DIA 2025 Global Annual Meeting: Full Schedule

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11:00am EDT

#110: Moving Toward Pragmatism in Clinical Trials

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

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-516-L04-P; CME 1.00; RN 1.00

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno

EMA Perspective
Andrew Thomson, PhD, MA, MS

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Kevin Bugin, PhD, MS, RAC

Speakers

Thomas Bognanno

Patient Representative, Alliance Practice, United States

Founder and Partner of Alliance Practice LLC, a firm dedicated to supporting select organizations in the trauma-informed care sector. Before retirement in 2023, Bognanno served as the Chief Executive Officer of Creating Healthier Communities for 17 years. Before that, he served as... Read More →

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 →

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States

Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →

Zhanna Jumadilova

Clinical Lead, Pfizer Inc, United States

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

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands

Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Advanced
Keyword Clinical Trial Design
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
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2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases

Monday June 16, 2025 2:15pm - 3:15pm EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-521-L04-P; CME 1.00; RN 1.00

Master Protocols, including basket trials and umbrella trials, enable efficiencies in investigating multiple conditions or multiple treatments, respectively, under a single trial design. Applying Master Protocol trial designs to Cell & Gene therapies (CGTs) can streamline clinical and regulatory processes to speed the delivery of treatments to patients with rare diseases.

Learning Objectives

Identify barriers to and solutions for leveraging Master Protocol clinical trial designs to study Cell & Gene Therapies for rare diseases.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Thought Leader Perspective
Philip (P.J.) Brooks, PhD

Innovator Perspective
Kiran Musunuru, MD, PhD, MPH

Researcher Perspective
Jeff Allen, PhD

Speakers

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →

Kiran Musunuru

Professor of Medicine, University of Pennsylvania, United States

An actively practicing cardiologist and committed teacher, Kiran Musunuru, MD, PhD, MPH, ML, MRA, is Professor of Cardiovascular Medicine, Genetics, and Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the development of novel... Read More →

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, United States

Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 20 years and has been active in the DC policy arena for three... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Rare Disease, Clinical Trial Design, Cell and Gene Therapy
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Clinical Trial Design,Cell and Gene Therapy
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3:45pm EDT

#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How

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

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-543-L04-P; CME 1.00; RN 1.00

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Chair

Emily Gebbia, JD

Speaker

Industry Perspective
Robert DiCicco, PharmD

MHRA Perspective
Jason Wakelin-Smith

Speakers

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States

Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB 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

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
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