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Session 4: Challenges and Opportunities for Implementing Innovative Designs Including Master Protocols and Borrowing External Data
Session Chair(s)
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
Professor of Neurology, Director, UCLA Brain Tumor Center, UCLA, United States
Panelist
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants, LLC, United States
Panelist
Elyse Katz, PHD
Senior Product Management Support, Warfighter Brain Health PMO, USAMMDA, Tunnell Government Services, Inc., United States
Panelist
Gregory Levin, PHD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Panelist
Satrajit Roychoudhury, PHD
Executive Director, Statistical Research and Innovation, Pfizer, United States
Panelist
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