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584 * ! Thu, 8/6/2020, 3:00 PM - 4:50 PM Virtual
Innovations and Breakthroughs in Oncology Dose Finding Designs for Time-to-Event Monitoring and Trial Acceleration in the New Age of Immunotherapy and Cell Therapy — Topic Contributed Papers
Section on Risk Analysis, Biopharmaceutical Section, Section on Bayesian Statistical Science, Biometrics Section
Organizer(s): Wei Zhong, Pfizer Inc
Chair(s): Christophe Le Corre, Pfizer Inc.
3:05 PM TITE-BOIN-ET: Time-to-Event Bayesian Optimal Interval Design to Accelerate Dose-Finding Based on Both Efficacy and Toxicity Outcomes
Kentaro Takeda, Astellas Pharma Global Development, Inc.
3:25 PM Probability-of-Decision Designs to Accelerate Dose-Finding Trials
Tianjian Zhou, University of Chicago; Yuan Ji, University of Chicago
3:45 PM Novel Bayesian Adaptive Designs and Their Software Implementation for Phase I Clinical Trials with Late-Onset Toxicity
Yanhong Zhou, MD Anderson Cancer Center; J. Jack Lee, MD Anderson Cancer Center; Ying Yuan, The University of Texas MD Anderson Cancer Center
4:05 PM The Direct Time-to-Event (DTITE) Designs: A Novel Type of Oncology Dose-Escalation Designs with Late-Onset Toxicities Monitoring
Wei Zhong, Pfizer Inc; Qing Xie, The Ohio State University; Ling Wang, Pfizer Inc.; Roberto Bugarini, Pfizer Inc
4:25 PM New Paradigm of Dose Finding Designs in Cell Therapy Development: Challenges and Solutions
Rachael Liu, Takeda Pharmaceuticals; Jianchang Lin, Takeda Pharmaceuticals; Pin Li, University of Michigan; Yuan Ji, University of Chicago; Jing Xu, Blue Bird
4:45 PM Floor Discussion