Legend:
CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme
Activity Details
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95 * !
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Mon, 7/31/2017,
8:30 AM -
10:20 AM
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CC-303
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Statistical Validation of Surrogate Endpoints — Invited Papers
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Pharmaceutical Research and Manufacturers of America , Biopharmaceutical Section , ENAR
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Organizer(s): Hong Tian, Janssen Research and Development
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Chair(s): Sudhakar Rao
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8:35 AM
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Response Biomarker Versus Surrogate Endpoints Validation: Evolution of Statistical Approaches
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Sue-Jane Wang, FDA
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9:00 AM
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Surrogacy for Regulatory Approval: The Follicular Lymphoma Analysis of Surrogate Hypothesis (FLASH) Project
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Qian Shi, Mayo Clinic
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9:25 AM
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The Surrogate Threshold Effect for Event-Free Survival as a Potential Surrogate for Overall Survival in Patients Treated for Acute Myeloid Leukemia
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Marc Buyse, IDDI Inc. ; Richard Schlenk, University Hospital of Ulm, Germany ; Hartmund Dohner, University Hospital of Ulm, Germany ; Tomasz Burzykowski, IDDI S.A.
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9:50 AM
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Issues Related to Statistical Validation of Minimal Residual Disease as a Surrogate Endpoint for Clinical Trials and Drug Approvals in AML
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Liang Xiu, Janssen Research and Development ; Rianka Bhattacharya, Janssen Research and Development ; Jianan Hui, University of California, Riverside ; Hong Tian, Janssen Research and Development
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10:15 AM
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Floor Discussion
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