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Virtual

Nov 04, 2021 9:50 AM - Nov 05, 2021 5:00 PM

(US Eastern Standard Time)

Master Protocols and Complex Innovative Design

Innovating for Modernized Clinical Trials

Session 3: The Art of Implementing and Conducting Platform Trials

Session Chair(s)

Michelle  Detry, PhD

Michelle Detry, PhD

Director, Adaptive Trial Execution & Senior Statistical Scientist

Berry Consultants LLC, United States

Anne-Marie  Duliege

Anne-Marie Duliege

Chief Medical Officer

Pancreatic Cancer Action Network, United States

This session will present the main strategic and operational considerations during the preparation and implementation of platform trials. Platform trials require an intense collaboration among numerous groups that differs from the standard clinical trial infrastructure. Their viewpoints must be integrated to meet the common goal of the platform. The speakers will describe their roles in the design and conduct of various ongoing platform trials, as well as some of the challenges they may face.

Learning Objective :
  • Understand the role of the various partners required to conduct a platform trial, and their contributions to the value of this trial
  • Identify the unique perspectives and operational challenges involved in conducting a platform trial
  • Understand the importance of an intense collaboration between the partners to address these challenges and contribute to an optimal conduct of a platform trial

Speaker(s)

Meredith  Buxton, PhD, MPH

Identifying the Right Industry Partners: The Role of the Sponsor

Meredith Buxton, PhD, MPH

Global Coalition For Adaptive Research, United States

Chief Executive Officer

Vincent  Picozzi

Advancing the Science: The Perspective of an Investigator

Vincent Picozzi

Virginia Mason Franciscan Health, United States

Ewa  Carrier, DrMed

Advancing the Science: Joining a Platform Trial: the Perspective of the Biopharma Partner

Ewa Carrier, DrMed

Fibrogen, United States

Executive Director

Len  Rosenberg, PhD, RPh

Operational Excellence: The Ultimate Collaboration Between the Sponsor and the CRO

Len Rosenberg, PhD, RPh

Beat AML, a division of The Leukemia and Lymphoma Society, United States

Head of Clinical Operations

Melanie  Quintana, PhD

The Critical Role of the Blinded Statistician: Role and Interactions with the FDA

Melanie Quintana, PhD

Berry Consultants, LLC, United States

Director & Senior Statistical Scientist

Sabrina  Paganoni, MD, PhD

Patients as Research Partners

Sabrina Paganoni, MD, PhD

Harvard Medical School, Healey Center for ALS at Mass General, United States

Assistant Professor

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