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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
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Activity Details


163 * Mon, 8/5/2013, 10:30 AM - 12:20 PM CC-511b
Enrichment Clinical Trials: Design, Implementation, and Regulatory Perspectives — Topic Contributed Papers
Biopharmaceutical Section , Mental Health Statistics Section , International Chinese Statistical Association , Biometrics Section , International Indian Statistical Association , Scientific and Public Affairs Advisory Committee
Organizer(s): Ray Liu, Millennium : The Takeda Oncology Company
Chair(s): Gregory Hather, Millennium: The Takeda Oncology Company
10:35 AM Challenges in Oncology Drug-Diagnostics Co-Development Ru-Fang Yeh, Genentech, Inc.
10:55 AM Quantitative Considerations for Enrichment Clinical Trial Implementation: Marker Prevalence, Effect Size, Diagnostic Assay Performance, Sample Size, and Beyond Ray Liu, Columbia
11:15 AM Decisionmaking for Enrichment Clinical Trial Implementation: Effect of Trial Strategies on Operations and Revenues Feng Gao, Millennium ; Hongliang Shi, Millennium ; Yanyan Zhu, Millennium
11:35 AM Biomarker Thresholding to Identify Subgroup of Patients with Treatment Benefit Yi Liu, Millennium : The Takeda Oncology Company ; Jason Hsu, Ohio State University
11:55 AM A Brief Overview of the Draft Enrichment Guidance Boguang Zhen, FDA
12:15 PM Floor Discussion



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