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Topic-Contributed Paper Session

Unleash the Power of Biomarker for Improved Decision-making in Oncology Trial in the Era of Precision Medicine

Tue, Aug 6, 8:30 AM - 10:20 AM

Liwen WuChairJianchang LinOrganizer

Biopharmaceutical Section

5 Presentations

Considerations on phase 2/3 biomarker-adaptive designs

8:35 AM - 8:55 AM

Heng Zhou (Merck)

Co-authors: Zhiping Sun, Cong Chen (Merck & Co., Inc.)

Design for immuno-oncology studies involving biomarker-defined subgroups

8:55 AM - 9:15 AM

Zhenzhen Xu (FDA)

Bayesian group sequential enrichment designs based on adaptive regression of response and survival time on baseline biomarkers

9:15 AM - 9:35 AM

A generalized Bayesian optimal interval design for dose optimization in immunotherapy

9:35 AM - 9:55 AM

Qing Xia (Amgen)

Co-authors: Kentaro Takeda (Astellas Pharma Global Development, Inc.)

Biomarker-Driven Oncology Clinical Trials: Innovative Master Protocol Designs in the Era of Precision Medicine

9:55 AM - 10:15 AM

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