JSM 2015 Online 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

372 Tue, 8/11/2015, 10:30 AM - 12:20 PM CC-4B
Contributed Oral Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Lan Xue, Oregon State University
1: Practical Approach to Missing Item Imputation in Asthma Quality-of-Life Questionnaire Tulin Shekar, Merck
2: Optimal Designs for Multiregional Clinical Trials with Regional Consistency Requirement Zhaoyang Teng, Takeda Pharmaceutical International Co. ; Mark Chang, AMAG Pharmaceuticals
3: Continuous Blinding Monitoring for Randomized Controlled Clinical Trials Yufan Zhao, Incyte Corporation ; Yingqi Zhao, University of Wisconsin - Madison ; Kevin Hou, Incyte Corporation
4: Statistical Methods for MIMIC Assay Data Robert D. Small, Sanofi Pasteur
5: Reducing Alpha Adjustment When Tests Are Structurally Correlated Jonathan Siegel, Bayer HealthCare Pharmaceuticals
6: Improved Power for 2x2, 3x3, and 4x4 Crossover Trials with Baselines Thomas Jemielita ; Mary Putt, University of Pennsylvania ; Devan Mehrotra, Merck
7: A Computational Procedure for Mean Kinetic Temperature Using Unequally Spaced Data Amy B. Lock, USDA ; Christopher Tong, USDA
8: Network Meta-Analysis Combining Aggregated and Individual Patient Data Anna Wiksten, Novartis Pharma AG ; Ekkehard Glimm, Novartis
9: Performance Evaluation of New Trial-Level Surrogacy Measures in Binary-Binary Endpoint Scenario in Clinical Trials Yiyi Chu, The University of Texas Health Science Center ; Qian Shi, Mayo Clinic ; Daniel Sargent, Mayo Clinic
10: Hypothesis Testing of Covariate-Adaptive Randomized Clinical Trials with Survival Outcomes Lu Wang, The University of Texas Health Science Center ; Hongjian Zhu, The University of Texas School of Public Health ; Jing Ning, MD Anderson Cancer Center
11: Bayesian Modeling and Prediction of Accrual in Multi-Regional Clinical Trials Yi Deng, Emory University ; Xiaoxi Zhang, Pfizer Inc. ; Qi Long, Emory University
13: Unblinded Sample Size Re-Estimation and the Negative Binomial Model in Clinical Trials Jerry Weaver, Novartis Pharmaceuticals ; Paul Gallo, Novartis Pharmaceuticals
14: Correlations of Patient-Reported Outcomes with PSA and Survival Endpoints in Prostate Cancer Patients Xuemei Li, Janssen R&D
15: Using Simulations for Regulatory Decision-Making: How Many Simulations Do We Need to Run? Paul Schuette, FDA/CDER
16: A Bayesian Approach for Designing Phase II Clinical Trials with Rare Tumor Types in Oncology Santosh Sutradhar, Novartis Pharmaceuticals ; Satrajit Roychoudhury, Novartis Pharmaceuticals
17: Generalized Error Rates for Subgroup Analyses Xiaolei Xun, Novartis ; Frank Bretz, Novartis ; Willi Maurer, Novartis
18: Sizing Clinical Trials When Comparing Two Interventions Using Two Time-to-Event Outcomes Tomoyuki Sugimoto, Hirosaki University ; Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Scott R. Evans, Harvard University ; Takashi Sozu, Kyoto University School of Public Health
19: Exact Statistical Tests for Comparing Tumor Incidence Trend in Transgenic Mouse Carcinogenicity Studies Lei Shu, AbbVie ; Lanju Zhang, AbbVie ; Bo Yang, AbbVie
20: Evaluating Methods for Estimating a Treatment Effect During Treatment-Switching in Time-to-Event Clinical Trials Carl Dicasoli, Bayer HealthCare Pharmaceuticals ; Martin Homering, Bayer HealthCare Pharmaceuticals ; Christian Kappeler, Bayer HealthCare Pharmaceuticals ; Harald Siedentop, Bayer HealthCare Pharmaceuticals ; Thomas Schmelter, Bayer HealthCare Pharmaceuticals ; Daniel Haverstock, Bayer HealthCare Pharmaceuticals
21: A Guidance of Using Meta-Analysis Method for Data with Rare Event Yao Yu, AbbVie ; Yuanyuan Tang, AbbVie ; Qi Tang, AbbVie ; Shihua Wen, AbbVie
22: Evidence for Model-Based Dose Response for Biological Products for Rheumatoid Arthritis and Psoriasis Anindita Banerjee, Pfizer Inc. ; Joseph Wu, Pfizer Inc. ; Bo Jin, Pfizer Inc. ; Steven Martin, Pfizer Inc.
23: Regularized Outcome Weighted Subgroup Identification for Differential Treatment Effects Yaoyao Xu, AbbVie ; Menggang Yu, University of Wisconsin - Madison ; Yingqi Zhao, University of Wisconsin - Madison ; Quefeng Li, Princeton University ; Sijian Wang, University of Wisconsin - Madison ; Jun Shao, University of Wisconsin - Madison
24: Exact Inference for 3-Treatment, 3-Period, 6-Sequence Crossover Design Ching-Ray Yu, Pfizer Inc. ; Michael Riggs, Pfizer Inc. ; Sam Weerahandi, Pfizer Inc.
25: Randomness and Variability in Restricted Randomization Hui Shao ; William F. Rosenberger, George Mason University
26: An Adaptive Method for the Normalization of MicroRNA Array Data Qing Zhao ; Yuda Zhu, Genentech, Inc. ; Karin Staflin, Genentech, Inc.
27: Assessing Agreement: A Graphical Approach Paul Hshieh, CBER/FDA ; Tie-Hua Ng, FDA/CBER
28: Graphical Approaches to Evaluate Liver Safety Data in Clinical Trials Melissa Schultz, University of Wisconsin ; Scott Diegel, University of Wisconsin
29: Statistical Assessment of Clinical Trials with Discordant Pairs of Observations James Lee, Daiichi Sankyo Pharma Development ; Dar Shong Hwang, B.R.S.I. ; Chyi-Hung Hsu, Janssen R&D
31: Agreement on the Interpretations of Beta-Amyloid Images Jonathan Mahnken, The University of Kansas Medical Center ; Alvin Beltramo, The University of Kansas Medical Center
32: Extending Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Vaccine-Vaccine Interactions in Vaccine Safety Surveillance Kijoeng Nam, CBER/FDA ; Nicholas C. Henderson, University of Wisconsin - Madison ; Patricia Rohan, CBER/FDA ; Emily Jane Woo, CBER/FDA ; Estelle Russek-Cohen, FDA
33: Blinded Sample Size Recalculation for Survival Data Kentaro Sakamaki, Yokohama City University
34: Bayesian Isotonic Regression Dose-Response Wen Li, Accenture Accelerated R&D Services ; Jeffrey A. Davidson, Accenture Accelerated R&D Services ; Haoda Fu, Eli Lilly and Company
35: Bayesian-Commensurate Approach for Safety Assessment in Clinical Studies with Count Outcomes Wei-Chen Chen, FDA ; Judy Li, FDA ; John Scott, FDA ; Paul Mintz, FDA
36: Hierarchical Bayesian Models for Understanding the Pharmacokinetics and Pharmacodynamics of Lorenzo's Oil Cynthia Basu, University of Minnesota ; Mariam Ahmed, University of Minnesota ; James C. Cloyd, University of Minnesota ; Richard C. Brundage, University of Minnesota ; Bradley P. Carlin, University of Minnesota
37: Construction of Tolerance Interval Based on Small Data Sets Yuanyuan Duan, AbbVie ; Lanju Zhang, AbbVie ; Jorge Quiroz, AbbVie Pharmaceutical Research & Development
38: Modern Ideas of Better DMC Report Yao Yao, Axio Research ; David Kerr, Axio Research ; Tingting Li, Axio Research ; Kent Koprowicz, Axio Research
39: Application of a Class of Copula-Type Models in Early-Phase Dose Drug Combination Trials Using Conditional Escalation with Overdose Control Galen Cook-Wiens, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars Sinai Medical Center ; Andre Rogatko, Cedars Sinai Medical Center
40: A Simulation Study Using Inverse Probability Weighting to Adjust for Multiple Types of Bias in Observational Studies Diqiong Xie, FDA
41: A Case Study on Practical Patient-Level Benefit-Risk Assessment in a Clinical Trial Bo Fu, AbbVie ; Shihua Wen, AbbVie
42: Shortcomings of the CONSORT 2010 Statement in the Reporting of Adaptive Trials Steven A. Julious, University of Sheffield ; Munyaradzi Dimairo, University of Sheffield ; Abigail Stevely, University of Sheffield ; Susan Todd, University of Reading
43: Predicting Survival Probability in Clinical Trials Beyond Follow-Up Periods Jerry Cheng, Rutgers University ; John Kostis, Rutgers University ; Javier Cabrera, Rutgers University
44: A Bayesian Meta-Analysis Method for Estimating Risk Difference of Rare Events Qi Tang ; Yuanyuan Tang, AbbVie ; Yao Yu, AbbVie ; Shihua Wen, AbbVie
45: Dose-Finding for Drug Combination in Early Cancer Phase I Trials Using Conditional Continual Reassessment Method Quanlin Li ; Mourad Tighiouart, Cedars Sinai Medical Center
46: Dose-Finding for Drug Combination in Early Cancer Phase I Trials in the Presence of a Baseline Binary Covariate Using Conditional Escalation with Overdose Control Sungjin Kim, Cedars Sinai Medical Center ; Mourad Tighiouart, Cedars Sinai Medical Center
47: More Balanced Treatment Allocation When Randomization by Center Ruji Yao ; Norman Ying Yao, Miller Institute for Basic Research in Science
48: Identification of Stably Expressed Genes from Arabidopsis RNA-Seq Data Bin Zhuo ; Yanming Di, Oregon State University ; Sarah Emerson, Oregon State University
49: A Novel Method of Subgroup Identification by Using Virtual Twins and GUIDE (VG) for Development of Personalized Medicines Jia Jia ; Qi Tang, AbbVie ; Wangang Xie, AbbVie ; Richard Rode, AbbVie
50: Statistical Analysis on Models Defined by Differential Equations Hongyuan Wang ; David Allen, University of Kentucky
51: Retrospective Meta-Analyses for Phase I Studies Sarah Zohar, INSERM UMR 1138 ; Anand Vidyashankar, George Mason University ; Jie Xu, George Mason University
52: Data-Driven Prior Distributions for a Phase II COPD Dose-Finding Clinical Trial Shuyen Ho, GSK ; Steven Novick, GlaxoSmithKline

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