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

Activity Details

479 * ! Wed, 7/31/2019, 10:30 AM - 12:20 PM CC-207
Complex Innovative Designs in Practice of Early Phase Drug Development — Invited Papers
Biopharmaceutical Section, ENAR, Society for Clinical Trials
Organizer(s): Vladimir Dragalin, Janssen R&D
Chair(s): Sue-Jane Wang, Center for Drug Evaluation and Research U.S. Food and Drug Administration
10:35 AM Incorporating Time-To-Event Total Toxicity Burden into Dose-Finding Trials
Ji Lin, Sanofi US; Yuan Ji, The University of Chicago; Meizi Liu, University of Chicago
10:50 AM Novel Designs to Accelerate Phase I Oncology Trials
Daniel Li, Juno Therapeutics, A Celgene Company
11:05 AM Adaptive Designs for Drug Combination Informed by Longitudinal Model for the Response

Tobias Mielke, Janssen
11:20 AM Bayesian Optimal Interval (BOIN) Design in Phase 1 Oncology Dose-Finding Trials: An Industry Experience

Wijith Prasantha Munasinghe, AbbVie Inc
11:35 AM Phase 1/2 Seamless Design
Inna Perevozskaya, GSK; Rosemary Schroyer, GSK; Helen Chen, GSK
11:50 AM Discussant: Yuan Ji, The University of Chicago
12:05 PM Floor Discussion