Name: 2018 Joint Statistical Meetings
Start: 2018-07-28T07:00:00+00:00
End: 2018-08-02
Location: Vancouver Convention Centre

Legend:
CC = Vancouver Convention Centre F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme

Activity Details

16 * !	Sun, 7/29/2018, 2:00 PM - 3:50 PM	CC-West 118
Big Data Detectives: Improving Human Health Through Informing Policy — Invited Panel
Health Policy Statistics Section, Biopharmaceutical Section, Biometrics Section
Organizer(s): Sherri Rose, Harvard Medical School
Chair(s): Ani Eloyan, Brown University
2:05 PM	Big Data Detectives: Improving Human Health Through Informing Policy Presentation 1 Presentation 2 Presentation 3 Presentation 4
Panelists:	Kristin Linn, University of Pennsylvania Laura Hatfield, Harvard Medical School Julian Wolfson, University of Minnesota Sherri Rose, Harvard Medical School
3:40 PM	Floor Discussion

17 * !	Sun, 7/29/2018, 2:00 PM - 3:50 PM	CC-West 306
Dose Selection and PDUFA VI: Advancing the Model Based Drug Development in Regulatory Environment — Topic Contributed Papers
Biopharmaceutical Section, Society for Clinical Trials, Health Policy Statistics Section
Organizer(s): Satrajit Roychoudhury, Pfizer
Chair(s): Satrajit Roychoudhury, Pfizer
2:05 PM	MIDD: Perspectives and Possibilities Presentation Dionne Price, Food and Drug Administration
2:25 PM	Dosing Designs for Bayesian Emax Models Presentation Neal Thomas, Pfizer
2:45 PM	Dose Selection Using Nonlinear Mixed-Effect Model Averaging Approaches in Conjunction with Adaptive Optimal Design Techniques Andrew Hooker, Uppsala Universitet
3:05 PM	Discussant: José Pinheiro, Janssen Research and Development
3:25 PM	Floor Discussion

20 *	Sun, 7/29/2018, 2:00 PM - 3:50 PM	CC-West 214
Statistical Considerations for Using Historical Controls in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Yeh-Fong Chen, US FDA
Chair(s): George Kordzakhia, US FDA
2:05 PM	Using Historical Controls in CNS Clinical Trials Xiang Ling, FDA/CDER/OTS/OB; Kun Jin, FDA; Hsien-Ming James Hung, PhD, Food and Drug Administration
2:25 PM	Designing Trials Using Bayesian Methods with Historical Controls Michael Sonksen, Eli Lilly and Company
2:45 PM	Advancing Methodologies for Clinical Trials Using Historical Control Presentation Min Min, U.S. Food and Drug Administration, CDER/OTS/OB; Yeh-Fong Chen, US FDA
3:05 PM	Use of Real-World in Clinical Drug Development Presentation Xiuyu Julie Cong, Boehringer Ingelheim Pharmaceuticals Inc; Susan Wang, Boehringer Ingelheim Pharmaceuticals Inc.
3:25 PM	Discussant: Aloka Chakravarty, Office of Biostatistics of CDER/FDA
3:45 PM	Floor Discussion

37 !	Sun, 7/29/2018, 2:00 PM - 3:50 PM	CC-West 304/305
Statistical Issues Specific the Therapeutic Areas - 1 — Contributed Papers
Biopharmaceutical Section
Chair(s): Hui Wang, Amgen, Inc.
2:05 PM	Robust Dose Response Estimation Presentation Shouhao Zhou, University of Texas MD Anderson Cancer Center
2:20 PM	Statistical Development in Addressing Delayed Treatment Effect or Crossing Survival Curves in Immuno-Oncology Clinical Trials Presentation Huyuan Yang, Takeda Oncology Pharmaceutical
2:35 PM	Cure Survival Data in Oncology Studies Presentation Shih-Yuan Lee, Takeda
2:50 PM	Meta-Analysis for the Adjuvant Treatment in Renal Cell Carcinoma Presentation Weichao Bao, Novartis Pharmaceuticals Corporation
3:05 PM	Correlation Between the Time-To-Event Endpoints in Prostate Cancer Clinical Trials Susan Li, Janssen R&D
3:20 PM	Statistical Evaluation of Oncology Drug Trial Portfolios and the Potential for Inappropriate Regulatory Approval: a Simulation Study Presentation Renee Gennarelli, Memorial Sloan Kettering Cancer Center; Peter Bach, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
3:35 PM	A Case Study on Model Based Meta-Analysis (MBMA) for Drug Development Decisions Presentation Guohui Liu, Takeda Pharmaceuticals Inc ; Zhaoyang Teng, Takeda pharmaceuticals international, Co; Zhaowei Hua, Takeda Pharmaceuticals International Co.; Neeraj Gupta, Takeda pharmaceuticals international, Co; Richard Labotka, Takeda pharmaceuticals international, Co

44 * !	Sun, 7/29/2018, 4:00 PM - 5:50 PM	CC-West 306
Innovative Clinical Trial Designs and Analytic Methods in Neuroscience — Invited Papers
Biopharmaceutical Section, ENAR, Biometrics Section
Organizer(s): Pilar Lim, PhD, Janssen Research & Development, LLC
Chair(s): Pilar Lim, PhD, Janssen Research & Development, LLC
4:05 PM	New Developments with the Sequential Parallel Comparison Design Presentation Gheorghe Doros, Boston University; Denis Rybin, Pfizer, Inc
4:25 PM	Missing Data Issues in the Studies of Neurodegenerative Disorders: The Methodology Presentation Sheng Luo, Duke University Medical Center; Kan Li, University of Texas Health Science Center
4:45 PM	Using Delayed Start Design and Analysis to Investigate Potential Disease Modifying Effects in Alzheimer's Disease Presentation Hong Liu-Seifert, Eli Lilly and Company; Scott Andersen, Eli Lilly and Company
5:05 PM	Practical Bayesian Modeling and Subgroup Inference in Alzheimer's Drug Development Brad Carlin, University of Minnesota; Patrick Schnell, Ohio State University; Mark Fiecas, University of Minnesota; Peter Müller, University of Texas Austin; Qi Tang, Sanofi; Walter Offen, AbbVie
5:25 PM	Discussant: Hsien-Ming James Hung, PhD, Food and Drug Administration
5:45 PM	Floor Discussion

55 * !	Sun, 7/29/2018, 4:00 PM - 5:50 PM	CC-East 16
Non-Proportional Hazards in Clinical Trials: Challenges and Opportunities — Topic Contributed Papers
Section on Statistical Graphics, Biopharmaceutical Section, International Society for Clinical Biostatistics, ENAR
Organizer(s): Junshan Qiu, FDA/CDER
Chair(s): Junshan Qiu, FDA/CDER
4:05 PM	Kaplan-Meier Based Methods to Address Non-Proportional Hazard Issues Presentation Bo Huang, Pfizer Inc.
4:25 PM	Design and Analysis of Survival Trials with Treatment Crossover Presentation Xiaodong Luo, Sanofi
4:45 PM	Case Studies of Non-Proportional Hazards in Oncology and Hematology Trials Jingjing Ye, FDA
5:05 PM	Design and Analysis of Cancer Immunotherapy Trials with Potential Violation of Proportional Hazards Assumption Xiaofei Wang, Duke University School of Medicine; Guangyu Yang , University of Michigan
5:25 PM	Discussant: Rajeshwari Sridhara, US Food and Drug Adminstration
5:45 PM	Floor Discussion

75 !	Sun, 7/29/2018, 4:00 PM - 5:50 PM	CC-West 222
Clinical Trial Design-1 — Contributed Papers
Biopharmaceutical Section
Chair(s): Genming Shi, Bayer
4:05 PM	The Win Ratio: What Is It? Presentation Victoria Chang, AbbVie; Gaohong Dong, iStats Inc.; Junshan Qiu, US Food and Drug Administration; Marc Vandemeulebroecke, Novartis; Roland Matsouaka, Duke University School of Medicine; Di Li, Bristol-Myers Squibb Co.; David Hoaglin, University of Massachusetts Medical School
4:20 PM	Sample Size and Power Calculation for Immuno-Oncology Clinical Trials Binbing Yu, MedImmune, Inc.; Dongyue FU, MedImmune, Inc.; Hefei (Harry) Yang, MedImmune, Inc.
4:50 PM	Clinical Trial Technologies for Precision Medicine: The Current State of the Art Presentation Steven J Schwager, Medidata Solutions; Ruthanna Davi, Medidata Solutions; Therese Dolan, Medidata Solutions; Jeff Wiser, Medidata Solutions
5:05 PM	A Hybrid Approach for Prediction of Event Times in Double-Blind Clinical Trials Ming Zhu, Sanofi Pasteur; Yunnan Xu, Virginia Tech; Zheng Su, Deerfield Institute
5:20 PM	MCP-Mod Based Quantitative Techniques for Decision Making Process in Phase II Dose-Finding Clinical Trials Presentation Na Cai, Astellas; Annie Wang, Astellas Pharma; Michael Smith, Astellas
5:35 PM	Novel Approach in Analyzing Difference in Binomial Proportions in Stratified Clinical Trials Anindita Banerjee, Pfizer; Vivek Pradhan, Pfizer

87	Sun, 7/29/2018, 8:30 PM - 10:30 PM	CC-West Hall B
Invited ePoster Session: a Statistical Smörgåsbord — Invited Poster Presentations
SSC, Section on Bayesian Statistical Science, Section on Statistics in Epidemiology, Section on Statistical Learning and Data Science, Section on Nonparametric Statistics, Biometrics Section, Section on Statistics and the Environment, Section for Statistical Programmers and Analysts, Section on Statistics in Imaging, WNAR, Social Statistics Section, Astrostatistics Special Interest Group, Biopharmaceutical Section, ENAR, Section on Risk Analysis, Section on Statistical Consulting
Chair(s): Paul McNicholas, McMaster University
1:	The LISA 2020 Program to Build Statistics Capacity in Developing Countries Eric Vance, LISA-University of Colorado Boulder
2:	Conditions for the Uniqueness, Finiteness, and Possible Location of the Maximum Likelihood Estimate with a Log Binomial Model Gurbakhshash Singh, University of Calgary; Gordon Hilton Fick, University of Calgary
3:	Two Mixture-Based Clustering Approaches: Modeling an Automobile Insurance Portfolio Tatjana Miljkovic, Miami University; Daniel Fernandez, Victoria University of Wellington
4:	An Expectation Conditional Maximization Approach for Gaussian Graphical Models Zehang Li, University of Washington; Tyler McCormick, University of Washington
5:	A Bayesian Model for Multivariate Micro-Level Insurance Claims Marie-Pier Côté, Universite Laval; Christian Genest, McGill University; David A Stephens, McGill University
6:	Deep Learning for Statistical Inference in Infectious Disease Systems Rob Deardon, University of Calgary; Carolyn Augusta, University of Guelph; Graham Taylor, University of Guelph
7:	Flexible Accelerated Failure Time Model in Survival Analysis Menglan Pang, McGill University; Michal Abrahamowicz, McGill University; Robert W Platt, McGill University
8:	Spatio-Temporal Analysis of Children and Adolescents' Emergency Department Use for Mental Health Reasons in Alberta, Canada Michelle Thiessen, Simon Fraser University; Joan Hu, Simon Fraser University; Rhonda J. Rosychuk, University of Alberta
9:	Approximate Bayesian Computation with Complex High-Dimensional Data and Limited Simulations Taylor Gene Pospisil, Carnegie Mellon University
10:	Zero Counts in Single Cell RNA-Seq Data Hao Wu, Emory University; Zhijin Wu, Brown University
11:	Quasi-Oracle Estimation of Heterogeneous Treatment Effects Xinkun Nie, Stanford University; Stefan Wager, Stanford University
12:	Estimation of Fire Duration Distribution with Missing Start Time Yi Xiong, Simon Fraser University; John Braun, University of British Columbia ; Joan Hu, Simon Fraser University
13:	Bayesian Nonparametric Hierarchical Models for Lightcurve Classification and Observation Decisions David Edward Jones, Duke University and SAMSI; Sujit Ghosh, North Carolina State Univ.; Ana-Maria Staicu, NC State University; Ashish Mahabal, Caltech
14:	Approximate Bayesian Computation for the Stellar Initial Mass Function Jessi Cisewski-Kehe, Yale University; Chad Schafer, Carnegie Mellon University; Grant Weller, Savvysherpa; David Hogg, New York University
15:	A Novel Bayesian Framework to Probe Closed Box Nature of Galaxy Clusters Arya Farahi, University of Michigan - Ann Arbor
16:	Statistical Approaches to Decreasing the Discrepancy of Non-Detects in QPCR Data Valeriia Sherina, University of Rochester Medical Center; Love Tanzy, University of Rochester Medical Center; Matthew N. McCall, University of Rochester Medical Center
17:	Generalized Statistical Inference for Astrophysical Discoveries Sara Algeri, Imperial College London; David A van Dyk, Imperial College London; Jan Conrad, Oskar Klein Centre for Cosmoparticle Physics
18:	Nonparametric Causal Effects Based on Incremental Propensity Score Interventions Edward Kennedy, Carnegie Mellon University; Matteo Bonvini, Carnegie Mellon University
19:	Addressing Overfitting in Mixtures of Factor Analyzers Jeffrey L Andrews, University of British Columbia Okanagan
20:	Spatiotemporal Analysis of Environmental Health Risk Renjun Ma, University of New Brunswick; Edward Hughes, Edward Hughes Consulting
21:	Probabilistic Partial Least Squares Regression Applied to Longitudinal and Cross-Sectional Compositional Data Peter A Tait, McMaster Univeristy; Paul McNicholas, McMaster University
22:	Detection of Trend Onset in Environmental Time Series Ying Zhang, Acadia University
23:	The Analysis of Face Perception MEG and EEG Data Using a Potts-Mixture Spatiotemporal Joint Model Yin Song, University of Victoria; Farouk Nathoo; Arif Babul, University of Victoria
24:	Infere Steven Cumming, Université Laval
25:	Functional Partial Linear Quantile Regression Based on Reproducing Kernel Hilbert Space Peng Liu, University of Alberta; Linglong KONG, University of Alberta; Bei JIANG, University of Alberta; Nan Zhang, Fudan University; Jianhua Z. Huang, Texas A&M University
26:	Gaussian Process Regression with Large Data Sets: Has the Problem Been Solved? Sonja Surjanovic, University of British Columbia; William Welch, University of British Columbia
27:	Sparse Estimation for Functional Semiparametric Additive Model Peijun Sang, Simon Fraser University; Richard Lockhart, Simon Fraser University; Jiguo Cao, Simon Fraser University
28:	Analysis of Paired Binary Data Subject to Misclassification Using a Random Effect Model Hua Shen, University of Calgary ; Richard John Cook, University of Waterloo
29:	A Grouped Weighted Quantile Regression Approach to Modeling Environmental Chemical Mixtures and Childhood Leukemia Risk David C. Wheeler, Virginia Commonwealth University
30:	Efficient Robust Doubly Adaptive Regularized Regression with Application to fMRI Data Wei Tu, University of Alberta
31:	A Model-Based Clustering to Identify Disease-Associated SNPs Li Xing, University of Victoria; Xuekui Zhang, University of Victoria; Yan Xu, University of Victoria; Weiliang Qiu, Brigham and Women's Hosptial/Harvard Medical School
32:	The Consequences of Requiring 'Greater Statistical Stringency' for Scientific Publication Harlan Campbell, University of British Columbia; Paul Gustafson, University of British Columbia
33:	Mixtures of Contaminated Shifted Asymmetric Laplace Factor Analyzers Brian C Franczak, MacEwan University
34:	Uncertainty Quantification of Stochastic Computer Model for Binary Black Hole Formation Luyao Lin, Simon Fraser University; Jim Barrett, University of Birmingham; Derek Bingham, Simon Fraser University; Ilya Mandel, University of Birmingham
35:	Network Meta-Analysis of Disconnected Networks: How Dangerous Are Random Baseline Treatment Effects? Audrey Béliveau, University of Waterloo; Sarah Goring, SMG Outcomes Research; Robert W Platt, McGill University; Paul Gustafson, University of British Columbia
36:	Nonparametric Measures of Local Causality and Tests of Local Non-Causality in Time Series Felix Camirand Lemyre, School of mathematics and statistics, University of Melbourne; Taoufik Bouezmarni, Université de Sherbrooke; Jean-François Quessy, Université du Québec à Trois-Rivières
37:	Sparse Functional Principal Component Analysis in a New Regression Framework YUNLONG NIE, Simon Fraser University; Jiguo Cao, Simon Fraser University
38:	Inference of Introgressive Hybridization in Anopheles Mosquito Genomes Jingxue(Grace) Feng, Simon Fraser University; Liangliang Wang, Simon Fraser University; Cedric Chauve, Simon Fraser University
39:	Statistical Methods for Addressing Missing Data in HIV/AIDS Surveillance Systems Sahar Zangeneh, Fred Hutchinson Cancer Research Center; Ying Qing Chen, Fred Hutchinson Cancer Research Center; Deborah Donnell, Fred Hutch
40:	Latent Mixtures of Functions to Characterize the Complex Exposure Relationships of Pesticides on Cancer Incidence Sung Duk Kim, National Cancer Institute; Paul S Albert, National Cancer Institute

88	Mon, 7/30/2018, 7:00 AM - 8:15 AM	CC-West Ballroom D
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
ML01:	Evaluating Drug Combinations in the Discovery and Pre-Clinical Stage Jocelyn Sendecki
ML02:	Composite Endpoints for Alzheimer's Disease Clinical Trials Steve Edland, University of California, San Diego

216504	Mon, 7/30/2018, 7:30 AM - 12:00 PM	F-Malaspina
Biopharmaceutical Section Executive Committee Meeting (Closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Heather Thomas, Biopharmaceutical Section

CE_15C	Mon, 7/30/2018, 8:00 AM - 12:00 PM	CC-East 2/3
Meta-Analysis for Biopharmaceutical and Public Health Research Using SAS (ADDED FEE) — Professional Development Continuing Education Course
ASA, Biopharmaceutical Section, Section on Teaching of Statistics in the Health Sciences
Instructor(s): Michael LaValley, Boston University School of Public Health; Ludovic Trinquart, Boston University School of Public Health
Meta-analysis is the gold standard statistical approach to combine the results of multiple studies and to examine sources of heterogeneity and potential biases. This course will review fixed-effect and random-effects models, including the newly-recommended approaches, that underlie the combination of study results in meta-analysis; the use of study-level predictors in meta-regression; novel limit meta-analysis models to adjust for small-study effects and related reporting biases; and the synthesis of individual participant data. Throughout the course, participants will apply each model by using the SAS/STAT software and produce high-quality graphs, with original macros developed by the instructors. The target audience includes biostatisticians, data analysts, and quantitative researchers from academia, the pharmaceutical industry, the FDA and other government institutions with a basic knowledge of study design and regression modeling.
8:00 AM	Meta-Analysis for Biopharmaceutical and Public Health Research Using SAS (ADDED FEE) Ludovic Trinquart, Boston University School of Public Health; Michael LaValley, Boston University School of Public Health

108 * !	Mon, 7/30/2018, 8:30 AM - 10:20 AM	CC-West 214
New Era for Safety Evaluation — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, American Public Health Association
Organizer(s): Freda Cooner, Sanofi
Chair(s): Freda Cooner, Sanofi
8:35 AM	The Role of Real World Evidence in a Regulatory Environment: Focus on Safety Presentation Estelle Russek-Cohen, US FDA CDER
8:55 AM	Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights Presentation Olga Marchenko, Bayer
9:15 AM	Propensity-Score-Based Controls: Its Use in Establishing Benefit/Risk of Medicines for Unmet Medical Need Presentation Junjing Lin, AbbVie; Margaret Gamalo-Siebers, Eli Lilly & Co; Ram Tiwari, Center for Devices and Radiologica Health, FDA
9:35 AM	Visual Analytics in the Real World Evidence Data Realm Melvin Munsaka, AbbVie, Inc.; Kefei Zhou, Theravance Biopharma; Krishan P. Singh, GlaxoSmithKline
9:55 AM	Discussant: Judy Li, Regeneron Pharmaceuticals Inc.
10:15 AM	Floor Discussion

110 * !	Mon, 7/30/2018, 8:30 AM - 10:20 AM	CC-West 215/216
Assessing Treatment Effects for Life History Processes — Topic Contributed Papers
Biopharmaceutical Section, Mental Health Statistics Section, ENAR
Organizer(s): Mouna Akacha , Novartis Pharma AG
Chair(s): Mouna Akacha , Novartis Pharma AG
8:35 AM	Symptom Trials Vs Morbidity/Mortality Trials: Are Different Estimands Required? Presentation Steven Snapinn, Amgen, Inc.
8:55 AM	Recurrent Event Estimands: With or Without Competing Terminal Event Presentation Jiawei Wei, Novartis
9:15 AM	Assessment of a Treatment Effect for Recurrent Event Data in the Presence of a Terminal Event Presentation Philip Hougaard, Lundbeck
9:35 AM	Comparison of Event Rates Between On- and Off-Drug Treatment Periods for a Recurrent Adverse Event Presentation Brenda Crowe, Eli Lilly & Co.; Haoda Fu, Eli Lilly and Company; Yebin Tao, Eli Lilly and Company
9:55 AM	Discussant: Hsien-Ming James Hung, PhD, Food and Drug Administration
10:15 AM	Floor Discussion

117 * !	Mon, 7/30/2018, 8:30 AM - 10:20 AM	CC-West 118
Four Decades of Statistical Consulting — Topic Contributed Panel
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Section on Statistical Consulting, Section on Teaching of Statistics in the Health Sciences
Organizer(s): Kent Koprowicz, Axio Research LLC
Chair(s): Vipin Arora, Eli Lilly and Company
8:35 AM	Four Decades of Statistical Consulting Presentation 1 Presentation 2 Presentation 3 Presentation 4
Panelists:	Kent Koprowicz, Axio Research LLC Steve Kirby, Covance Inc. Natasa Rajicic, Cytel Inc. Lisa Weissfeld, Statistics Collaborative
10:10 AM	Floor Discussion

122	Mon, 7/30/2018, 8:30 AM - 10:20 AM	CC-West 219
Clinical Trial Design and Missing Data — Contributed Papers
Biopharmaceutical Section
Chair(s): Mei Huang, Amgen
8:35 AM	Impact on Statistical Power by Different Imputation Methods for Binary Endpoints with Missing Data Xiaomei Liao, AbbVie Inc.; Jun Zhao, AbbVie; Bidan Huang, AbbVie Inc.
8:50 AM	Missing Data Framework for Estimating Biomarker Clinical Utility Under Incomplete Follow-Up Presentation Julie Kobie, Merck Research Laboratories; Lingkang Huang, Merck Research Laboratories; Robin Mogg, Merck Research Laboratories; Jared Lunceford, Merck Research Laboratories
9:05 AM	Assessing the Uncertainty Due to Chemicals Below the Detection Limit in Chemical Mixture Estimation Presentation Paul Hargarten, VCU; David C. Wheeler, Virginia Commonwealth University
9:20 AM	Linking Medicare Current Beneficiary Survey (MCBS) to Augment Post-Market Real World Data from Medicare Claims: a Multiple Imputation Approach Presentation Yun Lu, FDA; Xiyuan Wu, Acumen LLC; Yoganand Chillarige, Acumen LLC; Michael Wernecke, Acumen LLC; Hector Izurieta, FDA; Jeffrey Kelman, CMS; Richard Forshee , FDA
9:50 AM	Bayesian Nonparametric Analysis of Longitudinal Data with Ordinal Outcomes and Non-Monotone Non-Ignorable Missingness Yu Cao, Virginia Commonwealth University; Nitai Mukhopadhyay, Virginia Commonwealth University
10:05 AM	Floor Discussion

129 !	Mon, 7/30/2018, 8:30 AM - 10:20 AM	CC-West 210
Adaptive Design - 1 — Contributed Papers
Biopharmaceutical Section
Chair(s): John Han
8:35 AM	Basket Trial Design Using Bayesian Model Averaging Matthew Psioda, University of North Carolina; Jiawei Xu, University of North Carolina; Qi Jiang, Amgen; Chunlei Ke, Biogen; Zhao Yang, Amgen Inc; Joseph G Ibrahim, University of North Carolina Chapel Hill
8:50 AM	Formulation of Data Monitoring Committee Recommendations for Adaptive Design Clinical Trials Presentation Navneet Hakhu, Axio Research
9:05 AM	Efficient Two-Stage Designs and Proper Inference for Animal Studies Presentation Chunyan Cai, UT Health Science Center at Houston; Jin Piao, University of Southern California; Jing Ning, The University of Texas M.D. Anderson Cancer Center; Xuelin Huang, University of Texas MD Anderson Cancer Center
9:20 AM	How to Inform and Revise Dose in Pediatric Program --- Some Statistical and Strategic Thinking Presentation Yang Liu, Merck & Co Inc; Anne Chain, Merck; Rebecca Wrishko, Merck; Man (Mandy) Jin, Merck & Co., Inc.; Elizabeth Schaeffer, Merck; Kara Bickham, Merck
9:35 AM	Specification Setting - an Adaptive Approach Presentation Brad Evans, Pfizer, Inc
9:50 AM	A Novel Framework for Bayesian Response-Adaptive Randomization Jian Zhu, Takeda; Ina Jazic, Harvard University; Yi Liu, Takeda Pharmaceuticals
10:05 AM	Closed-Form Solutions for Group Sequential Design in Survival Trials with Non-Proportional Hazards Jianliang Zhang, Medimmune, LLC; Erik Pulkstenis, AbbVie

CE_16C	Mon, 7/30/2018, 8:30 AM - 5:00 PM	CC-East 1
Introduction to Bayesian Nonparametric Methods for Causal Inference (ADDED FEE) — Professional Development Continuing Education Course
ASA, Biometrics Section, Biopharmaceutical Section
Instructor(s): Michael Daniels, University of Florida; Jason Roy, University of Pennsylvania
Bayesian nonparametric (BNP) methods can be used to flexibly model joint or conditional distributions, as well as functional relationships. These methods, along with causal assumptions, can be used with the g-formula for inference about causal effects. This general approach to causal inference has several possible advantages over popular semiparametric methods, including efficiency gains, the ease of causal inference on any functionals of the distribution of potential outcomes, the use of prior information, and capturing uncertainty about causal assumption via informative prior distributions. In this short course we review BNP methods and illustrate their use for causal inference in the setting of point treatments, dynamic (longitudinal) treatments, and mediation. We present several data examples and discuss software implementation using R. The R code and/or packages used to run the data examples will be provided to the attendees at a specific github site.
8:30 AM	Introduction to Bayesian Nonparametric Methods for Causal Inference (ADDED FEE) Jason Roy, University of Pennsylvania; Michael Daniels, University of Florida

140 * !	Mon, 7/30/2018, 10:30 AM - 12:20 PM	CC-West 211
Design and Analysis of Cancer Immunotherapy Trials — Invited Papers
Biopharmaceutical Section, Society for Clinical Trials, Statistics in Biopharmaceutical Research Journal
Organizer(s): Zhenzhen Xu , FDA
Chair(s): Bifeng Ding, AbbVie
10:35 AM	A Bayesian Phase I/II Trial Design for Immunotherapy Presentation Suyu Liu, MD Anderson Cancer Center; Beibei Guo, Louisiana State University; Ying Yuan, University of Texas M.D. Anderson Cancer Center
11:00 AM	Achieving Optimal Power of Logrank Test with Random Treatment Time-Lag Effect Zhenzhen Xu , FDA; Yongsoek Park, Unversity of Pittsburgh; Boguang Zhen, FDA; Bin Zhu, NIH/NCI
11:25 AM	Use of Piecewise Weighted Log-Rank Test for Trials with Delayed Treatment Effect Presentation Boguang Zhen, FDA; Zhenzhen Xu , FDA; Bin Zhu, NIH/NCI; Yongsoek Park, Unversity of Pittsburgh
11:50 AM	Practical Considerations on the Challenges to the Design and Analysis of Immuno-Oncology Trials Presentation Yabing Mai, AbbVie, Inc; Yue Shentu, Merck and Co Inc
12:15 PM	Floor Discussion

150 * !	Mon, 7/30/2018, 10:30 AM - 12:20 PM	CC-East 17
Lead with Statistics in Medical Device Innovations and Beyond — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal
Organizer(s): Yunling Xu, FDA/CDRH
Chair(s): Rajesh Nair, CDRH/FDA
10:35 AM	Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges Presentation Lilly Yue, U.S. Food and Drug Administration; Nelson Lu, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:55 AM	A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies Presentation Chenguang Wang, John Hopkins University; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
11:15 AM	Bayesian Approach for Benefit-Risk Assessment with Examples Presentation Ram Tiwari, Center for Devices and Radiologica Health, FDA
11:35 AM	Statistics of Counting Molecules for Precision Medicine Svilen Tzonev
11:55 AM	Discussant: Gregory Campbell, GCStat Consulting
12:15 PM	Floor Discussion

162 * !	Mon, 7/30/2018, 10:30 AM - 12:20 PM	CC-West 215/216
Statistical Challenge and Issues in Vaccine Development — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section
Organizer(s): Frank G Liu, Merck Sharp & Dohme Inc.
Chair(s): Fabian Tibaldi, GSK
10:35 AM	Recent Challenges in Vaccine Clinical Development Tsai-Lien Lin, FDA/CBER
10:55 AM	Bridging to Bridges in Vaccine Development: Challenges in Comparing Multi-Serotype Vaccines Presentation Jonathan Hartzel, Merck
11:15 AM	Application of Futility Testing in Vaccine Outcome Studies (With a Recent Example) Presentation Aiying Chen, Sanofi Pasteur; Scott Patterson, Sanofi Pasteur; Ehab Bassily, Sanofi Pasteur
11:35 AM	Epidemiological Modeling to Guide Efficacy Study Design Evaluating Vaccines to Prevent Emerging Diseases Presentation An Vandebosch, Janssen; Joris Menten, Janssen ; Guillermo Herrera-Taracena, Janssen
11:55 AM	Maximum Diversity Weighting for Biomarkers with Application in HIV-1 Vaccine Studies Presentation Zonglin He, Fred Hutchinson Cancer Research Center; Youyi Fong, Fred Hutchinson Cancer Research Center
12:15 PM	Floor Discussion

174	Mon, 7/30/2018, 10:30 AM - 12:20 PM	CC-West 210
Biomarkers and Endpoint Validation — Contributed Papers
Biopharmaceutical Section
Chair(s): Veronica Powell, QST Consultations
10:35 AM	Leveraging Omics Biomarker in Early Clinical Trials - Concept, Utility and Impact on Decision Making Presentation Weidong Zhang, Pfizer Inc.
10:50 AM	Inference on Treatment Effect Modification by Marker Response in a Baseline Surrogate Measure Three-Phase Sampling Design Michal Juraska, Fred Hutchinson Cancer Research Center; Ying Huang, Fred Hutchinson Cancer Research Center; Peter Gilbert, Fred Hutchinson Cancer Research Center
11:05 AM	Comparison of Methods to Generate Reference Limits Bipasa Biswas, CDRH, FDA; Nairita Ghosal, University of Illinois at Chicago
11:20 AM	An Analysis of MIMIC Data for Potential Surrogate Markers for Vaccine Development Presentation Robert Small, Sanofi Pasteur; Pauline Jurvilliers, Sanofi Pasteur
11:35 AM	Statistics Used in Assay Validation Kenneth Liu
11:50 AM	Longitudinal Models for Kidney Function Decline Presentation Jing Zhang, Moores UCSD Cancer Center; Loki Natarajan, UCSD; Kumar Sharma, Division of Nephrology,University of Texas Health San Antonio; Tina Costacou, University of Pittsburgh; Janet Snell-Bergeon , University of Colorado Anschutz Medical Campus, School of Medicine; Rachel Miller, University of Pittsburgh; Trevor Orchard, University of Pittsburgh
12:05 PM	Floor Discussion

201	Mon, 7/30/2018, 12:30 PM - 1:50 PM	CC-West Ballroom D
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
ML11:	Challenges in Oncology: Pragmatic Trials Using Real-World Evidence Zhe Zhang, Pfizer
ML12:	Assessing Treatment Benefit in Patient-Centric Study Designs Jagadish Gogate, Johnson & Johnson-Janssen R&D
ML13:	Standard Analyses and Displays for Common Clinical Trial Data: An Industry-Wide Initiative Mercidita Navarro, Genentech

226 * !	Mon, 7/30/2018, 2:00 PM - 3:50 PM	CC-West 214
Pediatric Trials - to Extrapolate or Not to Extrapolate — Topic Contributed Papers
Biopharmaceutical Section, Biopharmaceutical Section, Biometrics Section
Organizer(s): Freda Cooner, Sanofi
Chair(s): Fanni Natanegara, Eli Lilly and Company
2:05 PM	Extrapolation in Pediatric Drug Development: an Evolving Science Presentation Yeruk Mulugeta, FDA; Lynne Yao, US FDA
2:25 PM	The Promise and Peril of Pediatric Extrapolation Presentation Robert Nelson, Johnson & Johnson
2:45 PM	Utilizing Partial Extrapolation of Adult Data to Develop Confirmatory Pediatric Trials Presentation JonDavid Sparks, Eli Lilly and Company; Ryan Sides, Eli Lilly and Company; Fanni Natanegara, Eli Lilly and Company
3:05 PM	Bayesian Applications for Extrapolation from Adult to Pediatric Data Presentation Amy Xia, Amgen
3:25 PM	Discussant: Margaret Gamalo-Siebers, Eli Lilly & Co
3:45 PM	Floor Discussion

228 * !	Mon, 7/30/2018, 2:00 PM - 3:50 PM	CC-West 215/216
Innovative Statistical Designs with Real Life Case Studies for New Paradigms in Oncology Drug Development — Topic Contributed Papers
Biopharmaceutical Section, Society for Clinical Trials, ENAR
Organizer(s): Xiaoyun (Nicole) Li, Merck
Chair(s): Robert Beckman, Georgetown University
2:05 PM	An Application of 2-In-1 Adaptive Phase 2/3 Design for Expedited Oncology Drug Development Xinqun (Maggie) Chen, Merck & Co., Inc.; Linda Sun, Merck & Co., Inc.; Cong Chen, Merck & Co.
2:25 PM	A Generalized Design for a Confirmatory Basket Trial Presentation Robert Beckman, Georgetown University; Xiaoyun (Nicole) Li, Merck
2:45 PM	GBM AGILE: a Phase II/III Platform Design with Signature Identification Presentation Todd Graves, Berry Consultants LLC; Donald A Berry, Berry Consultants and M.D. Anderson Cancer Center; Jason Connor, ConfluenceStat LLC
3:05 PM	A Parametric Multiple Comparison Procedure for Clinical Trials with Planned Evaluation of Treatment Effect in Pre-Defined Subgroups and Interim Analyzes Presentation Liang Fang, MyoKardia; Ron Yu, Gilead Sciences, Inc.; Zhishen Ye, Gilead Sciences; Neby Bekele, Gilead Sciences; Ming Lin, Gilead Sciences
3:25 PM	Discussant: Yu Ding, Merck
3:45 PM	Floor Discussion

238	Mon, 7/30/2018, 2:00 PM - 3:50 PM	CC-West 209
SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation — Contributed Speed
Biopharmaceutical Section
Chair(s): Jiawei Wei, Novartis
Poster Presentations for this session.
2:05 PM	Subgroup Mixable Exact Simultaneous Confidence Intervals for Logical Selection of a CDx Cut-Point Presentation Jason Hsu, Ohio State University
2:10 PM	A Location-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials Presentation Brian S Di Pace, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University; David C. Wheeler, Virginia Commonwealth University
2:15 PM	Sample Size Calculation for Pilot Studies Presentation Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
2:20 PM	Determine Appropriate Sample Size for a Biomarker Signature Discovery Problem Using Penalized Regression Xiang Li, Statistics and Decision Sciences, Janssen Research & Development, LLC; Hong Tian, Janssen Pharmaceutical; Liang Xiu, Janssen Research & Development, LLC
2:25 PM	Statistical Considerations for Using Multiple Databases to Build a Biomarker Probability Tool Presentation Feng Gao; Shijia Bian, Biogen; Wenting Wang, Biogen; Nancy Maserejian, Biogen; Judith Jaeger, Albert Einstein College of Medicine; Robert Robert Engle , Biogen; Timothy Swan, Biogen; James McIninch, Alnylam Pharmaceuticals; Feng Gao, Biogen
2:35 PM	Phase I Designs That Allow for Uncertainty in the Attribution of Adverse Events Presentation Alexia Iasonos, Memorial Sloan Kettering Cancer Center; John O'Quigley, Universit'e Pierre et Marie Curie,
2:40 PM	A Bayesian Analysis of Small N Sequential Multiple Assignment Randomized Trials (SnSMARTs) Presentation Boxian Wei, University of Michigan, Ann Arbor; Kelley M Kidwell, University of Michigan; Thomas M Braun, University of Michigan; Roy N Tamura, University of South Florida
2:50 PM	Pre-Specified Bias Evaluation of ECG Measurements for Assay Sensitivity Assessment Xiaoli Hou, Merck; Nancy Kim, Merck; Wei Gao, Merck; Leticia Arrington, Merck; Kajal Larson, Merck
3:00 PM	Improvements to the Escalation with Overdose Control Design and a Comparison with the Restricted Continual Reassessment Method Lingyun Ji, University of Southern California; Richard Sposto, University of Southern California; Juan Pablo Lewinger, University of Southern California; Mark Krailo, University of Southern California; David Conti, University of Southern California; Susan Groshen, University of Southern California; Shahab Asgharzadeh, University of Southern California
3:05 PM	Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials Presentation Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
3:15 PM	Statistical Considerations for Bridging Studies in Precision Medicine Programs with Drug-Device Co-Development Presentation Shunguang Wang, Novartis Analytics; Meijuan Li, FDA; Xiaohong Li, Novartis Analytics; Jincao Wu, CDRH/US. Food and Drug Adminstration; Robinson Douglas, Novartis Pharmaceuticals

247 !	Mon, 7/30/2018, 2:00 PM - 3:50 PM	CC-West 205
Clinical Trial Design- 2 — Contributed Papers
Biopharmaceutical Section
Chair(s): Weining Robieson
2:05 PM	Extension of Bayesian Logistic Regression Model (BLRM) for Dose Timing Selection in Oncology Phase I Combination Studies Yiyun Zhang, Novartis; Nigel Yateman, Novartis; Fang Xiang, Novartis; Lan Yi, Novartis; Kapildeb Sen, Novartis; Beat Neuenschwander, Novartis
2:20 PM	Considering Delayed Treatment Effect in Trial Designs with Survival Endpoints Presentation Kaushal Mishra, Novartis Oncology Pharmaceuticals; Kalyanee Viraswami Appanna, Novartis Pharmaceuticals
2:35 PM	Application of Bayesian Analyzes to Doubly-Randomized Delayed-Start, Matched Control Designs to Demonstrate Disease Modification Presentation 1 Presentation 2 Ibrahim Turkoz, Janssen Research and Development, LLC; Marcus Sobel, Temple Universisity; Larry Alphs, Janssen Scientific Affairs, LLC
2:50 PM	A Strategy for the Design and Analysis of Bridging Studies Presentation Eric Holmgren, Beigene
3:05 PM	Bayesian Isotonic Optimal Dose Design for Phase I/II Clinical Trials with Ordered Groups Presentation Xiaoqiang Xue
3:20 PM	Evaluation of Regional Efficacy Equivalence in Developing Biosimilars Ryuji Uozumi, Kyoto University Graduate School of Medicine; Shinjo Yada, A2 Healthcare Corporation
3:35 PM	Statistical Methodologies to Detect Ineffective Regional Treatment Effect in a Multiregional Trial Hsiao-Hui Tsou, National Health Research Institutes; Yu-Chieh Cheng, National Health Research Institutes; Chin-Fu Hsiao, National Health Research Institutes

248 !	Mon, 7/30/2018, 2:00 PM - 3:50 PM	CC-West 119
Statistical Issues Specific the Therapeutic Areas- 2 — Contributed Papers
Biopharmaceutical Section
Chair(s): Jie Li Jie Li
2:05 PM	A Meta-Analysis to Indirectly Compare Experimental Drugs Across Multiple Indications Using a Bayesian Hierarchical Model Presentation Ji Lin, Eli Lilly; Jingyi Liu, Eli Lilly; Zachary Thomas, Eli Lilly; Yumin Zhao, Eli Lilly & Co.; Mythili Koneru, Eli Lilly
2:20 PM	Sample Size Determination Under Non-Proportional Hazards Presentation Zhaowei Hua, Takeda Pharmaceuticals International Co.; Miao Yang, Oregon State University; Saran Vardhanabhuti, Takeda Pharmaceuticals
2:35 PM	Are Tumor Size Changes Predictive of Survival for Immunotherapy Trials? Meihua Wang, Merck & Co.; Thomas Jemielita, Merck & Co.; Cong Chen, Merck & Co.; Chen Hu, Johns Hopkins University
2:50 PM	Does Phase 2 PFS or ORR Predict Phase 3 OS? Russell Reeve, Quintiles
3:05 PM	Innovative Approaches to Deal with Delayed Treatment Effect, Cure Fraction and Treatment Switching in Time-To-Event Data in Cancer Immuno-Therapies Presentation Carl Di Casoli, Halozyme Therapeutics; Alessandro Previtali, Celgene; Jonathan Jaeger, Celgene; Marie-Laure Casaebaig, Celgene
3:20 PM	A Simulation-Based Comparison Study About Different Methods Adjusting for the Bias of Treatment Non-Adherence Presentation Jia Jia, AbbVie; Ying Zhang, Penn State College of Medicine; Jane Qian, Abbvie
3:35 PM	Predictive Probability on Interim Analysis of Time-To-Event Endpoints with Delayed Treatment Effects Presentation Matt Rosales, Astellas; Kentaro Takeda, Astellas Pharma Global Development, Inc.

262	Tue, 7/31/2018, 7:00 AM - 8:15 AM	CC-West Ballroom D
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
TL01:	Clinical Trial Data Transparency and Patient Privacy Darcy Hille, Merck & Company Inc; T. Ceesay, Merck ; Jonathan Hartzel, Merck

283 * !	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 118
Transforming of Statistical Programmers and Analysts: Past, Current and Future — Invited Panel
Section for Statistical Programmers and Analysts, Biopharmaceutical Section
Organizer(s): Kuolung Hu, Amgen
Chair(s): William Coar, Axio Research
8:35 AM	Transforming of Statistical Programmers and Analysts: Past, Current, and Future
Panelists:	Wenyun Ji, Amgen Satha Thill, Abbvie Melvin Munsaka, AbbVie, Inc.
10:10 AM	Floor Discussion

286 * !	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 120
Quantitative Methods for Decision-Making in Drug Development — Topic Contributed Papers
Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal, Society for Medical Decision Making
Organizer(s): Liang Fang, MyoKardia
Chair(s): Liang Fang, MyoKardia
8:35 AM	Data-Driven Biomarker Evaluation in Adaptive Designs Using SIDES Ilya Lipkovich, IQVIA; Alex Dmitrienko, Mediana Inc
8:55 AM	Optimal Approach for Addressing Multiple Stakeholders' Requirements in Drug Development Zoran Antonijevic
9:15 AM	Benefit Cost Ratio Analysis in Oncology Drug Development: Single Arm Vs RCT Thomas Jemielita, Merck & Co.; Cong Chen, Merck & Co.
9:35 AM	A General Analytical Framework for Deriving Probability of Success Presentation Ron Yu, Gilead Sciences, Inc.; Liang Fang, MyoKardia; Xiaomin Lu, Gilead Sciences, Inc.
9:55 AM	Leveraging Bayesian Methods, Modeling, and Simulation to Improve Decision-Making and Increase Probability of Success Karen Price; Stephen Ruberg, Analytix Thinking, LLC
10:15 AM	Floor Discussion

290 * !	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 301
Drug Safety Monitoring in a Complex World-Wide Regulatory Environment - Strategy Meets Methodologies — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Susan Duke, FDA/CDER/Office of Biostatistics
Chair(s): Amit Bhattacharyya, ACI Clinical
8:35 AM	Quantitative Regulatory Landscape Presentation Lothar Tremmel, CSL Behring
8:55 AM	Going from the Program Safety Analysis Plan to the Aggregate Safety Analysis Plan Presentation Barbara Hendrickson, AbbVie
9:15 AM	Specific Safety Monitoring Tools and How This Will Benefit Drug Safety Presentation James Buchanan, Covilance LLC
9:35 AM	Discussant: Jonathan Seltzer, ACI Clinical
9:55 AM	Floor Discussion

301	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 213
SPEED: Statistics for Biopharmaceutical Studies — Contributed Speed
Biopharmaceutical Section, Section on Bayesian Statistical Science
Chair(s): Michael M. Hoffman, Princess Margaret Cancer Centre/University of Toronto
Poster Presentations for this session.
8:35 AM	Probabilistic Modeling of Sleep and Awake States in Alzheimer's Disease Presentation Cici Bauer, Pfizer, Inc; Charmaine Demanuele, Pfizer, Inc. ; Dmitri Volfson, Pfizer
8:40 AM	Integrative Statistical Analysis Pipeline for RNA-Seq and NanoString with Application to Gene Expression Data of Cancer Patients Presentation Jeea Choi, Novartis Pharmaceuticals; Catarina D. Campbell, Novartis Institutes for BioMedical Research; Xiaoshan Wang, Novartis Pharmaceuticals; He Wei, Novartis Pharmaceuticals; Robinson Douglas, Novartis Pharmaceuticals; Stephane Wong, Novartis Pharmaceuticals; Bin Fu, Novartis Pharmaceuticals; Rebecca Leary, Novartis Institutes for BioMedical Research; Kavitha Venkatesan, Novartis Institutes for BioMedical Research; Ying A Wang, Novartis Pharmaceuticals
8:45 AM	Bridging Information Between Dose-Response Curves Across Populations in Early Phase Clinical Trials Moreno Ursino, Inserm DR PA 6
8:50 AM	A Simultaneous PK/PD Model for Muscle Relaxant Using Muscle Twitch Counts Presentation Elizabeth Sigworth; Matthew S Shotwell, Vanderbilt University
8:55 AM	STEPDOWN TESTING PROCEDURES for DOSE FINDING STUDY with ADAPTIVE DESIGN Presentation Gang Jia, Merck & Co.
9:00 AM	Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints Presentation Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute
9:05 AM	Explore Modified Organ Dysfunction Score System to Improve the Prediction of Survival Presentation Grace Zhang, GSK
9:10 AM	Discovering Biomarkers Jointly Modeled with Multiple Efficacy Variables in Early Phase Clinical Trials Presentation Danni Yu, Eli Lilly and Company
9:15 AM	Extended Rank Tests for Analyzing Recurrent Event Data Presentation Qiang Zhao; Mark Chang, Veristat; Michael LaValley, Boston University; Joseph M. Massaro, Boston University; Bin Zhang, Seqirus; Kathryn Lunetta, Boston University
9:20 AM	A Study in the Use of Unsupervised Random Forest in the Analysis of Data Sets Composed of Categorical Variables/Features Presentation Nelson Lee Afanador, Merck; Richard Baumgartner, Merck; Dai Feng, Merck
9:30 AM	A Statistical Evaluation of Cardiovascular Measurements Collected via Mobile Health Technology and Traditional Tools Qinlei Huang, Merck; Lori Mixson, Merck
9:35 AM	Method for Evaluating Longitudinal Follow-Up Frequency: Application to Dementia Research Presentation Leah Suttner, University of Pennsylvania; Sharon X Xie, University of Pennsylvania
9:40 AM	Performance Comparison of Post-Hoc Subgroup Search Algorithms for Clinical Trials Presentation Victor Talisa, University of Pittsburgh; (Joyce) Chung-Chou H. Chang, University of Pittsburgh
9:45 AM	Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies Presentation Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca
9:50 AM	Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints Presentation Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
9:55 AM	Sensitivity to Infusion and Blood Draw Time Recording Errors in Pharmacokinetic Modeling Presentation Hannah Weeks, Vanderbilt University; Matthew S Shotwell, Vanderbilt University
10:00 AM	A Testing Paradigm for Earl Biomedical Research with Many Correlated Tests Presentation Robert Montgomery; Jonathan D Mahnken, University of Kansas Medical Center

307 !	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 221
Clinical Trial Design-3 — Contributed Papers
Biopharmaceutical Section
Chair(s): Josephine Asafu-Adjei
8:35 AM	Social Media and Clinical Research Presentation Darcy Hille, Merck & Company Inc; T. Ceesay, Merck
8:50 AM	Incorporating Historical Information into the Analysis of Clinical Trials- a Case Study Presentation Guochen Song, Biogen; Yiqing Tian, Q2 Sulotions; John Zhong, Biogen; Stacy Lindborg, Biogen Idec
9:05 AM	Systematic Review of Test/Estimation Approach in Comparative Cancer Clinical Studies with Time-To-Event Outcomes Presentation Miki Horiguchi, Kitasato University; Hajime Uno, Dana Farber Cancer Institute
9:20 AM	Design Considerations in Clinical Trials with Cure Rate Survival Data: a Case Study in Oncology Presentation Grace Liu, Johnson & Johnson; Steven Sun, J&J; Tzu-min Yhe, janssen pharmaceuticals; Tianmeng Lyu, University of Minnesota; Rao Sudhakar, janssen pharmaceuticals; Bruce Xue, Johnson & Johnson China
9:35 AM	Multiplicity Adjustment for Multiple Endpoints Testing in Overall and Subgroup Populations Libo Sun, Janssen Pharmaceutical R&D; Grace Liu, Johnson & Johnson; Rui Qin, Janssen Pharmaceutical R&D
9:50 AM	Statistical Leadership in Clinical Trials: Opportunities from the Draft Estimand Guidance Presentation Jonathan Siegel, Bayer HealthCare Pharmaceuticals Inc.
10:05 AM	Safety Analysis of Clinical Trials in NDA Submissions Presentation Linyun Zhou, Takeda Global Research & Development

308 !	Tue, 7/31/2018, 8:30 AM - 10:20 AM	CC-West 304/305
Adaptive Design - 2 — Contributed Papers
Biopharmaceutical Section
Chair(s): John Scott John Scott
8:35 AM	Complexity of Implementing Sample Size Re-Estimation (SSR) in Oncology Trials Presentation Alicia Zhang, Amgen; Yuqi Chen, Amgen; Chris Holland, Amgen
8:50 AM	Desirability Functions for Evaluating Clinical Trial Design Quality Presentation Priscilla K Yen, UCLA; Weng Kee Wong, UCLA
9:05 AM	A Confirmatory Basket Trial Design for Multiple Tumor Types Based on Conditional Power Presentation Huiling Li; Jianming Wang, Celgene Corporation; Yeongjin Gwon, University of Connecticut; Xiaolong Luo, Celgene Corporation
9:20 AM	A Model-Based Conditional Power Assessment for Decision Making in Randomized Controlled Trial Studies Presentation Baiming Zou, University of Florida; Jianwen Cai, University of North Carolina; Gary G. Koch, University of North Carolina; Haibo Zhou, University of North Carolina; Fei Zou, University of North Carolina at Chapel Hill
9:35 AM	A Case Study of a Bayesian Adaptive Dose-Finding Phase 2 Trial Design Using Go/No-Go Criteria and Adaptive Randomization Ye Ting Du; James Bolognese, Cytel Inc
9:50 AM	Basket Trials Design and Analysis in Non-Oncology Therapeutical Areas Presentation Binbing Yu, MedImmune/AstraZeneca; Jingjing Chen, Takeda Pharmaceuticals; Dewei She, MedImmune/AstraZeneca; Jianliang Zhang, Medimmune, LLC
10:05 AM	Informative Grouping for Regression Presentation Juexin Lin, University of South Carolina; Dewei Wang, University of South Carolina

CE_25C	Tue, 7/31/2018, 8:30 AM - 5:00 PM	CC-East 2/3
Analysis of Clinical Trials: Theory and Applications (ADDED FEE) — Professional Development Continuing Education Course
ASA, Biopharmaceutical Section
Instructor(s): Alex Dmitrienko, Mediana Inc; Jeff Maca, Quintiles IMS; Devan V Mehrotra, Merck & Co., Inc.
The course covers seven important topics that commonly face statisticians and research scientists conducting clinical research: stratified trials, longitudinal trials with dropouts, time-to-event trials with small sample sizes, crossover trials, pharmacogenomics studies for personalized medicine, multiple comparisons, and interim decision making with adaptive designs. The course offers a well-balanced mix of theory and applications. It presents practical advice from experts and discusses regulatory considerations. The discussed statistical methods will be implemented using SAS and R software. Clinical trial examples will be used to illustrate the statistical methods. The course is designed for statisticians working in the pharmaceutical or biotechnology industries as well as contract research organizations. It is equally beneficial to statisticians working in institutions that deliver health care, government branches that conduct health-care related research and academics interested in learning about contemporary statistical topics in clinical drug development. The attendees are required to have a basic knowledge of clinical trials. Familiarity with drug development is highly desirable, but not necessary. This course was taught at JSM 2005-2017 and received the Excellence in Continuing Education Award in 2005.
8:30 AM	Analysis of Clinical Trials: Theory and Applications (ADDED FEE) Alex Dmitrienko, Mediana Inc; Devan V Mehrotra, Merck & Co., Inc.; Jeff Maca, Quintiles IMS

CE_26C	Tue, 7/31/2018, 8:30 AM - 5:00 PM	CC-East 1
Deep Learning, Prediction, and Validation: Innovations in Statistical Modeling and Applications to Medical/Health Big Data (ADDED FEE) — Professional Development Continuing Education Course
ASA, Biopharmaceutical Section
Instructor(s): Tze Leung Lai, Stanford University; Ying Lu, Stanford University; Hao Zou, Stanford University
We begin with a review of (a) recent advances in computer vision and deep learning and how it links with statistical/machine learning, (b) the underlying statistical theories of convolutional neural networks, gradient descent, graphical models, and hidden Markov random fields, and (c) AI applications to medical imaging and automated analysis of electronic medical and health data. Whereas high-performance computing and advanced programming have overcome the computational hurdles in the analysis of "big data" for prediction and classification, we next describe how statistical innovations have provided major breakthroughs in the validation of scientific theories based on complex experimental data in biomedical and astrophysics. Because big data typically require variable/hypothesis selection based on some sparsity assumption to make the inference problem feasible, there is contemporaneous awareness of irreproducible research in modern science. In particular, novel statistical methods in post-selection inference and hybrid resampling are presented to address this "reproducible (replication) crisis".
8:30 AM	Deep Learning, Prediction, and Validation: Innovations in Statistical Modeling and Applications to Medical/Health Big Data (ADDED FEE) Hao Zou, Stanford University; Tze Leung Lai, Stanford University; Ying Lu, Stanford University

315	Tue, 7/31/2018, 9:25 AM - 10:10 AM	CC-West Hall B
SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
21:	Subgroup Mixable Exact Simultaneous Confidence Intervals for Logical Selection of a CDx Cut-Point Jason Hsu, Ohio State University
22:	A Location-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials Brian S Di Pace, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University; David C. Wheeler, Virginia Commonwealth University
24:	Sample Size Calculation for Pilot Studies Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
25:	Determine Appropriate Sample Size for a Biomarker Signature Discovery Problem Using Penalized Regression Xiang Li, Statistics and Decision Sciences, Janssen Research & Development, LLC; Hong Tian, Janssen Pharmaceutical; Liang Xiu, Janssen Research & Development, LLC
26:	Statistical Considerations for Using Multiple Databases to Build a Biomarker Probability Tool Feng Gao; Shijia Bian, Biogen; Wenting Wang, Biogen; Nancy Maserejian, Biogen; Judith Jaeger, Albert Einstein College of Medicine; Robert Robert Engle , Biogen; Timothy Swan, Biogen; James McIninch, Alnylam Pharmaceuticals; Feng Gao, Biogen
28:	Phase I Designs That Allow for Uncertainty in the Attribution of Adverse Events Alexia Iasonos, Memorial Sloan Kettering Cancer Center; John O'Quigley, Universit'e Pierre et Marie Curie,
30:	A Bayesian Analysis of Small N Sequential Multiple Assignment Randomized Trials (SnSMARTs) Boxian Wei, University of Michigan, Ann Arbor; Kelley M Kidwell, University of Michigan; Thomas M Braun, University of Michigan; Roy N Tamura, University of South Florida
32:	Pre-Specified Bias Evaluation of ECG Measurements for Assay Sensitivity Assessment Xiaoli Hou, Merck; Nancy Kim, Merck; Wei Gao, Merck; Leticia Arrington, Merck; Kajal Larson, Merck
33:	Improvements to the Escalation with Overdose Control Design and a Comparison with the Restricted Continual Reassessment Method Lingyun Ji, University of Southern California; Richard Sposto, University of Southern California; Juan Pablo Lewinger, University of Southern California; Mark Krailo, University of Southern California; David Conti, University of Southern California; Susan Groshen, University of Southern California; Shahab Asgharzadeh, University of Southern California
34:	Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
36:	Statistical Considerations for Bridging Studies in Precision Medicine Programs with Drug-Device Co-Development Shunguang Wang, Novartis Analytics; Meijuan Li, FDA; Xiaohong Li, Novartis Analytics; Jincao Wu, CDRH/US. Food and Drug Adminstration; Robinson Douglas, Novartis Pharmaceuticals
Oral Presentations for this session.

322 * !	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 109
Data-Driven Patient Management in the Era of Precision Medicine - from Discovery, Diagnostics, to Therapeutics — Invited Papers
Council of Chapters, Biopharmaceutical Section, Section on Medical Devices and Diagnostics, SSC
Organizer(s): Ruixiao Lu, Genomic Health, Inc.
Chair(s): Li Zhang, UCSF School of Medicine, UCSF
10:35 AM	Big Data Analysis Points Toward New Cancer Therapeutic Discovery Approach Bin Chen, UCSF
11:00 AM	Using Genomic Features to Make Smart Clinical Decisions: The Power of Machine Learning with RNA-Seq Jing Huang, Veracyte Inc; Su yeon Kim , Veracyte Inc; Yangyang Hao, Veracyte Inc; Jing Lu, Veracyte Inc; Joshua Babiarz, Veracyte Inc; Sean Walsh, Veracyte Inc; Giulia Kennedy, Veracyte Inc
11:25 AM	Developing Genomic Biomarker to Guide Personalized Patient Management in Oncology: Validity and Utility of Clinical Diagnostic Applications Presentation Michael Crager, Genomic Health; Ruixiao Lu, Genomic Health, Inc.
11:50 AM	Biomarker-Defined Subgroup Selection Adaptive Design for Phase III Confirmatory Trial Presentation Rui Tang, Shire; Xiaoye Ma, University of Minnesota; Hui Yang, Amgen Inc.
12:15 PM	Floor Discussion

323 * !	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 203
Graphics in Statistical Practice: Saying it with Pictures in the Classroom, Boardroom, or the Consulting Cube — Invited Papers
Section on Statistical Graphics, Section on Statistical Consulting, Biopharmaceutical Section
Organizer(s): Suddhasatta Acharyya, Novartis pharmaceuticals corporation
Chair(s): Brad Evans, Pfizer, Inc
10:35 AM	Graphics in the Classroom: Making Statistics Picturesque Kaushik Ghosh, University of Nevada Las Vegas
11:00 AM	Graphics and Data Visualizations to Enhance Storytelling: Revealing Rather Than Obfuscating Presentation Abhijit Dasgupta, ARAASTAT
11:25 AM	Graphs for a Wider Audience: Distilling Complexity in Visuals to Inform Actions Alicia Y. Toledano, Biostatistics Consulting, LLC
11:50 AM	Statistical Graphics in Drug Development: Dose-Finding to Dossier Submission Suddhasatta Acharyya, Novartis pharmaceuticals corporation
12:15 PM	Floor Discussion

336 * !	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 224
Surrogate Endpoints: Bridging the Roles of Biology and Statistics for Clinical Outcome Prediction — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Hong Tian, Janssen Pharmaceutical
Chair(s): Sue-Jane Wang, Center for Drug Evaluation and Research U.S. Food and Drug Administration
10:35 AM	On the Relationship Between the Causal-Inference and Meta-Analytic Paradigms for the Evaluation of Surrogate Endpoints Geert Molenberghs, Universiteit Hasselt & Katholieke Universiteit Leuven
10:55 AM	Assessment of Biomarkers and Surrogate Endpoints in Drug Development Presentation Ivan Chan, AbbVie Inc; Shu-Chih Su, Merck Research Labs
11:15 AM	Limitations of Progression Free Survival as a Surrogate Marker for Overall Survival in Oncology Trials Presentation Robin Mogg, Merck Research Laboratories; Yiwei Zhang, Merck Research Laboratories
11:35 AM	Identifying and Validating Surrogate Endpoints for Overall Survial (OS) in Metastatic Castration-Resistant Prostate Cancer Presentation Xiaowei Guan, Pfizer, Inc.; Michelle Casey, Pfizer, Inc.; De Phung, Astellas Pharma, Inc. ; Suha Sari, Pfizer, Inc.; Eren Demirhan, Pfizer, Inc.
11:55 AM	Discussant: Vladimir Dragalin, Janssen R&D
12:15 PM	Floor Discussion

338	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 214
BIOP Student Paper Awards — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Qi Jiang, Amgen
Chair(s): Haoda Fu, Eli Lilly and Company
10:35 AM	The Reduced PC-Algorithm: Improved Causal Structure Learning in Large Random Networks Presentation Arjun Sondhi, University of Washington; Ali Shojaie, University of Washington
10:55 AM	A Robust Approach to Sample Size Calculation in Cancer Immunotherapy Trials with Delayed Treatment Effect Ting Ye, University of Wisconsin-Madison; Menggang Yu, University of Wisconsin-Madison
11:15 AM	Bayesian Personalized Multi-Criteria Benefit-Risk Assessment of Medical Products Kan Li, University of Texas Health Science Center; Sammy Yuan, Merck; Sheng Luo, Duke University Medical Center
11:35 AM	The Statistical Performance of Matching-Adjusted Indirect Comparisons Presentation David Cheng, Harvard University; Rajeev Ayyagari, Analysis Group; Timothy Juday, Allergan; Angelina Villasis Keever, Janssen Research and Development; James Signorovitch, Analysis Group
11:55 AM	AAA: Triple-Adaptive Bayesian Designs for the Identification of Optimal Dose Combinations in Dual-Agent Dose-Finding Trials Presentation Jiaying Lyu, University of Chicago; Fudan University; Yuan Ji, NorthShore Univ. HealthSystem / The University of Chicago
12:15 PM	Floor Discussion

343	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 213
SPEED: Tests, Trials, Biomarkers, and Other Topics in Biometrics — Contributed Speed
Biometrics Section, Biopharmaceutical Section, ENAR
Chair(s): Sayan Dasgupta, Fred Hutchinson Cancer Research Center
Poster Presentations for this session.
10:35 AM	Some T-Tests for N-Of-1 Trials with Serial Correlation Presentation Ji-Ling Tang, University of Arkansas for Medical Sciences; Reid D. Landes, University of Arkansas for Medical Sciences; Anne Holbrook, McMaster University; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas
10:40 AM	Some T-Tests for N-Of-1 Trials with Serial Correlation: Correction Factors for Trials with Few Observations Reid D. Landes, University of Arkansas for Medical Sciences; Ji-Ling Tang, University of Arkansas for Medical Sciences; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas; Anne Holbrook, McMaster University
10:45 AM	Hybrid Cluster-Individual Randomization Allocation Presentation Yi-Fan Chen, University of Illinois at Chicago; Jonathan Yabes, University of Pittsburgh
10:50 AM	Adjusting a Finite Population Block Kriging Estimator for Imperfect Detection Presentation Matthew Higham
10:55 AM	Using Logistical Regression to Build a Better Diathesis Model of Dupuytren's Contracture Recurrence Presentation Brian Cohen, ACI Clinical
11:10 AM	A Two-Stage Method to Analyze Multivariate Cluster Biomarkers in Prediction on a Single Binary Outcome Presentation Xiaoying Yu, University of Texas Medical Branch at Galveston; Wenyaw Chan, University of Texas Health Science Center at Houston; Gracie Vargas, University of Texas Medical Branch at Galveston; Rahul Pal, University of Texas Medical Branch at Galveston
11:15 AM	An Estimation Method for Enzyme Kinetic Model Parameters Based on Bayesian Approach Presentation Boseung Choi, Korea University; Jae Kyoung Kim, Korea Advanced Institute of Science and Technology; Grzegorz A Rempala, The Ohio State University
11:20 AM	Statistical Precision of Time-to-Event Endpoint in Single Arm Observational Study Using Monte Carlo Simulation Meijing Wu, AbbVie; Hongwei Wang, AbbVie Inc; Yabing Mai, AbbVie, Inc; Dajun Tian, Chiltern
11:30 AM	Multiple Testing Procedure Consideration in Clinical Trials Presentation Rachael Wen, Sanofi
11:35 AM	Practical Determining the Late Effect Parameter in Fleming-Harrington Test When a Delayed Treatment Effect Is Predicted Yuichiro Kaneko, Astellas Pharma; Satoshi Morita, Kyoto University
11:40 AM	Inferring Networks from Personal, Dense, Dynamic Data Clouds of Biological and Quantified-Self Data Presentation Elisa Sheng, Arivale
11:45 AM	Optimal Testing Configurations for Group Testing Presentation Brianna D. Hitt, University of Nebraska-Lincoln; Christopher R. Bilder, University of Nebraska-Lincoln; Joshua M. Tebbs, University of South Carolina; Christopher S. McMahan, Clemson University
11:50 AM	Common Risk Difference Test and Interval Estimation of Risk Difference for Stratified Bilateral Correlated Data Presentation Xi Shen, State University of New York At Buffalo; Changxing Ma, State University of New York At Buffalo; Guoliang Tian, Southern University of Science and Technology; Kam Chuen Yuen, The University of Hong Kong
11:55 AM	Functional Data Analysis in Dose-Adjusted Tacrolimus Trough Concentration Modeling: A New Method to Compare Intrapatient Variance Between Patient Cohorts Janet Kim, Astellas Pharma Global Development, Inc.; Sam Wilson, Astellas Pharma Global Development, Inc.; Jason J Schwartz, Astellas Pharma Global Development, Inc.
12:05 PM	Design Considerations When Comparing Control, Treatment, and Treatment Plus in Randomized Trials Presentation Abigail Shoben, Ohio State University

350	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 304/305
Statistical Issues In Drug Development - 1 — Contributed Papers
Biopharmaceutical Section
Chair(s): Tian Dai
10:35 AM	Reversals in Early Phase Dose Finding Trials Presentation Bethany Horton, University of Virginia; John O'Quigley, Universit'e Pierre et Marie Curie, ; Mark Conaway, University of Virginia
10:50 AM	The Emerging and Merging Fields of Benefit-Risk and Health Technology Assessments Presentation Susan Talbot, Amgen Ltd; Shahrul Mt-Isa, Merck; Jixian Wang, Celgene
11:05 AM	Application of Bayesian Approach in Evaluating Rare Adverse Events During a Clinical Study Presentation Ying Grace Li, Eli Lilly and Company
11:20 AM	Assessment of Treatment Effects in Single Cases and Small Groups: Assumptions, Logic, Algorithm, Computations Lev Sverdlov
11:35 AM	Monitoring Vaccine Safety by Studying Temporal Trend of Adverse Events Using VAERS Presentation Jing Huang, University of Pennsylvania; Yi Cai, Pieces Technology; Jingcheng Du, University of Texas Health Science Center; Ruosha Li, University of Texas School of Public Health; Susan S Ellenberg, University of Pennsylvania; Sean Hennessy, University of Pennsylvania; Cui Tao, University of Texas Health Science Center; Yong Chen, University of Pennsylvania
11:50 AM	Network Meta-Analysis: On the Use of the Standard Contrast-Based Approach in Disconnected Networks Audrey Béliveau, University of Waterloo; Paul Gustafson, University of British Columbia
12:05 PM	Three Intervals Used in Setting Quality Specification Limits Presentation Yi Tsong, CDER, FDA; Xin Hu, George Washington University

351 !	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West 219
Statistical Issues Specific the Therapeutic Areas- 3 — Contributed Papers
Biopharmaceutical Section
Chair(s): Dong Xi, Novartis Pharmaceuticals
10:35 AM	A Graphical Dissection of the Log-Rank Test and Cox Proportional Hazards Model Xiaofei Hu, Abbvie; Yabing Mai, AbbVie, Inc
10:50 AM	Unexpected Safety Signals in Dose Escalation Process Presentation Chunzhang Wu, Astellas Pharma Global Development, Inc.
11:20 AM	The Impact of Misspecification of Linear Modeling on the Prediction in SMART PK/PD Clinical Trials Presentation 1 Presentation 2 Tian Zhao, Merck; Li Fan, Merck
11:35 AM	Modeling Overall Survival Under Immuno-Oncology Therapies with Long-Term Survival Models Presentation Junshui Ma, Merck & Co., Inc.; Keaven Anderson, Merck & Co., Inc.
11:50 AM	Recurrent Events Analysis Using Landmark Andersen-Gill Model with Time-Varying Covariates Zheyu Liu, Bayer Pharmaceuticals; Vivian Lanius, Bayer AG; Dejian Lai, The University of Texas Health Science Center at Houston

359	Tue, 7/31/2018, 10:30 AM - 12:20 PM	CC-West Hall B
Contributed Poster Presentations: Biopharmacutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Paul McNicholas, McMaster University
26:	Assessing Reproducibility When Making Mid-Course Changes in Clinical Trials Based on External Data Yingqi Shi, Johnson & Johnson-Janssen R&D; Grace Gao, Janssen R&D; Keith Karcher, Janssen R&D
27:	Methods to Handle Missing Outcome Data in Studies of Acute Illnesses Followed by Recovery Dashiell Fellini Young-Saver, University of California, Los Angeles; Jeffrey Gornbein, University of California, Los Angeles; Sidney Starkman, University of California, Los Angeles; Jeffrey Lawrence Saver, University of California, Los Angeles
28:	Sample Size and Assurance Probability Calculation in Multi-Regional Clinical Trials Zuoshun Zhang, Celgene Corporation
29:	Nonparametric Survival Analysis with Delayed Treatment Effect Kijoeng Nam, Merck; Nicholas Henderson, Johns Hopkins University; Dai Feng, Merck
30:	A Bayesian Adaptive Model-Based Approach for Dose Selection in a FGF21 2nd Gen Phase 1 Study Yuping Dong
31:	Defining a More Powerful Endpoint in a Longitudinal Trial with information of correlation coefficient Ruji Yao; qing li, merck; wen-chi wu, merck
32:	A Bayesian-Frequentist Hybrid Sequential Design of a Single-Arm Study with Binary Outcome and Its Shiny App Yansong Cheng, Alkermes
33:	Applications of Neural Net Models to Identify Placebo Responders in Clinical Trials Mikhail Dmitrienko, Blue Valley North High School
35:	Clinical Trial Design Comparison with Covariate-Adjusted and Response Adaptive Randomization Wei Qiao, The University of Texas M.D. Anderson; Xuelin Huang, University of Texas MD Anderson Cancer Center; Jing Ning, The University of Texas M.D. Anderson Cancer Center
36:	Methods for Combining Controlled and Uncontrolled Clinical Trials Shuyan Sabrina Wan, Merck Research Lab; Yuan Feng, North Carolina State University; Hong Liu, Merck; Kenneth Koury, Pfizer
37:	Using Wearable Devices to Quantify Modulation of Circadian Rhythms Dmitri Volfson, Pfizer; Cici Bauer, Pfizer, Inc; Francois Gaudreault, Biogen Inc.; Cheng Chang, Pfizer; Arthur Simen, Takeda Inc; Travis Wager, Pfizer; Eve Pickering, Pfizer
38:	Sample Size Calculation for a Pilot Study Danielle Sim, UCLA; Chi-Hong Tseng, UCLA
39:	Use of Propensity Score and Disease Risk Score for Multiple Treatments with Time-To-Event Outcome DI ZHANG, University of Pittsburgh; Jessica Kim, Division of Biometrics VII/Office of Biostatistics/CDER, FDA
40:	Endpoint and Time-To-Event Analyzes in Interim Clinical Trial Reports Scott Diegel, University of Wisconsin-Madison; Ryan Zea, University of Wisconsin-Madison; Melissa Schultz, University of Wisconsin-Madison
41:	Univariate, Multivariate and Model-Based Prediction on Truncated Continuous Data with Shiny/R Qianqiu Li, Janssen Research & Development
42:	A Bayesian Adaptive Design in Cancer Phase I/II Trials with Drug Combinations Using Escalation with Overdose Control (EWOC) and Adaptive Randomization Sungjin Kim, Cedars-Sinai Medical Center; José L. Jiménez, Politecnico di Torino; Mourad Tighiouart, Cedars-Sinai Medical Center
43:	An Evaluation of Statistical Methods with Missing Data in Small Clinical Trials Takayuki Abe, Yokohama City University, School of Data Science; Kazuhito Shiosakai, Daiichi Sankyo Co., Ltd.; Manabu Iwasaki, Yokohama City University, School of Data Science
44:	Response to Regulatory Issues in an Adaptive Medical Device Study Jill Stankowski, ICON Plc
45:	A Comparison of MI and MMRM for Treatment of Missing Data Lori Davis, QST Consultations
46:	Evaluating the Impact of Missing Data Mechanisms and Imputation Methods in Analysis of Bivariate Longitudinal Data with Subject Effect Yonggang Zhao, Skyview Research; Qianqiu Li, Johnson & Johnson
47:	Some Statistical Issues Regarding to Assay Sensitivity in "Hybrid TQT" Study Dalong Huang, FDA/CDER; Janell Chen, FDA/CDER; Yi Tsong, CDER, FDA; Qianyu Dang, FDA/CDER
48:	Sample Size in Adaptive Design with Treatment Selection Zejiang Yang, Syneos Health
49:	Sequential Parallel Comparison Design with Binary and Time-to-Event Outcomes Rachel Silverman, Merck & Co.; Anastasia Ivanova, University of North Carolina, Chapel Hill; Jason P Fine, University of North Carolina at Chapel Hill
50:	Power and Type I Error Assessments on Methods to Size Binomial Endpoints Under Unequal Randomization Ratios Rong Wang, Pfizer Inc
51:	The Modified Toxicity Probability Interval Design with Consideration of Late Onset Toxicities Xiaohui Huang, Gilead Sciences; Guan Xing, Gilead Sciences
52:	Event Projection for Blinded Studies Guan Xing; Xiaohui Huang, Gilead Sciences
53:	A Novel Approach of Using Prior Elicitation Information to Direct Design of a Phase 2 POC Study Geng Chen, GlaxoSmithKline; Jonathan Haddad, Glaxosmithkline
54:	Statistical Methods to Estimate Diagnostic Testing Accuracy of ULTE4 to Determine Aspirin Intolerance in Asthma Using Meta-Analysis Data Nan Zhang, Mayo Clinic; John Hagan, Mayo Clinic; Matthew Rank, Mayo Clinic; Yu-Hui Chang, Mayo Clinic; Rohit Divekar, Mayo Clinic; Erin O'Brien, Mayo Clinic; Gerald Volcheck, Mayo Clinic; Devyani Lal, Mayo Clinic; Patricia Erwin, Mayo Clinic; Harry Teaford, Mayo Clinic; Hirohito Kita, Mayo Clinic; Tanya Laidlaw, Harvard Medical school; Christina Hagan, Baylor College of Medicine
55:	Non-Inferiority Margins in Superiority/Non-Inferiority Seamless Clinical Trials Ellen Gurary, Boston University; Joe Massaro, Boston University
56:	Determination of Optimal Cut-Off Points for Biomarkers in Oncology Research Shu-Pang Huang, Bristol-Myers Squibb Co.; Tian Chen, Bristol-Myers Squibb Co.; Ye Feng, Bristol-Myers Squibb Co.; Ming Zhou, Bristol-Myers Squibb Company; Ramachandran Suresh, Bristol-Myers Squibb Co.
57:	Using Tradition to Guide Non-Traditional Decisions in Phase 1 Clinical Trials Paul Frankel, City of Hope
58:	PFS2: Event or Censor? Dongmei Lan, ICON Plc; JIll Stankowski, ICON Plc
60:	Seeking Optimal Oral Cancer Drug Combinations Ricardo Palafox, CSU Fullerton; Jessica Jaynes , CSU Fullerton
61:	Safety Data Presentations in USPIs: Methodological Considerations Adam Boyd, Array BioPharma Inc; Michael Pickard, Array BioPharma Inc
63:	A Novel Outlier Test for Plate Based Dilution Bioassay Jerry W. Lewis, Biogen Idec
65:	Missing data imputation in confirmatory clinical trials - a comparison case study Yue Song, PAREXEL; Sophie (Xiongfei) Wang, PAREXEL

368	Tue, 7/31/2018, 11:35 AM - 12:20 PM	CC-West Hall B
SPEED: Statistics for Biopharmaceutical Studies — Contributed Poster Presentations
Biopharmaceutical Section, Section on Bayesian Statistical Science
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
21:	Probabilistic Modeling of Sleep and Awake States in Alzheimer's Disease Cici Bauer, Pfizer, Inc; Charmaine Demanuele, Pfizer, Inc. ; Dmitri Volfson, Pfizer
22:	Integrative Statistical Analysis Pipeline for RNA-Seq and NanoString with Application to Gene Expression Data of Cancer Patients Jeea Choi, Novartis Pharmaceuticals; Catarina D. Campbell, Novartis Institutes for BioMedical Research; Xiaoshan Wang, Novartis Pharmaceuticals; He Wei, Novartis Pharmaceuticals; Robinson Douglas, Novartis Pharmaceuticals; Stephane Wong, Novartis Pharmaceuticals; Bin Fu, Novartis Pharmaceuticals; Rebecca Leary, Novartis Institutes for BioMedical Research; Kavitha Venkatesan, Novartis Institutes for BioMedical Research; Ying A Wang, Novartis Pharmaceuticals
23:	Bridging Information Between Dose-Response Curves Across Populations in Early Phase Clinical Trials Moreno Ursino, Inserm DR PA 6
24:	A Simultaneous PK/PD Model for Muscle Relaxant Using Muscle Twitch Counts Elizabeth Sigworth; Matthew S Shotwell, Vanderbilt University
25:	STEPDOWN TESTING PROCEDURES for DOSE FINDING STUDY with ADAPTIVE DESIGN Gang Jia, Merck & Co.
26:	Conditional Power Calculation for the Interim Monitoring of Cluster-Randomized Trials with Interval-Censored Endpoints Kaitlyn Cook, Harvard University; Rui Wang, Harvard Pilgrim HealthCare Institute
27:	Explore Modified Organ Dysfunction Score System to Improve the Prediction of Survival Grace Zhang, GSK
28:	Discovering Biomarkers Jointly Modeled with Multiple Efficacy Variables in Early Phase Clinical Trials Danni Yu, Eli Lilly and Company
29:	Extended Rank Tests for Analyzing Recurrent Event Data Qiang Zhao; Mark Chang, Veristat; Michael LaValley, Boston University; Joseph M. Massaro, Boston University; Bin Zhang, Seqirus; Kathryn Lunetta, Boston University
30:	A Study in the Use of Unsupervised Random Forest in the Analysis of Data Sets Composed of Categorical Variables/Features Nelson Lee Afanador, Merck; Richard Baumgartner, Merck; Dai Feng, Merck
31:	A Statistical Evaluation of Cardiovascular Measurements Collected via Mobile Health Technology and Traditional Tools Qinlei Huang, Merck; Lori Mixson, Merck
32:	Method for Evaluating Longitudinal Follow-Up Frequency: Application to Dementia Research Leah Suttner, University of Pennsylvania; Sharon X Xie, University of Pennsylvania
33:	Performance Comparison of Post-Hoc Subgroup Search Algorithms for Clinical Trials Victor Talisa, University of Pittsburgh; (Joyce) Chung-Chou H. Chang, University of Pittsburgh
34:	Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca
35:	Real-Time Study Milestone Projection in Clinical Trials with Time-To-Event Endpoints Yanping Liu, Merck & Co.; Gang Jia, Merck & Co.
36:	Sensitivity to Infusion and Blood Draw Time Recording Errors in Pharmacokinetic Modeling Hannah Weeks, Vanderbilt University; Matthew S Shotwell, Vanderbilt University
37:	A Testing Paradigm for Earl Biomedical Research with Many Correlated Tests Robert Montgomery; Jonathan D Mahnken, University of Kansas Medical Center
Oral Presentations for this session.

370	Tue, 7/31/2018, 12:30 PM - 1:50 PM	CC-West Ballroom D
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
TL11:	Bayesian Methods in Real-World Evidence for Medicinal Product Development: Can Prior Distributions Provide a Platform for Creating Real-World Evidence? John Loewy, Dataforethought
TL12:	Uncertainty vs. Ambiguity in Structured Benefit-Risk (BR) Assessment Decisions Shahrul Mt-Isa, Merck
TL13:	The Importance of Protocol Objectives to the Statistical Analysis Richard McNally, Covance-Chiltern

385 * !	Tue, 7/31/2018, 2:00 PM - 3:50 PM	CC-West 110
Appropriate Estimators for Various Clinical Trial Estimands: Are We There Yet? — Invited Papers
Biopharmaceutical Section, ENAR, WNAR
Organizer(s): Pilar Lim, PhD, Janssen Research & Development, LLC
Chair(s): Yun Zhang, Janssen Research & Development, LLC
2:05 PM	What Do We Know About Estimators for the Treatment Policy Estimand? Presentation Elena Polverejan, Janssen R&D; Vladimir Dragalin, Janssen R&D
2:30 PM	Performance of Pattern Mixture Model Estimators with and Without Patient-Level Imputation Presentation Bohdana Ratitch, IQVIA; Ilya Lipkovich, IQVIA; Michael O'Kelly, IQVIA
2:55 PM	Undiluting the Treatment Effect Presentation Thomas Permutt, Food and Drug Administration
3:20 PM	Discussant: Craig Mallinckrodt, PhD, Eli Lilly and Company
3:45 PM	Floor Discussion

403 * !	Tue, 7/31/2018, 2:00 PM - 3:50 PM	CC-West 118
The Power of Podcast: Promoting Statistics and Data Science in the Age of Social Media — Topic Contributed Panel
Section on Statistical Graphics, Biopharmaceutical Section, International Statistical Institute, Professional Issues and Visibility Council, Section on Statistical Computing
Organizer(s): Richard Zink, TARGET PharmaSolutions
Chair(s): Forrest Williamson, Eli Lilly
2:05 PM	Panel Discussion for the Power of Podcast: Promoting Statistics and Data Science in the Age of Social Media
Panelists:	Richard Zink, TARGET PharmaSolutions John Bailer, Miami University Katie Malone, Civis Analytics Kyle Polich, Data Skeptic
3:40 PM	Floor Discussion

416 !	Tue, 7/31/2018, 2:00 PM - 3:50 PM	CC-West 121
Clinical Trial Design- 4 — Contributed Papers
Biopharmaceutical Section
Chair(s): Lanju Zhang
2:05 PM	A Bayesian Framework for Calculating Predictive Probability of Success in Biomarker Development Presentation Cong Li; Ling Wang, Takeda; Ray Liu, Takeda Pharmaceuticals Inc
2:20 PM	Dose Finding Model Selection in Oncology Combination Therapy Presentation Lixia Pei, Janssen Pharmaceuticals ; Yichen Guo, Harvard University; Kevin Liu, Janssen Pharmaceuticals
2:35 PM	Testing Strategy in Phase 3 Trials with Multiple Doses Presentation David Li, Pfizer; Simon Kirby, Pfizer
2:50 PM	ESTIMATION of SD for a LOG-TRANSFORMED VARIABLE BASED on SUMMARY STATISTICS in the ORIGINAL SCALE Hui Quan, Sanofi; Juan Zhang, Sanofi; Deborah Dukovic, Sanofi; Dongli Zhou, Merck Senoro
3:05 PM	Analysis of Stratified Clinical Trials with Time-To-Event Endpoints Presentation Devan V Mehrotra, Merck & Co., Inc.; Shanjun Helian, Merck & Co., Inc.; Shu-Chih Su, Merck Research Labs
3:20 PM	New Multiple Hypotheses Testing Procedures Based on Covering Principle Presentation Hong Zhou, Arkansas State University; Huajiang Li, Avanir Pharmaceuticals
3:35 PM	Improving the Standards for Reporting of Clinical Trial Data Presentation Jitendra Ganju, Consultant

436	Tue, 7/31/2018, 3:05 PM - 3:50 PM	CC-West Hall B
SPEED: Tests, Trials, Biomarkers, and Other Topics in Biometrics — Contributed Poster Presentations
Biometrics Section, Biopharmaceutical Section, ENAR
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
21:	Some T-Tests for N-Of-1 Trials with Serial Correlation Ji-Ling Tang, University of Arkansas for Medical Sciences; Reid D. Landes, University of Arkansas for Medical Sciences; Anne Holbrook, McMaster University; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas
22:	Some T-Tests for N-Of-1 Trials with Serial Correlation: Correction Factors for Trials with Few Observations Reid D. Landes, University of Arkansas for Medical Sciences; Ji-Ling Tang, University of Arkansas for Medical Sciences; Mark S Mennemeier, University of Arkansas for Medical Sciences; J. Tyler Floyd, University of Central Arkansas; Anne Holbrook, McMaster University
23:	Hybrid Cluster-Individual Randomization Allocation Yi-Fan Chen, University of Illinois at Chicago; Jonathan Yabes, University of Pittsburgh
24:	Adjusting a Finite Population Block Kriging Estimator for Imperfect Detection Matthew Higham
25:	Using Logistical Regression to Build a Better Diathesis Model of Dupuytren's Contracture Recurrence Brian Cohen, ACI Clinical
28:	A Two-Stage Method to Analyze Multivariate Cluster Biomarkers in Prediction on a Single Binary Outcome Xiaoying Yu, University of Texas Medical Branch at Galveston; Wenyaw Chan, University of Texas Health Science Center at Houston; Gracie Vargas, University of Texas Medical Branch at Galveston; Rahul Pal, University of Texas Medical Branch at Galveston
29:	An Estimation Method for Enzyme Kinetic Model Parameters Based on Bayesian Approach Boseung Choi, Korea University; Jae Kyoung Kim, Korea Advanced Institute of Science and Technology; Grzegorz A Rempala, The Ohio State University
30:	Statistical Precision of Time-to-Event Endpoint in Single Arm Observational Study Using Monte Carlo Simulation Meijing Wu, AbbVie; Hongwei Wang, AbbVie Inc; Yabing Mai, AbbVie, Inc; Dajun Tian, Chiltern
31:	Multiple Testing Procedure Consideration in Clinical Trials Rachael Wen, Sanofi
32:	Practical Determining the Late Effect Parameter in Fleming-Harrington Test When a Delayed Treatment Effect Is Predicted Yuichiro Kaneko, Astellas Pharma; Satoshi Morita, Kyoto University
33:	Inferring Networks from Personal, Dense, Dynamic Data Clouds of Biological and Quantified-Self Data Elisa Sheng, Arivale
34:	Optimal Testing Configurations for Group Testing Brianna D. Hitt, University of Nebraska-Lincoln; Christopher R. Bilder, University of Nebraska-Lincoln; Joshua M. Tebbs, University of South Carolina; Christopher S. McMahan, Clemson University
35:	Common Risk Difference Test and Interval Estimation of Risk Difference for Stratified Bilateral Correlated Data Xi Shen, State University of New York At Buffalo; Changxing Ma, State University of New York At Buffalo; Guoliang Tian, Southern University of Science and Technology; Kam Chuen Yuen, The University of Hong Kong
36:	Functional Data Analysis in Dose-Adjusted Tacrolimus Trough Concentration Modeling: A New Method to Compare Intrapatient Variance Between Patient Cohorts Janet Kim, Astellas Pharma Global Development, Inc.; Sam Wilson, Astellas Pharma Global Development, Inc.; Jason J Schwartz, Astellas Pharma Global Development, Inc.
38:	Design Considerations When Comparing Control, Treatment, and Treatment Plus in Randomized Trials Abigail Shoben, Ohio State University
Oral Presentations for this session.

216505	Tue, 7/31/2018, 5:30 PM - 7:30 PM	F-Malaspina
Biopharmaceutical Section Business Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Heather Thomas, Biopharmaceutical Section

216623	Wed, 8/1/2018, 7:00 AM - 8:30 AM	F-Burrard Suite
ASA BIOP Real World Data and Real World Evidence Scientific Working Group Meeting (Closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Weili He, AbbVie

439	Wed, 8/1/2018, 7:00 AM - 8:15 AM	CC-West Ballroom D
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
WL01:	Practical Guidelines and User-Friendly Software for Bayesian Adaptive Designs J. Jack Lee, Univ of Texas-M D Anderson Cancer Center

468 * !	Wed, 8/1/2018, 8:30 AM - 10:20 AM	CC-West 120
Blinded Data Reviews Are Necessary in Today's Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Ibrahim Turkoz, Janssen Research and Development, LLC
Chair(s): Ibrahim Turkoz, Janssen Research and Development, LLC
8:35 AM	Predicting the Timing of the Final Event by Fitting B Splines to Poisson Intensity Rates Presentation Marcus Sobel, Temple Universisity; Ibrahim Turkoz, Janssen Research and Development, LLC
8:55 AM	Estimating Event Rate Differences Using Data from Blinded Trials A. Gould, Merck Research Laboratories; Bill Wang, Merck
9:15 AM	Bayesian Blinded Sample Size Adjustment for Risk Differences Presentation Andrew Hartley, PPD, Inc.
9:35 AM	Blinded vs. Unblinded Sample Size Re-Estimation: When and What? Yili Pritchett, MedImmune
9:55 AM	Tools and Techniques for Blinded Data Reviews in Ongoing Clinical Trials Suresh Ankolekar, Cytel Inc.; Hrishikesh Kulkarni, Cytel Inc.
10:15 AM	Floor Discussion

469 *	Wed, 8/1/2018, 8:30 AM - 10:20 AM	CC-West 119
Novel Trial Designs in Precision Medicine — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jianchang Lin, Takeda Pharmaceuticals
Chair(s): Rachael Liu, Takeda Pharmaceuticals
8:35 AM	Subgroup Selection in Adaptive Signature Designs of Confirmatory Clinical Trials Presentation Zhiwei Zhang, University of California at Riverside
8:55 AM	A Case Study of Adaptive Seamless Design with Subpopulation Selection in Oncology Rui Qin, Janssen Pharmaceutical R&D
9:15 AM	REMAP-CAP: a Precision Medicine Embedded Platform Trial for Community Acquired Pneumonia Presentation Scott Berry, Berry Consultants
9:35 AM	A Biomarker-Directed Phase 2 Oncology Umbrella Trial to Target Combination Therapy in NSCLC Presentation Hua Ma, Merck; Robin Mogg, Merck Research Laboratories
9:55 AM	Adaptive Multi-Combination Platform Trials in Oncology; Considerations for Study Designs Presentation Stuart Bailey, Novartis Institutes for Biomed Research; Jennifer Gauvin, Novartis
10:15 AM	Floor Discussion

476	Wed, 8/1/2018, 8:30 AM - 10:20 AM	CC-West 212
SPEED: Clinical Trial Design, Longitudinal Analysis, and Other Topics in Biopharmaceutical Statistics — Contributed Speed
Biopharmaceutical Section
Chair(s): Mingbin Feng, University of Waterloo
Poster Presentations for this session.
8:35 AM	A Stagewise Prognostic Control Predictive Approach (SPCPA) for Subgroup Identification and Its Application in a Phase II Study Presentation Wanying Li, Gilead Sciences; Wangshu Zhang, Gilead Sciences; Lovely Goyal, Gilead Sciences; Yuanyuan Xiao, Gilead Sciences
8:40 AM	A Novel Blind Start Study Design to Investigate Vestronidase Alfa for Mucopolysaccharidosis VII, an Ultra-Rare Genetic Disease Presentation Wenjie Song, Ultragenyx Pharmaceutical Inc; Chao-Yin Chen, Ultragenyx Pharmaceutical Inc; Christine Haller, Ultragenyx Pharmaceutical Inc; Emil Kakkis, Ultragenyx Pharmaceutical Inc
8:45 AM	Statistical Models for Longitudinal Analysis of Preclinical Efficacy Screens Presentation William Forrest, Genentech, Inc; Bruno Alicke, Genentech; Oleg Mayba, Genentech; Alice Starr, Genentech
8:50 AM	Treatment Effect Estimation in Subgroups: a Comparative Study Presentation Weihua Cao, Novartis Pharmaceutical Corp; Bjoern Holzhauer, Novartis Pharma AG; Steffen Ballerstedt, Novartis Pharma AG; Dong Xi, Novartis Pharmaceuticals; Ieuan Jones, Novartis Pharma AG
8:55 AM	Sample Size Formulae and Application for the Two-Stage Continual Reassessment Method (CRM) Presentation Cody Chiuzan, Columbia University; Ying Kuen Ken Cheung, Columbia University; Zilan Chai, Columbia University
9:00 AM	Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
9:10 AM	Incorporating Intermediate Binary Responses into Interim Analysis of a Long-Term Binary Endpoint Presentation 1 Presentation 2 Jingjing Chen, Takeda Pharmaceuticals; Tina Liu, Takeda Pharmaceuticals; Andrejus Parfionovas, Takeda Pharmaceuticals; Cong Han, Takeda Pharmaceuticals; Xiaopan Yao, Takeda Pharmaceuticals
9:15 AM	MMRM Estimates Consideration for Longitudinal Data in Clinical Trials Presentation 1 Presentation 2 Zheng (Jason) Yuan, Vertex Pharmaceuticals; Yaohua Zhang, Vertex Pharmaceuticals; Chenkun Wang, Vertex Pharmaceuticals; Bingming Yi, Vertex Pharmaceuticals
9:20 AM	Further Extensions of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection and Treatment Preference Effects to Include Count Outcomes Presentation Denise Esserman, Yale University; Yu Shi, Yale University
9:30 AM	Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes Presentation 1 Presentation 2 Lee Kennedy-Shaffer, Harvard University; Michael David Hughes, Harvard University
9:35 AM	Estimation of Peak Expiratory Flow Under Stochastic Differential Equations Presentation Shan Yang, Merck & Co Inc
9:40 AM	A Novel Confidence Interval for a Single Proportion in the Presence of Clustered Binary Outcome Data Presentation Meghan Short, Boston University School of Public Health; Joseph M. Massaro, Boston University
9:45 AM	Analysis of Multiple Thresholds in a Responder Analysis of Patient-Reported Outcome Measures Presentation Lysbeth Floden, Clinical Outcome Solutions; Melanie L Bell, University of Arizona; Stacie Hudgens, Clinical Outcome Solutions
9:50 AM	A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy: Expected Trial Duration and Tools for Planning Michelle DeVeaux, Regeneron Pharmaceuticals; Michael John Kane, Yale University; Daniel Zelterman, Yale University
9:55 AM	Assessing MCP-Mod Relative to Pairwise Comparisons and Trend Tests in Dose-Ranging Design and Analysis Presentation Anran Wang, Merck & Co Inc; Fang Liu, Merck & Co., Inc; Sammy Yuan, Merck; Man (Mandy) Jin, Merck & Co., Inc.; Meihua Wang, Merck & Co.; Akshita Chawla, Merck & Co Inc; Pranab Kumar Mitra, Merck & Co Inc; Robin Mogg, Merck Research Laboratories
10:00 AM	Exposure-Response Analysis with Random Forest Presentation Zifang Guo, Merck; Thomas Jemielita, Merck & Co.; John Kang, Merck
10:05 AM	Statistical Considerations of Single Pivotal Vs Two Replicated Confirmatory Studies Presentation Zijiang Yang, Janssen R&D
10:10 AM	Reducing the Effects of Misclassification in Sequential Multiple Assignment Randomized Trials (SMART) Jun He, Virginia Commonwealth University; Donna McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University

483 !	Wed, 8/1/2018, 8:30 AM - 10:20 AM	CC-West 115
Multiplicity — Contributed Papers
Biopharmaceutical Section
Chair(s): Jingjing Schneider
8:35 AM	Hochberg Procedure Under Multivariate Normal Distribution with Some Negative Correlations Presentation Jiangtao Gou, Fox Chase Cancer Center, Temple University Health System
8:50 AM	General Covering Principle: a New Approach to Address Multiplicity in Hypothesis Testing Presentation Huajiang Li, Avanir Pharmaceuticals; Hong Zhou, Arkansas State University
9:05 AM	Considerations on MCPMod-Type Methods for Proof of Concept in Multi-Armed Studies Presentation Tobias Mielke, Janssen-Cilag GmbH
9:20 AM	Multiplicity for a Group Sequential Trial with Biomarker Subpopulations Jing Zhao, Merck
9:35 AM	Controlling the Family-Wise Type I Error Rate in a Phase II POC Trial of the Merck Pneumococcal Vaccine Program: An Application of the Hochberg Approach Jianing Li, Merck Research Lab
9:50 AM	Improving the Dunnett Test for Discrete Data Presentation Li He, Merck Research Laboratories; Joseph F. Heyse, Merck Research Laboratories
10:05 AM	Composite Endpoints in Clinical Trials with Multiple Correlated Dichotomous Outcomes Presentation Boris Zaslavsky, FDA/CBER

484 !	Wed, 8/1/2018, 8:30 AM - 10:20 AM	CC-West 121
Clinical Trial Design- 5 — Contributed Papers
Biopharmaceutical Section
Chair(s): Jane Qian, Abbvie
8:35 AM	Moving Beyond Longrank/Hazard Ratio Test/Estimation Approach in Cancer Clinical Trials Hajime Uno, Dana Farber Cancer Institute; Miki Horiguchi, Kitasato University
8:50 AM	Sample Size Allocation in Multi-Regional Equivalence Studies Presentation Jason Liao, Merck & Co. Inc.; Ziyi Yu, Jazz Pharmaceuticals Inc; Yulan Li, Myovant Sciences
9:05 AM	BLINDED SAMPLE SIZE RE-ESTIMATION Presentation Chien-Hua Wu, Chung-Yuan Christian University; Shu-Mei Wan, Lunghwa University of Science and Technology
9:20 AM	A Model-Based Approach for Simulating Adaptive Clinical Studies with Surrogate Endpoints Used for Interim Decision-Making Presentation Xiaotian Chen, AbbVie; Alan Hartford, AbbVie Inc; Mei Li, AbbVie; Jun Zhao, AbbVie
9:35 AM	A Curtailed Two-Stage Selection and Testing Procedure for Comparative Clinical Trials Presentation Mingyue Wang, Syracuse University; Pinyuen Chen, Syracuse University
9:50 AM	Longitudinal Parametric Dose-Response Surface Model Assisted Early Phase Study Design Presentation Yongming Qu, Eli Lilly and Company
10:05 AM	Assessment of Treatment Effect on Overall Survival in the Presence of Treatment Switching: a Bridging Approach Across Various Modeling Methods Presentation Yiyun Tang, Pfizer, Inc.; Selaru Paulina, Pfizer Inc.; Xin Huang, Pfizer Inc.

494 *	Wed, 8/1/2018, 10:30 AM - 12:20 PM	CC-West Ballroom A
Clinical Trial Design for Precision Oncology — Invited Papers
ENAR, Biopharmaceutical Section, Biometrics Section, SSC
Organizer(s): Mithat Gonen, Memorial Sloan Kettering Cancer Center
Chair(s): Mithat Gonen, Memorial Sloan Kettering Cancer Center
10:35 AM	Evaluating the Statistical Properties of Bayesian Basket Trial Designs Kristen May Cunanan, Memorial Sloan Kettering Cancer Center; Alexia Iasonos, Memorial Sloan Kettering Cancer Center; Ronglai Shen, Memorial Sloan-Kettering Cancer Center; Colin B Begg, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
11:05 AM	Bayesian Uncertainty Directed Trial Designs Lorenzo Trippa, Harvard
11:35 AM	Discussant: Gary Rosner, Johns Hopkins University
12:05 PM	Floor Discussion

504 *	Wed, 8/1/2018, 10:30 AM - 12:20 PM	CC-West 110
Novel Dose-Finding Methods in the Development of Combination Therapies — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, ENAR
Organizer(s): Bo Huang, Pfizer Inc.
Chair(s): Jing Wang, Pfizer, Inc
10:35 AM	Novel Model-Assisted Designs for Phase I Drug Combination Trials Presentation Ruitao Lin, MD Anderson Cancer Center
11:15 AM	Improving Dose-Finding for Early Oncology Trials with Monotherapy and Combination Therapy Zhen Zeng, Merck & Co.; Meihua Wang, Merck & Co.; Victoria Plamadeala Johnson, Merck & Co.; Cong Chen, Merck & Co.
11:35 AM	AAA: Triple-Adaptive Bayesian Designs for the Identification of Optimal Dose Combinations in Dual-Agent Dose-Finding Trials Yuan Ji, NorthShore Univ. HealthSystem / The University of Chicago; Jiaying Lyu, Fudan Universtiy
11:55 AM	Floor Discussion

511	Wed, 8/1/2018, 10:30 AM - 12:00 PM	CC-West 212
Statistical Considerations for Rare Disease Clinical Development: Opportunities and Challenges — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yang Song, Vertex Pharmaceuticals Inc.
Chair(s): Xihao Li, Harvard T.H. Chan School of Public Health
10:35 AM	What Constitutes Scientific Evidence - Controversies in Rare Disease Trial Designs and Personalized Medicine Mark Chang, Veristat
10:55 AM	A Statistical Framework on Clinical Trials for Information Integration Across Data Sources with Applications to Rare Disease Clinical Development Presentation Yang Song, Vertex Pharmaceuticals Inc.; Xihao Li, Harvard T.H. Chan School of Public Health
11:15 AM	On Randomized Controlled Trials with Integrated Real World Evidence for Drug Development in Rare Diseases Qing Liu, Amicus Therapeutics, Inc
11:35 AM	Bayes in Drug Development for Rare Diseases John Scott, FDA
11:55 AM	Integrative Statistical Learning with Real World Healthcare Data: Towards a Data Driven Suicide Prevention Framework Kun Chen, University of Connecticut
12:15 PM	Floor Discussion

515 * !	Wed, 8/1/2018, 10:30 AM - 12:20 PM	CC-West 109
Leadership at All Levels — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Alison Pedley
Chair(s): Lisa Lupinacci, Merck
10:35 AM	"Leading at the Entry Level" - Effective Leadership as a Protocol Level Statistician Presentation Alison Pedley
10:55 AM	"Leading Without Authority" - Effective Leadership as Program Lead Statistician Presentation Yabing Mai, AbbVie, Inc
11:15 AM	"Fostering Excellence" - Effective Leadership as a People Manager Presentation Duane Snavely, Merck & Co.
11:35 AM	Points to Consider for Effective Leadership as an Organizational Leader Presentation 1 Presentation 2 Bruce Binkowitz, Shionogi & Co., Ltd.
9:55 PM	Discussant: Erik Pulkstenis, AbbVie
12:15 PM	Floor Discussion

524	Wed, 8/1/2018, 10:30 AM - 12:20 PM	CC-West 111
Statistical Issues in Drug Development - 2 — Contributed Papers
Biopharmaceutical Section
Chair(s): Hui Yang, Amgen Inc.
10:35 AM	Application of the Win Ratio for Benefit-Risk Analysis Presentation T. Ceesay, Merck ; Shahrul Mt-Isa, Merck; Joseph F. Heyse, Merck Research Laboratories
10:50 AM	A Simulation Study of Consistency Evaluation Between Local and Global Results in Multi-Regional Clinical Trials Presentation Chunsheng He, Bristol-Myers Squibb; Jingyi Lin, Duke University; Stephane Munier, Bristol-Myers Squibb; Shein-Chung Chow, Duke University; Lisa Ying
11:05 AM	A Comparison of Statistical Models for Recurrent Events with Applications to Hospitalization and Death Events Jihong Chen, Alnylam Pharmaceuticals; Tim Lin, Alnylam Pharmaceuticals; Matthew T. White, Alnylam Pharmaceuticals; Christine Powell, Alnylam Pharmaceuticals; Andrew Strahs, Alnylam Pharmaceuticals
11:20 AM	Addressing the Issue of Subject Confusion Due to the Use of Two Visual Analog Scales in Human Abuse Potential Studies Presentation Ling Chen, CDER, FDA
11:35 AM	Rescue Medications from a Statistical Perspective - Case Studies and More qing li, merck; Man (Mandy) Jin, Merck & Co., Inc.
11:50 AM	Propensity Score Methods for Efficacy Comparison in the Lack of Randomization Presentation Qing Li, University of Iowa; Guang Chen, Celgene Corp.
12:05 PM	An Evaluation of Statistical Approaches to Post Marketing Surveillance Yuxin Ding, University at Buffalo; Marianthi Markatou, University at Buffalo; Robert Ball, U.S. Food and Drug Administration,Center for Drug Evaluation and Research

525 !	Wed, 8/1/2018, 10:30 AM - 12:20 PM	CC-West 209
Clinical Trial Design- 6 — Contributed Papers
Biopharmaceutical Section
Chair(s): Rachael Wen, Sanofi
10:35 AM	Asymptotic MinP Method for Responder Analysis Ming Zhou, Bristol-Myers Squibb Company; Mark Donovan, Bristol-Myers Squibb
10:50 AM	Estimating Probability of Simultaneous Success with Multiple Endpoints Using Truncated Multi-Variate Correlated Normal Distribution Presentation Tianshuang Wu, AbbVie; Yihua Gu, AbbVie; Ziqian Geng, AbbVie; Saurabh Mukhopadhyay, AbbVie
11:05 AM	Measuring the Individual Benefits of a Medical or Behavioral Treatment Using Generalized Linear Mixed-Effects Models Francisco Diaz, The University of Kansas Medical Center
11:20 AM	Comparison of Support Vector Machine and Conformal Inference of in Regression Prediction Presentation Kao-Tai Tsai, Celgene
11:35 AM	Adaptive Dose Finding in Oncology Phase I-II Studies with Consideration of Tolerability and Efficacy Rachael Liu, Takeda Pharmaceuticals ; Ling Wang, Takeda; David Sinclair, Google; Jianchang Lin, Takeda Pharmaceuticals
11:50 AM	How the ICH E9 Addendum Influenced a Phase III Clinical Trial with a Radiographic Endpoint Ruvie Martin, Novartis Pharmaceuticals
12:05 PM	Floor Discussion

540	Wed, 8/1/2018, 11:35 AM - 12:20 PM	CC-West Hall B
SPEED: Clinical Trial Design, Longitudinal Analysis, and Other Topics in Biopharmaceutical Statistics — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
21:	A Stagewise Prognostic Control Predictive Approach (SPCPA) for Subgroup Identification and Its Application in a Phase II Study Wanying Li, Gilead Sciences; Wangshu Zhang, Gilead Sciences; Lovely Goyal, Gilead Sciences; Yuanyuan Xiao, Gilead Sciences
22:	A Novel Blind Start Study Design to Investigate Vestronidase Alfa for Mucopolysaccharidosis VII, an Ultra-Rare Genetic Disease Wenjie Song, Ultragenyx Pharmaceutical Inc; Chao-Yin Chen, Ultragenyx Pharmaceutical Inc; Christine Haller, Ultragenyx Pharmaceutical Inc; Emil Kakkis, Ultragenyx Pharmaceutical Inc
23:	Statistical Models for Longitudinal Analysis of Preclinical Efficacy Screens William Forrest, Genentech, Inc; Bruno Alicke, Genentech; Oleg Mayba, Genentech; Alice Starr, Genentech
24:	Treatment Effect Estimation in Subgroups: a Comparative Study Weihua Cao, Novartis Pharmaceutical Corp; Bjoern Holzhauer, Novartis Pharma AG; Steffen Ballerstedt, Novartis Pharma AG; Dong Xi, Novartis Pharmaceuticals; Ieuan Jones, Novartis Pharma AG
25:	Sample Size Formulae and Application for the Two-Stage Continual Reassessment Method (CRM) Cody Chiuzan, Columbia University; Ying Kuen Ken Cheung, Columbia University; Zilan Chai, Columbia University
26:	Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
28:	Incorporating Intermediate Binary Responses into Interim Analysis of a Long-Term Binary Endpoint Jingjing Chen, Takeda Pharmaceuticals; Tina Liu, Takeda Pharmaceuticals; Andrejus Parfionovas, Takeda Pharmaceuticals; Cong Han, Takeda Pharmaceuticals; Xiaopan Yao, Takeda Pharmaceuticals
29:	MMRM Estimates Consideration for Longitudinal Data in Clinical Trials Zheng (Jason) Yuan, Vertex Pharmaceuticals; Yaohua Zhang, Vertex Pharmaceuticals; Chenkun Wang, Vertex Pharmaceuticals; Bingming Yi, Vertex Pharmaceuticals
30:	Further Extensions of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection and Treatment Preference Effects to Include Count Outcomes Denise Esserman, Yale University; Yu Shi, Yale University
31:	Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes Lee Kennedy-Shaffer, Harvard University; Michael David Hughes, Harvard University
32:	Estimation of Peak Expiratory Flow Under Stochastic Differential Equations Shan Yang, Merck & Co Inc
33:	A Novel Confidence Interval for a Single Proportion in the Presence of Clustered Binary Outcome Data Meghan Short, Boston University School of Public Health; Joseph M. Massaro, Boston University
34:	Analysis of Multiple Thresholds in a Responder Analysis of Patient-Reported Outcome Measures Lysbeth Floden, Clinical Outcome Solutions; Melanie L Bell, University of Arizona; Stacie Hudgens, Clinical Outcome Solutions
35:	A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy: Expected Trial Duration and Tools for Planning Michelle DeVeaux, Regeneron Pharmaceuticals; Michael John Kane, Yale University; Daniel Zelterman, Yale University
36:	Assessing MCP-Mod Relative to Pairwise Comparisons and Trend Tests in Dose-Ranging Design and Analysis Anran Wang, Merck & Co Inc; Fang Liu, Merck & Co., Inc; Sammy Yuan, Merck; Man (Mandy) Jin, Merck & Co., Inc.; Meihua Wang, Merck & Co.; Akshita Chawla, Merck & Co Inc; Pranab Kumar Mitra, Merck & Co Inc; Robin Mogg, Merck Research Laboratories
37:	Exposure-Response Analysis with Random Forest Zifang Guo, Merck; Thomas Jemielita, Merck & Co.; John Kang, Merck
38:	Statistical Considerations of Single Pivotal Vs Two Replicated Confirmatory Studies Zijiang Yang, Janssen R&D
39:	Reducing the Effects of Misclassification in Sequential Multiple Assignment Randomized Trials (SMART) Jun He, Virginia Commonwealth University; Donna McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University
Oral Presentations for this session.

542	Wed, 8/1/2018, 12:30 PM - 1:50 PM	CC-West Ballroom D
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Margaret Gamalo-Siebers, Eli Lilly & Co
WL11:	Confessions of an Independent DMC Statistician Brian Cohen, ACI Clinical
WL12:	Active Reference vs. Active Comparator: What Should We Include to Design Late-Phase Studies? Suchitrita Rathmann, Eli Lilly & Co

568 * !	Wed, 8/1/2018, 2:00 PM - 3:50 PM	CC-West 118
Leadership in Quantitative Sciences in the Pharmaceutical Industry Panel Discussion — Invited Panel
Biopharmaceutical Section, Health Policy Statistics Section, Committee on Applied Statisticians
Organizer(s): Amit Bhattacharyya, ACI Clinical
Chair(s): Sandeep Menon, Pfizer
2:05 PM	Statistical Leadership in Pharmaceutical Industry Panel Discussion Presentation
Panelists:	Lisa LaVange, University of North Carolina Nevine Zariffa, AstraZeneca Pandurang Kulkarni, Eli Lilly & Company Kannan Natarajan, Pfizer Lisa Lupinacci, Merck Cyrus Hoseyni, Janssen Amit Bhattacharyya, ACI Clinical
3:40 PM	Floor Discussion

575 *	Wed, 8/1/2018, 2:00 PM - 3:50 PM	CC-West 214
Translating Real World Data into Robust Evidence to Inform Decisions on Medical Product Development and Life Cycle Management — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Weili He, AbbVie
Chair(s): Weili He, AbbVie
2:05 PM	Evaluating Different Analytic Strategies to Translate Real World Data to Robust Evidence for Decision Making Presentation Hongwei Wang, AbbVie Inc; Weili He, AbbVie; Yabing Mai, AbbVie, Inc; Meijing Wu, AbbVie; Dajun Tian, Chiltern
2:25 PM	Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices Presentation Martin Ho, FDA
2:45 PM	Real World Data Analysis to Inform Clinical Trial Modeling and Simulation Presentation Zhaoling Meng, sanofi; Dimple Patel, sanofi; Qi Tang, Sanofi; Nadia Gaudel-Dedieu, sanofi; James Rogers, Metrum Research Group
3:05 PM	The Use of Real World Data as a Bayesian Prior in a Device Clinical Trial Presentation Roseann White, Duke Clinical Research Institute
3:25 PM	Discussant: Mark Levenson, FDA CDER
3:45 PM	Floor Discussion

590 !	Wed, 8/1/2018, 2:00 PM - 3:50 PM	CC-West 119
Missing Data — Contributed Papers
Biopharmaceutical Section
Chair(s): Xiaodong Luo
2:05 PM	Degrees of Freedom Adjustment in Mixed Model Repeated Measures Analyzes with Missing Data Michael McDermott, University of Rochester Medical Center; Madhurima Majumder, Bayer Pharmaceuticals
2:20 PM	Simulation Study in Handing Missing Data Due to Use of Rescue Therapy in Rare Disease Presentation Yiwei Zhang, Biogen; Peng Sun, Biogen; Baoguang Han, Biogen; John Zhong, Biogen
2:35 PM	Bias Reduction in Logistic Regression with Missing Responses When the Missing-Data Mechanism Is Non-Ignorable Presentation Vivek Pradhan
2:50 PM	Approaches to Tipping Point Analyzes for a Binary Endpoint in Longitudinal Clinical Trials Joseph Wu, Pfizer; Huaming Tan, Pfizer, Inc.; Neal Thomas, Pfizer; Cunshan Wang, Pfizer, Inc.
3:05 PM	Challenges in Analysis with Data Which Is Censored at Data Lockdown Presentation Tammy Massie
3:20 PM	Handling Missing Not at Random Data for Safety Endpoint in the Multiple Dose Titration Clinical Pharmacology Trial Presentation Li Fan, Merck; Tian Zhao, Merck; Patrick Larson, Merck
3:35 PM	The Application of Tipping Point Analysis in Clinical Trials Presentation HONG DING

604 * !	Thu, 8/2/2018, 8:30 AM - 10:20 AM	CC-West 206/207
Superbugs vs. Super-Statistics — Invited Papers
CHANCE, Biometrics Section, Biopharmaceutical Section
Organizer(s): Scott Evans, Harvard University
Chair(s): Toshi Hamasaki
8:35 AM	Dynamic Treatment Regimens for Superbug Infections Presentation Dean Follmann, NIAID
9:05 AM	Healthy Disruption for Diagnostic Studies Through Pragmatic Benefit:Risk Evaluation Scott Evans, Harvard University; Ying Liu, Harvard University
9:35 AM	Pragmatic Benefit:Risk Evaluation: Healthy Disruption for Clinical Trials Presentation Scott Evans, Harvard University; Ying Liu, Harvard University; Dean Follmann, NIAID
10:05 AM	Floor Discussion

614 * !	Thu, 8/2/2018, 8:30 AM - 10:20 AM	CC-West 110
Reasonable Possibility - Statistical Science of Safety Monitoring — Topic Contributed Papers
Biopharmaceutical Section, Quality and Productivity Section
Organizer(s): Hal Li, Merck Research Laboratories
Chair(s): Judy Li, Regeneron Pharmaceuticals Inc.
8:35 AM	Beware On-Treatment Safety Analysis Presentation Janet Wittes, Statistics Collaborative; Fred Yang, Innomed Consulting
8:55 AM	The Likelihood Principle and Its Application to Aggregate Safety Monitoring LiAn Lin; Bill Wang, Merck
9:15 AM	Visual Analytics to Assess Reasonable Possibility: Using DILI as an Example Presentation Kefei Zhou, Theravance Biopharma; Melvin Munsaka, AbbVie, Inc.; Krishan P. Singh, GlaxoSmithKline
9:35 AM	Practical Considerations in Planning and Implementing Aggregate Safety Monitoring Presentation Bill Wang, Merck
9:55 AM	Floor Discussion

617 * !	Thu, 8/2/2018, 8:30 AM - 10:20 AM	CC-West 214
Indirect Comparisons of Treatment Effects for Clinical Regulatory and Health Economic Evaluations — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yanyan Zhu, Takeda Pharmaceuticals
Chair(s): James Signorovitch, Analysis Group
8:35 AM	Retrospective Matched-Pairs Analysis for Clinical Trial Patient Level Data: a Simulation Study and General Considerations Bingxia Wang, Takeda Pharmaceuticals Inc.; Chenchen Ma; Yanyan Zhu, Takeda Pharmaceuticals; Guohui Liu, Takeda Pharmaceuticals Inc
8:55 AM	Inference for Clinical Trials That Rely on Historical Data: a Review of Statistical Approaches for Reducing Risk of Bias Presentation Lei Nie, Division of Biometrics V, office of Biostatistics, CDER/FDA; James Signorovitch, Analysis Group; Rajeev Ayyagari, Analysis Group
9:15 AM	An Overview of Matching Adjusted Indirect Comparisons in Single Arm Clinical Trials with Practical Recommendations and Potential Challenges Presentation Dawn Odom, RTI Health Solutions; Molly Purser, RTI Health Solutions; Lawrence Rasouliyan, RTI Health Solutions
9:35 AM	Matching Adjusted Indirect Comparisons: Sensitivity Analyzes and Graphical Diagnostics Presentation Wei Gao, Analysis Group, Inc.; Vanya Rybkin, Analysis Group, Inc.; Zhiwen Yao, Analysis Group, Inc.; Michael Hellstern, Analysis Group, Inc.; James Signorovitch, Analysis Group
9:55 AM	Uncontrolled Studies and Health Technology Appraisal ? The Need for Methods, Modeling, and Further Research Presentation Anthony Hatswell, University College London
10:15 AM	Floor Discussion

631 !	Thu, 8/2/2018, 8:30 AM - 10:20 AM	CC-West 114
Clinical Trial Design- 7 — Contributed Papers
Biopharmaceutical Section
Chair(s): Yuqi Chen, Amgen
8:35 AM	Impact of Clinical Center Effects on Objective Response Rate Presentation Fang Liu, Merck & Co., Inc; Cong Chen, Merck & Co.
8:50 AM	Utility and Challenges of Applying Quantitative Benefit-Risk Assessment for Regulatory Decision Making Presentation Weili He, AbbVie; Bo Fu, Astellas Pharma Inc.; John Scott, FDA
9:05 AM	Does it Pay to Repeat the Baseline? Presentation Shiyang Ma, University of Rochester; David Oakes , University of Rochester
9:20 AM	Extension to Signature Design Presentation Xiting Yang, Food and Drug Administration
9:35 AM	A Unified Framework for Weighted Parametric Multiple Test Procedures Presentation Dong Xi, Novartis Pharmaceuticals; Ekkehard Glimm, Novartis; Willi Maurer, Novartis; Frank Bretz, Novartis Pharma AG
9:50 AM	Target Toxicity Design for Phase 1 Dose-Finding: a Safe and Reliable Method Bob Zhong, Johnson and Johnson; Wenchuan Guo, University of California Riverside
10:05 AM	Bayesian Extrapolation in Pediatric Clinical Trials Presentation Mehreteab F Aregay, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis Pharamceutical Corporation

632 !	Thu, 8/2/2018, 8:30 AM - 10:20 AM	CC-West 115
Statistical Issues Specific the Therapeutic Areas-4 — Contributed Papers
Biopharmaceutical Section
Chair(s): Wen-Chi Wu, Merck
8:35 AM	Variational Inference for Proportional Hazards Model with Power Prior in Oncology Studies Presentation Bo Jin, Boston Biomedical Inc.; Yue Chang, Boston Biomedical Inc
8:50 AM	Utilization of Historical Data and Real World Evidence in Clinical Trial Development - Case Studies in Rare Disease and Oncology Florence H Yong, Pfizer Inc.; Ray Li, Pfizer Inc.; Steven Y Hua, Celgene - Receptos; Jeffery Palmer, Pfizer Inc.; Roberto Bugarini, Pfizer Inc.
9:05 AM	Mathematical Modeling Identifies Optimum Lapatinib Dosing Schedules for the Treatment of Glioblastoma Patients Presentation Shayna Stein, Harvard University; Franziska Michor, Dana Farber Cancer Institute
9:20 AM	Evaluation of Statistical Methods for Survival Analysis with Time-Dependent Variables Presentation Chris Holland, Amgen; Qui Tran, Amgen; Cassie Dong, Amgen
9:35 AM	Predicting the Long-Term Exposure in Acute Treatment of Migraine Using a Nonhomogeneous Poisson Process with Random Effects Kaifeng Lu
9:50 AM	Statistical Challenges and Opportunities in Drug Development for Rare Diseases Presentation Guowen Sun, BioMarin; Keith Gregg, BioMarin; Peter Slasor, BioMarin; Chito Hernandez, BioMarin Pharmaceutical Inc.
10:05 AM	Optimal Treatment Recommendation via Subgroup Identification in Randomized Control Trials Presentation Yang (Grace) Zhao, Gilead Sciences; Haoda Fu, Eli Lilly and Company

643	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 117
Biomarkers and Clinical Trials — Invited Papers
WNAR, Biopharmaceutical Section, Society for Clinical Trials, SSC
Organizer(s): Kathleen F. Kerr, University of Washington
Chair(s): Yingqi Zhao, Fred Hutchinson Cancer Research Center
10:35 AM	Evaluating Biomarkers for Prognostic Enrichment of Clinical Trials Kathleen F. Kerr, University of Washington; Jeremy Roth, University of Washington; Kehao Zhu, Axio Research; Heather Thiessen-Philbrook, Yale University; Allison Meisner, Johns Hopkins University; Francis Perry Wilson, Yale University; Steven Coca, Icahn School of Medicine at Mount Sinai; Chirag Parikh, Yale University
11:00 AM	Using Surrogate Biomarker Information to Plan a Future Clinical Trial Presentation Layla Parast, RAND; Tianxi Cai, Harvard T.H. Chan School of Public Health; Lu Tian, Stanford University School of Medicine
11:25 AM	Biomarker Guided Phase II Two-Stage Design for Targeted Therapy Zheyu Wang, Johns Hopkins University; Fujun Wang, Medimmune; Chenguang Wang, Johns Hopkins University; Gary Rosner, Johns Hopkins University; Jianliang Zhang, Medimmune; Hao Wang, Johns Hopkins University; Li Shi, Medimmune
11:50 AM	Evaluating the Ability of a Biomarker to Improve the Diagnosis of Malaria Infection in Malaria 'Challenge' Trials Holly Janes, Fred Hutchinson Cancer Research Center
12:15 PM	Floor Discussion

656 * !	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 110
Subgroup Evaluations in Advancing Drug Development — Topic Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, Committee on Applied Statisticians
Organizer(s): Parfionovas Andrejus, Takeda Pharmaceuticals, Inc.
Chair(s): Jing Xu, Takeda Pharmaceuticals, Inc.
10:35 AM	Quantitative Assessment of Risk with Subgroup Pursuit in Clinical Trials Xinzhou Guo, University of Michigan; Xuming He, University of Michigan
10:55 AM	Evaluation of Treatment Effect: Beyond Traditional Subgroups Yeh-Fong Chen, US FDA
11:15 AM	Using Hierarchical Models to Estimate Subgroup Effects in a Clinical Trial Anna McGlothlin, Berry Consultants
11:35 AM	Statistical Arguments for Regulatory Negotiation on Promising Subgroup Results Presentation Ming-Xiu Hu, Nektar Therapeutics
11:55 AM	Understand International Differences in Treatment Effect Presentation Li Chen, Amgen
12:15 PM	Floor Discussion

659 * !	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 121
Adaptive Dose Individualization — Topic Contributed Papers
Statistics and Pharmacometrics Interest Group, Biopharmaceutical Section
Organizer(s): Maha C Karnoub, Celgene
Chair(s): Maha C Karnoub, Celgene
10:35 AM	Bayesian Adaptive Dosing: Tailoring Patient Exposure Reduces Therapeutic Failures Presentation Diane Mould, Projections Research, Inc.
10:55 AM	Individualized Adaptive Dose-Response Modeling in Multiple Myeloma: Potential to Improve Patient Care Presentation Dean Bottino, Takeda Pharmaceuticals U.S.A.
11:15 AM	Individualized Dosing Sequences in Dynamic Precision Medicine for Cancer Presentation Robert Beckman, Georgetown University
11:35 AM	Discussant: Simon Zhou, Celgene
11:55 AM	Discussant: Laura L. Fernandes, U.S. Food and Drug Administration
12:15 PM	Floor Discussion

664	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 118
Using an Estimand Approach in Your Next Clinical Trial — Topic Contributed Panel
Biopharmaceutical Section
Organizer(s): Ye Tan, Pfizer Inc.
Chair(s): Ye Tan, Pfizer Inc.
10:35 AM	Using an Estimand Approach in Your Next Clinical Trial
Panelists:	Frank Bretz, Novartis Pharma AG Steven Gilbert, Pfizer Douglas S. Lee, Pfizer Jared Christensen, Pfizer Macaulay Okwuokenye, Syros Pharmaceuticals Inc
12:10 PM	Floor Discussion

673 !	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 120
Clinical Trial Design- 8 — Contributed Papers
Biopharmaceutical Section
Chair(s): John Pesko
10:35 AM	A Simulation Study Comparing MCP-Mod and a Model-Based Approach in Phase 2a Clinical Trials Presentation Hongtao Zhang; Alan Hartford, AbbVie Inc
10:50 AM	On Sample Size Requirement for Analytical Similarity Assessment Presentation Victoria Chang, AbbVie; Yi Zhao, Statistics Collaborative; Shein-Chung Chow, Food and Drug Administration
11:05 AM	Bayesian Predictive Probability for Interim Analysis Presentation Dung-Tsa Chen, Moffitt Cancer Center
11:20 AM	Periodic Benefit-Risk Assessment Using Bayesian Stochastic Multi-Criteria Acceptability Analysis Sammy Yuan, Merck; Kan Li, University of Texas Health Science Center; Bill Wang, Merck
11:35 AM	On Evaluation of Consistency in Multi-Regional Clinical Trials Lisa Ying; Fuyu Song, Center for Food and Drug Inspection, cFDA; Shein-Chung Chow, Food and Drug Administration; Na Zeng, National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital; Jiayin Zheng, Fred Hutchinson Cancer Research Center; Xiaodong Li, Bristol-Myers Squibb Company; David Henry, Bristol-Myers Squibb Company; Venkat Sethuraman, ZS Associates
11:50 AM	Selecting Among Treatments with Two Bernoulli Endpoints Presentation Elena M Buzaianu, University of North Florida; Pinyuen Chen, Syracuse University; Lifang Hsu, Le Moyne College
12:05 PM	Floor Discussion

674 !	Thu, 8/2/2018, 10:30 AM - 12:20 PM	CC-West 119
Adaptive Design - 3 — Contributed Papers
Biopharmaceutical Section
Chair(s): Ying Grace Li, Eli Lilly and Company
10:35 AM	A Bayesian Adaptive Phase 1/2 Design of Cisplatin and Cabazitaxel in Prostate Cancer with Visceral Metastasis Presentation Mourad Tighiouart, Cedars-Sinai Medical Center
10:50 AM	Adaptive Bayesian Interval-Based Oncology Dose Finding Design with Quasi-Continuous Toxicity Model Presentation Dan Zhao, University of Illinois at Chicago; Jian Zhu, Takeda; Eric Westin, ImmunoGen; Ling Wang, Takeda
11:05 AM	Bias-Corrected Estimation of Treatment Effects in Biomarker-Based Adaptive Subgroup Analysis: New Approach Based on Randomized Tests with Smooth Rejection Function Presentation 1 Presentation 2 Kiichiro Toyoizumi, Shionogi Inc.; Shigeyuki Matsui, Nagoya University
11:20 AM	Practical Considerations of Subgroups Quantification, Selection and Adaptive Enrichment in Confirmatory Trials Presentation Jianchang Lin, Takeda Pharmaceuticals; Rachael Liu, Takeda Pharmaceuticals ; Veronica Bunn, Florida State University
11:35 AM	An Adaptive Dose Selection Case Study: Statistical Methods and Operational Considerations Presentation Adam Hamm, Cytel, Inc.
11:50 AM	Statistical Monitoring of Semi-Competing Risk Outcomes in Clinical Trials Presentation Toshi Hamasaki; Scott Evans, Harvard University; Tomoyuki Sugimoto, Kagoshima University; Koko Asakura, National Cerebral and Cardiovascular Center; Susan Halabi, Duke University
12:05 PM	BOIN-ET: Bayesian Optimal Interval Design for Dose Finding Based on Both Efficacy and Toxicity Outcomes Presentation Kentaro Takeda, Astellas Pharma Global Development, Inc.; Masataka Taguri, Yokohama City University; Satoshi Morita, Kyoto University

JSM 2018 Online Program

Activity Details

American Statistical Association