Online Program Home
My Program

CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

164 * ! Mon, 7/29/2019, 10:30 AM - 12:20 PM CC-112
FDA Adaptive Designs and Master Protocols Guidance for Clinical Trials – Reflection and Outlook — Topic Contributed Papers
Biopharmaceutical Section, Section on Bayesian Statistical Science, Biometrics Section
Organizer(s): Aijun Gao, Covance/Chiltern; Fanni Natanegara, Eli Lilly and Company; Shiling Ruan, Novartis
Chair(s): Aijun Gao, Covance/Chiltern
10:35 AM How the 2018 FDA Adaptive Design Draft Guidance Can Help to Increase the Use of Adaptive Designs in Industry

David Manner, Eli Lilly & Company
10:55 AM Increasing Efficiency of Oncology POC Studies Using Bayesian Adaptive Approach
Rong Liu, Celgene Co.
11:15 AM Finding a Balance of Synergy and Flexibility in Master Protocols

Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants
11:35 AM Points to Consider in the Design of Adaptive Platform Clinical Trials in Non-Alcoholic Steatohepatitis

Peter Mesenbrink, Novartis Pharmaceuticals
11:55 AM Discussant: Telba Irony, FDA CBER
12:15 PM Floor Discussion