Sessions Were Renumbered as of May 19.
Legend:
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
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
