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15 * ! Mon, 8/3/2020, 10:00 AM - 11:50 AM Virtual
Incorporating Knowledge from Previous Clinical Trials into the Design of New Trials — Invited Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics
Organizer(s): Steven J Schwager, Cornell University
Chair(s): Steven J Schwager, Cornell University
10:05 AM Borrowing from Historical Data in Cancer Drug Development: A Cautionary Tale and Experience with Bayesian Adaptive Platform Designs
James Normington, University of Minnesota; Connor Jo Lewis, Securian Financial Group, Inc.; Somnath Sarkar, Flatiron, Inc.; Jiawen Zhu, Roche-Genentech; Federico Mattiello, F. Hoffman-La Roche, Inc.
10:30 AM Statistical Methods and Process for Historical Data Borrowing in Clinical Trials
Lanju zhang, AbbVie Inc; Zailong Wang, AbbVie Inc; Ivan Chan, AbbVie Inc
10:55 AM Bayesian Synthetic Control Approaches in Pediatric Drug Development: A Case Study in Acute Lymphoblastic Leukemia
Antara Majumdar, Medidata Solutions; Jingjing Ye, FDA; Rebecca Rothwell, FDA; Corinne Ahlberg, Acorn AI by Medidata, a Dassault Systèmes company
11:20 AM Discussant: Pallavi Mishra-Kalyani, US FDA
11:45 AM Floor Discussion