Name: 2020 Joint Statistical Meetings
Start: 2020-08-02T07:00:00+00:00
End: 2020-08-06

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Activity Details

220193	Mon, 8/3/2020, 8:30 AM - 10:00 AM	Virtual
Biopharmaceutical Section Executive Committee Meeting (Closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Bruce Binkowitz, Shionogi, Inc.

5	Mon, 8/3/2020, 10:00 AM - 11:50 AM	Virtual
Recent Development on Statistical Methods for Precision Medicine — Invited Papers
ENAR, Biometrics Section, Section on Statistics in Epidemiology, Biopharmaceutical Section
Organizer(s): Guanhua Chen, University of Wisconsin-Madison
Chair(s): Yanyao Yi, Eli Lilly and Company
10:05 AM	A Two-Part Model for Individualized Treatment Rule Estimation with Semi-Continuous Outcomes Guanhua Chen, University of Wisconsin-Madison; Maureen Smith, University of Wisconsin-Madison; Jared Huling, The Ohio State University
10:30 AM	Bayesian Nonparametric Survival Regression for Optimizing Precision Dosing of Intravenous Busulfan in Allogeneic Stem Cell Transplantation Presentation Peter F. Thall, M.D. Anderson Cancer Center; Yanxun Xu, Johns Hopkins University; William Hua, Johns Hopkins University; Borje Andersson, M.D. Anderson Cancer Center
10:55 AM	Targeted Learning of Causal Impact of Optimal Individualized Treatment Rules Based on Novel Sequentially Adaptive Designs Mark Van der Laan, University of California, Berkeley; Ivana Malenica, University of California, Berkeley
11:20 AM	Stochastic Tree Search for Estimating Personalized Treatment Decision Rules Lu Wang, University of Michigan; Yilun Sun, University of Michigan Medical School
11:45 AM	Floor Discussion

15 * !	Mon, 8/3/2020, 10:00 AM - 11:50 AM	Virtual
Incorporating Knowledge from Previous Clinical Trials into the Design of New Trials — Invited Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics
Organizer(s): Steven J Schwager, Cornell University
Chair(s): Steven J Schwager, Cornell University
10:05 AM	Borrowing from Historical Data in Cancer Drug Development: A Cautionary Tale and Experience with Bayesian Adaptive Platform Designs James Normington, University of Minnesota; Connor Jo Lewis, Securian Financial Group, Inc.; Somnath Sarkar, Flatiron, Inc.; Jiawen Zhu, Roche-Genentech; Federico Mattiello, F. Hoffman-La Roche, Inc.
10:30 AM	Statistical Methods and Process for Historical Data Borrowing in Clinical Trials Lanju zhang, AbbVie Inc; Zailong Wang, AbbVie Inc; Ivan Chan, AbbVie Inc
10:55 AM	Bayesian Synthetic Control Approaches in Pediatric Drug Development: A Case Study in Acute Lymphoblastic Leukemia Antara Majumdar, Medidata Solutions; Jingjing Ye, FDA; Rebecca Rothwell, FDA; Corinne Ahlberg, Acorn AI by Medidata, a Dassault Systèmes company
11:20 AM	Discussant: Pallavi Mishra-Kalyani, US FDA
11:45 AM	Floor Discussion

22 * !	Mon, 8/3/2020, 10:00 AM - 11:50 AM	Virtual
Design and Evaluation of Adaptive Design Clinical Trials: Software Demonstration — Invited Panel
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Society for Clinical Trials
Organizer(s): Navneet Hakhu, University of California, Irvine
Chair(s): Navneet Hakhu, University of California, Irvine
10:05 AM	Design and Evaluation of Adaptive Design Clinical Trials: Software Demonstration
Panelists:	Scott Berry, Berry Consultants Keaven Anderson, Merck & Co Yannis Jemiai, Cytel Inc Dan Gillen, University of California, Irvine
11:40 AM	Floor Discussion

31 * !	Mon, 8/3/2020, 10:00 AM - 11:50 AM	Virtual
Combination Therapy Dose-Finding in Oncology Drug Development — Topic Contributed Papers
Biopharmaceutical Section, Section on Bayesian Statistical Science, International Chinese Statistical Association
Organizer(s): Rong Liu, BMS
Chair(s): Olga Marchenko, Bayer
10:05 AM	Comparative Review of Phase I Dose-Finding Designs for Drug Combination Trials Heng Zhou, Merck; Ruitao LIN, The University of Texas MD Anderson Cancer Center
10:25 AM	Dual-Agent Drug-Combination Designs for Finding Multiple Maximum Tolerated Dose Combinations in Oncology Phase I Trials Xin Yang, Novartis
10:45 AM	Industry Experience on Combination Therapy Dose-Finding in Oncology Drug Development Rong Liu, BMS
11:05 AM	Emerging Approaches in Combination Phase I Trials: Utilization of Historical Data and the Need to Consider Model Guided Designs and Endpoints Other Than DLTs Suman Sen, Novartis Pharmaceuticals Corp
11:25 AM	Discussant: Cindy Gao, FDA
11:45 AM	Floor Discussion

62	Mon, 8/3/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Adaptive Designs: Adaptive-Seamless, Group Sequential and Other Designs — Contributed Papers
Biopharmaceutical Section
Chair(s): Cristiana Mayer, Janssen / Johnson & Johnson
	Seamless Adaptive Phase 2-3 Designs Allowing for Mid-Term Modifications Using Multiplicity Strategy Presentation Mandy Jin, AbbVie Inc.
	Overview of Recent Advances in Biomarker Driven Adaptive Designs Ilya Lipkovich, Eli LIlly and Company; Sarah E Johnson , University of Oklahoma Health Sciences Center; Alex Dmitrienko , Mediana, Inc; Daniel Zhao , University of Oklahoma Health Sciences Center
	Adaptive Simon’s Two-Stage Design with or Without Targeting Biomarker Subpopulation Weichao Bao, Bayer
	An Adaptive-Flavored Group Sequential Design with Connection to Conditional Error Presentation Dong Xi, Novartis; Paul Gallo, Novartis
	Automated Design of Adaptive Trials Using Bayesian Optimization Joe Marion, Berry Consultants
	Early Phase Cancer Clinical Trial Design for Dose Finding of Treatment Combinations Across Patient Groups Bethany Horton, University of Virginia

63 *	Mon, 8/3/2020, 10:00 AM - 2:00 PM	Virtual
Power and Sample Size: Methods and Applications — Contributed Papers
Biopharmaceutical Section
Chair(s): John J. Han, Janssen / Johnson & Johnson
	Sample Size and Power Estimation in a Rare Disease Trial Using Mixture of Negative Binomial Distributions Aparna Raychaudhuri, CSL Behring; Sergei Leonov, CSL Behring; Harald Iverson, CSL Behring
	Calculating Power for the Finkelstein and Schoenfeld Test Statistic for a Composite Endpoint with Two Components Thomas Zhou, Boston University; Michael P LaValley, Boston University; Kerrie P Nelson, Boston University; Howard Cabral, Boston University; Joseph M Massaro, Boston University
	Sample Size and Power Computations Methods for Two-Stage Randomized Trial, with Focus on Time-to-Event Data Rouba Chahine, University of Alabama at Birmingham; Inmaculada Aban, University of Alabama at Birmingham; Dustin Long, University of Alabama at Birmingham
	Model-Robust Inference for Clinical Trials That Improve Precision by Stratified Randomization and Adjustment for Additional Baseline Variables Bingkai Wang, Johns Hopkins Bloomberg School of Public Health; Michael Rosenblum, Johns Hopkins Univ, Bloomberg School of Public Health
	Improved Analyses of Randomized Clinical Trials with Stratified Enrollment Devan Mehrotra, Merck; Rachel Marceau West, Merck Research Laboratories; Julie Kobie, Merck & Company Inc
	Power Formulas for Mixed Effects Models with Random Slope and Intercept Comparing Rate of Decline Across Groups Presentation Yu Zhao, UC-San Diego; Sarah J Banks, UC San Diego; Mark W Bondi, UC San Diego; Steven D Edland, UC San Diego
	Uncover Evidence in Real World Data with Uncertain Genetic Information Wei Zhuang, NCTR, FDA

64	Mon, 8/3/2020, 10:00 AM - 2:00 PM	Virtual
Statistical Issues Specific to Therapeutic Areas — Contributed Papers
Biopharmaceutical Section
Chair(s): Gajanan Bhat, Spectrum Pharmaceuticals
	Simulation Studies of Different Statistical Methods for Time-to-Event Prediction Jia Jia, AbbVie; Yiding Zhang, University of Massachusetts Amherst ; Wenjing Lu, Abbvie; Ying Zhou, Abbvie; Danielle M Sullivan, Abbvie
	Borrowing Historical Data for Vaccine Efficacy Trials Guanghan Frank Liu, Merck Inc.; Mandy Jin, AbbVie Inc.; Dai Feng, AbbVie
	An Extension of Bayesian Principal Stratum Analysis of Clinical Disability Progression in SPMS Zhe Chen, Biogen; Katherine Riester, Biogen
	Bayesian Approaches for Modeling Repeated Computerized Assessment of Cognitive Function in Alzheimer’s Disease Nairita Ghosal, Merck & Co., Inc., ; Santosh Sutradhar, Merck & Co., Inc.; Sarah Janicki Hsieh, Merck & Co., Inc.,
	Prevalence of Response for Evaluation of Duration of Response with Application to Disability Improvement in Multiple Sclerosis Zheng Ren, Biogen - RTP, NC; Li Zhu, Biogen; Chunlei Ke, Biogen
	A Critical Appraisal of Statistical Practice in Translational Animal Studies Olivia Hogue, Cleveland Clinic and Case Western Reserve University; Eashwar Somasundaram, Case Western Reserve University School of Medicine; Kenneth B Baker, Department of Neurosciences, Cleveland Clinic; Jill S Barnholtz-Sloan, Department of Population and Quantitative Health Sciences, Case Western Reserve University; Abagail Postle, Neurological Institute, Cleveland Clinic; Tucker J Harvey, University of Pittsurgh; Dena Crozier, Cleveland Clinic Lerner College of Medicine; Francis May, Cleveland Clinic Lerner College of Medicine
	The Mechanistic Analysis of Founder Virus Data in Challenge Models Ana Maria Ortega-Villa, National Institutes of Health; Dean Follmann, NIAID
	Treatment Effect in Sequential Parallel Comparison Design Studies Xiaoyan Liu, Boston University; Gheorghe Doros, Boston University

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
30:	AUTOMATING the ORGANIZATION and PROCESSING of BIOASSAY DATA with the R PACKAGE and R SHINY APP AXL JENNIFER NGUYEN, Merck; TOM STEINMETZ, Merck
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 YIFEI ZHANG; YONG ZANG, INDIANA UNIVERSITY
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

87	Mon, 8/3/2020, 12:00 PM - 1:00 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
ML02:	Lunch with the Incoming 2021 Chair of the ASA Biopharmaceutical Section Weili He, AbbVie

100 * !	Mon, 8/3/2020, 1:00 PM - 2:50 PM	Virtual
Statistical Innovations for Drug Approval and Reimbursement for Rare Disease — Invited Papers
International Indian Statistical Association, Biopharmaceutical Section, Health Policy Statistics Section
Organizer(s): Amit Bhattacharyya, Alexion Pharmaceuticals
Chair(s): Amit Bhattacharyya, Alexion Pharmaceuticals
1:05 PM	On Analysis of Single Arm Trial with Natural History Controls Qing Liu, Quantitative and Regulatory Medical Science, LLC
1:25 PM	Challenges in Rare Disease Clinical Trials: The PREVENT Trial for NMOSD Fanny O'Brien, Alexion
1:45 PM	Predictive Models in Rare Diseases: Risks and Opportunities in Clinical Trials, with Examples in Amyotrophic Lateral Sclerosis (ALS) Alex Karanevich, EMB Statistical Solutions
2:05 PM	Innovative Designs and Rare Diseases: Bridging Information Through Evidence Synthesis Satrajit Roychoudhury, Pfizer Inc.
2:25 PM	Use Case Scenario: Indirect Comparisons to Enhance Reimbursement Negotiations in Rare Disease Jinesh Shah, CSL Behring
2:45 PM	Floor Discussion

114 * !	Mon, 8/3/2020, 1:00 PM - 2:50 PM	Virtual
ICH E9 R1 Addendum: Can We Deliver on the Promise? — Invited Panel
Council of Chapters, Biopharmaceutical Section, ENAR
Organizer(s): Pilar Lim, Janssen Research & Development, LLC; Akiko Okamoto, Janssen Research & Development, LLC
Chair(s): Pilar Lim, Janssen Research & Development, LLC
1:05 PM	ICH E9 R1 Addendum: Can We Deliver on the Promise? Presentation
Panelists:	Craig Mallinckrodt, Biogen Steve Ruberg, Analytix Thinking, LLC Elena Polverejan, Janssen Pharmaceuticals Scott Emerson, University of Washington H. M. James Hung, CDER at FDA
2:45 PM	Floor Discussion

118 * !	Mon, 8/3/2020, 1:00 PM - 2:50 PM	Virtual
Recent Advances in the Design and Analysis of Platform Trials — Topic Contributed Papers
Section on Statistical Graphics, Biopharmaceutical Section, Section on Statistical Computing
Organizer(s): Bo Huang, Pfizer Inc.
Chair(s): Enayet Talukder, Pfizer Inc.
1:05 PM	Basket Design Vs Umbrella Design for Exploratory Trials Cong Chen, Merck and Company, Inc.
1:25 PM	Finding a Balance of Synergy and Flexibility in Master Protocols Melanie Quintana, Berry Consultants
1:45 PM	RoBoT: A Robust Bayesian Hypothesis Testing Method for Basket Trials Yuan Ji, University of Chicago; Tianjian Zhou, University of Chicago
2:05 PM	Implementation of a Platform Trial in Early Development Dmitri Pavlov, Pfizer
2:25 PM	Discussant: Erik Bloomquist, FDA
2:45 PM	Floor Discussion

120 * !	Mon, 8/3/2020, 1:00 PM - 2:50 PM	Virtual
Recent Advances in Vaccine Dose and Regimen Finding — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Robert D Small, Dr.
Chair(s): Ayca Ozol-Godfrey, Sunovion Pharmaceuticals
1:05 PM	SOME ADAPTIVE METHODS for VACCINE DOSE-FINDING Presentation James Bolognese, Cytel Inc.
1:25 PM	Considerations in Vaccine Dose-Finding Studies Aiying Chen, sanofi Pasteur; Scott Patterson, Sanofi Pasteur ; Fabrice Bailleux, Sanofi Pasteur; Tifany Machabert, Sanofi Pasteur
1:45 PM	Model Informed Development in Vaccines Immunizes Against Choosing Poor Vaccine Candidates and/or Non-Informative Dose-Levels Presentation Radha Railkar, Merck & Co., Inc.; Jeff Sachs, Merck; Jos Lommerse, Certara; Nele Mueller-Plock, Certara; S.Y. Amy Cheung, Certara; Brian Maas, Merck; Luzelena Caro, Merck; Antonios Aliprantis, Merck; Kalpit Vora, Merck; Amy Espeseth, Merck; Andrew Lee, Merck
2:05 PM	Discussant: Lihan Yan, Vaccine Evaluation Branch-CBER-FDA
2:25 PM	Discussant: Debra Yeskey, CEPI
2:45 PM	Floor Discussion

146 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Methods to Evaluate and Correct for Bias in Patient-Reported Outcomes in Clinical Trials: Advancing the Validity of Patient-Centric Drug Development — Invited Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Joseph C. Cappelleri, Pfizer Inc.; Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania
Chair(s): Demissie Alemayehu, Pfizer Inc.
10:05 AM	Addressing Bias in Responder Analyses of Patient-Reported Outcomes Presentation Joseph C. Cappelleri, Pfizer Inc.
10:30 AM	Evaluating the Effect of Interventions on Patient Function in Trials of Severely Ill Patients Presentation Elizabeth Colantuoni, Johns Hopkins Bloomberg School of Public Health; Daniel O Scharfstein, Johns Hopkins University; Ximin Li, Johns Hopkins University
10:55 AM	Assessing Open-Label Bias in Patient-Reported Outcomes in Cancer Trials Jonathon Vallejo, FDA
11:20 AM	Discussant: Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania
11:45 AM	Floor Discussion

148 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Master Protocols in Oncology Drug Development — Invited Papers
ENAR, Biometrics Section, Biopharmaceutical Section
Organizer(s): Xiaoyun (Nicole) Li, Merck
Chair(s): Xiaoyun (Nicole) Li, Merck
10:05 AM	Master Protocols in Oncology: A Regulatory Perspective Min (Annie) Lin, FDA
10:30 AM	ASA Oncology Working Group Sub-Team Report on Oncology Master Protocols Chengxing (Cindy) Lu, Biogen Inc.; Xiaoyun (Nicole) Li, Merck
10:55 AM	Bayesian Platform Trials for Drug Registration Don Berry, Berry Consultants
11:20 AM	Discussant: Erik Bloomquist, FDA
11:45 AM	Floor Discussion

153 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Utilization of Historical Data for Confirmatory Trials — Topic Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Society for Clinical Trials
Organizer(s): Freda Cooner, Amgen Inc.
Chair(s): Freda Cooner, Amgen Inc.
10:05 AM	Use of Historical Data in Regulatory Applications – Advantages and Challenges Shiowjen Lee, FDA/CBER/OBE/DB
10:25 AM	Statistical Considerations for Borrowing Historical Data in Small Populations Fanni Natanegara, Eli Lilly and Company
10:45 AM	Historical Data Borrowing with Informative Inferential Prior for Bayesian Hypothesis Testing Presentation Hui Quan, Sanofi; Bingzhi Zhang, Sanofi; Yu Lan, Sanofi; Xiaodong Luo, Sanofi; Xun Chen, Sanofi
11:05 AM	Improving Clinical Trial Efficiency Using Natural History Study Data and Innovative Trial Design Presentation Barbara Wendelberger, Berry Consultants, LLC; Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants
11:25 AM	Discussant: Haijun Ma, NeKtar Therapeutics
11:45 AM	Floor Discussion

154 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Integrating Real World Data with Clinical Trials: Opportunities and Challenges — Topic Contributed Papers
Caucus for Women in Statistics, ENAR, Biopharmaceutical Section
Organizer(s): Yimei Li, University of Pennsylvania
Chair(s): Yimei Li, University of Pennsylvania
10:05 AM	An Integrated Analysis of Randomized Clinical Trials and Real World Evidence Studies: Theory and Application Xiaofei Wang, Duke University; Shu Yang, North Carolina State University
10:25 AM	Synthesizing External Aggregated Information in the Presence of Population Heterogeneity: A Penalized Empirical Likelihood Approach Mi-Ok Kim, UCSF
10:45 AM	Multiple Imputation Strategies for Handling Missing Data When Transporting Randomized Clinical Trial Findings Using Propensity Score-Based Methodologies Albee Ling, Stanford University; Maria Montez-Rath, Stanford University; Kris Kapphahn, Stanford University; Maya Mathur, Stanford University; Manisha Desai, Stanford University
11:05 AM	Evaluating the Use of Real-World Data as a Source for Full or Hybrid Control Arms for Clinical Trials Douglas Faries, Lilly Research Laboratories; Zhanglin Cui, Eli Lilly and Company
11:25 AM	COMET: An Active Surveillance Trial in Low Risk DCIS, Challenges and Integration with National Cancer Database Terry Hyslop, Biostat and Bioinformatics
11:45 AM	Floor Discussion

157 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Translational Statistics: Problems in Preclinical Studies and a Call for Change — Topic Contributed Papers
Section on Teaching of Statistics in the Health Sciences, Biopharmaceutical Section, Committee on Applied Statisticians
Organizer(s): Penny Reynolds, University of Florida School of Medicine
Chair(s): Sujata M Patil, Memorial Sloan Kettering Cancer Center
10:05 AM	Non-Informative Preclinical Research: What Statisticians Need to Know. Penny Reynolds, University of Florida School of Medicine
10:25 AM	Common Problems in the Design of Preclinical Animal Experiments Presentation Stanley Lazic, Prioris.ai Inc.
10:45 AM	Statistical Reporting Must Improve in Preclinical Research Presentation Romain-Daniel Gosselin, Lausanne University Hospital (CHUV)
11:05 AM	Discussant: Cynthia W Garvan, University of Florida School of Medicine
11:25 AM	Discussant: Nancy Flournoy, University of Missouri-Columbia
11:45 AM	Floor Discussion

164 * !	Tue, 8/4/2020, 10:00 AM - 11:50 AM	Virtual
Leveraging Real-World Data in the Drug Development Process — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, Health Policy Statistics Section
Organizer(s): Rebecca A Hubbard, University of Pennsylvania
Chair(s): Nandita Mitra, University of Pennsylvania
10:05 AM	Hybrid Controlled Trials with EHR-Derived Data for Cancer Trials: What, Why, When, and How Brian Segal, Flatiron Health; Melissa Curtis, Flatiron Health; Meghna Samant, Flatiron Health; Katherine Tan, Flatiron Health; Shrujal Baxi, Flatiron Health; Somnath Sarkar, Flatiron, Inc.
10:25 AM	Data-Adaptive Weighting of Real-World and Randomized Controls Using Propensity Scores Joanna Harton, University of Pennsylvania; Nandita Mitra, University of Pennsylvania; Rebecca A Hubbard, University of Pennsylvania
10:45 AM	Leveraging RWD and Historical Data in Design and Analysis of Clinical Trials Samson Ghebremariam, Novartis Pharmaceuticals; Lisa Hampson, Novartis Pharmaceuticals; Bharani Bharani-Dharan, Novartis Oncology; Amy Racine-Poon, Novartis Pharma AG; Beat Neuenschwander, Novartis pharmaceuticals
11:05 AM	Calibrated Survival Curve and Treatment Comparison with Imperfect Survival Outcomes from Electronic Health Records Chuan Hong, Harvard Medical School; Liang Liang, Harvard T. H. Chan School of Public Health; Tianxi Cai, Harvard University
11:25 AM	Discussant: Elizabeth Teeple, US Food and Drug Administration
11:45 AM	Floor Discussion

193	Tue, 8/4/2020, 10:00 AM - 2:00 PM	Virtual
Modeling, Design Strategies and Assessments of Biomarkers — Contributed Papers
Biopharmaceutical Section
Chair(s): Gitanjali Paul, GlaxoSmithKline plc
	Visualizing Biomarkers and Their Association with Clinical Outcomes: A Machine Learning Approach Hui Zheng, Harvard Medical School
	Modeling Count Data with Extreme High Counts Ping Xu, Merck & Co Inc; Qing Li, Merck Research Labs; Anjela Tzontcheva, Merck & Co., Inc; Ruji Yao, Merck; Guanghan Frank Liu, Merck Inc.
	A Three-Stage Deep Learning Method for Biomarker Identification from Gene Expression Data and Baseline Disease Activities Bochao Jia
	Effect of Tumor Size Change and Duration of Response on Overall Survival in Immunotherapy Trials Meihua Wang, Merck & Co.; Jing Yang, Merck & Co.; Iris Wu, Merck; Heng Zhou, Merck; Cong Chen, Merck and Company, Inc.
	Issues and Solutions in Biomarker Evaluation When Sub-Classes Are Involved Under Binary Classification Yingdong Feng, Eli Lilly & Company; Lili Tian, University at Buffalo
	A Linear Mixed Effects Model with Censored Response for Longitudinal Biomarker Data Subject to Lower Limits of Detection Xueli Liu, AbbVie Inc.; Chun Zhang, AbbVie Inc.
	Estimation and Construction of Confidence Intervals for the Cutoff-Points of Continuous Biomarkers in Trichotomous Settings Brian Mosier, University of Kansas Medical Center; Leonidas Bantis, University of Kansas Medical Center
	Should We Check the Normality? The Impact of Model Assumptions in Early Phase Clinical Studies Presentation Qianyu Dang, FDA Center for Drug Evaluation and Research (CDER); Ran Bi, FDA/HHS
	Assessment of Predictive Biomarkers for Vaccine Development Ivan David Ordonez, Sanofi Pasteur; Robert D Small, Dr.; Maïna L’Azou, Sanofi Pasteur; Edith Langevin, Sanofi Pasteur; Pauline Jurvilliers, Sanofi; Darin Edwards, Moderna Therapeutics

194	Tue, 8/4/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Clinical Trials - I — Contributed Papers
Biopharmaceutical Section
Chair(s): Sophie Sun, Novartis
	Study Design for Non-Oncology Combination Therapies Abigail Sloan, Pfizer Inc.
	Randomized Discontinuation Trials: Modified Amery-Dony Designs Presentation Valerii Fedorov, ICONplc; Parvin Fardipour, ICONplc
	OncCOVID: Integrated Survival Estimates from Cancer Treatment Delay During the Covid-19 Pandemic Presentation Holly Hartman, University of Michigan; Kelley Kidwell, University of Michigan; Matthew Schipper, University of Michigan
	A Simulation-Free Group Sequential Design Using Max-Combo Tests in the Presence of Non-Proportional Hazards Cheng Zheng, Sanofi; Lili Wang, University of Michigan; Xiaodong Luo, Sanofi
	Do Placebo Doses Vary Hot Flash Placebo Effects? Jun He, Mayo Clinic; Jennifer Le-Rademacher, Mayo Clinic; Charles L. Loprinzi, Mayo Clinic; David Zahrieh, Mayo Clinic
	A Two-Stage Stratified Clinical Trial Design with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers Shou-En Lu, Rutgers School of Public Health; Yanping Chen, Rutgers School of Public Health; Yong Lin, Rutgers School of Public Health; Weichung Joe Shih, Rutgers School of Public Health; Hui Quan, Sanofi
	Assurance in Clinical Development Planning and Decision Making Michael Fries, CSL Behring
	Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes David Benkeser, Emory University; Ivan Diaz, Weill Cornell Medicine; Alex Luedtke, University of Washington & Fred Hutchinson Cancer Research Center; Jodi Segal, Johns Hopkins University; Daniel O Scharfstein, Johns Hopkins University; Michael Rosenblum, Johns Hopkins Univ, Bloomberg School of Public Health

195	Tue, 8/4/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Personalized/Precision Medicine - II — Contributed Papers
Biopharmaceutical Section
Chair(s): Jennifer Bogert, Janssen / Johnson & Johnson
	From Illogical Efficacy Measures to Mistakes in Current Computer Packages – All That Is Wrong in Biomarker Subgroup Identification with Real Example and Proposed Solution Jason Hsu, Ohio State University; Yi Liu, Nektar Therapeutics; Bushi Wang, Boehringer Ingelheim Pharmaceuticals, Inc.
	One-Step Value Difference Test for the Existence of a Subgroup with a Beneficial Treatment Effect Using Random Forests Dana Johnson, North Carolina State University; Wenbin Lu , North Carolina State University; Marie Davidian, North Carolina State University
	Boosting Algorithms for Estimating Optimal Individualized Treatment Rules Duzhe Wang, University of Wisconsin-Madison; Haoda Fu, Eli Lilly and Company; Po-Ling Loh, UW-Madison
	Inference on Selected Subgroups in Clinical Trials Xinzhou Guo, Harvard University; Xuming He, University of Michigan
	A Benchmark Framework for Subgroup Identification Methods in Clinical Trials Hui Sun, Novartis Parmaceuticals; Ardalan Mirshani, Novartis; Bjoern Bornkamp, Novartis
	Matching-Based Classification Tree for Subgroup Effect Identification in Observational Data Bo Lu, The Ohio State University
	Three mistakes in current stratified analyses and confident patient subgroup identification for randomized controlled trials, using a Subgroup Mixable Estimation app Siyoen Kil, LSK Global PS; Jason Hsu, Ohio State University

228	Tue, 8/4/2020, 12:00 PM - 1:00 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
TL01:	Estimands and Sensitivity Analysis in Practice Vladimir Dragalin, Janssen R&D

244 *	Tue, 8/4/2020, 1:00 PM - 2:50 PM	Virtual
Recent Advances in Causal Inference with Applications for the Public Good — Invited Papers
Section on Statistics in Epidemiology, Biometrics Section, Health Policy Statistics Section, Biopharmaceutical Section
Organizer(s): Fan Yang, University of Colorado Anschutz Medical Campus
Chair(s): Fan Yang, University of Colorado Anschutz Medical Campus
1:05 PM	Assessing Surrogate Paradox Risk in the Meta-Analytic Causal Association Framework Michael R Elliott, University of Michigan; Jeremy Taylor, University of Michigan; Yun Li, University of Pennsylvania Perelman School of Medicine & The Children’s Hospital of Philadelphia; Anna Conlon, University of Michigan; Nico Kaciroti, University of Michigan
1:30 PM	Tobacco Use Epidemic: Understanding Its Public Impact in the New Era Jing Cheng, University of California, San Francisco
1:55 PM	Experimental Evaluation of Computer-Assisted Human Decision Making: Application to Pretrial Risk Assessment Instrument Kosuke Imai, Harvard University; Zhichao Jiang, University of Massachusetts, Amherst; James Greiner, Harvard Law School; Ryan Halen, Harvard Law School; Sooahn Shin, Harvard University
2:20 PM	Causal Ball Screening: Outcome Model-Free Causal Inference with Ultra-High-Dimensional Covariates Dingke Tang, University of Science and Technology China; Dehan Kong, University of Toronto; Wenliang Pan, Sun Yat-Sen University; Linbo Wang, University of Toronto
2:45 PM	Floor Discussion

247 *	Tue, 8/4/2020, 1:00 PM - 2:50 PM	Virtual
Wearable/Implantable Device Data in Clinical Trials — Invited Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Tracy Bergemann, Medtronic
Chair(s): Tyson Rogers, NAMSA
1:05 PM	Digital Health Technology: Use in Clinical Investigations to Evaluate Clinical Benefit in Patients Ebony Dashiell-Aje, BioMarin Pharmaceutical Inc.
1:25 PM	Statistical Challenges in Incorporating Data from Mobile Technology into Clinical Trials Manisha Desai, Stanford University
1:45 PM	Normalization of Minute-Level Activity Counts from Chest- and Wrist-Worn Accelerometers: An Example of Actiheart, Actiwatch, and Actigraph Vadim Zipunnikov, Johns Hopkins University, Bloomberg School of Public Health; Jiawei Bai, Johns Hopkins Bloomberg School of Public Health
2:05 PM	Use of Accelerometer Data to Evaluate Physical Activity as a Surrogate Endpoint in Heart Failure Clinical Trials Presentation Tracy Bergemann, Medtronic
2:25 PM	Data-Driven Chronotype Discovery Using Functional Data Methods Jeff Goldsmith, Columbia University Mailman School of Public Health
2:45 PM	Floor Discussion

262 *	Tue, 8/4/2020, 1:00 PM - 2:50 PM	Virtual
The FDA Complex Innovative Trial Design Pilot Program: Learning from Case Examples and Simulations for the Public Good — Topic Contributed Papers
Biopharmaceutical Section, ENAR, Section on Bayesian Statistical Science
Organizer(s): Dionne L Price, Food and Drug Administration
Chair(s): Dionne L Price, Food and Drug Administration
1:05 PM	An Overview of Innovative Designs and Statistical Considerations: Lessons Learned Laura Lee Johnson, FDA
1:25 PM	A Bayesian Adaptive Trial in Duchenne Muscular Dystrophy Stephen Lake, WAVE Life Sciences; Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants; Jennifer Panagoulias, Wave Life Sciences; Michael A. Panzara, Wave Life Sciences
1:45 PM	The Design, Challenges, and Benefits of Evaluating Multiple Assets and Disease Types in a Master Protocol JonDavid Sparks, Eli Lilly and Company; Saptarshi Chatterjee, Eli Lilly and Co; Karen L Price, Eli Lilly and Company
2:05 PM	Floor Discussion

272 * !	Tue, 8/4/2020, 1:00 PM - 2:50 PM	Virtual
Statistical Innovations in Regulatory Science — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, Health Policy Statistics Section
Organizer(s): Alejandra Avalos Pacheco, Harvard Medical School
Chair(s): Andrea Arfe, Harvard Medical School
1:05 PM	The Impact of Early Trials in Drug Development in Oncology: Design and Interpretation Alexia Iasonos, Memorial Sloan-Kettering Cancer Center
1:25 PM	A Semi-Mechanistic Dose-Finding Design in Oncology Using Pharmacokinetic/Pharmacodynamic Modeling Yisheng Li, University of Texas-MD Anderson Cancer Center; Xiao Su, PlayStation; Peter Müller, University of Texas Austin; Kim-Anh Do, The University of Texas MD Anderson Cancer Center
1:45 PM	Inference in response-adaptive clinical trials when the enrolled population varies over time Massimiliano Russo, Harvard Medical School; Lorenzo Trippa, Harvard School of Public Health; Steffen Ventz, Harvard School of Public Health; Victoria Wang, Harvard School of Public Health
2:05 PM	Leveraging External Data in Bayesian Adaptive Designs Alejandra Avalos Pacheco, Harvard Medical School; Steffen Ventz, Harvard School of Public Health; Lorenzo Trippa, Harvard School of Public Health; Brian Alexander, Foundation medicine; Andrea Arfe, Harvard Medical School
2:25 PM	Discussant: Lorenzo Trippa, Harvard School of Public Health
2:45 PM	Floor Discussion

277 * !	Tue, 8/4/2020, 1:00 PM - 2:50 PM	Virtual
Estimand Framework and Its Impact on Drug Development in Oncology — Topic Contributed Panel
Biopharmaceutical Section, Lifetime Data Science Section, Biometrics Section
Organizer(s): Jonathan Siegel, Bayer Pharmaceuticals Inc.
Chair(s): Jonathan Siegel, Bayer Pharmaceuticals Inc.
1:05 PM	Impact of Estimand Framework on Oncology Drug Development
Panelists:	Steven Sun, Janssen Anja Schiel , Norwegian Medicines Agency Kunthel By, FDA Catherine Njue, Health Canada and ICH E9(R1) working group Richard J. Cook, University of Waterloo
2:45 PM	Floor Discussion

220192	Tue, 8/4/2020, 7:30 PM - 8:30 PM	Virtual
Biopharmaceutical Section Open Business Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Bruce Binkowitz, Shionogi, Inc.
This Biopharmaceutical Section will host our annual open business meeting through Zoom. Zoom is graciously provided by Abbvie, Inc. Meeting URL: https://abbvie.zoom.us/j/95972313003?pwd=UXh6TGM5MTI1VVFWQU1KTU9YZ3R1Zz09 Meeting ID: 959 7231 3003 Password: 444589

298 * !	Wed, 8/5/2020, 10:00 AM - 11:50 AM	Virtual
Confirmatory Adaptive Designs in Action: Recent Advances in Statistical Frameworks and Operational Models — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yihua Gu, Data and Statistical Sciences, AbbVie
Chair(s): Tianyu Zhan, AbbVie
10:05 AM	Accelerating Drug Development with Adaptive Clinical Trial Designs – What Have We Learned? Ivan Chan, AbbVie Inc
10:25 AM	A Fresh View of the Efficiency of Sample Size Adaptive Designs Lu Cui, UCB Biosciences
10:45 AM	Group-Sequential Design Strategies for Testing Co-Primary Endpoints in Clinical Trials Presentation Toshimitsu Hamasaki, George Washington University; Koko Asakura, National Cerebral and Cardiovasculer Center; Frank Bretz, Novartis Pharma AG
11:05 AM	An Overview of U.S. Regulatory Considerations for Confirmatory Adaptive Design Trials John Scott, FDA
11:25 AM	Adaptive Borrowing of Historical Data in Clinical Trials John Zhong, REGENXBIO; Peng Sun, Biogen; Charlie Cao, Biogen; Ming-Hui Chen, UNIVERSITY OF CONNECTICUT; Bo Lu, The Ohio State University; Yingying Liu, Biogen; Richard Foster, Biogen; Susie Sinks, Biogen; Fan Wu, Biogen; Giulia Gambino, Biogen
11:45 AM	Floor Discussion

304 * !	Wed, 8/5/2020, 10:00 AM - 11:50 AM	Virtual
Extrapolation as a Default Strategy in Pediatric Drug Development: Implications to Clinical Trial Designs and Statistical Analysis — Topic Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Margaret Gamalo, Eli Lilly & Co
Chair(s): Junjing Lin, Takeda
10:05 AM	Clinical Development Using Pediatric Extrapolation Presentation Robert "Skip" Nelson, J7J
10:25 AM	Real World Evidence Utilization in Pediatric Clinical Development Reflected by US Product Labeling: Statistical Review Yodit Seifu; Freda Cooner, Amgen Inc.; Margaret Gamalo-Siebers, Eli Lilly & Co; Junjing Lin, Takeda; Junshan Qiu, FDA/CDER; Shiling Ruan, Novartis; Ros Walley, UCB Celltech ; Sophie Barthel, PRA Health Sciences
10:45 AM	Hierarchical Models for Clinical Trials Involving Multiple Pediatric Cohorts Margaret Gamalo-Siebers, Eli Lilly & Co
11:05 AM	A Quantitative Method to Evaluate Exposure-Response Similarity Between Pediatrics and Adults to Support Efficacy Extrapolation Junshan Qiu, FDA/CDER; Margaret Gamalo-Siebers, Eli Lilly & Co; Freda Cooner, Amgen Inc.; Junjing Lin, Takeda; Yodit Seifu; Yaning Wang, FDA/CDER/DPM
11:25 AM	Bayesian Analysis in Pediatric Settings Presentation Mark Rothmann, Division of Biometrics II, Office of Biostatistics, OTS, CDER, FDA
11:45 AM	Floor Discussion

313 * !	Wed, 8/5/2020, 10:00 AM - 11:50 AM	Virtual
Data Analytics and Visualization: Advances and Challenges — Topic Contributed Papers
Section on Statistical Graphics, Biopharmaceutical Section, Statistics and Pharmacometrics Interest Group
Organizer(s): Priyam Mitra, Bristol-Myers Squibb
Chair(s): Priyam Mitra, Bristol-Myers Squibb
10:05 AM	Improved Signal Detection and Evaluation Using New Open-Source Interactive Safety Graphics Presentation James Buchanan, Covilance LLC
10:25 AM	Graphical Exploration of the Association Between Biomarkers and Efficacy Parameters in Oncology Trials Presentation Arteid Memaj, Bristol-Myers Squibb; David Paulucci, Bristol-Myers Squibb; David Gold, Bristol-Myers Squibb
10:45 AM	Visualization of Population Pharmacokinetic Model Evaluation and Applications Amit Roy, Bristol-Myers Squibb
11:05 AM	Tumor-Agnostic Modeling in a Phase I Oncology Trial Courtney Henry, GlaxoSmithKline (GSK); Ruby Sung, GlaxoSmithKline (GSK); Helen Zhou, GlaxoSmithKline (GSK)
11:25 AM	Discussant: Zhiheng Xu, US Food and Drug Administration
11:45 AM	Floor Discussion

314 * !	Wed, 8/5/2020, 10:00 AM - 11:50 PM	Virtual
Statistical Advancements in Neurodegeneration Trial Designs and Analyses — Topic Contributed Papers
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Biometrics Section, Committee on Applied Statisticians
Organizer(s): Fanni Natanegara, Eli Lilly and Company
Chair(s): Fanni Natanegara, Eli Lilly and Company
10:05 AM	Impact of Model Misspecification on Alzheimer Trial Operating Characteristics Saptarshi Chatterjee, Eli Lilly and Co; Shrabanti Chowdhury, Icahn school of Medicine at Mount Sinai; Fanni Natanegara, Eli Lilly and Company
10:25 AM	Multivariate Endpoint, Disease Progress Model and Other New Features of the DIAN-TU Platform Trial Guoqiao Wang, Washington University in St Louis; Scott Berry, Berry Consultants; Chengjie Xiong, Washington University in St Louis; Jason Hassenstab, Washington University in St Louis; Melanie Quintana, Berry Consultants; Eric McDade, Washington University in St Louis; Paul Delmar, F. Hoffmann-La Roche Ltd; Matteo Vestrucci, University of Texas at Austin; Randall Bateman, Washington University in St Louis; Andrew Aschenbrenner, Washington University in St Louis
10:45 AM	TRCPAD: Accelerating Participant Recruitment in Alzheimer’s Disease Clinical Trials Using Machine Learning Techniques Oliver Langford, University of Southern California; Michael C Donohue, University of Southern California; Gustavo Jimenez-Maggiora, University of Southern California; Reisa Sperling, Harvard Medical School; Jeff Cummings, Cleveland Clinic Lou Ruvo Center for Brain Health; Paul S Aisen, University of Southern California; Rema C Raman, University of Southern California
11:05 AM	Construction of Composite End Points to Better Align with Disease Progression and Improve Power Samuel P Dickson, Pentara; Suzanne B Hendrix, Pentara; Newman Knowlton, Pentara; Noel Ellison, Pentara
11:25 AM	Discussant: Richard Entsuah, Merck
11:45 AM	Floor Discussion

316 * !	Wed, 8/5/2020, 10:00 AM - 11:50 AM	Virtual
Statistical Leadership for the Future of Healthcare Industry — Topic Contributed Panel
Caucus for Women in Statistics, Biopharmaceutical Section, Committee on Career Development, Biometrics Section
Organizer(s): Rong Liu, BMS; Rui Sammi Tang, Servier Pharmaceuticals
Chair(s): Rong Liu, BMS
10:05 AM	Statistical Leadership for the Future of Healthcare Industry
Panelists:	Zoran Antonijevic Ouhong Wang, Vertex Richard Vonk, Bayer Oncology Qi Jiang, Seattle Genetics Liang Fang, Myokardia Rui Sammi Tang, Servier Pharmaceuticals
11:40 AM	Floor Discussion

320	Wed, 8/5/2020, 10:00 AM - 2:00 PM	Virtual
Methods Tailored to Unique Data and Trial Features — Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Biometrics Section
Chair(s): James Bost, Children's National Hospital
	Efficacy Lead-In Phase 2 Single-Arm Trial Designs Seongho Kim, Wayne State University; Weng-Kee Wong, UCLA; Nithya Ramnath, Department of Medicine, University of Michigan; Manohar Ratnam, Department of Oncology, Wayne State University
	Order Constrained ROC Regression with Application to Facial Recognition Presentation Xiaochen Zhu, George Mason University; Martin Slawski, George Mason Univ; Larry Tang, University of Central Florida; Jonathon Phillips, National Institute of Standards and Technology
	The Impact of Misclassification on Covariate-Adaptive Randomized Clinical Trials Tong Wang, Texas A&M University; Wei Ma, Institute of Statistics and Big Data, Renmin University of China
	Median Regression Models for Clustered, Interval-Censored Survival Data: An Application to Prostate Surgery Study Piyali Basak, Florida State University; Stuart Lipsitz, Brigham and Women's Hospital; Debajyoti Sinha, Florida State University
	Inference with Joint Models Under Mis-specified Random Effects Distributions Abdus Sattar; Sanjoy K. Sinha, Carleton University
	Gumbel Regression Models for Longitudinal Continuous Biomarker Outcome Subject to Measurement Error Noorie Hyun, Medical College of Wisconsin; David Couper, University of North Carolina at Chapel Hill; Donglin Zeng, University of North Carolina at Chapel Hill
	A Regression Approach to Estimating the Discrete Diagnostic Likelihood Ratio for Nontraditional Biomarkers Hanna Lindner, University of Pennsylvania; Warren Bilker, University of Pennsylvania; Phyllis Gimotty, University of Pennsylvania

341	Wed, 8/5/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Adaptive Designs: Sample Size, Randomization and Related Topics — Contributed Papers
Biopharmaceutical Section
Chair(s): Christine Gause, Merck & Co, Inc
	Sample Size Recalculation Methods for Three-Arm Non-Inferiority Trials Lanyu Lei, Pfizer Inc.
	Deep Neural Networks Guided Hypothesis Testing Framework with Application to Sample Size Reassessment Adaptive Clinical Trials Tianyu Zhan, AbbVie; Jian Kang, University of Michigan
	Bayesian Adaptive Randomization for A Phase 2 Dose-Ranging Clinical Trial Morgan de Ferrante, Regeneron Pharmaceuticals, Inc. ; Ming-Dauh Wang, Regeneron Pharmaceuticals, Inc.
	New Covariate-Adaptive Randomization Procedure: Balancing Continuous and Discrete Covariates Simultaneously Yifan Zhou; feifang Hu, George Washington University
	Statistical Considerations of Data Transformation in Non-Inferiority Testing Presentation Ran Bi, FDA/HHS; Yi Tsong, FDA/HHS
	Robust Blocked Response-Adaptive Randomization Designs Thevaa Chandereng, University of Wisconsin; Rick Chappell, University of Wisconsin
	Integrated Multiple Adaptive Clinical Trial Design Involving Sample Size Re-Estimation and Response-Adaptive Randomization for Continuous and Binary Outcomes Christine M Orndahl, Virginia Commonwealth University Dept of Biostatistics
	Adaptive Bayesian Clinical Trial Design for Improving Robustness to Sample Size Calculation Assumptions: A Simulation Study Shirley Liao, Biogen; Fabio Pellegrini, Biogen International GmbH; Bernd Kieseier, Biogen; Christophe Hotermans, Biogen; Jason Mendoza, Biogen; Christine Lebrun, Centre Hospitalier Universitaire de Nice; Daniel Pelletier, University of Southern California; Aksel Siva, e Department of Neurology of Istanbul University, Cerrahpa?a School of Medicine; Maria Pia Sormani, Università degli Studi di Genova; Orhun Kantarci, Mayo Clinic ; Darin Okuda, UT Southwestern Medical Center; Carl de Moor, Biogen Inc

342 *	Wed, 8/5/2020, 10:00 AM - 2:00 PM	Virtual
Clinical Trial Design: Statistical Methods and Applications in Oncology — Contributed Papers
Biopharmaceutical Section
Chair(s): Davis Gates, Merck
	Application of Modulated Markov Models and Modulated Renewal Process for Analyzing Clinical Trial Data with Non-Proportional Hazard Rianka Bhattacharya, Abbvie Inc.
	A Generalized Framework of Optimal Two-Stage Designs for Exploratory Basket Trials Presentation Fang Liu, Merck & Co., Inc; Xiaoqiang Wu, Florida State University; Iris Wu, Merck; Heng Zhou, Merck; Cong Chen, Merck and Company, Inc.
	A Dose Escalation Design Considering Different Toxicity Onset Time Frames Using a Bayesian Piecewise Proportional Hazard Model Hongjie Zhu, Beigene
	The Optimal Randomization Ratio in Time-to-Event Trials Is Not 1:1 Godwin Yung, Genentech/Roche; Yi Liu, Nektar Therapeutics
	Two-Stage Design for Single-Arm Phase II Cancer Clinical Trials with Two Alternative Primary Endpoints Hui Gu, Boehringer Ingelheim; Yong Lin, Rutgers School of Public Health; Weichung Joe Shih, Rutgers School of Public Health; Yaqun Wang, Rutgers, School of Public Health, Dept. of Biostatistics; Kejian Liu, Sanofi

343	Wed, 8/5/2020, 10:00 AM - 2:00 PM	Virtual
Longitudinal Analysis, Clinical Trial Design, and Other Topics in Biopharmaceutical Statistics — Contributed Papers
Biopharmaceutical Section
Chair(s): Yanping Liu, Merck
	A Flexible Framework to Estimate the Impact of Preplanned Dose Titrations on Delayed Response Yu Du, Eli Lilly and Company; Yongming Qu, Eli Lilly and Company
	Predicted Response Rate Differences of Antidepressants at End Point Among Patients Not Meeting Study Early Response Marc Sobel, temple university; Ibrahim Turkoz, Janssen Research and Development, LLC; Xiwu Lin, Janssen Research and Development, LLC; Ella Daly, Janssen Scientific Affairs LLC
	Exploring Heterogeneity of Treatment Response: Longitudinal Aspect Lev Sverdlov, Redmond Analytics, LLC
	Modeling Considerations in a Dose-Finding Study for a Rare Disease Treatment Younan Chen, CSL Behring; Sergei Leonov, CSL Behring; Michael Fries, CSL Behring
	A Statistical Evaluation of Agreement Between Mobile Health Technology and Traditional Tools Qinlei Huang, Merck & Co., Inc; Radha Railkar, Merck & Co., Inc.
	Estimating Knots in Bilinear Spline Growth Mixture Models with Time-Invariant Covariates in the Framework of Individual Measurement Occasions Jin Liu; Robert A Perera, Virginia Commonwealth University Dept of Biostatistics; Le Kang, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University

370	Wed, 8/5/2020, 12:00 PM - 1:00 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
WL01:	Treatment Compliance in Real World Setting Jagadish Gogate, Johnson & Johnson-Janssen R&D; CV Damaraju, Johnson & Johnson - Janssen R&D
WL02:	How We Make the Most Out of the Implementation of Bayesian Methodology on the Early-Phase Oncology? Shaoyi Li, BMS

394 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Challenges and New Directions in Precision Medicine for Large-Scale and Complex Data — Invited Papers
Biometrics Section, Section on Statistical Learning and Data Science, International Chinese Statistical Association, Biopharmaceutical Section
Organizer(s): Yichuan Zhao, Georgia State University
Chair(s): Min Qian, Columbia University
1:05 PM	Building Cancer Prognostic Models Generated via Automatic Data-Driven Sequential Processes Hyokyoung (Grace) Hong, Michigan State University
1:30 PM	On Restricted Optimal Treatment Regime Estimation for Competing Risks Data Jie Zhou, University of South Carolina; Jiajia Zhang, University of South Carolina; Wenbin Lu , North Carolina State University; Xiaoming Li, University of South Carolina
1:55 PM	Depth Importance in Precision Medicine (DIPM): A Tree- and Forest-Based Method for Right-Censored Survival Outcomes Victoria Chen, Yale University; Heping Zhang, Yale University
2:20 PM	Discussant: Yichuan Zhao, Georgia State University
2:40 PM	Floor Discussion

396 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Drug Approval and Labeling Based on Bayesian Approach — Invited Panel
Biopharmaceutical Section, Section on Bayesian Statistical Science, ENAR
Organizer(s): Lei Nie , FDA
Chair(s): Frank Harrell, Vanderbilt University School of Medicine
1:05 PM	Drug Approval and Labeling Based on the Bayesian Approach
Panelists:	Deborah Ashby, the School of Public Health, Imperial College Londo Frank Bretz, Novartis Pharma AG Maria Ciarleglio, Yale School of Public Health Brian Hobbs, University of Texas at Austin Ying Yuan, The University of Texas MD Anderson Cancer Center Jeni Zhou, Amgen
2:40 PM	Floor Discussion

398 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Beyond Traditional Approaches: Evolving Artificial Intelligence and Machine Learning to Advance Clinical Research and Drug Development — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, Section on Statistical Learning and Data Science, Text Analysis Interest Group
Organizer(s): Demissie Alemayehu, Pfizer Inc.
Chair(s): Birol Emir, Pfizer Inc.
1:05 PM	Adaptive Online Machine Learning for Real-Time Individualized Forecasting in Clinician-AI Team Rachael Phillips, University of California, Berkeley; Mark Van der Laan, University of California, Berkeley
1:25 PM	Recent Advances in the Application of Natural Language Processing to Unstructured and Semi-Structured Data in the Pharmaceutical Industry Presentation Peter Henstock, Pfizer Inc
1:45 PM	Learning Decision Rules with Observational Data Xinkun Nie, Stanford University; Stefan Wager, Stanford University
2:05 PM	“Data Nuggets” Tools for Analyzing Big Data Javier Cabrera, Rutgers University
2:25 AM	Floor Discussion

399 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Recent Developments in Precision Medicine — Topic Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Xinyi Li, SAMSI / University of North Carolina at Chapel Hill
Chair(s): David Banks, Duke University / SAMSI
1:05 PM	Individualized Treatment Regimes Incorporating Imaging Features Xinyi Li, SAMSI / University of North Carolina at Chapel Hill; Michael R. Kosorok, University of North Carolina at Chapel Hill
1:25 PM	Precision Medicine Using a Joint Longitudinal-Survival Model Elizabeth Slate, Florida State University; Yuxi Zhao, Florida State University
1:45 PM	Personalized Monitoring Is Good for Patients and Clinical Science Glen Wright Colopy, Cenduit LLC
2:05 PM	Bayesian Pharmacokinetic Models for Dose Personalization Daniel Lizotte, University of Western Ontario; Demetri Pananos, University of Western Ontario
2:25 PM	Discussant: Marie Davidian, North Carolina State University
2:45 PM	Floor Discussion

409	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Complex Innovative Approaches in Emerging Neurodegenerative / Neuroimaging Drug Developments — Topic Contributed Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Section on Statistics in Imaging
Organizer(s): Tristan Massie, FDA
Chair(s): Sue-Jane Wang, FDA
1:05 PM	A ROC Surface Methodology in Diagnosing Early Stage Neurodegenerative Diseases for Early Interventions Chengjie Xiong, Washington University in St Louis; Jingqin Luo, Washington University in St. Louis
1:25 PM	Alternatives to MMRM for Preclinical Alzheimer’s Clinical Trials Presentation Michael C Donohue, University of Southern California; Gopalan Sethuraman, University of Southern California; Oliver Langford, University of Southern California; Wenyi Lin, University of California, San Diego; Philip S Insel, Lund University; Wesley Thompson, University of California, San Diego; Rema C Raman, University of Southern California; Reisa Sperling, Harvard Medical School; Paul S Aisen, University of Southern California
1:45 PM	Comparative Performance of Some Testing Approaches in Two-Arm Studies with Count Data Potentially Highly Skewed Sue-Jane Wang, FDA; Zhipeng Huang, U.S. Food and Drug Administration (Intern); Hai Zhu, The University of Texas Health Science Center at Houston
2:05 PM	Statistical Issues and Challenges Seen in Drug Development for Neurodegenerative Diseases Tristan Massie, FDA
2:25 PM	Floor Discussion

410 *	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Benefit-Risk Methods for Medical Devices and Diagnostics — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Biometrics Section
Organizer(s): Tyson Rogers, NAMSA
Chair(s): Richard Kotz, NAMSA
1:05 PM	Using Outcomes to Analyze Patients Rather Than Patients to Analyze Outcomes Scott Evans
1:25 PM	Using Patient-Centered Utility-Weighted Outcomes in a Bayesian Adaptive Enrichment Trial Kert Viele, Berry Consultants
1:45 PM	Classification Accuracy Goals for Diagnostic Tests Based on Risk Stratification Presentation Qin Li, Food and Drug Administration; Gene Pennello, Food and Drug Administration; Dandan Xu, Food and Drug Administration
2:05 PM	Discussant: Telba Irony, CBER – FDA
2:25 PM	Discussant: Gregory Campbell, GCStat Consulting
2:45 PM	Floor Discussion

412 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Incorporation of Real-World Evidence in Clinical Trial Designs and Associated Statistical Methodologies — Topic Contributed Papers
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Section on Statistical Learning and Data Science, Section on Statistical Computing
Organizer(s): Jeffrey Joseph, Covance; Swarna Reddy, Covance
Chair(s): Swarna Reddy, Covance
1:05 PM	Using Real World Data to Evaluate the Generalizability of Evidence from Randomized Clinical Trials Wei Shen, Eli Lilly and Company; Douglas Faries, Lilly Research Laboratories; Mark Belger, Eli Lilly and Company; Chen-Yen Lin, Eli Lilly and Company
1:25 PM	Real World Evidence Use at CBER: Emerging Issues from Submissions Jennifer Kirk, FDA, Center for Biologics Evaluation and Research (CBER)
1:45 PM	Data Standardization to Facilitate Comparison of Real World Data and Clinical Trial Data Aaron Galaznik, Acorn AI, a Medidata Company
2:05 PM	Analytic Considerations for Constructing Real-World Control Arms Katherine Tan, Flatiron Health; Brian Segal, Flatiron Health; Jonathan Bryan, Flatiron Health; Melissa Curtis, Flatiron Health; Nathan Nussbaum, Flatiron Health; Rebecca Miksad, Flatiron Health; Meghna Samant, Flatiron Health; Somnath Sarkar, Flatiron, Inc.; Aracelis Torres, Flatiron Health
2:25 PM	Leverage Real World Evidence in Drug Development and Regulatory Decision Making Rongmei Zhang, FDA, Center for Drug Evaluation and Research (CDER).
2:45 PM	Floor Discussion

416 * !	Wed, 8/5/2020, 1:00 PM - 2:50 PM	Virtual
Collaboration in Data Science: How Biostatisticians and Epidemiologists Contribute to the Creation of Real World Evidence — Topic Contributed Panel
Section on Statistics in Epidemiology, Biopharmaceutical Section
Organizer(s): Rachael DiSantostefano, Janssen R&D, LLC
Chair(s): Jenna Krall, George Mason University
1:05 PM	Careers in Data Science: How Biostatisticians and Epidemiologists Collaborate in the Creation of Real-World Evidence
Panelists:	Rachael DiSantostefano, Janssen R&D, LLC Charles Hall, Albert Einstein College of Medicine Rebecca A Hubbard, University of Pennsylvania Jessica Chubak, Kaiser Permanente Washington Health Research Institute Pallavi Mishra-Kalyani, US FDA Therri Usher, FDA
2:40 PM	Floor Discussion

425 * !	Thu, 8/6/2020, 10:00 AM - 11:50 AM	Virtual
Novel Methods for Analyzing Genetic and Genomic Data on Complex Diseases — Invited Papers
Section on Statistics in Genomics and Genetics, Biopharmaceutical Section, Section on Statistics in Epidemiology
Organizer(s): Jichun Xie, Duke University
Chair(s): Jichun Xie, Duke University
10:05 AM	CCmed for Identifying Robust Trans-EQTLs and Assessing Their Effects on Human Traits Fan Yang, University of Colorado Anschutz Medical Campus; Kevin Gleason, University of Chicago; Jiebiao Wang, University of Pittsburgh; Jubao Duan, University of Chicago; Xin He, University of Chicago; Brandon Pierce, University of Chicago; Lin Chen, University of Chicago
10:35 AM	Statistical Analysis of Spatial Expression Pattern for Spatially Resolved Transcriptomic Studies Xiang Zhou, University of Michigan; Jiaqiang Zhu, University of Michigan ; Shiquan Sun, University of Michigan
11:05 AM	Floor Discussion

439 * !	Thu, 8/6/2020, 10:00 AM - 11:50 AM	Virtual
Role of External Evidence in Drug Development: Current Practices and Future Perspectives — Topic Contributed Papers
Biopharmaceutical Section, Section on Bayesian Statistical Science, Health Policy Statistics Section
Organizer(s): Satrajit Roychoudhury, Pfizer Inc.
Chair(s): Satrajit Roychoudhury, Pfizer Inc.
10:05 AM	Bayesian Approaches for Using Real-World Evidence for Regulatory Decision Making Gary L Rosner, Johns Hopkins University; Chenguang Wang, Johns Hopkins University
10:25 AM	Statistical Innovation in Rare Disease Clinical Development Kannan Natarajan, Pfizer Pharmaceuticals Inc.
10:45 AM	Dynamic Borrowing of Historical Data Using the Power Prior: Overview and New Developments Joost van Rosmalen, Erasmus MC
11:05 AM	Use of External Evidence for Decision Making in Early Phase Trials Maxine Bennett, AstraZeneca
11:25 AM	Floor Discussion

440 * !	Thu, 8/6/2020, 10:00 AM - 11:50 AM	Virtual
Let’s Make Everyone and Everything Count! Benefit-Risk Assessment Challenges, Lessons and Impacts in the Age of Big Data from Clinical Trials to Real-World Evidence — Topic Contributed Papers
Biopharmaceutical Section, ENAR, Royal Statistical Society
Organizer(s): Shahrul Mt-Isa, Merck
Chair(s): Shahrul Mt-Isa, Merck
10:05 AM	Individualized Treatment Choices and Benefit-Risk Prediction in Cardiovascular Clinical Trials John Gregson; Ruth Owen, LSHTM; Stuart Pocock, LSHTM; Shahrul Mt-Isa, Merck; Richard Baumgartner, Merck
10:25 AM	Do Birds of a Feather Flock Together? a Question of Credible Subgroup Identification and Inference on Benefitting Populations in Clinical Trials Duy Ngo, Western Michigan University; Patrick Schnell, The Ohio State University College of Public Health; Richard Baumgartner, Merck; Shahrul Mt-Isa, Merck; Jie Chen, Merck & Co., Inc.; Dai Feng, AbbVie
10:45 AM	Bayesian Bivariate Subgroup Analysis for Risk–benefit Evaluation Nicholas C. Henderson, University of Michigan-Ann Arbor
11:05 AM	Opportunities and Challenges of Real-World Data (RWD) in Benefit-Risk Assessment (BRA) Emilie Scherrer, Merck & Co Inc
11:25 AM	Everyone Counts - Regulating the Evidence from Clinical Trial Data to Real-World Evidence for the Public Good: The Past, Present, and Future Lisa LaVange, UNC-CH
11:45 AM	Floor Discussion

446 * !	Thu, 8/6/2020, 10:00 AM - 11:50 AM	Virtual
High-Dimensional Biomarkers in Drug Discovery and Early Drug Development Studies: An Integrated Data Analysis Approach — Topic Contributed Papers
Biopharmaceutical Section, Section on Statistics in Genomics and Genetics, Section on Statistical Consulting
Organizer(s): Rudradev Sengupta, Janssen Pharmaceutical Companies of Johnson and Johnson, Beerse, Belgium; Ziv Shkedy, Hasselt University
Chair(s): Paulo Bargo, Janssen Pharmaceutical Companies of Johnson and Johnson
10:05 AM	High-Dimensional Biomarkers in Drug Discovery Studies: An Introduction Adetayo Kasim, Durham University, UK
10:25 AM	From a Single to Multiple Biomarkers: Partials Surrogacy Approach in Drug Discovery Ziv Shkedy, Hasselt University
10:45 AM	High-Dimensional Surrogacy and Biomarkers: Computational Aspects of an Upscaled Integrated Data Analysis Rudradev Sengupta, Janssen Pharmaceutical Companies of Johnson and Johnson, Beerse, Belgium
11:05 AM	Enriched Approaches for Deriving Biomarkers from Multiple Platform Data Dhammika Amaratunga, -
11:25 AM	Discussant: Shahina Rahman, Texas A & M University
2:45 PM	Floor Discussion

487	Thu, 8/6/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Clinical Trials - II — Contributed Papers
Biopharmaceutical Section
Chair(s): Melvin Munsaka, AbbVie
	Oncology Dose Escalation Using Bayesian Logistic Regression Model and Pharmacokinetic Data Arnab K Maity, Pfizer; Satrajit Roychoudhury, Pfizer Inc.; Ray Li, Pfizer; Lada A. Markovtsova, Pfizer; Roberto Bugarini, Pfizer Inc
	Bayesian Frameworks And Their Relationships – An Application In Pediatric Drug Development Amarjot Kaur, Merck & Co., Inc; Qing Li, Merck Research Labs
	Bayesian Hierarchical Model for Safety Signal Detection in Multiple Clinical Trials Presentation Yafei Zhang, Merck; Li-An Lin, Merck; William W Wang, Merck & Co, Inc; Sammy Yuan, Kite Pharma; Barry Eagel, Clinical Research and Pharmacovigilance Consultant; Hal Li, Merck & Co., Inc.
	Adjusted Survival Comparisons at Fixed Points in Time Kyle Rudser, University of Minnesota; John Connett, University of Minnesota

488 *	Thu, 8/6/2020, 10:00 AM - 2:00 PM	Virtual
Estimands and Imputation Methods — Contributed Papers
Biopharmaceutical Section
Chair(s): Nabanita Mukherjee, AbbVie
	Monotonicity Assumption in the Estimation of Treatment Effect for a Principal Stratum Yongming Qu, Eli Lilly and Company; Ilya Lipkovich, Eli LIlly and Company; Steve Ruberg, Analytix Thinking, LLC
	Statistical Analysis Approach for Principle Stratum Estimand David Li, Eisai
	Estimating Causal Effects for Adherers in a Randomized Trial Using Multiple Imputation Junxiang Luo, Sanofi; Yongming Qu, Eli Lilly and Company; Steve Ruberg, Analytix Thinking, LLC
	Missing Data Analysis for Recurrent Events Madhurima Majumder, Bayer US LLC; Yuan Hong, University of South Carolina-Columbia; Arno Fritsch, Bayer AG
	Tipping Point Analysis for Time-to-Event Endpoints in Oncology Clinical Trials Arunava Chakravartty, Novartis Pharmaceuticals
	Multiple Imputation for the Estimation of Treatment and Biomarker Interaction Effect in Oncology Phase III Clinical Trials Feng Liu, Astrazeneca; Binbing Yu, Astrazeneca; Helen Mann, AstraZeneca

489 *	Thu, 8/6/2020, 10:00 AM - 2:00 PM	Virtual
Multiplicity: Methods and Applications — Contributed Papers
Biopharmaceutical Section
Chair(s): Elena Rantou, Food and Drug Administration
	Venous Thromboembolism (VTE) Risk Scoring in Ambulatory Surgical Patients In-Lu Liu, Kaiser Permanente; Yi-Lin Wu, Kaiser Permanente; Stacy J Park, Kaiser Permanente; Michael K. Gould, Kaiser Permanente
	A Bayesian Approach to Optimizing Graphical Testing Schemes in Clinical Trials Nathan Morris, Eli Lilly and Company; Huayu Liu, Eli Lilly and Company; Xingyuan Li, Eli Lilly and Company; Vipin Arora, Eli Lilly and Company
	A Comparison of the Prediction Test with Other Global Hypothesis Tests for Small Samples Robert Montgomery; Jonathan Mahnken, Department of Biostatistics and Data Science, The University of Kansas Medical Center
	Rectangular Reference Regions for Multivariate Measurements in Laboratory Medicine Presentation Michael Daniel Lucagbo, University of Maryland, Baltimore County; Thomas Mathew, University of Maryland, Baltimore County
	Assessing the Incidence and Severity of Drug Adverse Events: A Bayesian Hierarchical Cumulative Logit Model Jiawei Duan, Novartis Pharmaceuticals Corporation; Byron J Gajewski, KUMC; Jo A. Wick, University of Kansas Medical Center
	Quick Multiple Test Procedures Jiangtao Gou, Villanova University

490	Thu, 8/6/2020, 10:00 AM - 2:00 PM	Virtual
Topics in Personalized/Precision Medicine - I — Contributed Papers
Biopharmaceutical Section
Chair(s): Zhiguo Li, Duke University
	Use of Bayesian Hierarchical Models in Adaptive Basket Trial Designs Chian Chen, National Health Research Institutes; Chin-Fu Hsiao, National Health Research Institutes
	Models for Precision Medicine on Vital Capacity Using Longitudinal Information After Start of Pirfenidone Treatment for Patients with Idiopathic Pulmonary Fibrosis Hiroki Sakaguchi, Shionogi & Co., Ltd.; Keiko Kawaguchi, Shionogi & Co., Ltd.; Yukio Tada, Shionogi & Co., Ltd.; Hideaki Watanabe, Shionogi & Co., Ltd.; Takahiro Hasegawa, Shionogi & Co., Ltd.
	Machine Learning of Survival Model with Treatment Switch Xiaolong Luo, Bristol Meyers Squibb; Mike Branson, Bristol Myers Squibb
	Practical Consideration of Causal Inference for Time-to-Event Endpoints Hongwei Wang, AbbVie; Yixin Fang, AbbVie Inc. ; Weili He, AbbVie
	Estimating Individual Benefits of Medical or Behavioral Treatments in Severely Ill Patients Francisco Diaz, University of Kansas Medical Center

509	Thu, 8/6/2020, 12:00 PM - 1:00 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
RL01:	Making Drug Development More Quantitative: Applying Bayesian Decision-Making to Stage-Gate the Risk of Development Gengqian Cai, GlaxoSmithKline; Timothy Montague, GlaxoSmithKline; Inna Perevozskaya, GlaxoSmithKline
RL02:	Improving Quantitative Understanding Across Diverse Functions in Research and Development Richard Davies, GSK

525 * !	Thu, 8/6/2020, 1:00 PM - 2:50 PM	Virtual
Translating Real-World Data into Real-World Evidence for Regulatory Decisions and Medical Practice: Opportunities and Challenges — Invited Papers
Biopharmaceutical Section, Biometrics Section, Health Policy Statistics Section
Organizer(s): Weili He, AbbVie
Chair(s): Hongwei Wang, AbbVie
1:05 PM	The Biostatistical Landscape of Regulations, Data Sources, Study Variables, and Estimands for Real-World Evidence Mark Steven Levenson, FDA/CDER
1:30 PM	The Biostatistical Landscape of RWE Study Design and Analysis Weili He, AbbVie
1:55 PM	The Biostatistical Landscape of Causal Inference Frameworks of Clinical Studies using RWD/RWE Presentation Martin Ho, FDA-CBER
2:20 PM	Discussant: Frank Rockhold, Duke
2:45 PM	Floor Discussion

541 *	Thu, 8/6/2020, 1:00 PM - 2:50 PM	Virtual
Informative Prior Applications in Nonclinical CMC Statistics — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Paul Faya, Eli Lilly and Company
Chair(s): John J. Peterson, GSK
1:05 PM	Informative Priors for Justification of Specifications (JoS) Presentation Dwaine Banton
1:25 PM	Bayesian Concepts in Process Validation: Designing a Process Performance Qualification (PPQ) Timothy Mutsvari, Pharmalex
1:45 PM	Platform Priors for Early-Phase CMC Development Studies Paul Faya, Eli Lilly and Company
2:05 PM	A Bayesian Statistical Approach to Continuous Qualification of a Bioassay Presentation Steven Novick, AstraZeneca
2:25 PM	Discussant: Meiyu Shen, FDA
2:45 PM	Floor Discussion

550 * !	Thu, 8/6/2020, 1:00 PM - 2:50 PM	Virtual
Looking for a Nail to Hammer? Come Find Data Sets from the Largest Clinical Trials Groups — Topic Contributed Panel
Health Policy Statistics Section, Biopharmaceutical Section, Statistics Without Borders
Organizer(s): Yunda Huang, Fred Hutchinson Cancer Research Center
Chair(s): Chris Barker, Statistical Planning and Analysis Services, Inc.
1:05 PM	Looking for a Nail to Hammer? Come Find Data Sets from the Largest Clinical Trials Groups Presentation
Panelists:	Yunda Huang, Fred Hutchinson Cancer Research Center Nick Williams, National Library of Medicine Michael LeBlanc, Fred Hutchinson Cancer Research Center Garnet Anderson , Fred Hutchinson Cancer Research Center
2:40 PM	Floor Discussion

553 * !	Thu, 8/6/2020, 3:00 PM - 4:50 PM	Virtual
Improving Patient Care Through Personalized/Stratified Medicine: Modern Data Science and Perspectives from Pharmaceutical Industry Leads and Regulatory — Invited Papers
Biopharmaceutical Section, Section on Statistical Learning and Data Science, Section on Statistics and Data Science Education
Organizer(s): Wen Li, Merck
Chair(s): Ilya Lipkovich, Eli LIlly and Company
3:05 PM	Machine Learning, AI and Personalized Intervention Haoda Fu, Eli Lilly and Company
3:30 PM	Pruned Targeted-Learning for Personalized Medicine Yixin Fang, AbbVie Inc.
3:55 PM	PRISM: Patient Response Identifiers for Stratified Medicine Thomas Jemielita, Merck & Co., Inc; Devan Mehrotra, Merck
4:20 PM	Discussant: Maria Matilde S. Kam, OTS/CDER, FDA
4:45 PM	Floor Discussion

575 * !	Thu, 8/6/2020, 3:00 PM - 4:50 PM	Virtual
Trial Design with Subpopulation Heterogeneity: What Is the Role of Real-World Evidence? — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, Section on Bayesian Statistical Science
Organizer(s): Brian Hobbs, University of Texas at Austin
Chair(s): Emily Zabor, Cleveland Clinic
3:05 PM	Promise and Challenge of RWE for Drug Development Lei Nie , FDA; Ying Yuan, The University of Texas MD Anderson Cancer Center
3:25 PM	Evaluating Off-Label Use of Targeted Cancer Treatments: Generating RWE for Precision Medicine Using CancerLinQ Discovery (CLQD) Data Presentation Elizabeth Garrett-Mayer, American Society of Clinical Oncology; Melinda Kaltenbaugh, American Society of Clinical Oncology
3:45 PM	Dynamic Borrowing in the Presence of Treatment Effect Heterogeneity Presentation Joseph Koopmeiners, University of Minnesota; Ales Kotalik, University of Minnesota; David Vock, University of Minnesota
4:05 PM	A Bayesian Adaptive Design for Concurrent Trials Involving Biologically-Related Diseases Xun Jiang, Amgen
4:25 PM	Basket Trial Design: Challenges and Potential Solutions Presentation Alexander Kaizer, University of Colorado; Joseph Koopmeiners, University of Minnesota; Nan Chen, University of Texas M.D. Anderson Cancer Center; Brian Hobbs, University of Texas at Austin
4:45 PM	Floor Discussion

577 * !	Thu, 8/6/2020, 3:00 PM - 4:50 PM	Virtual
Estimands: Some Perspectives from an FDA Working Group — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Susan Duke, FDA
Chair(s): Susan Duke, FDA
3:05 PM	Estimands for Use in Pulmonary-Allergy US FDA Regulatory Submissions Dong-Hyun Ahn, FDA; Yongman Kim, FDA; Susan Duke, FDA
3:25 PM	Patient-Reported Outcome Time-to-Event Estimands in Lung Cancer Trials: What Is the Question? Presentation Mallorie Fiero, U.S. Food and Drug Administration; Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania; Jonathon Vallejo, FDA; Jiaxi Zhou, FDA; Ting-Yu Chen, FDA; Bellinda King-Kallimanis, FDA; Paul Kluetz, FDA; Rajeshwari Sridhara, FDA
3:45 PM	Safety Estimands: A Regulatory Perspective Cesar Torres, FDA; Gregory Levin, FDA; Mat Soukup, FDA; Sai Dharmarajan, FDA; Tae Hyun Jung, FDA; Maria Matilde S. Kam, OTS/CDER, FDA; Bo Li, FDA; Sirisha Mushti, FDA; Therri Usher, FDA; Jialu Zhang, FDA
4:05 PM	Estimands in Clinical Endpoint Bioequivalence Trials Wanjie Sun, FDA
4:25 PM	Discussant: Estelle Russek-Cohen, Retired FDA
4:45 PM	Floor Discussion

579 * !	Thu, 8/6/2020, 3:00 PM - 4:50 PM	Virtual
30 Years Journey of Bayesian Adaptive Designs: From Bayesian Monitoring to Dynamic Treatment Regime — in Honor of Dr. Peter Thall’s 70th Birthday — Topic Contributed Papers
Biopharmaceutical Section, WNAR, Biometrics Section
Organizer(s): Ruitao LIN, The University of Texas MD Anderson Cancer Center
Chair(s): Ying Yuan, The University of Texas MD Anderson Cancer Center
3:05 PM	Subgroup-Specific Dose Finding in Phase I Clinical Trials Based on Time to Toxicity Allowing Adaptive Subgroup Combination Andrew Genius Chapple, LSUHSC; Peter F. Thall, M.D. Anderson Cancer Center
3:25 PM	An Adaptive Trial Design to Optimize Dose Schedule Regimes with Delayed Outcomes Ruitao LIN, The University of Texas MD Anderson Cancer Center; Ying Yuan, The University of Texas MD Anderson Cancer Center; Peter F. Thall, M.D. Anderson Cancer Center
3:45 PM	Robust Adaptive Incorporation of Historical Control Data in a Randomized Trial of External Cooling to Treat Septic Shock Presentation Thomas Murray, University of Minnesota; Peter F. Thall, M.D. Anderson Cancer Center; Frederique ARTHUR Schortgen, Groupe Hospitalier Henri-Mondor; Sarah ARTHUR Zohar, Centre de Recherche des Cordeliers; Sandrine Katsahian, Hopital Europen Georges-Pompidou
4:05 PM	Rethinking Prior Effective Sample Size Satoshi Morita, Kyoto University
4:25 PM	Utilizing Bayesian Analysis for Probabilistic Decision Making in a Platform Clinical Trial J. Wathen, Gilead Sciences
4:45 PM	Floor Discussion

584 * !	Thu, 8/6/2020, 3:00 PM - 4:50 PM	Virtual
Innovations and Breakthroughs in Oncology Dose Finding Designs for Time-to-Event Monitoring and Trial Acceleration in the New Age of Immunotherapy and Cell Therapy — Topic Contributed Papers
Section on Risk Analysis, Biopharmaceutical Section, Section on Bayesian Statistical Science, Biometrics Section
Organizer(s): Wei Zhong, Pfizer Inc
Chair(s): Christophe Le Corre, Pfizer Inc.
3:05 PM	TITE-BOIN-ET: Time-to-Event Bayesian Optimal Interval Design to Accelerate Dose-Finding Based on Both Efficacy and Toxicity Outcomes Kentaro Takeda, Astellas Pharma Global Development, Inc.
3:25 PM	Probability-of-Decision Designs to Accelerate Dose-Finding Trials Tianjian Zhou, University of Chicago; Yuan Ji, University of Chicago
3:45 PM	Novel Bayesian Adaptive Designs and Their Software Implementation for Phase I Clinical Trials with Late-Onset Toxicity Yanhong Zhou, MD Anderson Cancer Center; J. Jack Lee, MD Anderson Cancer Center; Ying Yuan, The University of Texas MD Anderson Cancer Center
4:05 PM	The Direct Time-to-Event (DTITE) Designs: A Novel Type of Oncology Dose-Escalation Designs with Late-Onset Toxicities Monitoring Wei Zhong, Pfizer Inc; Qing Xie, The Ohio State University; Ling Wang, Pfizer Inc.; Roberto Bugarini, Pfizer Inc
4:25 PM	New Paradigm of Dose Finding Designs in Cell Therapy Development: Challenges and Solutions Rachael Liu, Takeda Pharmaceuticals; Jianchang Lin, Takeda Pharmaceuticals; Pin Li, University of Michigan; Yuan Ji, University of Chicago; Jing Xu, Blue Bird
4:45 PM	Floor Discussion

JSM 2020 Online Program

Activity Details

American Statistical Association