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Virtual Event

2025年4月28日 (月) 午前 9:00 - 2025年4月28日 (月) 午後 4:00

(US Eastern Standard Time)

Fort Washington, PA 19034

Clinical Innovation and Biostatistics Summit

Gain access to novel, thought-provoking findings and collaborate with experts on charting the best path forward in biostatistics and clinical trial innovation.

Session 4: Challenges and Opportunities for Implementing Innovative Designs Including Master Protocols and Borrowing External Data

Session Chair(s)

Lisa  Rodriguez, PHD

Lisa Rodriguez, PHD

Deputy Division Director, OB, OTS, CDER, FDA, United States

Join academic, industry and regulatory experts for an interactive discussion on the challenges and opportunities of master protocols, innovative clinical designs and approaches, including borrowing external data. Audience participants can enter their questions to be answered during the discussion.

Speaker(s)

Timothy  Cloughesy, MD

Timothy Cloughesy, MD

Professor of Neurology, Director, UCLA Brain Tumor Center, UCLA, United States

Panelist

Michelle A Detry, PHD

Michelle A Detry, PHD

Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants, LLC, United States

Panelist

Elyse  Katz, PHD

Elyse Katz, PHD

Senior Product Management Support, Warfighter Brain Health PMO, USAMMDA, Tunnell Government Services, Inc., United States

Panelist

Gregory  Levin, PHD

Gregory Levin, PHD

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States

Panelist

Satrajit  Roychoudhury, PHD

Satrajit Roychoudhury, PHD

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

Panelist

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