DIA 2026 Global Annual Meeting: Full Schedule

1:00pm EDT

12P : Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies

Monday June 8, 2026 1:00pm - 4:00pm EDT

Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-26-501-L04-P; IACET 2.75

Pre-Registration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

This Short Course will be offered virtually – Join from anywhere!

This short course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is transforming the regulatory landscape for drugs and biologics. The course begins with an overview of global regulatory trends, highlighting the increasing acceptance and integration of RWE alongside randomized controlled trials to inform approvals, label expansions, and clinical development planning. Participants will learn to identify and assess diverse sources of real-world data (RWD), applying practical frameworks to determine when data are “fit for purpose” for regulatory use. Through case studies and recent regulatory guidance, the course illustrates the evolution of RWE from safety evaluation to supporting efficacy, label extensions, and population bridging, underscoring the importance of methodological rigor and early engagement with regulators. The curriculum emphasizes structured approaches and frameworks, for designing transparent and valid real-world studies, including the use of external control arms. Participants will learn that RWE generation for regulatory decision-making requires thoughtful study design and use of transparent frameworks to ensure data fitness and validity. The course will be interactive with the use of polling questions and participants are encouraged to raise scenarios they encounter for open discussion.

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

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

Speakers

Jaclyn Bosco

Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology & Scientific Strategy in Real World Evidence at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated... Read More →

Kourtney Davis

Vice President, Global Epidemiology at Janssen R&D, LLC, The Janssen Pharmaceutical Companies of Johnson & Johnson, United States

Dr. Kourtney Davis is currently Senior Director and Therapy Area Matrix Lead for Global Epidemiology at Janssen R&D, where she leads a team of 20+ epidemiologists aligned to therapy areas (CNS, Immunology, CV/Met, Oncology, ID/Global Public Health/Vaccines, and Pulmonary Hypertension... Read More →

Linda Kalilani

Executive Director and Head of Oncology Epidemiology, GSK, United States

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

Isha Riley

Associate Director, Pharmacoepidemiololgy & Risk Management Implementation, Regeneron, United States

Isha Mehta Riley is an Associate Director of Pharmacoepidemiology and Risk Management at Regeneron Pharmaceuticals. She has extensive experience in post-authorization safety strategies, including real-world evidence generation and risk management activities to inform global regulatory... Read More →

Monday June 8, 2026 1:00pm - 4:00pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Tutorial | 10: Stats-EvidenceGeneration-RWE, Tutorial | 17: Short-Courses, Tutorial

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Credit Type ACPE, IACET
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11:00am EDT

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

Monday June 15, 2026 11:00am - 12:15pm EDT

201AB

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data, identify emerging trends, and assess the implications of this transparency initiative.

Learning Objectives

Discuss FDA's process for issuing and publicly posting Complete Response Letters (CRLs); Analyze trends in CRLs over the past year, including common reasons for issuance; Evaluate the benefits and potential drawbacks of public CRL disclosure.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho

Speakers

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States

A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States

Eric Gascho

Vice President, CRD Associates, United States

Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →

Eva Temkin

Partner, Arnold & Porter, United States

A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
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2:30pm EDT

#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)

Monday June 15, 2026 2:30pm - 3:30pm EDT

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P; CME 1.00; RN 1.00

This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.

Learning Objectives

Explain how current CDISC standards set the foundation for RWD/RWE submissions; Discuss evolving data standards, including Dataset-JSON and HL7 FHIR, focusing on how they may complement or extend CDISC; Identify actions sponsors can take now to prepare for evolving regulatory data standards.

Chair

James Browning, MPH

Speaker

Panelist
Chris Decker, MS

Panelist
Anne-Marie Meyer, MS

Speakers

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 16 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →

Chris Decker

President and CEO, CDISC, United States

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →

Anne-Marie Meyer

Advisor, Lind AI, Switzerland

Dr. Meyer is Vice President of Healthcare Consulting at acc solutions and advisor to LindAI. As Adjunct Associate Professor at UNC Chapel Hill, she has bridged epidemiology and health informatics for 20+ years. At Lineberger Cancer Center, she built a secure data platform linking... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Data Management & Data Standards,Biostatistics
Tags Forum

2:30pm EDT

#444: Driving Efficiency in Clinical Development with Master Protocols

Monday June 15, 2026 2:30pm - 3:30pm EDT

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P; CME 1.00; RN 1.00

Master protocols are innovative designs for simultaneous evaluation of multiple drug or population under one protocol, enhancing efficiency. Despite their potential, these protocols pose complex scientific, operational, and regulatory challenges.

Learning Objectives

Explain the different master protocols (basket, umbrella, platform) in various therapeutic areas; Identify key statistical, operational, and governance challenges; Describe regulatory perspectives and recent guidance; Discuss practical case studies illustrating successes, pitfalls, and innovations.

Chair

Satrajit Roychoudhury, PHD

Speaker

Pooling shared controls in platform trials: operational and statistical considerations
Megan McCabe, PHD

The Art of Borrowing: Practical Strategies to Power Master Protocols
Haitao Chu, MD, PHD

Learnings Across Master Protocols – A Design Perspective
Purvi Prajapti, PHD, MS

Speakers

Haitao Chu

Senior Director, Pfizer, United States

Dr. Haitao Chu is a Senior Director at Pfizer’s Statistical Research and Data Science Center, a role he has held since 2022. He earned his PhD in Biostatistics from Emory University. Dr. Chu has held several academic appointments, including Assistant Professor of Epidemiology at... Read More →

Megan McCabe

Assistant Professor, Department of Biostatistics, The University of Alabama at Birmingham, United States

Megan McCabe is an Assistant Professor in the Department of Biostatistics at the University of Alabama at Birmingham (UAB), and the Assistant Director for Clinical Trials Development for the UAB DATA coordinating and Collaborative Research Unit (DATA CRU). She graduated with her PhD... Read More →

Purvi Prajapati

Sr. Advisor, Eli Lilly, United States

Purvi earned her PhD in Statistics from Baylor University prior to joining Lilly in 2020. Since joining she’s been a member of the Clinical Design Team where she collaborates with multiple study teams to design clinical trials across all phases of drug development across the immunology... Read More →

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States

Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Biostatistics
Tags Session

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes

Monday June 15, 2026 4:00pm - 5:00pm EDT

116

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00

Real-world data that encompass race, ethnicity, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.

Learning Objectives

Describe precision medicine approaches involving clinical phenotype RWD in context with race, ethnicity, ancestry data, that can be instrumental to address unmet patient and health system needs; Discuss how regulators have reacted to precision medicine-based research approaches in context with race, ethnicity, ancestry information, inclusive of research design modifications made along the way.

Chair

Rachele Hendricks-Sturrup, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS

Speakers

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France

Lysel Brignoli is an expert in Real-World Evidence and epidemiologic research, with over a decade of experience designing and leading studies that generate insights for healthcare decision-making. Her work focuses on innovative study designs, patient registries, and the integration... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), 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 →

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States

Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Advanced
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Tags Session

4:00pm EDT

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints

Monday June 15, 2026 4:00pm - 5:00pm EDT

204AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions.

Learning Objectives

Describe an evidence-based overview of the development and utilization of surrogate endpoints in FDA approvals; Examine the increasing reliance on surrogates, particularly case studies in fields like rare diseases and oncology, where overall survival data may be years away; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.

Chair

Bridget Doherty, MPH, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD

Speakers

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States

Kara Berasi

CEO, Haystack Project, United States

Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States

Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States

Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →

Alexis Miller

Head, Global Regulatory Policy, MSD, United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Basic
Area Evidence Innovation
Level Basic
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Biostatistics
Tags Forum

4:00pm EDT

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding

Monday June 15, 2026 4:00pm - 5:00pm EDT

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-554-L04-P; CME 1.00; RN 1.00

This session highlights methodological challenges in External Control Arms (ECAs) using Real-World Data (RWD). Speakers will address time-related biases, endpoint alignment challenges between RWD and trial standards, and methodological strategies to address unmeasured confounding.

Learning Objectives

Discuss exposure and time-related issues in ECA construction, including defining time-zero and avoiding immortal time bias; Describe endpoint alignment challenges between RWD and trial standards, and outline methods to address measurement error and bias. Evaluate approaches for handling missing data and unmeasured confounding, and explain new insights on defining index dates in EC studies.

Chair

Ju-Young Shin, PHD

Speaker

Choosing an Index Date for Untreated Patients in External Comparator Studies
Ju Hwan Kim, PHARMD, PHD

Quantifying and mitigating measurement bias in real-world endpoints when constructing external control arms
Benjamin Ackerman, PHD

Choosing an Index Date for Untreated Patients in External Comparator Studies
Gerd Rippin, PHD

Speakers

Benjamin Ackerman

Principal Scientist, Biostatistics, Johnson & Johnson, United States

Ben Ackerman is a Principal Scientist at Johnson & Johnson Innovative Medicine, where he provides support across therapeutic areas to design and analyze randomized trials, namely those that combine trial data with real-world data. He has expertise in causal inference methods to address... Read More →

Benjamin Ackerman

Director, Real-world Biostatistics, GSK, United States

Ben Ackerman is a Director of Real-world Biostatistics at GSK, where he designs and analyzes real-world evidence studies in oncology. He has expertise in causal inference methods to address various biases in both randomized trials and non-experimental studies. Previously, he led a... Read More →

Ju Hwan Kim

Research Professor, Sungkyunkwan University, Korea, Republic of

Ju Hwan (Joe) Kim, PharmD, PhD, is a Research Professor at the School of Pharmacy, Sungkyunkwan University, South Korea. His work spans pharmacoepidemiology, clinical pharmacy, regulatory science, and real-world data/evidence. He leads international collaborative studies leveraging... Read More →

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Tags Session

4:00pm EDT

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?

Monday June 15, 2026 4:00pm - 5:00pm EDT

203AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00

This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions

Learning Objectives

Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA, PMDA, MHRA) and discuss recent progress within the EU on this topic; Analyze the key similarities and differences in regulatory recommendations for study design, and describe the rationale for greater alignments across agencies.

Chair

Gracy G Crane, MS

Speaker

Panelist
Motiur Rahman, PHD, MPHARM, MS

Panelist
Denise Umuhire, MBA, MSC

Panelist
Tricia Luhn, PHD, MPH

Speakers

Gracy Crane

Policy Lead, Roche, United Kingdom

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →

Tricia Luhn

RWD Oncology, Genentech, United States

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands

I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Clinical Development & Operations
Tags Forum

10:15am EDT

#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development

Tuesday June 16, 2026 10:15am - 11:30am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P; CME 1.25; RN 1.25

This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.

Learning Objectives

Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches; Apply FDA recommendations for use of AI/RWE in regulatory submissions.

Chair

Marie Bradley, MPH

Speaker

Panelist
Hussein Ezzeldin, PHD

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States

Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee... Read More →

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States

Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Evidence Innovation, Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation,Artificial Intelligence
Interest Area Health Technology & AI,Regulatory
Tags Session

10:15am EDT

#519: Patient Registries: Basket Trial or Basket Case?

Tuesday June 16, 2026 10:15am - 11:30am EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P; CME 1.25; RN 1.25

Akin to basket trials which study a single treatment for multiple conditions, patient registries enroll people with similar conditions, look for safe and effective treatments and disease management strategies, and are used to guide decision-making by clinicians, regulators and payers. Yet the very nature of real-world evidence requires that patient registries be nimble and opportunistic -- desirable attributes to maintain relevance, but ones that inevitably raise questions about data quality and completeness, transparency, provenance and Fitness for Use. Recent guidance documents from regulators and professional societies hint that real-world data from patient registries may be viewed more favorably than other, less traceable and auditable sources of real-world data. This session will illustrate key attributes of high quality, trustworthy patient registries, the criticisms and barriers they generally face and what they do to bolster trust.

Learning Objectives

Explain the value of RWE on population groups that may not be fully representative of all cases, and who may have some missing data; Explain expectations for quality, transparency and provenance; Describe key values of patient registries and common approaches to bolster trustworthiness.

Chair

Nancy Dreyer, MPH, FISPE

Speaker

How registries are changing with technology and AI, and what that means for quality
Richard Gliklich, MD

Gauging registry quality according to its intended use
Mike D'Ambrosio

Life in the trenches of a patient registry: navigating the reality of RWD
Angela Dobes, MPH

Speakers

Mike D'Ambrosio

Parexel, United States

22 Years Industry experience at top 5 CRO’s including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross functional teams. Currently leads Parexel's Real World Research (RWD/RWE) business franchise - Helping customers build innovative RWD/RWE solutions to... Read More →

Angela Dobes

SVP, IBD Plexus, Crohn's & Colitis Foundation, United States

Angela Dobes is the senior vice president of IBD Plexus, a real-world data platform and biorepository that redefines how researchers study inflammatory bowel disease to advance precision-medicine strategies and cut years off the R&D timeline. She strives to elevate the important role... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness... Read More →

Richard Gliklich

Founder & Director, OM1, United States

Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Data Management & Data Standards,Biostatistics
Tags Forum

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

116

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25

Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope, principles, and current thinking reflected in their respective documents, as well as discuss areas of alignment, divergence, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion, participants will gain insight into how Bayesian methods are being evaluated in practice, including considerations for trial design, external data integration, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.

Learning Objectives

Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods; Compare regulatory perspectives and areas of alignment and divergence across regions; Explain applications of Bayesian approaches in clinical trial design, analysis, and regulatory decision-making; Identify current expectations, implementation challenges, and opportunities for industry engagement in shaping future guidance.

Chair

May F Mo, MBA, MS

Speaker

Panelist
Juan Jose Abellan

Panelist
Andrew Thomson, PHD, MA, MSC

Speakers

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

May Mo

Associate Vice President, Biostatistics, Amgen, United States

May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →

Andrew Thomson

Consultant, Regnitio, Netherlands

Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Alignment in Practice
Interest Area Clinical Development & Operations
Tags Forum

4:15pm EDT

#551: Operationalizing Large Language Models in Drug Development

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-585-L04-P; CME 1.00; RN 1.00

Generative AI and large language models (LLMs) are reshaping drug development and Real-World Evidence (RWE). This session explores real-world applications, debunks common myths, and outlines what’s needed for safe, scalable, and compliant use across the drug development lifecycle.

Learning Objectives

Distinguish between the current capabilities and limitations of generative AI and large language models (LLMs) in drug development; Identify practical and regulatory challenges in adopting GenAI across evidence generation workflows; Discuss future opportunities for integrating GenAI into the various areas of the drug development pipeline; Identify/mitigate bias in regulated workflows

Chair

Wesley Anderson, PHD

Speaker

GenAI for literature-based evidence synthesis: From systematic literature review to digitization of trial publications
Emily Nieves

Panelist
Danielle Boyce, MPH

Speakers

Wesley Anderson

Scientist, Quantitative Medicine, Critical Path Institute, United States

Wes Anderson, Ph.D. is a Quantitative Medicine Scientist at the Critical Path Institute, where he develops data-driven solutions to support drug development using machine learning, artificial intelligence, natural language processing, and informatics. He has also contributed to the... Read More →

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Dr. Danielle Boyce is Principal Investigator of Real World Evidence at the ALS Therapy Development Institute and a faculty member at Johns Hopkins University, with affiliations at the University of Calgary, University of Chicago, and Emory University. A mother of a child with rare... Read More →

Emily Nieves

CEO/ Co-Founder, Delineate, United States

Emily Nieves is the co-founder and CEO of Delineate, a seed-stage startup partnering with pharmaceutical companies to accelerate Model-Informed Drug Development workflows through advanced AI techniques. Prior to founding Delineate, Emily pursued graduate studies in Biological Engineering... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Artificial Intelligence, Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence,Evidence Innovation
Interest Area Biostatistics,Health Technology & AI
Tags Session

4:15pm EDT

#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

115C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-593-L04-P; CME 1.00; RN 1.00

This session will showcase how Real-World Evidence (RWE) supports pediatric drug development in Asian countries, share US and EU perspectives, and highlight innovations in regulatory strategies, policies, and methodologies to enhance regulatory-grade pediatric RWE.

Learning Objectives

Demonstrate emerging trends in the use of RWE in regulatory decision-making in Asia, with real examples of leveraging RWE to accelerate pediatric drug development, highlighting innovative approaches and successful outcomes; Discuss challenges and strategies for high-quality pediatric RWE and explore regulatory frameworks for RWE evaluation through innovative cross-organizational collaborations.

Chair

Yongjing Zhang, PHD

Speaker

Panelist
Reiko Nakashima

Panelist
Shaoqing Ni, PHD

Panelist
Ju-Young Shin, PHD

Speakers

Reiko Nakashima

Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Ms. Reiko Nakashima is a Deputy Review Director in the Office of New Drug III at the Pharmaceuticals and Medical Devices Agency (PMDA), where she is responsible for the review of new drugs for central nervous system (CNS) disorders.

Shaoqing Ni

Attending Pharmacist , Director, Children's Hospital Zhejiang University School of Medicine, China

30+ years in pediatric pharmacy & clinical research. PhD, Chief Pharmacist, Doctoral Supervisor. Director of Clinical Trial Office, Children's Hospital, Zhejiang University; Head of Secretariat, China Pediatric Clinical Trial Network; Course Director, Zhejiang University graduate... Read More →

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Yongjing Zhang

Senior Director, Global Epidemiology, Johnson & Johnson, China

Dr. Zhang has been working on Real-World research in the pharmaceutical and medical device industry for over 18 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Data Management & Data Standards
Tags Session

4:15pm EDT

#562: Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Diseases: Statistical Innovation and Novel Applications

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-596-L04-P; CME 1.00; RN 1.00

Learn how the Real-World Evidence (RWE) can be utilized in studies of rare outcomes and diseases. Speakers from industry, academia, and regulators share insights on external controls, causal inference, and evidence synthesis to inform regulatory submissions.

Learning Objectives

Identify when to use hybrid design and or external controls for rare outcomes and diseases using RWE sources; Design RWE-based studies and address confounding, missing data, and intercurrent events; Evaluate robustness of study results with sensitivity analyses.

Chair

Huan Wang, PHD

Speaker

Assessing the Validity of External Versus Randomized Controls in Pancreatic Cancer and Other Diseases
Ruthie Davi, PHD, MS

Real World Evidence for Post-Marketing Drug Safety Outcomes: FDA’s Sentinel System
Jennifer Lyons, PHD, MPH

Single Arm, External-Controlled Studies – Pitfalls and Pathways
Van Tran, PHD

Speakers

Ruthie Davi

Senior Vice President, Medidata, a Dassault Systèmes Company, United States

Ruthie Davi is Senior Vice President, Statistics and Regulatory Science Innovation at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At... Read More →

Jennifer Lyons

Research Scientist, Harvard Pilgrim Health Care Institute, United States

Jennifer Lyons is a Research Scientist in the Therapeutics and Infectious Disease Epidemiology group at the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. She works on the FDA-sponsored Sentinel Initiative for drug safety surveillance... Read More →

Van Tran

Mathematical Statistician, OTS, CDER, FDA, United States

Van Tran, PhD, is a Senior Mathematical Statistician at the U.S. Food and Drug Administration, where she provides statistical review of clinical trials and real-world evidence to support regulatory decisions on drug safety and efficacy. Her interests include evaluation of rare and... Read More →

Huan Wang

Mathematical Statistician, CDER, FDA, United States

Dr. Huan Wang joined the FDA in 2021, where he focuses on statistical reviews for drug approval applications in non-malignant hematologic diseases. Prior to this role, he earned his Ph.D. in Biostatistics from the George Washington University, where he conducted research on developing... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Biostatistics
Tags Session

10:15am EDT

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures

Wednesday June 17, 2026 10:15am - 11:30am EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25

Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.

Learning Objectives

Discuss the US and EU regulatory rationale and expectations for RMM evaluations; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.

Chair

Daniele Sartori, MSC

Speaker

Panelist
Gita Toyserkani, PHARMD, MBA

Panelist
Elaine Lippmann, JD

Panelist
Helga Gardarsdottir, FISPE

Panelist
Priya Bahri, PHD

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands

Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →

Elaine Lippmann

Principal, Leavitt Partners, United States

Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States

Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
Tags Session

10:15am EDT

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

Wednesday June 17, 2026 10:15am - 11:30am EDT

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objectives

Describe the core principles of Gen AI and explain their relevance to clinical operations; Identify practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

Chair

Ioannis Spyroglou, PHD

Speaker

Panelist
Roshan D'Souza

Bootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation Reporting
Frederik Collin, MS

Operational Impact, Scaling, and Limitations: From Algorithm to Practice
Karin Jonczak

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States

Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Interest Area Biostatistics,Health Technology & AI
Tags Session

1:45pm EDT

#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00

Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges.

Learning Objectives

Explain how trial emulation using real-world data can be used to enhance design of future clinical trials; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice; Discuss the challenges of emulating trial endpoints, eligibility criteria, and other design elements.

Chair

Leo Russo, MS

Speaker

Panelist
Jingchuan Serena Guo, MD, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Speakers

Jingchuan Serena Guo

Associate Professor, Purdue University, United States

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States

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

Leo Russo

Advisor, Get Real Institute, United States

I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Tags Forum

1:45pm EDT

#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P; CME 1.00; RN 1.00

Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed.

Learning Objectives

Discuss the use of RWE to support regulatory decisions; Identify use cases based on regulatory assessment, stage of lifecycle and therapeutic area; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies.

Chair

Denise Umuhire, MBA, MSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Rohini Hernandez, PHD, MPH

Panelist
Motiur Rahman, PHD, MPHARM, MS

Speakers

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States

Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States

Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Biostatistics
Tags Session

4:00pm EDT

#659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

203AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-642-L04-P; CME 1.00; RN 1.00

This session highlights innovative Real World Data (RWD) methods, including AI, for enhancing Real World Evidence (RWE) for regulatory decisions. Through case studies and discussion, it will examine practical integration strategies for these innovations.

Learning Objectives

Define the key challenges and limitations in the use of real-world evidence (RWE) for regulatory decision-making; Illustrate how innovative methodologies can be integrated into study design and analysis to enhance the robustness and credibility of RWE; Describe practical insights, informed by multi-stakeholder perspectives, for developing a framework of regulatory acceptability of RWE.

Chair

Alison Cave

Speaker

Advancing Real-World Evidence for Regulatory Decision-Making: Academic perspective
Olaf Klungel, FISPE

Advancing Real-World Evidence for Regulatory Decision-Making: industry perspective
Gracy G Crane, MS

Advancing Real-World Evidence for Regulatory Decision-Making: FDA perspective
Motiur Rahman, PHD, MPHARM, MS

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →

Gracy Crane

Policy Lead, Roche, United Kingdom

Olaf Klungel

Professor of Pharmacoepidemiologic Methods, Utrecht University, Netherlands

Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology and the scientific director of the Utrecht Institute for Pharmaceutical Sciences (UIPS) at Utrecht University. He is also member of the Methodology working... Read More →

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Interest Area Biostatistics
Tags Session

8:00am EDT

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

Thursday June 18, 2026 8:00am - 9:00am EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00

The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.

Learning Objectives

Identify the nuances while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.

Chair

Satrajit Roychoudhury, PHD

Speaker

Panelist
Xiaofei Wang, PHD

Panelist
Scott Berry, PHD

Panelist
Kannan Natarajan, PHD

Panelist
Pralay Mukhopadhyay, PHD

Speakers

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →

Pralay Mukhopadhyay

Vice President, Medicines Development Leader, Oncology R&D, GSK, United States

Dr. Mukhopadhyay has a proven track record in oncology drug development. He currently works as Vice President, Medicine Development Leader at GlaxoSmithKline. Over the years, he has made significant contributions in the development of several anti-cancer agents in both hematologic... Read More →

Kannan Natarajan

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States

Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides... Read More →

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States

Xiaofei Wang

Professor, Biostatistics & Bioinformatics, Duke University Medical Center, United States

Xiaofei Wang is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Statistics at the Alliance Statistics and Data Management Center. He received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2003... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum