a decade of experience in conducting rigorous economic analyses to inform health policy issues. As a Senior Health Economist at RA Capital, he collaborates with diverse stakeholders to communicate the value of pharmaceutical innovation to payers, policymakers... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum
  • Level Intermediate
  • Keyword Payers
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Payers
  • Tags Forum

11:00am EDT

#113: Accelerating Global Access to Drugs for Chronic Diseases
Monday June 16, 2025 11:00am - 12:00pm EDT
Salon B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-677-L04-P; CME 1.00; RN 1.00

In a world increasingly burdened by chronic diseases, the timely access to effective medications is a critical component of global health initiatives. This conference session aims to explore strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy. We will delve into the innovative regulatory approaches that can pave the way for faster development and registration and more equitable access of these vital medications.

Learning Objectives

Describe the strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy.

Chair

Carlos Garner, PhD

Speaker

Panelist
Francisco Nogueira, MBA

Panelist
Naoyuki Yasuda, MSc

Panelist
Anantha Shekhar


Speakers
CG

Carlos Garner

Vice-President Global Regulatory Affairs, Eli Lilly and Company, United States
Executive leader for North American regulatory affairs for Eli Lilly and Company. The organization is responsible for all US and Canadian human drugs and devices regulatory affairs, and global manufacturing regulatory affairs. Organization provides strategic and operational regulatory... Read More →
avatar for Francisco Nogueira

Francisco Nogueira

Chief Executive Officer, Accumulus Synergy, United States
Francisco Nogueira is a highly accomplished and forward-thinking C-suite executive with over 25 years of impactful leadership in the pharmaceutical and health technology sectors. Known for his strategic insight and agility, Francisco has developed a reputation for excellence in drug... Read More →
AS

Anantha Shekhar

Dean, School of Medicine, University of Pittsburgh, United States
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
Salon B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session
  • Level Intermediate
  • Keyword Non-CE
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Non-CE
  • Tags Session

11:00am EDT

#108: Advancing Innovation Through Essential Drug Delivery Outputs
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-514-L04-P; CME 1.00; RN 1.00

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Recognize the technology landscape for more complex drug delivery combination products, specific patient considerations informing design and clinical risk, and the role of new regulatory tools like Essential Drug Delivery Outputs; Discuss current challenges facing combination products to deliver advanced therapies (Cell & Gene) or biologics including submission expectations (IND, NDA/BLAs), verification, validation, Control Strategy, and post-market changes.

Chair

Rumi Raquel Young, MS

Speaker

Overview of complex combination product technologies (implantable, on-body) and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development (EDDO Focus)
James Bertram, PhD, MS, RAC

Emerging Policies Driving Complex Combination Product Development (How other Policies Work with EDDO)
Chelsea O'Connell, MS, RAC

Patient Perspectives on Advanced Therapies and use of Complex Combination Products
Stephen Karpen, PharmD


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
avatar for Stephen Karpen

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum |   06: PersonalizedMed-ComboProd-Diagnostics, Forum

11:00am EDT

#114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives
Monday June 16, 2025 11:00am - 12:00pm EDT
146BC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-519-L04-P; CME 1.00; RN 1.00

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

Chair

Janis Bernat, MSc

Speaker

Introduction of Regulatory Levers to Address the Problem: Global Implementation of Identification of Medicinal Products Standards
Ron Fitzmartin, PhD, MBA

Panelist
Vada Perkins, DrSc, MSc

EMA Perspective
Isabel Chicharo, MPharm

ANVISA Perspective
Raphael Sanches Pereira, SR

HealthCare Professional Perspective on the Issue and Examples
Joseph Kannarkat, MD

Panelist
Peter Hjelmstrom, MD, PhD


Speakers
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Isabel Chicharo

Isabel Chicharo

Head of Regulatory Data Management, European Medicines Agency, Netherlands
I am responsible for Regulatory Master Data Management Services, currently on Substances, Products, Organisations and Referential data (also known as SPOR). I also coordinate the implementation of ISO IDMP in EU. I over 20 years of data management experience in the field of Medicines... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is a Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provides policy and strategy consultation on electronic regulatory submissions and standardized data. Ron serves as Rapporteur for... Read More →
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre, Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
avatar for Joseph Kannarkat

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States
Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →
avatar for Raphael Sanches Pereira

Raphael Sanches Pereira

General Manager of the Office for Medicines, ANVISA, Brazil
General Manager of the Office of Medicines, responsible for evaluations off small molecules registrations and post-approval changes requests. Previously manager of Office for Quality Evaluation for Registration of Small Molecules and Manager of Office for Quality Evaluation of Small... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   14: DIAmond, Forum

12:00pm EDT

#POS 1: Student Poster Session I
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH
Component Type: Session

Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
avatar for Xianwen Chen

Xianwen Chen

Student, University of Macau, Macao
Chen Xianwen is currently a PhD candidate in the Institute of Chinese Medical Sciences at the University of Macau. Her research interests include drug regulatory science and drug policy. In 2020–2022 she obtained her Master’s degree at University of Macau, then she worked as an... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
DS

Dhruv Sunil Choudhary

Student, University of Westminster, United Kingdom
avatar for Kimberly Dayato

Kimberly Dayato

Full Time Student, Mount St Mary's University, United States
Kimberly Dayato is a Biology major at Mount St. Mary's University, Class of 2026. She conducts antibiotic resistance research under Dr. lee, analyzing drug-resistant bacteria in water sources from Kent County, Delaware. At Mount St. Mary's she also works under Dr. Vilmen, studying... Read More →
avatar for Tanvi Gupte

Tanvi Gupte

Student, University of Maryland, United States
Tanvi is a researcher dedicated to advancing translational research in healthcare. With a strong foundation in pharmacy, medical devices (MS), and material science (PhD), she brings a unique perspective to drug development and healthcare innovation. She is pursuing MS in Pharmacometrics... Read More →
avatar for Jackson Hanf

Jackson Hanf

Student, University of Southern California, United States
avatar for Md Rashedul Islam

Md Rashedul Islam

Student, Undergraduate Research Scholar, Queensborough Community College, United States
Md Rashedul Islam is an undergraduate researcher at Queensborough Community College, City University of New York, majoring in Computer Science & Information Security. As a 2024–2025 CUNY Research Scholars Program scholar, he conducts research in medical & radiation physics, focusing... Read More →
avatar for Nabeela Jahangeer

Nabeela Jahangeer

Student, University of Southern California, United States
I am a graduate researcher specializing in antimicrobial resistance, with a focus on optimizing the global regulatory landscape for antibiotic development. My work explores clinical trial design, international approval trends, and policy frameworks that influence the introduction... Read More →
avatar for Xiangxiang Jiang

Xiangxiang Jiang

PhD student, University of South Carolina, United States
Xiangxiang Jiang is a Ph.D. candidate in Pharmacoepidemiology and Pharmacoeconomics at the University of South Carolina College of Pharmacy. His research focuses on evaluating the cost-effectiveness of medications and identifying risk factors for disease using real-world data and... Read More →
avatar for Patricia Jumelle

Patricia Jumelle

Student, University of Southern California, United States
Patricia Jumelle, MD, MS’25 is an anesthesiology trained interventional pain management physician. She received her BA in Economics from Yale University and her MD from Jefferson Medical College in Philadelphia. She completed her Anesthesiology residency at the University of Illinois... Read More →
avatar for Emma Kikerkov

Emma Kikerkov

Pharmacy and MPH Student, Eshelman School of Pharmacy, United States
I am a dual degree Pharmacy and Public Health Student at UNC. I am interested in learning how to leverage both of my degrees in the pharmaceutical industry and managed care space to ultimately work towards increased medication access.
avatar for Lauren Le

Lauren Le

Student, Butler University, United States
Lauren Le is a Doctor of Pharmacy candidate on the accelerated pathway at Butler University in Indianapolis, Indiana, USA. Under the mentorship of Dr. Hala Fadda, her research focuses on assessing the age-appropriateness of oral drug formulations based on pediatric labeling changes... Read More →
avatar for Jeremiah Lee

Jeremiah Lee

Research Ambassador, University of Southern California, United States
Jeremiah Lee (they/them) is a budding queer health researcher with an emphasis in inclusive clinical practice. As a M.S. student in Clinical Trial Management at USC Mann and Research Ambassador for the SC CTSI Regulatory Science Research Team, they explore how and why clinical trials... Read More →
avatar for Ritika Malik

Ritika Malik

Student, Temple University, United States
avatar for Taraneh Mousavi

Taraneh Mousavi

PhD Student, University of Maryland, Baltimore, United States
Taraneh Mousavi is a PhD student in Pharmaceutical Health Services Research at the University of Maryland, Baltimore. She holds a Doctor of Pharmacy degree and has nearly five years of experience in the pharmaceutical sector, including roles as a community and hospital pharmacist... Read More →
avatar for SRIVIDYA NARAYANAN

SRIVIDYA NARAYANAN

Student, Northeastern University, United States
Srividya Narayanan is a dedicated regulatory affairs professional with a background in dentistry, now specializing in medical devices and AI integration in health systems. She currently works with Culture Care Collective, contributing to an AI-driven platform to enhance community... Read More →
avatar for Ebere Okpara

Ebere Okpara

PhD Candidate, University of Illinois Chicago, United States
Ebere Okpara is a PhD Candidate in Pharmacy Systems, Outcomes, and Policy at the University of Illinois Chicago. Her research focuses on real-world evidence generation in chronic diseases, including oncology and respiratory conditions. She also applies mixed methods to evaluate health... Read More →
avatar for Mercy Owusu-Asante

Mercy Owusu-Asante

Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
Mrs Mercy Owusu-Asante is a pharmacist with an MSc in Pharmaceutical Services and Medicines Control obtained from the University of Bradford, UK. In the area of personal professional development, Mercy is pursuing a PhD in Regulatory Science at the University of Herfordshire, UK... Read More →
avatar for Ruonan Peng

Ruonan Peng

Graduate Research Assistant, University of California, Riverside, United States
Ruonan Peng is a Ph.D. candidate in Chemical Engineering at University of California, Riverside, specializing in CRISPR-based diagnostics and microfluidic platforms for infectious disease detection. She previously worked as a Regulatory Affairs Specialist at Ferring Pharmaceuticals... Read More →
avatar for Yen Phan

Yen Phan

Student, University of Oxford, Ireland
Yen Phan has completed an MSc in Medical Statistics at the University of Oxford and is currently pursuing a Doctor of Health Science (DHSc) in Leadership in Clinical Practice and Education at The George Washington University School of Medicine and Health Sciences. She works as a Clinical... Read More →
avatar for Ran Tu

Ran Tu

Phd Student, Georgetown University, United States
My name is Ran Tu, and I am a Ph.D. candidate in Biostatistics at Georgetown University. I got my Bachelor’s degree in Mathematics from Wuhan University and my Master’s degree in Biostatistics from Yale University. Currently, under the mentorship of Professors Ming Tan and Ao... Read More →
avatar for Alice Vanneste

Alice Vanneste

PhD Student, KU Leuven, Belgium
Alice Vanneste is a PhD researcher at the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven. Her PhD research focusses on the systematic implementation of patients' perspectives across the medical drug life cycle. By collecting more patient-based evidence derived... Read More →
avatar for Jenna Wildeman

Jenna Wildeman

PharmD Candidate, University of Washington, United States
Jenna Wildeman is a PharmD candidate at the University of Washington School of Pharmacy with a strong interest in real-world evidence and health outcomes research. Jenna is passionate about improving care through data-driven insights and aspires to contribute to evidence-based policy... Read More →
avatar for Siqian Zheng

Siqian Zheng

Doctor of Biomedical sciences, University of Macau, China
Zheng Siqian obtained her Bachelor of Engineering degree in Pharmaceutical Engineering from the School of Pharmacy at Shandong University. She continued her academic journey and earned a Master of Science in Pharmaceutical Management from the University of Macau, where she was awarded... Read More →
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session

12:00pm EDT

Luncheon Service
Monday June 16, 2025 12:00pm - 2:00pm EDT
Exhibit Hall Lunch
Component Type: Social Event



Monday June 16, 2025 12:00pm - 2:00pm EDT
Exhibit Hall Lunch Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

12:10pm EDT

#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs; Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions; Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Speakers
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

Senior Consultant, IPM, United States
Vidya Narayanaswamy is a Senior Consultant at IPM, bringing over 12 years of experience across the life sciences industry—from early development through late-stage programs and global regulatory submissions. She holds an MS in Biotechnology and an MBA with a focus on Leadership... Read More →
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

12:15pm EDT

#115.1 IT: Salesforce Innovation Theater: Personalized Patient Engagement from Recruitment to Enrollment and Beyond with Life Sciences Cloud
Monday June 16, 2025 12:15pm - 12:45pm EDT
Innovation Theater 2
Component Type: Session

We'll explore innovative strategies for engaging patients throughout the clinical trial process, from initial recruitment to trial completion. Including how technology can be used to engage study participants, build trust, and maintain participation. We'll discuss patient-centric communication, digital tools for engagement, and Agentforce, a comprehensive agentic AI platform, for recruitment strategy recommendations, patient screening, drop-out risk prediction, and personalized recommendations.

Speaker

Speaker
Lorie McClain

Speaker
Sharmin Nasrullah, MS


Speakers
avatar for Lorie McClain

Lorie McClain

Distinguished, Strategic Solution Engineer, Salesforce, United States
avatar for Sharmin Nasrullah

Sharmin Nasrullah

General Manager, Life Sciences, Clinical, Salesforce, United States
Sharmin Nasrullah brings over 20 years of experience across multiple disciplines across technology development, medical devices, digital health, clinical operations and clinical software. She is inspired by bringing cutting edge technology into the life sciences space to transform... Read More →
Monday June 16, 2025 12:15pm - 12:45pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

#118 IT: PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success
Monday June 16, 2025 12:55pm - 1:25pm EDT
Innovation Theater 3
Component Type: Session

This panel brings together experts from across the research continuum to explore how community-based research models contribute to trial success. Through real-world experiences and case studies, panelists will discuss the operational, medical, and regulatory considerations of integrating community research into clinical trials. Attendees will gain insights into how these approaches work together to improve patient reach, retention, and overall trial efficiency.

Speaker

Speaker
Mark McKenzie, MD

Speaker
Thad Wolfram

Speaker
Tajuana Barron


Speakers
avatar for Tajuana Barron

Tajuana Barron

Vice President Project Management Global Clinical Trials, PCM Trials, United States
Tajuana Barron is the Vice President of Project Management responsible for project delivery. Ms. Barron joined PCM Trials in 2022 with over 30 years of clinical research experience working for Pharma companies and CROs. Prior to joining PCM Trials, Ms. Barron served as a Senior Director... Read More →
avatar for Mark McKenzie

Mark McKenzie

Chief Medical Officer, EmVenio Research, United States
Mark McKenzie, MD is the Chief Medical Officer responsible for strategies and new initiatives in the clinical and therapeutic areas. He also provides medical and clinical oversight to EmVenio’s team of principal investigators involved in trials at community research sites globally... Read More →
avatar for Thad Wolfram

Thad Wolfram

Chief Strategy Officer, EmVenio Research, United States
With a foundation of more than 20+ years in clinical trials, healthcare, and the pharmaceutical industry, Thad Wolfram brings a wealth of knowledge and experience to EmVenio. As President, he is focused on the growth of hybrid and decentralized trial capabilities and increased clinical... Read More →
Monday June 16, 2025 12:55pm - 1:25pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

#117 IT: AlphaLife Science Innovation Theater: AI in Action - End-to-End Automation and Quality Control in Regulatory Document Authoring with AI and Veeva Integration
Monday June 16, 2025 12:55pm - 1:55pm EDT
Innovation Theater 1
Component Type: Session

Discover how AI-powered regulatory document automation is transforming medical writing across various regulatory medical document types for global pharmaceutical companies. This session presents real-world use cases and a demo of an enterprise authoring platform that integrates seamlessly with Veeva Vault. Experience end-to-end automation—from AI-driven drafting and seamless workflow integration to automated updates, cross-functional reviews, and finalization. Key features include a document template engine with expert-curated templates, automated quality control (QC) for factual accuracy and compliance, and real-time data synchronization. Learn how this solution accelerates timelines, ensures audit readiness, and enhances data integrity through AI integration, while streamlining review cycles and propagating changes across documents.

Speaker

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen is a visionary leader at the intersection of computer science and life sciences, boasting over 25 years of pioneering software development experience. As the Founder and CEO of AlphaLife Sciences, she drives innovation in generative AI-powered clinical development solutions... Read More →
Monday June 16, 2025 12:55pm - 1:55pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:30pm EDT

#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Speakers
avatar for Ana Sengupta

Ana Sengupta

Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in global regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in... Read More →
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop

1:35pm EDT

#120 IT: Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 3
Component Type: Session

Case managers play a crucial role in educating patients about their treatment options, including access to cutting-edge oncology clinical trials. Attendees of this session will learn about success in supporting research enrollment through a collaboration between Cigna Health Plan and Leal Health to guide patients through the process starting with awareness, to receiving a personalized list of precise trial matches, and partnering with a dedicated trial navigator.

Speaker

Speaker
Ria Westergaard, PharmD

Speaker
Anthony Gulotta


Speakers
avatar for Anthony Gulotta

Anthony Gulotta

Head of Sales and Strategic Partnerships, Leal Health, United States
Anthony Gulotta is a tech executive with a track record of launching and scaling AI-driven startups. As the founding sales team member at Leal Health, he leads sales and strategic partnerships across payers, sponsors, and providers. With deep industry connections and a strong belief... Read More →
avatar for Ria Westergaard

Ria Westergaard

Head of Product Strategy and Innovation, Evernorth Clinical Trial and RWE Solutions, United States
Ria Westergaard is an experienced leader with background in clinical research and pharmacy benefit management. At Evernorth, the health services division of The Cigna Group that serves more than 180 million people, Ria's role focuses on designing solutions that use integrated health... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

#121 IT: Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 1
Component Type: Session

Embrace the future of Data Management and TMF management with the power of Agentic AI. These intelligent systems automate processes, including protocol -> CRF/DVP -> eCRF/EC, and document filing -> QC. By leveraging the power of LLM and eClinical platform capabilities, we can experience a new era of clinical operations where AI is not just a function of an eClinical platform, but an integral part of the process, driving smarter, more efficient outcomes.

Speaker

Speaker
Kevin Lu

Speaker
Shou Yuan


Speakers
avatar for Kevin Lu

Kevin Lu

CTO, Taimei Technology, United States
Kevin Yiming Lu is Chief Technology Officer at Taimei Technology. Since joined Taimei in 2018, Kevin led the R&D effort of TrialOS, the digital platform of life science, and is responsible for Taimei's global technical strategy. Kevin has extensive experience in database, cloud computing... Read More →
avatar for Shou Yuan

Shou Yuan

Director, Global Solutions, Taimei Technology Inc., United States
Shou leads customer success efforts at Taimei Technology, fostering enduring relationships with CROs and Sponsors to align with their needs. He oversees global customer success and consulting teams, ensuring top-tier service delivery. Shou spearheads strategic planning and product... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

#122 IT: Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 2
Component Type: Session

The drug development landscape is evolving rapidly, characterized by increasing complexity, innovative trial designs, advanced technologies & AI, and the integration of real-world data. Outsourcing models are adapting to these changes, with a growing trend towards hybrid (blending FSO/FSP outsourcing) approaches. We’ll share our comprehensive research findings that examine these shifts, with recommendations for driving innovation and efficiencies while cultivating the workforce of the future.

Speaker

Speaker
Stephen Pyke, MSc

Speaker
Jenny Denney


Speakers
avatar for Jenny Denney

Jenny Denney

EVP, Global Head Parexel FSP, Parexel , United States
avatar for Stephen Pyke

Stephen Pyke

Chief Clinical Data and Digital Officer, Parexel, United Kingdom
Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-521-L04-P; CME 1.00; RN 1.00

Master Protocols, including basket trials and umbrella trials, enable efficiencies in investigating multiple conditions or multiple treatments, respectively, under a single trial design. Applying Master Protocol trial designs to Cell & Gene therapies (CGTs) can streamline clinical and regulatory processes to speed the delivery of treatments to patients with rare diseases.

Learning Objectives

Identify barriers to and solutions for leveraging Master Protocol clinical trial designs to study Cell & Gene Therapies for rare diseases.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Thought Leader Perspective
Philip (P.J.) Brooks, PhD

Innovator Perspective
Kiran Musunuru, MD, PhD, MPH

Researcher Perspective
Jeff Allen, PhD


Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
avatar for Kiran Musunuru

Kiran Musunuru

Professor of Medicine, University of Pennsylvania, United States
An actively practicing cardiologist and committed teacher, Kiran Musunuru, MD, PhD, MPH, ML, MRA, is Professor of Cardiovascular Medicine, Genetics, and Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the development of novel... Read More →
avatar for Nancy Myers

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, United States
Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 20 years and has been active in the DC policy arena for three... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

2:15pm EDT

#123: A Masterclass: Patient Recruitment Campaign Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-520-L04-P; CME 1.00; RN 1.00

Go beyond platitudes and qualitative advice on planning, deploying, and measuring the success of your recruitment campaign. Enjoy this Master Class in Recruitment Campaign Management from some of the industry's best minds

Learning Objectives

Discuss how to build an evidence based forecast for centralized patient recruitment campaigns; Describe ways to optimize channel mixes, vendor management, performance models, technology selection; Identify methods to measure and optimize campaign performance and ROI.

Chair

Chris Venezia

Speaker

Case Study Presentation
Helen West

Case Study Presentation
Gretchen Goller, MA

Case Study Presentation
Adrienne Walstrum, MSc

Case Study Presentation
Tom Julian


Speakers
avatar for Gretchen Goller

Gretchen Goller

Head, Recruitment and Retention, Pfizer, United States
Gretchen leads the Patient Recruitment and Retention team at Pfizer working with a team of strategists and specialists to implement recruitment and retention programs on all Pfizer studies across therapeutic areas. Most recently Gretchen was the Head leading the Patient Recruitment... Read More →
avatar for Tom Julian

Tom Julian

Assoc. Director Design and Innovation, Gilead Sciences, United States
At Gilead Sciences, Tom leads efforts to improve clinical trial design and implements technologies to improve trial efficiency and reduce costs. He is focused in Virology and Inflammation. Previously, at Bristol Myers Squibb, he worked on testing and scaling digital solutions to improve... Read More →
CV

Chris Venezia

Chief Executive Officer, ProofPilot, United States
As the CEO., Chris Venezia brings more than 18 years of strong leadership experience to ProofPilot with a track record of success in product commercialization, patient recruitment, marketing, and sales. With his most recent role as the Chief Commercial Officer at Citeline Connect... Read More →
AW

Adrienne Walstrum

Senior Director, Global Trial Optimization, Merck, United States
Adrienne Walstrum is a Senior Director with Global Trial Optimization (GTO). She has over 15 years of clinical trial operations experience, with the last 9 years spent at Merck within GTO. In Adrienne’s current role, she oversees GTO’s Recruitment & Retention Center of Excellence... Read More →
avatar for Helen West

Helen West

Senior Director, Innovative Patient Recruitment, Evinova, United States
Helen West is a senior digital patient recruitment strategist with Evinova's Innovative Patient Recruitment group. Her background is in clinical operations, trial optimization and healthcare communications. She has lead patient recruitment strategies for more than 200 global studies... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session |   05: Patient-Impact-Product-Dev, Session

2:15pm EDT

#127: Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-524-L04-P; CME 1.00; RN 1.00

This session will delve into the historical and ethical context for distinguishing between clinical care and research and how the blurring poses a risk for engagement with patients. Experts in ethics and health literacy will discuss potential pitfall

Learning Objectives

Recognize the ethical and historical context for distinguishing between clinical care and research; Describe the regulatory and ethical challenges that are exposed when sponsors and investigators push patients to clinical research; Discuss how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Speaker

Bioethics Perspective
Lindsay McNair, MD, MPH, MS

Patient and Health Literacy Perspective
Catina O'Leary, PhD

IRB perspective
David Borasky, MPH


Speakers
avatar for David Borasky

David Borasky

Vice President, IRB Compliance, WCG Clinical, United States
David A. Borasky serves as Vice President of IRB Compliance for WCG IRB. Mr. Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities... Read More →
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States
Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum |   04: MedAffairs-SciComm, Forum
  • Level Advanced
  • Keyword Bioethics
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

2:15pm EDT

#128: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Monday June 16, 2025 2:15pm - 3:15pm EDT
204ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-525-L04-P; CME 1.00; RN 1.00

Through this session, we will explore the advantages of incorporating AI and digital pathology for drug and biomarker discovery as part of a long-term companion diagnostic (CDx) partnership. We will also explore potential regulatory challenges in this ever-evolving space.

Learning Objectives

Discuss the importance of a complete development lifecycle of drug and companion diagnostic; Describe a complete development lifecycle of a drug and companion diagnostic; Describe potential regulatory challenges facing AI, Digital Pathology, and CDx development.

Chair

Greg Morehouse, MS

Speaker

Panelist
Brendan O'Leary

Panelist
Mark Stewart, PhD

Panelist
Elaine Katrivanos

Panelist
Andrew Ciupek, PhD


Speakers
avatar for Andrew Ciupek

Andrew Ciupek

Associate Director, Clinical Research, GO2 for Lung Cancer, United States
Andrew Ciupek, PhD, is Associate Director of Clinical Research at GO2 for Lung Cancer. Originally a translational cancer researcher, Andrew transitioned to patient-advocacy to have increased impact on driving patient-centered research. At GO2, Andrew leads implementation of patient-centric... Read More →
avatar for Elaine Katrivanos

Elaine Katrivanos

Vice President Regulatory Affairs, Tempus AI, United States
Elaine Katrivanos is Vice President, Regulatory Affairs at Tempus Labs, Inc. and, in this role, is responsible for leading the Regulatory Affairs department. Prior to joining Tempus, Elaine was a global regulatory lead in pharmaceutical drug development at AstraZeneca. Before that... Read More →
avatar for Greg Morehouse

Greg Morehouse

Senior Manager, RA Device, Combination Products, Abbvie, United States
Greg Morehouse has worked in regulatory affairs for precision medicine, both within in vitro diagnostics and pharmaceutical products, since 2018. Greg's experience with companion diagnostics across the pharmaceutical, medical device, and CRO industries affords him unique insights... Read More →
BO

Brendan O'Leary

Consultant, United States
Brendan O’Leary is Deputy Director of the Digital Health Center of Excellence (DHCoE) at FDA and led the DHCoE as its Acting Director throughout 2022. Over his nearly 14-year tenure with FDA, Mr. O’Leary has built an international reputation as an expert on digital health, medical... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart, PhD, is Vice President of Science Policy at Friends of Cancer Research, a Washington, DC-based organization that brings together stakeholders to advance science, policy, and regulation in cancer care. He leads the organization’s research and policy agenda, overseeing... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

2:15pm EDT

#129: Models of Collaborations to Advance Regulatory Science: Lessons Learned
Monday June 16, 2025 2:15pm - 3:15pm EDT
151B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-526-L04-P; CME 1.00; PDU 1.00 PMI 2166X8AYYG; RN 1.00

Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.

Learning Objectives

Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.

Chair

Huong Huynh, PhD

Speaker

Panelist
Liang Zhao, PhD

Panelist
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA

Panelist
Meghana Chalasani, MHA


Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and co-leads the Advisory Committee workstream... Read More →
avatar for Huong Huynh

Huong Huynh

Director of Regulatory Science, Critical Path Institute, United States
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
LZ

Liang Zhao

Professor and Director for Center of Global Regulatory Science and Innovation, University of California San Francisco, United States
Dr. Liang Zhao is currently a professor and establishing the Center for Global Regulatory Science and Innovation at the School of Pharmacy, University of California San Francisco (UCSF). Prior to joining UCSF, he had served as the Director of Division of Quantitative Methods and Modeling... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Session

2:15pm EDT

#130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-527-L04-P; CME 1.00; RN 1.00

This forum will present: Health Authority (HA) expectations related to QbD, RBQM, and issue management. Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.

Learning Objectives

Discuss Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.

Chair

Michael Torok, PhD

Speaker

Industry Perspective
Michael Torok, PhD

FDA Perspective
Emily Gebbia, JD

Industry Perspective
Kevin Richards


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Kevin Richards

Kevin Richards

Head Quality Investigations & Analytics, AstraZeneca, Canada
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   03: Data-Tech, Session |   02: ClinTrials-Ops, Session

2:15pm EDT

#131: International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here
Monday June 16, 2025 2:15pm - 3:15pm EDT
150AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-528-L04-P; CME 1.00; RN 1.00

The International Council for Harmonisation (ICH) was established in 1990 by regulatory authorities and industries in the United States, Japan, and Europe with a mission to harmonize requirements for the development of medicines. Since, the Association was reformed in 2015 to establish ICH as a true global entity, increase participation from regulatory authorities and industry around the world and increase the implementation of ICH guidelines globally thereby speeding access to medicines for patients and supporting the global supply of medicines. It has been nearly 10 years since the ICH reforms were completed. In this session, Regulatory and Industry experts will reflect on how far we’ve come and the progress achieved in harmonizing scientific and technical requirements for the development of medicines since 1990. Speakers will share perspectives on the evolution of medicines development as a result of ICH guideline development. Further, speakers will exchange perspective on future opportunities for international regulatory harmonization with consideration of the increasing globalized nature of medicines development and navigating the evolving landscape and use of innovative approaches before turning it over to the audience to hear their ideas around how to promote international harmonization and continued global drug development and patient access to medicines.

Learning Objectives

Discuss progress in international harmonization of regulatory requirements for the development of medicines since ICH was established in 1990 and its increased global footprint following the reforms in 2015; Evaluate impact of ICH guidelines in global drug development; Identify future opportunities and how ICH can evolve to keep pace with innovation and further promote international regulatory harmonization and increased patient access to medicines.

Chair

Amanda Roache, MS

Speaker

US Regulatory Perspective on the Future of International Harmonization
Theresa Mullin, PhD

Industry Priorities for the Future of International Regulatory Harmonization
Wassim Nashabeh, PhD

ANVISA Perspective on International Global Harmonization and Future Opportunities
Marcelo Moreira, MS

EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities
Peter Twomey, MA, MPharm


Speakers
avatar for Marcelo Moreira

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Wassim Nashabeh

Wassim Nashabeh

Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States
Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific... Read More →
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

2:15pm EDT

#132: FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?
Monday June 16, 2025 2:15pm - 3:15pm EDT
147AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-529-L04-P; CME 1.00; RN 1.00

The forum will explore key legislative proposals affecting FDA regulation of drugs and devices, while FDA and industry prepare to negotiate the next round of user fees and performance goals.

Learning Objectives

Describe key legislative initiatives that could alter FDA's regulation of drugs and medical devices; Discuss the interplay between current FDA legislative proposals and the upcoming FDA user fee negotiations and legislation; Recognize the impact of legislative proposals on FDA and regulated industries.

Chair

Jeffrey K. Francer, JD, MPA

Speaker

Panelist
Andrea Stern Ferris, MBA

Panelist
Barrett Tenbarge


Speakers
avatar for Andrea Ferris

Andrea Ferris

President and CEO, LUNGevity Foundation, United States
Andrea is the President and Chairman of LUNGevity Foundation, the nation's leading lung cancer non-profit. Andrea's strong business background combined with her connections to the worlds of research and advocacy have enabled her to build the preeminent patient advocacy organization... Read More →
avatar for Jeffrey Francer

Jeffrey Francer

Vice President, Head of Global Regulatory Policy & Strategy, Eli Lilly and Company, United States
Jeff Francer serves as Vice President, Head of Global Regulatory Policy & Strategy for Eli Lilly and Company. In this role, Jeff leads Lilly’s U.S. and international regulatory policy and research teams. Jeff has led and advised biopharmaceutical companies and policy makers for... Read More →
BT

Barrett Tenbarge

General Counsel, U.S. Senate HELP Committee, United States
Monday June 16, 2025 2:15pm - 3:15pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

2:15pm EDT

#133: Health Canada Town Hall
Monday June 16, 2025 2:15pm - 3:15pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-530-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Speakers
avatar for Alysha Croker

Alysha Croker

Director of the Centre for Policy, Pediatrics and International Collaboration, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

2:15pm EDT

#125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
Monday June 16, 2025 2:15pm - 3:15pm EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-522-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory guidance and frameworks on data quality and feasibility assessments of RWD sources to support RWE study proposals for health authority and HTA engagements. It will include information about how to leverage diverse sources of targeted RWD to support and improve the evolution of new therapies and indications for product safety, outcomes, reduction in label use, and help HC professionals and industry to create a knowledge base for use of RWD.

Learning Objectives

Examine the challenges and value of real-world data (RWD) in regulatory decision-making; Discuss the guidance on data quality and feasibility of RWD for real-world evidence (RWE) studies in health authority interactions; Recognize strategies to integrate RWD into dossier data for regulatory alignment; Identify challenges in standardizing data collection and sharing across industry, regulators, and academia for global acceptance.

Chair

Mehmet Burcu, PhD, MS, FISPE

Speaker

Data Quality Framework and EMA Regulatory Perspectives
Patrice Verpillat, DrMed, MD, PhD, MPH

Oncology Quality, Characterization, and Assessment of Real-world Data: US Regulatory Perspectives
Donna Rivera, PharmD, MSc, FISPE

Building Transparency and Reproducibility into the Practice of Real World Evidence Research
Shirley Wang, PhD, MSc, FISPE

Facilitating robust evidence: integrating digital health data into multi-modal datasets
Laura Lasiter, PhD


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
LL

Laura Lasiter

Regulatory Affairs Director- Digital Health, Astrazeneca, United States
avatar for Donna Rivera

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
avatar for Shirley Wang

Shirley Wang

Associate Professor of Medicine, Harvard Medical School, United States
Dr. Wang is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School. She co-led the 1st and 2nd joint task forces between ISPE and ISPOR, co-directs the REPEAT Initiative, a non-profit program with projects aimed at improving the transparency, reproducibility... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   03: Data-Tech, Session

2:15pm EDT

#126: Best Practices for Navigating Divergent Regulatory Feedback
Monday June 16, 2025 2:15pm - 3:15pm EDT
151A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-523-L04-P; CME 1.00; RN 1.00

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Recognize ways to gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

EMA Perspective
Anabela Marcal, PharmD

Perspective on Best Practices for Navigating Divergent Regulatory Feedback - My Perspectives from Previous Experience at FDA
Namandjé Bumpus, PhD

Best Practices for Navigating Divergent Regulatory Feedback
Natalie Tolli, MS, RPh


Speakers
avatar for Namandjé Bumpus

Namandjé Bumpus

Founding Principal, Bumpus Advising, United States
Dr. Namandjé N. Bumpus serves as a strategic advisor on regulatory science and policy. She is also a member of the Board of Directors of Recursion Pharmaceuticals, a clinical stage techbio company. Dr. Bumpus served at FDA from 2022-2024 first as the Chief Scientist and then as the... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
avatar for Natalie Tolli

Natalie Tolli

Vice President, Regulatory Intercontinental/RPI, AbbVie, Inc., United States
Natalie joined Abbott in 2000 and has held several positions at Abbott/AbbVie in Regulatory Affairs. Natalie assumed her current role as Vice President, Regulatory Affairs (Regulatory Intercontinental/Regulatory Policy & Intelligence) in 2018. Prior to joining AbbVie, Natalie was... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   04: MedAffairs-SciComm, Forum

2:15pm EDT

#134: Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-531-L04-P; CME 1.00; RN 1.00

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Ingrid Markovic, PhD

Panelist
Leanne Hickman

Panelist
Jennifer McCafferty, PhD

Panelist
Sean Barry, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Jennifer McCafferty

Jennifer McCafferty

Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
LH

Leanne Hickman

Senior Vice President, Global Quality Analytical Sciences & QC Operations, Eli Lilly and Company, United States
Leanne Hickman, Sr. VP of Global Quality Analytical Sciences and QC Strategy, leads efforts to standardize and transform QC labs across the manufacturing network. She oversees analytical methods, systems, and technologies to support testing for current and pipeline molecules. Her... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Ingrid Markovic

Ingrid Markovic

United States
Ingrid Markovic, Ph.D. is Senior Science Advisor for CMC at the FDA's Center for Biologics where she spearheads CMC policy activities partnering with internal and external stakeholders to ensure consistent application of CMC policies and programs. She led FDA efforts for modernization... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

2:15pm EDT

#135: Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
Monday June 16, 2025 2:15pm - 3:15pm EDT
144ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-532-L04-P; CME 1.00; RN 1.00

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc


Speakers
avatar for Ankush Chandna

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States
avatar for Kevin Lee

Kevin Lee

Data Scientist, Clinvia, United States
Kevin Lee is a Data Scientist and Biometrics Leader with 20 years of experience in Big Data, Cloud, Open-Source Programming, Data Sciences and Machine Learning in pharmaceuticals. His leadership and passion for innovation drive continuous advancement in Pharma. Recently focused on... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

2:15pm EDT

#136: Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Monday June 16, 2025 2:15pm - 3:15pm EDT
201
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-533-L04-P; CME 1.00; RN 1.00

Data science, AI and LLMs are redefining how we conduct clinical development to be faster, more efficient and more patient-centric. The National Insititute of Health, in partnership with the private sector, is leading the charge in driving change.

Learning Objectives

Describe examples of NIH innovation in tech-enabling clinical development through the application of data science, AI and LLMs; Identify potential opportunities for future public-private partnerships to accelerate tech enablement of clinical development.

Chair

Peter Ronco

Speaker

Panelist
Warren A Kibbe, PhD, FACMI

Panelist
Arnaub Chatterjee, MHA, MPA

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Susan Gregurick


Speakers
avatar for Arnaub Chatterjee

Arnaub Chatterjee

President & GM - Life Sciences, Datavant, United States
Arnaub Chatterjee is Chief Product and Solutions Officer at TriNetX, a health technology platform focused on improving clinical research, evidence generation and safety. He also serves as Senior Advisor at the Carlyle Group where he evaluates investments in the life sciences and healthcare... Read More →
avatar for Susan Gregurick

Susan Gregurick

Associate Director, Data Science and Director, NIH ODSS, National Institute of Health, United States
avatar for Warren Kibbe

Warren Kibbe

Deputy Director, Data Science and Strategy, National Cancer Institute, United States
Dr. Kibbe is the inaugural NCI deputy director for data science and strategy, working across NCI, NIH, and with other agencies, academia, and industry to define the data science strategy for cancer research. Previously, he was the Vice Chair and Professor of Biostatistics and Bioinformatics... Read More →
avatar for Peter Ronco

Peter Ronco

CEO, Emmes, United States
Peter is an accomplished drug developer and innovative senior pharmaceutical executive who advises boards, private equity investors, and leaders across the pharmaceutical and biotech industry. He has extensive global experience across a broad range of therapeutic areas, including... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Forum

2:15pm EDT

#136.1: Ushering in a New Era of Africa Healthcare
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-534-L04-P; CME 1.00; RN 1.00

Crossing 1.5 billion population in 2024, Africa's demographic boom is urging new models of development and innovation. In this fireside chat, four pioneers (from leading U.S. medical centers to Top 10 pharma to big-name philanthropies) will share their ground-breaking journey in advancing Africa healthcare and R&D capabilities, and ambitious plans ahead. The panelists will be joined by DIA's incoming and past Board Chairs to help unlock our community's collective energy and creativity on this worthy front and explore win-win collaborations.

Learning Objectives

Discuss the significant social progress and momentum in the world's fastest growing continent, as well as implications for healthcare development, patient needs and opportunities, and life science innovations. Recognize the vision, achievements, lessons learned, and future goals shared by this cross-section of global and on-the-ground change makers.

Speaker

Panelist
Huwaida Bulhan, MD, MPH

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca Vermeulen, RPh

Panelist
David Mukanga, PhD, MPH


Speakers
avatar for Huwaida Bulhan

Huwaida Bulhan

Senior Clinical Research Operations Lead Area Africa, Roche Kenya Limited, Kenya
avatar for Katherine Van Loon

Katherine Van Loon

Director, Global Cancer Program, UCSF Helen Diller Family Comprehensive Cancer Center, United States
avatar for Tariro Makadzange

Tariro Makadzange

Executive Director, Founder, Zimbabwe Clinical Research Center, United States
avatar for David Mukanga

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Forum |   13: Spotlight, Forum

3:45pm EDT

#137: Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
Monday June 16, 2025 3:45pm - 4:45pm EDT
207A
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-535-L04-P; CME 1.00; RN 1.00

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PhD, MS, RPh, FISPE

Beyond Signal Detection: Management at FDA - From Identification to Action Using Multiple Data Sources
Lisa Wolf, PharmD

Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PhD, MS


Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
avatar for Saad Shakir

Saad Shakir

Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
avatar for Lisa Wolf

Lisa Wolf

Deputy Director, Division of Pharmacovigilance I, CDER, FDA, United States
Dr. Lisa Wolf joined the Division of Pharmacovigilance-I (DPV-I), Center for Drug Evaluation and Research, US Food and Drug Administration in 2016, where she served as a Safety Evaluator for gastroenterology products, followed by Team Leader covering multiple therapeutic areas, and... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
  • Level Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

3:45pm EDT

#138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
Monday June 16, 2025 3:45pm - 4:45pm EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-536-L04-P; CME 1.00; RN 1.00

In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.

Learning Objectives

Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.

Chair

Mehdi Najafzadeh, PhD

Speaker

Challenges and lessons in Linkage of RWD to Trials: An Academic Perspective
Elisabetta Patorno, DrPH, MD

Pragmatic Approaches in Hybrid Designs: Industry Perspective
Mehmet Burcu, PhD, MS, FISPE

Linkage of trials to RWD: Evolving landscape and overview of US regulatory guidance
Marie C. Bradley, PhD, MPH, MPharm


Speakers
MB

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Senior Director, Medidata Solutions, United States
Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →
EP

Elisabetta Patorno

Associate Professor of Medicine, Brigham and Women's Hospital; Harvard Medical School, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

3:45pm EDT

#139: Efficient Data Exchange: Drivers for End-to-End Standards Adoption
Monday June 16, 2025 3:45pm - 4:45pm EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-537-L04-P; CME 1.00; RN 1.00

Internal solutions for translation between regulatory frameworks to assure right use of control vocabularies to exchange data as structured components of submissions to Health Authorities, CMOs, CROs. Controlled vocabularies, ontologies. Presentation of AstraZeneca core data model to enable translation and mapping for data integration. Define use case for data exchange (with data products TLFs for CMC, iterative submissions by piloting the future representing data). vocabularies and business rules to enable data exchange. How everything connects to each Semantic Model Patient Centric vs. Study Centric for reuse scenarios - Amgen will present PQI Standards to build a regulatory filing. Map different regulatory standards frameworks to enable translation between frameworks (e.g., EMA and FDA) into messaging standards like HL7 FHIR. Reference Global Standard benefits (ICH M4Q, Q12, SPQS, IDMP and GSRS). A call for a solution – Interoperability as a Plan – open sources and sharing the standards – What would Dom do? Exchanging structured data everyone is using the same viewer in the Amgen use case. Regulatory Authorities and Industry must collaborate on solutions for development and application of standards to data. Platforms like Accumulus[2] to present the CMC data and translate from one set of standards to another for access for information. Finally we will discuss Digitial Equity and Transparency - one set of data, exposed in a variable output to HAs, supporting critical operations from source whilst maintaining the Digitial nature of data.

Learning Objectives

Analyze how regulatory digital data from divergent sources must meet varying ICH and Regulatory Authority standards; Identify gaps in applying external regulatory standards to internal industry data; Examine specific examples of gaps, such as enhanced granularity and differing regulatory frameworks (e.g., IDMP, XEVMPD, GSRS); Discuss AI and RWD Dimensions of interoperability.

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark, PhD

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS


Speakers
avatar for Rita Algorri

Rita Algorri

Associate Director, Global Regulatory Affairs (CMC), Amgen, United States
Rita Algorri, PhD is an Associate Director, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, she leads and orchestrates internal and external activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
MW

Mathew Woodwark

Head of Data Standards, Interoperability and Governance, AstraZeneca, United Kingdom
Mathew Woodwark, Head of Data Standards, Interoperability and Governance in the R&D Data Office, has a long interest in bringing data sets together. He instigated AstraZeneca's Science Data Foundation, providing analytics ready data for machine learning and AI, establishing R&D’s... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

3:45pm EDT

#141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
Monday June 16, 2025 3:45pm - 4:45pm EDT
202A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-539-L04-P; CME 1.00; RN 1.00

A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.

Learning Objectives

Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Valentina Mantua

Patient-Experience Data in Development Programs and Regulatory Decision-Making
Juan Garcia-Burgos, MD, PhD

Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch, MA

Industry Perspective
Samantha Roberts, PhD


Speakers
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development... Read More →
VM

Valentina Mantua

Associate Director of Regulatory Science, OND, CDER, FDA, United States
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
SS

Silke Schoch

Director, Research & Programs, National Health Council, United States
Silke Schoch is the Director of Research & Programs at the National Health Council. Ms. Schoch joined the National Health Council in 2017 and has been a project manager for many of the NHC’s patient engagement-focused projects including the Patient Experience Mapping Toolbox and... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

3:45pm EDT

#142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
Monday June 16, 2025 3:45pm - 4:45pm EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-540-L04-P; CME 1.00; RN 1.00

Addressing data gaps in drug development, especially capturing patient experiences in both rare and non-rare diseases, is crucial. From Proof of Concept to Proof of Value, integrated evidence planning and incorporating patient voices in Target Product Profile (TPP) creation drive comprehensive evidence generation.

Learning Objectives

Discuss the utility in global drug development context, including post-marketing efforts; Identify strategies to create a patient informed comprehensive Target Product Profile; Recognize strategies outlined in the interactive guide to align PAG and industry efforts in creating a comprehensive Target Product Profile.

Chair

Agathe Le Lay, PhD, MSc

Speaker

What are we Missing: Potential Data Gaps in Drug Development and the Importance of Capturing Lived Experience in rare and non-rare Diseases
Kristin Hatcher, MEd

From Proof of Concept to Proof of Value: An Industry Approach to Integrated Evidence Planning Throughout the Product Lifecycle
Agathe Le Lay, PhD, MSc

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Patricia Roselle

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Bruce E. Miller, PhD

Panelist
Martine Zimmermann, PharmD


Speakers
avatar for Kristin Hatcher

Kristin Hatcher

Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate, Global Liver Institute/Alpha One Patient, United States
avatar for Agathe Le Lay

Agathe Le Lay

Global Head of Value Evidence & Patient Insights, H. Lundbeck A/S, Denmark
Agathe Le Lay is the Global Head of Value Evidence and Patient Insights at H. Lundbeck A/S, and is responsible for leading a global team responsible for the strategic planning and delivery of scientific evidence supporting R&D assets as well in-line brands. Agathe is an expert in... Read More →
avatar for Bruce Miller

Bruce Miller

Chief Scientific Officer, COPD Foundation, United States
Dr. Miller is the Chief Scientific Officer of the COPD Foundation overseeing its patient-focused research programs. Inclusion of patient partners is a requirement for any research activity the foundation supports. Dr. Miller has been a participant in the Paladin Consortium since its... Read More →
avatar for Patricia Roselle

Patricia Roselle

Head of Patient Stakeholder Engagement, Sanofi, United States
Patricia leads a global team of Patient Engagement Leads within the Patient Informed Development & Health Value Translation unit within R&D at Sanofi, using patient insights to drive a patient disease strategy and to guide Research & Development decision making. Ultimately, we aim... Read More →
avatar for Martine Zimmermann

Martine Zimmermann

Senior Vice President, Head of Global Regulatory Affairs, Ipsen , France
Dr Zimmermann joined Ipsen in January 2023 as SVP, Head of Regulatory & Quality R&D, based in France and since January 2024, SVP, Head of Global Regulatory Affairs. . She has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

3:45pm EDT

#143: Ethics in the Era of Precision Medicine and Advancing Technologies
Monday June 16, 2025 3:45pm - 4:45pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-541-L04-P; CME 1.00; RN 1.00

Precision medicine integrates advanced technology and healthcare to tailor treatments to individuals, aiming to enhance outcomes. However, the rise of artificial intelligence (AI) and advanced technologies in this field introduces new ethical complexities. Privacy, informed consent, and social justice remain central concerns, but evolving technologies brings additional challenges, such as biases in algorithmic predictions and the transparency of decision-making processes. AI-driven models used to predict treatment outcomes or develop personalized care plans can reflect societal biases if trained on unrepresentative or flawed data. This raises concerns about fairness, as patients could be unjustly stratified based on genetic, racial, or socioeconomic factors. Precision medicine, which stratifies patients by genetic profiles, risks perpetuating discrimination or exacerbating health disparities.

Learning Objectives

Discuss the bioethical impact within the next generation of medicine; Recognize the importance of the inclusion of diverse, representative populations and handling of incidental findings.; Discuss how pharmaceutical company possesses its own data that can be explored, which is specific to their organization and reflective of their trial designs; Describe methods that have potential to enhance patient safety in RCTs by leveraging these unique datasets.

Chair

James Wabby, MHS

Speaker

Panelist
Robert Danny Huntington, Esq, JD

Panelist
Scott Schell, MD, PhD, MBA, MPH

Panelist
Ann Marie Hake, MD

Panelist
Chris Schneiderman, MPH


Speakers
avatar for Ann Marie Hake

Ann Marie Hake

Executive Director, Medical – Digital Health, Eli Lilly and Company, United States
Ann Marie Hake is a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In her current role at Lilly, she is a clinical research physician in the Digital Health R&D group, as well as the Vice Chair of... Read More →
avatar for Robert Huntington

Robert Huntington

Lawyer, ROTHWELL, FIGG, ERNST & MANBECK, P.C. , United States
Danny Huntington is involved in all phases of intellectual property law, including United States and foreign patent prosecution, litigation in the federal courts, licensing, and general client counseling. He has extensive experience with patent interferences and inter partes proceedings... Read More →
SS

Scott Schell

Chief Medical Officer, Cognizant, United States
Scott R. Schell, PhD, MD, MBA, is a distinguished professional with a wealth of experience in healthcare and life sciences. He is a surgical oncologist and PhD Immunologist with deep expertise in pharma, precision therapies, and population health practices. Dr. Schell has held significant... Read More →
avatar for Chris Schneiderman

Chris Schneiderman

Director, Data & Digital Convergence Catalyst, Abbvie, United States
Chris Schneiderman is an epidemiologist, earning his Master's degree in Public Health from the University of Illinois at Chicago and has spent nearly two decades in roles of increasing responsibility with AbbVie. He currently serves as the Director, Data & Digital Convergence at AbbVie... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

3:45pm EDT

#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-543-L04-P; CME 1.00; RN 1.00

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Chair

Emily Gebbia, JD

Speaker

Industry Perspective
Robert DiCicco, PharmD

Site Perspective
Ryan Ferguson

MHRA Perspective
Jason Wakelin-Smith


Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
RF

Ryan Ferguson

Acting Director, Cooperative Studies Program, VA Boston Healthcare System, United States
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

3:45pm EDT

#146: FDA Accelerated Approval Program: Putting Withdrawals in Context
Monday June 16, 2025 3:45pm - 4:45pm EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-544-L04-P; CME 1.00; RN 1.00

The FDA Accelerated Approval Program has been criticized for employing lower regulatory standards than traditional approval, undue delays in withdrawing therapies approved under Accelerated Approval for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence . Of specific focus for critics has been withdrawn treatments, which are being used as examples of the program’s ineffectiveness and basis for proposed changes. However, the purpose of the program is to allow acceptable risk in order to address patients with a large unmet need. The small percentage of drugs whose clinical benefit is ultimately not confirmed should not be viewed as a failure of the accelerated approval program. Rather, they represent an expected trade-off in expediting drug development that benefits patients with serious or life-threatening diseases. Withdrawals make up a small percentage of the total number of therapies approved under Accelerated Approval and do not reflect overall management of the program over its 30-year history, particularly improvements seen in the last decade in the time from accelerated approval to conversion. In addition, the reasons for the withdrawals are complex and need to be understood within the context of the overall impact on patient outcomes due to early access enabled by the program.

Learning Objectives

Examine the reasons for product withdrawals after Accelerated Approval and identify the different situations where a withdrawal may occur; Recognize clinical impact including life years gained and uptake after Accelerated Approval of oncology products that were later withdrawn; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of AAP and withdrawals.

Chair

Bridget Doherty, MPH, MS

Speaker

Industry Perspective
Kevin Bugin, PhD, MS, RAC

Non-Profit Perspective
Jeff Allen, PhD


Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Bridget Doherty

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson Innovative Medicine, United States
Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

#147: Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
Monday June 16, 2025 3:45pm - 4:45pm EDT
146BC
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-545-L04-P; CME 1.00; RN 1.00

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch, MA, MBA

J&J Experience
Joseph Markmann

BMS Experience
Sandra Krogulski, MA

Novartis Experience
David Yao, PharmD


Speakers
avatar for Paul Bolot

Paul Bolot

Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot works in Regulatory Policy & Science at Bayer. Prior to joining Bayer, he worked as consultant in regulatory affairs at PharmaLex. He is a pharmacist (PharmD) by training and has a master's degree in international drug development and registration. He is based in Basel... Read More →
avatar for Sandra Krogulski

Sandra Krogulski

Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of... Read More →
JM

Joseph Markmann

Principal Data Science Lead, Global Regulatory Affairs, Johnson&Johnson, United States
avatar for Ben Moscovitch

Ben Moscovitch

Public Policy, Amazon Web Services, United States
Ben Moscovitch leads Amazon Web Services public policy efforts in the Americas for healthcare, life sciences, education, and other sectors. Ben focuses on legislative and regulatory policy reforms to facilitate responsible AI adoption, enable data interoperability, support innovation... Read More →
DY

David Yao

Associate Director, Regulatory Affairs CMC, Novartis, United States
David Yao is an experienced regulatory CMC project lead at Novartis. He is a pharmacist by training with expertise on global regulatory submissions and registrations in the oncology area. In recent years, David has also been leading digital innovation in regulatory affairs, overseeing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

3:45pm EDT

#148: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Monday June 16, 2025 3:45pm - 4:45pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-546-L04-P; CME 1.00; RN 1.00

This session will focus on assessing the effectiveness of current regulatory collaboration efforts and identifying how those principles can be applied to chronic disease areas outside of oncology, such as metabolic disease and obesity.

Learning Objectives

Describe the impact of global regulatory collaboration on patient outcomes; Discuss risks associated with chronic disease and its impact on society as a whole; Identify innovative ways to address chronic disease through regulatory innovation and collaboration.

Chair

Brad Jordan, PhD

Speaker

Project ORBIS and ACCESS Experience
Melissa Hunt, MSc

Panelist
Magda Bujar, PhD, MSc

Applying Learnings from Project ORBIS
R. Angelo De Claro, MD

Industry Perspective
Laura Mccary-Bloss, PhD


Speakers
avatar for Magda Bujar

Magda Bujar

Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Dr Magda Bujar is Associate Director, Regulatory Programme and Strategic Partnerships and has over 10 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Melissa Hunt

Melissa Hunt

Director, Health Canada, Canada
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
avatar for Laura Mccary-Bloss

Laura Mccary-Bloss

Vice President Global Regulatory Affairs, Amgen, Inc., United States
Laura is the Global Regulatory Therapeutic Area Head at Amgen for the Inflammation and Rare Disease product portfolio, which includes products across the development and commercialization lifecycle. Laura has been with Amgen since 1998. She has worked in several leadership roles in... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

#149: WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation
Monday June 16, 2025 3:45pm - 4:45pm EDT
150AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-547-L04-P; CME 1.00; RN 1.00

Explore WHO-led initiatives and global collaborations driving regulatory harmonization and innovation to ensure equitable access to medical products. This session highlights strategic efforts to address shared challenges and advance global health.

Learning Objectives

Discuss the progress and challenges in achieving regulatory convergence and harmonization; Recognize the role of regulatory reliance and collaboration in facilitating access to medical products; Discuss international partner’s perspective on navigating regulatory landscapes to enhance global health equity.

Chair

Hiiti Sillo, MSc, RPh

Speaker

CIP Network and its role in Advancing Global and Regional Regulatory Harmonization, Collaboration, and Work-Sharing
Jude Nwokike, MPH, MSc, RPh, RAC

Regulatory Harmonization: Advancing Global Health through Collaboration
Marion Laumonier, MSc

Shaping Global Health Research and Development through WHO Resources and Coordinated Scientific Advice
Mercedes Perez Gonzalez, MSc


Speakers
MP

Mercedes Perez Gonzalez

Technical officer, WHO, Switzerland
Mercedes Perez Gonzalez serves as a Technical Officer in the Science Division of WHO, focusing on optimizing WHO's R&D activities, including the development of target product profiles for health products and coordinating WHO's scientific advice for product developers of medicines... Read More →
avatar for Marion Laumonier

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
Marion Laumonier is Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
avatar for Jude Nwokike

Jude Nwokike

Vice President, Global Health & Manufacturing Services, USP, United States
avatar for Hiiti Sillo

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

#140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
Monday June 16, 2025 3:45pm - 4:45pm EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-538-L04-P; CME 1.00; RN 1.00

The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content

Learning Objectives

Recognize the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explain Customization and Multi-View Capabilities; Discuss how to evaluate the Impact on Decision-Making and Efficiency for Key Roles; Describe ways to examine Multi-Format Exchange of Protocol Information.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Digital Protocol Template: Industry Perspective
Vivian Combs, MS


Speakers
avatar for Vivian Combs

Vivian Combs

Director of Scientific Communications, Eli Lilly and Company, United States
Vivian Combs is a full-time Process Owner within Eli Lilly and Company's Clinical Trial Foundations organization, where she is focused on medical writing, content reuse, and automation. She recently completed her duties as the rapporteur for the ICH M11 CESHarP (Clinical Electronic... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Principal Consultant, Decision Analytics, United States
Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   04: MedAffairs-SciComm, Session

3:45pm EDT

#144: Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
Monday June 16, 2025 3:45pm - 4:45pm EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-542-L04-P; CME 1.00; PDU 1.00 PMI 2166OVTGM7; RN 1.00

Explore strategies for high complexity projects, focusing on collaborations, regulatory submissions and asset integration. Gain insights on stakeholder management, risk mitigation, strategic planning to turn potential chaos into streamlined success.

Learning Objectives

Discuss challenging biopharmaceutical collaborations and efficient integration of assets; Identify effective strategies for managing complex regulatory submissions in the pharmaceutical industry; Recognize ways to assess risks and develop contingency plans for project timelines and budgets; State how to apply multiple stakeholder management techniques to ensure alignment and informed decision-making across governances.

Chair

Matthew Curin, PharmD

Speaker

Speaker
Andrea Jux


Speakers
avatar for Matthew Curin

Matthew Curin

Sr. Dir, Head of Program Management, Therapeutic Dermatology, Galderma, United States
Matt has been working in the pharmaceutical industry for more than 25 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →
avatar for Andrea Jux

Andrea Jux

Senior Director, Development Program Management, Genmab US, Inc., United States
Accomplished Leader with 3 decades of experience in the pharmaceutical industry, focusing on strategic initiatives, operational excellence and regulatory compliance. Adept at leading cross-functional teams and forging partnerships to execute complex projects. Passionate about optimizing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   07: ProjectManagement-StrategicPlanning, Session

3:45pm EDT

#150: Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
Monday June 16, 2025 3:45pm - 4:45pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-548-L04-P; CME 1.00; RN 1.00

This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.

Learning Objectives

Describe what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Discuss how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon, MS

Overview of ICH Q6
Andrew Chang, PhD

Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche


Speakers
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Sarah Demmon

Sarah Demmon

Vice President, Eli Lilly, United States
Sarah Demmon, M.S., is Vice President at Eli Lilly and Company. With 28 years in biopharmaceutical development, she specializes in late phase development and commercialization of fusion proteins and monoclonal antibodies. She started as an analytical chemist developing methods for... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is a seasoned industry professional with 18 years of experience in the field. As a Senior Director of Global Regulatory Affairs – CMC at Merck & Co., she spearheads the company's global CMC policy efforts. In this role, Celeste engages externally... Read More →
WR

Warren Roche

Statistician, Sanofi, Ireland
Monday June 16, 2025 3:45pm - 4:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

3:45pm EDT

#151: Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
Monday June 16, 2025 3:45pm - 4:45pm EDT
206
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-549-L04-P; CME 1.00; RN 1.00

This session will include techniques for having robust documentation to deliver clear, confident messages and strategies which improve individual and team performance, confidence and compliance using insights backed by data and real-world examples.

Learning Objectives

Discuss the Impact of Language and how the choice of words and tone can influence performance, collaboration and compliance in the workplace; Recognize practical techniques and strategies for communicating with confidence in various professional scenarios; Describe ways to enhance performance through effective communication.

Chair

Tony Johnson, MS

Speaker

Panelist
Ana Sharma, MPH

Panelist
Anne Marie Inglis, PhD


Speakers
avatar for Anne Marie Inglis

Anne Marie Inglis

Senior Director, Clinical Operations Asset Lead, GSK, United States
Dr. Inglis has over 25+ years of experience in clinical research, spanning all phases of research, specializing in clinical operations. While at Mallinckrodt Pharmaceuticals, she led the initiative to define the Risk Based Quality Management approach within Clinical Development. In... Read More →
avatar for Tony Johnson

Tony Johnson

Senior Director, Clinical Quality, Mallinckrodt Pharmaceuticals, United States
avatar for Ana Sharma

Ana Sharma

Vice President, Global Head of Research and Development Quality Assurance, Abivax, United States
Ana Sharma is an accomplished quality leader with over 20 years of expertise across all GxP areas, successfully bringing more than 30 drugs and medical devices to market. She has worked at large and small pharmaceutical companies and healthcare companies such as Abivax, Takeda, Novartis... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

3:45pm EDT

#152: AI in Patient Care: Aspirations and Considerations
Monday June 16, 2025 3:45pm - 4:45pm EDT
201
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-550-L04-P; CME 1.00; RN 1.00

We will discuss potential applications of AI in making diagnoses and treatment decisions, the appropriate ethical and regulatory boundaries, and how to progress forward balancing patient benefits against the potential risks.

Learning Objectives

Recognize the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions; Discuss ways to formulate plans to bring artificial intelligence solutions to market and shape regulations.

Chair

Eli Weinberg, PhD, MS

Speaker

Panelist
Isaac Kohane, MD, PhD

Panelist
Shweta Maniar

Panelist
Subha Madhavan, PhD, FACMI


Speakers
avatar for Isaac Kohane

Isaac Kohane

Chair, Department of Biomedical Informatics, Harvard Medical School, United States
Isaac Kohane, MD, PhD, is the chair of Harvard Medical School’s Department of Biomedical Informatics, whose mission is to develop methods and tools for a new generation of scientists and doctors to move biomedicine rapidly forward with the insight and precision offered by big data... Read More →
avatar for Subha Madhavan

Subha Madhavan

Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States
Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →
avatar for Shweta Maniar

Shweta Maniar

Director, Healthcare and Life Sciences Solutions, Google Cloud, United States
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
avatar for Eli Weinberg

Eli Weinberg

Partner, Bain & Co., United States
Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Session |   09: Regulatory, Session

4:45pm EDT

DIA Annual Meeting Opening Reception
Monday June 16, 2025 4:45pm - 6:00pm EDT
The Opening Reception is not merely a formality but a celebration of our community's collective efforts and achievements. It is a time to come together, connect with fellow industry leaders, and engage in stimulating discussions that will undoubtedly shape the future of our industry.
Complimentary to all registered attendees. 
Monday June 16, 2025 4:45pm - 6:00pm EDT
  19: Networking-Opportunities

5:30pm EDT

FDA Appreciation Event
Monday June 16, 2025 5:30pm - 6:00pm EDT
For more than 60 years DIA has partnered with regulators, industry, academia and patient stakeholders across the medical product development continuum to support better patient outcomes, worldwide. With gratitude and recognition of our colleagues in public health, we’re excited to announce the FDA Appreciation Event at the DIA 2025 Global Annual Meeting (DIA 2025). In honor of the individuals who safeguard public health and fuel global innovation, this gathering is dedicated to the professionals – past and present – who make our industry possible.

This event is complimentary and registration is not required. 
Monday June 16, 2025 5:30pm - 6:00pm EDT
  19: Networking-Opportunities

6:45pm EDT

DIA at the Nationals Park
Monday June 16, 2025 6:45pm - 9:00pm EDT
Nationals Park
Limited Availability – Register Now!
Immerse yourself in the electric atmosphere of Nationals Park as the Washington Nationals take on the Colorado Rockies during the DIA 2025 Global Annual Meeting. This exclusive opportunity grants DIA attendees reserved seating in Section 242 for two thrilling matchups on Monday, June 16th and Tuesday, June 17th, both starting at 6:45 PM.
Secure your seats and be part of the action as you network, unwind, and enjoy America's pastime with your peers.

This is a unique chance to experience the passion and camaraderie of professional baseball in the nation's capital, all while strengthening connections within the dynamic DIA community.

Matchups will take place Monday, June 16th and Tuesday, June 17th and both games start at 6:45pm

Secure Your Seats For an Unforgettable Night at Nationals Park and be Part of The Action!Click here to purchase your tickets for Monday, June 16th
Click here to purchase your tickets for Tuesday, June 17th

Monday June 16, 2025 6:45pm - 9:00pm EDT
Nationals Park 1500 South Capitol St SE, Washington, DC 20003
  19: Networking-Opportunities
 
Tuesday, June 17
 

6:30am EDT

CISCRP's Annual 2025 Medical Heroes Appreciation 5K Run & Walk
Tuesday June 17, 2025 6:30am - 7:30am EDT
Online registration for CISCRP’s Medical Heroes Appreciation 5K Run & Walk is now open! In-person registration opportunities will be available on Sunday, June 15, and Monday, June 16, from 10 AM to 4 PM in the lobby of the Walter E. Washington Convention Center.

To learn more about this event, visit: https://www.ciscrp.org/event/2024-medical-heroes-appreciation-5k-run-walk/

If you have questions about the event, please contact Hope Ventricelli at hventricelli@ciscrp.org

Packet Pick-up: Packets will contain bibs, t-shirts, fun branded giveaways, and educational materials. Racers can visit the CISCRP booth in the lobby of the Walter E. Washington Convention Center on June 15 and 16 from 10 AM-4 PM to receive their packet.

Race Date: Tuesday, June 17, 2025 - rain or shine!
Start Time: 6:00 AM EDT check-in and onsite registration; 6:30 AM EDT race begins
Location: 4940 Canal Rd NW, Washington, DC 20016
Entry Registration Fee: Register before 5/1 for $30 registration fee | $40 registration fee begins on 5/1 | Registration includes t-shirt, bib, and medal


Tuesday June 17, 2025 6:30am - 7:30am EDT
  19: Networking-Opportunities

8:00am EDT

Coffee and Light Refreshments
Tuesday June 17, 2025 8:00am - 8:30am EDT
Room 145-147 Lobby
Component Type: Social Event



Tuesday June 17, 2025 8:00am - 8:30am EDT
Room 145-147 Lobby Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

8:30am EDT

#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
Tuesday June 17, 2025 8:30am - 9:30am EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-551-L04-P; CME 1.00; RN 1.00

This session will introduce the latest efforts to enhance the quality of safety signal generation from government, industry, and academia (e.g., recommendations, regulatory frameworks, case examples) and will conclude with a panel discussion.

Learning Objectives

Explain the latest recommendations for reporting the results of safety signal generation (transparency, completeness) and relevant case example; Examine case examples to enhance the quality of safety signal generation in industry and academia: task process and methodologies; Discuss perspectives from government, industry, and academia to enhance the quality of safety signal generation.

Chair

Judy Shin, PhD

Speaker

A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and Beyond
Michele Fusaroli, DrMed, PhD

Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD

Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh

Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Michele Fusaroli

Michele Fusaroli

Uppsala Monitoring Centre, Sweden
Michele Fusaroli, MD, PhD, serves as a Senior Pharmacovigilance Scientist at the Uppsala Monitoring Centre's Research Department. He steered the READUS_PV group, which focused on establishing reporting guidelines for disproportionality analysis. Fusaroli Michele has implemented innovative... Read More →
avatar for Wei-I Huang

Wei-I Huang

Director, Division of Drug Safety, Taiwan Drug Relief Foundation, Taiwan
Ms. Wei-I Huang is a clinical pharmacist specializing in pharmacovigilance and regulatory pharmacoepidemiology. Her expertise includes drug safety signal detection, risk assessment, and regulatory compliance. As Director of the Taiwan National ADR Reporting Center, operated by the... Read More →
avatar for HYUN JOO JUNG

HYUN JOO JUNG

Departiment of Drug Safty Information, Korea Institute of Drug Safety & Risk Management, Korea, Republic of
I am currently working as the director of the office of drug safety information of department of drug safety information in Korea Institute of Drug Safety & Risk Management. Based on the Pharmaceutical Affairs Act of Korea, we collect, analyze, assess and management drug safety information... Read More →
avatar for Judy Shin

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

#202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Tuesday June 17, 2025 8:30am - 9:30am EDT
206
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-552-L04-P; CME 1.00; RN 1.00

Imagine a future where AI measures patient burden from provided inputs. In this interactive workshop, participants will design input logic for AI using mock data and protocols, then present their rationale to foster collaborative learning.

Learning Objectives

Define and categorize key factors affecting patient burden in clinical trials; Analyze patient-related data to design effective AI inputs; Evaluate and justify the role of human insight in enhancing AI-driven patient burden assessments for patient-centric trial outcomes.

Chair

Mihail Tanev, DMD, PhD

Speaker

Panelist
Karen Correa, PhD

From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Mihail Tanev, DMD, PhD


Speakers
MT

Mihail Tanev

Medical Advisor, FindMeCure Ltd, Bulgaria
Dr. Mihail Tanev, DMD, PhD is a health practitioner and scientist with a doctorate in Oral Pathology Science and Photochemistry. Coming from a strong academic foundation in disease biology, diagnostics and clinical research, he brings a uniquely cross-disciplinary perspective to the... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Workshop

8:30am EDT

#203: Realizing Value Through Responsible AI in Clinical Development
Tuesday June 17, 2025 8:30am - 9:30am EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-553-L04-P; CME 1.00; RN 1.00

Leveraging expertise from industry, this session will explore how responsible AI frameworks can maximize value in clinical research by ensuring ethical, transparent, and accountable AI use.

Learning Objectives

Recognize a set of responsible principles for AI in drug development; Demonstrate the ability to drive innovation and strategic advantage in AI-driven clinical trials; Propose how organizations can lead with integrity and trust in their AI applications.

Chair

Stephen Pyke, MSc

Speaker

Patient Perspectives on AI in Clinical Development
Alicia Staley, MBA, MS

Regulatory Perspectives on AI in Clinical Development
Tala Fakhouri, PhD, MPH

Industry Perspectives on AI in Clinical Development
Raja Shankar, MS


Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Stephen Pyke

Stephen Pyke

Chief Clinical Data and Digital Officer, Parexel, United Kingdom
Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions... Read More →
avatar for Raja Shankar

Raja Shankar

Vice President, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
avatar for Alicia Staley

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States
Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

8:30am EDT

#205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Tuesday June 17, 2025 8:30am - 9:30am EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-555-L04-P; CME 1.00; RN 1.00

This session will explore the evaluation and implementation of assistive technology for clinical document content creation. The panelists will describe experimental design and adoption of solutions, cross-functional partnerships, and the impact to Medical Writing organizations.

Learning Objectives

Discuss and evaluate the potential benefits and challenges of implementing assistive technology, including both rule-based and AI-based solutions; Recognize the criticality of working with cross-functional teams to assess and implement technologies, ensuring successful adoption and return on investment; Discuss how AI can positively influence Medical Writing organizations.

Chair

Nancy Tam, MS

Speaker

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Matthew Renda, PhD, MS

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Aliza Nathoo


Speakers
avatar for Aliza Nathoo

Aliza Nathoo

Senior Director, Content Strategy, F. Hoffmann-La Roche Ltd., Canada
Aliza began her career on molecular teams and leading complex regulatory submissions. Over her 20+ years in biopharmaceuticals, she has expanded her focus into automation-assisted content authoring, generation, and management. Today, she leverages her foundation to drive content innovation... Read More →
avatar for Matthew Renda

Matthew Renda

Senior Director Medical Writing Operations, Alexion, Astrazeneca Rare Disease, United States
Matt Renda has 13 years of academic research experience focused on gene therapy and 17 years of pharmaceutical development experience providing regulatory submission management and medical writing leadership to optimize cross-functional processes, implement innovative technologies... Read More →
avatar for Nancy Tam

Nancy Tam

Head of Medical Writing, Pfizer Inc, United States
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has implemented automated solutions for content creation at several sponsor companies and is working to implement... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

8:30am EDT

#206: Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective
Tuesday June 17, 2025 8:30am - 9:30am EDT
152AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-556-L04-P; CME 1.00; RN 1.00

This session covers the importance of the trial risk assessment process, change control implementation and presents case studies from multiple regulators where effective RBQM could have helped prevent significant GCP non compliances for eSystems/DHTs

Learning Objectives

Discuss QbD and critical to quality factors for data reliability and participant safety in clinical trials including requirements in ICH E6 R3; Recognize the importance of change control and risk assessment for data governance and eSystems/ DHTs; Identify routine GCP inspection requests.

Chair

Mandy Kaur Budwal-Jagait, MSc

Speaker

FDA Perspective
Kassa Ayalew, MD, MPH

Panelist
Peter Twomey, MA, MPharm

PMDA Perspective
Hina Fukuta, RPh


Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Hina Fukuta

Hina Fukuta

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hina Fukuta currently serves as a inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA).
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

8:30am EDT

#207: Japan Town Hall
Tuesday June 17, 2025 8:30am - 9:30am EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-557-L04-P; CME 1.00; RN 1.00

This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.

Learning Objectives

Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.

Chair

Daisuke Koga, MSc, RPh

Speaker

Panelist
Sarah Rhee

Panelist
Shinichi Noda, PhD


Speakers
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
avatar for Shinichi Noda

Shinichi Noda

Division Director, Division of Planning and Management, Office of International, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2024-present Division Director, Division of Planning and Management, Office of International Strategy and Planning, PMDA 2019-2024 Deputy Review Director, Office of Cellular and Tissue-based Products, PMDA 2015-2019 Senior Reviewer, Office of pharmacovigilance II, PMDA 2013-2015 Section... Read More →
SR

Sarah Rhee

Vice President, Head of Global Regulatory Affairs, Alexion Pharmaceuticals, Inc, United States
avatar for Eri Sekine

Eri Sekine

Executive Vice President Data Business, CMIC Co., Ltd, Japan
Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes CDM, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing, Quality Management and Dx Strategy. Eri Sekine has over 30 years' experience in various functions in clinical... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
Tuesday June 17, 2025 8:30am - 9:30am EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-558-L04-P; CME 1.00; RN 1.00

This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.

Learning Objectives

Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.

Chair

Stephanie Choi, PhD

Speaker

Barriers and Enablers in International RWE Harmonization
Nicole Mahoney, PhD

Comparison of RWE guidelines across regions
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH Efforts in International RWE Harmonization
David Moeny, MPH, RPh

Emerging Guidelines in RWE
Patrice Verpillat, DrMed, MD, PhD, MPH


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Stephanie Choi

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States
Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Nicole Mahoney

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis, United States
Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →
DM

David Moeny

Acting Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States
David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge
Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-559-L04-P; CME 1.00; RN 1.00

The Platform Technology Designation program reflects longtime practice to leverage prior knowledge to speed development through advanced regulatory science, based on what's already known. But how will this practice and policy continue to evolve?

Learning Objectives

Describe how the FDA, other Health Authorities (HAs), and sponsors have historically leveraged prior knowledge to accelerate innovative product development and review; Examine the FDA’s perspective on applying prior knowledge to enhance the platform technology designation program and other regulatory science advancements or pathways; Discuss how the FDA plans to ensure the consistent application of these policies across review divisions and Centers.

Chair

Alexis Miller, JD

Speaker

Historic Application of Prior Knowledge
Rachel Turow, JD, MPH

Industry Perspective
Danielle Friend Economo, PhD


Speakers
avatar for Danielle Friend Economo

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
avatar for Rachel Turow

Rachel Turow

Of Counsel, FDA Regulatory Law, Skadden, United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#210: MHRA Town Hall
Tuesday June 17, 2025 8:30am - 9:30am EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-560-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.

Learning Objectives

Describe MHRA’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with MHRA regulators.

Chair

Alison Cave, PhD

Speaker

Panelist
James Pound

Panelist
Julian Beach

Panelist
Lawrence Tallon


Speakers
JB

Julian Beach

Interim Executive Director of Healthcare Quality and Access (HQA), MHRA, United Kingdom
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
avatar for James Pound

James Pound

Group Manager - British Pharmacopoeia & Laboratory Services, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency, United Kingdom
Tuesday June 17, 2025 8:30am - 9:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence
Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-554-L04-P; CME 1.00; RN 1.00

This session will engage an expert panel in a discussion on traceability of RWD. Panelists will describe challenges and discuss potential solutions to maintain and document traceability of RWD used in regulatory submissions.

Learning Objectives

Describe the inherent challenges in maintaining and documenting the traceability of Real-World Data (RWD) for regulatory purposes; Discuss potential solutions, including new and existing technologies, to enhance RWD traceability; Evaluate the strengths and weaknesses of various approaches to RWD traceability in a regulatory context.

Chair

James Browning, MPH

Speaker

Healthcare Organization Research Technology Perspective
Christopher Herrick, MBA

Traceability - Tools & Implementation Perspective
Anand Shroff, MBA, MS

Regulator Perspective
Marie C. Bradley, PhD, MPH, MPharm

Epidemiologist/Observational Researcher Perspective
Nancy Dreyer, PhD, MPH, FISPE


Speakers
MB

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise... Read More →
avatar for Christopher Herrick

Christopher Herrick

VP of Research Systems and Technology, Mass General Brigham (MGB), United States
Christopher Herrick is the Vice President of Research Technology at Mass General Brigham, where he leads the strategic development of data and technology platforms that support clinical research across one of the nation’s largest academic health systems. He co-leads the Hospital... Read More →
AS

Anand Shroff

President, Verantos, United States
Anand Shroff is a co-founder and President of Verantos, a company which specializes in rich and reliable RWD and high-validity RWE using AI. Previously, he was one of the founders of Health Fidelity (acquired by Edifecs/Francisco Partners), which focused on identifying and quantifying... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   03: Data-Tech, Forum

8:30am EDT

#211: Redesigning Research and Development with Women in Mind: Turning Ambition to Impact
Tuesday June 17, 2025 8:30am - 9:30am EDT
146BC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-561-L04-P; CME 1.00; RN 1.00

Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.

Learning Objectives

Recognize the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Describe ways to develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.

Chair

Anna Bode, PhD

Speaker

Panelist
Jessica Federer, MPH

Panelist
Nicole Richie, PhD

Panelist
Martin Hodosi, MSc

Panelist
Melissa H. Laitner, PhD, MPH

Panelist
Neosho Ponder, PhD


Speakers
avatar for Anna Bode

Anna Bode

Principal, Kearney, Germany
avatar for Jessica Federer

Jessica Federer

Board Member, Angelini Ventures, United States
Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Melissa Laitner

Melissa Laitner

Director, Strategic Initiatives, National Academy of Medicine, United States
Melissa Laitner is Director of Strategic Initiatives and Special Assistant to the President at the National Academy of Medicine, where she leads initiatives addressing critical domestic and global health policy challenges and directs cross-cutting projects on biomedical innovation... Read More →
avatar for Neosho Ponder

Neosho Ponder

National A.N.G.E.L. Lead, Tigerlily Foundation, United States
Dr. Neosho C. Ponder is an accomplished educator, passionate advocate, and impactful speaker originally from Kansas City, Missouri. As the Marketing and Communications Officer at the National Council of the Churches of Christ in the USA (NCC), she brings her extensive background in... Read More →
avatar for Nicole Richie

Nicole Richie

Vice President & Global Head Health Equity & Population Science, Genentech, United States
Dr. Nicole Richie, Ph.D. is the Vice President and Global Head of Health Impact & Population Science at Genentech, Roche responsible for leading the product development vision and developing strategies to broaden scientifically driven representation of understudied populations in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session
  • Level Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

9:30am EDT

Coffee Break
Tuesday June 17, 2025 9:30am - 10:30am EDT
EH
Component Type: Social Event



Tuesday June 17, 2025 9:30am - 10:30am EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

9:45am EDT

#212 IT: IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 1
Component Type: Session

In today's rapidly evolving regulatory landscape, AI/ML, NLP, & RPA are revolutionizing regulatory activities in the biopharma industry. Discover how these advanced technologies are transforming regulatory workflows, enhancing efficiency, and ensuring compliance. Attendees will learn about leveraging AI and ML for proactive regulatory intelligence, informed decision-making, dynamic task management, knowledge institutionalization, resource optimization, and real-time compliance monitoring.

Speaker

Speaker
Michelle Gyzen


Speakers
avatar for Michelle Gyzen

Michelle Gyzen

Senior Director, Regulatory Innovation & Technology, IQVIA, United States
Michelle has over 20 years of experience in pharmaceuticals, biotech, and medical devices. A senior director with expertise in designing large-scale regulatory outsourcing programs, offshore resource modeling, and regulatory tech integration and automation. In her current role, Michelle... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

#213 IT: Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 2
Component Type: Session

There is a critical balance to be struck, ensuring that study designs and digital endpoint solutions are not overburdensome to participants, but are still sufficiently robust to generate the quality data required to determine drug efficacy, safety, and impact to quality of life. In this engaging panel, we’ll review why maintaining patient focus is essential for success in today’s clinical studies, and how to do so successfully while maintaining the scientific rigor needed to achieve study goals.

Speaker

Speaker
Todd Rudo, MD

Speaker
Jay Ferro, MBA

Speaker
Kelly Dumais, PhD

Speaker
Stacy Hurt, MBA, MHA


Speakers
avatar for Kelly Dumais

Kelly Dumais

Director, eCOA Science and Consulting, Clario, United States
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient-reported outcomes (PROs) to support labeling... Read More →
avatar for Jay Ferro

Jay Ferro

EVP & Chief Information and Technology Officer, Clario, United States
Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years’ experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Todd Rudo

Todd Rudo

EVP, Chief Medical Officer, Clario, United States
Dr. Todd Rudo provides medical and scientific leadership across Clario. He has nearly 20 years of clinical cardiology & pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

#214 IT: Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 3
Component Type: Session

Global pharma companies are successfully implementing Gen AI across safety and regulatory workflows, driving efficiency and measurable ROI. Emmanuel “Manny” Belabe, Global Head of Operational Excellence at ArisGlobal, will discuss key strategies for implementation success, overcoming cultural challenges, and ensuring adoption.

Speaker

Speaker
Emmanuel Belabe


Speakers
avatar for Emmanuel Belabe

Emmanuel Belabe

Global Head, Operational Excellence • Global Customer Excellence, ArisGlobal, United States
Emmanuel Belabe, better known as “Manny”, has worked within ArisGlobal in a number of different roles over his 15 years with the company. During that time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products, while advocating... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:30am EDT

#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-562-L04-P; CME 1.00; RN 1.00

The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.

Learning Objectives

Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.

Chair

Mayur Patel, PharmD

Speaker

Panelist
Suranjan De, MBA, MS

Panelist
Andrew Bate, PhD, MA

Panelist
Phil Tregunno

Panelist
Jeremy Jokinen, PhD, MS


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
MP

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States
Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

#216: The Globalization of Risk Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-563-L04-P; CME 1.00; RN 1.00

This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.

Learning Objectives

Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.

Chair

Jamie Wilkins, PharmD

Speakers
avatar for Jamie Wilkins

Jamie Wilkins

Head, Risk Management Center of Excellence, Pfizer Inc, United States
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

#217: Case Studies of Application of AI in Risk-Based Quality Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-564-L04-P; CME 1.00; RN 1.00

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Recognize the key benefits and challenges of applying AI technologies in RBQM; Identify insights into real-world examples of AI's impact on clinical trial risk management; Discuss strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance; Describe how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Speaker

Panel Discussion: AI Teammates in Trials - Elevating Risk Management and Human Insight
Brian Barnes, MA

Novo Nordisk’s Path to Integrated Quality and Risk Management with AI-Powered Study Builder
Bo Maach-Møller, MPharm

Unlocking AI Potential In RBQM: Today and Tomorrow
Cheng Su, PhD


Speakers
avatar for Artem Andrianov

Artem Andrianov

CEO, Cyntegrity Germany GmbH, Germany
With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical... Read More →
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal... Read More →
BM

Bo Maach-Møller

Vice President, Risk Based Quality Management, Novo Nordisk A/S, Denmark
As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives... Read More →
CS

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical, United States
Cheng is the Executive Director of Data Sciences at BioMarin, where he leads RBQM transformation, AI innovation, and statistical support for research and early development. Prior to joining BioMarin, he led the development of centralized statistical monitoring and directed the Research... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

#219: Resilient Leadership: Overcoming Isolation and Adversity
Tuesday June 17, 2025 10:30am - 11:30am EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-566-L04-P; CME 1.00; RN 1.00

In the ever-evolving pharma/biotech landscape, leaders face challenges that test their professional and personal resilience. The past year has seen a significant strain on the industry, marked by the disruption of new technologies (and expectations associated with it), the failure of promising compounds, economic pressures, and layoffs. As leaders, we are often left to shoulder the weight of these challenges, managing not only our own emotional burden but also the morale of our teams and the broader organizational impacts. This presentation, delivered by a panel of seasoned professionals in the regulatory writing space, will explore the often-unspoken loneliness of leadership in times of upheaval. We will share personal insights from our career journeys, addressing the ways in which leadership can feel isolating, especially when navigating industry setbacks. In addition, we will provide practical strategies for coping with these burdens, drawing from experiences in career pivots, reskilling/retooling, and personal resilience. We will discuss ways to maintain emotional well-being, foster collaboration, and lead with transparency, even in the face of industry-wide adversity. Attendees will leave with actionable strategies to support their teams and themselves, and insights into how to continue leading effectively in times of uncertainty.

Learning Objectives

Discuss the unique emotional and professional challenges faced by regulatory writing leaders during periods of significant change; Describe developing strategies for maintaining personal resilience and emotional well-being while leading teams through industry-wide setbacks and economic pressures; Recognize ways to implement actionable techniques for fostering skill development, reskilling, and collaboration to effectively support both individual and team growth during challenging times.

Chair

Robin Whitsell

Speaker

Panelist
Cathy Tyrrell

Panelist
Matthew Robillard, MBA


Speakers
avatar for Matthew Robillard

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States
Matthew Robillard is a Senior Director of Strategic Medical Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has progressed... Read More →
avatar for Cathy Tyrrell

Cathy Tyrrell

Head of Medical Writing and Disclosure, Seqirus, United States
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session |   12: ProfDevelopment, Session

10:30am EDT

#220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Tuesday June 17, 2025 10:30am - 11:30am EDT
202A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-567-L04-P; CME 1.00; RN 1.00

A new community-focused, multi-stakeholder, disease-agnostic framework addressing solutions to sustainably improve clinical trial participation. Learn about, and how to apply, the framework along with a case study of its initial implementation in Atlanta.

Learning Objectives

Discuss an innovative framework for multi-stakeholder, community-focused clinical trial participation developed by patient advocacy and community-based organizations, trial sites, industry sponsors, and communications partners; Recognize its practical applications, real-world experiences, and initial impact through the grassroots pilot, Reflections Atlanta.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Nove Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Ellyn Getz, MPH

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Victoria DiBiaso, BSN, MPH, RN

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Patricia Davidson, MPA

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Dawn Rotellini


Speakers
avatar for Patricia Davidson

Patricia Davidson

PALADIN Consortium Director, Tufts Center for the Study of Drug Development, United States
avatar for Victoria DiBiaso

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Ellyn Getz

Ellyn Getz

Director, R&D Partnerships, CSL Behring, United States
Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →
avatar for Dawn Rotellini

Dawn Rotellini

Chief Operating Officer, National Bleeding Disorder Foundation, United States
Dawn Rotellini has been a leader in the bleeding disorders community for 27 years. As a parent of a son with Hemophilia, she founded the Rocky Mountain Bleeding Disorders Association in Bozeman, Montana, and served as its Executive Director. After moving to Pittsburgh, PA, she served... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

10:30am EDT

#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
Tuesday June 17, 2025 10:30am - 11:30am EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-568-L04-P; CME 1.00; RN 1.00

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Recognize participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce, MS

Speaker

Moderator
Donna Libretti Cooke, JD

Panelist
James Lovett, JD

Contributor-Industry
Karen Correa, PhD

Contributor-Academia
Kenneth Getz, MBA


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for James Lovett

James Lovett

CEO, Myonex, United States
James Lovett is Chief Executive Officer and Board Member of Myonex Inc., a leading clinical trial supply company with operations in US, France, Germany and UK and distribution to 80 countries. Myonex partners with pharma and biotech companies, CROs, and other pharma service providers... Read More →
avatar for Carie Pierce

Carie Pierce

Global Head of Growth & Business Development, DIA, United States
Carie serves as Global Head of Growth for DIA. She comes to DIA with over 25 years in the Medical Device, Diagnostic, and Pharmaceutical industry. She has spent much of her career with Terumo Blood and Cell Technologies in various commercial leadership roles, including responsibility... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Keyword Bioethics
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

10:30am EDT

#222: Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Tuesday June 17, 2025 10:30am - 11:30am EDT
204ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-569-L04-P; CME 1.00; RN 1.00

This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test

Learning Objectives

Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Recognize approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Speaker

Establishing a National Clinical Laboratory Network of Validated Assays
Chris Karlovich, PhD

Regulatory Considerations and Strategies for Rare Biomarker Validation
Dun Liang, PhD

Discuss challenges and best practices for CDx validation
Elaine Katrivanos

Provide global regulatory expectations, challenges, and approaches
Chris Bray


Speakers
avatar for Hillary Andrews

Hillary Andrews

Director, Regulatory and Research Partnerships, Friends of Cancer Research, United States
Hillary Andrews serves as the Director, Regulatory and Research Partnerships at Friends of Cancer Research (Friends) where she supports the development and implementation of the organization’s research and policy agenda. She uses her scientific and advocacy background to develop... Read More →
avatar for Chris Bray

Chris Bray

Head of Global Regulatory Affairs Precision Medicine & Companion Diagnostics, Merck Serono Ltd., United Kingdom
Chris has worked within the biotechnology and pharma industry for over 25 years, including over 20 years in the IVD and personalized healthcare space. He has a successful track record in CDx and drug (co-) development, collaborating with global teams to deliver on precision medicine... Read More →
avatar for Chris Karlovich

Chris Karlovich

Director, Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, United States
Chris Karlovich Ph.D. is Director of the Molecular Characterization (MoCha) Laboratory at the Frederick National Laboratory (FNL). Since joining FNL in 2017, he has made key contributions to several important NCI precision medicine initiatives. Among these was NCI-MATCH, the largest... Read More →
avatar for Elaine Katrivanos

Elaine Katrivanos

Vice President Regulatory Affairs, Tempus AI, United States
Elaine Katrivanos is Vice President, Regulatory Affairs at Tempus Labs, Inc. and, in this role, is responsible for leading the Regulatory Affairs department. Prior to joining Tempus, Elaine was a global regulatory lead in pharmaceutical drug development at AstraZeneca. Before that... Read More →
avatar for Dun Liang

Dun Liang

Director, Global Regulatory Affairs, Diagnostics, Eli Lilly & Co., United States
Dun is a diagnostics and regulatory expert uniquely positioned at the intersection of pharma, diagnostics, and regulation. At Eli Lilly, he provides critical guidance, interpretation, risk assessments, and troubleshooting on precision medicine strategy globally. He coordinates and... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

10:30am EDT

#223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects
Tuesday June 17, 2025 10:30am - 11:30am EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-570-L04-P; CME 1.00; PDU 1.00 PMI 2166B7YYGZ; RN 1.00

This pilot expanded Project Manager (PM) from R&D to encompass launch activities, enhancing cross-functional collaboration and planning, stakeholder communication and alignment with country organizations. A PM covering the entire value chain drives project success.

Learning Objectives

Assess the impact of end-to-end coverage of projects, including commercialization, on project value; Integrate critical components of launch planning, including R&D, marketing, access, and medical tactics; Develop skills to enhance cross-functional collaboration among R&D and global and local commercial teams to improve project outcomes.

Chair

Andreas Sutter, PhD, MPharm, RPh

Speaker

Industry Perspective
Jo Ann Kerwin

Industry Perspective
Stacy Hurt, MBA, MHA


Speakers
avatar for Jo Kerwin

Jo Kerwin

Senior Director Strategic Planning &. Operations, Jo Ann Kerwin, United States
Experienced global pharmaceutical senior director with over 30 years of pharma experience spanning early research, clinical operations, project, program, portfolio management and medical affairs. A solutionner who provides analytical and critical thinking skills to drive innovation... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Andreas Sutter

Andreas Sutter

Senior Program Management Leader, Bayer AG, Germany
Andreas Sutter is a senior program management leader in the pharmaceutical industry, with expertise spanning from early research to product launches. He focuses on implementing R&D and commercialization strategies for oncology, especially radioligand therapies. His experience includes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

10:30am EDT

#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct
Tuesday June 17, 2025 10:30am - 11:30am EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-571-L04-P; CME 1.00; RN 1.00

Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.

Learning Objectives

Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight to he importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.

Chair

Cheryl Grandinetti, PharmD

Speaker

Industry Perspectives
Michael Torok, PhD

MHRA Perspective
Jason Wakelin-Smith


Speakers
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

10:30am EDT

#225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
Tuesday June 17, 2025 10:30am - 11:30am EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-572-L04-P; CME 1.00; RN 1.00

This session will explore engagement pathways with global regulators to obtain feedback on AI technologies in drug development. It will also identify effective evaluation strategies to support regulatory acceptance of novel methodologies.

Learning Objectives

Identify the appropriate regulatory pathways and mechanisms for engaging with health authorities to discuss AI technologies in drug development applications; Discuss regulatory strategies, use cases, and considerations for AI model development based on context of use; Evaluate lessons learned and experiences from manufacturers, developers and health authorities.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speaker

EMA Perspectives on the Use of AI in the Lifecycle of Medicines
Luis Pinheiro, PharmD, MSc

AI and Machine Learning in Pharmaceutical Manufacturing
Gert Thurau, DrSc, PhD

FDA Perspectives on the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products
Tala Fakhouri, PhD, MPH

Technical and Regulatory Considerations for Streamlining Drug Development with Digital Twins: Sample-size Reduction Case Study
Aaron Smith, PhD


Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Ryan Hoshi

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States
Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, artificial intelligence, and advanced therapies. Before joining AbbVie, Ryan served as an international... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Aaron Smith

Aaron Smith

Founder, Machine Learning Scientist, Unlearn.AI, United States
Aaron is a mathematician with interests in AI, machine learning, and statistics. As a founder of Unlearn.ai, he has focused for the last 8 years on the development of digital twin models and their applications in drug development.
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

#226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Tuesday June 17, 2025 10:30am - 11:30am EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-573-L04-P; CME 1.00; RN 1.00

The US Orphan Drug Act and the European regulatory framework have accelerated orphan medicine development, boosting investments in rare disease treatments. This session will gather key stakeholders to discuss successes a and challenges

Learning Objectives

Discuss the impact of regulatory policies on the rare disease ecosystem; Discuss the challenges and opportunities associated with orphan drug regulations; Examine the role of regulatory frameworks in fostering innovation and access to therapies for rare diseases; Explain the importance of collaboration between regulatory agencies, industry stakeholders, and patient advocacy groups.

Chair

Imran Shah, PhD

Speaker

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Anabela Marcal, PharmD

Panelist
Amy Comstock Rick, JD

Panelist
Carolyn Shore, PhD

Panelist
Victoria Gemme, MBA, MS


Speakers
avatar for Victoria Gemme

Victoria Gemme

Director, Policy and Regulatory Affairs, National Organization for Rare Disorders, United States
Victoria Gemme is a research associate at the Duke-Margolis Center for Health Policy, where she works on a range of policy topics related to medical product development and regulation. Prior to Duke-Margolis, Victoria worked at the Cystic Fibrosis Foundation where she oversaw a diverse... Read More →
avatar for Imran Shah

Imran Shah

SVP & Head, Global Regulatory, R&D Quality and Safety (RQS), EMD Serono, United States
avatar for Carolyn Shore

Carolyn Shore

Director, National Academies, United States
Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →
SM

Segundo Mariz

European Medicines Agency, Netherlands
AC

Amy Comstock Rick

Director of Strategic Coalitions, Rare Disease Innovation Hub, FDA, United States
https://www.fda.gov/industry/fda-rare-disease-innovation-hub/amy-comstock-rick-jd
Tuesday June 17, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

#227: ANVISA Town Hall
Tuesday June 17, 2025 10:30am - 11:30am EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-574-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator

Chair

Bianca Zimon, LLM

Speaker

Panelist
Daniel Pereira

Panelist
Marcelo Moreira, MS

Panelist
Dandara Braga Santana, MHS


Speakers
avatar for Marcelo Moreira

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
DP

Daniel Pereira

ANVISA, Brazil
avatar for Dandara Santana

Dandara Santana

CMC reviewer, ANVISA, Brazil
Bachelor's degree in Pharmaceutical Sciences with Clinical and Industrial qualification. Master's degree in Health Science. Professional experience as a pharmacist at the Ministry of Health in Brazil. Since 2014, working as a CMC reviewer at the National Health Surveillance Agency... Read More →
avatar for Bianca Zimon

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

#218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence
Tuesday June 17, 2025 10:30am - 11:30am EDT
207B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-565-L04-P; CME 1.00; RN 1.00

This session will explore how Intelligent Automation (IA) and AI are transforming R&D and Regulatory Affairs by automating document-heavy processes and driving data-driven decisions. Through real-world use cases presented by industry sponsors, attendees will learn how IA and AI are being applied to improve efficiencies, reduce timelines, and optimize regulatory outcomes.

Learning Objectives

Discuss AI applications in drug discovery, clinical trials, regulatory, manufacturing, and pharmacovigilance; Explain practical use cases of AI in Regulatory Operations; Discuss advancing fit-for-purpose, risk-based frameworks for AI and global regulatory alignment.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

AI: Accelerating Clinical Trials Through Smarter Site Selection
Kevin Bugin, PhD, MS, RAC

Harnessing AI and Automation in Regulatory:  Insights from the Recent DIA RIM Intelligent Automation Survey
Cary Smithson, MBA

Industry Perspective
Cedric Berger, PhD, MBA

AI-Driven Drug Development: Transforming Life Sciences with Data and Innovation
Sridevi Nagarajan, PhD, MS, MSc


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States
Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management... Read More →
avatar for Cedric Berger

Cedric Berger

Head of Knowledge Extraction and Integration, F. Hoffmann-La Roche, Switzerland
avatar for Cedric Berger

Cedric Berger

Head of Knowledge Extraction and Integration, F. Hoffmann-La Roche, Switzerland
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Sridevi Nagarajan

Sridevi Nagarajan

DIA Communities Lead for AI in Healthcare, Ayusarogya, United Kingdom
An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →
avatar for Cary Smithson

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session |   03: Data-Tech, Session

10:30am EDT

#228: Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-575-L04-P; CME 1.00; RN 1.00

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project.

Learning Objectives

Describe the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.

Chair

Michael McDonald, PhD

Speaker

Supporting regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management
Theresa Mullin, PhD

PQKM collaborative assessment pilot programme - Regulator's perspective and udpates
Sean Barry, PhD

PQKM pilot programmes – Industry perspective
Susanne Ausborn, PhD

Panelist
Evdokia Korakianiti, PhD, MSc


Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Stephen Mahoney

Stephen Mahoney

Head of Quality Policy and Advocacy, Gilead Sciences, United States
Stephen Mahoney is an Executive Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on critical regulatory and manufacturing matters. Previously, Stephen served as a Compliance Officer in the FDA's Center for Drug Evaluation and Research... Read More →
avatar for Michael McDonald

Michael McDonald

Programme Manager, Office of the Chief Executive, Health Products Regulatory Authority, Ireland
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session |   08: RD-Quality-Compliance, Session

10:30am EDT

#229: Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development
Tuesday June 17, 2025 10:30am - 11:30am EDT
144ABC
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-576-L04-P; CME 1.00; RN 1.00

The benefit-risk assessment of a new medicinal product or intervention is crucial through all stages of its development and ultimately leading to regulatory approval. This process can be complex, as it involves trade-offs between often conflicting multiple efficacy and safety endpoints, along with different methodologies for assessing benefits and risks. Therefore, clearly and transparently describing the benefit-risk profile and communicating the trade-offs using all available evidence is essential for regulatory decision-making and individual patient management. Bayesian inference, in addition to conventional approaches, offers a natural framework for conducting quantitative assessments of the benefit-risk trade-off. It allows for the formal use of prior information and the integration of various sources of information and uncertainty, while also linking to optimal decision theory. With a growing focus on improving the process of benefit-risk assessment at the FDA, sponsors are increasingly making efforts to apply quantitative benefit-risk assessments, often utilizing a Bayesian framework. This session will present innovative Bayesian methods for benefit-risk assessment, along with empirical examples. Industry and regulatory experts will reflect on their diverse research experiences with Bayesian benefit-risk methods, highlighting its strengths, limitations, and potential future applications. The impact of these methodological advancements as evident in stakeholders' enhanced ability to make informed decisions regarding benefit-risk assessments, ultimately contributing to improved patient safety and healthcare outcomes will be shared. General recommendations for planning and implementation of Bayesian benefit-risk assessments, including regulatory perspectives, will touch upon all areas of the structured benefit-risk assessment process starting from defining key outcomes and eliciting preference information through to the final integrated analysis of benefits and

Learning Objectives

Explain the critical importance of quantitative benefit-risk assessment and its impact; Describe how Bayesian methods can provide a natural framework for such quantitative assessments, along with empirical examples; Discuss strengths, limitations and general recommendations, including regulatory perspectives, for planning and implementation of Bayesian benefit-risk assessments.

Chair

Madhurima Majumder, PhD

Speaker

Speaker
Bennett Levitan, MD, PhD

Speaker
Saurabh Mukhopadhyay, PhD

Speaker
Sai Dharmarajan, PhD


Speakers
SD

Sai Dharmarajan

Director, Biostatistics, Sarepta Therapeutics, United States
Sai Dharmarajan is a Director of Biostatistics at Sarepta Therapeutics. Prior to joining Sarepta he was a Senior Statistical Reviewer at FDA from 2018 to 2023. He is an active member of multiple cross-industry working groups on Real World-Evidence, Benefit-risk and Artificial Intelligence... Read More →
avatar for Bennett Levitan

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
Bennett Levitan, MD-PhD is Executive Director, Global R&D Epidemiology at J&J. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development... Read More →
avatar for Madhurima Majumder

Madhurima Majumder

Associate Director, Clinical Statistics and Analytics, Bayer US LLC, United States
Madhurima Majumder, PhD is an Associate Director of Clinical Statistics and Analytics at Bayer US LLC. She is responsible for the statistical aspects of clinical trials, from endpoint selection and design to regulatory approval, with experience in cardiovascular, oncology and hematology... Read More →
avatar for Saurabh Mukhopadhyay

Saurabh Mukhopadhyay

Research Fellow, Statistical Innovations, Abbvie, United States
Saurabh Mukhopadhyay, PhD is a Research Fellow in the Statistical Innovation Group at AbbVie. He leads impactful and novel statistical research at AbbVie, spanning various therapeutic domains. His many years of extensive consultancy background includes founding and leading his own... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

10:30am EDT

#230: Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being
Tuesday June 17, 2025 10:30am - 11:30am EDT
206
Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-577-L04-P; CME 1.00; RN 1.00

Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.

Learning Objectives

Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.

Chair

Leanne Woehlke, MA

Speaker

Pause, Breathe, Connect
Jess Thompson, MBA, MS, PMP

The Effects of Mindful Breathing on Stress and Well-Being
Eddie Stern


Speakers
ES

Eddie Stern

CEO, The Breathing App, Inc, United States
avatar for Jess Thompson

Jess Thompson

Founder, CEO, Clinical Research Pro, United States
Jess Thompson brings over 15 years of clinical research experience across labs, sites, CROs, and pharma. She founded Clinical Research Pro to empower professionals through education, development, and career growth. Under her leadership, Clinical Research Pro fosters a supportive community... Read More →
avatar for Leanne Woehlke

Leanne Woehlke

Executive Vice President, SOGLIA, SOGLIA - Entrada Ventures Group, United States
Leanne is the EVP at Soglia. As a Patient Experience Organization, or PXO, we are driven to reimagine the way patients interact with pharmaceutical companies throughout their treatment journey.  With over 25 years of experience in clinical research and coaching, Leanne brings a unique... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Workshop

11:00am EDT

DIA Global Annual Meeting Blood Drive
Tuesday June 17, 2025 11:00am - 4:00pm EDT
Exhibit Hall Lunch
Component Type: Session



Tuesday June 17, 2025 11:00am - 4:00pm EDT
Exhibit Hall Lunch Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Session

11:30am EDT

#POS 2: Professional Poster Session II
Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH
Component Type: Session

Professional Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
avatar for Meha Ahmed

Meha Ahmed

ORISE Research Fellow, U.S. Food and Drug Administration, United States
An epidemiologist with expertise in pharmacoepidemiology, risk management, and pharmacovigilance. Meha Ahmed holds a Master of Health Science degree in Epidemiology from Johns Hopkins Bloomberg School of Public Health. She currently serves as an ORISE Research Fellow at the FDA, where... Read More →
avatar for Abdulaziz Alageel

Abdulaziz Alageel

Alert and Monitoring Expert, Saudi Food and Drug Authority, Saudi Arabia
avatar for Saeed Alshahrani

Saeed Alshahrani

Alarm & Control Expert, Saudi Food & Drug Authority, Saudi Arabia
avatar for Vasanti Anand

Vasanti Anand

Regulatory Writer, BMS, United States
Have a doctorate in Molecular Biology and Biochemistry and completed a prestigious postdoctoral fellowship as a Michael J. Fox Fellow in Neuroscience. With over 11 years of experience as a scientific and regulatory writer, I have developed a diverse skill set in both publication and... Read More →
avatar for Troy Astorino

Troy Astorino

CTO, PicnicHealth, United States
Troy Astorino is the co-founder and Chief Technology Officer of PicnicHealth, where he leads the development of AI for conducting faster, more efficient, and more reliable clinical research. His team at PicnicHealth developed LLMD, the world’s highest-performing AI model for interpreting... Read More →
avatar for Maree Beare

Maree Beare

Founder and CEO, Clinials, Australia
avatar for Amanda Kirby Bowles

Amanda Kirby Bowles

Managing Director, Deloitte, United States
Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →
avatar for Maryann Chapin

Maryann Chapin

ORISE Fellow, Food and Drug Administration, United States
Maryann is a current postdoctoral ORISE fellow at the Food and Drug Administration (FDA) within the Division of Pharmacovigilance (DPV), focusing on the characterization of newly identified safety signals (NISS). Prior to her FDA fellowship, she completed a 2-year fellowship at the... Read More →
JC

Joan Cheung

Senior Consultant, NNIT, United States
Joan Cheung is a Senior Consultant at NNIT where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs with projects... Read More →
avatar for Pamela Concepcion

Pamela Concepcion

Patient Safety Scientist, Astrazeneca, United States
AC

Ana Corona

Translator, University of Utah, United States
SD

Sahith Doppalapudi

Associate Director, PV Analytics Analytics Center of Excellence, Bristol-Myers Squibb Company, United States
Sahith Doppalapudi holds a master's degree in Chemical Engineering from Oklahoma State University and has accumulated over 14 years of experience in the pharmaceutical industry. Throughout his career, he has served in different roles including Quality Analyst, Validation Lead, and... Read More →
avatar for Heidi Grabenstatter

Heidi Grabenstatter

Scientific Director, RDCA-DAP, Critical Path Institute, United States
Heidi Grabenstatter, Ph.D., is the Scientific Director of the Rare Disease Cures Accelerator- Data Analytics Platform (RDCA-DAP). In this role, she leads neutral convenings of clinician experts, data scientists, industry partners, and patient advocacy leaders to identify disease-specific... Read More →
avatar for Hannah Graunke

Hannah Graunke

Senior Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Hannah Graunke, MPP is a Senior Policy Analyst with the Biomedical Innovation team at the Duke-Margolis Institute for Health Policy. Her research focuses on coverage and access for novel medical technologies, medical product payment, and condition-based models. She is a former Peace... Read More →
avatar for Tarek Hammad

Tarek Hammad

Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera, Takeda, United States
Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished... Read More →
avatar for Eimy Honda

Eimy Honda

Pharmacovigilance Specialist, University of São Paulo, MBA USP/Esalq, Brazil
Eimy holds a Bachelor's degree in Pharmacy from the Federal University of São Paulo (Unifesp) and an MBA in Business Management from USP/Esalq. She currently works as a Pharmacovigilance Specialist, with a strong focus on implementing technology solutions such as RPA and AI. With... Read More →
avatar for Alice Hsu

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States
Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →
avatar for Angela Hu

Angela Hu

VP, Biostatistics, Parexel, United States
Angela Hu is an accomplished Biostatistics professional with extensive experience in the global pharmaceutical industry. Her career has been marked by a consistent focus on operating at the highest levels of the organization, ensuring that robust and insightful input is provided to... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer Inc, United States
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →
avatar for Aarthi Iyer

Aarthi Iyer

Senior Corporate Counsel, Cogent Biosciences, Inc., United States
Aarthi B. Iyer is a Senior Corporate Counsel for Cogent Biosciences, Inc., a biotechnology company developing real solutions to treat genetically driven diseases. Aarthi supports transactional needs across the company including clinical development, research, and medical affairs activities... Read More →
avatar for HYUN JOO JUNG

HYUN JOO JUNG

Departiment of Drug Safty Information, Korea Institute of Drug Safety & Risk Management, Korea, Republic of
I am currently working as the director of the office of drug safety information of department of drug safety information in Korea Institute of Drug Safety & Risk Management. Based on the Pharmaceutical Affairs Act of Korea, we collect, analyze, assess and management drug safety information... Read More →
avatar for MIDHUN RAJ K

MIDHUN RAJ K

Manager, Signal Management, IQVIA, India
Pharmacovigilance professional, with bachelor's in pharmacy and master's in data sciences with 15+ years of working experience in drug safety surveillance industry with a special focus on its quality management aspects. Worked with number of pharmaceutical, biological and medical... Read More →
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
avatar for Yoon Jeon (Jamey) Kim

Yoon Jeon (Jamey) Kim

Director, Cluster Pharmacovigilance Lead, Merck & Co., Inc., Rahway, NJ, USA, Panama
Yoon Jeon (Jamey) Kim, the Director and North Cluster PV lead for Latin America at MSD, has more than 20 years of experience with the company. She provides strategic leadership for cluster countries (Colombia, Ecuador, Venezuela, Central America, and the Caribbean), with an extensive... Read More →
avatar for Ray Kirchmier

Ray Kirchmier

Manager, Deloitte, United States
Ray Kirchmier, B.S. Biological Sciences, PMP - Manager, Deloitte - Ray has over 9 years of experience in the pharmaceutical industry. Before joining Deloitte, he was a Scientist and Quality Assurance Specialist at Patheon–Thermo Fisher Scientific. In 2018, he brought his pharmaceutical... Read More →
avatar for Toshitatsu Kobayashi

Toshitatsu Kobayashi

Senior Regulatory Expert, Otsuka Pharmaceutical Co., Ltd., Japan
After completing a Ph.D. and postdoctoral research, the speaker joined their current pharmaceutical company in 2007, beginning a career in drug development. He spent six years conducting nonclinical pharmacokinetics research on biologics before transitioning to the regulatory affairs... Read More →
avatar for Daisuke Koide

Daisuke Koide

Project Professor, Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Japan
Dr. Daisuke Koide is Project Professor at the Department of Biostatistics and Bioinformatics at Graduate School of Medicine, the University of Tokyo. He is also head of safety management division at clinical research promotion center in the University of Tokyo Hospital. He holds a... Read More →
avatar for Sue Lee

Sue Lee

Director, Global Patient Safety Signal Management and Innovation, Takeda, United States
ML

Marie Liles-Burden

Director, Pharmacovigilance Risk Management, Takeda, United States
Marie A. Liles-Burden, MPH, is a seasoned expert in pharmacovigilance and epidemiology. She obtained a Bachelor of Science from the Massachusetts College of Pharmacy and Health Sciences and a Master of Public Health from Boston University. Currently, Marie serves as the Director of... Read More →
avatar for Anran Liu

Anran Liu

ORISE Postdoctoral Fellow, U.S. Food and Drug Administration, United States
Anran is a postdoctoral fellow at the U.S. FDA, CDER Office of Surveillance and Epidemiology, conducting research in pharmacovigilance and drug safety surveillance. She earned her PhD in Biostatistics from SUNY Buffalo in August 2024, where she developed approaches for adverse event... Read More →
avatar for Niamh McGuinness

Niamh McGuinness

Director, Pharma Solutions, IQVIA Applied AI Science, IQVIA, United States
Niamh McGuinness is Director of Pharma Solutions with the Applied AI Science Team in IQVIA. Niamh leads a diverse group of experts who build AI solutions and utilize a suite of award-winning technology to help pharma customers protect participant privacy and surface critical insights... Read More →
AM

Amanda McMannis

Associate Director, Clinical Operations, The Prostate Cancer Clinical Trials Consortium, United States
Amanda McMannis is the Associate Director of Clinical Operations at the Prostate Cancer Clinical Trials Consortium within Memorial Sloan Kettering Cancer Center. She manages the late phase clinical trials and registry studies within the company’s portfolio.
GM

Greeshma Mundayat

Solution Owner, Maxisit, United States
avatar for Lindsey Murray

Lindsey Murray

Executive Director, Rare Disease COA Consortium, Critical Path Institute, United States
Lindsey Murray, PhD, MPH, is Executive Director of the Rare Disease Clinical Outcome Assessment (COA) Consortium at C-Path. Dr. Murray has nearly 20 years of experience in clinical and health outcomes research, specializing in quantifying the patient’s perspective of health, illness... Read More →
avatar for Evon Okidi

Evon Okidi

Senior Data Scientist, Medidata Solutions, A Dassault Systemes Company, United States
Evon Okidi is senior data scientist at Medidata AI, where she builds models that leverage machine learning, deep learning and statistical methods to predict and forecast clinical trial activities. In her early career, she worked as a Biostatistician focusing on HIV/AIDS research and... Read More →
avatar for Feisal Othman

Feisal Othman

Benefit Risk Assessment Lead, Bristol Myers Squibb, United States
Feisal Othman is a drug safety and risk management professional with over 16 years of experience in various roles in healthcare and medication safety, currently serving as a Benefit-Risk Assessment Lead at Bristol Myers Squibb. His background includes developing and overseeing global... Read More →
SP

Sohyeon Park

pharmacist, KIDS, Korea, Republic of
Sohyeon Park is currently working at the Korea Institute of Drug Safety & Rist Management(KIDS) as a pharmacist. She earned a bachelor's degree in Pharmacy from Dukseong Women's Univeristy. Currently, she is part of the Office of ADR Relief, engaged in the causality assessment of... Read More →
avatar for Mohit Raizada

Mohit Raizada

Director - Signal Management Services, IQVIA, India
Dr. Mohit Raizada is the Director and Head of Signal Management Services in the Lifecycle Safety department at IQVIA, India. He is an expert in signal management and has successfully onboarded, led, executed, and completed complex signal management projects for various companies... Read More →
avatar for Patrick Rodriguez

Patrick Rodriguez

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Patrick Rodriguez is a Policy Analyst at the Duke-Margolis Institute for Health Policy on the Biomedical Innovation team. He primarily supports projects under the FDA and Real-World Evidence portfolios. He holds a MA in Bioethics and Science Policy with concentrations in both technology... Read More →
avatar for Andrea Russell

Andrea Russell

Assistant Professor, Northwestern University Feinberg School of Medicine, United States
I am an Assistant Professor of Medicine in the Department of Psychiatry & Behavioral Sciences and the Division of General Internal Medicine at Northwestern Feinberg School of Medicine. In addition, I am faculty within the Center for Applied Health Research on Aging (CAHRA) with expertise... Read More →
avatar for Molly Shields

Molly Shields

Policy Research Assistant, Duke-Margolis Institute For Health Policy, United States
Molly Shields is a Policy Research Assistant on the Biomedical Innovation team at Duke-Margolis, supporting work under U.S. Food and Drug Administration grants and the Institute’s collaboration with Highlander Health to optimize clinical research. She has experience working on health... Read More →
avatar for Cristiano Silva

Cristiano Silva

Data Manager, Albert Einstein Israelite Hospital, Brazil
avatar for Margaret Studzinska

Margaret Studzinska

Senior Director, Regulatory and Medical Writing, MMS Holdings, United States
Margaret Studzinska, MBA is a Senior Director in Regulatory and Medical Writing, with over 15 years of experience in medical and regulatory writing for the clinical research and pharmaceutical industries. She has supported multiple regulatory submissions to global health authorities... Read More →
avatar for Kimberly Tableman

Kimberly Tableman

Founder & CEO, Espero, United States
With a robust background in clinical development and a sharp focus on digital health, my journey has led me to found ESPERO, where we're revolutionizing drug development through insight-driven protocol design. At the helm of ESPERO, my team and I are committed to enhancing operational... Read More →
JT

Julie Tripp

Senior Director of Toxicology, Mind Medicine Inc., United States
MT

Michael Trulli

Associate Director, Science Capability and Delivery, Evinova, United States
Michael Trulli is a dedicated professional in the Digital Health industry with 6 years of experience. He focuses on successfully bringing together science and technology to create innovative approaches to remote patient monitoring, particularly in the oncology space. Michael has played... Read More →
RV

Rishi Verma

Medical Director, Roche & Stethy, Australia
avatar for Benjamin Worley

Benjamin Worley

Senior Director, Sustainability & ESG, LabConnect, United States
Ben Worley is a sustainability and technology executive with more than a decade of experience driving ESG strategy, carbon measurement innovation, and digital solutions across several industries and research sectors. With multiple patents in AI-powered sustainability systems and a... Read More →
avatar for Takayuki Yasuda

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
Takayuki Yasuda has been serving as a Statistical Programmer in the Biometrics department at Chugai Pharmaceutical Co., Ltd. since 2020. He worked in the CRO industry from 2014 to 2020. Since 2024, he has been leading an initiative on implementing generative AI in the clinical development... Read More →
avatar for Teresa Zhang

Teresa Zhang

Safety Scientist, Beone Medicines, United States
Teresa is a Safety Scientist at BeOne Medicines (formerly BeiGene). She has over 5 years of experience in pharmacovigilance at biotech companies in the oncology space. In her current role, she is also exploring the application of artificial intelligence in signal detection and case... Read More →
avatar for Andrea Zuleta

Andrea Zuleta

Manager, Office of Health Literacy, Abbvie, United States
Andrea Zuleta is a Manager at AbbVie’s Office of Health Literacy. Prior to AbbVie, Andrea worked at Northwestern University’s Health Literacy and Learning Program (HeLP), where she managed the team's industry-sponsored project portfolio. She brings her experience in academia to... Read More →
Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session

11:30am EDT

Luncheon Service
Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH
Component Type: Social Event



Tuesday June 17, 2025 11:30am - 1:30pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster; Discover how digital protocols are already driving connections and efficiencies at research sites; Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Speakers
DM

Denise Meade

Vice President, Life Sciences and MedTech, Verily, United States
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

11:45am EDT

#232: Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 1
Component Type: Session

The global biosimilars market is growing rapidly. Today, there are over 50 biosimilars approved in the U.S. and over 120 biosimilars approved in Europe. However, only about 10% of the over 100 biologics expected to lose market exclusivity in the next decade have a biosimilar currently under development. This session will examine the different landscapes of biosimilar regulation and uptake in the global market today, focusing on a comparative analysis between the Europe and the United States.

Speaker

Speaker
Mariana Socal, MD, PhD, MS

Speaker
Gillian Woollett, PhD, MA


Speakers
avatar for Mariana Socal

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →
avatar for Gillian Woollett

Gillian Woollett

Vice President, Head Regulatory Strategy and Policy, Samsung Bioepis, United States
Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a U.S. presence for science-based regulatory strategy and policy in the leading global market for biologics. Previously, she was SVP and Principal Regulatory... Read More →
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

#233 IT: Yseop Innovation Theater: Scaling Regulatory Automation - The One-Click Vision
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 2
Component Type: Session

As automation evolves, regulatory teams are moving beyond isolated tools toward intelligent ecosystems that connect documents, data, and decisions. This session explores the path to One Click Dossier Generation, where multi-document submissions are generated seamlessly using a blend of AI, dynamic workflows, and connected systems. Learn what it takes to scale this vision, and how it’s already taking shape across the industry.

Speaker

Speaker
Jenni Pickett


Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

#233.1 IT: Microsoft Innovation Theater: Innovating Responsibly - AI in Regulated Environments
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 3
Component Type: Session

Join us for "Innovating Responsibly: AI in Regulated Environments," where we explore the practical impact of AI on the life sciences industry. Discover real-world examples of AI applications in regulated environments, highlighting how AI drives innovation and efficiency. Learn how Microsoft collaborates with regulatory bodies to support compliance and safer AI implementation. Gain insights into the technological safeguards that support responsible and secure AI use. This session will provide an overview of how these innovations are reshaping the future of work and discovery in our industry.

Learning Objectives

12:15 PM - 12:19 PM Welcome and Kickoff: Todd Mersch
12:19 PM - 12:27 PM AI Use Cases: Eunice Youhanna
12:27 PM - 12:35 PM MSFT Technology Working with Regulators: Vinita Grover
12:35 PM - 12:43 PM Technology Supporting Safeguards: John Burke
12:43 PM - 12:45 PM Closing Remarks: Akilah Daniels-Vincent

Speaker

Welcome and Kickoff
Todd Mersch

AI Use Cases
Eunice Youhanna

MSFT Technology Working with Regulators
Vinita Grover

Technology Supporting Safeguards
John Burke

Closing Remarks
Akilah Daniels-Vincent
Speakers
avatar for John Burke

John Burke

Cybersecurity Sales Director, Microsoft, United States
John Burke is a passionate technology advocate dedicated to helping customers unlock their full potential through the power of cloud services and digital transformation. In his role at Microsoft, he partners with organizations to deliver innovative solutions that drive efficiency... Read More →
avatar for Akilah Daniels-Vincent

Akilah Daniels-Vincent

Sr. Product Marketing Manager, Microsoft Cloud Marketing - Industry, United States
Akilah Daniels-Vincent is a visionary vanguard at Microsoft, where she leverages the power of data and AI to design cutting-edge marketing strategies that are reshaping the healthcare landscape. With a passion for innovation and impact, she is dedicated to empowering organizations... Read More →
avatar for Vinita Grover

Vinita Grover

Microsoft, United States
avatar for Todd Mersch

Todd Mersch

Consulting Leader, Microsoft, United States
avatar for Eunice Lin Youhanna

Eunice Lin Youhanna

Industry Advisor, Microsoft, Canada
Eunice Youhanna is a strategic leader and Industry Advisor with deep expertise in pharmaceutical innovation, particularly at the intersection of AI and commercial, medical, regulatory, and R&D functions. She partners with global life sciences organizations to drive transformation... Read More →
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:00pm EDT

#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A
Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Carolyn Shore, PhD

Speakers
avatar for Carolyn Shore

Carolyn Shore

Director, National Academies, United States
Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

12:00pm EDT

#235.1 RT: Roundtable Discussion: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion and Updating Ethics What's New in Declaration of Helsinki
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion (Monday, June 16 | 3:45pm - 4:45pm EDT) and Updating Ethics What's New in Declaration of Helsinki (Tuesday, June 17 | 1:45pm - 2:45pm EDT) . Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session

12:00pm EDT

#235 RT: Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Building a Regulatory Landscape to Support CMC Innovation (Monday, June 16 | 2:15pm - 3:15pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   10: RegCMC-Product Quality, Session

12:25pm EDT

#236.1 IT: Whatfix Innovation Theater: Closing the Digital Execution Gap in Life Science - A Practical Path to Compliance, Efficiency, and Speed
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 1
Component Type: Session

Despite investments in digital transformation, life sciences firms still face hurdles with tech adoption, compliance, and workforce efficiency. This session covers closing the “digital execution gap” using in-app guidance, automation, and behavioral analytics. Learn how teams across clinical, regulatory, and other functions use digital adoption platforms to: Ensure SOP adherence and GxP compliance; Reduce training time, support tickets, and operational errors; Drive consistent use of CTMS, QMS.

Speaker

Speaker
Parth Thesia


Speakers
avatar for Parth Thesia

Parth Thesia

Solutions Consulting - LifeSciences NA, Whatfix , United States
Parth Thesia is a seasoned Senior Solution Consultant with over 12 years of experience, specializing in Digital Transformation, Customer and Employee Experience, and Life Sciences. As the Solutions Consulting Leader for the Life Sciences GTM team at Whatfix, he leads strategic account... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

#237 IT: Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 3
Component Type: Session

Join Lilly for a hands-on presentation on the impact of digital health technologies (DHTs) in clinical trials. Discover how DHTs enhance patient experiences and increase access through an in-person demonstrations of the tools. During this presentation, Lilly will introduce DHT Templates, developed by BIO membership, designed to standardize the inclusion of DHT data within product submissions and provide a predictable approach to regulatory review.

Chair

Lauren Tobe, JD

Speaker

Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Ann Marie Hake, MD


Speakers
avatar for Ann Marie Hake

Ann Marie Hake

Executive Director, Medical – Digital Health, Eli Lilly and Company, United States
Ann Marie Hake is a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In her current role at Lilly, she is a clinical research physician in the Digital Health R&D group, as well as the Vice Chair of... Read More →
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

#237.1 IT: Salesforce Innovation Theater: Life Sciences Cloud - An Intelligent Clinical Engagement Platform
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

See how Salesforce is reimagining end-to-end clinical operations from study start up through close out. With Life Sciences Cloud and Agentforce, a comprehensive agentic AI platform, you can transform clinical systems of record to systems of insight and facilitate collaboration and automating study activities between sites, sponsors, vendors, and patients. The platform can automatically alert you to study risks and issues and manage outstanding tasks to ensure effective clinical trial management.

Speaker

Speaker
Lorie McClain

Speaker
Sharmin Nasrullah, MS


Speakers
avatar for Lorie McClain

Lorie McClain

Distinguished, Strategic Solution Engineer, Salesforce, United States
avatar for Sharmin Nasrullah

Sharmin Nasrullah

General Manager, Life Sciences, Clinical, Salesforce, United States
Sharmin Nasrullah brings over 20 years of experience across multiple disciplines across technology development, medical devices, digital health, clinical operations and clinical software. She is inspired by bringing cutting edge technology into the life sciences space to transform... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements; Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions; Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Speaker

Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Alex Asiimwe


Speakers
AA

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

1:05pm EDT

#239 IT: Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

2025 is the year to scale AI—but only a fraction of pilots make it to production. Discover why, where to invest now, and how to align emerging tech with real business needs. Hear real-world use cases in protocol optimization and clinical trial monitoring and discover how to align tech with true business needs. If you're ready to turn AI ambition into enterprise value, this session is a must-attend.

Speaker

Speaker
Ashley Bates

Speaker
Rachel Belani-Barker

Speaker
Dyke Simpson


Speakers
AB

Ashley Bates

Syneos Health, United States
avatar for Rachel Belani-Barker

Rachel Belani-Barker

Sr Account Development Mgr, Syneos Health, United States
avatar for Dyke Simpson

Dyke Simpson

Sr Account Development Mgr, Syneos Health, United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:05pm EDT

#239.1 IT: Faro Health, Inc Innovation Theater: Real World Applications of AI to Clinical Development
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 3
Component Type: Session

Clinical development is complex, with trials becoming increasingly costly and time-consuming. Generative AI holds promise to reduce time and cost through automation and data insights. In this talk, Patrick Leung (CTO, Faro Health Inc.) will explore how Faro applies its expertise in clinical science and AI to overcome challenges and develop next-generation tools that transform clinical development.

Speaker

Speaker
Patrick Leung


Speakers
PL

Patrick Leung

Chief Technology Officer, Faro Health Inc. , United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-578-L04-P; CME 1.00; RN 1.00

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Speaker

Panelist
Joseph Dustin


Speakers
avatar for Joseph Dustin

Joseph Dustin

Founder and Managing Partner, eClinical Consulting, United States
For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up 12 year run with Medidata. He has worked with top Pharmaceutical, Biotech and CRO... Read More →
avatar for Joseph Dustin

Joseph Dustin

Founder and Principal, Dauntless Eclinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

1:45pm EDT

#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS


Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Melissa Heidelberg

Melissa Heidelberg

Director, Global Bioethics and Technology Ethics Lead, Takeda, United States
I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Director, Office of Clinical Policy, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

#242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
150AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-580-L04-P; CME 1.00; RN 1.00

As the potential of artificial intelligence (AI) is increasingly piquing the interest of researchers, it is critical to discuss how AI works by learning from the data, and how to leverage the results. Choosing the right approach for integrating AI into the research lifecycle can have a massive impact on likelihood of success. As one example, both generalized large language models (LLMs) and purpose build LLMs have their place in the toolkit needed to curate and analyze medical record and other patient data. This presentation will explore best practices/learnings for ensuring the right AI tool for the task, including LLMs tailored to the unique needs of pharmaceutical research; the impact for pharmaceutical research and for patients this can have; and imperatives for ascertaining the reliability and trustworthiness of AI solutions for medical research, as key to promoting adoption and responsible deployment in practice.

Learning Objectives

Identify key factors to consider when selecting AI strategies and methods for use in biomedical settings and pharmaceutical research; Describe the potential impact of AI strategies on research quality and patient outcomes, using real-world use cases and examples; Apply a framework to evaluate the suitability and readiness of AI technologies, such as large language models, for specific research or clinical applications.

Chair

Sarah Lyons, MSc

Speaker

Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact
Alex Asiimwe

Deploying Large Language Models in Clinical Research: Practical Considerations from Real World Examples
Troy Astorino


Speakers
AA

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom
avatar for Troy Astorino

Troy Astorino

CTO, PicnicHealth, United States
Troy Astorino is the co-founder and Chief Technology Officer of PicnicHealth, where he leads the development of AI for conducting faster, more efficient, and more reliable clinical research. His team at PicnicHealth developed LLMD, the world’s highest-performing AI model for interpreting... Read More →
avatar for Sarah Lyons

Sarah Lyons

Head of Operations, Applied AI Science, IQVIA, Canada
Sarah Lyons is head of operations for IQVIA’s global Applied AI Science organization, empowering healthcare and life science organizations to unleash the full potential of AI, reliably and responsibly. She leads a team delivering award-winning platforms and deep expertise to help... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

#244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-582-L04-P; CME 1.00; RN 1.00

This session will explore the FDA START program for accelerating rare disease therapies. Three speakers from companies involved in the START pilot and an FDA representative will provide insights.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how the cadence of medical writing and regulatory affairs shifts for those participating in the START program.

Chair

Robin Whitsell

Speaker

Panelist
Quyen Tran, PharmD

Panelist
Paulette Robinson, PhD, RAC

Panelist
Madiha Khalid, PhD

Panelist
Jhon Cores, PhD


Speakers
avatar for Jhon Cores

Jhon Cores

Associate Director, Medical Writing, Moderna, Inc, United States
Jhon is an Associate Director of Medical Writing at Moderna Inc., where he serves as the Medical Writing lead for various rare disease an oncology programs. He has 10 years of experience in the field working in different sectors, including university startups and contract research... Read More →
avatar for Madiha Khalid

Madiha Khalid

Senior Director, Medical Writing, Larimar Therapeutics, United States
Madiha is a pharmaceutical industry professional with a background in fundamental bench research. Her experience as a regulatory medical writer working with small, mid-size, and large pharmaceutical companies over the past 10 years has given her an in-depth understanding of all phases... Read More →
PR

Paulette Robinson

Senior Director, Regulatory Affairs, Neurogene Inc., United States
Paulette Robinson, PhD, RAC is the Senior Director, Regulatory Affairs at Neurogene Inc. Her regulatory affairs experience has focused on gene therapies in rare central nervous system and ophthalmic indications. She continues to lead the global regulatory strategy for the NGN-401... Read More →
QT

Quyen Tran

Science Policy Analyst, OND, CDER, FDA, United States
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

1:45pm EDT

#243: The Adoption of Artificial Intelligence and Machine Learning in Clinical Research
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207B
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-581-L04-P; CME 1.00; RN 1.00

Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.

Learning Objectives

Describe the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Discuss the impact of AI/ ML on time savings, investment, and deployment of organizational resources.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Use Case Examples within Clinical Development
Emily Carter, MBA

Organizational Use Case
Amanda Donovan


Speakers
avatar for Emily Carter

Emily Carter

Director, Data Science & Analytics, AbbVie, United States
Emily leads the Data Science & Analytics Trial Execution teams in R&D at AbbVie. Her teams’ focus is on enhancing the efficiency and quality of end-to-end trial execution through comprehensive data analysis and insights across RBQM, Feasibility & RWD, Medical & Safety, Trial Diversity... Read More →
avatar for Amanda Donovan

Amanda Donovan

Director, Emerging Priorities & Innovation, Takeda, United States
Amanda Donovan is part of Takeda’s Emerging Priorities & Innovation (EP&I) team within the R&D Global Development organization. The EP&I Team is focused on creating the next generation clinical trial, where innovation, the site, and the patient journeys converge. With 19 years of... Read More →
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Director of Sponsored Research, Research Associate Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including... Read More →
avatar for Mukul Virmani

Mukul Virmani

Director, Clinical Data Science, AI Research Center, Gilead, United States
Strategic and visionary leader with over a decade of experience driving innovation in clinical data science, AI/ML analytics, and operational excellence within global pharmaceutical and CRO settings. Demonstrated expertise in managing high-performing teams, delivering transformational... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum

1:45pm EDT

#245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-583-L04-P; CME 1.00; RN 1.00

This session examines the relationship between protocol complexity, participant burden, and enrollment challenges, alongside the development and impact of participant feedback questionnaires. Patient advisors and attendees will interpret results and discuss improvements in trial performance.

Learning Objectives

Discuss patient participation burden based on protocol design characteristics and requirements; Identify design elements driving elevated levels of burden and impacting clinical trial performance; Recognize how to manipulate results into practical improvements for clinical research projects; State the value of participant feedback and compose rationale for inclusion of feedback in future studies; Describe strategies to reduce and address clinical trial and portfolio-wide participation burden.

Chair

Lani Hashimoto

Speaker

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Sabina Kineen

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Patrick Gee, SR, PhD, MS

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Stephanie Manson

Addressing Participation Burden in Clinical Trials: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA


Speakers
avatar for Patrick Gee

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States
As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Rare Disease Patient Advocacy, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
SM

Stephanie Manson

IND Directions, LLC, United States
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum

1:45pm EDT

#246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-584-L04-P; CME 1.00; RN 1.00

As of April 2, 2025, President Trump signed 103 Executive Orders in 2025 (EO 14147 to EO 14249) and sweeping government actions have led to widespread change in the health and biomedical research industries. Impacts on precision the effects of many of the Orders are largely unknown and tied up in legislative process. This has created considerable uncertainty for biomedical research and subsequent development of precision medicines and diagnostics. In this session we will review the 2025 Executive Orders, the court decision striking down the LDT Final Rule, and certain organizational changes at FDA that impact precision medicine and research and will delve deeper into the global impacts that are expected as a result.

Learning Objectives

List 2025 Executive Orders affecting personalized medicine and innovation in product and diagnostics development; Summarize impacts of 2025 Executive Orders on health innovation, research, regulations including the LDT final rule and patients; Discuss potential implications of current changes in the environment on global R&D.

Chair

Courtney Granville, PhD, MPH

Speaker

Panelist
Megan Doyle, JD, MPH

Panelist
Lia Ridout

Panelist
Carly McWilliams, MBA

Panelist
Nathan Brown, JD


Speakers
avatar for Nathan Brown

Nathan Brown

Partner, Akin Gump Strauss Hauer & Feld LLP, United States
Nathan Brown leads the FDA practice at Akin LLP. Drawing upon his diverse health care industry and governmental experience, Nathan provides his clients with strategic, practical advice on cutting-edge regulatory, compliance, enforcement, and policy matters. He has worked extensively... Read More →
avatar for Megan Doyle

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
avatar for Courtney Granville

Courtney Granville

Chief Scientific Officer, GO2 For Lung Cancer, United States
Courtney Granville heads the Research Team at GO2 for Lung Cancer. In this role, she oversees GO2’s community engaged and clinical research efforts, the Lung Cancer Registry, and the LungMATCH program. She identifies areas of unmet clinical research need and develops innovative... Read More →
avatar for Carly McWilliams, MBA

Carly McWilliams, MBA

Head of Regulatory Policy, Roche Diagnostics, United States
avatar for Lia Ridout

Lia Ridout

Patient Advocate, N/A, United States
Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

1:45pm EDT

#247: Guerrilla Strategic Delivery
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-585-L04-P; CME 1.00; PDU 1.00 PMI 2166OM1274; RN 1.00

Traditional project management methodologies often burden teams with unnecessary complexity, slowing progress and stifling innovation. Guerilla Strategic Delivery explores bold, adaptive, and pragmatic approaches to project execution that cut through the noise and deliver real results. This session will challenge outdated frameworks, offering fresh strategies that meet teams where they are—maximizing efficiency, flexibility, and impact without the bureaucratic bloat. Whether you're leading a startup, managing cross-functional teams, or driving change within a large organization, you'll leave with actionable insights to streamline delivery and achieve strategic success on your terms.

Learning Objectives

Discuss implementing adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Identify ways to optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; Describe ways to facilitate team empowerment by balancing structure and support with minimal bureaucracy; Apply innovative techniques to accelerate decision-making and improve problem-solving efficiency.

Chair

Sajida Roberson, MBA, MPH

Speaker

Short-Cycle Strategy: Adaptive Execution for High-Impact Delivery
Marina Kobiashvili, MA

Breaking the Waterfall: A Pragmatic Agile Approach in Drug Development Perspective - Applying Agile Principles in a Traditionally Rigid Lifecycle
Sean Ogle

Panelist
Jennifer Trevor, PhD, MS


Speakers
avatar for Marina Kobiashvili

Marina Kobiashvili

Independent Consultant, United States
SO

Sean Ogle

Senior Consultant, SEI Inc., United States
avatar for Sajida Roberson

Sajida Roberson

Business Transformation, Independent Consultant, United States
Meet Sajida Roberson, a dynamic consultant blending strategic leadership with hands-on expertise to drive impactful business transformations. With a proven track record in global pharmaceutical companies, Sajida seamlessly transitioned from corporate strategy roles to independent... Read More →
avatar for Jennifer Trevor

Jennifer Trevor

Director-Global Category Lead- Development, Astellas, United States
Jen Trevor, PhD, combines scientific expertise with business acumen, driving innovation in pharma. With a PhD in Chemistry from the University of Illinois at Chicago, Jen began her career in biosensor research at Argonne National Laboratory and as a Forensic Chemist at the DEA. She... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

1:45pm EDT

#248: Embracing ICH E6(R3) with Risk-Based Quality Management
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-586-L04-P; CME 1.00; RN 1.00

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.

Learning Objectives

Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.

Chair

Madeleine Whitehead

Speaker

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS


Speakers
avatar for Abigail Dirks

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →
MW

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom
Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-587-L04-P; CME 1.00; RN 1.00

This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Elena Popa, MPharm

Speaker

Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH

Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Elena Popa

Elena Popa

Chief of Staff, Global Regulatory Affairs, Bayer, Switzerland
Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →
avatar for Kelly Robinson

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

#250: Pediatric Cluster Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-588-L04-P; CME 1.00; RN 1.00

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

Speaker

PMDA Perspective
Junko Sato, PhD

EMA Perspective
Corinne de Vries, PhD, MA, MSc

Panelist
Franca Ligas

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD


Speakers
avatar for Dionna Green

Dionna Green

Director, Office of Pediatric Therapeutics, FDA, United States
Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →
avatar for Robyn Langham

Robyn Langham

Chief Medical Adviser, Australia Health Products Regulation Group, Australia
Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.
FL

Franca Ligas

Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands
Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →
avatar for Melodi McNeil

Melodi McNeil

Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Corinne de Vries

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

1:45pm EDT

#251: China Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-589-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.

Chair

Ling Su, PhD

Speaker

Brief Introduction from the NMPA
Feng Zhu

The Progress of China's Drug Review and Approval Reform
Jianwu Zhang, PhD

Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective
Wei Zhang

The Past Decade of China's Biopharma Innovation
Xiaoyuan Chen, PhD


Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
avatar for Ling Su

Ling Su

Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
JZ

Jianwu Zhang

Division Director, Drug Registration Department, National Medical Products Administration, China
FZ

Feng Zhu

Director, Cooperation Department, China Center for Food and Drug International Exchange (CCFDIE), China
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-590-L04-P; CME 1.00; RN 1.00

During this session, speakers will share insights and recent experiences regarding the implementation of Inspection Reliance from both Regulatory Authorities and Industry perspectives, including unilateral reliance and work-sharing.

Learning Objectives

Identify Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Describe Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Discuss the modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections.

Chair

Maria Cristina Mota Pina, MBA

Speaker

ANVISA Perspective
Bianca Zimon, LLM

Pathways to Inspection Reliance: A 20 Year Journey
Andrea Kurz, RPh


Speakers
avatar for Andrea Kurz

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland
Andrea Kurz is Senior Director, Lead External Advocacy for Europe and Middle East at Roche in Basel, Switzerland. She has +20 years’ experience in the Pharmaceutical Industry holding various positions in Quality & Compliance and Regulatory Affairs. Andrea is a Pharmacist and graduated... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
avatar for Bianca Zimon

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

1:45pm EDT

#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-591-L04-P; CME 1.00; RN 1.00

In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.

Learning Objectives

Recognize the pros/cons and challenges in designing clinical trials with composite endpoints; Discuss advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.

Speaker

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD

Application of win statistics in non-malignant hematology
Wenquan Wang, PhD

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD


Speakers
QT

Qian Tang

University of Iowa, United States
Qian Tang is a Ph.D. candidate in Statistics at the University of Iowa, specializing in machine learning, optimization, and statistical computation. Her research focuses on developing efficient algorithms for analyzing high-dimensional data, with applications in statistical learning... Read More →
avatar for Jialu Wang

Jialu Wang

Statistician, Vertex Pharmaceuticals, United States
Jialu is a senior biostatistician at Vertex Pharmaceuticals. She closely works with health economic and research and market access teams for reimbursements and HTA submissions of multiple therapies. She also works on late Phase 3b/4 studies. Her research interests include adaptive... Read More →
avatar for Wenquan Wang

Wenquan Wang

Senior Director, Pfizer, United States
Wenquan got his PhD degree in Biostatistics from the University of Iowa. He was an assistant professor at University of Alabama at Birmingham before joining the pharmaceutical industry. He has over 20 years of experience in applying statistics in translational research and phase I-IV... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
206
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-592-L04-P; CME 1.00; RN 1.00

This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.

Learning Objectives

Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.

Chair

Amber Meriwether, JD, MA

Speaker

Industry Perspective
Elizabeth Iorns, PhD

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec


Speakers
avatar for Elizabeth Iorns

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States
Elizabeth Iorns, Ph.D., is the CEO and co-founder of Science Exchange. Science Exchange accelerates scientific discovery by enabling instant connections to the world’s best R&D facilities through a marketplace of pre-qualified and pre-contracted scientific service providers. Science... Read More →
avatar for Amber Meriwether

Amber Meriwether

Corporate Strategy, Astellas Pharma, United States
Amber Meriwether is a global leader with 20+ years in healthcare, driving initiatives that accelerate innovation and deliver measurable impact. As Director of Corporate Strategy at Astellas Pharma, she leads cross-functional teams to develop strategic capabilities and deliver key... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
CZ

Cecilia Zvosec

Strategy & Insights, ZS, United States
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

2:45pm EDT

Refreshment Break
Tuesday June 17, 2025 2:45pm - 3:45pm EDT
EH
Component Type: Social Event



Tuesday June 17, 2025 2:45pm - 3:45pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

2:55pm EDT

#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Good Clinical Practices & QA - RBQM Working Group for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   16: Community-Rounds, Session

2:55pm EDT

#256.1 RT: Roundtable Discussion: Participant Compensation in Clinical Trials and Using Generative AI to Explore our Track Record on Paying Participants
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C
Component Type: Workshop

Join the Bioethics Community for a follow up round table discussion tied to session: Participant Compensation in Clinical Trials - Exploring Today's Landscape and Unlocking Opportunities (Tuesday June 17 | 10:30am - 11:30am EDT) and Using Generative AI to Explore our Track Record on Paying Participants: What Can we Learn to Support More Diverse Representation (Tuesday June 17 | 4:00pm - 5:00pm EDT) and Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation (Tuesday, June 17, 2025 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Workshop

2:55pm EDT

#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session,

Chair

Chaitanya Koduri, DDS, MHS

Speakers
avatar for Chaitanya Koduri

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session

3:00pm EDT

#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge
Component Type: Workshop

Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

Identify innovative methodologies, technologies and tools for innovative therapy development; Collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

3:00pm EDT

#258 IT: Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 2
Component Type: Session

Generative AI adoption within the regulatory writing field has made tremendous progress over the last year. However, to maximize ROI, teams need to identify ways to expand automation beyond traditional benchmarks and clinical study report (CSR) applications. In this session Certara will share practical approaches for leveraging generative AI across the submission dossier from pre-clinical module 3 documents to PK study reports to PBRERs and more.

Speaker

Speaker
Nick Brown

Speaker
David Meats, II


Speakers
avatar for Nick Brown

Nick Brown

Director, Global Portfolio Leader, Certara.AI, Certara, United States
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing... Read More →
avatar for David Meats

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States
Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

#259 IT: Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 3
Component Type: Session

Current (pre-)screening methods are slow and expensive… but did you know that they also miss critical information? IntelliScript’s studies show that ineligible participants are randomizing into trials in shocking numbers. Irix® can fill the information gap and speed up enrollment by retrieving and interpreting health data on trial participants in a matter of seconds. Just collect a HIPAA authorization to access our proprietary, nationwide data and make better, faster eligibility decisions.

Speaker

Speaker
Alyssa Vincze


Speakers
avatar for Alyssa Vincze

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript , United States
Alyssa is an actuary serving as Principal and Director of R&D at Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She leads new product development and recently launched Irix®, a trial eligibility tool that leverages... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

#260 IT: Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 1
Component Type: Session

Clinical submissions demand extensive documentation, making manual processes slow and error-prone. AutoCT automates workflows for CSRs, protocols, and safety reports, reducing turnaround time, improving data quality, and enabling teams to focus on strategy. Learn about: AI-driven templates for rapid submission creation. Automated checks to reduce errors. Two-click data traceability. AI-assisted tools keep users in control. Join us for a live demo of AutoCT’s end-to-end workflow.

Speaker

Speaker
Brandon Rice


Speakers
avatar for Brandon Rice

Brandon Rice

CPO, Weave Bio, United States
Brandon leads Product at Weave, overseeing the development of AutoIND, an AI-powered platform streamlining IND preparation. His work focuses on building products that impact lives, deliver value, and enhance user experience. With a background in life science startups, he has worked... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

4:00pm EDT

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-593-L04-P; CME 1.00; RN 1.00

We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).

Learning Objectives

Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.

Chair

Greg Ball, PhD

Speaker

PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS

PHUSE Safety Analytics Education Library
William Palo, MS

FDA Medical Queries (FMQs)
Linda Jeng, MD, PhD

Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MEd, MPH


Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →
avatar for Linda Jeng

Linda Jeng

Associate Director for Biomedical Informatics, FDA, United States
Dr. Linda Jeng holds an MD and PhD in Cell and Molecular Biology from the University of Pennsylvania. She completed a residency in Pediatrics and Medical Genetics at Rainbow Babies and Children's Hospital and the University Hospitals of Cleveland, followed by a fellowship in Clinical... Read More →
avatar for William Palo

William Palo

Director, Safety Statistics, AbbVie, United States
Bill has an MS in Applied Statistics from the University of Iowa and has been an industry statistician for over 30 years with over half that time dedicated to product safety. He is currently the therapeutic head of safety statistics for the late-stage oncology portfolio at AbbVie... Read More →
avatar for Y. Veronica Pei

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

4:00pm EDT

#262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-594-L04-P; CME 1.00; RN 1.00

This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. The session will address the challenges sites face in adopting new technologies, from budget constraints to staff resistance, and the challenge of integrating automation into existing workflows.

Learning Objectives

Explain how automation and integration reduce site burden and improve trial efficiency; Identify compliance challenges in implementing automated systems; Discuss best practices for overcoming barriers to technology adoption.

Chair

Denise N Bronner, PhD

Speaker

Strategic Implementation of Automation
Amber Michelle Hill, PhD

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration and Compliance
Cal Collins


Speakers
avatar for Denise Bronner

Denise Bronner

Founder & CEO, Empactful Ventures, United States
Denise N Bronner, Ph.D. has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global... Read More →
avatar for Cal Collins

Cal Collins

Chief Technology Officer, OpenClinica, LLC, United States
Cal co-founded OpenClinica with colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active... Read More →
avatar for Amber Hill

Amber Hill

Founder & CEO, R.grid, United Kingdom
avatar for Amber Hill

Amber Hill

Founder & CEO, R.grid, United Kingdom
Dr. Amber Hill founded Research Grid (R.grid) to automate clinical trials to cut costs, reduce delays, and increase patient engagement and retention. Her expertise is in end-to-end medical research, patient engagement, and smart software systems. Prior to R.grid, her career in biomedical... Read More →
avatar for Kimberly Tableman

Kimberly Tableman

Founder & CEO, Espero, United States
With a robust background in clinical development and a sharp focus on digital health, my journey has led me to found ESPERO, where we're revolutionizing drug development through insight-driven protocol design. At the helm of ESPERO, my team and I are committed to enhancing operational... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-595-L04-P; CME 1.00; RN 1.00

We present trends and insights from an analysis of participant payment language of more than 7,500 consent forms reviewed by a large, independent IRB and discuss the ethical implications of insufficient compensation for trial participants.

Learning Objectives

Explain trends and insights in clinical trial participant payments based on 7500 clinical trial ICFs collected and analyzed between 2019 and 2024; Examine the language used to describe payments and how that impacts participants; Discuss ethical issues and assumptions about IRB approval of participant compensation for research.

Chair

Kelly Fitzgerald, PhD

Speaker

Panelist
Kelly Fitzgerald, PhD

Panelist
Donna Libretti Cooke, JD


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Kelly Fitzgerald

Kelly Fitzgerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States
Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

4:00pm EDT

#264: How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-596-L04-P; CME 1.00; RN 1.00

This panel will explore available regulatory guidance for Real-World Data (RWD) quality assessments and how available implementing tools and frameworks may be applied for different types of RWD and use cases to help drug developers meet regulator expectations.

Learning Objectives

Recognize expectations for real-world data (RWD) quality assessments in studies intended for regulatory submissions; Identify available tools and frameworks for implementing RWD quality assessments; Explain ways to incorporate RWD quality assessments into internal workflows using practical approaches.

Chair

Eleanor Caplan, PharmD, PhD

Speaker

Regulatory Perspective
Luis Pinheiro, PharmD, MSc

Balancing Patient Centricity with Data Quality Requirements and Standards
Jennifer Farmer, MS

Learnings About Meeting RWD Fitness Standards From FDA Use Cases
Ulka B Campbell, PhD

Can we Separate Relevance From Reliability in Data Quality Assessments? Quality-by-Design in Secondary use of Health Data
Pamela Dobay, PhD, MSc


Speakers
avatar for Ulka Campbell

Ulka Campbell

Head of Scientific Strategy, Aetion Inc, United States
Ulka Campbell is an epidemiologist and the Head of Scientific Strategy at Aetion, a healthcare technology and research services company, providing methods and regulatory support across therapeutic areas and leading research to inform regulatory RWE best practices. Previously, she... Read More →
avatar for Eleanor Caplan

Eleanor Caplan

Senior Principal Scientist, Johnson & Johnson Innovative Medicine, United States
Eleanor Caplan, PharmD, PhD, is a Senior Principal Scientist in the Data Science & Digital Health organization at Johnson & Johnson Innovative Medicine. She has over 15 years of experience in healthcare and research, encompassing pharmacy practice, academia, consulting, payer, and... Read More →
avatar for Pamela Dobay

Pamela Dobay

Director, Biogen, Switzerland
As Director in the Quantitative Sciences and Development Operations unit, Pamela is responsible for developing and leading Biogen’s RWD / RWE generation activities through registry partnerships. Pamela started at Biogen in 2022 as a Global Medical Director before undertaking a broader... Read More →
avatar for Jennifer Farmer

Jennifer Farmer

Chief Executive Officer, Friedreich's Ataxia Research Alliance (FARA), United States
Jennifer Farmer is the Chief Executive Officer of the Friedreich’s Ataxia Research Alliance (FARA). She is one of the founders and the coordinator for the Collaborative Clinical Research Network in FA. In her current role at FARA as CEO, she helps to carry out the strategic mission... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

#265: Breaking Barriers: Making Health Information Accessible to All
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151A
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-597-L04-P; CME 1.00; RN 1.00

The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.

Learning Objectives

Discuss the basics of health literacy and how they relate to health outcomes; Explain ways to apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.

Chair

Chantelle Rein-Smith, PhD

Speaker

Panelist
Anna Osinski

Panelist
James Lindsay Cobbs


Speakers
JC

James Cobbs

Founder and Principal, Apath Nexus Consulting, United States
Founder of Apath Nexus, Lindsay provides strategic regulatory guidance and intelligence to support innovation and compliance with FDA and select international frameworks. He has worked with pharmaceutical and biotechnology companies, patient groups, and trade associations to align... Read More →
AO

Anna Osinski

Associate Director, Development Unit Lead, Patient Centricity and Engagement, Biogen, Inc., United States
Anna Osinski is an Associate Director, Development Unit Lead in Biogen’s Patient Centricity and Engagement team. Anna has more than 17 years of experience in clinical trial recruitment and currently oversees patient engagement strategy for trials in Movement Disorders, MS & Immunology... Read More →
CR

Chantelle Rein-Smith

Principal Medical Writer and Consultant, Whitsell Innovations, Inc., United States
Chantelle holds a PhD in Medical and Molecular Genetics from Oregon Health & Science University and completed postdoctoral training at the University of North Carolina (UNC) at Chapel Hill prior to transitioning into a medical writer role at Whitsell Innovations, Inc. (WI), where... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

4:00pm EDT

#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-602-L04-P; CME 1.00; RN 1.00

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?

Learning Objectives

Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance

Chair

Melissa Herman, MSc

Speaker

Industry Perspective
Maria Apostolaros, JD, PharmD, MS, RPh

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS


Speakers
avatar for Maria Apostolaros

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →
MP

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark
Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.
avatar for Lesley Maloney

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session |   09: Regulatory, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum


Speakers
avatar for Stiina Aarum

Stiina Aarum

Senior Scientific Specialist, Scientific Advice, Product Development Scientific, European Medicines Agency, Netherlands
AR

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
Adriana Racolta, PhD is an industry professional with 12 years of experience in the field. As a Director of Regulatory Affairs at Pfizer Inc., she spearheads the company's efforts to implement diagnostic regulatory requirements in support of precision medicine development. In this... Read More →
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
avatar for Jennifer Tucker

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Forum |   09: Regulatory, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#267: Delivering Effective Business Transformations and How to Apply them to Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-599-L04-P; CME 1.00; PDU 1.00 PMI 2166K30VP9; RN 1.00

Significant business transformations can be critical to achieve organizational vision and goals in an evolving landscape. In this session we will discuss how to effectively plan, execute and monitor significant business transformations.

Learning Objectives

Discuss the importance of business transformations in defining future-states and driving organizations forward; Explain how to effectively plan, execute and monitor business transformations; Describe how to apply business transformations to drug development.

Chair

Ashar Choudhry, MBA

Speaker

Delivering Effective Business Transformations and How to Apply them to Drug Development
Jason Eisfelder


Speakers
AC

Ashar Choudhry

Executive Director, Enterprise Program Leadership & Operational Excellence, Bristol Myers Squibb, United States
Ashar Choudhry has over 25 years of experience within the BioPharma industry in leading transformational changes across a variety of major divisions and at the enterprise level. He is highly experienced in strategy development, business operations, operational excellence/process improvement... Read More →
avatar for Jason Eisfelder

Jason Eisfelder

DSO Practitioner, Bayer, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

4:00pm EDT

#268: New Data and Insights on the Vendor Qualification Process in Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-600-L04-P; CME 1.00; RN 1.00

Review and panel discussion of the results from a new Tufts Center for the Study of Drug Development (TCSDD) Working Group study assessing the vendor qualification and selection process

Learning Objectives

Discuss the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Recognize the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Neil McCullough

Panelist
Patty Leuchten

Panelist
Shyard Wong, DrMed

Panelist
Tran V. Huynh


Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
TH

Tran Huynh

Director, Clinical Vendor Strategy, Fortrea, United States
avatar for Patty Leuchten

Patty Leuchten

Founder and CEO, Diligent Pharma, United States
Patricia Leuchten is the Founder and CEO of Diligent Pharma, a quality and compliance organization with tech-enabled service offerings that help mitigate risk in clinical trials. Leuchten has over 30 years of experience as a business owner and entrepreneur in the pharmaceutical industry... Read More →
avatar for Neil McCullough

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, IQVIA, United States
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →
avatar for Shyard Wong

Shyard Wong

Global Head, Clinical Quality and Continuous Improvement, Sanofi, France
A physician by training who graduated from the National University of Singapore in 1991, Shyard Wong rotated through a series of clinical postings in both the public and private healthcare sectors in Singapore and then undertook a career switch to become a full time healthcare administrator... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#269: Pharmacovigilance Inspections Fireside Chat
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
152AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-601-L04-P; CME 1.00; RN 1.00

A rare opportunity to hear inspectors from three global regulators and a European industry association compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts. It is well recognized that pharmacovigilance is a global activity; however, the regulation of pharmacovigilance (PV) still occurs very much at a country-specific level. Regulation is enforced by inspectors in each country which results in organizations being inspected frequently by multiple regulators. Inspectors from three global world-renowned regulatory agencies (US FDA, Health Canada, UK MHRA) will come together in this fireside chat in a rare opportunity to hear inspectors’ perspectives and how they can envision working together to ensure the systems in place are adequately capturing safety issues. The regulator perspective will be complemented by industry views from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Discussions will focus on differences and similarities in inspection styles and requirements across the three regulators, including inspector expectations and conduct of inspections. You will have the opportunity to hear from inspectors about key emerging issues. Common inspection trends will be discussed highlighting areas where inspectors see compliance issues across all three regulators. There will be a chance to hear from the panel discussing the future of inspections, including hot topics such as AI and new initiatives in each of the respective regions . Discussions will also focus on collaboration efforts, such as efforts to reduce burden on industry and looking into the future about upcoming best practices in pharmacovigilance. The audience will have a chance to pose questions to panel members to gain simultaneous insights from regulators and industry.

Learning Objectives

Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators and understand their impact on industry; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.

Chair

Sophie Radicke, MSc

Speaker

Industry Perspective
Carrie Scott

FDA Perspective
Namita Kothary, PharmD, RAC

Health Canada Perspective
Stephane Berard, MS


Speakers
avatar for Stephane Berard

Stephane Berard

Interim Supervisor-Health Product Compliance East Unit, Health Canada, Canada
Stéphane is acting supervisor for the Health Product Compliance East Unit at Health Canada since 2022. He joined the organization in 2012 as an inspector and he had been involved in various compliance and enforcement activities for drugs and natural health products. In 2016, he became... Read More →
avatar for Namita Kothary

Namita Kothary

Associate Director, DEPS, OSI, OC, CDER, FDA, United States
Namita Kothary, PharmD, RAC (US) currently serves as Associate Director of Scientific Affairs within FDA-CDER's Office of Scientific Investigations - Division of Enforcement and Postmarketing Safety, where she develops and executes strategies for international collaborations and outreach... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
avatar for Carrie Scott

Carrie Scott

Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety, AbbVie Ltd, Portugal
Responsibility to lead the strategic positioning & direction of Pharmacovigilance (PV) quality & compliance across AbbVie's global PV QMS. Act as an expert in critical assessment & interpretation of PV compliance regulations, and consequential internal PV policy and process determination... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum |   01: ClinSafety-PV, Forum

4:00pm EDT

#271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-603-L04-P; CME 1.00; RN 1.00

Global key initiatives towards harmonization, convergence and collaborative efforts in advancing the development and accessibility of advanced therapy medicinal products (ATMPs) will be explored, with a special focus on supporting MICs.

Learning Objectives

Outline global efforts on collaboration and harmonization initiatives for ATMPs; Identify and discuss efforts to build regulatory capacity, provide technical assistance, and facilitate access to ATMPs in middle-income countries (MICs); Discuss strategies for achieving convergence and harmonization for ATMPs.

Chair

Maria Antonieta Tony Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Kowid Ho, PharmD

Panelist
Julia Djonova

Panelist
Dianliang Lei

Panelist
Caroline Pothet, PharmD, RPh, RAC

Panelist
Yasuhiro Kishioka, PhD

Panelist
Renata Miranda Parca, AHIP


Speakers
JD

Julia Djonova

Head Division ATMP, Swissmedic, Switzerland
avatar for Kowid Ho

Kowid Ho

Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of regenerative medical products (gene/cell therapy products). Since joining PMDA in 2008, Dr. Kishioka has been involved in various international... Read More →
DL

Dianliang Lei

Scientist of Technology, Standard and Norm, World Health Organization (WHO), Switzerland
RP

Renata Parca

Health regulatory specialist, ANVISA, Brazil
I hold a degree in Biology from the University of Brasília, where I also completed my master’s degree. I work as a health specialist at Anvisa since 2005, in the office of blood, tissues, cells, and advanced therapy medicinal products.
avatar for Caroline Pothet

Caroline Pothet

Head of advanced therapies and haemato-oncology, European Medicines Agency, Netherlands
Caroline Pothet is head of the office for advanced therapies and haemato-oncology at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug... Read More →
avatar for Maria Antonieta Roman

Maria Antonieta Roman

Head Regulatory Policy LaCan, Novartis, Mexico
Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

4:00pm EDT

#272: Towards Instantaneous Regulatory Decisions and Better Predictability
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-604-L04-P; CME 1.00; RN 1.00

An interactive sesion to reimagine regulatory frameworks and streamline product approvals globally. This session will focus on focus on data transparency, collaboration, process optimization and technology to accelerate medicine development and patient access.

Learning Objectives

Recognize the power of data to accelerate submissions; Initiate pilot projects aiming at sharing data, not documents, and lay the groundwork for dynamic reviews; Create better pre-competitive collaborations to share more safety data and endpoints.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Debra Yeskey

Panelist
Len Rosenberg, PhD, RPh

Panelist
Tony Fantana, PhD

Panelist
Tala Fakhouri, PhD, MPH


Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Tony Fantana

Tony Fantana

Sr. Dir, Eli Lilly, United States
Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →
avatar for Debra Yeskey

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States
Debra Yeskey, Pharm.D., is the Head of Regulatory Policy and Intelligence for the Coalition for Epidemic Preparedness Innovations (CEPI). She has been with CEPI since December 2018, and was instrumental in the creation of the Regulatory Affairs Group under COVAX that is co-led by... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

4:00pm EDT

#273: Regulatory Cooperation Between US and Japan
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Salon B
Component Type: Forum
Level: Intermediate

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Washington, DC Office in November, 2024 for one of the purposes of strengthening regulatory cooperation between US and Japan. After the establishment of the Office, direct communication and practical cooperation at DC time make possible, and it is also possible to make the foundation of regulatory cooperation. This session will explore the purpose behind the establishment of PMDA’s Washington, DC Office and its role in strengthening U.S.-Japan regulatory cooperation. Representatives from PMDA and FDA will share their perspectives on collaborative opportunities, followed by a panel discussion on how this initiative can enhance global regulatory alignment and communication.

Learning Objectives

Analyze the strategic purpose behind the establishment of PMDA’s Washington, DC Office and evaluate its role in enhancing regulatory cooperation between the US and Japan; Engage in a panel discussion to identify and propose opportunities for collaborative initiatives between PMDA and FDA that support global regulatory alignment and improved international communication.

Chair

Naoyuki Yasuda, MSc

Speaker

Panelist
Richard Pazdur, MD

Panelist
Akihiro Ishiguro, PhD

Panelist
Mark Abdoo

Panelist
Yasuhiro Fujiwara, MD, PhD


Speakers
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
avatar for Mark Abdoo

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States
avatar for Richard Pazdur

Richard Pazdur

Director, Oncology Center of Excellence, CDER, FDA, United States
Richard Pazdur, M.D., is the director of the FDA’s Oncology Center of Excellence (OCE), which leverages the combined skills of FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products. In this... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Salon B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

#274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-605-L04-P; CME 1.00; RN 1.00

The pharmaceutical industry faces challenges due to global regulations. Structured data and cloud platforms can facilitate global collaborations. Visualizing the control strategy can enhance understanding of patient benefit-risk.

Learning Objectives

Recognize how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Discuss the concepts of IDMP and PQ/CMC and their roles in product quality discussions; Illustrate how an overall control strategy supports efficient product quality communication.

Chair

Ciby Joseph Abraham, PhD

Speaker

Panelist
Katie Duncan, PhD

Panelist
David Sidney Ross, MBA, MSc, PMP, RAC

Panelist
Vada Perkins, DrSc, MSc

Panelist
Omar Serang


Speakers
avatar for Ciby Abraham

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →
KD

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States
Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
avatar for Omar Serang

Omar Serang

Chief Cloud Officer, DNAnexus, United States
General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

4:00pm EDT

#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-606-L04-P; CME 1.00; RN 1.00

Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.

Learning Objectives

Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Explain statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.

Chair

Xiang Zhang, PhD

Speaker

Externally Controlled Trials in Oncology: Regulatory Considerations and a Case Example
Arup Sinha, PhD

Panelist
Charles Lee, MBA, MS

An EU Regulatory Perspective on External Controls
Andrew Thomson, PhD, MA, MS

Uncovering the Challenges of Utilizing RWE in Regulatory Decision Making: Barriers, Mitigations and Future Directions
Ran Duan, PhD


Speakers
RD

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States
avatar for Charles Lee

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →
AS

Arup Sinha

Statistician, OTS, CDER, FDA, United States
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
XZ

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States
Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

#276: Exploring Regulator Career Paths: How Breadth of Experience Informs Decision Making and Medicines Development?
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
206
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-607-L04-P; CME 1.00; RN 1.00

Regulatory decisions are often a widely discussed topic, but have you considered how a breadth of experience in the career journeys of regulators positively influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths in the critical work that they do. This is your opportunity to hear directly from regulators from the UK, Canada & Brazil about what they do, how they got there and what they have experienced and learnt along the way!

Learning Objectives

Recognize how breadth of experience within regulators supports medicines development for patients and society; Identify how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators).

Chair

Paula Walker, MA

Speaker

ANVISA Career Pathway: Impact to Medicines Development
Bianca Zimon, LLM


Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
avatar for Bianca Zimon

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

4:00pm EDT

#277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
201
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-608-L04-P; CME 1.00; RN 1.00

This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.

Learning Objectives

Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.

Chair

Denyse Baker, RAC

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Transforming Talent: Leveraging Partnerships for Biopharma Success
Dedric Day


Speakers
DB

Denyse Baker

Assoc. Vice President Global Quality Compliance, Eli Lilly and Company, United States
Denyse Baker is Associate Vice President of Global Quality Compliance with Lilly. She has more than 35 years of experience in the pharmaceutical industry including leadership roles with AstraZeneca, US FDA and PDA. Denyse’s expertise includes policy development, external engagement... Read More →
avatar for Dedric Day

Dedric Day

Senior Director- Strategic Talent Partnerships, Eli Lilly and Company, United States
Dedric Day has worked at Eli Lilly and Company for 22 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing... Read More →
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

Drug Development Multi-Functionalist, LifeSciHub , United States
Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

6:45pm EDT

DIA at the Nationals Park
Tuesday June 17, 2025 6:45pm - 9:00pm EDT
Nationals Park
Limited Availability – Register Now!
Immerse yourself in the electric atmosphere of Nationals Park as the Washington Nationals take on the Colorado Rockies during the DIA 2025 Global Annual Meeting. This exclusive opportunity grants DIA attendees reserved seating in Section 242 for two thrilling matchups on Monday, June 16th and Tuesday, June 17th, both starting at 6:45 PM.
Secure your seats and be part of the action as you network, unwind, and enjoy America's pastime with your peers.

This is a unique chance to experience the passion and camaraderie of professional baseball in the nation's capital, all while strengthening connections within the dynamic DIA community.

Matchups will take place Monday, June 16th and Tuesday, June 17th and both games start at 6:45pm

Secure Your Seats For an Unforgettable Night at Nationals Park and be Part of The Action!Click here to purchase your tickets for Monday, June 16th
Click here to purchase your tickets for Tuesday, June 17th

Tuesday June 17, 2025 6:45pm - 9:00pm EDT
Nationals Park 1500 South Capitol St SE, Washington, DC 20003
  19: Networking-Opportunities
 
Wednesday, June 18
 

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Wednesday June 18, 2025 8:30am - 9:30am EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-609-L04-P; CME 1.00; RN 1.00

The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.

Learning Objectives

Discuss the Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Explain the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Identify strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Claudia Ana Ianos, MD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Carmit Strauss, PharmD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Scott Evans, PhD, MS


Speakers
avatar for Scott Evans

Scott Evans

Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute of Public Health, United States
Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer Inc, United States
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →
avatar for Carmit Strauss

Carmit Strauss

Executive Director, Head of Risk Management and Organ Toxicity, Takeda, United States
Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the Risk Management and Organ Toxicity centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety, Pharmacovigilance and Medical Affairs. Carmit participants... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

#302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-610-L04-P; CME 1.00; RN 1.00

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Discuss improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy).

Chair

Allison Cuff Shimooka, MBA

Speaker

Panelist
Rebecca Noss, MS

Panelist
Narayan Nair, MD

Panelist
Jeremy Jokinen, PhD, MS


Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Narayan Nair

Narayan Nair

Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Narayan Nair, M.D. is the Director of the Division of Pharmacovigilance in the Center for Biologic Evaluation and Research at the FDA. He oversees the Division that performs pharmacovigilance activities for vaccines and other biologic products regulated by FDA. Dr. Nair is a Board-Certified... Read More →
RN

Rebecca Noss

President, Global Pharmacovigilance Consultant, Noss Research Consulting, United States
Global Pharmacovigilance ‘PV’ Consultant with twenty-eight years of solid clinical research experience and post-marketing in pharmaceuticals. Excellence in providing safety strategy to product development teams, ensuring timely and high-quality execution of safety documents such... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

8:30am EDT

#303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Wednesday June 18, 2025 8:30am - 9:30am EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-611-L04-P; CME 1.00; RN 1.00

Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.

Learning Objectives

Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS; Describe how to prepare and be ready to submit electronically; Discuss reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Industry Perspective: ICH E2B R3 Regional Implementations
Donald Williams

Beyond Borders: Navigating the Complexities of ICH E2B R3 Regional Implementations
Una Kessi


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Una Kessi

Una Kessi

Product Management Director, Safety and Pharmacovigilance, Oracle Health & Life Sciences, United Kingdom
Una works as a Product Management Director, Safety and Pharmacovigilance, at Oracle Health and Life Sciences. Her main focus is on Regulator Strategy, Safety and PV Regulations, Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also... Read More →
avatar for Donald Williams

Donald Williams

Global Patient Safety and Pharmacovigilance, Regulatory Reporting, Boehringer Ingelheim Pharmaceuticals, Inc., United States
Donald Williams currently works in the Global Patient Safety & Pharmacovigilance department of Boehringer Ingelheim Pharmaceuticals, Inc. He is a member of the Regulatory Reporting Team, and his responsibilities include overseeing ICSR submission activities and monitoring global regulatory... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

#304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities
Wednesday June 18, 2025 8:30am - 9:30am EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-612-L04-P; CME 1.00; RN 1.00

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators

Chair

Jane Myles, MSc

Speaker

Industry Perspective
Shelly Barnes

Industry Perspective
Brittany Niland


Speakers
avatar for Shelly Barnes

Shelly Barnes

Global Clinical Innovations Lead, UCB Biosciences, United States
Shelly Barnes is the UCB Global Innovations Lead based in Raleigh, NC, USA. She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Shelly is delivering solutions using novel technologies... Read More →
avatar for Jane Myles

Jane Myles

Program Director, Decentralized Trials and Research Alliance, United States
Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →
avatar for Brittany Niland

Brittany Niland

Senior Director-Clinical Trials Foundation Community Based Research, Eli Lilly and Company, United States
In May of 2016, I began my exciting career at Lilly. I fully embraced the project management role and swiftly advanced to become a subject matter expert in clinical development. As the technical leader, I mentored others and served as the point of contact for my trials, ensuring deliverables... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

8:30am EDT

#305: Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review
Wednesday June 18, 2025 8:30am - 9:30am EDT
207B
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-613-L04-P; CME 1.00; RN 1.00

Come learn about the exciting world of digital protocol and how industry innovators are taking the steps to transition from a document-centric protocol to a data-centric protocol, how digital protocol use cases can be enabled by AI and listen to how you and your company can prepare for the change required to adopt digital protocol. We will start with an update on current initiatives including the TransCelerate Digital Data Flow (DDF), CDISC Unified Study Definition Model (USDM), and ICH M11 Harmonized Protocol. Then we will explore the opportunities industry has to leverage structured digital protocol information to enable AI supporting innovation such as intelligent study design, automation of data transformation and analysis, and dynamic regulatory review. Finally, we will share our thoughts on how you and your company can get started on the digital protocol journey.

Learning Objectives

Recognize how various digital protocol collaborations are working together including ICH M11, TransCelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Discuss possible AI use cases that can leverage standard digital protocol information; Describe ways to prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Preparing for ICH M11 and Digital Protocols: Am I Ready?
William Illis, MPH

Industry Initiative Updates: How TransCelerate DDF, CDISC, USDM, and ICH M11 are Transforming Industry
Chris Decker, MS

Opportunities for Digital Protocol Standards Can Enable AI
Robert DiCicco, PharmD


Speakers
avatar for Chris Decker

Chris Decker

President and CEO, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
avatar for William Illis

William Illis

Global Head, Collaboration/Technology Strategy, Clinical Development & Analytics, Novartis , United States
Bill is Executive Director, Technology and Scientific Computing in the Advanced Quantitative Sciences line function at Novartis. He responsible for developing and implementing the analytics technology strategy focused on end-to-end clinical data flows, systems and processes. For the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   04: MedAffairs-SciComm, Session

8:30am EDT

#306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-614-L04-P; CME 1.00; RN 1.00

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials; Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Identify case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

Chair

Junko Sato, PhD

Speaker

How to Combat Fraud?
Kentaro Ichinose

FDA Perspective
Regina Zopf

MHRA Perspective
Jason Wakelin-Smith


Speakers
KI

Kentaro Ichinose

Inspector, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kentaro Ichinose currently serves as a inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA).
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
RZ

Regina Zopf

Senior Medical Officer, CDER, FDA, United States
Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

8:30am EDT

#307: Regulators and Communication in a Changing World: The ICMRA Role
Wednesday June 18, 2025 8:30am - 9:30am EDT
Room 151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-676-L04-P; CME 1.00; RN 1.00

ICMRA played a key role during the COVID-19 pandemic, ensuring sharing of vital information, providing common responses and aligning regulatory practices. A critical lesson learnt was that during a global crisis regulators need to become the main source of trusted information, both for each other and for the general public.

Learning Objectives

Evaluate ICMRA’s role in promoting global regulatory alignment and information sharing during the COVID-19 pandemic; Analyze strategies used by regulators to counter misinformation and disinformation during health emergencies.; Formulate evidence-based communication approaches to build public trust in regulatory authorities.

Chair

Tony Lawler, MD, MBA

Speaker

Panelist
Daniel Pereira

Regulators as Communicators in High-Income Settings
Emer Cooke, MBA, MSc

Findings from the 2025 Edelman Trust Barometer Special Report: Trust and Health
Camille DeSantis


Speakers
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
CD

Camille DeSantis

Managing Director, US Lead Health Brand Development, Edelman, United States
Camille DeSantis is Managing Director and U.S. Lead of Health Brand Development at Edelman. She returned to Edelman after founding Guard Dog Brand Development and SIGNAVA. A pioneer in archetypal brand strategy and inventor of research methods, she builds successful health brands... Read More →
avatar for Tony Lawler

Tony Lawler

Deputy Secretary, Health Products Regulation Group, Australian Department of Health and Aged Care, Australia
Professor Lawler is the Deputy Secretary, Health Products Regulation Group with the Australian Department of Health and Aged Care. Prior to this he was the Chief Medical Officer and Deputy Secretary Clinical Quality, Regulation and Accreditation with the Tasmanian Department of H... Read More →
DP

Daniel Pereira

ANVISA, Brazil
Wednesday June 18, 2025 8:30am - 9:30am EDT
Room 151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-615-L04-P; CME 1.00; RN 1.00

This presentation will explore the pivotal role of regulatory affairs consulting in the medical device/IVD industry, focusing on how consultants provide strategic value at every stage of product development and commercialization.

Learning Objectives

Analyze the strategic role of regulatory affairs consulting in the medical device/IVD industry and its impact on product development and commercialization; Evaluate how specialized regulatory consulting helps manufacturers navigate evolving regulatory requirements while fostering innovation and market competitiveness; Apply practical strategies for partnering with regulatory consultants to achieve regulatory compliance and commercial success.

Chair

Michael Ageboh, PhD, RAC

Speaker

Drug Delivery Device Combination Products - Exploring FDA Expectations from Clinical Investigation to Market Approval
Bryce Whited, PhD, MS


Speakers
MA

Michael Ageboh

Senior Manager, MedTech Services, Pharmalex / Cencora, United States
Michael Ageboh is a regulatory affairs professional with extensive experience within the MedTech industry. He has been involved in the end-to-end process of getting new products to market and maintaining products post market launch. He has worked for small, medium and large companies... Read More →
BW

Bryce Whited

Founder and Principal Consultant, WCI Medtech, United States
Bryce Whited, Ph.D. is the Founder and Principal Consultant at WCI MedTech, a consulting firm dedicated to providing medical device and pharma / biologics clients with expert regulatory affairs services for product development, market approval and post-market compliance. Bryce has... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
Wednesday June 18, 2025 8:30am - 9:30am EDT
150AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-616-L04-P; CME 1.00; RN 1.00

This forum will focus on practical Quality by design (QbD) and risk-based monitoring (RBM) clinical trial implementation strategies based on new case study examples of overcoming persistent adoption challenges, fostering organizational change management, and demonstrating value of implementation.

Learning Objectives

Apply practical QbD-RBM implementation strategies based on case study examples not previously publicly presented; Discuss new initiatives under development that will serve as additional future QbD tools; Identify persistent obstacles to broader QbD and RBM implementation, address their negative impacts, and provide applicable solutions to enable future adoption.

Chair

Gerrit Hamre, MA

Speaker

Existing Adoption Tools for All to Use
Morgan Hanger, MPA

Evidence of the QbD-RBM Continuum in Action
Marion Wolfs, MS

Agency Supporting Mechanisms for Clinical Trial Modernization
Alissa Mun, MS

New Case Study Examples for Others to Build Upon
Sameera Ibrahim


Speakers
avatar for Gerrit Hamre

Gerrit Hamre

Research Director, Duke-Margolis Institute For Health Policy (DMI), United States
Gerrit Hamre, MA, is a Research Director in Biomedical Regulatory Policy at the Duke Margolis Institute for Health Policy Institute. Gerrit has worked for nearly 20 years in the pharmaceutical industry with a focus on clinical research, regulatory, and commercial roles. Central to... Read More →
avatar for Morgan Hanger

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
AM

Alissa Mun

Health Scientist Policy Analyst, OMP, CDER, FDA, United States
Alissa Mun is a Health Scientist Policy Analyst in the Division of Clinical Trial Quality of the Office of Medical Policy in CDER/FDA. She provides scientific and technical input for ongoing policy initiatives such as risk-based monitoring, quality by design, and risk management with... Read More →
MW

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands
Wednesday June 18, 2025 8:30am - 9:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

#310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards
Wednesday June 18, 2025 8:30am - 9:30am EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-617-L04-P; CME 1.00; RN 1.00

National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.

Learning Objectives

Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.

Chair

Amira Deia Younes

Speaker

Panelist
Maria Cristina Mota Pina, MBA

Panelist
Sara Torgal, MPharm

Panelist
Hamada Sherief

Panelist
Donia Albastaki


Speakers
avatar for Donia Albastaki

Donia Albastaki

Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
HS

Hamada Sherief

Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt
Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating... Read More →
avatar for Sara Torgal

Sara Torgal

Global Regulatory Policy Lead, DIA, Switzerland
Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA... Read More →
avatar for Amira Younes

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates
Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

8:30am EDT

#311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Wednesday June 18, 2025 8:30am - 9:30am EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-618-L04-P; CME 1.00; RN 1.00

This session will highlight the complexity of regulatory frameworks for PACs drawing from an IFPMA/Clarivate study and case studies. An expert panel from industry and regulatory agencies will discuss solutions and lessons learned on reliance implementation.

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Identify lessions learned from reliance implementation for PACs to facilitate supply of medicinal products.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management (PQKM) Capability
Theresa Mullin, PhD

Bringing Reliance into Action - Our Journey From Pilots to Practice
Susanne Ausborn, PhD

Why is Regulatory Reliance a Necessity and not a Choice? An Illustration Using Industry Survey Results
Andrew Deavin, PhD, MS


Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Andrew Deavin

Andrew Deavin

Senior Director, Regulatory Affairs, GSK, Belgium
Andrew Deavin has spent over 25 years in Regulatory Affairs, after having gained a M.Sc. and Ph.D. in Immunology and working in vaccine research. He has managed regulatory projects in development, registration and life-cycle primarily in vaccines but also in haematology/oncology... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

8:30am EDT

#312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
Wednesday June 18, 2025 8:30am - 9:30am EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-619-L04-P; CME 1.00; RN 1.00

Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.

Learning Objectives

Identify hurdles and solutions to clinical trial recruitment, including early diagnosis and newborn screening; Identify approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Philip (P.J.) Brooks, PhD

Panelist
Anish Bhatnagar, MD

Panelist
Kim Quaintance-Lunn

Panelist
Matthew Klein, MD, MS

Panelist
Annie Kennedy

Panelist
Kerry Jo Lee, MD


Speakers
AB

Anish Bhatnagar

Chief Executive Officer, Soleno Therapeutics Inc, United States
Dr. Bhatnagar, CEO of Soleno since its inception in 2017, brings over 20 years of medical expertise to the biopharmaceutical and medical device industries. His extensive background encompasses the development of biologics, drugs, drug-device combinations, and diagnostic/therapeutic... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
avatar for Annie Kennedy

Annie Kennedy

Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States
Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
MK

Matthew Klein

CEO, PTC Theraputics, United States
Dr. Matthew Klein is CEO or PTC Therapeutics, a global biopharmaceutical company that discovers, develops and commercializes innovative therapies for rare disorders. Dr. Klein completed his undergraduate degree at the University of Pennsylvania graduating summa cum laude and Phi Beta... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare Disease Cures, FDA, United States
Dr. Kerry Jo Lee is a pediatric gastroenterologist/hepatologist and the Associate Director for Rare Diseases in the Office of New Drugs (OND), CDER. In this role she leads CDER’s Rare Diseases Team and the Accelerating Rare disease Cures (ARC) Program. Dr. Lee joined the FDA in... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution, Alexion, United States
Kim Quaintance-Lunn is Vice President, Head of Regulatory Science & Execution, for Alexion Pharmaceuticals; Strategic Advisor to the DIA Board of Directors; and Director at Large and Treasurer for the FDA Alumni Association. At Alexion, Kim is responsible for leading and implementing... Read More →
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session

9:30am EDT

Coffee Break
Wednesday June 18, 2025 9:30am - 10:30am EDT
EH
Component Type: Social Event



Wednesday June 18, 2025 9:30am - 10:30am EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

9:45am EDT

#313 IT: IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness
Wednesday June 18, 2025 9:45am - 10:15am EDT
Innovation Theater 1
Component Type: Session

The transformative potential for artificial intelligence (AI) in medical affairs is vast, accelerating insight and evidence generation from diverse real world data sources at unprecedented speed and scale. In this session we will explore the broad applicability of AI solutions - from chart and scientific literature review to strategic decision support, competitive landscaping and beyond - while emphasizing the crucial importance of expert validation and privacy for trust and compliance.

Speaker

Speaker
Niamh Catherine McGuinness, PhD


Speakers
avatar for Niamh McGuinness

Niamh McGuinness

Director, Pharma Solutions, IQVIA Applied AI Science, IQVIA, United States
Niamh McGuinness is Director of Pharma Solutions with the Applied AI Science Team in IQVIA. Niamh leads a diverse group of experts who build AI solutions and utilize a suite of award-winning technology to help pharma customers protect participant privacy and surface critical insights... Read More →
Wednesday June 18, 2025 9:45am - 10:15am EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

#313.1 IT: Synterex, Inc Innovation Theater: AgileWriter.ai™ - Your All-in-One Solution for Authoring and Managing Clinical Trial Documentation
Wednesday June 18, 2025 9:45am - 10:15am EDT
Innovation Theater 2
Component Type: Session

Synterex’s AgileWriter.ai™ is an all-in-one solution for writing and managing CSRs, ICFs, plain language documents, Module 2 summaries (clinical/nonclinical for INDs or BLAs/NDAs), manuscripts, DSURs, and more. Scalable with your current tech stack, it includes editing, publishing and redaction features and can be priced per document or via license. Secure architecture enables hosting by Synterex or the client to best suit your needs, saving you on average 50% of time and cost on quality drafts.

Speaker

Speaker
Pallabi De, PhD


Speakers
avatar for Pallabi De

Pallabi De

Senior Director, Medical Writing Technology and Content Architecture, Synterex, Inc., United States
Pallabi De is a medical writing professional with 15+ years of experience in the industry. She has managed and authored a variety of regulatory documents and led multiple IND and NDA submissions across different therapeutic areas and has a deep knowledge of clinical trial transparency... Read More →
Wednesday June 18, 2025 9:45am - 10:15am EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session |   18: InnovationTheaters, Session

10:30am EDT

#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-620-L04-P; CME 1.00; RN 1.00

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speaker

Panelist
Jie Li

Panelist
Susan A. Oliveria, DrSc, MPH

Panelist
Alice Hsu, MPH


Speakers
avatar for William Blumentals

William Blumentals

Head of Pharmacoepidemiology, Specialty Care, Sanofi, United States
William has spent over 20 years supporting and leading epidemiology teams in biopharma, including roles in pharmacovigilance and medical affairs. Currently, he co-leads the real-world data access and availability workstream with TransCelerate and is the Head of Pharmacoepidemiology... Read More →
avatar for Alice Hsu

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States
Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →
JL

Jie Li

Associate Director for RWE, OSE, CDER, FDA, United States
SO

Susan Oliveria

Vice President, Global Head of Epidemiology and Scientific Affairs Peri- and Pos, Thermo Fisher Scientific, United States
Dr. Oliveria's career as a pharmacoepidemiologist spans more than 25 years in academia, industry, and non-profit settings. She is trained as a pharmacoepidemiologist, having received her Doctor of Science from the Harvard School of Public Health. In her current role she leads the... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

10:30am EDT

#315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art
Wednesday June 18, 2025 10:30am - 11:30am EDT
207A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-621-L04-P; CME 1.00; RN 1.00

Signal detection remains central to Pharmacovigilance activities. Better access and use of data, ever improving methods to maximise the utility of data, and better processes and governance to optimise signal detection activities are key focus areas as we continuously strive to do ever earlier and more effective safety signal detection. This session will discuss the current status of signal detection from all these aspects as well as how we anticipate the field evolving moving forwards.

Learning Objectives

Demonstrate and discuss how Generative AI can facilitate the future approach in augmenting PV systems in a trusted, compliant, and transparent manner; Summarize the opportunities and challenges with such an approach.

Chair

Andrew Bate, PhD, MA

Speaker

Industry Perspective
Mariette Boerstoel-Streefland, MD, MBA, MS


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Mariette Boerstoel Streefland

Mariette Boerstoel Streefland

Senior Vice President, Patient Safety Officer, Bristol-Myers Squibb Company, United States
Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

#316: Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent
Wednesday June 18, 2025 10:30am - 11:30am EDT
150AB
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-622-L04-P; CME 1.00; RN 1.00

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Recognize the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Speaker

Sharing Clinical/Investigator Perspective
Thos Cochrane, MD, MBA

Sharing an IRB Perspective
Linda Reuter, MS


Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Thos Cochrane

Thos Cochrane

Director, Fellowships in Bioethics, Harvard Medical School, United States
Thos Cochrane is a medical ethicist, neuromuscular neurologist, and specialist in drug development for rare diseases. He currently directs the Fellowships in Bioethics at Harvard Medical School (HMS). He has completed two fellowships in medical ethics and was the first Director of... Read More →
avatar for Linda Reuter

Linda Reuter

Senior Director, BRANY IRB, United States
Over a 34-year career, Linda has held multiple IRB administrative positions and for several years ran a consulting business providing training and assistance for several institutional IRB programs across the country. Currently serving as Sr. IRB Director at BRANY, Linda supervises... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Advanced
  • Keyword Bioethics
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

10:30am EDT

#317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa
Wednesday June 18, 2025 10:30am - 11:30am EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-623-L04-P; CME 1.00; RN 1.00

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Kwaku Marfo, PharmD, MBA, MPH

Speaker

Harnessing Partnerships and Collaboration to Sustain the Ecosystem
Chimwemwe Chamdimba

Clinical Trial Conduct In Africa: Current Regulatory Systems and Regulations
Yvonne Adu-Boahen

Unlocking Clinical Research to Drive Access to Innovation
Beno Nyam Yakubu, DVM


Speakers
avatar for Yvonne Adu-Boahen

Yvonne Adu-Boahen

Head of Clinical Trials Department, Food and Drugs Authority, Ghana
avatar for Chimwemwe Chamdimba

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa
Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →
avatar for Kwaku Marfo

Kwaku Marfo

Africa Market Development Specialist, IQVIA, Ghana
Kwaku Marfo currently holds a role of Market Development Specialist for sub-Sahara Africa with IQVIA. Kwaku is a dynamic Life Sciences leader with 18 years of experience in Pharma and Global Health across US, Europe and Africa markets in diverse therapeutic areas such as Hematology... Read More →
BY

Beno Yakubu

Head of Clinical Trial Department, National Agency for Food and Drug Administration, Nigeria
Dr Yakubu background training is Veterinary Medicine, have undergone related trainings on vaccines, epidemiology, Bioethics, and other regulatory activities for over 20 years. has attended many WHO trainings on Vaccines regulatory activities. Dr Yakubu has been involved in the review... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

#318: Patient Referral: Is It Hope or Hype?
Wednesday June 18, 2025 10:30am - 11:30am EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-624-L04-P; CME 1.00; RN 1.00

This highlights the challenges of using real-world data (RWD) for patient referral in clinical trials, focusing on issues like data variability, lack of investigator training, and insufficient incentives. It proposes strategic solutions to overcome these barriers.

Learning Objectives

Identify innovative strategies for patient recruitment using RWD referrals that challenge existing practices; Propose new methods for integrating naïve sites into the clinical trial process to expand participation; Evaluate the potential impact of broader patient inclusion on clinical trial outcomes.

Chair

Kim Ribeiro, MS

Speaker

Panelist
Joan Chambers

Panelist
Barbara Isquith Arone, MS

Panelist
Karen Correa, PhD

Panelist
Irfan A. Khan, MD


Speakers
avatar for Barbara Isquith Arone

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
Barbara has worked within late phase research for 25+ years, 20+ with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
avatar for Joan Chambers

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States
As the Chief Operating Officer for CenterWatch, Joan is responsible for the business operations, financial performance, marketing, and sales of the company along with setting strategic direction. Joan's work experience includes: CHI, Tufts CSDD at Tufts University, Thomson CenterWatch... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
avatar for Irfan Khan

Irfan Khan

Founder and Chief Executive Officer, Circuit Clinical, United States
Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.
avatar for Kim Ribeiro

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States
Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

10:30am EDT

#319: Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
207B
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-625-L04-P; CME 1.00; RN 1.00

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Panelist
Alex Bliu, PhD

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Anja Schiel, PhD


Speakers
avatar for Alex Bliu

Alex Bliu

Senior Biostatistician, Health Canada, Canada
Dr. Bliu, a senior biostatistician at Health Canada, boasts over 22 years of expertise in statistics, pharmaceutical development, and regulations. He has made significant contributions to oncology, vaccines, autoimmune diseases, pediatrics, and rare disorders therapeutic areas. His... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Anja Schiel

Anja Schiel

Special Advisor, Lead Methodologist/Statistician; NoMA, Norwegian Medical Products Agency (noma), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc on a range of subjects focusing on oncology, immunology and molecular biology, first at the... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   01: ClinSafety-PV, Session

10:30am EDT

#320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing
Wednesday June 18, 2025 10:30am - 11:30am EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-626-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) and Structured Content Authoring (SCA) tools are here. The challenge of seamlessly integrating these technologies into compliant and efficient workflows is reshaping the regulatory document development process. This session will delve into the balance and interdependence of four pillars (technology, process, people, and organization) to drive the business value of these tools. The interplay of these elements stokes an environment of thriving innovation, leading to enhanced efficiency, quality, and value proposition for the underlying business. AI/SCA have been thoroughly discussed in the regulatory writing process. Now there is focus on evolving technologies, the challenge lies in integrating these advancements into our workflows and processes, or implementing change management processes to allow for their use. Utilizing these tools coupled with organizational and process driven acceleration levers will condense the time to document approval and decrease the number of resources need to produce these documents. Moreover, the concerted and collaborative efforts across various functions, ranging from clinical sciences to biostatistics programming to review and approval pathways, ensures a thorough and compliant documentation process. It is time to focus and clearly define, emphasize, and promote the importance of the human element in the utilization of these tools, the people and the processes, at the heart of transformative authoring. Attendees will gain insights into the strategic integration of the four pillars in medical writing, drawing real-world use cases of these technologies in industry. These strategies, while transformative, do not necessitate a radical shift when applied independently. Instead, their true power lies in their harmonious application, which collectively refines traditional authoring paradigms.

Learning Objectives

Analyze the business value of AI and Structured Content Authoring tools in Regulatory Medical Writing to enhance efficiency and compliance; Evaluate process modifications in document development resulting from technology innovations to optimize workflow; Develop strategies to implement change management and organizational shifts that support technology-driven solutions.

Chair

David Meats, II

Speaker

Industry Perspective
James Best, MBA

Speakers
Louise Lind Skov, PhD


Speakers
avatar for James Best

James Best

Digital Transformation Lead (Medical Writing), GSK, United Kingdom
Focused on human centered digital transformation - leading strategy, design, end execution. Developer of the pragmatic trust model, a framework informed by psychology and change management models, for trusting and accepting AI within sociotechnical systems.
avatar for David Meats

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States
Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →
avatar for Louise Lind Skov

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Louise is Director and Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

10:30am EDT

#321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
Wednesday June 18, 2025 10:30am - 11:30am EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-627-L04-P; CME 1.00; RN 1.00

Multiple stakeholders, including patients, will demonstrate how patient/site collaboration enhances the simultaneous digital health technologies (DHT)/patient journey to produce potential improvements/efficiencies in patient experience, data capture/quality, equitable access, and site/participant burden.

Learning Objectives

Describe the value of patient involvement to improve site engagement and user experience in application of DHTs in clinical research; Discuss key issues with accessibility of patient-reported outcome measurements; Identify how to incorporate patient-defined measurements into potential clinical endpoint development to better align with patient experience.

Chair

Stacy Hurt, MBA, MHA

Speaker

Patient Involvement to Improve Use of eCOA in Clinical Trials
Stacy Hurt, MBA, MHA

Lets Make Sure Accessibility is Considered in ePRO Best Practices: Are We Risking Our Data?
Florence Mowlem, PhD, MSc

Patient-Defined Flare Measurement Development in Conditions with Known Flares
Nell Meosky Luo

Speaker
Alicia Staley, MBA, MS

Speaker
Brian Hunter, MA


Speakers
BH

Brian Hunter

Chief Operating Officer, SiteCentric, United States
BH

Brian Hunter

Chief Operating Officer, SiteCentric, United States
NM

Nell Meosky Luo

Chief Executive Officer, Folia Health, United States
Nell Meosky Luo is the Found & CEO of Folia Health, a patient-driven health informatics company where since 2017, she has led a team to develop novel methods for enabling the collection, analysis, and use of home-reported outcomes of patients and caregivers for precision care and... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Florence Mowlem

Florence Mowlem

Chief Scientific Officer, Umotif, United Kingdom
Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of COAs and the use of DHTs in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked... Read More →
avatar for Alicia Staley

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States
Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum

10:30am EDT

#323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
151B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-629-L04-P; CME 1.00; RN 1.00

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speaker

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, MD, PhD, MBA

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm


Speakers
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
avatar for Nobutaka Kobayashi

Nobutaka Kobayashi

Deputy Director, Mitsubishi Tanabe Pharma Corporation, Japan
Kobayashi was engaged in medicinal chemistry as a research scientist in the pharmaceutical company for 13 years. After that, he was engaged in medical policy, drug price application, and management planning for 13 years.
avatar for Kenichi Nakamura

Kenichi Nakamura

Chief, Department of International Clinical Development, National Cancer Center Hospital, Japan
Dr. Nakamura is Chief of International Clinical Development at the National Cancer Center Hospital. After earning his MD from Kyoto University in 1999 and completing surgical training, he joined NCC to manage JCOG, Japan’s largest cancer clinical trial group. Since 2015, he has... Read More →
avatar for Toshiharu Sano

Toshiharu Sano

Associate Vice President, MSD, Japan
Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

10:30am EDT

#324: Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Wednesday June 18, 2025 10:30am - 11:30am EDT
152AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-630-L04-P; CME 1.00; RN 1.00

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Speaker

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Cheryl Grandinetti, PharmD

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Catherine Gregor, MA, MBA

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Kenneth Wiley. Jr., PhD


Speakers
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for Catherine Gregor

Catherine Gregor

Chief Clinical Trial Officer, Florence Healthcare, United States
Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide... Read More →
KW

Kenneth Wiley. Jr.

Section Chief, National Center For Advancing Translational Sciences, United States
Dr. Ken Wiley, Jr., is the Chief of the Clinical Research Resources Section within the National Center for Advancing Translational Sciences, where he manages, coordinates, and provides technical and scientific leadership and guidance for activities related to the planning, implementing... Read More →
avatar for Lindsay Kehoe

Lindsay Kehoe

Senior Project Manager, Lead Emerging Programs, Clinical Trials Transformation Initiative (CTTI), United States
Lindsay Kehoe, M.S., is a senior project manager and lead Emerging Programs at the Clinical Trials Transformation Initiative (CTTI), where she manages the development and implementation of CTTI projects. She has convened teams around disease progression modeling, AI, integrating trials... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum |   02: ClinTrials-Ops, Forum

10:30am EDT

#325: Practical Implementation of MRCTs Based on ICH E17 Guidelines
Wednesday June 18, 2025 10:30am - 11:30am EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-631-L04-P; CME 1.00; RN 1.00

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning a study or evaluating results.

Learning Objectives

Explain how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Chair

Yoshiaki Uyama, PhD, MS, RPh

Speaker

Panelist
Armin Koch, DrSc

Panelist
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka, PhD

Panelist
William Wang, PhD


Speakers
avatar for Hideki Hiraoka

Hideki Hiraoka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
AK

Armin Koch

Head, Institute of Biometry, Hannover Medical School, Germany
Dr. Armin Koch, Ph.D., received his diploma in Mathematics and then worked in the Biostatistics Department at the German Cancer Research Center in Heidelberg. From there he moved to the Biostatistics Department at Heidelberg University where he wrote his PhD-thesis (1994). He has... Read More →
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

Health Regulation Expert, ANVISA, Brazil
Health Regulation Expert with 11 years of experience monitoring non-clinical and clinical development of drugs and biological products, with a focus on monoclonal antibodies and vaccines. She is also Good Clinical Practice(GCP) inspector and participated as a representative of Anvisa... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for William Wang

William Wang

President, Merck & Co, Inc, United States
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

10:30am EDT

#326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
Wednesday June 18, 2025 10:30am - 11:30am EDT
147AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-632-L04-P; CME 1.00; RN 1.00

This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.

Learning Objectives

Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.

Chair

Samantha Roberts, PhD

Speaker

Industry Reflection
Rasika Kalamegham, PhD

Industry Reflection
Victoria A. Dohnal, RAC


Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and co-leads the Advisory Committee workstream... Read More →
avatar for Victoria Dohnal

Victoria Dohnal

Director, Global Regulatory Policy and Intelligence, Johnson & Johnson, United States
Victoria Dohnal is currently Director, Regulatory Policy, North America at Johnson and Johnson (J&J) where she is responsible for driving US regulatory policy work related to rare diseases, patient focused drug development, cell and gene therapies, precision medicine, and PDUFA VII... Read More →
avatar for Rasika Kalamegham

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum

10:30am EDT

#322: Navigating the Challenges of Drug Delivery Using a Novel Device
Wednesday June 18, 2025 10:30am - 11:30am EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-628-L04-P; CME 1.00; RN 1.00

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Explain the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Yoshiko Stowell, PhD, MS, PMP, RAC

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC


Speakers
avatar for Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products, AbbVie, United States
Sarah Fairfield is a dedicated and passionate regulatory professional with extensive expertise in medical devices and combination products. Currently, she serves as the Associate Director of Regulatory Affairs at AbbVie, Inc., where she supports global product development. She also... Read More →
avatar for John Lockwood

John Lockwood

Sr. Director, Cencora Pharmalex, United States
John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →
avatar for Yoshiko Stowell

Yoshiko Stowell

Vice President Regulatory Affairs, Kenai Therapeutics, United States
Yoshiko Stowell, PhD is VP Regulatory Affairs at Kenai Therapeutics. She has over 20 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   06: PersonalizedMed-ComboProd-Diagnostics, Session

10:30am EDT

#327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-633-L04-P; CME 1.00; RN 1.00

Perceived and real lapses in Manufacturing Quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss issues and opportunities to enhance oversight and communication by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Discuss the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP and submission issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction, application of the Quality Management Maturity model, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
avatar for Holly Kleinschrodt

Holly Kleinschrodt

Head, Device & Operations Quality, Astellas, United States
Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →
avatar for Rosemary Orciari

Rosemary Orciari

Senior Director, Reg Intel, Policy and QMS Lead, Pfizer, United States
Rosemary Orciari is the Senior Director of Regulatory Intelligence and Quality Standards at Pfizer, Inc. In this role, she is responsible for enabling quality and compliance excellence to support breakthroughs that change patients' lives. Together with her team, Rosemary actively... Read More →
avatar for Patrick Saunders

Patrick Saunders

Senior Director-Quality, Lilly del Caribe, Eli Lilly & Co., United States
Patrick A. Saunders currently serves as the Sr Director - Quality at Lilly del Caribe in Carolina, Puerto Rico. Patrick is a seasoned professional with nearly two decades of experience in the pharmaceutical industry. His expertise spans across both parental and oral solid dosage drug... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

10:30am EDT

#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-634-L04-P; CME 1.00; RN 1.00

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Chair

Luis Pinheiro, PharmD, MSc

Speaker

Panelist
Timothe Menard, PharmD, MSc

Panelist
Tala Fakhouri, PhD, MPH


Speakers
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

10:30am EDT

#329: Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
206
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-635-L04-P; CME 1.00; RN 1.00

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; List the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Inclusive Leadership Strategies to Effectively Manage Teams
Ruby Madison Ford, MPH


Speakers
avatar for Tamei Elliott

Tamei Elliott

Director, Global Scientific Content, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
avatar for Ruby Ford

Ruby Ford

Research Analyst, Tufts School of Medicine, United States
Madison Ford is a Research Analyst at the Center where she conducts grant-funded research including survey and database design, quantitative and qualitative data analysis, and literature reviews. In 2021, Madison received her BS in Public Health from The University of Alabama. She... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

11:30am EDT

#POS 3: Professional Poster Session III
Wednesday June 18, 2025 11:30am - 1:30pm EDT
EH
Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
ZA

Zinah Alabdulkarim

Senior Scientific Evaluation Expert, SFDA, Saudi Arabia
NA

Nicolai Ayasse

Clinical Outcome Assessment Scientist, Critical Path Institute, United States
Cole Ayasse is a quantitative researcher with expertise in statistics, psychometrics, and research design. Dr. Ayasse has experience working in multiple therapeutic areas, including rare diseases and oncology, but with an emphasis on and particular interest in neurological disorders... Read More →
MB

Maria Baier

Data Scientist, Boehringer Ingelheim, Germany
Maria is a Data Scientist at Boehringer Ingelheim, where she leverages her expertise to drive innovation and data-driven decision-making in the realm of Quality Management. Her background in mathematics and consulting has equipped her with strong analytical acumen and a diverse perspective... Read More →
avatar for Anna-Marika Bauer

Anna-Marika Bauer

Regulatory Specialist, Critical Path Institute, United States
Anna-Marika Bauer is a regulatory specialist with the Regulatory Science program at the Critical Path Institute (C-Path). She received her undergraduate degree in Neuroscience from Franklin & Marshall College and her Master of Regulatory Affairs from the University of Pennsylvania... Read More →
AB

Andrea Bell-Vlasov

Science Policy Analyst, U.S. Food & Drug Administration, United States
avatar for Jason Casavant

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States
Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.
JC

Joan Cheung

Senior Consultant, NNIT, United States
Joan Cheung is a Senior Consultant at NNIT where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs with projects... Read More →
avatar for Susan Chong

Susan Chong

Senior Manager, Global Regulatory Policy and Intelligence, Amgen Inc., United States
Susan Chong is Senior Manager, Global Regulatory Policy and Intelligence at Amgen, where she is responsible for the global regulatory commenting process on draft guidance documents, proposed rules and legislation, and more. Prior to this role, she was a Senior Associate Regulatory... Read More →
SD

Saurabh Das

Associate Consultant, Tata Consultancy Services Ltd, India
avatar for Motoki Fujii

Motoki Fujii

Senior Professional, EPS Group, Japan
[Expertise] Medical device regulatory consultant Support for the creation of medical device regulatory-related materials Strategy planning and support for face-to-face advice provided by PMDA Correspondence with overseas clients [Career] After joining EPS in 2008, engaged in consulting... Read More →
avatar for Denise Fulton

Denise Fulton

Vice President, Research & Content Strategy, Regulatory Affairs Professionals Society (RAPS), United States
Denise Fulton, Vice President for Research & Content Strategy, leads the Regulatory Focus, journals, books, and research teams at the Regulatory Affairs Professionals Society. She joined RAPS in early 2020 after 20 years of leading newsrooms for MDedge/Medscape, a company dedicated... Read More →
avatar for Lincy George

Lincy George

Vice President, Oncology Global Regulatory Affairs, Sanofi, United States
Lincy Thomas George has more than 20 years of experience in global pharmaceutical companies working in regulatory affairs across early development and late stage assets. (Novartis, BMS, now Global Oncology Regulatory Head at Sanofi)
avatar for Katharina Goldner

Katharina Goldner

Regional Regulatory Affairs Manager, Bayer AG, Germany
Katharina is a biologist with an M.Sc. who has been making waves at Bayer since 2016. Starting as a CMC Manager for herbal medicinal products in Consumer Health, she transitioned in 2020 to become Regional Regulatory Affairs Manager for Eastern Europe, the Middle East, and Africa... Read More →
avatar for Fadhilah Hasbullah

Fadhilah Hasbullah

GCP Inspector, National Pharmaceutical Regulatory Agency (NPRA) Malaysia, Malaysia
She completed her Master of Science (MSc) in Clinical Research from The University of Sheffield, United Kingdom, in 2014 and her Bachelor of Pharmacy (Hons) from the International Islamic University Malaysia in 2007. She started to working at the National Pharmaceutical Regulatory... Read More →
avatar for Nicole Herk

Nicole Herk

Analytics Director, Medtronic, United States
Nicole Herk, M.S., is an Advanced Analytics Program Director and manages the Employee Listening Program at Medtronic. She joined Medtronic in 2018 and is responsible for the enterprise engagement survey and other active and passive listening solutions throughout the organization designed... Read More →
avatar for Li Huang

Li Huang

Principal Biostatistician, Phastar, United States
Li Huang is a Principal Biostatistician at PHASTAR. She holds a Doctor of Dental Surgery (DDS) degree from Hubei Medical University (China), a Master of Science in Dentistry from the National University of Singapore (NUS), and a Master of Science in Applied Statistics from California... Read More →
avatar for Tse-Yin Huang

Tse-Yin Huang

Reviewer, Center for Drug Evaluation, Taiwan, Taiwan
Tse Yin Huang received a Doctor of Philosophy degree from China Medical University. He has been working as a reviewer at the Center for Drug Evaluation (CDE) in Taiwan for over two years, responsible for reviewing the clinical pharmacology sections of new drug applications. In his... Read More →
avatar for Stephen Karpen

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →
avatar for Timothy Kline

Timothy Kline

Senior Director, Global Regulatory Affairs, GSK, United States
Programmed to change the trajectory of patient lives by harnessing 10 years of strategic regulatory design and execution in oncology, rare diseases both BLA (cell & gene therapy) and NDA (oncology & neurological disorders) with successful Health Authority track record in complex innovative... Read More →
avatar for Hema Kothari

Hema Kothari

Scientific Writer II, Bristol Myers Squibb, United States
Hema Kothari is a Scientific Writer II at Bristol Myers Squibb, specializing in the development of scientific and regulatory documents. With a strong foundation in scientific communication and as a subject matter expert in Investigator's Brochure, Hema brings expertise in synthesizing... Read More →
IL

Iyn-Hyang Lee

Professor, College of Pharmacy, Yeungnam University, Korea, Republic of
avatar for Tyler Ludlow

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States
Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →
avatar for Yuki Miyatake

Yuki Miyatake

Sr Manager, Eli Lilly Japan, Japan
Yuki Miyatake is a Senior Manager of Regulatory Policy at Eli Lilly Japan KK, specializing in regulatory policy strategy and intelligence. Driven by his personal experiences as a former patient, Yuki is passionate about fostering an innovative regulatory environment that enables individuals... Read More →
avatar for Katie Moy

Katie Moy

Associate Director, Medical Information & Review, Acadia Pharmaceuticals, United States
Katie Moy currently serves as Associate Director in Medical Information and Review at Acadia Pharmaceuticals Inc. She has supported 7 product launches in her career, globalized Medical Information workstreams, and led Medical Communications and Information content creation across... Read More →
avatar for Nancy Ngum

Nancy Ngum

Public Health Officer, AUDA-NEPAD, South Africa
avatar for Miyako Okayama

Miyako Okayama

Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs, Otsuka Pharmaceutical, Co., Ltd., Japan
Miyako Okayama is a Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs Department at Otsuka Pharmaceutical, Co., Ltd., where she leads eCTD publishing and management of the global regulatory systems. Prior to joining Otsuka, she served as the Event Manager... Read More →
avatar for Valerie Parker

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States
Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →
avatar for Jaymin Patel

Jaymin Patel

HEOR, AESARA, United States
Jaymin Patel is an Associate Director in the Value & Evidence team at AESARA, where he focuses on both pre- and post-approval strategy, patient experience data, and clinical outcome assessments for Phase 2 and 3 studies. His work emphasizes aligning endpoints and PROs with what matters... Read More →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
avatar for Aysha Rana

Aysha Rana

Regulatory Affairs Specialist, Spectra Medical/Northeastern University, United States
Aysha Rana, PharmD, MS is a Regulatory Affairs professional with 7+ years of global experience spanning pharmaceuticals, biologics, and medical devices. A recent graduate of Northeastern University’s Master’s in Regulatory Affairs program, she has led regulatory strategy, eCTD... Read More →
SR

Sarah Roberge

IBC Chair, IBC Services, WCG Clinical, United States
I am currently an Institutional Biosafety Committee (IBC) Chair at WCG, working with research sites, sponsors, and CROs to ensure that human gene transfer clinical trials are conducted safely. Prior to joining WCG in early 2019, I worked at Seattle Cancer Care Alliance, BloodworksNW... Read More →
avatar for Cynthia Rothblum-Oviatt

Cynthia Rothblum-Oviatt

Science Policy Analyst, Rare Disease Team, OND, CDER, FDA, United States
Dr. Cynthia Rothblum-Oviatt serves as the External Engagement Lead for the FDA’s Center for Drug Evaluation and Research (CDER) Rare Diseases Team within the Office of New Drugs. Prior to joining FDA, Dr. Rothblum-Oviatt spent approximately 20 years in the non-profit rare disease... Read More →
avatar for Sandeep Singh

Sandeep Singh

Associate Director, Global Medical Information, Genmab, United States
I'm Sandeep Singh, PharmD, currently working as Associate Director of Global Medical Information at Genmab. Since earning my Doctorate of Pharmacy in 2017, I’ve had the opportunity to support multiple medical communication strategies across both pharmaceutical companies and agencies... Read More →
avatar for Cecilia Speck

Cecilia Speck

Post-Doctoral Fellow, Novartis, United States
Cecilia is a recent graduate of the Raabe College of Pharmacy at Ohio Northern University. She is currently a post-doctoral fellow at Novartis through the Rutgers Pharmaceutical Industry Fellowship Program. Her 2-year fellowship is in US Publications and Medical Content, Strategy... Read More →
avatar for Yu Fa Su

Yu Fa Su

Project Manager, Taiwan Center For Drug Evaluation, Taiwan
As a Project Manager at the Center for Drug Evaluation (CDE), Taiwan, in the Division of Consultation, I manage drug consultation applications across all stages of development and review cases involving cell therapy technologies. My responsibilities include developing project plans... Read More →
avatar for Toru Suzuki

Toru Suzuki

Head, Regulatory and Development policy, Novartis Pharma, Japan
Toru Suzuki is the Head of Development and Regulatory Policy, Regulatory Affairs Japan at Novartis Pharma K.K. in Tokyo. In this role, he leads the policy team and oversees the analysis of the regulatory environment using both external and internal data. His responsibilities include... Read More →
ST

Sarah Tanios

Pharmacovigilance and Medication Safety Fellow, Purdue University, United States
Sarah Tanios, PharmD, is a Regulatory Pharmaceutical Fellow in Medication Safety with Purdue University, AbbVie, and the FDA. She earned her PharmD from Midwestern University’s Chicago College of Pharmacy. Prior to her current role in drug safety and pharmacovigilance, she gained... Read More →
avatar for Jayashree Tikhe

Jayashree Tikhe

Senior Product Marketing Manager, Dassault Systemes, United States
Jaya Tikhe has extensive experience and deep knowledge in early drug discovery and project management. As a medicinal and organic chemist, she has a proven track record of successful delivery of candidate quality molecules on programs in CNS, immunology, inflammation and oncology... Read More →
JV

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States
Dr. Jackie Vanderpuye-Orgle is a health economist with over 20 years of progressive experience in the application of econometric principles and statistical analysis to patient data. At Parexel, Jackie is responsible for providing technical expertise on network meta-analysis, advanced... Read More →
avatar for Stuart Walker

Stuart Walker

Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK
avatar for Kim Wilkinson

Kim Wilkinson

Associate Director, Medical Writing, Alexion RDU, Astrazeneca, United States
Kim Wilkinson, Associate Director of Medical Writing at Alexion's Rare Disease Unit, AstraZeneca, brings over a decade of expertise in clinical regulatory documentation. With a Ph.D. in Immunology and Cell Biology, Kim has leveraged their strong scientific background to excel in the... Read More →
avatar for Baiyu Yang

Baiyu Yang

Principal Quantitative Scientist, Roche Molecular Systems, United States
Baiyu Yang, PhD, is a Principal Quantitative Scientist at Roche Molecular Systems. She is a seasoned epidemiologist with 10+ years of experience leading large observational studies and 40+ manuscript publications. For the past seven years, she has been leading Real-World Data (RWD... Read More →
Wednesday June 18, 2025 11:30am - 1:30pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session

11:30am EDT

Luncheon Service
Wednesday June 18, 2025 11:30am - 1:30pm EDT
Exhibit Hall Lunch
Component Type: Social Event



Wednesday June 18, 2025 11:30am - 1:30pm EDT
Exhibit Hall Lunch Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment
Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

In the current political environment where anything related to diversity is at risk, ensuring clinical trials represent the real world is a scientific imperative, not a DEI initiative. The concept of pharmacoequity not only aims to balance the needs

Learning Objectives

Understand the concept of pharmacoequity; Explain how to apply pharmacoequity to ensure representative clinical trial.

Chair

Dyan Bryson

Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

12:00pm EDT

#332 RT: Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Clinical Research Community for a follow up round table discussion tied to session: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint (Tuesday, June 17 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Noel Ellison, MS

Speakers
NE

Noel Ellison

Director of Biostatistics, Trialwise, Inc., United States
A biostatistician and statistical programmer, Noel has more than 13 years of experience in clinical research. She has gained significant therapeutic area experience in Alzheimer’s, Cushing’s, Parkinson's, ALS, and phase 1 clinical pharmacology trials, including PK/EKG safety summary... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   16: Community-Rounds, Session

12:00pm EDT

#333 RT: Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C
Component Type: Session

Join the Clinical Safety & Pharmacovigilance Community for a follow up round table discussion tied to session: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships (Tuesday June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PhD

Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   01: ClinSafety-PV, Session

12:00pm EDT

#331 RT: Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects (Tuesday, June 17 | 10:30am - 11:30am EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Nancy Linda Styple

Speakers
avatar for Nancy Styple

Nancy Styple

Project Management Leader, Bayer AG, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   07: ProjectManagement-StrategicPlanning, Session

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products; Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development; Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Workshop |   15: Content-Hubs, Workshop

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?
Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Using case examples, the session will be an interactive discussion to share learnings and the impact of the use of drug repurposing from different end users such as industry and academia with input from regulators, patients and HTA representatives.

Learning Objectives

Understand drug repurposing and share lessons learnt so far based on case examples; Identify what could be opportunities using repurposing for rare diseases; Explain what has been done as part of the pilot on repurposing initiated by EMA at the end of 2021.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Can Drug Repurposing benefit drug development in Children & in Paediatric Rare Diseases?
David Sidney Ross, MBA, MSc, PMP, RAC


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

1:45pm EDT

#336: Addressing Challenges in Devices Safety Monitoring
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
202A
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-636-L04-P; CME 1.00; RN 1.00

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Discuss and assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Chair

Sarah Vaughan

Speaker

Industry Perspective
Khaudeja Bano, DrMed, MD, MS

WHO Perspective
Hiiti Sillo, MSc, RPh


Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Genentech, United States
Dr. Bano is the Global Head - Vice President of Device / Combination product Quality at Genentech / Roche. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional... Read More →
avatar for Hiiti Sillo

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
  • Level Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

1:45pm EDT

#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-637-L04-P; CME 1.00; RN 1.00

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Discuss the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Recognize how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson, PhD

Panelist
Szczepan Baran


Speakers
SB

Szczepan Baran

Tech4Pets, Chief Barks and Purrs Officer, United States
avatar for Julie Frearson

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

#338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-638-L04-P; CME 1.00; RN 1.00

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Discuss PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Describe the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speaker

Industry Perspective
Sumati Nambiar, DrMed, MPH

Panelist
Teppei KIUCHI, MD, PhD, MPH


Speakers
avatar for Edward Ian

Edward Ian

Head of Integrated Innovation Service Center, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
avatar for Teppei KIUCHI

Teppei KIUCHI

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Teppei Kiuchi, M.D., MPH, PhD, is an associate executive director in the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In this role, Kiuchi is in charge of the review of regenerative medical products, Bio-CMC, vaccine and blood products. In his career Kiuchi has been... Read More →
avatar for Sumati Nambiar

Sumati Nambiar

Senior Director, Johnson and Johnson, United States
Dr. Nambiar is board certified in pediatrics and pediatric infectious diseases. She is a Fellow of the American Academy of Pediatrics and has over 20 years of experience in drug development and regulatory science. Currently, she is a Senior Director in the Child Health Innovation... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

#340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
201
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-640-L04-P; CME 1.00; RN 1.00

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Judy Shin, PhD

Speaker

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD


Speakers
avatar for Bonggi Kim

Bonggi Kim

Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of
avatar for Jeff Lange

Jeff Lange

Director of Observational Research in Asia, Amgen, Hong Kong
Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the... Read More →
avatar for Min-Jung Lim

Min-Jung Lim

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of
avatar for Judy Shin

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
SW

Shinya Watanabe

Reviewer (Epidemiology), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinya Watanabe is an epidemiologist at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. He conducts pharmacoepidemiological studies using medical information databases, such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   01: ClinSafety-PV, Session

1:45pm EDT

#341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-641-L04-P; CME 1.00; RN 1.00

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speaker

From Data to Action: Driving Inclusive Clinical Trials
Del Smith, PhD, MS

Placing Patients First in the Era of Advanced Tech and AI
Patrick Gee, SR, PhD, MS

Responsible AI and Diversity in Clinical Trials
Nicole Ward, MBA, MS, PMP


Speakers
avatar for Patrick Gee

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States
As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →
avatar for Katrina Rice

Katrina Rice

Chief Delivery Officer, Biometrics Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →
avatar for Del Smith

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States
Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →
avatar for Nicole Ward

Nicole Ward

Senior Product Manager, Business Insights & Technology, Bristol Myers Squibb, United States
Nicole G. Ward is a customer-centric servant leader with 15+ years of project / program management expertise and solid track record of translating complex business requirements into simple technology solutions spanning across multiple industries (Healthcare, IT, Consumer, Pharmaceutical... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-643-L04-P; CME 1.00; PDU 1.00 PMI 2166DQV2DD; RN 1.00

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Speaker

Biotech Perspective
Christine Mears, MA

Rare Disease Industry Perspective
Katie Bloom

Large Pharma Industry Perspective
Rosa Tarng, MA


Speakers
avatar for Katie Bloom

Katie Bloom

Executive Director, Co-Head of PMO, Program Management Office, Ultragenyx, United States
Katie Bloom, Executive Director of Program and Portfolio Management with over 25 years of industry experience. Currently, she co-leads the Program Management Office at Ultragenyx. Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment... Read More →
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
avatar for Rosa Tarng

Rosa Tarng

Translational Program Management, Takeda, United States
Rosa Tarng is a program management professional with ~20 years of industry experience. Rosa is currently the Head of Oncology Translational Program Management at Takeda where she has also held roles in Cell Therapy Program Operations and Oncology Research Program Management. Prior... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Forum

1:45pm EDT

#344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-644-L04-P; CME 1.00; RN 1.00

This session will outline the risk assessment approaches undertaken by four global regulators, the US FDA, UK MHRA and EMA to identify suitable candidates for inspection and explain the differences in inspection cycles. The session will focus on the risk assessment methodologies undertaken by each regulator, highlighting information sources, risk assessment processes and decision-making factors which help determine define the appropriate type of inspection and frequencies. The session will provide information into the types of inspection which may be undertaken for pharmacovigilance and why a company may be subject to one of these inspection types as well as explain why the same company may be subject to more frequent inspections. The session will include information on new and existing initiatives between regulators to collaborate on inspection risk assessments to share information, improve process, and reduce the inspection burden on industry. Companies can use the information from this session to gain tips to help identify and assess high-risk areas of their own pharmacovigilance systems for quality processes such as auditing.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Chair

Sophie Radicke, MSc

Speaker

EMA Perspective
Peter Twomey, MA, MPharm

US FDA Perspective
Sheilyn Huang, PharmD


Speakers
avatar for Sheilyn Huang

Sheilyn Huang

Consumer Safety Officer, Pharmacovigilance Compliance Team, FDA, United States
Sheilyn Huang is a licensed pharmacist who currently serves as a Consumer Safety Officer on the Pharmacovigilance Compliance Team in FDA's Center for Drug Evaluation and Research. Over the past 16 years at FDA, she has had the opportunity to work in areas such as drug information... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   01: ClinSafety-PV, Session

1:45pm EDT

#345: Africa's Evolving Regulatory Landscape
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-645-L04-P; CME 1.00; RN 1.00

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Janis Bernat, MSc

Speaker

Panelist
David Mukanga, PhD, MPH

Panelist
Grace Matimba, MS

Panelist
Chimwemwe Chamdimba


Speakers
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Chimwemwe Chamdimba

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa
Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →
avatar for David Mukanga

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →
GM

Grace Matimba

Chief Regulatory Officer, Medicines Control Authority of Zimbabwe, Zimbabwe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

#347: EMA Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-647-L04-P; CME 1.00; RN 1.00

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Chair

Ralf Herold, DrMed, MD

Speaker

Panelist
Anabela Marcal, PharmD

Panelist
Corinne de Vries, PhD, MA, MSc

Panelist
Luis Pinheiro, PharmD, MSc


Speakers
avatar for Ralf Herold

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Corinne de Vries

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

#348: Indonesia Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
150AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-648-L04-P; CME 1.00; RN 1.00

The Indonesian regulation for clinical research has shown a significant transformation during the past year, after practically being at a very low level for the past decade. The Ministry of Health, together with the Indonesian Drug and Food Regulatory Body are prepared to welcome global pharmaceutical companies to conduct researches in various hospitals in the country.

Learning Objectives

Discuss the recent transformations in Indonesian clinical research regulations and their impact on the country's research environment; Recognize the opportunities and challenges for global pharmaceutical companies conducting clinical research in Indonesia under the new regulatory framework.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Indonesia’s Health Research Revolution: Fast-Tracking Innovation & Global Collaboration in Clinical Trials
Budi Gunadi Sadikin

Indonesia’s Regulatory Readiness in Embracing Clinical Trial Transformation
Taruna Ikrar, MD

INA-CRC: The Catalyst of Indonesia’s Clinical Trial Ecosystem Transformation
Indri Rooslamiati Supriadi

Strengthening Indonesia’s Clinical Research Quality: The Critical Role of Clinical Research Unit
Yuli Felistia, MD

Panelist
Ria Siagian


Speakers
avatar for Yuli Felistia

Yuli Felistia

Head of Clinical Research Unit, Research Manager, National Brain Center, Mahar Mardjono Hospital, Indonesia
Dr Yuli is a neurologist specializing in neuro-oncology and currently serves as Head of the Clinical Research Unit at the National Brain Center Hospital Mahar Mardjono in Jakarta, Indonesia. She is pursuing a doctoral research program at Universitas Airlangga. She earned her medical... Read More →
avatar for Endang Hoyaranda

Endang Hoyaranda

President, Indonesian Association For the Study of Medicinals (IASMED), Indonesia
Endang is currently the President of the Indonesian Association for the Study of Medicinals, aside from holding her responsibilities as President of Prodia Utama which is the holding company of Prodia Group, a Group of 8 healthcare companies including the largest health laboratory... Read More →
avatar for Taruna Ikrar

Taruna Ikrar

Chairperson, Indonesia Food and Drug Authority, Indonesia
Prof. dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. Since August 2024, Prof. Ikrar brings exceptional expertise in pharmacology, cardiovascular science, and neuroscience to DIA's Annual Meeting. His remarkable journey spans education at Hasanuddin University, University of Indonesia, and... Read More →
avatar for Budi Gunadi Sadikin

Budi Gunadi Sadikin

Minister, Ministry of Health, Indonesia
Mr. Sadikin was the Vice Minister I of State-owned Enterprises and tasked to establish market leading and globally competitive state-owned enterprises. From July 2020 until December, 22nd 2020, he lead the National Economic Recovery and Transformation Task Force amidst the COVID-19... Read More →
RS

Ria Siagian

Director, Drug Registration Directorate, Indonesia Food and Drug Authority, Indonesia
avatar for Indri Supriadi

Indri Supriadi

Director, Center for Biomedical and Health Genomics and INA-CRC, Indonesia Ministry of Health, Indonesia
Indri Rooslamiati Supriadi is Director of Indonesia’s National Center for Biomedical and Health Genomics and the Indonesia Clinical Research Center (INA-CRC) under the Ministry of Health. She leads national efforts in precision medicine and clinical research, streamlining regulations... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

1:45pm EDT

#342: Evolving Regulatory Considerations for Medical Affairs Communications
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-642-L04-P; CME 1.00; RN 1.00

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Discuss and assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Speaker

Evolving Regulatory Considerations for Medical Affairs Communications
Bill Cook

Evolving Regulatory Considerations for Medical Affairs Communications
Lisa Hubbard, RPh, RAC


Speakers
BC

Bill Cook

Senior Global Medical Affairs Leader, AstraZeneca, United States
avatar for Torrey Cope

Torrey Cope

Partner, Sidley Austin LLP, United States
Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been... Read More →
avatar for Lisa Hubbard

Lisa Hubbard

Principal Consultant, Regulatory Advertising and Promotion, Opus Regulatory, Inc., United States
Lisa Hubbard is a Principal Consultant in Advertising and Promotion at Opus Regulatory, Inc. Her prior roles included Director, Advertising and Promotional Compliance at Alexion/Astra Zeneca and Senior Regulatory and Medical Consultant at One Source Regulatory. Lisa spent 15 years... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   04: MedAffairs-SciComm, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

1:45pm EDT

#346: Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
147AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-25-646-L04-P; CME 1.00; RN 1.00

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Discuss successes and challenges with different operating models.

Chair

Anton Mihic, MSc

Speaker

Panelist
Donna Boyce, MS, RAC

Panelist
Lisa Ruiz, PhD, MBA

Panelist
Alison Maloney, PhD, MBA, MS


Speakers
avatar for Donna Boyce

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Anton Mihic

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
avatar for Lisa Ruiz

Lisa Ruiz

VP, Regulatory Affairs Operations, CMC & Device, Abbvie, United States
Lisa Ruiz is a Regulatory Affairs executive leader with over 30 years in the pharmaceutical industry and broad experience in regulatory having held strategic roles across therapeutic areas, functions and geographies. She is currently the Vice President of Regulatory Affairs Operations... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   07: ProjectManagement-StrategicPlanning, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

1:45pm EDT

#349: Potency Measurements for Cellular and Gene Therapy Products
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-649-L04-P; CME 1.00; RN 1.00

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Describe the potency requirements for CGT products; Discuss the latest FDA’s guideline regarding potency testing and industry perspectives; Explain the Role of Surrogate Assays enhancing the overall potency assurance strategy; Examine the approaches adopted by sponsors to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Potency matrix for a complex mechanism of action: case-study for a multi-component plasmid immunotherapy for prevention or delay of type 1 diabetes
David Campard, PhD, MSc

Comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices
Maria Amaya, PhD, MS

Developing a matrix approach for potency assessment in allogeneic cell therapy: a case study in standardization and predictive analytics
Simge Baloglu, PhD, MS


Speakers
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
avatar for Maria Amaya

Maria Amaya

Lead External Advocacy, North America, Genentech, A Member of the Roche Group, United States
Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal... Read More →
avatar for Simge Baloglu

Simge Baloglu

SVP Analytical and Quality Control, Bluerock Therapeutics, United States
Simge Baloglu, PhD, is an Analytical Development and Quality Control leader with over 20 years of experience in biologics, gene and cell therapy, and vaccines. She has led analytical and CMC strategies from discovery through commercialization, regulatory approval, and lifecycle management... Read More →
avatar for David Campard

David Campard

CMC RA Specialist, Novo Nordisk A/S, Denmark
David Campard is CMC Regulatory Affairs Specialist and leads multiple early development projects at Novo Nordisk for cell and gene therapy products (CGTPs). In this role, he set the regulatory strategy for CMC development of CGTPs in alignment with other areas (clinical, non-clinical... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

1:45pm EDT

#339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-639-L04-P; CME 1.00; RN 1.00

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speaker

Industry Perspective
David Sidney Ross, MBA, MSc, PMP, RAC

EMA Perspective
Hilmar Hamann, PhD

Health Canada Perspective
Marcin Boruk, MBA, MSc


Speakers
MB

Marcin Boruk

acting Director, Business Facilitation and Modernization Directorate, Health Can, Health Canada, Canada
Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is an acting Director in the Business Facilitation and Modernization Directorate, Health Canada supporting the branch in projects related to... Read More →
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr Hilmar Hamann is currently the Head of Information Management at the European Medicines Agency (EMA) where he focuses on improving technological capabilities within the EU Regulatory Medicines Agencies Network to support efficient, all-digital, and data-driven operations. Previously... Read More →
avatar for David Isom

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Global Product Devel, Pfizer Inc, United States
David Isom is Senior Director, Global Regulatory Policy and Intelligence at Pfizer. He leads policy and advocacy for digital modernization of the regulatory ecosystem. Before joining GRPI (2016), David led Pfizer information management, digital, and data services for clinical and... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session |   03: Data-Tech, Session

1:45pm EDT

#350: Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
144ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-650-L04-P; CME 1.00; RN 1.00

In the rapidly evolving landscape of medical product development, the utilization of synthetic data and digital twins has gained increasing interest as a transformative approach to accelerate the development and approval of medical products. This session aims to explore the potential and innovative applications of these technologies in the realm of drug development, featuring speakers from health authorities, academia and industry. Dr. Khaled El Emam, Professor at the University of Ottawa, will present his latest research on generating synthetic data to augment clinical trials. Additionally, he will explore practical applications of synthetic data generation using real-world data. Dr. Arman Sabbaghi, Associate Professor at Purdue University, with prior experience at Unlearn, will present AI-Generated Digital Twins to deliver more efficient clinical trials. He will discuss the innovative statistical methodologies and novel trial designs that combine historical data, artificial intelligence (AI), and randomization to deliver smaller, faster, and more powerful RCTs that are built with regulatory guidance in mind. Dr. Ye Li, Mathematical Statistician, CDER, FDA will present statistical challenges leveraging machine learning in clinical trials. Several key factors that may influence the application of ML and AI algorithms in analyzing efficacy data will be discussed, including estimand and type I error rate control, as well as the importance of interpretability and reproducibility of ML/AI models to ensure robust and reliable results. Furthermore, she will address corresponding considerations related to these factors when using Digital Twins.

Learning Objectives

Describe what synthetic data and digital twins are; Discuss ways to apply AI to generate synthetic data and digital twin; Illustrate the potential of synthetic data and digital twins in medical product development.

Chair

Di Zhang, PhD

Speaker

Applications of Synthetic Data in Clinical Trials and Real-World Studies
Khaled El Emam, PhD

Statistical Methods for Unleashing AI-Generated Digital Twins to Deliver More Efficient Randomized Controlled Trials
Arman Sabbaghi, PhD, MA

Leveraging Machine Learning in Clinical Trials: Statistical Challenges
Ye Li, PhD


Speakers
KE

Khaled El Emam

Professor, University of Ottawa, Canada
Dr. Khaled El Emam is the Canada Research Chair (Tier 1) in Medical AI at the University of Ottawa, where he is a Professor in the School of Epidemiology and Public Health. He is also a Senior Scientist at the Children’s Hospital of Eastern Ontario Research Institute, and Scholar-in-Residence... Read More →
avatar for Ye Li

Ye Li

Mathematical Statistician, OTS, CDER, FDA, United States
Dr. Ye Li is a mathematical statistician in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. In this role, she performs statistical reviews on submissions of neurology products. Dr. Li worked in Office of Quality Surveillance, Center for Drug Evaluation and... Read More →
AS

Arman Sabbaghi

Head of Biostatistics Research, Unlearn, United States
avatar for Arman Sabbaghi

Arman Sabbaghi

Associate Professor of Statistics, Purdue University, United States
Dr. Arman Sabbaghi is a creative and principled statistical scientist with over a decade of experience at the intersection of AI and statistical innovation. He has been recognized for pioneering the combination of AI/ML algorithms with causal, Bayesian, and experimental design methods... Read More →
avatar for Di Zhang

Di Zhang

Associate Director of RWE Statistics, Teva, United States
Di Zhang is the Associate Director of RWE Statistics and Data Science at Teva Pharmaceuticals. Her research interests include causal inference, RWE study designs and methods, the utilization of machine learning in clinical trials and real-world applications and leveraging real-world... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   03: Data-Tech, Session
  • Level Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

1:45pm EDT

#351: Transforming Industry through Mentorship
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
206
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-651-L04-P; CME 1.00; RN 1.00

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Discuss how mentorship fosters meaningful connections and knowledge sharing, impacting engagement, retention, and growth; Identify clear roles and responsibilities to ensure program success; Recognize mentorship’s role in collaboration and career development; Discuss ways to inspire organizations to adopt mentorship and individuals to seek or become mentors.

Chair

Carol Morales

Speaker

Insights as a Mentorship Program Organizer
Meghann Hartnett

Panelist
Tywnia Brewton

The Executive Mentor Perspective
Leslie Sam

The Mentee Perspective
Sarah Tremethick


Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, Astellas , United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Meghann Hartnett

Meghann Hartnett

Associate Director, Global Products, DIA, United States
Meghann Hartnett is the Associate Director of Global Products at DIA, where she manages a diverse portfolio of both dues-based and non-dues products, including DIA’s Membership and Communities. With over seven years at DIA, she has led the development and implementation of innovative... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management and Capabilities professional at Astellas, leading the QA Astellas Professional Development Program, which includes the Chicago State University Pharm D Rotation and Mentor Intensive Program. With extensive experience in business development... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for Sarah Tremethick

Sarah Tremethick

Global Consortia Program Lead and Global Member Network Executive Sponsor, Roche Products Limited, United Kingdom
A catalyzer for change who connects like-minded people across the biopharmaceutical community to solve common challenges. A Roche leader responsible for mobilizing a diverse team of innovators from across the organization, passionate about solving problems and disrupting our industry... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

2:45pm EDT

Refreshment Break
Wednesday June 18, 2025 2:45pm - 3:45pm EDT
EH
Component Type: Social Event



Wednesday June 18, 2025 2:45pm - 3:45pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

2:55pm EDT

#353 RT: Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma (Wednesday, June 18 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Erin Mulrooney, MSc, PMP

Speakers
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session |   16: Community-Rounds, Session

2:55pm EDT

#352 RT: Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A
Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products (Tuesday, June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Brett Howard, JD, PhD

Speakers
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

2:55pm EDT

#354 RT: Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C
Component Type: Session

Join the Digital Acceleration & Documents and Records Management Community for a follow up round table discussion tied to session: Towards Instantaneous Regulatory Decisions and Better Predictability (Tuesday, June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Cary Smithson, MBA

Speaker

Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
Tony Fantana, PhD


Speakers
avatar for Tony Fantana

Tony Fantana

Sr. Dir, Eli Lilly, United States
Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving... Read More →
avatar for Cary Smithson

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation; Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals; Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Speakers
avatar for Jason Casavant

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States
Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

4:00pm EDT

#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-652-L04-P; CME 1.00; RN 1.00

This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.

Learning Objectives

Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.

Chair

Daniele Sartori, MPharm

Speaker

Regulatory Perspective
Brett Howard, JD, PhD

From Text to Intelligence: Architecting AI Systems for Drug Labeling and Pharmacovigilance
Fatima Sabar

AI in Drug Labelling: Toward Harmonized, Globally Aligned Product Information
Daniele Sartori, MPharm

Computerized Labeling Assessment Using AI
Suranjan De, MBA, MS


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →
FS

Fatima Sabar

President, Bluenote AI, United States
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre, Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

4:00pm EDT

#357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-653-L04-P; CME 1.00; RN 1.00

This session will be based on a recent effort that examined lung cancer studies to determine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from sponsors, research sites, and academia to discuss challenges and areas of opportunities for re-thinking how to make lung cancer protocols more inclusive, and will include perspectives from the clinical operations, regulatory, research sites, and academia.

Learning Objectives

Identify areas within a study protocol that can adversely exclude marginalized patient populations; Identify organizational challenges that may hinder redesign efforts, and the implications these challenges can have on the clinical operations and regulatory front; Discuss approaches, strategies, and lessons-learned to help simplify protocol design.

Chair

Jennifer Kim, PhD

Speaker

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Ritesh Jain, PhD

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Umit Tapan, MD

Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS

Application of Large Language Models (LLM) to Examine Lung Cancer Protocol Exclusion Criteria
Abigail Dirks, MS


Speakers
avatar for Abigail Dirks

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
RJ

Ritesh Jain

Senior Director, EMD Serono, United States
Ritesh Jain is Senior Director and Portfolio Lead in Global Regulatory Affairs Oncology at EMD Serono, Inc. In his role he is accountable for driving global regulatory strategy for several projects in the oncology and immuno-oncology portfolio. Prior to joining EMD Serono, he has... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →
avatar for Kim Ribeiro

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States
Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →
UT

Umit Tapan

Assitant Professor of Medicine, Boston University, United States
Dr. Umit Tapan is an Assistant Professor of Medicine at Chobanian and Avedisian School of Medicine and practicing Thoracic Oncologist at Boston Medical Center. His clinical interests are Non-small cell lung cancer, Small cell lung cancer, Mesothelioma, Immunotherapy, Targeted therapy/Precision... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

4:00pm EDT

#358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-654-L04-P; CME 1.00; RN 1.00

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Identify privacy-preserving approaches for accessing and sharing real-world data (RWD); Discuss use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine policy and regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

Global Privacy and Regulatory Considerations for Synthetic Data
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Real-World Applications of Distributed Data Analytic Solutions in Real-World Data Networks
Darren Toh, DrSc, FISPE

Privacy-Preserving Solutions for RWD Access and Collaboration: A Life Science Industry Perspective on Challenges & Opportunities
Mehmet Burcu, PhD, MS, FISPE


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Darren Toh

Darren Toh

Professor, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States
Darren Toh, ScD is DPM Endowed Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. He is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research... Read More →
EW

Echo Wang

Director, Outcome Research, Merck & Co., Inc, United States
Echo Wang is currently a Director, Outcome Research in Merck & Co., Inc. and based in Massachusetts, United States. In her current role, she manages strategic partnerships and drives emerging capabilities that support real-world evidence (RWE) generation. She has led several studies... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao


Speakers
LB

Leo Barella

Chief Technology Officer, Takeda, United States
avatar for Jessica Federer

Jessica Federer

Board Member, Angelini Ventures, United States
Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →
DR

Diogo Rao

Chief Information Officer, Eli Lilly, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

4:00pm EDT

#360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-656-L04-P; CME 1.00; RN 1.00

Patient experience data (PED) is sought by regulators, payers, and value/health technology assessment (V/HTA) bodies globally and used in different ways. Actively including PED in scientific, regulatory, and V/HTA processes has been a recent feature of regulatory and HTA reform, notably FDA guidance on patient-focused drug development (PFDD) and the EU Joint Clinical Assessment framework. Evolving perspectives on V/HTA have brought attention to the role of PED and there is a need to more systematically integrate PED into payer decision-making. Yet, the PED needs and perspectives of different stakeholders must be better understood for PED to have meaningful impact on product development, evaluation, and related decision-making. Many questions remain. Where do patients believe they have the most impact? What is industry experience gathering and leveraging PED globally? Do government agencies believe their efforts to include patient perspectives are being impactful on evidence they finally review? How can the impact of PED on V/HTA increase and be optimized globally? We will explore options to increase the impact of PED on development, V/HTA, and access decisions through optimal coordination and information sharing, and highlight options and good practices for integrating PED into regulatory, V/HTA, and payer decisions. We will discuss learnings across various opportunities for leveraging PED through policies and processes that affect patient access. Perspectives on PED from patient-group, EMA, payer, and industry panelists will showcase differences and similarities in stakeholder views and evidence needs to inform PFDD, V/HTA, and payer decisions, ultimately impacting patient access. Panelists’ experiences provide a lens on how current processes are working in concert or opposition, and opportunities for meaningful multi-stakeholder collaborations maximize PED impact on access decisions.

Learning Objectives

Discuss patient-group, payer, regulator, and industry perspectives on PED, in general, and regarding how to optimize PED use in decision-making in their respective roles; List the benefits and challenges to integrating PED in regulatory, V/HTA, and payer decision-making, from various stakeholder perspectives; Describe two examples of good practices and recommendations for integrating PED into regulatory, V/HTA, and payer decisions.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

Panelist
Maria Mavris, PhD

Panelist
Maxwell Isaacoff

Panelist
Magdalena Harrington, PhD

Panelist
Anna Hyde, MA


Speakers
avatar for Magdalena Harrington

Magdalena Harrington

Senior Director, Patient-Centered Outcomes Assessment (PCOA) Team Lead, Pfizer, United States
Magdalena Harrington is a subject matter expert in clinical outcomes assessment (COA) research with over 15 years of experience in delivering health outcomes strategies that demonstrate clinical and economic value of new medicines. She has extensive training in qualitative and quantitative... Read More →
avatar for Anna Hyde

Anna Hyde

Vice President of Advocacy & Access, Arthritis Foundation, United States
Anna Hyde is VP of Advocacy and Access at the Arthritis Foundation, overseeing federal/state legislative programs and grassroots engagement. She works to elevate arthritis as a public health priority, expand access to affordable care, and involve patients in policymaking. Since joining... Read More →
MI

Maxwell Isaacoff

Director, Federal & External Affairs, Elevance Health, Inc, United States
avatar for Maria Mavris

Maria Mavris

Patient Relations, European Medicines Agency, Netherlands
Maria Mavris joined EMA in 2014 as a Patient Liaison in the Public and Stakeholder Engagement department. Her work focuses on engaging patients all along the regulatory lifecycle and supporting them in their involvement as members of EMA’s scientific committees, as representatives... Read More →
avatar for Eleanor Perfetto

Eleanor Perfetto

Independent Consultant, Consultant, United States
Dr. Perfetto is a caregiver and recognized advocate for people with head-trauma-related dementias. She is a current member and past secretary and governance-committee chair for the Brain Injury Association of America’s Board of Directors and past chair of the Concession Legacy Foundation... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

4:00pm EDT

#362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-658-L04-P; CME 1.00; RN 1.00

Federally Qualified Health Centers and Community Health Workers play a critical role in reaching underserved populations, often serving as the first point of contact for healthcare in their communities. By partnering with these trusted entities, we can better connect with communities, bridging the gap between clinical research and underrepresented groups to ensure that clinical trials are more inclusive and reflective of the populations they aim to serve. This session will highlight the power of grassroots partnerships in expanding access to clinical research and showcase effective models that can be replicated in other regions.

Learning Objectives

Identify key components of the partnership between Reaching Communities, FQHCs, and CHWs; List ways to leverage the strengths of Federally Qualified Health Centers and Community Health Workers to effectively raise awareness and promote participation in clinical trials among underrepresented populations; Discuss how to foster greater inclusivity and accessibility for historically underserved populations in clinical research.

Chair

Perla Nunes

Speaker

NCCHCA and the FQHCs
Korrey Monroe, MPH

MedNorth Health Center and CHWs
Sharon Renee Brown-Singleton, LPN, MS

Durham Technical Community College and Clinical Research
Sharleen Traynor, PhD, MPH


Speakers
avatar for Sharon Brown-Singleton

Sharon Brown-Singleton

Chief Strategy Officer, MedNorth Health Center, United States
Sharon Brown-Singleton is currently the Chief Strategy Officer at MedNorth Health Center. She led the implementation of the Community Health Worker program, having experience in writing, developing, and implementing various CHW programs centered around maternal and child health, substance... Read More →
avatar for Korrey Monroe

Korrey Monroe

Program Manager, North Carolina Community Health Center Association, United States
Korrey Monroe is the Research Program Manager at the North Carolina Community Health Center Association (NCCHCA). In this role, he collaborates with the department director, Dr. Becca Hayes, to facilitate innovative research to raise awareness and provide resources for underserved... Read More →
avatar for Perla Nunes

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Thought Leader, United States
Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →
avatar for Sharleen Traynor

Sharleen Traynor

Instructor, Durham Tech, United States
Sharleen Traynor is an epidemiologist and educator with 20 years of public health experience in government and academic settings. In her current role as Director of the Clinical Trials Research Associate program at Durham Technical Community College, Dr. Traynor now focuses on clinical... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Forum

4:00pm EDT

#361: Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
202A
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-657-L04-P; CME 1.00; RN 1.00

Join us for an engaging discussion on an ongoing DIA study on enhancing the integration of tolerability patient experience data into immune-oncology clinical trials. This session will explore the study’s efforts to address regulatory requirements for the collection of core tolerability patient experience data and the need for a comprehensive, multidimensional approach to assessing tolerability in cancer treatments. With a multistakeholder focus, the study aims to define tolerability more holistically by incorporating treatment-related factors, convenience, and patient beliefs. Learn about the study’s progress, next steps, and its potential to align with regulatory needs while addressing real-world patient concerns.

Learning Objectives

Recognize the significance of advancing patient-centric tolerability measurement in immune-oncology trials to enhance patient outcomes; List insights into the ongoing study and future steps aimed at addressing the real-world needs of patients through a multistakeholder framework.

Chair

Maria Paula Bautista Acelas, MSc

Speaker

Moderator
Rohini Sen, PhD, MS

Unlocking Insights: Progress and Key Findings from the Tolerability Study
Ryan Murphy, PhD

Panelist
Catherine Coulouvrat, DrMed

Panelist
Lia Ridout


Speakers
avatar for Maria Paula Bautista Acelas

Maria Paula Bautista Acelas

Senior Scientific Project Manager, DIA, United States
Maria Paula offers expert scientific content guidance and project management support for DIA's global consortium initiatives and specialty meetings. She is dedicated to ensuring the development and delivery of impactful, patient-centric scientific content that generates evidence to... Read More →
avatar for Catherine Coulouvrat

Catherine Coulouvrat

Head of Health Value Translation, Sanofi, France
Catherine Coulouvrat earned her medical degree from the Medical University of Cracow, Poland and completed her residency in psychiatry at the University René Descartes in Paris, France. She holds a diploma in applied statistics from CESAM and a certificate in PV from the Facult... Read More →
avatar for Ryan Murphy

Ryan Murphy

Associate Outcomes Researcher, ICON, United States
avatar for Lia Ridout

Lia Ridout

Patient Advocate, N/A, United States
Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →
RS

Rohini Sen

Director, HEOR, AbbVie, United States
Rohini Sen, PhD, is a prominent advocate for patient experience data (PED) with over ten years of experience in patient-centered outcomes research, particularly in oncology and rare diseases. As the Director of Patient Centered Outcomes Research (PCOR) Oncology HEOR at AbbVie, she... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum

4:00pm EDT

#363: Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-659-L04-P; CME 1.00; RN 1.00

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Critical to Quality Assessment Report (CAR). Sponsors will weigh in on the challenges and opportunities related to the value of the CAR for their internal stakeholders.

Learning Objectives

Recognize the internal value proposition of the Critical to Quality Assessment Report and its application throughout the QMS and beyond; Discuss ways to apply different tactics to persuade and engage internal stakeholders on the value and application of the Critical to Quality Assessment Report.

Chair

Kiernan Trevett, MSc

Speaker

A Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Jennifer Emerson, PhD, MPH, RN, PMP

A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Cheryl Grandinetti, PharmD


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
avatar for Kiernan Trevett

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

4:00pm EDT

#365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-661-L04-P; CME 1.00; RN 1.00

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Chair

Ralf Herold, DrMed, MD

Speaker

The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges
Louis Stancato, PhD

Accelerating Translation of Regulatory Science Research – EFPIA’s perspective
Solange Corriol-Rohou, DrMed, MD, PhD


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Ralf Herold

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
avatar for Louis Stancato

Louis Stancato

VP Enabling Technologies, Indiana Biosciences Research Institute, United States
Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

#366: FDA Rare Disease Town Hall
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-662-L04-P; CME 1.00; RN 1.00

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speaker

Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD

Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD


Speakers
TB

Teresa Buracchio

Director, Office of Neuroscience, OND, CDER, FDA, United States
Teresa Buracchio, MD, is Director of the Office of Neuroscience in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA). She oversees the review of new drug programs for neurologic and psychiatric diseases. Dr. Buracchio joined FDA in 2013. Dr. Buracchio... Read More →
NN

Nikolay Nikolov

Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States
Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist and is currently the Director of the Office of Immunology and Inflammation, CDER. During rheumatology fellowship at NIAMS, NIH, he studied cellular and molecular mechanisms of autoimmunity. Then, at the Sjögren's... Read More →
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum

4:00pm EDT

#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
147AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-663-L04-P; CME 1.00; RN 1.00

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of obesity drug development; Identify the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Speaker

Panelist
Joseph Nadglowski, JR

Panelist
Maria Vassileva, PhD

Panelist
John Sharretts

Panelist
Brad Jordan, PhD


Speakers
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →
avatar for Joseph Nadglowski

Joseph Nadglowski

President/Chief Executive Officer, Obesity Action Coalition, United States
Joe Nadglowski is President & CEO of the Obesity Action Coalition (OAC) – a nonprofit organization formed in 2005 dedicated to elevating and empowering individuals affected by obesity through education, advocacy and support. A frequent speaker and author, Mr. Nadglowski is especially... Read More →
JS

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum

4:00pm EDT

#368: Perspectives on the Adoption of Advanced Manufacturing Technologies
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-664-L04-P; CME 1.00; RN 1.00

Share regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Listen to Industry cases studies showing implementation journeys and interactions with Regulators globally. Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss remaining challenges and priority areas for Industry and Regulators to work collaboratively to promote the adoption of advanced manufacturing technologies.

Learning Objectives

Discuss regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss priority areas for regulatory consideration to promote the adoption of advanced manufacturing technologies.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

Implementation Journey for AI use in Manufacturing (without hallucinating)
Gert Thurau, DrSc, PhD

Implementation Journey of a Digital Twin
Benjamin Stevens, PhD, MPH

mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
Brian Doyle


Speakers
avatar for Brian Doyle

Brian Doyle

Senior Director, Technical Development, Moderna, United States
Brian Doyle has over 15 years of experience in technical and CMC development for vaccines and therapeutics. Since joining Moderna in 2019, Brian has led organizations focused on late-stage and commercial process development and CMC technical writing, with a particular interest at... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

4:00pm EDT

#370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-666-L04-P; CME 1.00; RN 1.00

Regulatory, industry, and academic organizations discuss modern approaches to clinical drug development by describing novel methods and use cases integrating real-world data and AI to generate real-world evidence, with focus on oncology and rare diseases.

Learning Objectives

Discuss global regulatory guidance and frameworks supporting innovative designs using real-world data as well as approaches to inclusion of artificial intelligence (AI); Describe innovative approaches and methods through examples of applied AI use in drug development; Discuss areas of research interest and promote community collaboration.

Chair

Donna Rivera, PharmD, MSc, FISPE

Speaker

Applying Artificial Intelligence in Drug Development
Sid Jain, MBA

Use of Artificial Intelligence Approaches for Rare Diseases
Christina Mack, PhD, MPH


Speakers
avatar for Sid Jain

Sid Jain

Senior Vice President, Clinical Development and Data Science, Recursion, United States
Sid Jain is a healthcare innovator reimagining drug discovery and clinical development through data, technology, and biology. As SVP of Clinical Development & Data Science at Recursion, he leads teams integrating AI, real-world data, and clinical expertise to modernize therapy development... Read More →
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
avatar for Donna Rivera

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
avatar for Kelly Robinson

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum

4:00pm EDT

#369: Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
144ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-665-L04-P; CME 1.00; RN 1.00

In this session, we will provide a brief overview of the evolving ICH E20 effort with the goal to provide a transparent and harmonized set of principles for the design, conduct, analysis, and interpretation of adaptive clinical trials.

Learning Objectives

Discuss considerations specific to adaptive design using Bayesian methods; Recognize opportunities and challenges of using Bayesian methods in the regulatory setting.

Chair

Amy Xia, PhD

Speaker

E20 Updates
Amy Xia, PhD

FDA Bayesian Updates
Mark Rothmann, PhD

Bayesian Trial Design Case Studies
John Zhong, PhD


Speakers
avatar for Mark Rothmann

Mark Rothmann

Division Director, OTS, OB, CDER, FDA, United States
Dr. Rothmann is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990. He then spent nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, he has been involved in the review on... Read More →
avatar for Amy Xia

Amy Xia

Vice President, Center for Design and Analysis, Amgen Inc., United States
Amy Xia is Vice President, Center for Design and Analysis at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies over the past two decades. Currently, she heads up the Center for Design and Analysis organization... Read More →
avatar for John Zhong

John Zhong

Vice President, Head of Biometrics, REGENXBIO, Inc., United States
Dr. Zhong is the Vice President of Biometrics at REGENXBIO. Prior to REGENXBIO, he was a Group Head at Biogen, accountable for Innovative Analytics, Rare Disease Statistics, and others. He has 20 years of industry experience successfully bringing the needed treatments to patients... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session |   09: Regulatory, Session

4:00pm EDT

#364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-660-L04-P; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Discuss current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Recognize common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Chair

Robyn Bent, BSN, MS, RN

Speaker

Panelist
Pujita Vaidya, MPH

Panelist
Brett Hauber, PhD, MA


Speakers
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
avatar for Brett Hauber

Brett Hauber

Patient Preference Evidence Integration Lead, Pfizer Inc, United States
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum |   09: Regulatory, Forum

4:00pm EDT

#371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-667-L04-P; CME 1.00; RN 1.00

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Speaker

Beyond Borders: Impact of Economic Shifts on Regulatory Strategies in Obesity Care
Tetyana Fine, MS

Global Strategy Considerations for Biosimilar Approvals
Rosalyn Janine Bailey, MPharm, MS

Artificial Intelligence in Drug Development
Darshini Trivedi, PhD


Speakers
avatar for Rosalyn Bailey

Rosalyn Bailey

Executive Director NA & LATAM Head – Global Regulatory Affairs Solultions, Syneos Health, United States
Rosalyn Bailey, MS, is an experienced Regulatory Affairs leader with over 20 years in the drug development industry. As Executive Director of Global Regulatory Affairs Solutions at Syneos Health, she oversees regulatory teams across the Americas, guiding products through the regulatory... Read More →
avatar for Lawrence Fine

Lawrence Fine

Business Consultant, Lawrence Fine, LLC, United States
Extensive experience working with companies of various sizes, including Fortune 500 companies. Deep expertise in Technology, Healthcare, Hospitality and Biotechnology industries across different functions including but not limited to marketing, information technology, and personnel... Read More →
avatar for Tetyana Fine

Tetyana Fine

Director, Global Regulatory Affairs, Astrazeneca, United States
Fifteen (15) years of diverse biotechnology and pharmaceutical industry experience, including leadership, regulatory strategy development and execution, chemistry manufacturing and controls (CMC), and program and project management. Effectively direct multinational, cross-functional... Read More →
avatar for Darshini Trivedi

Darshini Trivedi

Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
Thursday, June 19
 

8:00am EDT

Coffee and Light Refreshments
Thursday June 19, 2025 8:00am - 9:00am EDT
Room 145-147 Lobby
Component Type: Social Event



Thursday June 19, 2025 8:00am - 9:00am EDT
Room 145-147 Lobby Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

9:00am EDT

#401: Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements
Thursday June 19, 2025 9:00am - 10:00am EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-668-L04-P; CME 1.00; RN 1.00

Planning safety reviews for a compound developed for multiple diseases is complex, requiring consistency across studies and analyses. A compound-level Data Monitoring Committee ensures unblinded safety review consistency, while an Aggregate Safety Assessment Plan (ASAP) supports post-study assessments. This presentation explores how an ASAP was implemented across a program to enable ongoing safety profile development as studies complete. It also introduces an interactive R Markdown application for real-time aggregate reviews, aligning with new draft regulatory guidance. This approach provides reviewers with access to program-level and individual study data during development, improving safety oversight. Key topics include the importance of coordination, teamwork, and standards to maintain a reliable safety database. A "year in review" will highlight lessons learned and enhancements made, concluding with an example of the application’s interactive capabilities.

Learning Objectives

Recognize and apply the Aggregate Safety Assessment Planning (ASAP) concept to drug development and aggregate safety analysis; Discuss implementing the ASAP effectively within an organization; Identify and utilize the importance of an interactive application for performing ongoing aggregate safety reviews.

Chair

Robert (Mac) Gordon, MS

Speaker

An Industry Perspective
Lisa Kammerman, PhD, MS

Overview of the ASAP Process
Greg Ball, PhD

Perspective on the ASAP Process
Y. Veronica Pei, MD, MEd, MPH


Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →
avatar for Lisa Kammerman

Lisa Kammerman

Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States
Lisa Kammerman, PhD, owner of Kammerman Consulting, draws upon her industry and FDA experience, and provides statistical regulatory expertise and endpoint development guidance to pharmaceutical projects advancing to regulatory interactions and submissions. At AstraZeneca, as a Senior... Read More →
avatar for Y. Veronica Pei

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

9:00am EDT

#402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Thursday June 19, 2025 9:00am - 10:00am EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-669-L04-P; CME 1.00; RN 1.00

A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol decentralized clinical trial (DCT) and outline potential mitigation activities.

Learning Objectives

Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Discuss developing fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speaker

Panelist
Gina Lisette Williamson, BSN, MBA

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Maryrose Petrizzo, MS

Panelist
Terry Katz, MS


Speakers
avatar for Paula Horowitz

Paula Horowitz

Program Manager, QA, GCP Software Validation, AbbVie, United States
Paula Horowitz is a Quality, Project and Data Management professional with 25+ years experience in Biopharmaceutical, CRO and academic environments. Currently, at AbbVie, Ms. Horowitz is a Program Manager, Software Validation within the QA organization. She provides QA risk-based... Read More →
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
avatar for Maryrose Petrizzo

Maryrose Petrizzo

President and Consultant, Clinical Quality Assured,LLC, United States
Maryrose has over 25years of GCP experience in Clinical Quality Assurance and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, risk management, acquisition integrations, and clinical... Read More →
avatar for Gina Williamson

Gina Williamson

Associate Director Site solutions, Illingworth, A Syneos Health Company, Spain
A seasoned professional with over 19 years of experience in the Contract Research Organization (CRO) and pharmaceutical industry. Demonstrated expertise in leading and managing clinical trials, with hand on experience from both site and industry perspectives. Proficiency in overseeing... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

9:00am EDT

#403: How AI is Transforming the Area of Data Standards and Access to Source Data
Thursday June 19, 2025 9:00am - 10:00am EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-670-L04-P; CME 1.00; RN 1.00

The use of generative AI (genAI) is already shown to be useful in content generation. The use of genAI to accelerate development and maintainance of data standards and data transformation is rapidly evolving as it will be shown in this session.

Learning Objectives

Describe the current landscape of AI applications for developing, maintaining, and utilizing data standards to accelerate access to source data in electronic health records (EHRs) and registries; Evaluate how AI is currently shaping data standardization and transformation and anticipate its future impact on the landscape.

Chair

Jesper Kjær, MS

Speaker

Industry Feedback to AI in Data Standards
Robert DiCicco, PharmD

OHDSI OMOP AI and open science
Patrick Ryan

CDISC and AI
Chris Decker, MS

HL7 and the AI Train
Charles Jaffe, MD, PhD, FACMI, FACP


Speakers
avatar for Chris Decker

Chris Decker

President and CEO, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
CJ

Charles Jaffe

Chief Executive Officer, HL7, United States
Dr. Jaffe is the CEO of Health Level 7 International (HL7). He completed his medical training at Johns Hopkins and Duke Universities and post-doctoral training at the National Institutes of Health and the Lombardi Cancer Center. At NIH, he worked in the Laboratory of Clinical Investigation... Read More →
avatar for Jesper Kjaer

Jesper Kjaer

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark
Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →
PR

Patrick Ryan

Vice President Observational Health Data Analytics, Janssen Pharmaceuticals, Inc., United States
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

9:00am EDT

#404: Embedding and Leveraging AI for Quality and Compliance in Pharma
Thursday June 19, 2025 9:00am - 10:00am EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-671-L04-P; CME 1.00; RN 1.00

This session explores the transformative potential of AI in pharma quality and compliance, sharing use cases, strategies, and regulatory insights. Attendees will learn how AI can transform quality and compliance in pharmaceutical companies.

Learning Objectives

Describe AI use cases in pharmaceutical quality management and compliance processes; Recognize the role, benefits, and risks of using AI in quality management; Discuss strategies for integrating AI technologies into existing pharmaceutical quality and compliance frameworks.

Chair

Hangyu (cedric) Liu, MS

Speaker

AI and the Quality Professional
Michael Pelosi, MA, MBA, MSc

AI in Pharma Quality and Compliance
Roshan D'Souza

Explainable Natural Language Processing: Why you see What you see
Meera Nagaria, MS


Speakers
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche Products Limited, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
avatar for Hangyu (cedric) Liu

Hangyu (cedric) Liu

Associate Director, AI/ML, Biogen, United States
Hangyu Liu is currently an Associate Director of Artificial Intelligence Innovation at Biogen. He leads an advanced analytics group with a focus on R&D portfolio and quality analytics. He obtained a Master's degree in Data Science from Brown University. His research interests include... Read More →
avatar for Meera Nagaria

Meera Nagaria

Senior Data Scientist, Johnson & Johnson, United States
avatar for Michael Pelosi

Michael Pelosi

Director, Quality Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
Thursday June 19, 2025 9:00am - 10:00am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

9:00am EDT

#405: EMA - FDA Question Time
Thursday June 19, 2025 9:00am - 10:00am EDT
146BC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-672-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD

Speaker

Artificial Intelligence
Luis Pinheiro, PharmD, MSc

Advanced Manufacturing
Manuel Osorio, PhD

GCP
Kassa Ayalew, MD, MPH

GCP
Peter Twomey, MA, MPharm

Artificial Intelligence
Tala Fakhouri, PhD, MPH


Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →
avatar for Corinne de Vries

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Manuel Osorio

Manuel Osorio

Senior Scientist for Emerging Technologies, OD, CBER, FDA, United States
Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

9:00am EDT

#406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial
Thursday June 19, 2025 9:00am - 10:00am EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-673-L04-P; CME 1.00; RN 1.00

Alternative methods to a frequentist approach, such as Bayesian, may be superior in certain situations; particularly, when analyzing trial data to support approvals in small populations. Regulators are increasingly considering novel methods.

Learning Objectives

Examine global considerations for leveraging Bayesian approaches in pivotal trials to support marketing authorization; State and debate the situations and circumstances where the Bayesian approach may be the most appropriate method of analysis; Discuss health authority considerations that could facilitate the use of alternative analytical methods beyond the frequentist approach; Identify ways to bridge existing gaps in applying Bayesian methods in clinical research.

Chair

Philip Hougaard, DrSc, PhD

Speaker

FDA perspective
Yun Wang, PhD

EMA Perspective
Andrew Thomson, PhD, MA, MS

Industry Perspective
Scott Berry, PhD


Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
PH

Philip Hougaard

Vice President, Biostatistics and Data Science, Lundbeck A/S, Denmark
Vice President in biostatistics at H. Lundbeck A/S, Denmark. He has worked 40 years in the industry. He is Doctor of Science based on frailty models. He is the author of “Analysis of multivariate survival data”. He is external professor at University of Southern Denmark.
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
avatar for Yun Wang

Yun Wang

Deputy Division Director, CDER/OTS/OB, FDA, United States
Dr. Yun Wang is the Deputy Division Director for Division of Biometrics II in the Office of Biostatistics at CDER/FDA since March 2021. Before taking her current role, Dr. Wang was a statistical team leader and reviewer supporting anti-diabetic and hematologic products development... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session

9:00am EDT

#407: Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship
Thursday June 19, 2025 9:00am - 10:00am EDT
151B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-674-L04-P; CME 1.00; RN 1.00

This session empowers pharmaceutical scientists and researchers with essential business skills, strategies for commercialization, and solutions for industry challenges, enabling a successful transition from lab innovation to entrepreneurial leadership.

Learning Objectives

Identify essential business and entrepreneurial skills to navigate the transition; Discuss the intersection of scientific innovation and business strategy, helping professionals identify and develop viable commercial opportunities from their research; Recognize the unique challenges in the pharmaceutical industry, from regulatory complexities to funding obstacles, and provide strategies for overcoming them.

Chair

Angela Men, MD, PhD

Speaker

Panelist
Bei Ma

Panelist
Matthew Chervenak

Panelist
Shou-Bai Chao


Speakers
SC

Shou-Bai Chao

Chief Operating Officer, CanSino Biologics Inc., China
avatar for Matthew Chervenak

Matthew Chervenak

Founder & CEO, Allsci, United States
Matthew Chervenak is an entrepreneur and investor advancing science and liberal democracy. He is Founder and CEO of AllSci, an AI platform transforming how researchers explore and share scientific knowledge, and of Legis1, a data and news company supporting lawmakers, advocates, and... Read More →
BM

Bei Ma

Founder and CEO, The Pinea Group, LLC, United States
avatar for Angela Men

Angela Men

Chief Executive Officer, The Whiteoak Group, Inc, United States
Thursday June 19, 2025 9:00am - 10:00am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

10:00am EDT

Coffee Break
Thursday June 19, 2025 10:00am - 10:30am EDT
Room 145-147 Lobby
Component Type: Social Event



Thursday June 19, 2025 10:00am - 10:30am EDT
Room 145-147 Lobby Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  19: Networking Opportunities, Social Event

10:30am EDT

#408: FDA Town Hall
Thursday June 19, 2025 10:30am - 12:00pm EDT
146ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-25-675-L04-P; CME 1.50; RN 1.50

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Amy Bertha

Speakers
avatar for Amy Bertha

Amy Bertha

Executive Director, Regulatory Policy and Science, Bayer, United States
Amy Bertha is currently Executive Director, Regulatory Policy and Science at Bayer. Her prior experience includes, regulatory program and project management at FDA Center for Drug Evaluation and Research, regulatory affairs at Pfizer, and research scientist at Hoffman-La Roche. She... Read More →
Thursday June 19, 2025 10:30am - 12:00pm EDT
146ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   02: ClinTrials-Ops, Forum
 
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143ABC
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145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Room 151A
Salon B
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming