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CC = Walter E. Washington Convention Center   M = Marriott Marquis Washington, DC
* = applied session       ! = JSM meeting theme

Activity Details

138 * ! Mon, 8/8/2022, 10:30 AM - 12:20 PM CC-202B
Dose Optimization in Drug Development: Where We Are, and Where We Want to Be — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, Health Policy Statistics Section
Organizer(s): Bo Huang, Pfizer Inc.
Chair(s): Bo Huang, Pfizer Inc.
10:35 AM A Bayesian Predictive Platform Design for Proof of Concept and Dose-Finding Using Early and Late Endpoints
Ruitao Lin, MD Anderson; Li Wang, Abbvie; Peter Thall, The University of Texas MD Anderson Cancer Center; Ying Yuan , the University of Texas MD Anderson Cancer Center
10:55 AM Statistical Methods for Dose Optimization in Oncology; One Size Does Not Fit All
Roberto Bugarini, Pfizer Inc.; Wei Zhong, Pfizer Inc.; Christophe Le Corre, Pfizer Inc.; Cynthia Basu, Pfizer Inc.; Ray Li, Pfizer Inc.
11:15 AM Dose-Finding in Retinal Gene Therapy Trials – Optical Illusion or Not?
Jialin Xu, Janssen; George Capuano, Janssen
11:35 AM Data-Informed Oncology Dosing Decisions: Trade-Off Between Efficacy/Safety/Convenience Including a Case Study with a Bi-Specific Immunotherapy
Erik Rasmussen, Amgen
11:55 AM Bayesian Approaches to Identify Multiple Recommended Phase 2 Doses
Erik Bloomquist, Ph.D.; Jianjin Xu, FDA/CDER
12:15 PM Floor Discussion
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