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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)
Panelist
Timothy Cloughesy, MD
UCLA, United States
Professor of Neurology, Director, UCLA Brain Tumor Center
Panelist
Michelle A Detry, PhD
Berry Consultants, LLC, United States
Director, Adaptive Trial Execution & Senior Statistical Scientist
Panelist
Elyse Katz, PhD
Tunnell Government Services, Inc., United States
Senior Product Management Support, Warfighter Brain Health PMO, USAMMDA
Panelist
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Panelist
Satrajit Roychoudhury, PhD
Pfizer, Inc., United States
Executive Director, Statistical Research and Innovation