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300 * Tue, 7/31/2012, 8:30 AM - 10:20 AM CC-Room 28E
Analysis of Biomarker Data — Contributed Papers
Biopharmaceutical Section , Biometrics Section , Section on Statistics in Epidemiology
Chair(s): Aloka Chakravarty, FDA/CDER
8:35 AM Standardized Statistical Framework for Comparison of Biomarkers Danielle J Harvey, University of California at Davis ; Clifford Jack Jr, Mayo Clinic ; Norbert Schuff, University of California at San Francisco ; Michael Weiner, University of California at San Francisco ; Laurel Beckett, University of California at Davis
8:50 AM Strategies for Identifying Predictive Biomarkers in Clinical Trials Using Variable Importance Ilya Lipkovich, Quintiles, Inc. ; Alex Dmitrienko, Quintiles, Inc.
9:05 AM Leveraging Early Biomarker Data to Assess Futility in an Oncology Test-of-Concept Study Robin Mogg, Merck Research Laboratories ; Devan Mehrotra, Merck Research Laboratories
9:20 AM Biomarker Assay Data: How Well Quantified Is the Limit of Quantification? Ying Guo, Merck
9:35 AM A Phase II Design with Direct Assignment Option in Stage II for Initial Marker Validation Ming-Wen An, Vassar College ; Sumithra J. Mandrekar, Mayo Clinic ; Daniel J. Sargent, Mayo Clinic
9:50 AM Statistical Methodology for Generalized Linear Models with Censored Covariates Paul Bernhardt, North Carolina State University ; Huixia Judy Wang, North Carolina State University ; Daowen Zhang, North Carolina State University
10:05 AM Floor Discussion



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