Online Program Home
  My Program

All Times EDT

* = applied session       ! = JSM meeting theme

Activity Details

77 Mon, 8/3/2020, 10:00 AM - 2:00 PM Virtual
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
1: The Framework of a Three-Stage Design for Allergen Immunotherapy Trials
Xinyu Tang, FDA; Lihan Yan, Vaccine Evaluation Branch-CBER-FDA
2: Using Digital Data in an Early Phase Clinical Trial to Quantitate Baroreceptor Sensitivity Variability
Anwesha Mukherjee, Merck & Co Inc; Geoffrey Walford, Merck& Co., Inc; Leticia Arrington, Merck & Co, Inc; Adrienne DiBenedetto, Merck & Co., Inc; Ruben Declercq, Merck & Co, Inc; Inge DeLepeleire, Merck & Co., Inc; Helia Norouzizadeh, Merck & Co., Inc
3: Statistical Impact of Delayed Treatment Effect: A Simulation Study
Yuanbo Song, Novartis Pharmaceuticals Corp; Bharani Bharani-Dharan, Novartis Oncology
4: The Role of Design and Analysis Methods on Go/No-Go Decision in Proof-of-Concept Trials
Macaulay Okwuokenye
5: Accounting for Suboptimal Treatment Adherence When Estimating Heterogenous Treatment Effects from Observational Data
Gabrielle Simoneau, Biogen Canada; Fabio Pellegrini, Biogen International GmbH; Carl de Moor, Biogen Inc; Lu Tian, Department of Biomedical Data Sciences, Stanford University
6: Regional Efficacy Evaluation in Multi-Regional Clinical Trials Using a Discounting Factor Weighted Z Test
Jingwei Wu, College pf Public Health, Temple University; XUANXUAN YU, Dept of Epidemiology & Biostatistics, School of Public Health, University of South Carolina; Jianling Bai, School of Public Health, Nanjing Medical University; Hao Yu, School of Public Health, Nanjing Medical University
7: Multiplicity in Vaccine Clinical Studies – A Case Study with Gate-Keeping Testing Strategy
Huajun Wang, GSK Vaccines; Ellen Ypma, GSK Vaccines; Uwe Nicolay, GSK Vaccines
8: Interim Analysis in Double Blinded Vaccine Trials Using the Semiparametric Density Ratio Model
Jing Qin, National Institute of Allergy and Infectious Diseases
9: TITE-ToBI: The Time-to-Event Toxicity Burden Interval Design to Accelerate Phase I Trials
Meizi Liu, University of Chicago; Yuan Ji, University of Chicago
10: Revisiting Prior Selection for Scale Parameters in Hierarchical Models
Qianqiu Li, Janssen Research & Development; Jyh-Ming Shoung, Janssen Research & Development; Bill Pikounis, Janssen Research & Development
11: Bioequivalence Study Design for Multiplicity
Michelle Quinlan, Novartis Oncology; Ekkehard Glimm, Novartis; Bharani Bharani-Dharan, Novartis Oncology
12: Bayesian Topic Modeling of Adverse Event Data
Andrew Bean, Novartis; Thibaud Coroller, Novartis
13: Statistical Analysis Considerations for Clinical Outcome Assessments Based Endpoints
Chul Ahn, FDA-CDRH
14: Randomization and Randomization Tests for Multi-Armed Randomized Clinical Trials
Yanying Wang
15: A Multiomics Statistical Framework for Drug Repositioning
Zhaolong Yu, Yale University; Kexuan Liang, Peking University; Hongyu Zhao, Yale University
16: Imputation Strategies Within the Estimand Framework to Evaluate the Overall Likelihood of Patient Improvement in Longitudinal Trails
Lysbeth Floden, Clinical Outcomes Solutions
17: Cost-Efficient Two Stage Sequential Multiple Assignment Randomized Trial Designs
Grecio Sandoval, The George Washington University; Ionut Bebu, The George Washington University; John Lachin, The George Washington University
18: Evaluation of Safety Signals Using Association Rule Mining (ARM)
Jagannath Ghosh, Novartis Pharmaceutical; Tania Roy, Novartis Pharmaceutical
19: Evaluation of Improper Analysis of Clinical Trials with Prognostic Factor Not Pre-Specified in Stratified Randomization
Shuyan Wan, Merck; Pingye Zhang, Merck & Co, Inc; Christine Gause, Merck & Co, Inc
21: Estimation of Discrete Survival Function Through Modeling Diagnostic Accuracy for Mismeasured Outcome Data
Hee-Koung Joeng, MERCK
22: Dismantling the Fragility Index: A Demonstration of Statistical Reasoning
Gail Potter, The EMMES Corporation
23: ATCV: A Shiny Application for Safety Tables Review
Lie Li, Merck & Co., Inc.; Yiwen Luo, Merck & Co., Inc.; Clare Bai, Merck & Co., Inc.
24: Development of MSD Multiplex Antigenicity Assay
Yongwei Liu, Sanofi Pasteur; Lingyi Zheng, Sanofi; Jason Szeto, Immunology Platform, Sanofi Pasteur; Melinda Donovan, Immunology Platform, Sanofi Pasteur; Tricia Chen, Immunology Platform, Sanofi Pasteur
25: Bayesian Prior Choice in Clinical Trials with Binary Responses Using Historical Data
Yonggang Zhao, I-Mab Biopharma; Qianqiu Li, Janssen Research & Development
26: Evaluation of Dependency of Multiple Events
Dateng Li
27: Just in Time, on the Job Statistics Training for Biologics Process Characterization
Melissa Matzke, Merck & Co., Inc.; Seth Clark, Merck & Co., Inc.; Richard K. Burdick, Burdick Statistical Consulting, LLC; David Christopher, Merck & Co., Inc.
28: Implementations and Interim Monitoring for Two-Stage Phase II/III Adaptive Designs with a Case Example
Aijun Gao, Covance; Lingyun Liu, Cytel
29: On the Use of the Bootstrap to Test Functions of Correlated Variances in Pre-Post Clinical Trials
Navneet Hakhu, University of California, Irvine; Dan Gillen, University of California, Irvine
31: Curtailed Binomial Sampling Design for Clinical Trials with Two Dependent Endpoints
Chishu Yin, Syracuse University; Pinyuen Chen, Syracuse University
32: Bayesian Data Envelopment Analysis for Assessing Drug Benefit-Risk
Guangyi Gao; Jo A. Wick, University of Kansas Medical Center; Byron J Gajewski, KUMC
33: A Bayesian Adaptive Phase I/II Clinical Trial Design with Late-Onset Competing Risk Outcomes
35: Prediction of Long Term Joint Damage in Placebo Patients with Active Psoriatic Arthritis
Yan Liu, Johnson and Johnson; Prasheen Agarwal, Johnson and Johnson; Xiwu Lin, Janssen Research and Development, LLC; Bei Zhou, Johnson and Johnson
36: The Use of Subgroup Meta-Analysis to Support Decision Making of Prescription Label Change
Mehreteab Aregay, Novartis Pharmaceuticals Corporation; Baldur Magnusson, Novartis Pharmaceuticals Corporation; Gregory Ligozio, Novartis Pharmaceuticals Corporation
37: Preparation and Qualification of an Internal Rabies Reference Standard for RFFIT: From Present to Future
Mohammad Rahman, Sanofi; Lingyi Zheng, Sanofi
38: Using Bootstrap to Verify Normal Assumptions in Statistical Inference for Treatment Difference
Ruji Yao, Merck; Amarjot Kaur, Merck & Co., Inc; Qing Li, Merck Research Labs; Anjela Tzontcheva, Merck & Co., Inc
39: Evaluations of Methods for Missing Data Imputation Under Missing Not at Random
Weining Robieson, AbbVie; Mandy Jin, AbbVie Inc.
40: On the No Free Lunch and Logistic Regression in Healthcare Prediction Problems
Xuan Zhou, Merck Research Lab; Thomas Jemielita, Merck & Co., Inc; Jie Chen, Merck & Co., Inc.; Xin Chen, Merck Co. & Inc; Gail Fernandes, Merck Co. & Inc; Zifang Guo, Merck Co. & Inc; Zhiwen Liu, Merck Co. & Inc; Richard Baumgartner, Merck
41: Evaluation of Type I Error Control for Testing Clinical Endpoint with Pre-Testing Surrogate Endpoint
Hsiao-Hui Tsou, National Health Research Institutes; Yu-Chieh Cheng, National Health Research Institutes; Hsiao-Yu Wu, National Health Research Institutes; Ya-Ting Hsu, National Health Research Institutes; Fang-Jing Lee, National Health Research Institutes; James Hung, Center for Drug Evaluation and Research, FDA
43: Yet Another Randomization System
Dennis Sweitzer
44: Quantitative Determination of Threshold in Clinical Outcome Assessments (COA) for a Clinically Meaningful Change
Wenting Cheng, Biogen; Zijuan Chen, Texas A&M University; Kun Chen, Biogen; Li Zhu, Biogen; Chunlei Ke, Biogen
46: One- and Two-Sided Hypothesis Tests for a Single Proportion with Clustered Binary Data: Derivation, Type I Error, and Power
Meghan I Short, UT Health San Antonio; Howard Cabral, Boston University; Janice M Weinberg, Boston University; Michael P LaValley, Boston University; Gina Peloso, Boston University; Joseph M Massaro, Boston University
47: Modified Factorial Design
Li Yu, Merck & Co., Inc.; Shu-Chih Su, Merck & Co., Inc.
48: Utilizing Historical Data in Bayesian Interval Dose-Escalation Designs
Frank Shen
49: The Effect of Unobserved Covariate in Statistical Inference Under Covariate-Adaptive Randomized Experiment
Yang Liu, George Washington University; feifang Hu, George Washington University
50: Impact of Competing Risk on Win Ratio Analysis for Composite Time-to-Event Endpoint
Ran Liao, Eli Lilly and Company ; Bochao Jia; Margaret Gamalo-Siebers, Eli Lilly & Co; Guanglei Yu, Eli Lilly and Company; Sujatro Chakladar, Eli Lilly and Company
51: Bayesian Design of Clinical Trials for Joint Models of Recurrent Event with a Terminating Event
Jiawei Xu, UNC Chapel Hill; Matthew A. Psioda, University of North Carolina; Joseph G. Ibrahim, University of North Carolina at Chapel Hill