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.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 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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