JSM 2015 Preliminary Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details
658 ! Thu, 8/13/2015, 8:30 AM - 10:20 AM CC-605
Statistical Issues Specific to Therapeutic Areas II — Contributed Papers
Biopharmaceutical Section
Chair(s): Yanli Zhao, MedImmune
8:35 AM A Novel Approach in Subgroup Identification Using a Quantitative Benefit-Risk Index — Ramin Arani, AstraZeneca ; Ian Hirsch, AstraZeneca ; Jonathan Norton, MedImmune ; Christy Chuang-Stein, Pfizer Inc. ; Weili He, Merck ; Shihua Wen, AbbVie ; Qi Jiang, Amgen
8:50 AM Tolerance Intervals for Assessing Biosimilarity — Ginto Pottackal, University of Maryland, Baltimore County ; Thomas Mathew, University of Maryland, Baltimore County
9:05 AM Combining Survival Trials Using Aggregate Data Based on Misspecified Models: Method and Application — Yabing Mai, Merck ; Tinghui Yu, FDA/CDRH ; Sherry Liu, FDA/CDRH ; Xiaofei Hu
9:20 AM Sample Size Considerations for Dose-Finding with MCP-Mod — Sergei Leonov, ICON Clinical Research ; Tobias Mielke, ICON PLC
9:35 AM Power Analysis and Sample Size Calculation of Statistical Interaction Model for Evaluation of Biomarker Predictive Effect — Dung-Tsa Chen, Moffitt Cancer Center ; Hui-Yi Lin, Moffitt Cancer Center ; Po-Yu Huang, National Chung Hsing University
9:50 AM Equivalence Test and Margin Determination for Biosimilar Analytical Assessment — Yi Tsong, FDA ; Xiaoyu Dong, FDA ; Meiyu Shen, FDA/CDER/OB
10:05 AM Dose-Finding in Early Phase I/II Cancer Clinical Trial Using Drug Combinations of Cytotoxic Agents — Mourad Tighiouart, Cedars Sinai Medical Center ; Quanlin Li ; Andre Rogatko, Cedars Sinai Medical Center




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