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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

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

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
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 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 →
avatar for Andreas Sutter

Andreas Sutter

Senior Program Management Leader, Bayer AG, Germany
Andreas Sutter is a senior program management leader in the pharmaceutical industry, with expertise spanning from early research to product launches. He focuses on implementing R&D and commercialization strategies for oncology, especially radioligand therapies. His experience includes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
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 Sridevi Nagarajan

Sridevi Nagarajan

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

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
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
avatar for Meha Ahmed

Meha Ahmed

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

Abdulaziz Alageel

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

Saeed Alshahrani

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

Vasanti Anand

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

Troy Astorino

CTO, PicnicHealth, United States
Troy Astorino, 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 →
avatar for Maryann Chapin

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 →
EC

Eunmi Choi

Manager, Korea Institute of Drug Safety & Risk Management, Korea, Republic of
avatar for Pamela Concepcion

Pamela Concepcion

Patient Safety Scientist, Astrazeneca, United States
AC

Ana Corona

Translator, University of Utah, United States
SD

Sahith Doppalapudi

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

Heidi Grabenstatter

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

Hannah Graunke

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

Eimy Honda

University of São Paulo - USP, Brazil
avatar for Alice Hsu

Alice Hsu

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

Angela Hu

VP, 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 MIDHUN RAJ K

MIDHUN RAJ K

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

Terry Katz

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

Yoon Jeon (Jamey) Kim

Director, Cluster Pharmacovigilance Lead, Merck & Co., Inc., Rahway, NJ, USA, Panama
Yoon Jeon (Jamey) Kim, the Director and North Cluster PV lead for Latin America at MSD, has 23 years of experience with the company. She provides strategic leadership for cluster countries (Colombia, Ecuador, Venezuela, Central America, and the Caribbean), with an extensive background... Read More →
avatar for Ray Kirchmier

Ray Kirchmier

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

Toshitatsu Kobayashi

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

Sue Lee

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

Marie Liles-Burden

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

Anran Liu

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

Niamh McGuinness

Director 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 →
AM

Amanda McMannis

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

Greeshma Mundayat

Solution Owner, Maxisit, United States
EO

Evon Okidi

Senior Data Scientist, Medidata Solutions, A Dassault Systemes Company, United States
avatar for Feisal Othman

Feisal Othman

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

Mohit Raizada

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

Patrick Rodriguez

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

Molly Shields

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

Margaret Studzinska

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

Julie Tripp

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

Rishi Verma

Medical Director, Roche & Stethy, Australia
DW

Doug Weatherhead

Chief Commercial Officer, ESPERO, United States
avatar for Benjamin Worley

Benjamin Worley

Senior Director, Sustainability and ESG, Labconnect, United States
avatar for Takayuki Yasuda

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
Takayuki Yasuda has been serving as a Statistical Programmer in the Biometrics department at Chugai Pharmaceutical Co., Ltd. since 2020. He worked in the CRO industry from 2014 to 2020. Since 2024, he has been leading an initiative on implementing generative AI in the clinical development... Read More →
TZ

Teresa Zhang

Safety Scientist, Beigene, United States
CZ

Chenan Zhang

Director, Epidemiology, Pfizer, United States
avatar for Andrea Zuleta

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

11:40am EDT

CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster. Discover how digital protocols are already driving connections and efficiencies at research sites. Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Chair

Denise Meade, MBA

Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

11:45am EDT

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
Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

12:00pm EDT

Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Building a Regulatory Landscape to Support CMC Innovation (Monday, June 16 | 2:15pm - 3:15pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   10: RegCMC-Product Quality, Session

12:20pm EDT

CH: Diversity Action Plans - Listen, Learn, and Execute
Tuesday June 17, 2025 12:20pm - 12:50pm EDT
TBD
Component Type: Workshop
Level: Intermediate

The session will provide an overview of FDA Diversity Action Plans and relevant implications for industry, equipping pharma and biotech professionals with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.

Learning Objectives

Discuss key changes in recent guidance, impact on clinical trials, and trends for FDA Diversity Action Plans; Collect essential knowledge and pragmatic guidance to navigate the evolving regulatory landscape for Diversity Action Plans

Chair

Teresa Oblak, PhD

Tuesday June 17, 2025 12:20pm - 12:50pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

12:25pm EDT

Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
TBD
Component Type: Session

Join Lilly for a hands-on presentation on the impact of digital health technologies (DHTs) in clinical trials. Discover how DHTs enhance patient experiences and increase access through an in-person demonstrations of the tools. During this presentation, Lilly will introduce DHT Templates, developed by BIO membership, designed to standardize the inclusion of DHT data within product submissions and provide a predictable approach to regulatory review.

Chair

Lauren Tobe, JD

Speakers
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:00pm EDT

CH: Navigating AI Regulation in Pharma - Global Trends, Compliance Challenges, and Harmonization Efforts
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
TBD
Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

1. Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements. 2. Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions. 3. Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Tuesday June 17, 2025 1:00pm - 1:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

1:05pm EDT

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 Joseph Dustin

Joseph Dustin

Founder and Principal, Dauntless Eclinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
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 →
avatar for Madiha Khalid

Madiha Khalid

Senior Director, Medical Writing, Larimar Therapeutics, United States
Madiha is a pharmaceutical industry professional with a background in fundamental bench research. Her experience as a regulatory medical writer working with small, mid-size, and large pharmaceutical companies over the past 10 years has given her an in-depth understanding of all phases... Read More →
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

US Executive Orders: Impact on Precision Medicine and Diagnostic Development
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

As of April 2, 2025, President Trump signed 103 Executive Orders in 2025 (EO 14147 to EO 14249) and sweeping government actions have led to widespread change in the health and biomedical research industries. Impacts on precision the effects of many of the Orders are largely unknown and tied up in legislative process. This has created considerable uncertainty for biomedical research and subsequent development of precision medicines and diagnostics. In this session we will review the 2025 Executive Orders, the court decision striking down the LDT Final Rule, and certain organizational changes at FDA that impact precision medicine and research and will delve deeper into the global impacts that are expected as a result.

Learning Objectives

List 2025 Executive Orders affecting personalized medicine and innovation in product and diagnostics development; Summarize impacts of 2025 Executive Orders on health innovation, research, regulations including the LDT final rule and patients; Discuss potential implications of current changes in the environment on global R&D.

Chair

Courtney Granville, PhD, MPH

Speaker

Panelist
Megan Doyle, JD, MPH

Panelist
Lia Ridout

Panelist
Carly McWilliams, MBA

Panelist
Nathan Brown, JD


Speakers
avatar for 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

Discuss implementing adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Identify ways to optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; Describe ways to facilitate team empowerment by balancing structure and support with minimal bureaucracy; Apply innovative techniques to accelerate decision-making and improve problem-solving efficiency.

Chair

Sajida Roberson, MBA, MPH

Speaker

Short-Cycle Strategy: Adaptive Execution for High-Impact Delivery
Marina Kobiashvili

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 →
avatar for Jennifer Trevor

Jennifer Trevor

Director-Global Category Lead- Development, Astellas, United States
Jen Trevor, PhD, combines scientific expertise with business acumen, driving innovation in pharma. With a PhD in Chemistry from the University of Illinois at Chicago, Jen began her career in biosensor research at Argonne National Laboratory and as a Forensic Chemist at the DEA. She... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
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
avatar for Abigail Dirks

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, 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

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD


Speakers
avatar for Dionna Green

Dionna Green

Director, Office of Pediatric Therapeutics, OC, FDA, United States
Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →
avatar for 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 →
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

CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Workshop

Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

To identify innovative methodologies, technologies and tools for innovative therapy development; To collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

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
  15: Content-Hubs, Workshop

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

Balancing Patient Centricity with Data Quality Requirements and Standards
Jennifer Farmer, MS

Learnings about meeting RWD fitness standards from FDA use cases
Ulka B Campbell, PhD

Can we separate relevance from reliability in data quality assessments? Quality-by-design in secondary use of health data
Pamela Dobay, PhD, MSc


Speakers
avatar for Ulka Campbell

Ulka Campbell

Head of Scientific Strategy, Aetion Inc, United States
Ulka Campbell is an epidemiologist and the Head of Scientific Strategy at Aetion, a healthcare technology and research services company, providing methods and regulatory support across therapeutic areas and leading research to inform regulatory RWE best practices. Previously, she... Read More →
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

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

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


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 Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
avatar for Jennifer Tucker

Jennifer Tucker

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

New Data and Insights on the Vendor Qualification Process in Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Review and panel discussion of the results from a new Tufts Center for the Study of Drug Development (TCSDD) Working Group study assessing the vendor qualification and selection process

Learning Objectives

Discuss the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Recognize the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Neil McCullough

Panelist
Patty Leuchten

Panelist
Shyard Wong

Panelist
Tran Huynh


Speakers
avatar for Kenneth Getz

Kenneth Getz

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

Tran Huynh

Director, Clinical Vendor Strategy, Fortrea, United States
PL

Patty Leuchten

Founder and CEO, Diligent Pharma, United States
A pharma industry leader and entrepreneur with a focus on driving improvements in clinical trial execution, at scale, through innovative solutions. In 1999, she founded The Avoca Group, whose Avoca Quality Consortium paved the way for Diligent Pharma.
avatar for Neil McCullough

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, IQVIA, United States
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →
SW

Shyard Wong

Global Head, Clinical Quality and Continuous Improvement, Sanofi, France
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 A. 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 A. Perkins

Vada A. 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
 
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Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 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