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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

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