DIA 2026 Global Annual Meeting: Full Schedule

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10:15am EDT

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

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

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P; CME 1.25; RN 1.25

We will share case examples and trends from 24,000 records, analyze ethical challenges involved in paying participants, and discuss how protective policies or administrative practices can result in unjust treatment.

Learning Objectives

Explain the ethical considerations that govern payment to research participants; Evaluate the potential for institutional and administrative policies to inadvertently create unjust treatment of research participants; Apply the Belmont Principles of Beneficence and Justice to real-world cases involving payment to research participants and propose strategies for ethical decision-making.

Chair

Kelly Fitzgerald, PHD

Speaker

Panelist
Karla Childers, MS

Panelist
Wenora Johnson

Panelist
Sam Whitaker

Panelist
Robin Kuprewicz, MA

Speakers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Karla Childers is Vice President, Bioethics, Policy & Partnerships 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 has... Read More →

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 →

Wenora Johnson

Administrative Support & Research/Patient Advocate, United States

Robin Kuprewicz

Clinical Trials Director, Georgetown University, United States

Robin Kuprewicz is the Clinical Trials Director for the Georgetown University Huntington's Disease Care, Education and Research Center. She holds a Masters in Medical Anthropology and has ten years of experience in clinical trials. She has helped Huntington's Disease participants... Read More →

Sam Whitaker

Founder & CEO, Mural Health, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention

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

118AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P; CME 1.25; RN 1.25

This session explores pharmacovigilance for biosimilars, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA, academia, and industry will discuss suffix-related challenges and future directions.

Learning Objectives

Describe the FDA’s nonproprietary naming convention for biological products and its intended role in pharmacovigilance; Analyze empirical evidence from FAERS to evaluate how suffix reporting impacts pharmacovigilance activities; Assess the role of naming conventions in broader active surveillance systems, such as the Sentinel System, and their implications for biosimilar safety monitoring.

Chair

Stacey Ricci, DRSC

Speaker

TBD
Mary Jo Carden, JD

TBD
Judith Maro, MS

TBD
Mariana Socal, MD, PHD, MS

Speakers

Mary Jo Carden

Carden Associates, United States

Mary Jo Carden is President of Carden & Associates. She previously served as Head of Policy at Sandoz, Inc., Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities... Read More →

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States

Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →

Stacey Ricci

Director, Scientific Review Staff, OTBB, CDER, FDA, United States

As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance... Read More →

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 →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

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

1:45pm EDT

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

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

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P; CME 1.25; RN 1.25

This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10 companies, FDA, EMA, and many other advisors from patient advocacy organizations across the Americas and Europe.

Learning Objectives

Identify key clinically meaningful endpoints used in GLP-1 trials; Describe current opportunities and challenges in obesity drug development; Explain how the public private partnership led by Drug Information Association is advancing trial endpoint alignment.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Katherin Ruiz

Panelist
Alison Matsui, MPH

Panelist
Brad Jordan, PHD

Panelist
Jingyu (Julia) Luan, PHD

Speakers

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →

Alison Matsui

Senior Principal PCOR Scientist, Genentech, A Member of the Roche Group, United States

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

1:45pm EDT

#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials

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

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P; CME 1.25; RN 1.25

Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials, highlighting conceptual model progress and stakeholder insights for regulatory decisions.

Learning Objectives

Describe recent developments from the DIA study integrating patient experience into immuno-oncology tolerability assessments; Examine findings from literature and KOL interviews; Identify strategies for operationalizing a multidimensional tolerability framework; Recognize multistakeholder perspectives to support trial design, data collection, and benefit–risk evaluation.

Chair

Devin Peipert, PHD

Speaker

Panelist
Efrat Dotan, MD

Panelist
Maria Paula Bautista Acelas, MSC

Panelist
Lia Ridout

Speakers

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States

Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →

Efrat Dotan

Executive Medical Director, Ann B Barshinger Cancer Institute, Lancaster General, Penn Center for Cancer Care Innovation, United States

Devin Peipert

Professor of Health Outcomes Measurement, University of Birmingham, United Kingdom

Prof Peipert holds a 125th Anniversary Chair in the Department of Applied Health Sciences at the University of Birmingham, where he is affiliated with the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation... Read More →

Lia Ridout

Patient Advocate, -, 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 →

Angela Rylands

Global Head of Patient Centred Outcomes, Kyowa Kirin, United Kingdom

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Patient Engagement
Feature Topics Therapeutic Pathways,Patient-Centered Design and Experience
Tags Session

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
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice
Tags Forum

4:15pm EDT

#554: Reverse Pitches: How Pharma Actually Buys

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

103A

Component Type: Session
Level: Advanced

Founders pitch to pharma expecting a straightforward evaluation, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders, this session flips the script—showing how pharma actually evaluates, negotiates, and commits to partnerships with innovative companies.

Learning Objectives

Identify the hidden criteria and decision-makers that determine whether a pharma deal moves forward; Understand MSAs, compliance requirements, and relationship dynamics that shape biopharma partnerships; Recognize common deal-stoppers and structure early conversations to align with how pharma actually evaluates and buys.

Chair

Ligia Kilinski Kilinski Cevasco

Speaker

Panelist
Mindy Gruba

Speakers