DIA 2026 Global Annual Meeting: Full Schedule

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10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

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

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25

Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.

Learning Objectives

Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.

Chair

Kevin Bugin, MS, RAC

Speaker

Panelist
Mary Thanh Hai, MD

Panelist
Henry Wei, MD

Panelist
Zhanna Jumadilova, MD, MBA

Speakers

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States

Dr. Kevin Bugin is the head of global regulatory policy 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 →

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 →

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 →

Zhanna Jumadilova

Clinical Lead, Pfizer, United States

Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs. Her diverse experience in both large pharmaceutical... Read More →

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Workshop | 02: ClinicalTrialOps-Innovation, Workshop

Audience Intermediate
Area Global Alignment in Practice, Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Alignment in Practice,Evidence Innovation
Interest Area Clinical Development & Operations
Tags Workshop

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

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 →

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

#649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation

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

119AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-635-L04-P; CME 1.00; RN 1.00

Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Speakers across patient advocacy, clinical research, and medical ethics examine the social conception of long-term follow-up, its challenges, and practical solutions for sustainable participation and evidence generation.

Learning Objectives

Identify scientific, operational and regulatory factors driving the growing significance of long-term follow-up (LTFU) in gene therapy; Compare stakeholder challenges and solutions in sustaining LTFU participation and data quality for gene therapy programs; Evaluate strategies to strengthen accountability and align incentives to ensure sustained LTFU participation.

Chair

Alen Agaronov, DRSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Dennis Akkaya

Panelist
Carolyn Riley Chapman, PHD

Speakers

Alen Agaronov

Independent, United States

Alen Agaronov ScD is a social scientist, bioethicist, and business ethicist focusing on new medical technologies and patient advocacy and engagement. He holds a doctoral degree in Social & Behavioral Sciences from the Harvard T.H. Chan School of Public Health and completed postdoctoral... Read More →

Dennis Akkaya

Corporate Development, My Tomorrows, United States

Carolyn Chapman

Independent Consultant, Freelance, United States

Dr. Chapman is currently an Independent Consultant at the intersections of pharmaceutical development, genetic technologies, policy, ethics, and strategy. Previously, she directed the CGT project at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital (BWH) and... Read More →

Patricia Furlong

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

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Forum

Audience Basic
Area Evidence Innovation, Therapeutic Pathways
Level Basic
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation,Therapeutic Pathways
Interest Area Rare Disease & Special Populations
Tags Forum

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

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 →

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 →