Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme
Activity Details
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164 * !
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Mon, 7/29/2019,
10:30 AM -
12:20 PM
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CC-112
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FDA Adaptive Designs and Master Protocols Guidance for Clinical Trials – Reflection and Outlook — Topic Contributed Papers
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Biopharmaceutical Section, Section on Bayesian Statistical Science, Biometrics Section
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Organizer(s): Aijun Gao, Covance/Chiltern; Fanni Natanegara, Eli Lilly and Company; Shiling Ruan, Novartis
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Chair(s): Aijun Gao, Covance/Chiltern
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10:35 AM
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How the 2018 FDA Adaptive Design Draft Guidance Can Help to Increase the Use of Adaptive Designs in Industry
David Manner, Eli Lilly & Company
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10:55 AM
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Increasing Efficiency of Oncology POC Studies Using Bayesian Adaptive Approach
Rong Liu, Celgene Co.
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11:15 AM
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Finding a Balance of Synergy and Flexibility in Master Protocols
Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants
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11:35 AM
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Points to Consider in the Design of Adaptive Platform Clinical Trials in Non-Alcoholic Steatohepatitis
Peter Mesenbrink, Novartis Pharmaceuticals
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11:55 AM
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Discussant: Telba Irony, FDA CBER
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12:15 PM
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Floor Discussion
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