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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

263 Mon, 8/1/2016, 2:00 PM - 3:50 PM CC-Hall F1 West
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
23: Evaluation of Sensitivity of Statistical Methods That Assume Missing at Random Takayuki Abe, Keio University School of Medicine ; Kazuhito Shiosakai, Daiichi Sankyo Co. ; Rachel Roberts, Keio University School of Medicine ; Fumiya Sano, Keio University School of Medicine ; Manabu Iwasaki, Seikei University
24: Subgroup Analyses for Count Data Using Bayesian Empirical Meta-Analytical Predictive Priors Wei-Chen Chen, FDA/CBER ; Judy X. Li, FDA ; John Scott, FDA
25: Comparison Between Continuous- and Discrete-Dose EWOC Designs Marcio Diniz, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Andre Rogatko, Cedars-Sinai Medical Center
26: Statistical Analysis of the Progression of Tumors in Rats Mary Esther Nevener, University of Central Oklahoma ; Cynthia Murray, University of Central Oklahoma ; Wei Chen, University of Central Oklahoma
27: Sample Size and Duration of Study in Clinical Trials with Time-to-Event Endpoint Ryunosuke Machida, Tokyo University of Science ; Yosuke Fujii, Pfizer Japan ; Takashi Sozu, Tokyo University of Science
28: A Bayesian Adaptive Design in Cancer Phase I Trials Using Dose Combinations in the Presence of a Baseline Covariate Sungjin Kim ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center
29: Statistical Inference on Dynamic System Models with Multiple Observation Units Hongyuan Wang ; David Allen, University of Kentucky
31: Bayesian Adaptive Designs Using Copula-Type Models in Phase I Cancer Trials Using Drug Combination Galen Cook-Wiens, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center ; Andre Rogatko, Cedars-Sinai Medical Center
32: Optimal Sample Size Determination for Adaptive Seamless Phase II/III Design Zhongying Xu, University of Pittsburgh ; John A. Kellum, University of Pittsburgh ; Gary M. Marsh, University of Pittsburgh ; Chung-Chou H. Chang, University of Pittsburgh
33: An Extension of Clinical Trial Assurance to a Setting of Multiple Unknown Parameters in a Single-Arm Binomial Trial — Yizhou Jiang, Kite Pharma ; Lynn Navale, Kite Pharma ; Allen Xue, Kite Pharma
34: The Impact of Regional Baseline Variation on the Type I Error and Power of Multiregional Clinical Trials Weining Robieson, AbbVie ; Jun Zhao, AbbVie
35: A Novel Approach to Non-Muscle Invasive Bladder Cancer Trials: Making Lemonade Out of Apples and Oranges Yuqun Luo, FDA ; John Scott, FDA
36: A Generalized Hochberg Procedure for Multiple Tests of Significance Chen Chen, Prosoft Clinical ; Dror Rom, Prosoft Clinical ; Jaclyn McTague, Prosoft Clinical
37: Dose Finding for Drug Combination in Early Cancer Phase I Trials using Conditional Continual Reassessment Method Quanlin Li ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center
38: A Simulation Study to Compare Recurrent Event Methods Yansong Cheng ; Helen Millns, GlaxoSmithKline ; Tal Otiker, GlaxoSmithKline
39: Estimating Survivor Average Causal Effect of Dynamic Treatment Regimes in Randomized Cancer Clinical Trial: A Simulation Study Takuya Kawahara, University of Tokyo ; Yutaka Matsuyama, University of Tokyo
40: Tolerance Cpk Contours: A New Tool to Enable Specification Setting in Development Yuanyuan Duan, AbbVie ; Russell L. Hertzler, AbbVie ; Lanju Zhang, AbbVie ; Dennis A. Stephens, AbbVie ; David W. Werst, AbbVie ; Paul A. David, AbbVie ; Jie Zheng, AbbVie ; Jian-Hwa H. Han, AbbVie
41: Design of Experiments for Hydrophobic Interaction Chromatography Optimization Na Zhang, Bristol-Myers Squibb ; Lily Squibb Tsang, Bristol-Myers Squibb ; Kedar Dave, Bristol-Myers Squibb ; Joseph Calzada, Bristol-Myers Squibb ; Gregory A. Barker, Bristol-Myers Squibb ; Angela Lewandowski, Bristol-Myers Squibb ; Zhengjian Li, Bristol-Myers Squibb
42: Bayesian Adaptive Design for Delayed Binary Response Dose-Finding Studies Xiaobi Huang, Sanofi ; Haoda Fu
43: Web-Based Application of Likelihood Ratio Test (LRT)--Based Method for Signal Detection in OpenFDA Yuyi Hsu ; Jyoti Zalkikar, FDA ; Ram Tiwari, FDA/CDER/OT/OB ; Jay Levine, FDA
44: A Simulation Method Based on Interim Results to Assess Conditional Power in Clinical Trials Lin Pan, ICON PLC ; Jill Stankowski, ICON PLC ; Joseph M. Massaro, Boston University
45: Confounder Adjustments by Propensity Score and Disease Risk Score in the Early Stage of Post-Marketing Drug Safety Surveillance Tae Hyun Jung, Yale University ; Jessica Kim , FDA
46: Internal Pilot Design for Clinical Trials with Repeated Measures Xinrui Zhang ; Yueh-Yun Chi, University of Florida
47: Assessment of Effect Size and Power for Survival Analysis Through a Binary Surrogate Endpoint in Clinical Trials Judah Abberbock, University of Pittsburgh ; Gong Tang, University of Pittsburgh
48: Statistical Issues Associated with Subjective Outcome Measures in Animal Drug Evaluation Kyunghee Song, FDA/CVM
49: Bayesian Noncomparative Designs to Account for Uncertainty in Historical Response Rates Francesca Matano, Carnegie Mellon University ; Valeria Sambucini, University of Rome "La Sapienza"
50: Evaluation of Biosimilarity Between Two Biological Products Using Alternative Approaches Hsiao-Hui Tsou, National Health Research Institutes ; Chinfu Hsiao, National Health Research Institutes ; Chi-Tian Chen, National Health Research Institutes ; Wan-jung Chang, National Health Research Institutes
51: Robust Rules for Imputation of Binary Toxicity or Efficacy Indicators for Use in BCRM Tao Feng ; Aaron Camp, PPD ; Joseph Adair, PPD ; Kevin Lawson, PPD
52: Optimizing Adaptive Enrichment Designs Aaron Fisher, The Johns Hopkins University ; Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health
54: The Three-at-Risk Design: Reducing the Duration of Phase I Trials with a Queue-Based Method Paul Frankel, City of Hope ; Jeffrey Longmate, City of Hope ; Richard Sposto, University of Southern California ; Edward Newman, City of Hope ; Susan Groshen, University of Southern California
56: Statistician Credit for Collaboration Charles Goldsmith, GoldStats Consulting ; Lehana Thabane, McMaster University ; Yanling Jin, McMaster University ; Fiona (Feng) He, McMaster University
57: Extended O'Brien Global Test for Multiple Endpoints with Survival and Continuous Outcomes Chenkun Wang, Vertex Pharmaceuticals ; Cynthia DeSouza, Vertex Pharmaceuticals
59: Time and Cluster Interactions in the Stepped Wedge Trial Design Christopher M. Keener, University of Pittsburgh ; Chung-Chou H. Chang, University of Pittsburgh
60: Is Type I error control for multiplicity really "out of the picture" in epidemiology? Yueqin Zhao, FDA/CDER ; Rima Izem, FDA ; Mark Levenson, FDA
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