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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
TBD
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
TBD 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
TBD
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-502-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!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
TBD 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 Jessica Thompson

Jessica 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
TBD
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-504-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! 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
TBD 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
TBD
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
TBD 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
TBD
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-506-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! 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
TBD 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
TBD
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 22 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
TBD 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
 

9:00am EDT

62F: Electronic Patient-Reported Outcomes (ePRO): An Implementation Masterclass
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-25-509-L04-P; CME 6.50; RN 6.50

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. Patient experience data, through patient-reported outcomes (PROs) and other clinical outcome assessments (COAs) are an increasingly important component of regulatory drug submissions and health technology assessments (HTAs). Instructors will take participants on an in-depth evaluation of the key topics important in successful ePRO implementation, including:
  • Selecting, adapting and developing patient-reported outcome measures to meet protocol objectives
  • The case for ePRO – when to select an electronic approach, and when paper might suffice
  • ePRO implementation best practices to ensure good measurement science
  • Migration validity considerations and evidentiary requirements
  • Language, translation and licensing considerations
  • Implementation steps including vendor selection and user acceptance testing (UAT) best practices
  • Modality choices – web vs app, and bring-your-own-device (BYOD) considerations
  • Hot topics such as data change processes, mixing modes, special populations, etc.
  • Q&A – discussion of participants' own hot topics.
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 who have experience in clinical trials and patient engagement and wish to develop their skills on how PRO measurement is best implemented in clinical drug development programs.

Learning Objectives

  • Demonstrate when to select electronic capture, when to use web vs app, and when to enable patients to use their own devices (BYOD)
  • Apply industry best practices to ePRO implementation, translations and other processes such as PRO data changes
  • Describe the implementation steps, possible bottlenecks and mitigations, and user acceptance testing best practices


Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 80 publications and two industry textbooks on ePRO. Bill serves on 2 ISPOR task forces, the C-Path working... Read More →
avatar for Willie Muehlhausen

Willie Muehlhausen

Co-Founder, SAFIRA Clinical Research, Ireland
Willie Muehlhausen started his career as a Veterinary Surgeon in Berlin, Germany, before he joined a large CRO in March 1998. Throughout his career he worked in Germany, UK, USA and Ireland for eCOA vendors and CROs and developed a keen interest in patient-facing technologies such... Read More →
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Tutorial

9:00am EDT

61F: Root Cause Analysis and CAPA Management: Your Essential Toolkit for Best Practices
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-25-508-L04-P; CME 6.50; RN 6.50

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. According to the FDA (as well as other regulators), corrective and preventive action (CAPA) management and lack of proper investigation of challenges is a top observation among companies in the industry. In this short course, through interactive case studies, participants will learn how to conduct a proper investigation into a robust root cause analysis using industry standard tools in a toolkit approach. Additionally, participants will explore the challenges of proper CAPA planning and define appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. Real-life case studies from various FDA 483s will be explored to showcase how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. 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 who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

  • Determine the best approach to train individuals on industry best practices in CAPA management
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and effectiveness checks to ensure compliance and remediation of observations
  • Analyze case studies for techniques and strategies that will help solidify how to use the different tools


Speakers
avatar for Brendan Burns

Brendan Burns

Manager, Document Control & Training, Mersana Therapeutics, United States
Brendan is a Manager, Document Control & Training at Mersana Therapeutics, with over 15 years of biopharma industry experience in development landscapes ranging from preclinical to commercial organizations. Overall background includes roles ranging from manufacturing operator on the... Read More →
avatar for Christy Mazzarisi

Christy Mazzarisi

Quality and Clinical COE Lead, Network Partners Group, United States
Head of Quality, with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing (sterile and non-sterile) experience with over 17 years industry practice. Overall background and specialties include GMP... Read More →
avatar for Danielle Metzger

Danielle Metzger

Principal Quality Consultant, PharmaQ Consulting, United States
Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25 years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working... Read More →
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Tutorial |   20: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Tutorial
 
Monday, June 16
 

8:30am EDT

Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact
Monday June 16, 2025 8:30am - 10:00am EDT
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

The Patient Experience
Jimi Olaghere

The Future of Innovative Treatments
Doug Melton, PhD


Speakers
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 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 →
Monday June 16, 2025 8:30am - 10:00am EDT
  00: Plenary, Forum

10:15am EDT

IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
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


Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:15am EDT

Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
Component Type: Session

Clinical trials rely on historical data, causing inefficiencies in site selection, patient matching, and execution. To drive change, the industry must apply the scientific method—testing AI-driven approaches to optimize outcomes. Lokavant leads this shift, improving protocol-matching accuracy by 20% and using predictive analytics. CEO Rohit Nambisan shares real-world evidence of AI’s impact on de-risking trials and accelerating enrollment. Learn why pharma leaders now see AI as a necessity.

Speaker

Speaker
Rohit Nambisan


Speakers
avatar for Rohit Nambisan

Rohit Nambisan

CEO & Co-Founder, Lokavant, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:00am EDT

A Regulator's View on the Future Vision for Pharmacovigilance
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Basic

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.

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 →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

11:00am EDT

Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Basic

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

Academic Perspective
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

TAE HYUN

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 →
SS

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 →
VZ

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

11:00am EDT

Is Real-World Evidence Always a Last Resort?
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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; Discuss how HTA evaluate RWE and current collaborations with regulators.

Chair

Nancy A 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


Speakers
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

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

11:00am EDT

From Approval to Access: Integrating Patient Insights into Coverage Decisions
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Speaker
Kristi Martin, MA, MPA

Speaker
James D. Chambers, PhD, MPharm, MSc


Speakers
JC

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

Associate Professor, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, United States
James D. Chambers, PhD, MPharm, MSc, is an Associate Professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. His research interests include examining the factors that influence how insurance companies cover and reimburse medical technology... Read More →
KM

Kristi Martin

Director, Camber Collective, United States
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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

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
TBD
Component Type: Forum
Level: Intermediate

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
Reza Salehzadeh-Asl


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 of Regulatory Operations, OSI, OC, CDER, FDA, United States
Captain Kavita Dada is the Associate Director of Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. In this role, she leads initiatives and provides expertise... Read More →
RS

Reza Salehzadeh-Asl

National Supervisor Clinical Trial Compliance Program, Health Canada, Canada
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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

Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Advanced

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
Jyothis George

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno


Speakers
TB

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 →
JG

Jyothis George

Global Medical Vice President, Obesity and Related Conditions, Amgen, United Kingdom
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 →
ZJ

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 →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

11:00am EDT

Project Orbis: Six Years Later
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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; Explain how sponsors can benefit from participating in Project Orbis.

Chair

Sema Hashemi, MSc

Speaker

Panelist
Sarah Golding, MD

ANVISA Perspective
Marcelo Moreira, MS

Panelist
Michal Hirsh-Vexberg, PharmD

Panelist
R. Angelo De Claro, MD

Panelist
Dianne Spillman

Panelist
Ulrich Rohr


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 →
SG

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 →
SH

Sema Hashemi

Senior International Policy Advisor, OGPS, OC, 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 →
MM

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.
UR

Ulrich Rohr

Unit Head Clinical Review, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

11:00am EDT

Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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 K Martin, PhD, MS

Speaker

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
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 →
JP

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 →
RX

Richard Xie

Senior Health Economist, RA Capital, United States
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

11:00am EDT

Advancing Innovation Through Essential Drug Delivery Outputs
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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 an Assistant Director with the Regulation, Policy, and Guidance Staff in CDRH/OPEQ. In this capacity, James and his team collaborate across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.
SK

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 a Global Regulatory Policy & Intelligence Director, 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 Stevens is acting Division Director of FDA's Division of Drug Delivery, General Hospital and Human Factors. His division is responsible for regulation of drug delivery and general hospital device premarket submissions and postmarket safety and compliance. The division also provides... 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
TBD 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

Putting Patients First: 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
TBD
Component Type: Forum
Level: Intermediate

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

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 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 →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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

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 →
avatar for Tanvi Gupte

Tanvi Gupte

Student, University of Maryland, United States
JH

Jackson Hanf

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

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 →
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Lauren Le

Student, Butler University, United States
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Ritika Malik

Student, Temple University, United States
avatar for Ebere Okpara

Ebere Okpara

Research Assitant, 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 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 →
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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 →
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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 →
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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 →
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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

12:55pm EDT

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
TBD
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


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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma
Monday June 16, 2025 12:55pm - 1:55pm EDT
TBD
Component Type: Session

This session will showcase a GenAI-powered platform for Medical and Regulatory Authoring, transforming global pharma operations. Real-world case studies highlight how the platform reduces CSR and protocol preparation time by 50%. Key features include integrated authoring solutions, scalable content reuse, GenAI-driven quality control, and change management strategies. Designed for medical writers, regulatory executives, and digital innovation professionals aiming to streamline processes.

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

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
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

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
TBD
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


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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

2:15pm EDT

Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Intermediate

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 Myers, JD

Speaker

Academic 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 →
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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 19 years and has been active in the DC policy arena for three... 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
  02: ClinTrials-Ops, Forum

2:15pm EDT

A Masterclass: Patient Recruitment Campaign Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Intermediate

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
Tom Julian

Case Study Presentation
Kelly Johnston McKee, MS


Speakers
TJ

Tom Julian

Assoc. Director Design and Innovation, Gilead Sciences, United States
avatar for Kelly McKee

Kelly McKee

Head of Innovative Patient Recruitment, Evinova, An Astrazeneca Company, United States
Kelly McKee is the Head of Innovative Recruitment at Evinova, AstraZeneca’s digital healthcare company, where she is responsible for leading the department in developing and deploying digital and innovative patient recruitment strategies and tactics. Kelly is a proven clinical trial... Read More →
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Chris Venezia

Chief Executive Officer, ProofPilot, United States
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
  02: ClinTrials-Ops, Session |   05: Patient-Impact-Product-Dev, Session

2:15pm EDT

Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Advanced

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 IRB, 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 →
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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
TBD 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

2:15pm EDT

Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Basic

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

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Brendan O'Leary

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Mark Stewart, PhD

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Elaine Katrivanos

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
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 →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
GM

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 →
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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 is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... 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
  06: PersonalizedMed-ComboProd-Diagnostics, Session

2:15pm EDT

Models of Collaborations to Advance Regulatory Science: Lessons Learned
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Advanced

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
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA


Speakers
avatar for Huong Huynh

Huong Huynh

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

Carla Rodriguez-Watson

Reagan-Udall Foundation for the FDA, United States
Dr. Carla Rodriguez-Watson is the Scientific Director of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program at the Reagan-Udall Foundation for the FDA. The Foudation’s mission is to advance FDA’s mission to modernize product development, accelerate... 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 →
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
  07: ProjectManagement-StrategicPlanning, Session

2:15pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Industry Perspective
Kevin Richards


Speakers
KR

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
TBD 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

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
TBD
Component Type: Forum
Level: Intermediate

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 Francer, JD, MPA

Speakers
JF

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 →
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
  09: Regulatory, Forum

2:15pm EDT

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
TBD
Component Type: Forum
Level: Intermediate

Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.

Learning Objectives

Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6(R2) Good Clinical Practice, E17 Multi-Regional Clinical Trials and M4Q(R2); Identify opportunities for greater regulatory harmonization to advance global drug development.

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


Speakers
MM

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 - Strategic Initiatives, 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 →
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
  09: Regulatory, Forum

2:15pm EDT

Health Canada Town Hall
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Intermediate

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
TBD 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

Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Intermediate

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

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
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 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
TBD 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

Best Practices for Navigating Divergent Regulatory Feedback
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

FDA Perspective on Best Practices for Navigating Divergent Regulatory Feedback
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 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 Affairs, 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 (Global Labeling, US Ad Promo and Regulatory Policy & Intelligence) in 2015. Prior to joining AbbVie, Natalie... 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
  09: Regulatory, Forum |   04: MedAffairs-SciComm, Forum

2:15pm EDT

Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Advanced

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 reguatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Jennifer McCafferty, 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 Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, 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 →
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
  10: RegCMC-Product Quality, Session

2:15pm EDT

Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Basic

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
KL

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

2:15pm EDT

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Basic

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

Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Forum

2:15pm EDT

Ushering in a New Era of Africa Healthcare
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Advanced

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.

Chair

Rachel Zhang, MA, MBA

Speaker

Panelist
Huwaida Bulhan, MD, MPH

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca A. 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
KV

Katherine Van Loon

Director, Global Cancer Program, UCSF Helen Diller Family Comprehensive Cancer Center, United States
TM

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 →
avatar for Rachel Zhang

Rachel Zhang

Chair-Elect, Drug Information Association, United States
Rachel has over two decades of healthcare consulting and life science management experiences. Formerly a partner in McKinsey & Company’s New York Office, Rachel oversaw the design and delivery of corporate and R&D transformation programs, working with leading pharmaceutical companies... 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

3:45pm EDT

Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Basic

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: 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 →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

3:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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


Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

3:45pm EDT

Efficient Data Exchange: Drivers for End-to-End Standards Adoption
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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).

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS


Speakers
avatar for Rita Algorri

Rita Algorri

Senior Manager, Global Regulatory Affairs (CMC), Amgen, United States
Rita Algorri, PhD is a Senior Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging... 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 and Interoperability, AstraZeneca, United Kingdom
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

3:45pm EDT

Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

From Proof of Concept to Proof of Value, an industry approach to integrated evidence planning throughout the product lifecycle
Agathe Le Lay, PhD, MSc

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

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


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 →
BM

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
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD 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

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
TBD
Component Type: Session
Level: Intermediate

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

Industry Perspective
Samantha Roberts, PhD


Speakers
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 →
avatar for Pujita Vaidya

Pujita Vaidya

North America Lead, 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
TBD 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

Ethics in the Era of Precision Medicine and Advancing Technologies
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 medcine; Recognize the importance of the inclusion of diverse, representative populations and handling of incidental findings.

Chair

James Wabby, MHS

Speaker

Ethics in the Era of Precision Medicine and Advancing Technologies
James Wabby, MHS

Ethics in the Era of Precision Medicine and Advancing Technologies
Amanda Burkhardt, PhD


Speakers
avatar for Amanda Burkhardt

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... 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 22 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

3:45pm EDT

Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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.

Speaker

MHRA Perspective
Jason Wakelin-Smith


Speakers
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
TBD 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

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

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

Considerations for Regulatory Collaboration in Chronic Disease
John Sharretts

Industry Perspective
Kevin Bugin, PhD, MS, RAC


Speakers
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 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.
JS

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

FDA Accelerated Approval Program: Putting Withdrawals in Context
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Forum
Level: Basic

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

J&J Experience
Joseph William Markmann

BMS experience
Sandra Krogulski, MA

Novartis Experience
David Yao


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, United States
BM

Ben Moscovitch

Public Policy, Amazon Web Services, United States
DY

David Yao

Associate Director, Regulatory Affairs CMC, Novartis, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

3:45pm EDT

WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 →
JN

Jude Nwokike

Vice President and Director, PQM+, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

3:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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.

Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD 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

Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 →
AJ

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
TBD 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

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
TBD
Component Type: Session
Level: Advanced

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

Regulatory Perspective
Ingrid Markovic, PhD

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 →
SD

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 →
avatar for Ingrid Markovic

Ingrid Markovic

Senior Science Advisor, Office of the Center Director, CBER, FDA, 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 →
WR

Warren Roche

Statistician, Sanofi, Ireland
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

3:45pm EDT

Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 →
TJ

Tony Johnson

Senior Director, Clinical Quality, Mallinckrodt Pharmaceuticals, United States
AS

Ana Sharma

Global Head of Quality, Abivax, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

3:45pm EDT

AI in Patient Care: Aspirations and Considerations
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Advanced

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

Speakers
EW

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  13: Spotlight, Session |   09: Regulatory, Session
 
Tuesday, June 17
 

8:30am EDT

Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

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

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

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


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 →
MF

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 →
WH

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 →
HJ

HYUN JOO JUNG

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

Diversity Action Plans in Rare Genetic Disease Drug Development: Obstacles and Opportunities
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Advanced

This forum will provide information regarding new requirements for Diversity Action Plans. A panel of experts will describe details of these requirements, implementation challenges for rare genetic diseases, and strategies to address these challenges.

Learning Objectives

Describe how regulatory requirements for Diversity Action Plans might apply to orphan drug development; Plan regulatory strategy for inclusive and representative rare disease drug development; Identify challenges regarding compliance to Diversity Action Plan requirements in rare disease settings.

Chair

Mark Tobolowsky, JD

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

8:30am EDT

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
TBD
Component Type: Workshop
Level: Intermediate

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

Maya Zlatanova

Speakers
MZ

Maya Zlatanova

CEO & Co-founder, Findmecure Ltd., Bulgaria
Maya Zlatanova is the CEO and co-founder of FindMeCure (patient navigation platform) and TrialHub (data-intelligence platform for clinical trials). Her team and Maya are on a mission to bring clinical research closer to patients by improving the way we design and conduct clinical... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Workshop

8:30am EDT

Realizing Value Through Responsible AI in Clinical Development
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Industry perspectives on AI in clinical development
Raja Shankar, MS


Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

8:30am EDT

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

This session will explore the evaluation and integration of assistive technology for clinical document content creation. The panelists will describe experimental design, cross-functional team formation, and the adoption of tailored solutions.

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; Recognize how to design a strategy for integrating technologies into existing systems and behaviors.

Chair

Ulrike Kochendoerfer, PhD

Speaker

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technolgy Ecosystem
Matthew Renda, PhD, MS

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technolgy Ecosystem
Aliza Nathoo


Speakers
avatar for Ulrike Kochendoerfer

Ulrike Kochendoerfer

Senior Director, Medical Writing, Pfizer Inc, United States
Dr. Ulrike Kochendoerfer has over 20 years of experience in pharmaceutical research. She started her career in pre-clinical research in toxicology and biochemistry, before entering the regulatory medical writing field in 2005. Dr. Kochendoerfer holds a PhD from the University of Bonn/Germany... Read More →
avatar for Aliza Nathoo

Aliza Nathoo

Senior Director, Content Strategy, F. Hoffmann-La Roche Ltd., Canada
Aliza began her career supporting 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... 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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

8:30am EDT

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
TBD
Component Type: Session
Level: Advanced

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

Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Kassa Ayalew, MD, MPH

Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Debbi Fox


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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

8:30am EDT

A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
avatar for Alexis Miller

Alexis Miller

Acting Global Lead, 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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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


Speakers
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 Pharmaceuticals Corporation, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

Japan Town Hall
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Speaker
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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

MHRA Town Hall
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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

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


Speakers
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 →
CH

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
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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

Redesigning Research and Development Policies with Women in Mind: Turning Ambition to Impact
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Basic

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 Laitner


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 →
ML

Melissa Laitner

Director, Strategic Initiatives, National Academy of Medicine, United States
avatar for Nicole Richie

Nicole Richie

Vice President & Global Head Health Equity & Population Science, Genentech, United States
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

9:45am EDT

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
TBD
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

Senior Global Head, Operational 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD
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

Chief Information, Technology and Product 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, for 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

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
TBD
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

Sr. Director, Strategic Solutions - Regulatory Affairs & Drug Development, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:30am EDT

The Globalization of Risk Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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 A Patel, PharmD

Speakers
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 →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

Case Studies of Application of AI in Risk-Based Quality Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

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 →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

Resilient Leadership: Overcoming Isolation and Adversity
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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


Speakers
MR

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States
Matthew Robillard is a Senior Director of Regulatory Strategic 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... 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
TBD 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

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
TBD
Component Type: Session
Level: Intermediate

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
PD

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, Sanofi, 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 →
DR

Dawn Rotellini

Chief Operating Officer, National Bleeding Disorder Foundation, United States
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

10:30am EDT

Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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


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 PROFILE A compassionate pioneer driving clinical trial solutions for a healthier world. (2) Donna Libretti Cooke, JD | LinkedIn BIOGRAPHY Donna is a strategic and collaborative Life Sciences professional... 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
TBD 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

10:30am EDT

Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Advanced

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, Leidos Biomedical 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 →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
DL

Dun Liang

Director, Global Regulatory Affairs, Diagnostics, Eli Lilly & Co., United States
Dun is a diagnostics and regulatory expert with unique experience across pharma, diagnostics, and government. At Eli Lilly, He provides critical strategic and tactical guidance, interpretation, and assessments on diagnostic regulations globally. He coordinates, plans, and executes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

10:30am EDT

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
TBD
Component Type: Session
Level: Intermediate

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, for equal access to better treatments... Read More →
AS

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

10:30am EDT

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
TBD
Component Type: Session
Level: Intermediate

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
DF

Debbi Fox

Compliance and Enforcement Specialist, Health Canada, Canada
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

10:30am EDT

ANVISA Town Hall
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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
MM

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
DS

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

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

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


Speakers
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 →
AS

Aaron Smith

Founder, Machine Learning Scientist, Unlearn.AI, United States
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
IS

Imran Shah

SVP & Head, Global Regulatory, R&D Quality and Safety (RQS), EMD Serono, United States
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Advanced

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 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 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
TBD 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

Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Advanced

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.

Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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

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
TBD
Component Type: Forum
Level: Advanced

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 →
MM

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum

10:30am EDT

Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Workshop
Level: Basic

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

Practical Response to Industry Stressors- A Personal Journey
Jessica Marie Thompson, MBA, MS, PMP

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

Mindfulness Tools
Allison McDougall, MBA


Speakers
avatar for Allison McDougall

Allison McDougall

Executive Vice President, G3, United States
With 20+ years’ experience in Life Sciences business development, Allison serves as EVP at G3, a boutique-at-scale agency dedicated to AI-First solutions to ensure healthcare awareness and access from a multi-cultural and accessibility perspective. Evangelizing AI-First, some of... Read More →
ES

Eddie Stern

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

Jessica 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, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Workshop

11:30am EDT

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
MA

Meha Ahmed

ORISE FELLOW, FDA, United States
AA

Abdulaziz Alageel

Senior Alert and Monitoring Expert, Saudi Food and Drug Authority, Saudi Arabia
SA

Saeed Alshahrani

Alarm & Control Expert, Saudi Food & Drug Authority, Saudi Arabia
VA

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, co-founder and Chief Technology Officer of PicnicHealth, holds degrees in Aerospace Engineering and Physics from MIT. At PicnicHealth, Troy spearheads the development of technologies transforming unstructured medical records into research datasets. His team has pioneered... 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 →
MC

Maryann Chapin

ORISE Fellow, Food and Drug Administration, United States
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 →
PC

Pamela Concepcion

Patient Safety Scientist, Astrazeneca, United States
AC

Ana Corona

Translator, University of Utah, United States
HG

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 →
HG

Hannah Graunke

Senior Policy Analyst, Duke-Margolis Institute For Health Policy, United States
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 →
EH

Eimy Honda

University of São Paulo - USP, Brazil
AH

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 →
AH

Angela Hu

VP, PAREXEL International Inc., Taiwan
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 Aarthi Iyer

Aarthi Iyer

Corporate Counsel, Cogent Biosciences, Inc., United States
Aarthi B. Iyer is a Senior Regulatory Attorney & Managing Director for Kinetiq, a consulting and technology division of Quorum Review IRB. Aarthi provides guidance and regulatory analysis on issues related to human subjects research including informed consent, privacy, data use, and... 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 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 →
TK

Toshitatsu Kobayashi

Senior Regulatory Expert, Otsuka Pharmaceutical Co., Ltd., Japan
ML

Marie Liles-Burden

Director, PhV Risk Management, Takeda, United States
AL

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 →
AM

Amanda McMannis

Associate Director, Clinical Operations, The Prostate Cancer Clinical Trials Consortium, United States
EO

Evon Okidi

Senior Data Scientist, Medidata Solutions, A Dassault Systemes Company, United States
FO

Feisal Othman

Associate Director, Global Risk Management Strategy, Bristol Myers Squibb, United States
MR

Mohit Raizada

Director - Signal Management Services, IQVIA, India
MS

Molly Shields

Policy Research Assistant, Duke-Margolis Institute For Health Policy, United States
JT

Julie Tripp

Senior Director of Toxicology, Mind Medicine Inc., United States
BW

Benjamin Worley

Senior Director, Sustainability and ESG, Labconnect, United States
TY

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
TZ

Teresa Zhang

Safety Scientist, Beigene, United States
CZ

Chenan Zhang

Director, Epidemiology, Pfizer, United States
AZ

Andrea Zuleta

Manager, Office of Health Literacy, Abbvie, United States
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

11:45am EDT

Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?
Tuesday June 17, 2025 11:45am - 12:15pm EDT
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:00pm EDT

Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD
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
CS

Carolyn Shore

Senior Program Officer, National Academies, United States
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

1:05pm EDT

Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
TBD
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
Rachel Belani-Barker

Speaker
Georgia Lytra

Speaker
Dyke Simpson


Speakers
avatar for Rachel Belani-Barker

Rachel Belani-Barker

Managing Director, Syneos Health Consulting, United States
avatar for Georgia Lytra

Georgia Lytra

Engagement Manager, R&D Advisory, Syneos Health , United States
avatar for Dyke Simpson

Dyke Simpson

Executive Managing Director and Lead, Data, AI & Analytics Services Practice, Syneos Health , United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:45pm EDT

Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Risk mitigation (RM) decisions commonly lack conclusive data and reproducibility. This session presents regulatory initiatives, TRIM, the first tool to support RM decision-making, and case studies of evidence-guided RM implementation and evaluation.

Learning Objectives

Summarize new initiatives that support regulatory decision-making on risk mitigation; Explain the use of pharmacoepidemiologic and decision-science approaches in developing an explicit risk mitigation decision tool; Discuss how qualitative and quantitative evidence can support REMS implementation; Compare study design options for formal REMS evaluation.

Chair

Almut G Winterstein, PhD, RPh, FISPE

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

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
TBD
Component Type: Forum
Level: Intermediate

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 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

1:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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, Office of Clinical Policy and Programs, OC, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

Reliable AI in Biomedical Settings: A Framework for Trust and Innovation in an Evolving Landscape
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

With AI-based technologies used across biomedical settings, this session will share considerations and proven examples on selecting the right AI strategy, assuring AI suitability and reliability, and staying onside of regulatory expectations.

Learning Objectives

Discuss what to consider when selecting AI strategies and methods for use in biomedical settings; Recognize the importance in having a framework for evaluating and determining the suitability and readiness of AI (for example, large language models) for a specific application; Identify necessary inputs and approaches to navigating an evolving regulatory landscape for the application of AI solutions in biomedical settings.

Chair

Sarah Lyons, MSc

Speaker

Not all AI is Equal: Value of Purpose-Tuned Models for High Quality Research
Troy Astorino


Speakers
avatar for Troy Astorino

Troy Astorino

CTO, PicnicHealth, United States
Troy Astorino, co-founder and Chief Technology Officer of PicnicHealth, holds degrees in Aerospace Engineering and Physics from MIT. At PicnicHealth, Troy spearheads the development of technologies transforming unstructured medical records into research datasets. His team has pioneered... 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

How Medical Writing 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
TBD
Component Type: Session
Level: Intermediate

This session will explore the FDA START program for accelerating rare disease therapies. We will invite companies who participated in the START pilot and a FDA representative.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how medical writers can support companies applying for and participating in the START program.

Chair

Robin Whitsell

Speaker

Panelist
Madiha Khalid, PhD

Panelist
Jhon Cores, PhD


Speakers
JC

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 →
MK

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 →
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

1:45pm EDT

The Adoption of Artificial Intelligence and Machine Learning in Clinical Research
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Basic

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 →
MV

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
TBD 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

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

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: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA

Participant Feedback Forum: Active Interpretation of Signals by Patient Advisors and Attendees
Lani Hashimoto


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 →
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 →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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

The Laboratory-Developed Tests Final Rule: New Developments and Compliance Insights
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

The FDA has published a final rule to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act. The publication of the rule has far-reaching implications for the quality and availability of diagnostic tests in the United States, as well as impacts on pharmaceutical product research. This session will discuss the final rule in a panel format, focusing on the impact to various stakeholders, as well as current compliance efforts and next steps for ensuring compliance. The session will also address the impact of the recent election, legislative and executive actions, and litigation, on the FDA’s regulation of laboratory developed tests.

Learning Objectives

List requirements of the LDT Final Rule and phased approach to regulation; Explain implications of the FDA LDT Final Rule for patients, developers, health care systems, providers and regulatory decision making; Discuss approaches to implementing requirements of the final rule.

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 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

1:45pm EDT

Guerrilla Strategic Delivery
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Implement adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; 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

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
MK

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 →
JT

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

1:45pm EDT

Embracing ICH E6(R3) with Risk-Based Quality Management
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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
AD

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, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... 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
TBD 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

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

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
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly... 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, Marketed Health Products Directorate, Health Canada, Canada
Kelly is the Director General of Health Canada’s Marketed Health Products Directorate. She leads a diverse team on a range of health product regulatory activities including surveillance, assessment, and risk management; risk communications; health product advertising; use of real-world... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

Pediatric Cluster Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

Australia Perspective
Robyn Langham, MD, PhD


Speakers
RL

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.
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 →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

1:45pm EDT

China Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speakers
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 →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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

Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Pathways to inspection reliance- a 20 year journey
Andrea Kurz

ANVISA Perspective
Bianca Zimon, LLM


Speakers
AK

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

1:45pm EDT

Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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 →
JW

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
TBD 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

Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec


Speakers
EI

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

2:55pm EDT

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
TBD
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
TBD 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

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
TBD
Component Type: Session

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

Speakers
CK

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
TBD 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

Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

4:00pm EDT

Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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


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 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

4:00pm EDT

Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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 Hill

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration & 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 Executive 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 →
AH

Amber Hill

Founder & CEO, R.grid, United Kingdom
avatar for Kimberly Tableman

Kimberly Tableman

Founder & CEO, Espero, United States
Kimberly Tableman is Chief Clinical Development Officer (CCDO) at Castor. She has more than 23 years of experience in clinical development and technology. Over the past decade, she has focused on applying digital health technologies to reimagine the patient journey. She was most recently... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

4:00pm EDT

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
TBD
Component Type: Forum
Level: Advanced

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 PROFILE A compassionate pioneer driving clinical trial solutions for a healthier world. (2) Donna Libretti Cooke, JD | LinkedIn BIOGRAPHY Donna is a strategic and collaborative Life Sciences professional... 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

4:00pm EDT

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
TBD
Component Type: Session
Level: Advanced

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

Data Holder and Patient Advocacy Perspectives
Jennifer Farmer, MS

Health Technology Perspective
Ulka B Campbell, PhD

Sponsor Perspective
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 →
EC

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 →
PD

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

Breaking Barriers: Making Health Information Accessible to All
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Basic

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

Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

4:00pm EDT

Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA


Speakers
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 Jennifer Tucker

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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

4:00pm EDT

Delivering Effective Business Transformations and How to Apply them to Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
AC

Ashar Choudhry

Executive Director, Enterprise Operational Excellence, Bristol Myers Squibb, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

4:00pm EDT

Updated Tufts Center for the Study of Drug Development Benchmarks on Vendor Qualification Practices: Insights from the Evolving Pharma Landscape
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Tufts Center for the Study of Drug Development (TCSDD) Working Group on Vendor Qualification will present updated Research Findings and Interactive Discussion on Addressing Industry-wide Challenges Associated with Qualification.

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

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 →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum

4:00pm EDT

Pharmacovigilance Inspections Fireside Chat
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

Health Canada Perspective
Stephane Berard


Speakers
SB

Stephane Berard

Interim Supervisor-Health Product Compliance East Unit, Health Canada, Canada
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
TBD 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

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
TBD
Component Type: Session
Level: Intermediate

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
Sarah Adam

Collaborative and Harmonization Initiatives Advancing the Development and Accessibility of Advanced Therapy Medicinal Products
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

ANVISA Perspective
Renata Miranda Parca, AHIP


Speakers
avatar for Sarah Adam

Sarah Adam

Associate Director, Regulatory Affairs, IFPMA, Switzerland
Sarah Adam coordinates IFPMA activities in the Regulatory field focussing on policy, regulatory system strengthening and harmonisation. She also leads Regulatory Science Policy for Africa. Prior, Sarah worked for many years, for ICH, supporting the harmonisation of ICH technical Guidelines... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Reviewer 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 gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... 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 Maria Antonieta Roman

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

4:00pm EDT

Towards Instantaneous Regulatory Decisions and Better Predictability
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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
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 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 →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

4:00pm EDT

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
TBD
Component Type: Session
Level: Intermediate

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how can authorities provide aligned review, guidance and expectations towards these activities and how should sponsors communicate patient engagement?

Learning Objectives

Discuss US (FDA) and EU (EUCTR and country ethics committees) initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from sponsor survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance; Describe emerging markets.

Chair

Melissa Pauline Herman, MSc

Speakers
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 engagement across neurology and neuro-rare development programs.
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Panel
David Sidney Ross, MBA, MSc, PMP, RAC

Panel
Vada Perkins, DrSc, MSc

Panel
Brooke Casselberry, MS, RAC


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 →
avatar for Brooke Casselberry

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States
Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... 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 →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

4:00pm EDT

Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Industry Perspective
Ran Duan, PhD

Industry Perspective
Jingyu (Julia) Luan, PhD


Speakers
RD

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States
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 →
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 (FORExcellence) at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists that promotes best practices in RWE generation at CSL. His team... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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

Exploring Regulator Career Paths: The Impact of Inclusion on Decision Making and Medicines Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Basic

Inclusion in clinical trials is a widely discussed topic, but have you considered how inclusion in career journeys influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths.

Learning Objectives

Recognize how inclusion 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); Examine how inclusion in recruitment and career pathways supports inclusion in decision making in medicines development.

Chair

Paula Walker, MA

Speaker

Health Canada Career Pathway: Impact to Medicines Development
Reza Salehzadeh-Asl


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 →
RS

Reza Salehzadeh-Asl

National Supervisor Clinical Trial Compliance Program, Health Canada, Canada
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

4:00pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Looking Internally and Externally to Optimize Workforce Development
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
Wednesday, June 18
 

8:30am EDT

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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 →
UK

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 →
DW

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Basic

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

Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

8:30am EDT

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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; Discuss resources to assist teams in navigating regulatory documentation.

Chair

Jane Myles, MSc

Speaker

Regulator Perspective
Timil Patel, MD

Industry Perspective
Shelly Barnes


Speakers
SB

Shelly Barnes

Global Clinical Innovations Lead, UCB, United States
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 Timil Patel

Timil Patel

Clinical Team Lead (Acting), Division of Oncology 2, FDA, FDA, United States
Timil Patel, M.D., is a medical oncologist who serves as a clinical reviewer on the Gastrointestinal Cancers and Melanoma Team in the Division of Oncology 3 at the U.S. Food and Drug Administration. His research interests include evaluating ways to modernize clinical trials and evidence... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

8:30am EDT

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
TBD
Component Type: Session
Level: Basic

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 Digitial Protocol: Am I Prepared?
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, CDISC, 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. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
avatar for William Illis

William Illis

Global Head, Collaboration/Technology Strategy, Clinical Development & Analytics, Novartis , United States
Bill is Global Head of Technology Strategy and Collaboration in Clinical Development and Analytics responsible for developing and implementing the analytics technology strategy and managing collaborations with internal and external partners. He has been responsible for leading large-scale... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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

Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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; State 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

MHRA Perspective
Jason Wakelin-Smith


Speakers
KI

Kentaro Ichinose

Inspector, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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 →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

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
At the Clinical Trials Transformation Initiative (CTTI), Ms. Hanger leads strategic planning and new initiatives. Previously, she was vice president of the online patient research network PatientsLikeMe, where she oversaw programs utilizing patient-generated health data in life sciences... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
MW

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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

Speakers
avatar for Amira Younes

Amira Younes

Director, Global Regulatory Policy EEMEA, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

8:30am EDT

The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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, MSc, RAC

Speakers
MA

Michael Ageboh

Senior Manager, Medical Device/IVD, Pharmalex / Cencora, United States
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

8:30am EDT

How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

ICMRA Pilot, Assessment Summary Report
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 Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, 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 →
LR

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

8:30am EDT

Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

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.

Speaker

Panelist
Annie Kennedy


Speakers
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 →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session

9:45am EDT

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
TBD
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 of Pharma Solutions, Applied AI Science Team, 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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

Speakers
WB

William Blumentals

Head of Pharmacoepidemiology, Special Care, Sanofi, United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Trustworthy AI Solutions for Next-Generation Pharmacovigilance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

Despite advances in AI and Generative AI, its routine use in pharmacovigilance (PV) and high-risk applications is limited. This session will explore what’s needed to enable trusted use, highlighting technical challenges with multistakeholder input.

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

Jens-Ulrich Stegmann, MD, RN

Speakers
avatar for Jens Stegmann

Jens Stegmann

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium
Jens-Ulrich Stegmann, MD, RN, is Senior Vice President, Head of Clinical Safety and Pharmacovigilance, and EU QPPV at GSK, Belgium. With an M.D. in nursing from the University of Essen and a Ph.D. in Physiology from Christian-Albrechts University in Kiel, Germany, Jens began his career... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
avatar for Kwaku Marfo

Kwaku Marfo

Africa Market Development Specialist, IQVIA, Ghana
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

Patient Referral: Is It Hope or Hype?
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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

Sanghita Bhattacharya, PhD

Speaker

Patient Referral: Is It Hope or Hype?
Joan Chambers

Patient Referral: Is It Hope or Hype?
Barbara Isquith Arone, MS

Patient Referral: Is It Hope or Hype?
Karen Correa, PhD

Patient Referral: Is It Hope or Hype?
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 Sanghita Bhattacharya

Sanghita Bhattacharya

Director Data Science Global Function, Johnson & Johnson Innovative Medicine, United States
Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →
avatar for Joan Chambers

Joan Chambers

Senior Consultant, Tufts CSDD, 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.
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

10:30am EDT

Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Advanced

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 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 →
LR

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

10:30am EDT

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
TBD
Component Type: Session
Level: Basic

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

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 →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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

Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc


Speakers
EA

Eishita Agarwal

Digital Innovation Manager, Medical Writing, GSK, India
Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into... 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 →
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

10:30am EDT

Why Patient/Site Collaboration is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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

Vice President of Contracts and Trial Management, CNS Healthcare, 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, for equal access to better treatments... Read More →
FM

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
TBD 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

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
TBD
Component Type: Forum
Level: Intermediate

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, DrMed

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm


Speakers
NK

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

Director, Department of International Clinical Development, National Cancer Center Hospital, Japan
Dr. Nakamura is the Director of the Department of International Clinical Development at the National Cancer Center Hospital. He completed his degree at Kyoto University in 1999. After spending seven years training as a general surgeon, he joined the National Cancer Center to participate... 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

10:30am EDT

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Basic

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
Catherine Gregor, MA, MBA

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Ken Wiley. Jr.


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

Ken Wiley. Jr.

Section Chief, National Center For Advancing Translational Sciences, United States
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
TBD 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

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

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 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
TBD 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

Practical Implementation of MRCTs Based on ICH E17 Guidelines
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka

Panelist
William Wang, PhD


Speakers
HH

Hideki Hiraoka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

Health Regulation Expert, Brazilian Health Regulatory Agency (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
TBD 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

Navigating the Challenges of Drug Delivery Using a Novel Device
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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
TBD 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

Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Lapses in quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss enhancements to oversight 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 issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction; Identify ways to improve contracts, agreements, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
HK

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 →
RO

Rosemary Orciari

Senior Directory, Reg Intel, Policy and QMS Lead, Pfizer, United States
PS

Patrick Saunders

Senior Director, Quality, Lilly del Caribe, Eli Lilly & Co., United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

10:30am EDT

Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

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.

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

10:30am EDT

Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

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

What's Next for Developing Inclusive Leaders?
Christine Mayer-Nicolai, PharmD

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

Associate Director, Scientific Programs, 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 Christine Mayer-Nicolai

Christine Mayer-Nicolai

Vice President, Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany
Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

11:30am EDT

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
MB

Maria Baier

Data Scientist, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
AB

Andrea Bell-Vlasov

Science Policy Analyst, U.S. Food & Drug Administration, United States
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 →
SC

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 →
avatar for Lorraine Danks

Lorraine Danks

Senior Program Officer, Gates Foundation, South Africa
After spending 22 years in the pharmaceutical industry in regulatory affairs, QA and PV roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, Lorraine Danks joined the South African medicines regulator, SAHPRA, in June 2020 to head up the organization’s... Read More →
MF

Motoki Fujii

Senior Professional, EPS Corporation, Japan
DF

Denise Fulton

Vice President, Research & Content Strategy, 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 →
KG

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 →
FH

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 →
NH

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 →
TH

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 →
NJ

Nakyung Jeon

Assistant Professor, Pusan National University, Korea, Republic of
TK

Timothy Kline

Senior Director, Global Regulatory Affairs, GSK, United States
HK

Hema Kothari

Scientific Writer II, Bristol Myers Squibb, United States
avatar for Catherine Lee

Catherine Lee

Associate Director - US Policy and Intelligence, Johnson and Johnson, United States
Catherine Lee, DrPH is currently Associate Director, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy work on Real-World Evidence, Pediatrics and Immunology Therapeutic Area, Janssen Pharmaceutical Companies of Johnson & Johnson. Before joining... Read More →
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 →
TM

Toru Morishita

Manager, Global Regulatory Affairs, GlaxoSmithKline, United States
KM

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 →
NN

Nancy Ngum

Public Health Officer, AUDA-NEPAD, South Africa
MO

Miyako Okayama

Regulatory Expert, Regulatory Technology & Operations Office, Regulatory Affairs, Otsuka Pharmaceutical, Co., Ltd., Japan
VP

Valerie Parker

Assistant Research Director, Duke Margolis Institute For Health Policy, United States
JP

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

Aysha Rana

Regulatory Affairs Specialist, Spectra Medical/Northeastern Universitu, United States
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 →
CS

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 →
YF

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 →
TS

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

FDA, United States
JT

Jayashree Tikhe

Senior Product Marketing Manager, Dassault Systemes, United States
JV

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States
KW

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 →
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

12:00pm EDT

Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
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

Speakers
NE

Noel Ellison

SENIOR QUALITY ASSURANCE ASSOCIATE, Trialwise, Inc., United States
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD 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

Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
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
TBD 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

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
TBD
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   07: ProjectManagement-StrategicPlanning, Session

1:45pm EDT

Addressing Challenges in Devices Safety Monitoring
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

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.

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 →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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


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 →
SN

Sumati Nambiar

Senior Director, Johnson and Johnson, United States
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh


Speakers
BK

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
TBD 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

Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Speakers
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 20 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 →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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

Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

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 →
CM

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

1:45pm EDT

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

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

Health Canada Perspective
Myriam Salem, MSc


Speakers
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 →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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

Africa's Evolving Regulatory Landscape
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Saba Berhane, BSN, MPharm

Speakers
SB

Saba Berhane

Manager, Regulatory Affairs, IFPMA, Switzerland
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

EMA Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

Indonesia Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Basic

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

Analyze the recent transformations in Indonesian clinical research regulations and their impact on the country's research environment; Evaluate the opportunities and challenges for global pharmaceutical companies conducting clinical research in Indonesia under the new regulatory framework.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Panelist
Indri Rooslamiati

Panelist
Budi Sadikin, PhD

Panelist
Yuli Felistia


Speakers
YF

Yuli Felistia

Head of Clinical Research Unit, Research Manager, National Brain Center, Mahar Mardjono Hospital, Indonesia
EH

Endang Hoyaranda

President, Indonesian Association for the Student of Medicinals (IASEMD), Indonesia
IR

Indri Rooslamiati

Head of Indonesia Clinical Research Center INA-CRC, Indonesia Ministry of Health, Indonesia
BS

Budi Sadikin

Minister of Health, Ministry of Health, Indonesia
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

1:45pm EDT

Evolving Regulatory Considerations for Medical Affairs Communications
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

Speakers
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 →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   04: MedAffairs-SciComm, Forum

1:45pm EDT

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

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 →
AM

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   07: ProjectManagement-StrategicPlanning, Session

1:45pm EDT

Potency Measurements for Cellular and Gene Therapy Products
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

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

Panelist
Andrew Byrnes, PhD

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
LR

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 →
AB

Andrew Byrnes

Director, Division of Gene Therapy 1, FDA CBER, United States
Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing... 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

1:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Health Canada Perspective
Marcin Boruk, MBA, MSc


Speakers
MB

Marcin Boruk

Manager RMOD, HFPB, 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 a manager in the Information Sciences and Openness Division, Health Canada supporting the branch in projects related to data governance... Read More →
DI

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
TBD 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

Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

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.

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

Academic Perspective
Khaled El Emam, PhD

Industry Perspective
Arman Sabbaghi, PhD, MA

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 →
YL

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
AS

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 →
DZ

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
TBD 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

1:45pm EDT

Transforming Industry through Mentorship
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Basic

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

The Executive Mentor Perspective
Leslie Sam

The Mentee Perspective
Sarah Tremethick

Insights as a Mentorship Program Organizer
Clare Bedford


Speakers
CB

Clare Bedford

Member Engagement & Operations Manager, DIA, United States
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

2:55pm EDT

Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD
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
TBD 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

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
TBD
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
TBD 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

Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD
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

Speakers
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session

4:00pm EDT

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

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 →
DS

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

4:00pm EDT

Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Julieta Argüelles, DrMed

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

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Laura Huggins


Speakers
JA

Julieta Argüelles

Researcher, MD Anderson Cancer Center, United States
AD

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 Laura Huggins

Laura Huggins

VP & Head, Global Regulatory Affairs Oncology & CDx, Merck KGaA (EMD Serono), Germany
Laura Huggins has worked in drug development for over 20 years and is currently the VP and Global Head of Regulatory Affairs for Oncology and Companion Diagnostics at Merck KGaA, Darmstadt Germany. Her team is responsible for the regulatory strategy for a broad innovative oncology... 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

Chief Client Officer, Inside Edge Consulting Group, 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 4:00pm - 5:00pm EDT
TBD 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
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Session

4:00pm EDT

Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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
Cindy Hoots

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 →
avatar for Cindy Hoots

Cindy Hoots

Chief Digital Officer and Chief Information Officer, AstraZeneca, United States
DR

Diogo Rao

Chief Information Officer, Eli Lilly, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

4:00pm EDT

Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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 regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

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
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 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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

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
TBD
Component Type: Forum
Level: Intermediate

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 →
KM

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 →
ST

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
TBD 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
  • Feature Topics Diversity Equity and Inclusion (DEI)
  • Tags Forum

4:00pm EDT

Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

To guide patient focused drug development, patient input is sought by regulators and Health Technology Assessment (HTAs) in different ways around the world. The session will explore options to increase impact on development through greater coordination and information sharing.

Learning Objectives

Describe different options and processes for patient input into regulatory and HTA advice across key product development milestones; Discuss best practices in maximising the overall impact of patient input on development plans; Identify policy and process changes that would allow continuous improvement and learning across the various set pieces for patient engagement.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

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 →
AH

Anna Hyde

Vice President of Advocacy & Access, Arthritis Foundation, United States
Anna Hyde is the Vice President of Advocacy and Access at the Arthritis Foundation. She oversees both the federal and state legislative programs, in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority, build support for... Read More →
MI

Maxwell Isaacoff

Director, Federal & External Affairs, Elevance Health, Inc, United States
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
TBD 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

Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Advanced

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
TBD 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

Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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 Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Maria Koukounari, MS, MSc


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 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 →
MK

Maria Koukounari

Senior Director Therapeutic Area Quality, BMS, United Kingdom
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

4:00pm EDT

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
TBD
Component Type: Forum
Level: Intermediate

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.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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
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 →
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
TBD 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

FDA Rare Disease Town Hall
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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

Speakers
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
TBD 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

Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

Advanced manufacturing (AM) can be a tool to strengthen drug manufacturing and supply chain robustness. Regulatory programs are dedicated to facilitating the adoption and regulation of AM technologies to improve drug development and manufacturing.

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.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

4:00pm EDT

Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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.

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 statistical methods for use of hybrid trial designs and examples of AI informed studies for clinical decision making; Discuss areas of current need and promote community collaboration.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum

4:00pm EDT

Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Advanced

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
TBD 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

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
TBD
Component Type: Forum
Level: Intermediate

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

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 →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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

Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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


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 →
TF

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 →
DT

Darshini Trivedi

Senior Director, Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
Thursday, June 19
 

9:00am EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Industry Perspective on the ASAP Process
Walter Straus, DrMed, MD, MPH, FACP

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 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 →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

9:00am EDT

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
TBD
Component Type: Forum
Level: Intermediate

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; Develop fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speaker

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
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

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
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 20years 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, acquisition integrations, and clinical vendor management... Read More →
GW

GINA Williamson

Principal Site solutions, Illingworth, A Syneos Health Company, Spain
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

9:00am EDT

How AI is Transforming the Area of Data Standards and Access to Source Data
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Session
Level: Intermediate

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

OHDSI OMOP AI and open science
Patrick Ryan

CDISC and AI
Chris Decker, MS

HL7 and the AI Train
Charles Jaffee


Speakers
avatar for Chris Decker

Chris Decker

President and CEO, CDISC, 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 →
CJ

Charles Jaffee

Chief Executive Officer, HL7, United States
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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

9:00am EDT

Embedding and Leveraging AI for Quality and Compliance in Pharma
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Session
Level: Intermediate

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, PMP

Explainable Natural Language Processing: Why you see What you see
Meera Nagaria, MS


Speakers
RD

Roshan D'Souza

Head of Data Analytics and Operations, PDQ, Roche Products Limited, United Kingdom
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
MP

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

9:00am EDT

EMA - FDA Question Time
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Forum
Level: Intermediate

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.

Speakers
avatar for Tamei Elliott

Tamei Elliott

Associate Director, Scientific Programs, 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 →
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

9:00am EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Speakers
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.
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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

Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Forum
Level: Intermediate

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
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 →
avatar for Angela Men

Angela Men

Chief Executive Officer, The Whiteoak Group, Inc, United States
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

10:30am EDT

FDA Town Hall
Thursday June 19, 2025 10:30am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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
TBD 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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    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
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Monday, June 9
Tuesday, June 10
Wednesday, June 11
Thursday, June 12
Sunday, June 15
Monday, June 16
Tuesday, June 17
Wednesday, June 18
Thursday, June 19
EH
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
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 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