Name: 2021 Joint Statistical Meetings
Start: 2021-08-08T07:00:00+00:00
End: 2021-08-12

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Activity Details

17 * !	Sun, 8/8/2021, 1:30 PM - 3:20 PM	Virtual
Innovative Statistical Strategies and Designs in Oncology Drug Development — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section, International Chinese Statistical Association
Organizer(s): Olga Marchenko, Bayer
Chair(s): Qi Jiang, Seagen
1:35 PM	Opportunities and Challenges of Master Protocol Trials: ASA Oncology Working Group Master Protocol Subteam Update Xiaoyun (Nicole) Li, Merck & Co.; Chengxing (Cindy) Lu, Biogen
1:55 PM	Application of Historical Data in Oncology Combination Therapy Development Rong Liu, Bristol Myers Squibb
2:15 PM	Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Presentation Sunhee Ro, Sierra Oncology
2:35 PM	Discussant: Xin Cindy Gao, FDA
2:55 PM	Floor Discussion

29	Sun, 8/8/2021, 1:30 PM - 3:20 PM	Virtual
Statistical Issues Specific to Therapeutic Areas, Power and Sample Size Calculations, and Trial Monitoring — Contributed Speed
Biopharmaceutical Section
Chair(s): Jonathan Moscovici, QuintilesIMS
1:35 PM	A Bayesian Network Meta-Analysis on Treatments of Brain Metastases in Patients with Non-Small Cell Lung Cancer Uma Siangphoe, Johnson and Johnson
1:40 PM	On Characterizing Survival Curve of CAR-T Cell Therapy xiaoling wu, Legend Biotech
1:45 PM	On Treatment Effect in Sequential Parallel Comparison Design Xiaoyan Liu, Boston University; Zifei Han, University of International Business and Economics; Chanmin Kim, Sungkyunkwan University; Gheorghe Doros, Boston University
1:50 PM	WITHDRAWN: Comparison of Methods for Adjusting for Crossover in Oncology Trials Jin Zhang, Merck
1:55 PM	Handling Multiple Imputation in Wilcoxon Signed-Rank Test: A Case Study Applied to a Hemophilia Clinical Trial Presentation Eunhee Hwang, Pfizer Inc; Joseph Cappelleri, Pfizer Inc; Satrajit Roychoudhury, Pfizer Inc.; Dan Meyer, Pfizer
2:00 PM	An Alternate Method to Find the Confidence Interval for the Difference Between Two Proportions of Rare Event Presentation Ruji Yao, Merck & Co., Inc.; Amarjot Kaur, Merck & Co., Inc.; qing li, Merck & co., Inc.
2:05 PM	A Flexible Ensemble Learning Method for Survival Extrapolation Presentation Meijing Wu, Abbvie Inc.; Ran Dai, University of Nebraska Medical Center ; Yabing Mai, Boehringer Ingelheim; Weili He, AbbVie
2:10 PM	Methods for Vaccine Efficacy in a Fixed Duration Design with Censoring Ying Zhang, Merck & Co., Inc.; G. Frank Liu, Merck Sharp & Dohme Corp.; Radha A Railkar, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
2:15 PM	Novel Measures of Treatment Efficacy Under Delayed Treatment Effects Kijoeng Nam, Merck & Co., inc. ; Nicholas Henderson, University of Michigan; Dai Feng, AbbVie Inc.
2:20 PM	Sample Size Reestimation for the Finkelstein and Schoenfeld Test Statistic for a Composite Endpoint with Two Components Thomas Zhou, Boston University; Joseph Massaro, Boston University
2:30 PM	Power Analyses of Oncology Clinical Trials with Stratified Randomization Xiao Fang, Merck; Paul DeLucca, Merck; Fang Liu, Merck & Co., Inc.; Xuan Deng, Merck & Co. Inc; Devan V Mehrotra, Merck & Co., Inc.
2:35 PM	Something Out of Nothing? The Influence of 0-0 Studies in Bayesian Meta-Analysis of Drug Safety Studies Zhaohu(Jonathan) Fan, University of Cincinnati ; Dungang Liu, University of Cincinnati; Yuejie Chen , North Carolina State University; Nanhua Zhang, Cincinnati Children's Hospital Medical Center
2:40 PM	Incorporating Historical Controls in Analyses of Clinical Trial Data: An Empirical Power Prior Approach Duncan Rotich, Bristol Myers Squibb; Yun Shen, Bristol Myers Squibb; Kay Tatsuoka, Bristol Myers Squibb
2:45 PM	Do unadjusted pilot analyses lead to biased decision in proceeding to a larger trial? Robert Montgomery, University of Kansas Medical Center
2:50 PM	Optimizing Precision and Power in COVID-19 Trials by Covariate Adjustment Nicholas Williams, Weill Cornell Medicine; Ivan Diaz, Weill Cornell Medical College; Michael Rosenblum, Johns Hopkins University
2:55 PM	Collaborative Biostatistics as a Bridge from Preclinical Discovery to Population Data Science Emily Slade, University of Kentucky; Heather Bush, University of Kentucky
3:00 PM	Interim Analysis Incorporating Intermediate Binary Responses Gang (Gerry) Li, Alexion Pharmaceuticals; Jiuzhou Wang, University of Minnesota Twin Cities; Jingnan (Jenna) Zhang, Alexion Pharmaceuticals
3:05 PM	Predicting Analysis Times in Clinical Trials with Nonproportional Hazards David Paulucci, Bristol Myers Squibb; Nikolas Weissmueller, Bristol Myers Squibb; Ming Zhou, Bristol Myers Squibb; Kay Tatsuoka, Bristol Myers Squibb
3:10 PM	Realistic Patient-Level Simulators Considering Two Dependent Time-to-Event Endpoints Yalin Zhu, Merck & Co Inc; Jing Zhao, Merck & Co., Inc.; Jing Wei, University of Kentucky

3:15 PM	Floor Discussion

35 * !	Sun, 8/8/2021, 3:30 PM - 5:20 PM	Virtual
Stories from COVID-19 Vaccine Development: Statistical Challenges and Opportunities — Invited Papers
Biopharmaceutical Section, Biometrics Section, Committee on Applied Statisticians
Organizer(s): Charlotte Baidoo, GlaxoSmithKline plc; Wenji Pu, GlaxoSmithKline plc
Chair(s): Fabian Tibaldi, GlaxoSmithKline plc
3:35 PM	COVID-19: Modeling, Epidemiological, Clinical, and Vaccine Aspects Presentation Geert Molenberghs, Universiteit Hasselt and KU Leuven
4:00 PM	Statistical Observations on Vaccine Clinical Development for Pandemic Diseases Scott Patterson, Sanofi Pasteur; Bo Fu, Sanofi Pasteur; Fabrice Bailleux, Sanofi Pasteur; Josh Chen, Sanofi Pasteur
4:25 PM	Statistical Challenges in COVID-19 Vaccine Trials Ye Yang, FDA/CBER
4:50 PM	Discussant: Tsai-Lien Lin, CBER, FDA
5:10 PM	Floor Discussion

45 * !	Sun, 8/8/2021, 3:30 PM - 5:20 PM	Virtual
Statistical Methods Utilizing Historical and Real-World Data for Clinical Studies — Topic-Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, International Society for Clinical Biostatistics, Caucus for Women in Statistics
Organizer(s): Yuan Ji, The University of Chicago
Chair(s): Tianjian Zhou, Colorado State University
3:35 PM	Robust Use of External Control Information in Clinical Trials Heinz Schmidli, Novartis
3:55 PM	Performance of LTMLE in the Presence of Missing Patterns Sue-Jane Wang, FDA; Zhipeng Huang, FDA
4:15 PM	Using Historical Data in Developing Novel Therapies: A Roadmap and Case Studies Rui (Sammi) Tang, Servier Pharmaceuticals; chenkun wang, vertex pharmarcetical
4:35 PM	Single Arm Trials with a Synthetic Control Arm Built from RWD Peter Mueller, University of Texas Austin; Noirrit Kiran Chandra, University of Texas at Austin; Choudur Lakshminarayan, Teradata Labs/The University of Texas at Austin
4:55 PM	Floor Discussion

64 * !	Mon, 8/9/2021, 10:00 AM - 11:50 AM	Virtual
Innovative Practical Improvements in Biomarker Development and Evaluation — Invited Papers
Section on Medical Devices and Diagnostics, Biometrics Section, Biopharmaceutical Section, Caucus for Women in Statistics
Organizer(s): Laura Yee, National Cancer Institute, National Institutes of Health
Chair(s): Hari Sankaran, National Cancer Institute, National Institutes of Health
10:05 AM	Emulating a Target Trial to Evaluate the Clinical Utility of a Biomarker-Based Treatment Rule Michael Charles Sachs, Karolinska Institutet
10:25 AM	Two-Stage Adaptive Design for Prognostic Biomarker Signatures with a Survival Endpoint Mei-Yin C Polley, University of Chicago; Biyue Dai, University of Iowa
10:45 AM	Biologically Informed Development of Treatment Selection Scores from High-Dimensional Omics Data Lisa McShane, National Cancer Institute
11:05 AM	Sample Size Methods for Validation of Predictive Biomarkers Kevin K Dobbin, University of Georgia; Lisa McShane, National Cancer Institute
11:25 AM	Discussant: Ana Best, National Cancer Institute, National Institutes of Health
11:45 AM	Floor Discussion

73 * !	Mon, 8/9/2021, 10:00 AM - 11:50 AM	Virtual
Data Visualization Game: Who Is Winning? Sponsors, Third Parties, or Someone Else? — Invited Panel
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Section on Statistical Graphics
Organizer(s): Vipin Arora, Eli Lilly and Company
Chair(s): Vipin Arora, Eli Lilly and Company
10:05 AM	Data Visualization Game: Who Is Winning? Sponsors, Third Parties, or Someone Else?
Panelists:	Kent Koprowicz, Axio Research Douglas Landsittel, Indiana University Neby Bekele, Exelixis Inc Richard C. Zink, Lexitas Pharma Services, Inc. Melvin Munsaka, AbbVie Inc
11:40 AM	Floor Discussion

78 *	Mon, 8/9/2021, 10:00 AM - 11:50 AM	Virtual
Key Steps in Deriving Real-World Evidence from Analysis of Real-World Data — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section, Section on Statistical Learning and Data Science
Organizer(s): Yixin Fang, AbbVie
Chair(s): Weili He, AbbVie
10:05 AM	Estimands: From Concepts to Applications in Real-World Setting (RWS) Jie Chen, On behalf of ASA Biop RWE SWG Estimand Team
10:25 AM	Principles and Approaches for the Use and Evaluation of Fit-for-Purpose, Real-World Data Sources Mark Levenson, FDA; Weili He, AbbVie
10:45 AM	Examples of Applying Causal-Inference Roadmap to RWE Clinical Studies Presentation Martin Ho, Google; Yixin Fang, AbbVie
11:05 AM	From Sensitivity Analysis to Evidence-Value: Ways to Interpret Real-World Evidence Yixin Fang, AbbVie ; Weili He, AbbVie
11:25 AM	Discussant: Hana Lee, FDA
11:45 AM	Floor Discussion

82 * !	Mon, 8/9/2021, 10:00 AM - 11:50 AM	Virtual
Evaluating Causal Effects Using Incomplete Data with Interference in Public Health Research — Topic-Contributed Papers
ENAR, Section on Statistics in Epidemiology, Biopharmaceutical Section
Organizer(s): TingFang Lee, College of Pharmacy, University of Rhode Island
Chair(s): Ashley Buchanan, College of Pharmacy, University of Rhode Island
10:05 AM	Causal Effects with Hidden Treatment Diffusion Over Partially Unobserved Networks Costanza Tortù, Ecole Polytechnique; Irene Crimaldi, IMT Lucca; Fabrizia Mealli, University of Florence; Laura Forastiere, Yale University
10:25 AM	Doubly Robust Treatment Effect Estimation with Missing Attributes Imke Mayer, Centre d'Analyse et de Mathématiques Sociales, EHESS; Erik Sverdrup, Graduate School of Business, Stanford University; Tobias Gauss, Department of Anesthesia and Intensive Care, Beaujon Hospital, AP-HP; Jean-Denis Moyer, Department of Anesthesia and Intensive Care, Beaujon Hospital, AP-HP; Stefan Wager, Stanford University; Julie Josse, INRIA Sophia-Antipolis
10:45 AM	Evaluating Disseminated Effects of Incomplete Data in Network-Based Studies for Public Health Presentation TingFang Lee, College of Pharmacy, University of Rhode Island; Ashley Buchanan, College of Pharmacy, University of Rhode Island; Natallia Katenka, Department of Computer Science and Statistics, University of Rhode Island; M. Elizabeth Halloran, Public Health Sciences Division, Fred Hutch; Samuel Friedman, Department of Population Health, NYU Grossman School of Medicine; Georgios Nikolopoulos, Medical School, University of Cyprus
11:05 AM	Leveraging Influencers in the Design of Network-Structured Studies to Estimate Direct and Spillover Effects Junhan Fang, Yale School of Public Health; Donna Spiegelman, Yale School of Public Health; Laura Forastiere, Yale University
11:25 AM	Discussant: Samrachana Adhikari, NYU School of Medicine
11:45 AM	Floor Discussion

94	Mon, 8/9/2021, 12:00 PM - 1:20 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
ML01:	Enhancing Pediatric Drug Development Fei Wang, Boehringer Ingelheim; Susan Wang, Boehringer Ingelheim
ML02:	Practical Considerations of Weighted Log-Rank Test in Immunotherapy Trials Philip He, Astrazeneca
ML03:	Promoting Awareness and Education of Bayesian Statistical Topics Among Our Clinical Drug Development Colleagues Ross Bray, Eli Lilly and Company

123 * !	Mon, 8/9/2021, 1:30 PM - 3:20 PM	Virtual
Innovative Designs for Benefit of Patients — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Rong Liu, Bristol Myers Squibb
Chair(s): Cristiana Mayer, Janssen R&D
1:35 PM	Adaptive Endpoints Selection with Application in Rare Disease Heng Xu, Nektar Therapeutics; Yi Liu, Nektar Therapeutic; Robert Allen Beckman, Georgetown University Medical Center
1:55 PM	Master Protocols and Their Benefits for Clinical Trial Participants and Patients Presentation Robert Allen Beckman, Georgetown University Medical Center
2:15 PM	A Roadmap to Using Historical Controls in Clinical Trials, by Drug Information Association Innovative Design Scientific Working Group Mercedeh Ghadessi, Bayer Pharamceuticals
2:35 PM	Ethics: Patients, Research Subjects, and Drug Development Gianna McMillan, Loyola Marymount University Bioethics Institute
2:55 PM	Discussant: Zoran Antonijevic, MedSource
3:15 PM	Floor Discussion

135	Mon, 8/9/2021, 1:30 PM - 3:20 PM	Virtual
Multiplicity, Missing Data and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Madhurima Majumder, Bayer
1:35 PM	On Assessing Effectiveness of New Assets Using Historical Response Data: A Bayesian Approach Chunsheng He, BMS; Yike Tang, UIC; Shu-Pang Huang, BMS
1:40 PM	Evidence Synthesis of Randomized and Nonrandomized Studies for Decision-Making Hongwei Wang, AbbVie; Weili He, AbbVie; Tianming Gao, AbbVie; Linyu Shi, AbbVie
1:45 PM	Indirect Treatment Comparison with Evidences of Different Sources and Quality Tianming Gao, AbbVie; Hongwei Wang, AbbVie; Weili He, AbbVie; Linyu Shi, AbbVie
1:50 PM	Continuous Learning from Small Efficacy Studies in Drug Development Haiyuan Zhu, Sunovion Pharmaceuticals; Robert Hayes, Sunovion Pharmaceuticals
1:55 PM	Simulating Clinical Trials Data with Synthetic.Cdisc.Data and Respectables Gabriel Becker, Clindata Insights; Adrian Waddell, F. Hoffmann-La Roche
2:00 PM	Expedite Rare Disease Drug Development Through Bayesian Analyses, External Controls, and Real-World Data Florence Yong, Pfizer Inc.; Jeffrey Palmer, Pfizer Inc
2:05 PM	A Novel Approach to Augment Single-Arm Clinical Studies with Real-World Data Archie Sachdeva, University of Florida; Ram Tiwari, Bristol Myers Squibb; Subharup Guha, University of Florida
2:10 PM	Treatment Effects Across Subgroups Based on Shrinkage Estimation Amarjot Kaur, Merck & Co., Inc.; qing li, Merck & co., Inc.; Jia Hua, Merck
2:15 PM	Exploring the Impact of Different Endpoint Definitions for MMRM and Related Missing Data Problems Yaoyuan Vincent Tan, Vertex Pharmaceuticals; Fengjuan Xuan, Vertex Pharmaceuticals
2:20 PM	A Novel Return-to-Baseline Imputation Method for Missing Data in Clinical Trials Biyue Dai, Eli Lilly and Company; Yongming Qu, Eli Lilly and Company
2:30 PM	Analysis of Crossover Designs for Longitudinal Binary Data with Ignorable and Nonignorable Dropout Presentation Xi Wang, Pennsylvania State University College of Medicine; Vernon M. Chinchilli, Pennsylvania State University College of Medicine
2:35 PM	Simulating Treatment Discontinuation in Clinical Trials Ahmad Hakeem Abdul Wahab, Purdue University, Department of Statistics; Hege Michiels, Department of Applied Mathematics, Computer Science and Statistics, Ghent University; Arman Sabbaghi, Purdue University, Department of Statistics; Stephen J Ruberg, Analytix Thinking, LLC
2:40 PM	A Bias Correction Method for Hazard Ratio Estimation and Its Inference in a Multiple-Arm Clinical Trial Liji Shen, Merck & Co. Inc; Ziwen Wei, Merck & Co. Inc; Xuan Deng, Merck & Co. Inc
2:45 PM	Treatment Effect Bias from Sample Snooping: Blinding Outcomes Is Neither Necessary nor Sufficient Aaron Fisher, Foundation Medicine Inc
2:50 PM	On Weighted Holm Procedures Beibei Li, New Jersey Institute of Technology; Wenge Guo, New Jersey Institute of Technology
2:55 PM	Statistical Methods to Assess In-Vitro Comparability Michael Daniel Cid Lucagbo, University of Maryland, Baltimore County and University of the Philippines Diliman; Tianjiao Dai, U.S. Food and Drug Administration; Yixin Ren, Merck & Co., Inc.; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA

3:00 PM	Floor Discussion

220773	Tue, 8/10/2021, 8:30 AM - 1:00 PM
Biopharmaceutical Section Executive Committee meeting (closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Weili He, AbbVie

148 * !	Tue, 8/10/2021, 10:00 AM - 11:50 AM	Virtual
Considerations in Clinical Trial Endpoints’ Selection — Invited Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Freda Cooner, Amgen
Chair(s): Laura Fernandes, FDA
10:05 AM	Treatment-Free Survival and Depth of Response as Novel Endpoints of Immuno-Oncology (IO)-Based Therapy for Metastatic Renal Cell Carcinoma (MRCC) Presentation Meredith M Regan, Dana-Farber Cancer Institute; Laura Fernandes, FDA
10:30 AM	Handling Missing Data Through Combining of Endpoints Jitendra Ganju, Ganju Clinical Trials, LLC; Ron Yu, Gilead Sciences
10:55 AM	Win Statistics: Impact of Follow-up Time and Unbiased Estimators of Treatment Effect in the Presence of Censoring Gaohong Dong, BeiGene; Victoria Chang, BeiGene; Bo Huang, Pfizer Inc.; James Song, BeiGene; Duolao Wang, Liverpool School of Tropical Medicine, UK; Lu Mao, University of Wisconsin; Jiuzhou Wang, ImmunoGen Inc.; Johan Verbeeck, University Hasselt, Belgium ; Margaret Gamalo-Siebers, Pfizer Inc.; David C. Hoaglin, University of Massachusetts Medical School
11:20 AM	How to Measure the Treatment Effect in COVID-19 Clinical Studies? Lu Tian, Stanford University ; LJ Wei, Harvard University; Zachary McCaw, Google Inc
11:45 AM	Floor Discussion

150 !	Tue, 8/10/2021, 10:00 AM - 11:50 AM	Virtual
COVID-19 Vaccine Statistics: A Reflection on a Year at Warp Speed — Invited Papers
Biometrics Section, Biopharmaceutical Section, Section on Statistics in Epidemiology
Organizer(s): David Benkeser, Emory University
Chair(s): David Benkeser, Emory University
10:05 AM	US Regulatory Considerations for COVID-19 Vaccine Trials John Scott, FDA / CBER
10:25 AM	The Burden of Selecting a Primary Efficacy Endpoint: Consideration of a COVID-19 Burden of Disease Endpoint Jonathan V Hartzel, Merck & Co., Inc.; Devan V Mehrotra, Merck & Co., Inc.
10:45 AM	Understanding the Effects of COVID-19 Vaccines on Reducing Secondary Transmission Holly Janes, Fred Hutchinson Cancer Research Center
11:05 AM	Inference for Natural Mediation Effects Under Case-Cohort Sampling with Applications in Identifying COVID-19 Vaccine Correlates of Protection Ivan Diaz, Weill Cornell Medical College
11:25 AM	Discussant: Dean Follmann, NIH
11:45 AM	Floor Discussion

161 * !	Tue, 8/10/2021, 10:00 AM - 11:50 AM	Virtual
Collaboratively Improve Trial Design and Result Interpretation Through the Estimand Framework — Topic-Contributed Panel
Biopharmaceutical Section, ENAR, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Lei Nie, Office of Biostatistics (OB), OTS, CDER, FDA
Chair(s): Roderick Joseph Little, University of Michigan
10:05 AM	Collaboratively Improve Trial Design and Result Interpretation Through the Estimand Framework
Panelists:	Paul Kluetz, The US FDA Gregory Levin, The US FDA Bohdana Ratitch, Bayer Anthony Man, Novartis Sally Seymour, Food and Drug Administration
11:40 AM	Floor Discussion

166	Tue, 8/10/2021, 10:00 AM - 11:50 AM	Virtual
Non-Clinical Statistics, Personalized Medicine, and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Vivien Yin, Mayo Clinic
10:05 AM	A Meta-Inference Framework to Integrate Multiple External Models into a Current Study Tian Gu, Department of Biostatistics, University of Michigan; Jeremy M.G. Taylor, University of Michigan; Bhramar Mukherjee, University of Michigan
10:10 AM	Best Practices of Double Score Matching for Estimating Causal Effects Yunshu Zhang, NC State University; Shu Yang, North Carolina State University; Wendy Ye, Eli Lilly and Company; Douglas Faries, Eli Lilly and Company; Ilya Lipkovich, Eli Lilly; Zbigniew Kadziola, Eli Lilly and Company
10:15 AM	In Vitro Dissolution Profile Comparison Using Bootstrap Bias Corrected Similarity Factor, F2 Xiaoyu Cai, U.S. Food and Drug Administration; Shaobo Liu, U.S. Food and Drug Administration; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:20 AM	Quadratic Slope-Ratio Model for Nonlinear Dose-Response of CBPA Assay Ming Luo, AbbVie
10:25 AM	Statistical Approaches for Shelf Life Determination of a Drug Product Xutong Zhao, CDER, US FDA; Tengfei Li, Georgetown University; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:30 AM	Practical Conformal Prediction Methods for QSAR Yuting Xu, Merck & Co., Inc.; Andy Liaw, Merck & Co., Inc.; Vladimir Svetnik, Merck & Co.
10:35 AM	Power and Sample Size Estimation in Stability and Analytical Comparability Presentation Qianqiu Li, Janssen Research & Development
10:40 AM	Comparing the Means of Continuous Measurements for Noninferiority and Equivalence Shaobo Liu, U.S. Food and Drug Administration; Xiaoyu Cai, U.S. Food and Drug Administration; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:45 AM	Risk Difference, Relative Risk, and Odds Ratio for Noninferiority Clinical Trials: Assessment with Negative Event Rate Endpoint Senmiao Ni, Nanjing Medical University; Jingwei Wu, Temple University; Quanji Yu, Nanjing Medical University; Jianling Bai, Nanjing Medical University; Hao Yu, Nanjing Medical University
10:50 AM	WITHDRAWN: Challenges and Strategies of Handling of PKPD Data in CDISC Standards Sanjeeva Thalla, COVANCE
11:00 AM	A Principal Stratification Approach to Estimating the Effect of Continuing Treatment After Observing Early Outcomes Patrick Schnell, The Ohio State University College of Public Health; Richard Baumgartner, Merck Research Laboratories; Shahrul Mt-Isa , MSD; Vladimir Svetnik, Merck & Co.
11:05 AM	Utility-Based Approach in Individualized Optimal Dose Selection Using Machine Learning Methods Pin Li, University of Michigan ; Jeremy M.G. Taylor, University of Michigan; Philip Boonstra, University of Michigan; Theodore S. Lawrence, University of Michigan; Matthew J. Schipper, University of Michigan
11:10 AM	Addressing Covariate Unbalance in Subgroup Identification for Censored Survival Data via Weighted Gradient Tree Boosting JINCHUN ZHANG, Merck & Co.; PINGYE ZHANG, MERCK & Co.; Yue Shentu, Merck Sharp & Dohme; JUNSHUI MA, Merck & Co.
11:15 AM	A Comparison of Precision Medicine Methods for Count Outcomes: A Simulation Study and a Case Study in Multiple Sclerosis Xiaotong Jiang, Biogen; Gabrielle Simoneau, Biogen; Bora Youn, Biogen; Changyu Shen, Biogen; Fabio Pellegrini, Biogen; Carl de Moor, Biogen
11:20 AM	Finding Associations in a Heterogeneous Setting: Novel Statistical Test for Aberration Enrichment. The Signal Is in the Tails Mohamed Aziz Mezlini, Evidation Health Inc, University of Toronto, Harvard Medical school
11:25 AM	Model-Robust Inference for Clinical Trials That Improve Precision by Stratified Randomization and Covariate Adjustment Bingkai Wang, Johns Hopkins Bloomberg School of Public Health; Ryoko Susukida, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; Ramin Mojtabai, Johns Hopkins Bloomberg School of Public Health; Masoumeh Amin-Esmaeili, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; Michael Rosenblum, Johns Hopkins University
11:30 AM	WITHDRAWN: Calibrated Dynamic Borrowing Using Capping Priors Sharon Ling, University of Minnesota, Twin Cities; Joseph Koopmeiners, University of Minnesota, Twin Cities
11:35 AM	Bayesian Multivariate Probability of Success Using Historical Data with Family-Wise Error Rate Control Ethan Alt, University of North Carolina at Chapel Hill; Matthew Psioda, UNC Chapel Hill; Joseph G Ibrahim, UNC
11:40 AM	Innovations in the Use of External Data to Augment Controls in Clinical Trials Frank Shen, Bristol Myers Squib; Rong Liu, Bristol Myers Squibb

171	Tue, 8/10/2021, 12:00 PM - 1:20 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
TL01:	Borrowing Historical Information or Real-World Information for Clinical Trials in Regulatory Environment Madhuja Mallick, Abbvie
TL02:	Improving Precision and Power in Randomized Trials Using Covariate Adjustment Michael Rosenblum, Johns Hopkins University; Bingkai Wang, Johns Hopkins Bloomberg School of Public Health; Alex Luedtke, University of Washington; David Benkeser, Emory University; Ivan Diaz, Weill Cornell Medical College; Daniel Scharfstein, University of Utah; Jodi Seagal, Johns Hopkins University
TL03:	Meet and Greet with the Biopharmaceutical Section Chairs Weili He, AbbVie

200 * !	Tue, 8/10/2021, 1:30 PM - 3:20 PM	Virtual
Statistical Challenges and Opportunities for Expedited Oncology Drug Development — Topic-Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, Biometrics Section
Organizer(s): Qing Li, Takeda Pharmaceuticals
Chair(s): Jianchang Lin, Takeda Pharmaceuticals
1:35 PM	Multiplicity Issues for Platform Trials with a Shared Control Arm Xiaofei Bai, Boehringer-Ingelheim Pharmaceutical Inc.; Qiqi Deng, Boehringer-Ingelheim Pharmaceutical Inc.; Dacheng Liu, Boehringer-Ingelheim Pharmaceutical Inc.
1:55 PM	A Unified Framework for Time-to-Event Dose-Finding Designs Tianjian Zhou, Colorado State University; Yuan Ji, The University of Chicago
2:15 PM	Prediction of Combination Treatment Effect and Its Application in Oncology Trial Design Presentation Linda Sun, Merck & Co., Inc.; Cong Chen, Merck & Co., Inc.; Cai (Iris) Wu, Merck & Co., Inc.; Fang Liu, Merck & Co., Inc.; Yixin Ren, Merck & Co., Inc.; Leah Suttner, Merck & Co., Inc.; Xiaoyun (Nicole) Li, Merck & Co.
2:35 PM	Incorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Reestimation Qing Li, Takeda Pharmaceuticals; Jianchang Lin, Takeda Pharmaceuticals; Mengya Liu, Takeda Pharmaceuticals; Liwen Wu, University of Pittsburgh
2:55 PM	Hierarchical Testing of a Primary and Secondary Endpoint in a Group Sequential Design with Different Information Times Presentation Dong Xi, Novartis Pharmaceuticals, East Hanover, New Jersey, USA ; Jiangtao Gou, Villanova University
3:15 PM	Floor Discussion

203 * !	Tue, 8/10/2021, 1:30 PM - 3:20 PM	Virtual
Recent Advances in Bayesian Adaptive Designs, from Early Phase to Confirmatory Trials — Topic-Contributed Papers
Caucus for Women in Statistics, Biopharmaceutical Section, Committee on Women in Statistics
Organizer(s): Jun Yin, Mayo Clinic
Chair(s): Jun Yin, Mayo Clinic
1:35 PM	Design Experiences of an Adaptive Dose-Finding Study Utilizing Bayesian Model Averaging in Autoimmune Disease Mitchell Thomann, Eli Lilly
1:55 PM	BOIN12: Bayesian Optimal Interval Phase I/II Trial Design for Utility-Based Dose-Finding Ruitao Lin, The University of Texas MD Anderson Cancer Center
2:15 PM	A Bayesian Phase II Clinical Trial Design for Multinomial Endpoints Rui Qin, Janssen Pharmaceuticals; Yalin Zhu, Merck & Co Inc
2:35 PM	Statistical Considerations for Small-Sized Clinical Trials Utilizing a Platform Setting Feiran Jiao, FDA; Yeh-Fong Chen, FDA
2:55 PM	Dynamic Borrowing from a Single Prior Data Source Using the Conditional Power Prior Jianjin Xu, Food and Drug Administration; Laura Thompson, Food and Drug Administration
3:15 PM	Floor Discussion

220770	Tue, 8/10/2021, 5:30 PM - 7:00 PM
Biopharmaceutical Section Business Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Weili He, AbbVie
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219 * !	Wed, 8/11/2021, 10:00 AM - 11:50 AM	Virtual
Artificial Intelligence and Machine Learning in Medical Imaging for Drug Development — Invited Papers
Section on Statistics in Imaging, Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Bushi Wang, Boehringer Ingelheim Pharmaceuticals Inc.
Chair(s): Sue-Jane Wang, FDA
10:05 AM	Using Deep Learning on HRCT Scan to Predict Pulmonary Fibrosis Progression and Support Early Clinical Development Decision Bushi Wang, Boehringer Ingelheim Pharmaceuticals Inc.; Yi Liu, Boehringer Ingelheim; Hao Li, Boeringer-Ingelheim
10:25 AM	Application of Machine Learning in Medical Imaging: Overview of Novartis Radiomics Projects Thibaud Coroller, Novartis
10:45 AM	Histopathology and AI for Cancer Subtype and Mutation Detection Narges Razavian, New York University Langone Health
11:05 AM	Development and Clinical Evaluation of Quantitative Lung Fibrosis Scores on CT Images in Clinical Trials: Idiopathic Pulmonary Fibrosis and Scleroderma Lung Disease Grace Hyun Kim, UCLA; Jonathan Goldin, UCLA; Matthew Brown, UCLA
11:25 AM	Recent Advances in Machine Learning in Medical Image Analysis Fei Wang, Weill Cornell Medicine
11:45 AM	Floor Discussion

236 * !	Wed, 8/11/2021, 10:00 AM - 11:50 AM	Virtual
New Developments in Integrated Analysis of Complex Data from Multiple Sources — Topic-Contributed Papers
Biometrics Section, Biopharmaceutical Section, International Chinese Statistical Association
Organizer(s): Xiaofei Wang, Duke University
Chair(s): Herbert Pang, Genentech
10:05 AM	Identifying Temporal Pathways Using High-Dimensional Biomarkers Shanghong Xie , Columbia Unviersity; Donglin Zeng, UNC Chapel Hill; Yuanjia Wang, Columbia University
10:25 AM	Fusion Designs and Estimators Stephen Cole, UNC
10:45 AM	Improving Trial Generalizability Using Observational Studies Lin Dong, Wells Fargo; Shu Yang, North Carolina State University
11:05 AM	Causally Interpretable Meta-Analysis: Transporting Inferences from Multiple Randomized Trials to a Target Population Issa J. Dahabreh, Harvard T. H. Chan School of Public Health; Sarah E. Robertson, Brown University; Lucia C. Petito, Northwestern University; Miguel Hernán, Harvard T. H. Chan School of Public Health; Jon Steingrimsson, Brown University
11:25 AM	Discussant: Miguel Hernan, Harvard School of Public Heatlh
11:45 AM	Floor Discussion

238 * !	Wed, 8/11/2021, 10:00 AM - 11:50 AM	Virtual
Addressing Nonproportional Hazards Issues in Oncology Clinical Trial Design — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section, Statistics and Pharmacometrics Interest Group
Organizer(s): Revathi Ananthakrishnan, Bristol-Myers Squibb; Daniel Li, Bristol-Myers Squibb
Chair(s): Daniel Li, Bristol-Myers Squibb
10:05 AM	New alternative measures to hazard ratio HAJIME UNO, Dana-Farber Cancer Institute
10:25 AM	Max-Combo Test for Time-to-Event Endpoints Under Nonproportional Hazards Ray Lin, Genentech
10:45 AM	Design for Immuno-Oncology Clinical Trials with Nonproportional Hazards Patterns ZHENZHEN XU, FDA; Bin Zhu, National Cancer Institute; YONGSOEK PARK, University of Pittsburg
11:05 AM	A 5-Step Stratified Testing and Amalgamation Routine Rachel Marceau West, Merck & Co. ; Devan V Mehrotra, Merck & Co., Inc.
11:25 AM	Discussant: Kay Tatsuoka, Bristol Myers Squibb
11:45 AM	Floor Discussion

249	Wed, 8/11/2021, 12:00 PM - 1:20 PM	Virtual
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
WL01:	COVID-19 Pandemic Impact on Data Analysis in Infectious Disease Clinical Trials Presentation Hong Wan, Merck
WL02:	Role of Statisticians in Digital Transformation and Democratization of Clinical Trials Li Chen, Amgen
WL03:	The Use of Placebo Participant Information Across Intervention-Specific Trials Within a Platform Study of the Treatment of Moderate to Severely Active Crohn’s Disease Presentation Dwaine Banton, Janssen R&D; Kim Hung Lo, Johnson and Johnson; Grace Liu, Johnson and Johnson

272 * !	Wed, 8/11/2021, 1:30 PM - 3:20 PM	Virtual
Data Science and Statistics in Pharmaceutical Engineering and Experimental Studies: Where Is It? Where Is It Going? — Invited Panel
Biopharmaceutical Section, Section on Physical and Engineering Sciences, Pharmaceutical Research and Manufacturers of America
Organizer(s): Stan Altan, Janssen Pharmaceutical R&D
Chair(s): Stan Altan, Janssen Pharmaceutical R&D
1:35 PM	Data Science and Statistics in Pharmaceutical Engineering and Experimental Studies: Where Are They, Where Are They Going?
Panelists:	Mark Daniel Ward, Purdue University Terri Bui, Merck & Co. Ke Wang, Pfizer, Inc. Jonathan E. Allen, Lawrence Livermore Nattional Laboratory Huanyu Zhou, Teva Pharmaceutical Industries Ltd.
3:15 PM	Floor Discussion

280 *	Wed, 8/11/2021, 1:30 PM - 3:20 PM	Virtual
Application of Machine Learning in Clinical Development — Topic-Contributed Papers
Biopharmaceutical Section, Section on Statistical Learning and Data Science, International Chinese Statistical Association, Text Analysis Interest Group
Organizer(s): Dooti Roy, Boehringer Ingelheim Pharmaceuticals, Inc.; Nan Shao, Boehringer Ingelheim Pharmaceuticals, Inc.
Chair(s): Zheng Zhu, Boehringer Ingelheim Pharmaceuticals, Inc.
1:35 PM	Application of Digital Medicine in Drug Development Sandeep M Menon, Pfizer; Tim McCarthy, Pfizer; F. Isik Karahanoglu, Pfizer Global Research and Development
1:55 PM	Predicting Patient Adherence in a Changing World Dooti Roy, Boehringer Ingelheim Pharmaceuticals, Inc.
2:15 PM	Automatic Disease Screening of Borderline Personality Disorder Using Electronic Health Records (EHR) Nan Shao, Boehringer Ingelheim Pharmaceuticals, Inc.; Marianne Goodman, Icahn School of Medicine at Mount Sinai; James J Peters VA Medical Center; Chengxi Zang, Weill Cornell Medicine, Cornell University; Zheng Zhu, Boehringer Ingelheim Pharmaceuticals, Inc.; Zsuzsanna Tamas, Boehringer Ingelheim; Rachel Ovens, Boehringer Ingelheim; Agnes Koczon-Jaremko , Boehringer Ingelheim; Vikas_Mohan Sharma, Boehringer Ingelheim
2:35 PM	Application of Natural Language Processing in Drug Development Hua Xu, The University of Texas Health Science Center at Houston
2:55 PM	Floor Discussion

282 * !	Wed, 8/11/2021, 1:30 PM - 3:20 PM	Virtual
Tools to Enable the Use of R by the Biopharmaceutical Industry in a Regulatory Setting — Topic-Contributed Papers
Biopharmaceutical Section
Organizer(s): Marly Gotti, Biogen; Juliane Manitz, EMD Serono
Chair(s): Juliane Manitz, EMD Serono
1:35 PM	A Risk-Based Approach for Assessing R Package Accuracy Within a Validated Infrastructure Paulo Bargo, Janssen R&D; Juliane Manitz, EMD Serono; Andy Nicholls, GSK; Doug Kelkhoff, Roche; Yilong Zhang, Merck & Co., Inc.; Lyn Taylor , Phastar; Joe Rickert, R Consortium; Marly Gotti, Biogen; Keaven M Andersen, Merck & Co. Inc.
1:55 PM	riskmetric: A Risk-based Workflow to Evaluate the Quality of R Packages Doug Kelkhoff, Roche
2:15 PM	Paving the Way for Regulatory Submissions Using R: the Risk Assessment Shiny Application Marly Gotti, Biogen
2:35 PM	Packages for Automated Assessment and Standards Alignment of R Packages Mark Padgham, rOpenSci; Noam Ross, Ecohealth Alliance
2:55 PM	R2rtf - A Lightweight R Package to Produce Submission-Ready Tables and Figures in RTF Format Yilong Zhang, Merck & Co., Inc.; Siruo Wang, John Hopkins University; Simiao Ye, Merck & Co., Inc.; Madhusudhan Ginnaram, Merck & Co., Inc.; Keaven M Andersen, Merck & Co. Inc.
3:15 PM	Floor Discussion

316	Wed, 8/11/2021, 3:30 PM - 5:20 PM	Virtual
40 Years of the Biopharmaceutical Section: Celebrating Our Past, Planning for Our Future — Topic-Contributed Panel
Biopharmaceutical Section, History of Statistics Interest Group
Organizer(s): Richard C. Zink, Lexitas Pharma Services, Inc.
Chair(s): Margaret Gamalo, Pfizer
3:35 PM	40 Years of the Biopharmaceutical Section: Celebrating Our Past, Planning for Our Future
Panelists:	Anna Nevius, Retired Bruce Binkowitz, Shionogi & Co., Ltd. Dionne Price, US Food and Drug Administration Karl Peace, Georgia Southern University Ralph Buncher, Retired Steve Snapinn, Seattle-Quilcene Biostatistics LLC
5:10 PM	Floor Discussion

318	Wed, 8/11/2021, 3:30 PM - 5:20 PM	Virtual
Adaptive (and Other) Clinical Trial Designs — Contributed Speed
Biopharmaceutical Section
Chair(s): Theodore Lystig, BridgeBio
3:35 PM	Algorithms for Minimization Randomization and the Implementation with an R Package Man (Mandy) Jin, AbbVie Inc
3:40 PM	A Bayesian Adaptation Method for Clinical Trials Under Nonproportional Hazards Li Yu, Merck & Co.; Yue Shentu, Merck Sharp & Dohme; Xieyang Jia, Merck & Co.
3:45 PM	Changing Frequency of Analyses with Multiple Endpoints in Group-Sequential Clinical Trials Koko Asakura, National Cerebral and Cardiovascular Center; Toshimitsu Hamasaki, George Washington University Biostatitics Center; Diane Uschner, George Washington University; Frank Bretz, Novartis AG
3:50 PM	Evaluating Two-Stage Adaptive Designs with Data-Driven Biomarker Selection Sarah E Johnston, OUHSC Hudson College of Public Health; Ilya Lipkovich, Eli Lilly; Daniel E Zhao, OUHSC Hudson College of Public Health
3:55 PM	A Novel Statistical Test for Treatment Differences in Clinical Trials Using a Response Adaptive Forward Looking Gittins Index Rule Sofia Villar, University of Cambridge; Thomas Jaki, Lancaster University; Helena Geys, Janssen Pharmaceutica; Helen Barnett, University of Cambridge
4:00 PM	Inference for a Two-Stage Enrichment Design Zhantao Lin, Eli Lilly and Company; William Rosenberger, George Mason University; Nancy Flournoy, University of Missouri
4:05 PM	Application of Recursive Adaptive Design with Maximum Two Interim Analysis Chuhan Zhou, Pacira Pharmaceuticals, Inc; Chao Li, Pacira Pharmaceuticals, Inc; Vincent Yu, Pacira Pharmaceuticals, Inc
4:10 PM	Allocation-Blind Adaptive Analysis Strategies for Randomized Trials with Serial Assessments of a Normally-Distributed Outcome Phillip Schulte, Mayo Clinic; Kent Bailey, Mayo Clinic
4:15 PM	Faster and More Informative Phase 2b Dose-Ranging Trials Through Bayesian Uncertainty-Directed Designs with Model Averaging Daniel Schwartz, University of Chicago; Yuan Ji, The University of Chicago
4:20 PM	Two-Stage Enrichment Clinical Trial Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers Yanping Chen, Bristol Myers Squibb; Yong Lin, Rutgers University; Shou-En Lu, Rutgers School of Public Health and Cancer Institute of New Jersey
4:30 PM	Identifying Targeted Patients Population in Major Depressive Disorder by Enhanced Enrichment Design Peter Zhang, Otsuka Pharmaceuticals Dev & Com, Inc.
4:35 PM	Properties of Log-Rank Test Following Covariate-Adaptive Randomization in Multi-Center Oncology Trials Jerry J Li, Daiichi Sankyo Inc.; Olga M Kuznetsova, Merck & Co., Inc.; Gang Han, Department of Statistics, Iowa State University
4:40 PM	Bayesian Optimal Phase II Design for Basket Trials Heng Zhou, Merck & Co., Inc; Tian He, Indiana University
4:45 PM	A Bayesian Platform Trial Design to Simultaneously Evaluate Multiple Drugs in Multiple Indications with Mixed Endpoints Yujie Zhao, Department of Biostatistics, University of Texas MD Anderson Cancer Center ; Rui (Sammi) Tang, Servier Pharmaceuticals; Yeting Du, Servier Pharmaceuticals; Ying Yuan, Department of Biostatistics, University of Texas MD Anderson Cancer Center
4:50 PM	Elastic Meta-Analytic-Predictive Prior for Dynamically Borrowing Information from Historical Data with Application to Biosimilar Clinical Trials Wen Zhang, University of Texas Health Science Center at Houston; Ying Yuan, Department of Biostatistics, University of Texas MD Anderson Cancer Center; Zhiying Pan, Amgen, Inc.
4:55 PM	Adaptive Semiparametric Bayesian Borrowing Model in Basket Trials for Robust Inference and Decision-Making Rachael Liu, Takeda Pharmaceuticals; Veronica Bunn, Takeda Pharmaceuticals; Jianchang Lin, Takeda Pharmaceuticals; Junjing Lin, Takeda Pharmaceuticals
5:00 PM	The Benefits of Conducting Bayesian Adaptive Designs in Dose-Finding Studies for Healthy Volunteers in Non-Oncology Clinical Trials Carl Di Casoli, Sunovion Pharmaceuticals ; Hailong Cheng, Sunovion Pharmaceuticals; HoiWun (Natalie) Au, Sunovion Pharmaceuticals
5:05 PM	The Impact of Scientific Review on Early-Phase Clinical Trial Design Bethany Jablonski Horton, University of Virginia
5:10 PM	A Clustering-Based Information Borrowing Under Local Multisource Exchangeability Assumption Yilin Liu, Yale University; Wei Wei, Yale University

332 *	Thu, 8/12/2021, 10:00 AM - 11:50 AM	Virtual
Synthetic Clinical Trials Design to Accelerate FDA Approvals — Invited Papers
Biopharmaceutical Section, Section on Statistics in Epidemiology, Section on Statistical Learning and Data Science
Organizer(s): Choudur Lakshminarayan, Teradata Labs/The University of Texas at Austin
Chair(s): Peter Mueller, University of Texas Austin
10:05 AM	Machine Learning-Enabled Real-World Evidence in Synthetic Arms Trials Prater Edmund, The University of Texas at Arlington; Kay-Yut Chen, The University of Texas at Arlington; Sridhar Nerur, The University of Texas at Arlington
10:30 AM	Incorporating External Data into the Analysis of Clinical Trials via Bayesian Additive Regression Trees Tianjian Zhou, Colorado State University; Yuan Ji, The University of Chicago
10:55 AM	A Novel Bayesian Nonparametric Method to Use Real-World Data in Clinical Trials Presentation Noirrit Kiran Chandra, University of Texas at Austin; Peter Mueller, University of Texas Austin
11:20 AM	Discussant: Choudur Lakshminarayan, Teradata Labs/The University of Texas at Austin
11:40 AM	Floor Discussion

351 * !	Thu, 8/12/2021, 10:00 AM - 11:50 AM	Virtual
Statistical Modeling in Pre-Clinical Drug Proarrhythmic Assessment — Topic-Contributed Panel
Biopharmaceutical Section, Section on Statistical Learning and Data Science, Biometrics Section
Organizer(s): Dalong Huang, FDA
Chair(s): Dalong Huang, FDA
10:05 AM	Statistical Modeling in Pre-Clinical Drug Proarrhythmic Assessment
Panelists:	Yu-yi Hsu, FDA/CDER Nan Xi, UCLA
11:40 AM	Floor Discussion

366 *	Thu, 8/12/2021, 12:00 PM - 1:50 PM	Virtual
Trial Design and Analysis Methods for COVID-19 Treatment/Prevention — Invited Papers
ENAR, Biopharmaceutical Section, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Michael Rosenblum, Johns Hopkins University
Chair(s): Bingkai Wang, Johns Hopkins Bloomberg School of Public Health
12:05 PM	Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment for Binary, Ordinal, or Time-to-Event Outcomes David Benkeser, Emory University; Ivan Diaz, Weill Cornell Medical College; Alex Luedtke, University of Washington; Daniel Scharfstein, University of Utah; Jodi Seagal, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University
12:30 PM	Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue? Cornelia Kunz, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany ; Silke Jörgens, Janssen-Cilag GmbH, Neuss, Germany ; Frank Bretz, Novartis AG; Nigel Stallard, The University of Warwick, Coventry, UK; Kelly Van Lancker, Ghent University, Belgium; Dong Xi, Novartis Pharmaceuticals, East Hanover, New Jersey, USA ; Sarah Zohar, Sorbonne Université, Paris, France; Christoph Gerlinger, Statistics and Data Insights, Bayer AG, Berlin, Germany ; Tim Friede, University Medical Center Göttingen, Göttingen, Germany
12:55 PM	Challenges in clinical trial design during a pandemic: Experiences from the UK and beyond Thomas Jaki, University of Cambridge
1:20 PM	Discussant: Laura Lee Johnson, Center for Drug Evaluation and Research, U.S. FDA
1:40 PM	Floor Discussion

373 * !	Thu, 8/12/2021, 12:00 PM - 1:50 PM	Virtual
Analysis of Duration Data, with Applications to the COVID-19 Pandemic — Topic-Contributed Papers
IMS, Biometrics Section, Biopharmaceutical Section
Organizer(s): Piet Groeneboom, Delft University
Chair(s): Geurt Jongbloed, Delft Institute of Applied Mathematics
12:05 PM	The Generation Time Distribution: Problems with Estimating It and Consequences Thereof Tom Britton, Stockholm University
12:25 PM	Estimating the Generation Time and Relative Infectiousness from Contact Tracing Data Hiroshi Nishiura, Kyoto University School of Public Health
12:45 PM	Estimation of Incubation Time and Latency Time Distribution of SARS-CoV-2 Presentation Ronald Geskus, Oxford University Clinical Research Unit
1:05 PM	Estimation in the singly and doubly interval censored model Presentation Piet Groeneboom, Delft University
1:25 PM	Floor Discussion

374 * !	Thu, 8/12/2021, 12:00 PM - 1:50 PM	Virtual
Statistical Approaches for Evidence Integration and Considerations to Communication in Product Labeling — Topic-Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Jennifer Clark, FDA
Chair(s): Ross Bray, Eli Lilly and Company
12:05 PM	Unified Framework of Meta-Analysis, Composite Likelihoods, and Bayesian Methods for Evidence Integration in Pediatric Extrapolation Development Archetypes Margaret Gamalo-Siebers, Pfizer Inc.; Junjing Lin, Takeda Pharmaceuticals
12:25 PM	Using Robust Bayesian Priors to Borrow Information from Historical Adult Trials for a Clinical Trial in Pediatric Multiple Sclerosis Marius Thomas, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis; Dieter Haering, Novartis
12:45 PM	Extrapolating Adult Efficacy Data to Pediatric Populations via Bayesian Hierarchical Models Benjamin R Saville, Berry Consultants; Kert Viele, Berry Consultants
1:05 PM	Partial Extrapolating of Efficacy from Adult to Pediatrics: A Case Study in Systemic Lupus Erythematosus Juan Jose Abellan, GSK
1:25 PM	Discussant: James Travis, FDA
1:45 PM	Floor Discussion

378 *	Thu, 8/12/2021, 12:00 PM - 1:50 PM	Virtual
Study Design and Statistical Challenges for AI/ML Based Medical Tests — Topic-Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Rajesh R Nair, CDRH/FDA
Chair(s): Sung Hee Kim, CDRH/FDA
12:05 PM	Statistical Challenges in the Design and Validation of Medical Deep Learning Models Andrew Beam, Harvard
12:25 PM	Validation of a Breakthrough AI-Guided Echocardiography System: Overcoming Challenges in Testing AI-Based Medical Device Ha Hong, Caption Health, Inc.; Samuel Surette, Caption Health, Inc.; Yngvil Thomas, Caption Health, Inc.; Charles Cadieu, Caption Health, Inc.; Ali Chaudhry, Caption Health, Inc.; Randolph Martin, Caption Health, Inc.
12:45 PM	AI/ML Application and Challenges in Medical Diagnostic Tests Bipasa Biswas, FDA
1:05 PM	DADP: Dynamic Abnormality Detection and Progression for Longitudinal Knee Magnetic Resonance Images from the Osteoarthritis Initiative Chao Huang, Florida State University
1:25 PM	Statistical Consideration in Demonstrating Standalone Performance for AI/ML-Based Computer-Aided Detection Devices Jessie Moon, FDA
1:45 PM	Floor Discussion

385	Thu, 8/12/2021, 12:00 PM - 1:50 PM	Virtual
Biomarkers, Endpoint Validation and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Susan Wang, Boehringer Ingelheim
12:05 PM	Statistical Design and Methodology for Validating a Multiplex Electrochemiluminescent Assay Detecting Multiple Endpoints in Human Sera Samples Mohammad Lutfur Rahman, Sanofi Pasteur; Lingyi Zheng, Sanofi Pasteur
12:10 PM	Validating Surrogate Endpoints with Longitudinal Outcomes Emily Roberts, University of Michigan; Michael R. Elliott, University of Michigan; Jeremy M.G. Taylor, University of Michigan
12:15 PM	A Generalized Linear Mixed Model Framework for Calculating Inter-Rater Reliability Jonathan D Mahnken, The University of Kansas Medical Center; Katelyn A McKenzie, The University of Kansas Medical Center
12:20 PM	On Appropriate Use of Fold Change in Immunogenicity Studies Ting Zeng, University of Kentucky; Kerry W Go, Sanofi Pasteur; Anthony Homer, Medtronic
12:25 PM	Digital Endpoints and Digital Therapeutics in RCTs, PCTs, and RWE Kelly H. Zou, Viatris
12:30 PM	Using Statistical Methods to Modify and Repurpose the Composite Assessment of Index Lesion Severity Scoring System in Cutaneous Lichen Planus Nan Zhang, Mayo Clinic; Caitlin Brumfiel, Mayo Clinic; Meera Patel, Mayo Clinic; Amylou Dueck, Mayo Clinic; Mark Pittelkow, Mayo Clinic; Aaron Mangold, Mayo Clinic
12:35 PM	A Simulation-Based Evaluation of Statistical Methods for Hybrid Real-World Control Arms in Clinical Trials Mingyang Shan, Eli Lilly and Company; Douglas Faries, Eli Lilly and Company; Andy Dang, Eli Lilly and Company; Zhanglin Cui, Eli Lilly and Company; Xiang Zhang, CSL Behring; Kristin Sheffield, Eli Lilly and Company
12:40 PM	Standardized mortality ratio-weighted power prior approach for covariate-adjusted borrowing of historical control data Ryo Sawamoto, The University of Tokyo; Yutaka Matsuyama, The University of Tokyo
12:45 PM	Statistical Design and Data Analysis for the Effect of the Multiple Doses of a Treatment on Renal Functions Using a Pharmacodynamic Biomarker Meiyu Shen, Office of Biostatistics CDER, FDA; Kimberly Smith, FDA
12:50 PM	Integrated Propensity Score-Power Prior Approach for Augmenting the Control Arm of a Randomized Controlled Trial Yeonil Kim, Merck & Co., Inc.; Erina Paul, Merck & Co., Inc.; Santosh Sutradhar, Merck & Co., Inc.
1:00 PM	P-Value Distribution with Historical Data Borrowing Jasmine Zhang, University of Illinois at Urbana Champaign
1:05 PM	Up-Front Matching: An Ongoing Recruitment Method for Prospective Observational Studies That Mimics Randomization for Selected Baseline Covariates Ibrahim Turkoz, Janssen Research and Development, LLC; William H Olson, WHO Statistical Consulting, LLC
1:10 PM	Optimal Dose Finding Using Bayesian Utility with Toxicity and Efficacy Endpoints Haolun Shi, Simon Fraser University; Ruitao Lin, The University of Texas MD Anderson Cancer Center; Ying Yuan, Department of Biostatistics, University of Texas MD Anderson Cancer Center; Jiguo Cao, Simon Fraser University
1:15 PM	Flexible Use of Copula-Type Model for Dose-Finding in Drug Combination Clinical Trials Koichi Hashizume, Graduate School of Engineering, Tokyo University of Science; Jun Tsuchida, Doshisha University; Takashi Sozu, Faculty of Engineering, Tokyo University of Science
1:20 PM	Using a Piecewise Model to Account for Treatment Gaps When Evaluating Continuous Outcomes Xiaolei Zhou, RTI Health Solutions
1:25 PM	Impact of Informative Follow-Up Visits on Longitudinal Real-World Data and Evidence Studies of Comparative Effectiveness: An Application in Multiple Sclerosis Paramita Saha Chaudhuri, University of Vermont; Gabrielle Simoneau, Biogen; Shirley Liao, Biogen; Changyu Shen, Biogen; Fabio Pellegrini, Biogen; Carl de Moor, Biogen
1:30 PM	Statistical Consideration of Extrapolation of Adult Efficacy Data to Pediatric Population Cassie Dong, Takeda; Yulia Sidi, Takeda
1:35 PM	Practical Guidance for Successful BLA Submissions from a Statistician’s Perspective tulin shekar, Merck

390 * !	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
Scalable Bayes for Large Multi-Omics Data Integration and Inference — Invited Papers
Section on Bayesian Statistical Science, Biometrics Section, Biopharmaceutical Section
Organizer(s): Himel Mallick, Merck Research Laboratories
Chair(s): Richard Baumgartner, Merck Research Laboratories
2:05 PM	Bayesian Integrative Approaches to Enable Precision Medicine Veerabhadran Baladandayuthapani, University of Michigan
2:30 PM	Models for Microbial Community Multi-Omics Curtis Huttenhower, Harvard T.H. Chan School of Public Health
2:55 PM	Integrating Gene Networks and Multi-Omics Data to Understand Genetic Mechanisms of Human Complex Diseases Bingshan Li, Vanderbilt University
3:20 PM	Scalable Bayesian Inference of Networks and Covariate Effects Christine B. Peterson, The University of Texas MD Anderson Cancer Center
3:45 PM	Floor Discussion

394 * !	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
Population Diversity Considerations in Clinical Trials — Invited Papers
Health Policy Statistics Section, Social Statistics Section, Biopharmaceutical Section, Caucus for Women in Statistics
Organizer(s): Freda Cooner, Amgen
Chair(s): Freda Cooner, Amgen
2:05 PM	Digitizing Clinical Trials to Enhance Diversity Demissie Alemayehu, Pfizer; Kannan Natarajan, Pfizer Inc.; Satrajit Roychoudhury, Pfizer Inc.
2:25 PM	Diversity and Inclusion in Clinical Trials Rajaa Nahra, AstraZeneca; Claudia Cabrera, AstraZeneca
2:45 PM	Enrollment Disparities by Demographic Subgroups in Oncology Clinical Trials Submitted to the US FDA Laura Fernandes, FDA
3:05 PM	Leveraging Real-World Evidence to Increase Diversity of Populations in Clinical Trials Cody Chiuzan, Columbia University
3:25 PM	Discussant: Ruthanna Davi, Medidata Solutions
3:45 PM	Floor Discussion

406 !	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
Novel Approaches for Handling Complex Data in Treatment Diagnosis and Evaluation — Topic-Contributed Papers
Biometrics Section, Mental Health Statistics Section, Biopharmaceutical Section
Organizer(s): Thaddeus Tarpey, NYU
Chair(s): Hyung Park, NYU
2:05 PM	An Imputation Approach for Estimating Confidence in Personalized Treatment Decisions Nina Orwitz, NYU Grossman School of Medicine; Eva Petkova, New York University School of Medicine; Thaddeus Tarpey, NYU
2:25 PM	Prospective Individual Patient Data Meta-Analysis: Evaluating Convalescent Plasma for COVID-19 Danni Wu, NYU Grossman School of Medicine; Eva Petkova, New York University School of Medicine; Keith Goldfeld, NYU Grossman School of Medicine; Thaddeus Tarpey, NYU
2:45 PM	Extracting Scalar Measures from Functional Data with Missingness Lanqiu Yao, New York University; Thaddeus Tarpey, NYU
3:05 PM	Optimal Linear Transformations of Functional Data for Clustering Methods Hanchao Zhang, New York University Grossman School of Medicine
3:25 PM	Discussant: Thaddeus Tarpey, NYU
3:45 PM	Floor Discussion

407 *	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
Toward a Regulatory Guidance for the Use of Bayesian Methods in Nonclinical CMC Statistics — Topic-Contributed Papers
Section on Bayesian Statistical Science, Biopharmaceutical Section, Quality and Productivity Section
Organizer(s): Paul Faya, Eli Lilly and Compnay
Chair(s): Paul Faya, Eli Lilly and Compnay
2:05 PM	Toward a Regulatory Guidance for Bayesian Statistics in CMC Studies Dave LeBlond, Consultant
2:25 PM	Gaussian Process Modeling for Dissolution Curve Comparisons Tony Pourmohamad, Genentech, Inc.; Cristian Oliva Aviles, Genentech, Inc.; Robert Richardson, Brigham Young University
2:45 PM	Informative Priors for Formal Stability Studies Percy Sondag, Merck Center for Mathematical Sciences
3:05 PM	Floor Discussion

409 * !	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
Estimands in Oncology: Papers from an Industry Working Group — Topic-Contributed Papers
Biopharmaceutical Section, Lifetime Data Science Section, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Jonathan Siegel, Bayer US
Chair(s): Jonathan Siegel, Bayer US
2:05 PM	Utilizing Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect Jianchang Lin, Takeda Pharmaceuticals; Qing Li, Takeda Pharmaceuticals; Mengya Liu, Takeda Pharmaceuticals; Liwen Wu, University of Pittsburgh
2:25 PM	Use of Estimand Framework in Hematology Oncology Trials: Practical Implementation Presentation Steven C Sun, Janssen; Satrajit Roychoudhury, Pfizer Inc.
2:45 PM	Logic-Respecting Efficacy Measures in the Presence of Prognostic or Predictive Biomarker Subgroups Yi Liu, Nektar Therapeutic
3:05 PM	Treatment Switching and Estimands for Overall Survival in Oncology Clinical Trials: Issues and Controversies Natalia Kan-Dobrosky, PPD Inc
3:25 PM	Discussant: Satrajit Roychoudhury, Pfizer Inc.
3:45 PM	Floor Discussion

412	Thu, 8/12/2021, 2:00 PM - 3:50 PM	Virtual
The People, Project, and Particulars of Joining Biopharma as a Biostatistician — Topic-Contributed Panel
Biopharmaceutical Section, Biometrics Section, Section on Teaching of Statistics in the Health Sciences
Organizer(s): Glen Laird, Vertex Pharmaceuticals
Chair(s): Glen Laird, Vertex Pharmaceuticals
2:05 PM	The People, Projects, and Particulars of Joining Biopharma as a Biostatistician
Panelists:	Bo Yang, Vertex Pharmaceuticals Prabhu Bhagavatheeswaran, Daichi Sankyo Darcy Hille, Merck Ina Jazic, Vertex Pharmaceuticals
3:45 PM	Floor Discussion

421 * !	Thu, 8/12/2021, 4:00 PM - 5:50 PM	Virtual
Statistical Challenges Linked to Estimands of Interest: Leaving No Stone Unturned — Invited Papers
Biopharmaceutical Section, ENAR, Biometrics Section
Organizer(s): Pilar Lim, Janssen Research & Development, LLC; Elena Polverejan, Janssen Research & Development, LLC
Chair(s): Elena Polverejan, Janssen Research & Development, LLC
4:05 PM	The Only Missing Data Left in Town? Study Withdrawals and the Treatment Policy Approach Siying Sylvia Li, IQVIA; Michael O'Kelly, IQVIA
4:30 PM	The Role of Hypothetical Estimand Strategies in Clinical Trials Frank Bretz, Novartis AG; Mouna Akacha, Novartis
4:55 PM	Does This Treatment Cause That Outcome? Stephen J Ruberg, Analytix Thinking, LLC
5:20 PM	Discussant: H. M. James Hung, U.S. Food and Drug Administration (FDA)
5:45 PM	Floor Discussion

441	Thu, 8/12/2021, 4:00 PM - 5:50 PM	Virtual
Bayesian (and Other) Clinical Trials Designs — Contributed Speed
Biopharmaceutical Section
Chair(s): Madan G Kundu, Daiichi Sankyo, Inc.
4:05 PM	Statistical Properties of Phase 3 Randomized 3-Arm Umbrella Trials Yixin Ren, Merck & Co., Inc.; Xiaoyun (Nicole) Li, Merck & Co.; Cong Chen, Merck & Co., Inc.
4:10 PM	Operational Characteristics of Generalized Pairwise Comparisons for Hierarchically Ordered Endpoints Vaiva Deltuvaite-Thomas, IDDI; Tomasz Burzykowski, IDDI
4:15 PM	R Package Development for Evaluating Misclassification Effects on Single Sequential Treatment and Dynamic Treatment Regimens in Sequential Multiple Assignment Randomized Trial Jun He, The Mayo Clinic; Jason Sinnwell, The Mayo Clinic; Abraham D. Eyman Casey, The Mayo Clinic; Donna K McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University
4:20 PM	WITHDRAWN: Data-Driven Design of Targeted Gene Panels for Estimating Immunotherapy Biomarkers Jacob Richard Bradley, University of Edinburgh; Timothy Cannings, University of Edinburgh
4:25 PM	A Review of Dynamic Bayesian Borrowing of Individual Patient Data (IPD) in Survival Analysis Mohamad Hasan, Johnson & Johnson
4:30 PM	Bayesian Design of Superiority Trials: Methods and Applications Wenlin Yuan, University of Connecticut; Ming-Hui Chen, UCONN; John Zhong, REGENXBIO Inc.
4:35 PM	Bayesian Logistic Regression with Covariates in Oncology Dose Escalation Arnab Kumar Maity, Pfizer; MARZIEH GOLMAKANI, PFIZER; LADA ALEKSANDROVNA MARKOVTSOVA, PFIZER
4:40 PM	Bayesian Multi-Regional Clinical Trials Using Model Averaging Nathan Bean, University of North Carolina at Chapel Hill; Joseph G Ibrahim, UNC; Matthew Psioda, UNC Chapel Hill
4:45 PM	WITHDRAWN: Dynamic Borrowing Design for Randomized Study with Time-to-Event Endpoint Zangdong He, GlaxoSmithKline; Wei Guo, GlaxoSmithKline (former employee); Ilker Yalcin, Adagio Therapeutics
4:50 PM	Could Simulation Enrich Power Analysis and Sample Size Justification? A Case of Survival Analysis for Illustration Dung-Tsa Chen, Moffitt Cancer Center
5:00 PM	Dampening Placebo Effect with Enriched Run-In Design in Randomized Clinical Trials Ping Xu, Merck & Co.; qing li, Merck & co., Inc.; Richard Entsuah, Merck & Co.
5:05 PM	Replicate Testing Strategies in Vaccine Efficacy Trials Can Prevent No-Go Decisions for Beneficial Vaccines Radha A Railkar, Biostatistics and Research Decision Sciences, Merck & Co., Inc.; Jeffrey Sachs, Merck & Co.; Daniel Rosenbloom, Merck & Co.
5:10 PM	Facilitating go/no-go decision in early phase study with Average Distance to Decision threshold (ADD) Presentation Danni Yu, Nektar Therapeutics
5:15 PM	An Updated Pick-the-Winner Design Allowing a Flexible Allocation Ratio at Stage Two Bing Liu, University of Kansas, Medical Center; Jianghua He, University of Kansas Medical Center
5:20 PM	Pediatric Trial with Partial Extrapolation Madhuja Mallick, Abbvie
5:25 PM	Multi-Arm, Multi-Stage Clinical Trials for Time-to-Event Outcomes Vaidehi Ulhas Dixit, North Carolina State University; Priyam Mitra, Bristol Myers Squibb; Katy Simonsen, Bristol Myers Squibb
5:30 PM	Have the Stories Changed? Clinical Trial Data Analysis During a Pandemic Nicole C Close, EmpiriStat, Inc.
5:35 PM	Adjustment of Alpha for Final Analysis per Actual Number of Events in Event-Driven Clinical Trials Using Group Sequential Testing Procedure Li Wei, Bristol Myers Squibb; Stephen Lane, Bristol Myers Squibb
5:40 PM	Treatment Response vs. Treatment Effect Lev S Sverdlov, Redmond Analytics LLC

JSM 2021 Online Program

Activity Details

American Statistical Association