Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme
Activity Details
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479 * !
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Wed, 7/31/2019,
10:30 AM -
12:20 PM
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CC-207
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Complex Innovative Designs in Practice of Early Phase Drug Development — Invited Papers
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Biopharmaceutical Section, ENAR, Society for Clinical Trials
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Organizer(s): Vladimir Dragalin, Janssen R&D
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Chair(s): Sue-Jane Wang, Center for Drug Evaluation and Research U.S. Food and Drug Administration
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10:35 AM
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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
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10:50 AM
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Novel Designs to Accelerate Phase I Oncology Trials
Daniel Li, Juno Therapeutics, A Celgene Company
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11:05 AM
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Adaptive Designs for Drug Combination Informed by Longitudinal Model for the Response
Tobias Mielke, Janssen
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11:20 AM
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Bayesian Optimal Interval (BOIN) Design in Phase 1 Oncology Dose-Finding Trials: An Industry Experience
Wijith Prasantha Munasinghe, AbbVie Inc
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11:35 AM
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Phase 1/2 Seamless Design
Inna Perevozskaya, GSK; Rosemary Schroyer, GSK; Helen Chen, GSK
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11:50 AM
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Discussant: Yuan Ji, The University of Chicago
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12:05 PM
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Floor Discussion
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