JSM 2016 Online Program

Sessions Were Renumbered as of May 19.

Legend:
CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

CE_13C	Sun, 7/31/2016, 1:00 PM - 5:00 PM	CC-W470b
Making Quantitative Decisions During the Clinical Development of a New Drug (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): Christy Chuang-Stein, Independent Consultant
1:00 PM	Making Quantitative Decisions During the Clinical Development of a New Drug (ADDED FEE) — Christy Chuang-Stein, Independent Consultant

8 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W190b
Issues in Predictive Biomarker in Oncology Drug Development — Invited Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Peipei Shi, Biogen
Chair(s): Peipei Shi, Biogen
2:05 PM	Issues in Biomarker-Based Oncology Trial Design — Daniel Sargent, Mayo Clinic
2:25 PM	Accuracy Measures for Predictive Biomarkers — Richard Macey Simon, National Cancer Institute
2:45 PM	Adjusting for Enrichment Effects When Estimating Oncology Biomarker Clinical Utility — Jared Lunceford, Merck Research Laboratories
3:05 PM	Bias in Lifetime Data Analysis for Validation of Biomarkers — Tinghui Yu, FDA/CDRH ; Yabing Mai, Merck Research Laboratories
3:25 PM	Discussant: Gene Pennello, FDA/CDRH/OSB/DBS
3:45 PM	Floor Discussion

15 *	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W196a
Recent Advances in Early Phase I/II Cancer Trials Using Drug Combinations — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Mourad Tighiouart, Cedars-Sinai Medical Center
Chair(s): Ying Yuan, MD Anderson Cancer Center
2:05 PM	The Utility of Conditional Autoregressive (CAR) Models for Modeling Efficacy of Molecularly Targeted Agents in Early-Phase Trials — Thomas Braun, University of Michigan
2:25 PM	Two-Stage Design for Phase I/II Cancer Clinical Trials Using Drug Combinations of Cytotoxic Agents — Mourad Tighiouart, Cedars-Sinai Medical Center ; Quanlin Li
2:45 PM	Early-Phase Design for a Combination of Immunotherapies — Nolan Wages, University of Virginia ; Craig Slingluff, University of Virginia ; Gina Petroni, University of Virginia
3:05 PM	Discussant: Andre Rogatko, Cedars-Sinai Medical Center
3:25 PM	Floor Discussion

16 !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W186a
Practical Utility-Based Bayesian Clinical Trial Design — Topic Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA)
Organizer(s): Peter F. Thall, MD Anderson Cancer Center
Chair(s): Peter F. Thall, MD Anderson Cancer Center
2:05 PM	Robust Treatment Comparison Based on Utilities of Semi-Competing Risks in Non-Small-Cell Lung Cancer — Thomas Murray, MD Anderson Cancer Center ; Peter F. Thall, MD Anderson Cancer Center ; Ying Yuan, MD Anderson Cancer Center ; Daniel Gomez, MD Anderson Cancer Center ; Sarah McAvoy, MD Anderson Cancer Center
2:25 PM	A Decision-Theoretic Comparison of Treatments to Resolve Air Leaks After Lung Surgery Based on Nonparametric Modeling — Yanxun Xu ; Peter F. Thall, MD Anderson Cancer Center ; Peter Mueller, The University of Texas at Austin ; Reza Mehran, MD Anderson Cancer Center
2:45 PM	Bayesian Group Sequential Clinical Trial Design Using Total Toxicity Burden and Progression-Free Survival — Brian Hobbs, MD Anderson Cancer Center ; Peter F. Thall, MD Anderson Cancer Center ; Steven H. Lin, MD Anderson Cancer Center
3:05 PM	A Decision-Theoretic Phase I-II Design for Ordinal Outcomes in Two Cycles — Juhee Lee, University of California at Santa Cruz ; Peter F. Thall, MD Anderson Cancer Center ; Peter Mueller, The University of Texas at Austin ; Yuan Ji, The University of Chicago
3:45 PM	Floor Discussion

17 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W194b
Missing Data in Neuroscience Clinical Trials: Truth or Consequences — Topic Contributed Papers
Mental Health Statistics Section , ENAR , Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Pilar Lim, Janssen R&D
Chair(s): Hsien-Ming James Hung, FDA
2:05 PM	Choosing Estimands in Clinical Trials with Missing Data — Craig Mallinckrodt, Eli Lilly and Company
2:25 PM	Reference-Based Imputation Versus Dropout = Failure Imputation for Tackling Missing Data — Devan V. Mehrotra, Merck ; Fang Liu, Merck
2:45 PM	Role of Simulations in the Selection of the Primary Estimand and Statistical Methods for Handling Missing Data — Elena Polverejan, Janssen R&D
3:05 PM	Discussant: Scott Emerson, University of Washington
3:25 PM	Floor Discussion

18 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W192b
Exploiting Low-Dimensional Structures: Recent Advances of Statistical Learning Methods in Genetics and Genomics — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Irina Gaynanova, Texas A&M University
Chair(s): Ursula Mueller-Harknett, Texas A&M University
2:05 PM	A Scalable Empirical Bayes Approach to Variable Selection — Haim Y. Bar, University of Connecticut ; James Booth, Cornell University ; Martin T. Wells, Cornell University
2:25 PM	Biclustered Matrix Completion — Eric Chi, North Carolina State University
2:45 PM	Canonical Variate Regression for Integrative Analysis of Genomics Data — Kun Chen, University of Connecticut
3:05 PM	Estimating High-Dimensional Multi-Layered Networks Through Penalized Maximum Likelihood — George Michailidis, University of Florida
3:25 PM	Discussant: Irina Gaynanova, Texas A&M University
3:45 PM	Floor Discussion

28 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W193a
Recent Advances in Precision Medicine — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Neal Thomas, Pfizer
2:05 PM	A Subgroup Identification Method Based on Quantitative Criteria — Yan Sun, AbbVie ; Samad Hedayat, University of Illinois at Chicago
2:20 PM	Personalized Time-to-Event Prediction in Intensive Care — Yingying Xu ; Joel Dubin, University of Waterloo ; Joon Lee, University of Waterloo
2:35 PM	Nonparametric Bayesian Accelerated Failure-Time Models for Estimation of Heterogeneous Treatment Effects and Individualized Treatment Decisions — Nicholas Henderson, The Johns Hopkins University ; Ravi Varadhan, The Johns Hopkins University ; Thomas A. Louis, The Johns Hopkins University ; Gary Rosner, The Johns Hopkins University
2:50 PM	Joint Dichotomization of Continuous Variables to Discriminate Disease Status — Bethany Wolf, Medical University of South Carolina ; Sybil Prince-Nelson, Medical University of South Carolina ; Paul J. Nietert, Medical University of South Carolina ; Viswanathan Ramakrishnan, Medical University of South Carolina ; Paula S. Ramos, Medical University of South Carolina ; Diane Kamen, Medical University of South Carolina
3:05 PM	Adaptive Sampling for Subgroup Analyses — Alexander Luedtke, University of California at Berkeley ; Antoine Chambaz, L'Université Paris Ouest Nanterre
3:20 PM	Individualized Subgroup Variable Selection — Xiwei Tang, University of Illinois at Urbana-Champaign ; Annie Qu, University of Illinois at Urbana-Champaign
3:35 PM	Floor Discussion

30	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W195
Recent Developments in Biostatistical Research — Contributed Papers
ENAR , Biopharmaceutical Section
Chair(s): Zheng Ke, The University of Chicago
2:05 PM	A Hierarchical Approach to Multivariate Models for Global Climate Ensembles — Matthew Edwards, Newcastle University ; Stefano Castruccio, Newcastle University ; Dorit Hammerling, National Center for Atmospheric Research
2:20 PM	A Spatiotemporal Hierarchical Bayesian Model for Understanding Vectors and Vector-Borne Disease — Erica Billig, University of Pennsylvania ; Jason Roy, University of Pennsylvania ; Michael Levy, University of Pennsylvania ; Michelle Ross , University of Pennsylvania
2:35 PM	Surrogate-Guided Sampling Designs for Biomedical Natural Language Processing with Rare Outcomes — Wei Ling (Katherine) Katherine Tan, University of Washington ; Patrick Heagerty, University of Washington
2:50 PM	Accounting for Potential Measurement Errors in Environmental Preterm Studies — Yinjun Zhao, Yale University ; Shuangge Ma, Yale University
3:05 PM	Development of a Stochastic Model Using Setting the Clock Back to Zero (SCBZ) for Expected Time to Seroconversion Under Correlated Inter-Contact Times — Kannan R, Annamalai University ; Balasubramani G.K., University of Pittsburgh
3:20 PM	Functional Multiple Indicators, Multiple Causes Measurement Error Models — Carmen Tekwe, Texas A&M University ; Roger Zoh, Texas A&M University ; Raymond Carroll, Texas A&M University ; Guoyao Wu, Texas A&M University ; Fuller Bazer, Texas A&M University
3:35 PM	Floor Discussion

33	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W177
Efficient Methods for Structured Large Genomics Data — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science
Chair(s): Jing Ma, University of Pennsylvania
2:05 PM	Integrative Analysis of Transcriptomic and Metabolomic Data via Sparse Canonical Correlation Analysis with Incorporation of Biological Information — Sandra Safo, Emory University ; Qi Long, Emory University
2:20 PM	Statistical Inference in Partially Observed Stochastic Compartmental Models with Application to Cell Lineage Tracking of In-Vivo Hematopoiesis — Jason Xu, University of Washington ; Vladimir Minin, University of Washington ; Peter Guttorp, University of Washington ; Samson Koelle, University of Washington ; Janis Abkowitz, University of Washington ; Chuanfeng Wu, National Heart, Lung, and Blood Institute ; Cynthia Dunbar, National Heart, Lung, and Blood Institute
2:35 PM	An Empirical Bayes Approach to Adjust for Hidden Confounders in Large-Scale Gene Expression Studies — David Gerard, The University of Chicago ; Matthew Stephens, The University of Chicago
2:50 PM	Big Data Regression and Prediction for High-Throughput Genomic Data — Weiqiang Zhou, Johns Hopkins Bloomberg School of Public Health ; Ben Sherwood, Johns Hopkins Bloomberg School of Public Health ; Zhicheng Ji, Johns Hopkins Bloomberg School of Public Health ; Fang Du, Johns Hopkins Bloomberg School of Public Health ; Jiawei Bai, Johns Hopkins Bloomberg School of Public Health ; Hongkai Ji, Johns Hopkins Bloomberg School of Public Health
3:05 PM	Bayesian Nonlocal Prior-Based Gene Expression Data Analysis Using Chi-Square-Type Pathway Scores — Nilotpal Sanyal, Texas A&M University ; Wenyi Wang, MD Anderson Cancer Center ; Anirban Bhattacharya, Texas A&M University ; Valen E. Johnson, Texas A&M University
3:20 PM	Bayesian Large-Scale Multiple Regression with Summary Statistics from Genome-Wide Association Studies — Xiang Zhu, The University of Chicago ; Matthew Stephens, The University of Chicago
3:35 PM	RefCNV: Identification of Gene-Based Copy Number Variants Using Whole-Exome Sequencing — Lun-Ching Chang, National Cancer Institute ; Biswajit Das, Leidos Biomedical Research ; Chih-Jian Lih, Leidos Biomedical Research ; Corrine Camalier, Leidos Biomedical Research ; Paul Mcgregor, Leidos Biomedical Research ; Eric Polley, National Cancer Institute

34 *	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W193b
Advances in Analysis of Categorical Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Codruta Chiuzan, Columbia University
2:05 PM	A Power Study of the GFfit Statistic as a Lack-of-Fit Diagnostic for Sparse Two-Way Subtables — Junfei Zhu, ASU ; Mark Reiser, Arizona State University ; Silvia Cagnone, University of Bologna
2:20 PM	On the Discovery and Use of Disease Risk Factors with Logistic Regression: New Prostate Cancer Risk Factors — David Booth, Kent State University ; Venugopal Gopapalakrishna-Remani, The University of Texas at Tyler ; Matthew Cooper, Washington University ; Fiona Green, University of Manchester ; Margaret Rayman, University of Surrey
2:35 PM	A Generalized Estimating Equations Framework for the Analysis of Intracellaur Cytokine Staining Data — Amit Meir, University of Washington ; Raphael Gottardo, Fred Hutchinson Cancer Research Center ; Greg Finak, Fred Hutchinson Cancer Research Center
2:50 PM	A Latent Variable Poisson Model for Assessing Regularity of Circadian Pattern Over Time — Sung Duk Kim, Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Paul Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development
3:05 PM	Confidence Intervals for the Difference Between Two Proportions for Correlated Binary Response — Krishna Saha, Central Connecticut State University
3:20 PM	Estimation for Zero-Inflated Over-Dispersed Count Data Model with Ignorable Missing Response — Sudhir Paul, University of Windsor ; Rajibul Mian, University of Windsor
3:35 PM	Sobol Sensitivity Indices Under Generalized Linear Models — Rong Lu, The Ohio State University ; Grzegorz Rempala, The Ohio State University

35 *	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W178b
Epidemiologic Methods for Biomarker Discovery and Disease Prediction — Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Karen Messer, University of California at San Diego
2:05 PM	Estimation and Distribution of T-Cell Repertoire During Human HSV-2 Infection — Alvason Li, Fred Hutchinson Cancer Research Center ; Jia Zhu, Fred Hutchinson Cancer Research Center ; Trevor Bedford, Fred Hutchinson Cancer Research Center
2:20 PM	A Statistical Framework for Using External Information in Updating Prediction Models with New Biomarker Measures — Wenting Cheng, University of Michigan ; Jeremy M. G. Taylor, University of Michigan ; Bhramar Mukherjee, University of Michigan
2:35 PM	Developing Combinations of Prognostic and Diagnostic Biomarkers in Multicenter Studies — Allison Meisner, University of Washington ; Kathleen F. Kerr, University of Washington
2:50 PM	Sensitivity Analysis of a CD4-Based HIV Incidence Estimation Method — Ruiguang Song, CDC
3:05 PM	Automated Feature Selection for Prediction with Electronic Medical Records Data — Jessica Minnier, Oregon Health & Science University ; Sheng Yu, Tsinghua University ; Katherine Liao, Brigham and Women's Hospital ; Tianxi Cai, Harvard
3:20 PM	Comparison of Predictive Modeling Approaches for 30-Day All-Cause Nonelective Readmission Risk — Liping Tong, Advocate Health Care ; Cole Erdmann, Cerner Corporation ; Marina Daldalian, Cerner Corporation ; Jing Li, Cerner Corporation ; Tina Esposito, Advocate Health Care
3:35 PM	Optimum Sample Size Allocation in Multilevel Disease Detection Problem — Yinan Fang, Iowa State University ; Chong Wang, Iowa State University ; Jeffrey Zimmerman, Iowa State University

37 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W178a
Statistical and Computational Methods for Analysis of Rare Variant Association — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section , Royal Statistical Society
Chair(s): Yilong Zhang, New York University
2:20 PM	Statistical Methods for Rare Variant Test for Multiple Phenotypes — Diptavo Dutta ; Seunggeun Lee, University of Michigan
2:35 PM	Correcting for Population Stratification in Spatially Structured Populations for Sequencing Data — Ye Ting Du, Harvard T.H. Chan School of Public Health ; Xihong Lin, Harvard T.H. Chan School of Public Health
2:50 PM	Searching for Gene Sets with Mutually Exclusive Mutations — Paul Ginzberg, Imperial College London ; Federico Giorgi, Columbia University ; Andrea Califano, Columbia University
3:05 PM	Sparse Signal Detection in the Presence of Rare Variants and Binary Phenotype — Sixing Chen, Harvard ; Xihong Lin, Harvard T.H. Chan School of Public Health
3:20 PM	Detection of Associations Between a Set of Rare Variants and Multiple Continuous Phenotypes — Zhonghua Liu, Harvard ; Xihong Lin, Harvard T.H. Chan School of Public Health ; Zilin Li, Harvard T.H. Chan School of Public Health
3:35 PM	A Powerful Statistical Test for Rare Variant Associations in Pedigree Studies — Keng-Han Lin, University of Michigan ; Sebastian Zoellner, University of Michigan

38 *	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W191
Statistical Methods in Early Development Trials — Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Anjana Grandhi, Merck
2:05 PM	Enabling Robust Concentration-QTc Assessment for Single Ascending Dose (SAD) Clinical Pharmacology Trials — Li Fan, Merck ; Devan V. Mehrotra, Merck ; Fang Liu, Merck ; Kuenhi Tsai, Merck
2:20 PM	Comparison of Methods to Deal with Separation Problem in Clinical Trials with Binary Data — Shuyan Wan, Merck
2:35 PM	Cluster Enrichment Method to Identify Inhibitors of Down-Regulators of Immune Signaling in a Kinetic High-Throughput Screening Assay — Minya Pu, University of California at San Diego ; Karen Messer, University of California at San Diego ; Howard Cottam, University of California at San Diego ; Tomoko Hayashi, University of California at San Diego ; Maripat Corr, University of California at San Diego ; Dennis Carson, University of California at San Diego
2:50 PM	Concentration-Response (QT/QTc) Analysis for Classifying Risk of QT Prolongation — Xiaoli Glasgow, Merck ; Kuenhi Tsai, Merck ; Li Fan, Merck ; Fang Liu, Merck ; Wei Gao, Merck
3:05 PM	A Comparison Between Dried Blood Spots and Traditional PK Sampling Using Concordance Correlation Coefficient for Repeated Measurements — Yang Liu, Merck ; Tian Zhao , Merck ; Patrick Larson, Merck
3:20 PM	Bioassay Case Study Applying the Maximin D-Optimal Design Algorithm to the Four-Parameter Logistic Model — Todd Coffey, Washington State University

39 * !	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W192a
Disease-Specific Applied Case Studies — Contributed Papers
Biopharmaceutical Section
Chair(s): Feng Dai, Yale School of Public Health
2:05 PM	Dependence Liability Study Using Healthy Subjects — Ling Chen, FDA/CDER
2:20 PM	Ebola Vaccine Update: Data Analysis Challenges in Developing the Ebola Vaccine — Kenneth Liu, Merck
2:35 PM	Efficiency of N-of-1 Studies in Cystic Fibrosis Research — Michele Shaffer, Seattle Children's Research Institute ; Nicole Mayer-Hamblett, Seattle Children's Research Institute
2:50 PM	Can Early Analysis Predict Alzheimer's Trial Success? — Kun Jin, FDA/CDER
3:05 PM	Crossover Design and Its Application in Late-Phase Diabetes Studies — Tao Wang ; James Malone, Eli Lilly and Company ; Haoda Fu ; Cory Heilmann, Eli Lilly and Company ; Yongming Qu, Eli Lilly and Company ; William Huster, Eli Lilly and Company
3:20 PM	Sensitivity Analyses to Assess the Missing-at-Random Assumption — Shailaja Suryawanshi, Merck ; Anjela Tzontcheva, Merck ; Raymond Lam, Merck ; Gregory Golm, Merck
3:35 PM	Floor Discussion

44	Sun, 7/31/2016, 2:00 PM - 3:50 PM	CC-W194a
Trial Design and Analysis Issues in Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section
Chair(s): Zengri Wang, Medtronic
2:05 PM	Analysis of Matched Data for Noninferiority Trials — Jeremiah Perez, Boston University ; Joseph M. Massaro, Boston University
2:20 PM	A Constancy-Enforced Noninferiority Design of Medical Device Trials with a Binary Endpoint — Ying Yang, FDA/CDRH ; Yunling Xu, FDA/CDRH ; Nelson LU, FDA/CDRH ; Yu Zhao, FDA
2:35 PM	Incorporation of Historical Information in Bayesian Analysis of Crossover Medical Device Clinical Trials — Youssef Toubouti, Johnson & Johnson Vision Care ; Xiwei Chen, Johnson & Johnson Vision Care
2:50 PM	On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies — Nelson LU, FDA/CDRH ; Yunling Xu, FDA/CDRH
3:05 PM	Developing and Validating Visual Assessment Tools for Use in Medical Device Trials — Alvin Van Orden, FDA
3:20 PM	Tests for Interaction in Clinical Studies — Chul Ahn, FDA/CDRH ; Mourad Atlas, FDA/CDRH
3:35 PM	Statistical Study Design Considerations for Medical Device Clinical Studies from an FDA Reviewer's Perspective — Xu Yan, FDA ; Heng Li, FDA ; Vandana Mukhi, FDA

60 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W187a
Power of Blinded Data Reviews — Topic Contributed Papers
Section on Statistical Consulting , Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Ibrahim Turkoz, Janssen R&D
Chair(s): Ibrahim Turkoz, Janssen R&D
4:05 PM	Predicting the Timing of the Final Event in a Clinical Trial Using the Bayesian Bootstrap and Beyond — Marc Sobel, Temple University ; Ibrahim Turkoz, Janssen R&D
4:25 PM	Control Charts for Monitoring Accumulating Adverse Event Count Frequencies from Single and Multiple Blinded Trials — A. Gould, Merck Research Laboratories
4:45 PM	Continuous Event Monitoring via a Bayesian Predictive Approach — Jianing Di, Janssen R&D ; Daniel Wang, Janssen R&D ; Robert Brashear, Janssen R&D ; Vlad Dragalin, Janssen ; Michael Krams, Janssen R&D
5:05 PM	Enrollment and Event Prediction for Blinded Clinical Trials — Hrishikesh Kulkarni, Cytel ; Yannis Jemiai, Cytel
5:25 PM	Discussant: Sue-Jane Wang, FDA
5:45 PM	Floor Discussion

63 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W193b
New Developments on Network Meta-Analysis in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Cindy Lu, Bayer HealthCare Pharmaceuticals
Chair(s): Jerry Weaver, Celgene
4:05 PM	On the Sensitivity Analysis for Bayesian Network Meta-Analysis — Haoda Fu
4:25 PM	Network Meta-Analysis for Ordinal Outcomes: An Application in Comparing Crohn's Disease Treatments — May Mo, Amgen ; Yeongjin Gwon, University of Connecticut ; Ming-Hui Chen, University of Connecticut ; Amy Xia, Amgen ; Juan Li, Amgen ; Joseph G. Ibrahim, The University of North Carolina at Chapel Hill
4:45 PM	Incorporation of Individual Patient Data in Network Meta-Analysis for Multiple Continuous Endpoints, with Application to Diabetes Treatment — Hwanhee Hong, Johns Hopkins Bloomberg School of Public Health ; Haoda Fu ; Karen Price, Eli Lilly and Company ; Bradley Carlin, University of Minnesota
5:05 PM	Network Meta-Analysis for Missing Binary Outcomes from Part of the Network — Cindy Lu, Bayer HealthCare Pharmaceuticals ; Robert Wan, AstraZeneca
5:25 PM	Use of Informative Prior Information in Network Meta-Analysis of Rare Adverse Events — David Ohlssen, Novartis
5:45 PM	Floor Discussion

65 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W192b
Synthesizing Evidence from Different Sources for Robust Decision Making in Cancer Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Suddhasatta Acharyya, Novartis
Chair(s): Sofia Paul, Novartis
4:05 PM	Combining Safety and Efficacy Data for Assessing Risk Benefit in Cancer Clinical Trials: Some Recent Examples — Thomas Kelleher, Bristol-Myers Squibb
4:25 PM	Inference for Time-to-Event Endpoints in Combined Populations Under Disproportionate Stratified Sampling — Jyotirmoy Dey, AbbVie ; Wuyan Zhang, Pfizer
4:45 PM	Using Meta-Analysis in the Design and Analysis of Early-Phase Cancer Studies — Ashok Panneerselvam, Novartis Oncology ; Sofia Paul, Novartis ; Suddhasatta Acharyya, Novartis
5:05 PM	Regulatory Challenges in Evidence Synthesis in Cancer Clinical Trials — Rajeshwari Sirdhara, FDA
5:25 PM	Discussant: Amit Bhattacharyya, GlaxoSmithKline
5:45 AM	Floor Discussion

66 *	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W194b
Kathryn Chaloner: Contributions and Reflections from Former Students and Colleagues — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Jeffrey D. Dawson, University of Iowa
Chair(s): Jeffrey D. Dawson, University of Iowa
4:05 PM	Accounting for Uncertainty in the Design — Sharon Lohr, Westat
4:25 PM	Kathryn Chaloner: Contributions and Reflections from Former Students and Colleagues — Gideon Zamba, University of Iowa
4:45 PM	Prestige in Latent Social Space — Gary Oehlert, University of Minnesota
5:05 PM	A Bayesian Framework for Diagnosis of E2-Antibody Using ELISA Tests Without a Gold Standard — Jingyang Zhang, Fred Hutchinson Cancer Research Center
5:25 PM	Accelerating Computation for Bayesian Spatial Modeling — Mary Kathryn Cowles, University of Iowa
5:45 PM	Floor Discussion

69 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W193a
Novel Methods in Causal and Mediation Analysis — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Hrishikesh Chakraborty, University of South Carolina
4:05 PM	Multiple Imputation Framework to Estimate Causal Effect of Testing on Treatment Decision — Irina Bondarenko, University of Michigan ; Yun Li, University of Michigan
4:20 PM	Causal Moderation Assessment with Zero-Inflated Data — Robert Gallop ; Paul Crits-Christoph, University of Pennsylvania
4:35 PM	Characterizing Causal Treatment Effect Heterogeneity with Conditional Inference Trees — Julian Wolfson, University of Minnesota ; Lauren Erickson, HealthPartners Institute for Education and Research
4:50 PM	Sharp Bounds of Causal Effects on Ordinal Outcomes — Jiannan Lu, Microsoft ; Peng Ding, University of California at Berkeley ; Dasgupta Tirthankar, Harvard
5:05 PM	Centering of Interactions in Lower-Level Mediation Models — Haeike Josephy, UGent ; Tom Loeys, Ghent University
5:20 PM	Nonlinear Structural Equation Models in Environmental Epidemiology — Esben Budtz-Jørgensen
5:35 PM	Integrative Genomic Association Testing via Kernel Machine Mediation Analysis — Angela Hsiaohan Chen, University of Illinois at Urbana-Champaign ; Sihai Zhao, University of Illinois at Urbana-Champaign

70 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W191
Important Issues in Meta-Analysis and Clinical Trials — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Arkendu S. Chatterjee, Novartis
4:05 PM	Detecting Publication Bias in Multivariate Random-Effects Meta-Analysis — Chuan Hong, The University of Texas Health Science Center at Houston ; Haitao Chu, University of Minnesota ; Yong Chen, University of Pennsylvania Perelman School of Medicine
4:20 PM	Maximum Likelihood Estimation and EM Algorithm of Copas Selection Model for Publication Bias Correction — Jin Piao, The University of Texas Health Science Center at Houston ; Jing Ning, MD Anderson Cancer Center ; Yong Chen, University of Pennsylvania Perelman School of Medicine
4:35 PM	Integration of Significance Information from Independent Gene Expression Studies — Nusrat Jahan, James Madison University ; Aylin Alin, Dokuz Eylul University
4:50 PM	Falsification of Epidemiological Models from Ongoing Clinical Trials — Sayan Dasgupta, Fred Hutchinson Cancer Research Center ; Jim P. Hughes, University of Washington
5:05 PM	An Evaluation of Treatment Effect in Opt-In Versus Opt-Out Consent Frameworks Under a Mixture of Participant Motivation Levels — Alessandra Valcarcel, University of Pennsylvania
5:20 PM	Comparing Novel Approaches to Subgroup Analysis in Early-Phase Clinical Trials — Marius Thomas, Novartis ; Björn Bornkamp, Novartis
5:35 PM	Floor Discussion

75 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W194a
Bayesian Methods and Applications — Contributed Papers
Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science
Chair(s): Paulette Ceesay, Merck
4:05 PM	Use of Bayesian Approach for the Design and Evaluation of Multiregional Clinical Trials — Chinfu Hsiao, National Health Research Institutes ; Yu-Chieh Cheng, National Chiao Tung University ; Hsiuying Wang, National Chiao Tung University
4:20 PM	Comparing Parametric and Semiparametric Bayesian Models for Subgroup Analysis in Clinical Trials — Margaret Gamalo-Siebers, Eli Lilly and Company
4:35 PM	Bayesian Clinical Trial Design for Survival Studies with Historical Study Data Under a Proportional Hazards Assumption — Matthew Psioda, The University of North Carolina at Chapel Hill ; Joseph G. Ibrahim, The University of North Carolina at Chapel Hill
4:50 PM	Shelf Life Estimation: Bayesian Approach — Maryna Ptukhina ; Walter Stroup, University of Nebraska - Lincoln
5:05 PM	The Case for Bayesian Methods in Benefit-Risk Assessment: Overview and Future Directions — Carl DiCasoli, Bayer HealthCare Pharmaceuticals ; Yannis Jemiai, Cytel ; Maria Costa, GlaxoSmithKline ; Weili He, Merck ; Yueqin Zhao, FDA/CDER
5:35 PM	Bayesian Methods in Phase 3 HCV Trials: Borrowing Historical Control Arm Data — Ran Liu, AbbVie ; Qi Tang, AbbVie ; Martin King, AbbVie ; Bo Fu, AbbVie ; Sandra Lovell, AbbVie ; Alan Hartford, AbbVie

76 * !	Sun, 7/31/2016, 4:00 PM - 5:50 PM	CC-W196a
Network and Graphical Models for Analysis of Genomic Data — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Jiang Gui, Dartmouth Medical School
4:05 PM	Identification of Marginal Causal Relationships in Gene Networks from Observational and Interventional Expression Data — Andrea Rau, INRA ; Gilles Monneret, INRA/Universite Pierre et Marie Curie ; Florence Jaffrezic, INRA ; Gregory Nuel, Universite Pierre et Marie Curie
4:20 PM	Longitudinal Gaussian Graphical Models for Autism Risk Gene Detection — Kevin Lin, Carnegie Mellon University
4:35 PM	XTalk: A Path-Based Approach for Identifying Crosstalk Between Signaling Pathways — Allison Tegge ; T. M. Murali, Virginia Tech ; Nicholas Sharp, Virginia Tech
4:50 PM	Graphlet Screening for High-Dimensional Variable Selection — Qi Zhang, University of Nebraska - Lincoln ; Jiashun Jin, Carnegie Mellon University ; Cun-Hui Zhang, Rutgers University
5:05 PM	Pathway-Based Integrative Bayesian Modeling of Multi-Platform Genomics Data — Elizabeth McGuffey, U.S. Naval Academy ; Jeffrey S. Morris, MD Anderson Cancer Center ; Raymond Carroll, Texas A&M University ; Ganiraju C. Manyam, MD Anderson Cancer Center ; Veera Baladandayuthapani, MD Anderson Cancer Center
5:20 PM	Detecting Association to Precision Networks via Conditional Multi-Type Graphical Models — Yanming Li, University of Michigan ; Kevin He, University of Michigan ; Jian Kang, University of Michigan ; Hyokyoung (Grace) Hong, Michigan State University ; Ji Zhu, University of Michigan ; Yi Li, University of Michigan
5:35 PM	Network Analysis for Gene Signaling Pathways — Samir Lababidi, FDA ; Taxiarchis Botsis, FDA

213620	Mon, 8/1/2016, 7:30 AM - 12:30 PM	H-Astoria
Biopharmaceutical Section Executive Committee Meeting (Closed) — Other Cmte/Business
Biopharmaceutical Section
Chair(s): B Christine Clark

111 * !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W187c
Recent Statistical Developments in Cancer Research — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Sujay Datta, University of Akron
Chair(s): Sujay Datta, University of Akron
8:35 AM	Normalization for Single-Cell RNA-Seq — Christina Kendziorski, University of Wisconsin ; Rhonda Bacher, University of Wisconsin - Madison ; Li-Fang Chu, Morgridge Institute for Research ; James Thomson, Morgridge Institute for Research ; Ron Stewart, Morgridge Institute for Research
8:55 AM	Statistical Issues in Single-Cell Analysis for Cancer Research — Omar De La Cruz Cabrera, Case Western Reserve University
9:15 AM	Residual-Based Trees for Clustered Binary Data — Mousumi Banerjee, University of Michigan ; Rong Xia, University of Michigan
9:35 AM	Cancer Mortality in USA, 1999--2012: A Review and Inter-State Comparisons — Desale Habtzghi, DePaul University
9:55 AM	Discussant: Sunil Mathur, Georgia Regents University
10:15 AM	Floor Discussion

113 *	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W185bc
Challenges in Design and Analysis of Multi-Regional Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Gang Li, Johnson & Johnson
Chair(s): Gang Li, Johnson & Johnson
8:35 AM	MRCT Design Models and Drop-Min Data Analysis — Kuang-Kuo Lan, Janssen R&D
8:55 AM	Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective — Yunling Xu, FDA/CDRH ; Nelson LU, FDA/CDRH
9:15 AM	Why Can't We Agree on MRCTs? — Joshua Chen, Sanofi Pasteur
9:35 AM	Example-Based Illustrations of Design, Conduct, Analysis, and Result Interpretation of Multi-Regional Clinical Trials — Hui Quan, Sanofi ; Xuezhou Mao, Sanofi
9:55 AM	Discussant: Hsien-Ming James Hung, FDA
10:15 AM	Floor Discussion

116 !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W183a
What's Wrong with P-Value? — Topic Contributed Papers
ENAR , IMS , Biopharmaceutical Section , Section on Teaching of Statistics in the Health Sciences , Royal Statistical Society , Scientific and Public Affairs Advisory Committee , Conference on Statistical Practice Steering Committee , Statistics Without Borders
Organizer(s): Eugene Demidenko, Dartmouth College
Chair(s): James O'Malley, Geisel School of Medicine at Dartmouth
8:35 AM	On the Reproducibility of Psychology Experiments — Valen E. Johnson, Texas A&M University
8:55 AM	Problems with P-Value Reform: Who Can We Blame? — Regina Nuzzo, Gallaudet University
9:15 AM	P-Value Overdose in Medical Research: Problems and Solutions — J. Jack Lee, MD Anderson Cancer Center
9:35 AM	The Death of the P-Value: What's the Chance? — Philip Sedgwick, University of London
9:55 AM	P, Sorry, D-Value — Eugene Demidenko, Dartmouth College
10:15 AM	Floor Discussion

117 !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W187b
Methods and Applications in Multiplicity Adjustment — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Dong Xi, Novartis
Chair(s): Frank Bretz, Novartis Pharma
8:35 AM	Sequential Multiple Testing for Variable Selection in High-Dimensional Linear Model — Xinping Cui, University of California at Riverside ; Hailu Chen, University of California at Riverside
8:55 AM	A Flexible Choice of Critical Constants for the Improved Hybrid Hochberg-Hommel Procedure — Ajit Tamhane, Northwestern University ; Jiangtao Gou, Hunter College
9:15 AM	Adjustment for Multiplicity in Clinical Trials: When Is It Necessary and When Is It Not? — Boguang Zhen, FDA
9:35 AM	Optimizing Graphical Multiple Testing Schemes in Late-Phase Drug Development — Eric Nantz, Eli Lilly and Company
9:55 AM	Optimal Tests for Multiple Binary Endpoints — Dong Xi ; Robin Ristl, Medical University of Vienna ; Ekkehard Glimm, Novartis ; Martin Posch, Medical University of Vienna
10:15 AM	Floor Discussion

118 *	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W185d
Challenges in Metagenomic Data Analysis: Reproducibility and Interpretability of Inferences on Microbial Community Composition and Dynamics — Topic Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Hector Corrada Bravo, University of Maryland
Chair(s): Jianxin Shi, National Cancer Institute
8:35 AM	Dimensional Reduction of Metagenomic Data with Ecological Equivalence — Senthilkumar Muthiah, University of Maryland ; Eric Slud, U.S. Census Bureau ; Mihai Pop, University of Maryland ; Hector Corrada Bravo, University of Maryland
8:55 AM	Multivariate Dimension-Reduction Methods for Microbiome Data Analysis — Kim-Anh Le Cao, University of Queensland
9:15 AM	Mediation Analysis of High-Dimensional Human Microbiome Data in the Longitudinal Study — Huilin Li , New York University Langone Medical Center ; Yilong Zhang, New York University ; Martin J. Blaser, New York University
9:35 AM	Floor Discussion

125 *	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W187a
Statistical Methods for Functional Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section , Section on Nonparametric Statistics , Section on Statistics in Imaging
Chair(s): Andrada E. Ivanescu, Montclair State University
8:35 AM	Fast Covariance Estimation for Sparse Functional Data — Cai Li, North Carolina State University ; Luo Xiao, North Carolina State University ; William Checkley, The Johns Hopkins University ; Ciprian Crainiceanu, The Johns Hopkins University
8:50 AM	Estimation of Functional Connectivity Among Neuron Ensembles via Hawkes Processes — Shizhe Chen, University of Washington ; Eric Shae-Brown, University of Washington ; Ali Shojaie, University of Washington ; Daniela Witten, University of Washington
9:05 AM	Classification of Multivariate EEG Records via $\Epsilon$-Complexity of Continuous Vector-Functions — Alexandra Piryatinska, San Francisco State University ; Boris Darkhovsky, Institute for Systems Analysis ; Nathanael Aff, San Francisco State University
9:20 AM	Statistical Model Selection in Differential Equations Using PACE Software for Functional Regression. — Charles Smith, North Carolina State University
9:35 AM	Penalized Regression Method for Finding Differences in Brain Connectome Graphs — Donghyeon Yu, Keimyung University
9:50 AM	Tensor Regression with Functionally Linked Parameters — Su Chen, University of Memphis ; Ebenezer Olusegun George, University of Memphis
10:05 AM	Functional Mixed-Effects Models for Longitudinal Data: An Application to Electrical Impedance Myography Data — Kush Kapur, Boston Children's Hospital/Harvard Medical School ; Rajesh Selukar, SAS Institute ; Basil Darras, Boston Children's Hospital ; Seward Rutkove, Beth Israel Deaconess Medical Center

126 *	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W186b
Statistical Methods for High-Dimensional Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Kuolung Hu, Amgen
8:35 AM	EigenPrism: Inference for High-Dimensional Signal-to-Noise Ratios — Lucas Janson ; Emmanuel Candes, Stanford University ; Rina Foygel Barber, The University of Chicago
8:50 AM	Genomic Determination Index — Cheng Cheng, St. Jude Children's Research Hospital ; Robert J. Autry, St. Jude Children's Research Hospital ; Wenjian Yang, St. Jude Children's Research Hospital ; Steven Paugh, St. Jude Children's Research Hospital ; William E. Evans, St. Jude Children's Research Hospital
9:05 AM	Group Feature Screening via F-Test — Won Chul Song, Purdue University ; Jun Xie, Purdue University
9:20 AM	Modeling Micronuclei Count Data Using the Generalized Monotone Incremental Forward Stagewise Method: Application in Women with Breast Cancer — Rebecca Lehman, Virginia Commonwealth University ; Colleen Jackson-Cook, Virginia Commonwealth University ; Kellie J. Archer, Virginia Commonwealth University
9:35 AM	Annotation Regression of Genome-Wide Association Studies with Multiple Phenotypes — Sunyoung Shin, University of Wisconsin - Madison ; Sunduz Keles, University of Wisconsin - Madison
9:50 AM	Stochastic Optimization for High-Dimensional Mixed Effect Generalized Linear Models — Jun Guo, University of Michigan ; Yves F. Atchade, University of Michigan
10:05 AM	Truncation-Based Nearest Neighbors Imputation for High-Dimensional Data with Detection Limit Thresholds — Jasmit Shah, University of Louisville ; Guy N. Brock, The Ohio State University ; Shesh N. Rai, University of Louisville ; Aruni Bhatnagar, University of Louisville

133 * !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W185a
Adaptive Designs in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Jose Pinheiro, Johnson & Johnson
8:35 AM	Conditional Power for Testing Equivalence of Two Proportions — Zejiang Yang, INC Research ; Kalyan Ghosh, INC Research
8:50 AM	Bayesian Response-Adaptive Covariate-Adjusted Randomization Design for Clinical Trials — Jianchang Lin, Takeda ; LiAn Lin, Merck Research Laboratories ; Serap Sankoh, Takeda ; Fang Yang, Vertex Pharmaceuticals ; Guohui Liu, Takeda
9:05 AM	Consideration of the T-Statistic Adaptive Dose-Finding Design for Estimating Maximum Tolerated Dose — James Bolognese, Cytel
9:20 AM	On Exact Sample Size of K-Stage Group Sequential Designs for Rare Diseases — Man Jin
9:35 AM	Bayesian Adaptive Design for Trials with Delayed Binary Outcome Using Historical Control Data — Nusrat Harun, Cincinnati Children's Hospital ; Mi-Ok Kim, Cincinnati Children's Hospital Medical Center ; Chunyan Liu, Cincinnati Children's Hospital
9:50 AM	Evaluation of Adaptive Sequential Designs in the Setting of Anticipated Crossing Survival — William Koh, University of Washington ; Scott Emerson, University of Washington
10:05 AM	Risk Analysis on Using Surrogate Endpoint at Interim Analysis — Ziqian Geng, AbbVie ; Bo Fu, AbbVie ; Alan Hartford, AbbVie ; Jun Zhao, AbbVie

134 * !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W186c
Genome-Wide Association Studies and Related Topics — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Pixu Shi
8:35 AM	Weighted False Discovery Rate Control in Large-Scale Multiple Testing — Pallavi Basu, University of Southern California
8:50 AM	Identifying SNP Interaction Patterns Using an Intensive Approach — Hui-Yi Lin, Louisiana State University Health Sciences Center ; Dung-Tsa Chen, Moffitt Cancer Center ; Po-Yu Huang, National Chung-Hsing University ; Yung-Hsin Liu, INC Research ; Chia-Ho Cheng, Moffitt Cancer Center ; Jong Park, Moffitt Cancer Center
9:05 AM	Leveraging Functional Annotations in Genetic Risk Prediction for Human Complex Diseases — Yiming Hu, Yale University ; Qiongshi Lu, Yale University ; Hongyu Zhao, Yale University
9:20 AM	Generalized Functional Linear Models for Family Sequencing Data — Sneha Jadhav ; Hira L. Koul, Michigan State University ; Qing Lu, Michigan State University
9:35 AM	A Graphical Model to Prioritizing GWAS Results by Integrating Pleiotropy — Dongjun Chung, Medical University of South Carolina ; Hang J. Kim, University of Cincinnati ; Hongyu Zhao, Yale University
9:50 AM	Singular Values, Association Between Asthma and Single Nucleotide Polymorphisms, and Population Genetics — Marepalli Rao, University of Cincinnati ; Michael B. Wathen, University of Cincinnati ; Koffi B. Wima, University of Cincinnati ; Mohammad Alfred Nobel Bhuiyan, University of Cincinnati
10:05 AM	A Phylogenetic Model for Association Mapping with Multiple Loci — Katherine Thompson, University of Kentucky

137 * !	Mon, 8/1/2016, 8:30 AM - 10:20 AM	CC-W186a
Topics in Oncology Clinical Trial Design and Drug Development — Contributed Papers
Biopharmaceutical Section
Chair(s): Elande Baro, FDA
8:35 AM	Graphical Testing Procedure in a Hypothetical Seamless Phase II/III Oncology Study — Jiacheng Yuan, Bayer HealthCare Pharmaceuticals ; Jonathan Siegel, Bayer HealthCare Pharmaceuticals ; Daniel Haverstock, Bayer HealthCare Pharmaceuticals
8:50 AM	The Rapid Enrollment Design for Phase I Clinical Trials — Yunfei Wang, Children's National
9:05 AM	Paired Survival Endpoints in Crossover Trials — Rengyi Xu, University of Pennsylvania ; Devan V. Mehrotra, Merck ; Pamela A. Shaw, University of Pennsylvania
9:20 AM	Multiplicity Adjustment Considerations in Designing a Confirmatory Oncology Clinical Trial with Multiple Endpoints — Di Li
9:35 AM	A New Design for Drug Combination in Phase I Dose-Finding Clinical Trials — Jim Xiang, Janssen ; Grace Liu, Johnson & Johnson ; James Pan, Janssen
9:50 AM	Benefit-Risk Analysis for Dose-Escalation Trial — Hiya Banerjee
10:05 AM	Floor Discussion

CE_16C	Mon, 8/1/2016, 8:30 AM - 5:00 PM	CC-W474
Analysis of Clinical Trials: Theory and Applications (ADDED FEE) — Professional Development Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): Devan V. Mehrotra, Merck, Alex Dmitrienko, Quintiles, Jeff Maca, Quintiles
8:30 AM	Analysis of Clinical Trials: Theory and Applications (ADDED FEE) — Alex Dmitrienko, Quintiles ; Devan V. Mehrotra, Merck ; Jeff Maca, Quintiles

144 * !	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W184bc
Choosing Appropriate Estimands in Clinical Trials — Invited Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Frank Bretz, Novartis Pharma
Chair(s): Estelle Russek-Cohen, FDA
10:35 AM	Estimands: Are We Estimating What We Intend to Estimate? — Mouna Akacha , Novartis Pharma AG
11:00 AM	Some Observations on De Jure Estimation — Thomas Permutt, FDA
11:25 AM	The Treatment of Missing Data in a Large Cardiovascular Clinical Outcomes Study — Roderick Joseph Little, University of Michigan
11:50 AM	Discussant: Gary Koch, The University of North Carolina at Chapel Hill
12:10 PM	Floor Discussion

158 * !	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W184d
Advanced Methodology for Genetic Data Analysis — Topic Contributed Papers
ENAR , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Anne Buu, University of Michigan
Chair(s): Anne Buu, University of Michigan
10:35 AM	A Unified Framework for Variance Component Estimation with Summary Statistics in Genetic Association Studies — Xiang Zhou, University of Michigan
10:55 AM	Integrative Genetical Genomics Analysis Incorporating Network Structures — Yuehua Cui, Michigan State University ; Bin Gao, Michigan State University ; Xu Liu, Michigan State University
11:35 AM	Bayesian Variable Selection: An Alternative Route to Hierarchical Gene-Environment Interactions — Cen Wu, Kansas State University ; Yu Jiang, University of Memphis ; Jinfeng Wei, Maryville University ; Shuangge Ma, Yale University
11:55 AM	An Efficient Genome-Wide Association Test for Mixed Binary and Continuous Phenotypes with Applications to Substance Abuse Research — James Yang
12:15 PM	Floor Discussion

160	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W185bc
Design and Analysis of Bioequivalence and Biosimilar Assessment — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Yi Tsong, FDA/CDER
Chair(s): Mengdie Yuan, FDA
10:35 AM	Determination of Equivalence Margin of Analytical Biosimilar Assessment — Yi Tsong, FDA/CDER ; Cassie Dong, FDA ; Meiyu Shen, FDA/CDER
10:55 AM	Does the Direction of Scores Matter in Clinical Trials? — Wanjie Sun, FDA ; Stella Grosser, FDA/CDER ; Yi Tsong, FDA/CDER
11:15 AM	Statistical Design and Analysis of Treatment Switching Effect — Cassie Dong, FDA
11:35 AM	Discussant: Shein-Chung Chow, Duke University
11:55 AM	Floor Discussion

163 * !	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W187c
Biometrics Section Student Paper Award Session 1 — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Dipankar Bandyopadhyay, Virginia Commonwealth University
Chair(s): Colin O. Wu, National Heart, Lung, and Blood Institute
10:35 AM	Fast Approximation of Small P-Values in Permutation Tests by Partitioning the Permutation Space — Brian Segal ; Hui Jiang, University of Michigan ; Thomas Braun, University of Michigan
10:55 AM	Multivariate Functional Principal Component Analysis for Data Observed on Different (Dimensional) Domains — Clara Happ, Ludwig-Maximilians-University Munich ; Sonja Greven, Ludwig-Maximilians-University Munich
11:15 AM	Sequential BART for Imputation of Missing Covariates — Dandan Xu, University of Florida ; Michael Daniels, The University of Texas at Austin ; Almut G. Winterstein, University of Florida
11:35 AM	Recurrent Event Data Analysis with Intermittently Observed Time-Varying Covariates — Shanshan Li, Indiana University Fairbanks School of Public Health ; Yifei Sun, The Johns Hopkins University ; Chiung-Yu Huang, The Johns Hopkins University ; Dean Follmann, National Institute of Allergy and Infectious Diseases ; Richard Krause, National Institute of Allergy and Infectious Diseases
11:55 AM	Semiparametric Regression Analysis of Interval-Censored Competing Risks Data — Lu Mao, The University of North Carolina at Chapel Hill ; Danyu Lin, The University of North Carolina at Chapel Hill ; Donglin Zeng, The University of North Carolina at Chapel Hill
12:15 PM	Floor Discussion

165 * !	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W185d
Recent Advances on Interaction Modeling for Prediction in Personalized Medicine — Topic Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Li-Xuan Qin, Memorial Sloan Kettering Cancer Center, Pei Wang, Icahn School of Medicine at Mount Sinai
Chair(s): Pei Wang, Icahn School of Medicine at Mount Sinai
10:35 AM	Quantifying Treatment Benefit in Molecular Subgroups to Assess a Predictive Biomarker — Jaya M. Satagopan, Memorial Sloan Kettering Cancer Center ; Alexia Iasonos, Memorial Sloan Kettering Cancer Center
10:55 AM	Identifying Interactions Using Convex Optimization — Jacob Bien, Cornell University ; Robert Tibshirani, Stanford University ; Noah Simon, University of Washington
11:15 AM	Why Significant Variables Aren't Automatically Predictive — Adeline Lo ; Herman Chernoff, Harvard University ; Tian Zheng, Columbia University ; Shaw-Hwa Lo, Columbia University
11:35 AM	Phenotype Predictions by Genome and In-Between-Omes — Quan Long, University of Calgary
11:55 AM	Impact of Handling Effects on Gene-Gene Interaction Discovery: An Empirical Assessment — Li-Xuan Qin, Memorial Sloan Kettering Cancer Center
12:15 PM	Floor Discussion

172 *	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W186b
Bayesian Analysis with Health Applications — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science
Chair(s): RAJARSHI GUHANIYOGI, University of California at Santa Cruz
10:35 AM	Bayesian Variable Selection for Multivariate Count Data with Excess Zeros: Application to the Pediatric HIV/AIDS Cohort Study — Kyu Ha Lee, The Forsyth Institute ; Brent Coull, Harvard T.H. Chan School of Public Health ; Jacqueline R. Starr, The Forsyth Institute
10:50 AM	Semiparametric Bayesian Analysis of High-Dimensional Censored Outcome — Chetkar Jha, University of Missouri ; Yi Li, University of Michigan ; Steven Melly, Harvard ; Dr Subharup Guha, University of Missouri
11:05 AM	Practical Considerations in Analyzing Adverse Events with a Robust Mixture Prior — Jerry Weaver, Celgene ; Jixian Wang, Celgene
11:20 AM	Data-Driven Confounder Selection via Markov and Bayesian Networks — Jenny Haggstrom, Umea University
11:35 AM	A Bayesian Approach for the Integrative Analysis of Omics Data — Thierry Chekouo Tekougang, MD Anderson Cancer Center ; Francesco Stingo, MD Anderson Cancer Center ; Kim-Anh Do, MD Anderson Cancer Center ; James Doecke, CSIRO Health and Biosecurity
11:50 AM	Sparse Latent Class Regression for Multivariate Binary Data: A Bayesian Approach — Zhenke Wu, The Johns Hopkins University ; Scott L. Zeger, The Johns Hopkins University
12:05 PM	Floor Discussion

177 *	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W186a
New Challenges in Complex Data Modeling I — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Xiujuan Wang, Dow AgroSciences
10:35 AM	A Two-Stage Model for Wearable Device Data — Jiawei Bai, Johns Hopkins Bloomberg School of Public Health ; Yifei Sun, The Johns Hopkins University ; Ciprian Crainiceanu, The Johns Hopkins University ; Mei-Cheng Wang, The Johns Hopkins University
10:50 AM	Sample-Size Calculations for Stratified Micro-Randomized Trials in Mhealth — Walter Dempsey, University of Michigan ; Peng Liao, University of Michigan ; Susan A. Murphy, University of Michigan
11:05 AM	Graphical LASSO with Auxiliary Information: Application to Neural Connectivity — Giuseppe Vinci, Carnegie Mellon University ; Robert Kass, Carnegie Mellon University ; Valerie Ventura, Carnegie Mellon University ; Matthew A. Smith, University of Pittsburgh
11:20 AM	Modeling Nonlinearity Using Splines: Applications and Simulations — Leila Amorim, UFBA ; Maristela Dias Oliveira, Universidade Federal da Bahia ; Daniele B. Trindade, Universidade Federal de Pernambuco
11:35 AM	Binary Exposure and Longitudinal Cognition Outcomes in the Presence of Noningorable Dropout and Death — Maria Josefsson, CEDAR
11:50 AM	Biologically Pathway Information Incorporated Structured Model — Xuebei An, MD Anderson Cancer Center ; Jianhua Hu, MD Anderson Cancer Center ; Kim-Anh Do, MD Anderson Cancer Center
12:05 PM	Floor Discussion

178 *	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W187a
Statistical Solutions to Problems in Specific Therapeutic Areas or Populations — Contributed Papers
Biopharmaceutical Section
Chair(s): Lynn Navale, Kite Pharma
10:35 AM	An Integrated Bayesian Posterior Probability with Simon Two-Stage Design for a Randomized Phase II Clinical Trial — Dung-Tsa Chen, Moffitt Cancer Center ; Po-Yu Huang, National Chung-Hsing University ; Hui-Yi Lin, Louisiana State University Health Sciences Center
10:50 AM	Correcting Treatment Effect for Treatment Switching in Randomized Oncology Trials with a Generalized Rank-Preserving Structural Failure Time Model — Jin Zhang, Merck ; Cong Chen, Merck
11:05 AM	Comparison of Treatment Effects Between U.S. and Non-U.S. Study Sites in Multiregional Alzheimer's Disease Clinical Trials — Jingyu Luan, FDA ; Hsien-Ming James Hung, FDA ; Ranjit Mani, FDA
11:20 AM	Two-Stage Statistical Evaluation of Cardiovascular Safety Assessment of Diabetes Drugs — Raymond Lam, Merck ; Shailaja Suryawanshi, Merck
11:35 AM	A Bayesian Approach for Classification Based on Continuous Glucose Monitoring Data of Diabetic Patients — Hui Zheng, Harvard Medical School
11:50 AM	Mixture Model for Radiographic Progression in Psoriatic Arthritis — Bin Dong, Janssen R&D ; Jiandong lu, Janssen R&D
12:05 PM	Efficacy Outcomes in Elderly Patients Treated with Pembrolizumab and Nivolumab — Huanyu Chen, FDA ; Harpreet Singh, FDA ; Sirisha Mushti, FDA ; Kun He, FDA ; Rajeshwari Sridhara, FDA

184	Mon, 8/1/2016, 10:30 AM - 12:20 PM	CC-W179b
Bayesian Modeling in Life Sciences and Medicine I — Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Risk Analysis
Chair(s): Andrew Womack, Indiana University
10:35 AM	A Spatio-Temporal Model for Protein Structure Evolution and Alignment — Gary Larson, Duke University ; Scott Schmidler, Duke University
10:50 AM	Nonparametric Survival Analysis Using Bayesian Additive Regression Trees (BART) — Rodney Sparapani, Medical College of Wisconsin ; Brent Logan, Medical College of Wisconsin ; Robert McCulloch, The University of Chicago ; Purushottam Laud, Medical College of Wisconsin
11:05 AM	Bayesian Additive Regression Trees (BART) and Precision Medicine — Brent Logan, Medical College of Wisconsin ; Rodney Sparapani, Medical College of Wisconsin ; Robert McCulloch, The University of Chicago ; Purushottam Laud, Medical College of Wisconsin
11:20 AM	Robust Assessment of Trial Success Based on Co-Primary Endpoints by Bayesian and Bootstrapping Approaches with Discounting Option — Zongjun Zhang, Eli Lilly and Company ; Fanni Natanegara, Eli Lilly and Company ; Karen Price, Eli Lilly and Company
11:35 AM	Profiling Hospitals Based on Degree of Aggressiveness in Treating Patients with Advanced Cancer — Tianyi Cai, Harvard ; Sherri Rose, Harvard Medical School ; Deborah Schrag, Dana-Farber Cancer Institute ; Francesca Dominici, Harvard T.H. Chan School of Public Health
11:50 AM	Bayesian Analysis of Quantal Bioassay Experiments Incorporating Historical Controls via Bayes Factors — Luis Leon Novelo, The University of Texas Health Science Center at Houston ; Andrew Womack, Indiana University ; Hongxiao Zhu, Virginia Tech ; Xiaowei Wu, Virginia Polytechnic Institute and State University
12:05 PM	A Bayesian High-Dimensional Couple-Based Latent Risk Model with an Application to Infertility — Zhen Chen, Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Beom Seuk Hwang, Chung-Ang University ; Germaine M. Buck Louis, Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Paul Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development

208	Mon, 8/1/2016, 12:30 PM - 1:50 PM	CC-W375a
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Jennifer Gauvin, Novartis
ML11:	Design for Dose-Finding Trials (Phase I/II or Post-Marketing Trials) — Lei Nie, FDA
ML12:	Best Practices for Interim Analysis in Clinical Trials — Jiang Hu, FDA
ML14:	Communicating Our Value: Are You a Tipping Point Maven? — Susan Duke, AbbVie

231 * !	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W193a
Application of Novel Methods in Clinical Trials: Case Study Approaches — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Arkendu S. Chatterjee, Novartis
Chair(s): Soumi Lahiri, GlaxoSmithKline
2:05 PM	Some New Metrics to Test for Biosimilarity — Sujit K. Ghosh, North Carolina State University ; Yifang Li, Novartis
2:25 PM	BOIN: A Simple, Ethical Bayesian Optimal Design for Phase I Oncology Trials — Ying Yuan, MD Anderson Cancer Center ; Suyu Liu, MD Anderson Cancer Center
2:45 PM	Early-Phase Designs for Targeted and Immunotherapeutic Agents — Codruta Chiuzan, Columbia University
3:05 PM	Using Surrogate Marker Information to Test for a Treatment Effect — Layla Parast, RAND Corporation ; Tianxi Cai, Harvard ; Lu Tian, Stanford University
3:25 PM	A Note on Posterior Predictive Assessment to Assess Model Fit — Arkendu S. Chatterjee, Novartis ; Dandan Xu, University of Florida ; Michael Daniels, The University of Texas at Austin
3:45 PM	Floor Discussion

232	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W196c
Mediation Analysis and Sensitivity Analysis in Advanced Settings — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , Section on Statistics in Imaging , International Chinese Statistical Association
Organizer(s): Chanmin Kim, Harvard, Corwin Zigler, Harvard T.H. Chan School of Public Health
Chair(s): Chanmin Kim, Harvard
2:05 PM	Sparse Mediation Analysis for High-Dimensional Mediators with Application of Neuroimaging and Methylation Data — Seonjoo Lee, Columbia University
2:25 PM	Meta-Mediation Analysis for Generating Mechanistic Hypotheses — John Jackson, Harvard ; Tyler J. VanderWeele, Harvard
2:45 PM	Region-Based Hypothesis Test of Mediation Effect with Epigenomic Data Using Kernel Machine Regression — Jincheng Shen, Harvard T.H. Chan School of Public Health
3:05 PM	The Impact of Exposure Measurement Error in Mediation Analyses for Environmental Epigenetic Studies — Linda Valeri, Harvard ; Brent Coull, Harvard T.H. Chan School of Public Health
3:25 PM	Sharp Sensitivity Bounds for Mediation Under Unmeasured Mediator-Outcome Confounding — Peng Ding, University of California at Berkeley
3:45 PM	Floor Discussion

237 *	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W196a
Quantitative Sciences for Safety Monitoring and Confirmatory Safety in Clinical Development — Topic Contributed Papers
Biopharmaceutical Section , Scientific and Public Affairs Advisory Committee , Committee on Applied Statisticians
Organizer(s): Judy X. Li, FDA
Chair(s): Qi Jiang, Amgen
2:05 PM	ASA Biopharm's Safety Monitoring Subteam: Survey of Statisticians, Thought Leaders, and Regulatory Guidance — Mike Wright Colopy, UCB Bioscience ; Susan Duke, AbbVie
2:25 PM	Safety-Monitoring Methodology in the Premarketing Setting — Melvin Munsaka, Takeda Development Center
2:45 PM	Statistical Considerations for Cardiovascular Outcome Trials in Patients with T2DM — Maria Matilde Sanchez-Kam, Arena Pharmaceuticals
3:05 PM	Discussant: William Wang, Merck
3:25 PM	Discussant: Ram Tiwari, FDA/CDER/OT/OB
3:45 PM	Floor Discussion

242 *	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W193b
Methods for Genetics and Genomics Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Himel Mallick, Harvard
2:05 PM	Case-Oriented Pathways Analysis in Pancreatic Adenocarcinoma — Yen-Yi Ho, University of Minnesota ; Timothy K. Starr, University of Minnesota ; Rebecca S. LaRue, Minnesota Super Computing Institute ; David A. Largaespada, University of Minnesota
2:20 PM	A Bayesian GWAS Method Utilizing Haplotype Clusters for a Composite Breed Population — Danielle Wilson-Wells, University of Nebraska - Lincoln ; Stephen D. Kachman, University of Nebraska - Lincoln
2:35 PM	Region-Level Differential Methylation Testing with Smoothed Functional Principal Component Analysis — Mohamed Milad ; Gayla R. Olbricht, Missouri University of Science and Technology
2:50 PM	Mapping Three-Dimensional Organization in Repetitive Regions of the Genomes — Ye Zheng, University of Wisconsin - Madison ; Sunduz Keles, University of Wisconsin - Madison ; Ferhat Ay, La Jolla Institute for Allergy and Immunology
3:05 PM	Genomic Data Integration for GWAS and EQTL Analysis — Constanza Rojo, University of Wisconsin - Madison ; Sunduz Keles, University of Wisconsin - Madison ; Qi Zhang, University of Nebraska - Lincoln
3:20 PM	Fast and Accurate Power Calculation Methods for Rare-Variant Association Tests — Andriy Derkach, National Cancer Institute ; Nilanjan Chatterjee, The Johns Hopkins University
3:35 PM	Floor Discussion

245 *	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W178a
Statistical Methods for Inferring Genetic Associations — Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section
Chair(s): Tzu-Cheg Kao, Uniformed Services University of the Health Sciences
2:05 PM	USAT: A Unified Score-Based Association Test for Multiple Phenotype-Genotype Analysis — Debashree Ray, University of Michigan ; James S. Pankow, University of Minnesota ; Saonli Basu, University of Minnesota
2:20 PM	Characterizing Uncertainty in Genetic Association Landscapes by Functional Bayesian Bands — Olga A. Vsevolozhskaya, University of Kentucky ; Ilai Keren , Washington Department of Fish and Wildlife ; Dmitri Zaykin, National Institute of Environmental Health Sciences
2:35 PM	A Functional Data Analysis Framework for Investigating the Interaction Between Genetic Variant Profiles and Environmental Factors — Li Luo, University of New Mexico ; Marianne Berwick, University of New Mexico ; Ji-Hyun Lee, University of New Mexico
2:50 PM	Simultaneous Detection and Estimation of Trait Associations with Genomic Phenotypes — Jean Morrison, University of Washington ; Noah Simon, University of Washington ; Daniela Witten, University of Washington
3:05 PM	A Powerful Statistical Procedure for Pathway-Based Meta-Analysis Using Summary Statistics — Han Zhang, National Cancer Institute ; William Wheeler, Information Management Services ; Paula L. Hyland, National Cancer Institute ; Yifan Yang, University of Kentucky ; Jianxin Shi, National Cancer Institute ; Nilanjan Chatterjee, The Johns Hopkins University ; Kai Yu, National Cancer Institute
3:20 PM	A Bayesian Hierarchical Model for Pathway Analysis with Simultaneous Inference on Pathway-Gene-SNP Structure — Lei Zhang, The University of Texas at Dallas ; Swati Biswas, The University of Texas at Dallas ; Pankaj Choudhary, The University of Texas at Dallas
3:35 PM	Massive Significance Testing in Genetic Epidemiology Amid Replicability Crisis — Dmitri Zaykin, National Institute of Environmental Health Sciences ; Olga A. Vsevolozhskaya, University of Kentucky

247 *	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W184bc
Toward Better Communication of Information with Statistical Graphics — Contributed Papers
Section on Statistical Graphics , Biopharmaceutical Section , Section for Statistical Programmers and Analysts , Statistics Without Borders
Chair(s): Amelia McNamara, Smith College
2:05 PM	Clusters Beat Trend!? Testing Feature Hierarchy in Statistical Graphics — Susan VanderPlas, Nebraska Public Power District ; Heike Hofmann, Iowa State University
2:20 PM	Identifying the Effects of Clear Visualization: Reduced Time to a Deeper Understanding of Data — Kathleen Campbell, Saint Joseph's University ; Nicolle Clements, Saint Joseph's University ; Virginia Miori, Saint Joseph's University ; Corey Jones, Saint Joseph's University
2:35 PM	The Linked Microposter Plot as a New Means for the Visualization of Eye-Tracking Data — Chunyang Li, Utah State University ; Juergen Symanzik, Utah State University
2:50 PM	Optimizing Diffusion Cartograms for Areal Data Using a New Evaluation Method — Xiaoyue Cheng, University of Nebraska - Omaha
3:05 PM	Capitalizing on the Power of Dynamic Data Visualization — Neil Polhemus, Statpoint Technologies
3:20 PM	What Can We Learn from Exact Calculation of Histograms? — James Weber
3:35 PM	Interactive Graphics for Functional Data Analyses — Julia Wrobel, Columbia University ; Jeff Goldsmith, Columbia Mailman School of Public Health

250 *	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W194a
Time-to-Event Data: New Horizons — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Yang Liu, Fred Hutchinson Cancer Research Center
2:05 PM	Survival Trees for Left-Truncated and Right-Censored Data, with Application to Time-Varying Covariate Data — Wei Fu ; Jeffrey Simonoff, New York University
2:20 PM	A Pairwise Likelihood-Augmented Estimator for Left-Truncated Data with Time-Dependent Covariates — Fan Wu, University of Michigan ; Sehee Kim, University of Michigan ; Yi Li, University of Michigan
2:35 PM	Induced Smoothing and Efficient Variance Estimation for the Accelerated Gap Times Model with Recurrent Events Data — Tianmeng Lyu, University of Minnesota ; Gongjun Xu, University of Minnesota ; Chiung-Yu Huang, The Johns Hopkins University ; Xianghua Luo, University of Minnesota
2:50 PM	Semiparametric Estimation of the Accelerated Failure Time Model with Partly Interval-Censored Data — Fei Gao ; Donglin Zeng, The University of North Carolina at Chapel Hill ; Danyu Lin, The University of North Carolina at Chapel Hill
3:05 PM	Data-Transformation Approach to Lifetimes Data Analysis — Kobby Asubonteng, AstraZeneca ; Govind Mudholkar, University of Rochester
3:20 PM	Regression Analysis of Clustered Failure Time Data with Informative Cluster Size Under the Additive Transformation Models — Ling Chen, Washington University in St. Louis ; Yanqin Feng, Wuhan University ; Jianguo Sun, University of Missouri
3:35 PM	Analysis of Restricted Mean Survival Time for Length-Biased Data — Chi Hyun Lee, MD Anderson Cancer Center ; Yu Shen, MD Anderson Cancer Center ; Jing Ning, MD Anderson Cancer Center

251 * !	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W194b
Bayesian Modeling and Applications — Contributed Papers
Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science
Chair(s): John Han, Johnson & Johnson
2:05 PM	A Phase 2a Bayesian Adaptive Dose-Ranging Trial Evaluating Hypertension Therapy — Richann Liu, Pfizer
2:20 PM	A Simple Bayesian Design to Identify Maximum Tolerated Dose Contour for Drug Combination Trials — Liangcai Zhang, Rice University ; Ying Yuan, MD Anderson Cancer Center
2:35 PM	Exploring Bayesian Go/No-Go Decision Criteria in Clinical Trials — Rodney Croos-Dabrera, Astellas Pharma ; Misun Lee, Astellas Pharma
2:50 PM	Use of Bayesian Methods in Dose-Escalation Studies — Mani Lakshminarayanan, Pfizer
3:05 PM	Precision Medicine: How Bayesian Empirical Subgroup Analysis Plays a Role — Judy X. Li, FDA ; Wei-Chen Chen, FDA/CBER ; John Scott, FDA
3:20 PM	Bayesian Statistical Models Assessing Disease Modification Drug Effects Using Doubly Randomized Delayed-Start and Matched Control Designs — Ibrahim Turkoz, Janssen R&D ; Marc Sobel, Temple University
3:35 PM	Bayesian Modeling of Phase II Dose-Ranging Clinical Trials — Shu-Yen Ho, PAREXEL

252 * !	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W190b
Cancer Genomics and Tumor Sequencing — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Jingyang Zhang, Fred Hutchinson Cancer Research Center
2:05 PM	Modeling Multiple Primary Cancers Over Time Using a Novel Familywise Likelihood Under the Nonhomogeneous Poisson Process — Jialu Li, MD Anderson Cancer Center ; Seung Jun Shin, Korea University ; Wenyi Wang, MD Anderson Cancer Center
2:20 PM	Testing for Differentially Expressed Pathways from Within-Subject Matched Pairs of RNA-Seq Data Sets — Grant Schissler, Statistics GIDP ; Walter W. Piegorsch, University of Arizona ; Yves A. Lussier, University of Arizona
2:35 PM	Genomic Analysis with Common Binary Outcomes via Mediation — Sheila Gaynor, Harvard ; Xihong Lin, Harvard T.H. Chan School of Public Health
2:50 PM	Analysis of High-Throughput Drug Screening Data of Cancer Cell Lines — Hongmei Liu ; J. Sunil Rao, University of Miami
3:05 PM	Assessing Intra-Tumor Heterogeneity and Tracking Longitudinal and Spatial Clonal Evolution by Next-Generation Sequencing — Yuchao Jiang, University of Pennsylvania ; Yu Qiu, University of Pennsylvania ; Andy J. Minn, University of Pennsylvania ; Nancy Zhang, University of Pennsylvania
3:20 PM	A Beta-Binomial Model to Compare Somatic Mutation Rates Between Groups of Cancer Patients — Hong Wang, University of Kentucky ; Yong Chen, University of Pennsylvania Perelman School of Medicine ; Jinze Liu, University of Kentucky ; Heidi Weiss, University of Kentucky ; Susanne M. Arnold, University of Kentucky ; Aronld Stromberg, University of Kentucky ; Chi Wang, University of Kentucky
3:35 PM	Cell Type-Specific Deconvolution of Heterogeneous Tumor Samples with Immune Infiltration Using Expression Data — Zeya Wang, Rice University ; Jeffrey S. Morris, MD Anderson Cancer Center ; Jaeil Ahn, Georgetown University ; Svitlana Tyekucheva, Harvard ; Bo Li, Harvard ; Wei Lu, MD Anderson Cancer Center ; Ximing Tang, MD Anderson Cancer Center ; Ignacio I. Wistuba, MD Anderson Cancer Center ; Chris Holmes, University of Oxford ; Wenyi Wang, MD Anderson Cancer Center

254 * !	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W192c
Early-Phase Clinical Trials: Setting the Stage for Success — Contributed Papers
Biopharmaceutical Section
Chair(s): Yanxun Xu
2:05 PM	Randomization does not prevent bias when we assess treatment by covariate interaction — Lei Nie, FDA ; Zhiwei Zhang, FDA/CDRH ; Jialu Zhang, FDA
2:20 PM	Application of Propensity-Score Matching in Data Augmentation of Randomized Clinical Trials: A Case Study — Junjing Lin, AbbVie ; Margaret Gamalo-Siebers, Eli Lilly and Company ; Ram Tiwari, FDA/CDER/OT/OB
2:35 PM	Enabling Robust PK/QTc Assessment in Single and Multiple Ascending Dose Trials for Evaluation of QTc Prolongation — Fang Liu, Merck ; Li Fan, Merck ; Kuenhi Tsai, Merck ; Devan V. Mehrotra, Merck
2:50 PM	Enrichment Design with Patient Augmentation for Time-to-Event Data — Yijie Zhou, AbbVie ; Bo Yang, Vertex Pharmaceuticals ; Lanju Zhang, AbbVie ; Lu Cui, AbbVie
3:05 PM	Dose-Ranging Design and Analysis Based on MCP-Mod to Identify the Minimum Effective Dose (MED) — Ying Zhang, AbbVie ; Su Chen, AbbVie ; Yihan Li, AbbVie ; Wangang Xie, AbbVie ; Yijie Zhou, AbbVie ; Li Wang, AbbVie ; Alan Hartford, AbbVie
3:20 PM	Optimal Borrowing of Historical Control Data in Clinical Trials — Saurabh Mukhopadhyay, AbbVie ; Qi Tang, AbbVie ; Alan Hartford, AbbVie
3:35 PM	Never Fit Sequence: The Design and Analysis of Multi-Period Clinical Trials — Hans Hockey, Biometrics Matters Ltd.

261	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-W192a
Diagnostics, Classification, and Prediction — Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Alexander Kaizer, University of Minnesota
2:05 PM	Receiver Operating Characteristic Analysis Under Tree Orderings of Disease Classes — Dan Wang, SUNY Buffalo ; Lili Tian, SUNY Buffalo ; Kristopher Attwood, Roswell Park Cancer Institute
2:20 PM	Using ANOVA/Random-Effects Variance Estimates to Compute a Two-Sample U-Statistic of Order (1,1) Estimate of Variance — Lucas Tcheuko, FDA ; Brandon Gallas, FDA ; Frank Samuelson, FDA
2:50 PM	A Metric for the Optimal Length of a Sequence of Tests for Classification Tasks — Christine Schubert Kabban, Air Force Institute of Technology
3:05 PM	Design and Analysis Considerations for Precision Studies in In-Vivo Diagnostic Test Studies — Changhong Song, FDA
3:20 PM	Generalized Linear Mixed Models for Analysis of Cross-Correlated Binary Response in Multireader Studies of Diagnostic Accuracy — Yuvika Paliwal ; Andriy Bandos, University of Pittsburgh
3:35 PM	Localized Semiparametric Prediction: A Precision Medicine Approach in a Trauma Patient Population — Sara E. Moore, University of California at Berkeley ; Alan E. Hubbard, University of California at Berkeley ; Mitchell J. Cohen, University of California at San Francisco

263	Mon, 8/1/2016, 2:00 PM - 3:50 PM	CC-Hall F1 West
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
23:	Evaluation of Sensitivity of Statistical Methods That Assume Missing at Random — Takayuki Abe, Keio University School of Medicine ; Kazuhito Shiosakai, Daiichi Sankyo Co. ; Rachel Roberts, Keio University School of Medicine ; Fumiya Sano, Keio University School of Medicine ; Manabu Iwasaki, Seikei University
24:	Subgroup Analyses for Count Data Using Bayesian Empirical Meta-Analytical Predictive Priors — Wei-Chen Chen, FDA/CBER ; Judy X. Li, FDA ; John Scott, FDA
25:	Comparison Between Continuous- and Discrete-Dose EWOC Designs — Marcio Diniz, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Andre Rogatko, Cedars-Sinai Medical Center
26:	Statistical Analysis of the Progression of Tumors in Rats — Mary Esther Nevener, University of Central Oklahoma ; Cynthia Murray, University of Central Oklahoma ; Wei Chen, University of Central Oklahoma
27:	Sample Size and Duration of Study in Clinical Trials with Time-to-Event Endpoint — Ryunosuke Machida, Tokyo University of Science ; Yosuke Fujii, Pfizer Japan ; Takashi Sozu, Tokyo University of Science
28:	A Bayesian Adaptive Design in Cancer Phase I Trials Using Dose Combinations in the Presence of a Baseline Covariate — Sungjin Kim ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center
29:	Statistical Inference on Dynamic System Models with Multiple Observation Units — Hongyuan Wang ; David Allen, University of Kentucky
31:	Bayesian Adaptive Designs Using Copula-Type Models in Phase I Cancer Trials Using Drug Combination — Galen Cook-Wiens, Cedars-Sinai Medical Center ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center ; Andre Rogatko, Cedars-Sinai Medical Center
32:	Optimal Sample Size Determination for Adaptive Seamless Phase II/III Design — Zhongying Xu, University of Pittsburgh ; John A. Kellum, University of Pittsburgh ; Gary M. Marsh, University of Pittsburgh ; Chung-Chou H. Chang, University of Pittsburgh
33:	An Extension of Clinical Trial Assurance to a Setting of Multiple Unknown Parameters in a Single-Arm Binomial Trial — Yizhou Jiang, Kite Pharma ; Lynn Navale, Kite Pharma ; Allen Xue, Kite Pharma
34:	The Impact of Regional Baseline Variation on the Type I Error and Power of Multiregional Clinical Trials — Weining Robieson, AbbVie ; Jun Zhao, AbbVie
35:	A Novel Approach to Non-Muscle Invasive Bladder Cancer Trials: Making Lemonade Out of Apples and Oranges — Yuqun Luo, FDA ; John Scott, FDA
36:	A Generalized Hochberg Procedure for Multiple Tests of Significance — Chen Chen, Prosoft Clinical ; Dror Rom, Prosoft Clinical ; Jaclyn McTague, Prosoft Clinical
37:	Dose Finding for Drug Combination in Early Cancer Phase I Trials using Conditional Continual Reassessment Method — Quanlin Li ; Mourad Tighiouart, Cedars-Sinai Medical Center ; Marcio Diniz, Cedars-Sinai Medical Center
38:	A Simulation Study to Compare Recurrent Event Methods — Yansong Cheng ; Helen Millns, GlaxoSmithKline ; Tal Otiker, GlaxoSmithKline
39:	Estimating Survivor Average Causal Effect of Dynamic Treatment Regimes in Randomized Cancer Clinical Trial: A Simulation Study — Takuya Kawahara, University of Tokyo ; Yutaka Matsuyama, University of Tokyo
40:	Tolerance Cpk Contours: A New Tool to Enable Specification Setting in Development — Yuanyuan Duan, AbbVie ; Russell L. Hertzler, AbbVie ; Lanju Zhang, AbbVie ; Dennis A. Stephens, AbbVie ; David W. Werst, AbbVie ; Paul A. David, AbbVie ; Jie Zheng, AbbVie ; Jian-Hwa H. Han, AbbVie
41:	Design of Experiments for Hydrophobic Interaction Chromatography Optimization — Na Zhang, Bristol-Myers Squibb ; Lily Squibb Tsang, Bristol-Myers Squibb ; Kedar Dave, Bristol-Myers Squibb ; Joseph Calzada, Bristol-Myers Squibb ; Gregory A. Barker, Bristol-Myers Squibb ; Angela Lewandowski, Bristol-Myers Squibb ; Zhengjian Li, Bristol-Myers Squibb
42:	Bayesian Adaptive Design for Delayed Binary Response Dose-Finding Studies — Xiaobi Huang, Sanofi ; Haoda Fu
43:	Web-Based Application of Likelihood Ratio Test (LRT)--Based Method for Signal Detection in OpenFDA — Yuyi Hsu ; Jyoti Zalkikar, FDA ; Ram Tiwari, FDA/CDER/OT/OB ; Jay Levine, FDA
44:	A Simulation Method Based on Interim Results to Assess Conditional Power in Clinical Trials — Lin Pan, ICON PLC ; Jill Stankowski, ICON PLC ; Joseph M. Massaro, Boston University
45:	Confounder Adjustments by Propensity Score and Disease Risk Score in the Early Stage of Post-Marketing Drug Safety Surveillance — Tae Hyun Jung, Yale University ; Jessica Kim , FDA
46:	Internal Pilot Design for Clinical Trials with Repeated Measures — Xinrui Zhang ; Yueh-Yun Chi, University of Florida
47:	Assessment of Effect Size and Power for Survival Analysis Through a Binary Surrogate Endpoint in Clinical Trials — Judah Abberbock, University of Pittsburgh ; Gong Tang, University of Pittsburgh
48:	Statistical Issues Associated with Subjective Outcome Measures in Animal Drug Evaluation — Kyunghee Song, FDA/CVM
49:	Bayesian Noncomparative Designs to Account for Uncertainty in Historical Response Rates — Francesca Matano, Carnegie Mellon University ; Valeria Sambucini, University of Rome "La Sapienza"
50:	Evaluation of Biosimilarity Between Two Biological Products Using Alternative Approaches — Hsiao-Hui Tsou, National Health Research Institutes ; Chinfu Hsiao, National Health Research Institutes ; Chi-Tian Chen, National Health Research Institutes ; Wan-jung Chang, National Health Research Institutes
51:	Robust Rules for Imputation of Binary Toxicity or Efficacy Indicators for Use in BCRM — Tao Feng ; Aaron Camp, PPD ; Joseph Adair, PPD ; Kevin Lawson, PPD
52:	Optimizing Adaptive Enrichment Designs — Aaron Fisher, The Johns Hopkins University ; Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health
54:	The Three-at-Risk Design: Reducing the Duration of Phase I Trials with a Queue-Based Method — Paul Frankel, City of Hope ; Jeffrey Longmate, City of Hope ; Richard Sposto, University of Southern California ; Edward Newman, City of Hope ; Susan Groshen, University of Southern California
56:	Statistician Credit for Collaboration — Charles Goldsmith, GoldStats Consulting ; Lehana Thabane, McMaster University ; Yanling Jin, McMaster University ; Fiona (Feng) He, McMaster University
57:	Extended O'Brien Global Test for Multiple Endpoints with Survival and Continuous Outcomes — Chenkun Wang, Vertex Pharmaceuticals ; Cynthia DeSouza, Vertex Pharmaceuticals
59:	Time and Cluster Interactions in the Stepped Wedge Trial Design — Christopher M. Keener, University of Pittsburgh ; Chung-Chou H. Chang, University of Pittsburgh
60:	Is Type I error control for multiplicity really "out of the picture" in epidemiology? — Yueqin Zhao, FDA/CDER ; Rima Izem, FDA ; Mark Levenson, FDA

273	Tue, 8/2/2016, 7:00 AM - 8:15 AM	CC-W375a
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Jennifer Gauvin, Novartis
TL01:	Interim Futility Analysis in the Presence of Delayed Effect in Immunotherapy Clinical Trials — Xue Lin

300 * !	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W196c
Recent Advancement of Statistical Methods and Tools for Go/No-Go Decision Making — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Qi Tang, AbbVie
Chair(s): Deli Wang, AbbVie
8:35 AM	Comparison of Various Early-Phase Go/No Go Decision Criteria — Yili Pritchett, MedImmune ; Masanori Ito, Astellas Pharma
8:55 AM	Using Little 'Go' Decisions — Scott Berry, Berry Consultants
9:15 AM	Interim Go/No-Go Decision Making in Clinical Trials with Longitudinal Outcomes — Ming Zhou, Bristol-Myers Squibb ; Qi Tang, AbbVie ; Lixin Lang, Bristol-Myers Squibb ; Jun Xing, Bristol-Myers Squibb ; Kay Tatsuoka, Bristol-Myers Squibb
9:35 AM	Statistical Software for Decision Making in Clinical Development — Charles Liu, Cytel ; Yannis Jemiai, Cytel
9:55 AM	Enhancing the Probability of Success Framework for Go/No-Go Decision Making Using ROC Curves — Alan Hartford, AbbVie ; Qi Tang, AbbVie ; Deli Wang, AbbVie ; Jyotirmoy Dey, AbbVie ; Walt Offen, AbbVie ; Frank Shen, AbbVie
10:15 AM	Floor Discussion

302 * !	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W193a
Advanced Statistical Methods for High-Dimensional Microbiome Data Analysis — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): yilong zhang, New York University Langone Medical Center
Chair(s): Huilin Li , New York University Langone Medical Center
8:35 AM	Kernel-Based Association Test in Microbiome-Profiling Studies with Multivariate Outcomes — Xiang Zhan, Fred Hutchinson Cancer Research Center
8:55 AM	A Model for Paired-Multinomial Data and Its Application to Analysis of Data on a Taxonomic Tree — Pixu Shi ; Hongzhe Li, University of Pennsylvania
9:15 AM	Microbial Dynamical Systems INference Engine (MDSINE) — Georg Gerber, Harvard Medical School ; Vanni Bucci, University of Massachusetts - Dartmouth ; Belinda Tzen, Harvard Medical School
9:35 AM	MiCAM: A Powerful Microbial Association Test and Its Comprehensive Mapping Capability — Hyunwook Koh, New York University ; Martin J. Blaser, New York University ; Huilin Li , New York University Langone Medical Center
9:55 AM	Learning the Structure of Biological Networks — Richard Bonneau, New York University ; Christian Müller, Simons Foundation
10:15 AM	Floor Discussion

304 *	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W195
Innovative Bayesian Applications in Drug Development — Topic Contributed Papers
Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Fanni Natanegara, Eli Lilly and Company
Chair(s): JonDavid Sparks, Eli Lilly and Company
8:35 AM	Bayesian Framework in Small Sample Trials — Freda Cooner, FDA/CDER/OTS/OB/DB2
8:55 AM	Innovative Bayesian Applications in Clinical Trials — Soumi Lahiri, GlaxoSmithKline ; Satrajit Roychoudhury, Novartis
9:15 AM	Bayesian Predictive Approach to Concurrent Tailoring of Phase 3 Clinical Trials Intended for Registration — Ming-Dauh Wang, Eli Lilly and Company ; Aijun Gao, inVentiv Health ; Jinghui Liu, inVentiv Health ; Karen Price, Eli Lilly and Company ; MaryAnn Morgan-Cox, Eli Lilly and Company ; Lei Shen, Eli Lilly and Company
9:35 AM	Bayesian Assurance and Sample-Size Determination in the Process Validation Lifecycle — Paul Faya, Baylor University ; John W. Seaman, Jr., Baylor University ; James D. Stamey, Baylor University
9:55 AM	Discussant: Fanni Natanegara, Eli Lilly and Company
10:15 AM	Floor Discussion

306	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W181a
SPEED: Advances in Biopharmaceutical Research — Contributed Speed
Biopharmaceutical Section
Chair(s): Madan Gopal Kundu, Novartis Oncology
8:35 AM	Generalizing Results from Randomized Trials to Target Population via Weighting Methods Using Propensity Score — Ziyue Chen, The Ohio State University ; Eloise Kaizar, The Ohio State University
8:40 AM	Bone Marrow Stromal Cell Therapy for Ischemic Stroke: A Meta-Analysis of Randomized Control Animal Trials — Qing Wu, Nevada Institute of Personalized Medicine ; Yuexiang Wang, Mayo Clinic ; Bart Demaerschalk, Mayo Clinic ; Saruna Ghimire, Nevada Institute of Personalized Medicine ; Kay Wellik, Mayo Clinic ; Wenchun Qu, Mayo Clinic
8:50 AM	Stepped Wedge Cluster Randomized Controlled Trials with Two Layers of Clustering: Designs and Comparisons of Power — Ranran Dong, The Ohio State University ; Abigail Shoben, The Ohio State University
8:55 AM	On the Use of Nonparametric Tests for Comparing Immunological Reverse Cumulative Distribution Curves (RCDCs) — Lihan Yan, FDA ; Bob Small, Sanofi Pasteur ; Ayca Ozol-Godfrey, Sunovion Pharmaceuticals
9:05 AM	Impact of Mis-Specified Prior on the Bayesian Dose-Finding Method in Phase I Cancer Trials — Lixia Pei, Janssen R&D ; Kevin Liu, Janssen R&D ; Hong Tian, Janssen R&D
9:10 AM	Covariate Adjustment for Logistic Regression Analysis of Binary Clinical Trial Data — Honghua Jiang ; Pandurang Kulkarni, Eli Lilly and Company ; Craig Mallinckrodt, Eli Lilly and Company ; Linda Shurzinske, Eli Lilly and Company ; Geert Molenberghs, Universiteit Hasselt ; Ilya Lipkovich, Quintiles
9:15 AM	Improving Vaccine Inventory Utilization Using R-Based Statistical Heuristic Algorithm — Hesham Fahmy, Merck
9:20 AM	Value-Driven Decision Making at Late Stage of Drug Development: Statistical Simulation Approach — Masanori Ito, Astellas Pharma ; Hideki Hirooka, Astellas Pharma
9:30 AM	D-Optimal Designs for Multinomial Logistic Models — Xianwei Bu, UIC ; Jie Yang, University of Illinois at Chicago
9:35 AM	Finding Minimum Effective Dose With Multiple Testing Procedures — Lucy Kerns, Youngstown State University ; Flora Opoku Asantewaa, Youngstown State University
9:45 AM	Comparisons of Statistical Approaches and Procedures in Building Predicting Models to Drug Response from SNPs Through Simulation — Wencan Zhang, Takeda Development Center ; Pingye Zhang, University of Southern California ; Feng Gao, Takeda
9:50 AM	Finding the 'Missing Heritability' in Combined Phase 2 and Subset Phase 3 Analyses — Knut Wittkowski, Rockefeller University ; Benedetta Bigio, Rockefeller University
9:55 AM	The Analysis of Impact of Difference in Duration of Treatment — Jiejun Du, Merck
10:05 AM	Multiple Testing Procedures Under Group Sequential Design — Aiying Chen, Temple University
10:10 AM	Use of the Treatment-Free Interval in Driving Decision Making in Cancer Care: A Late-Phase Example — Suddhasatta Acharyya, Novartis ; Ashok Panneerselvam, Novartis Oncology ; Sofia Paul, Novartis

309 * !	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W193b
Case-Control, Case-Cohort and Other Epidemiological Designs — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Y. Ann Chen, Moffitt Cancer Center
8:35 AM	Shrinkage in Reduced-Rank Case-Control Regression: An Application in Non-Hodgkin's Lymphoma — Ananda Sen, University of Michigan ; Jaya M. Satagopan, Memorial Sloan Kettering Cancer Center
8:50 AM	Re-Use of Nested Case-Control Studies for Semi-Competing Risks Analysis — Ina Jazic, Harvard T.H. Chan School of Public Health ; Sebastien Haneuse, Harvard T.H. Chan School of Public Health
9:05 AM	Discriminating Among Correlated Aspects of Exposure — Robert Hirsch, Stat-Aid Consulting
9:20 AM	Logistic Analysis of Epidemiologic Studies with Augmentation Sampling Involving Re-Stratification and Population Expansion — Barry Graubard, National Cancer Institute ; Yan Li, Joint Program in Survey Methodology ; Mahboobeh Safaeian, National Cancer Institute ; Hilary Robbins , The Johns Hopkins University
9:35 AM	Enhancing Power of Case-Control Studies by Using Prevalent Cases — Marlena Maziarz, National Cancer Institute ; Jing Qin, National Institute of Allergy and Infectious Diseases ; Ruth Pfeiffer, National Cancer Institute
9:50 AM	Using Whole-Cohort Information in Case-Control Studies — Alastair Scott, University of Auckland ; Christopher Wild, University of Auckland ; Gustavo Amorim, Ghent University
10:05 AM	Measurement Error Models in the Case-Cohort Design — Klaus Holst

311 *	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W194a
All About Binary and Binomial Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Iryna Lobach, University of California at San Francisco
8:35 AM	Comparative GQL and GMM Bootstrap Methods for Hierarchical Data — Bei Wang, Arizona State University
8:50 AM	A Finite Mixture Model for Clustered Bivariate Binary Data: Application to Ophthalmologic Data Structures — John Kwagyan, Howard University College of Medicine
9:05 AM	Modeling Clustered Bivariate Binary Outcome — Edmund Ameyaw, Howard University ; Paul Bezandry, Howard University ; Victor Apprey, Howard University ; John Kwagyan, Howard University College of Medicine
9:20 AM	Joint Modeling for Logistic Regression Models with Generalized Method of Moments Estimators — Katherine Cai, Arizona State University ; Jeffrey Wilson, Arizona State University
9:35 AM	Multiple Intraclass Correlations for Higher-Level Nested Logistic Regression — Kyle Irimata, Arizona State University ; Jeffrey Wilson, Arizona State University
9:50 AM	Surrogate Aided Unsupervised Recovery of Sparse Signals in Single Index Models for Binary Outcomes Using Extreme Sampling — Abhishek Chakrabortty, Harvard ; Tianxi Cai, Harvard
10:05 AM	Mean-Minimum Exact Confidence Intervals for a Binomial Probability — Joseph Lang, University of Iowa

317	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W194b
Multiplicity Issues and Solutions — Contributed Papers
Biopharmaceutical Section
Chair(s): Krishan Singh, GlaxoSmithKline
8:35 AM	The Covering Principle: A New Approach to Address Multiplicity in Hypothesis Testing — Huajiang Li, Allergan ; Jihao Zhou, Allergan
8:50 AM	FDR-Controlling Procedures for Testing a Priori--Ordered Hypotheses — Anjana Grandhi, Merck ; Wenge Guo, New Jersey Institute of Technology ; Gavin Lynch, New Jersey Institute of Technology
9:05 AM	Logical Inference of Efficacy in Subgroups and Their Combinations — Jason C. Hsu, Eli Lilly and Company/The Ohio State University
9:20 AM	Adjustment for Categorization in Predictor Variables — Saptarshi Chatterjee, Northern Illinois University ; Sanjib Basu, Northern Illinois University
9:35 AM	Exact Multiple Testing Procedures for Categorical Data — Li He, Merck Research Laboratories ; Joseph Heyse, Merck Research Laboratories
9:50 AM	Multiplicity Adjustment Strategy for Oncology Biomarker Trials — Shu-Chih Su, Merck ; Jing Zhao, Merck
10:05 AM	Multiple Error Rate Concepts in Assessing Efficacy in Subgroups and Their Mixtures — Haiyan Xu, Johnson & Johnson ; Jason Hsu, The Ohio State University

318 * !	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W196a
Novel Approaches for Metagenomic, Phylogenetic, and Epigenetic Analysis — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Michael Sohn, University of Pennsylvania
8:35 AM	Estimating Cell-Type-Specific Associations from Whole Blood Methylation — Richard Barfield ; Xihong Lin, Harvard T.H. Chan School of Public Health
8:50 AM	A Robust Approach for Identifying Differentially Abundant Features in Metagenomic Samples — Lingling An, University of Arizona ; Michael Sohn, University of Pennsylvania ; Ruofei Du, University of Arizona
9:05 AM	Metabolomic Data Analysis: Data Preprocessing — Lauren McIntyre, University of Florida ; Rainey Patterson, University of Florida ; Timothy Garrett, University of Florida ; Alison Morse, University of Florida ; Alexander Kirpich, University of Florida ; Justin Fear, National Institutes of Health ; Miguel Ibarra, University of Florida ; Oleksandr Moskalenko, University of Florida ; Jeremy Koelmel, University of Florida
9:20 AM	Ultra-High-Dimensional Variable Selection with Application to Normative Aging Study: DNA Methylation and Metabolic Syndrome — Grace Yoon ; Yinan Zheng, Northwestern University ; Zhou Zhang, Northwestern University ; Haixiang Zhang, Tianjin University ; Brian Joyce, Northwestern University ; Wei Zhang, Northwestern University ; Wenxin Jiang, Northwestern University ; Lifang Hou, Northwestern University ; Lei Liu, Northwestern University ; Tao Gao, Northwestern University ; Andrea Baccarelli, Harvard ; Joel Schwartz, Harvard ; Pantel S. Vokonas, Boston University
9:35 AM	Statistical Issues in the Forensic Analysis of DNA Data — Alan Izenman, Temple University
9:50 AM	Statistical Models for Proteomic Screening and Analysis of Active Enzymes — William Forrest, Genentech
10:05 AM	Quantifying and Mitigating the Effect of Preferential Sampling on Phylodynamic Inference — Michael Karcher ; Julia Palacios, Harvard ; Trevor Bedford, Fred Hutchinson Cancer Research Center ; Marc Adam Suchard, University of California at Los Angeles ; Vladimir Minin, University of Washington

322	Tue, 8/2/2016, 8:30 AM - 10:20 AM	CC-W182
Bayesian Modeling in Life Sciences and Medicine II — Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA)
Chair(s): Anjishnu Banerjee, Medical College of Wisconsin
8:35 AM	Biomarker Detection and Categorization in RNA-Seq Meta-Analysis Using Bayesian Hierarchical Model — Tianzhou Ma, University of Pittsburgh ; Faming Liang, University of Florida ; George Tseng, University of Pittsburgh
8:50 AM	What's in That Ecology? A Latent Factor Dirichlet-Multinomial Model for Metagenomic Count Data — John O'Brien, Bowdoin College
9:05 AM	Bayesian Implementation of Integrated Population Models — Robert Richardson, Brigham Young University
9:20 AM	Analysis of RNA-Seq Data Using a Family of Negative Binomial Models — Lili Zhao, University of Michigan ; Weisheng Wu, University of Michigan ; Dai Feng, Merck ; Hui Jiang, University of Michigan ; XuanLong Nguyen, University of Michigan
9:35 AM	Allele-Specific RNA Expression Analysis Using Bayesian Hierarchical Models — Ignacio Alvarez, Iowa State University ; Jarad Niemi, Iowa State University ; Dan Nettleton, Iowa State University
9:50 AM	A Semiparametric Bayesian Survival Analysis Using Covariate-Dependent Clustering, with Application to Pediatric Kidney Transplantation Data — Hang J. Kim, University of Cincinnati ; Mi-Ok Kim, Cincinnati Children's Hospital Medical Center
10:05 AM	Using Hierarchical Models to Understand P300-Wave--Based Brain-Computer Interface Performance Among Disabled Adults — Maryclare Griffin ; Peter Hoff, University of Washington

339 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W195
Big Data Challenges and Statistical Advances in Functional Genomics — Topic Contributed Papers
WNAR , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Jingyi (Jessica) Li, University of California at Los Angeles
Chair(s): Hongkai Ji, Johns Hopkins Bloomberg School of Public Health
10:35 AM	Assessing Reproducibility of Hi-C Data — Qunhua Li, Penn State University ; Tao Yang, Penn State University
10:55 AM	Determination of Phased Genotypes and Allele-Specific Expression at Isoform Level by Hybrid Sequencing — Kin Fai Au, University of Iowa ; Benjamin Deonovic, University of Iowa ; Jason Weirather, University of Iowa ; Yunhao Wang, University of Iowa
11:15 AM	A Novel 2D Genome Segmentation Method for Modeling Epigenetic Landscapes in Multiple Cell Lines — Yu Zhang, Penn State University
11:35 AM	Integrated DNA Mutation, Copy Number, and Gene Expression Analysis Reveals a Highly Reproducible Prognostics Marker in Lung Adenocarcinomas — Hao Ho, University of California at Los Angeles
11:55 AM	Testing-Based Measures for Finding Correspondence of Genomic Samples — Jingyi (Jessica) Li, University of California at Los Angeles
12:15 PM	Floor Discussion

341 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W193a
Functional and Longitudinal Data Analysis Methods — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Andrada E. Ivanescu, Montclair State University
Chair(s): Ciprian Crainiceanu, The Johns Hopkins University
10:35 AM	Variable Selection in the Concurrent Functional Linear Model — Jeff Goldsmith, Columbia Mailman School of Public Health
10:55 AM	Functional Nearest Neighbor Ensembles with Application to Water Quality Monitoring — Jan Gertheiss, Clausthal University of Technology ; Karen Fuchs, Siemens AG
11:15 AM	Dynamic Child Growth Prediction: A Comparative Methods Approach — Andrada E. Ivanescu, Montclair State University ; Ciprian Crainiceanu, The Johns Hopkins University ; William Checkley, The Johns Hopkins University
11:35 AM	Joint Modeling of Noncommensurate Sparse Functional Predictors with an Application to Ecological Momentary Assessment (EMA) Data — Jaroslaw Harezlak, Indiana University Fairbanks School of Public Health ; Fei He, Indiana University Fairbanks School of Public Health ; Armando Teixeira-Pinto, University of Sydney
11:55 AM	Dynamic Prediction of Alzheimer's Disease Risk Based on Longitudinal Biomarkers and Functional Data — Sheng Luo, The University of Texas at Houston ; Kan Li, The University of Texas at Houston
12:15 PM	Floor Discussion

343 *	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W194b
Novel Missing Data Imputation Methods — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Freda Cooner, FDA/CDER/OTS/OB/DB2
Chair(s): John Scott, FDA
10:35 AM	Two Approaches for Conducting Control-Based Imputation in Handling Missing Data — Guanghan Liu, Merck Research Laboratories
10:55 AM	Making Use of the Predictive Distribution for Missing Data — Gerry Gray, FDA/CDRH
11:15 AM	Novel Missing Data Imputation Methods — Peter Mesenbrink, Novartis Pharma
11:35 AM	Novel Imputation Methods for Binary, Time-to-Event, and Recurrent-Event Outcomes — Michael O'Kelly, Quintiles
11:55 AM	Discussant: Feng Li, FDA/CDER/OTS/OB/DB2
12:15 PM	Floor Discussion

346 *	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W196a
Summarizing Case Studies to Learn from and Improve Adaptive Trial Design and Implementation — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Weili He, Merck
Chair(s): Weili He, Merck
10:35 AM	Highpoints of What We Learned from Case Studies of Less Well-Understood Adaptively Designed Trials — Eva Miller, InVentiv Health Clinical
10:55 AM	Case Study: How Promising Is the VALOR Trial for the Future of Adaptive Designs? — Yannis Jemiai, Cytel
11:15 AM	Regulatory and Practical Considerations for an Adaptive Trial in the Context of Evaluating a Combination Product: An Example Using Two Human MAbs to Prevent Recurrence of CDI — Kenneth Koury, Merck Research Laboratories ; Robert Tipping, Merck Research Laboratories
11:35 AM	Discussant: Jerry Schindler, Merck
11:55 AM	Discussant: Gregory Levin, FDA
12:15 PM	Floor Discussion

347 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W192b
Advances in Statistical Methods for Systems Biology — Topic Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Li Ma, Duke University
Chair(s): Barbara E. Engelhardt, Princeton
10:35 AM	A Big Table for Gene Regulatory Analysis — Wing Hung Wong, Stanford University
10:55 AM	Statistical Models for Single Cell RNA RNA Analysis — Nancy Zhang, University of Pennsylvania ; Cheng Jia, University of Pennsylvania ; Yuchao Jiang, University of Pennsylvania ; Mingyao Li, University of Pennsylvania
11:15 AM	A Bayesian Nonparametric Analysis of Heterogeneous Data on Microbial Communities — Sergio Bacallado
11:35 AM	Analysis of Distributional Variation: A Multi-Resolution Scanning Approach with Applications to DNase-Seq Analysis — Li Ma, Duke University
11:55 AM	Bayesian Nonparametric Multiple Testing for the Analysis of Microbiome Data — Michele Guindani
12:15 PM	Floor Discussion

348 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W192a
Statistical Methodology to Address Challenges in Medical Diagnostic Devices — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Jeng Mah, Beckman Coulter Inc.
Chair(s): Alvin Van Orden, FDA
10:35 AM	A Bayesian Adaptive Clinical Trial Design: Diagnostic Accuracy of an Olfactory Diagnostic Test for Traumatic Brain Injury in Combat Soldiers — Benjamin Saville, Berry Consultants
10:55 AM	The Effects on Diagnostic Accuracy of Repeated Testing and Decision Rule Design — Jeng Mah, Beckman Coulter Inc.
11:15 AM	Group Sequential Method for Correlated ROC Curves — Xuan Ye, FDA ; Larry Tang, George Mason University
11:35 AM	Method Comparison Study for Diagnostic Devices with Dichotomous Output — Bipasa Biswas, FDA/CDRH
11:55 AM	Floor Discussion

356 *	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W193b
Methods for Next-Generation Sequencing Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Jen-hwa Chu, Yale University
10:35 AM	Excess False Positives in Negative-Binomial-Based Analysis of Data from RNA-Seq Experiments — David Rocke, University of California at Davis ; Yilun Zhang, University of California at Davis
10:50 AM	Power Analysis for RNA-Seq Differential Expression Studies — Lianbo Yu, The Ohio State University ; Soledad Fernandez, The Ohio State University ; Guy N. Brock, The Ohio State University
11:05 AM	A Bayesian Hypothesis-Testing Framework for Detecting Differentially Expressed Genes — Claudio Fuentes, Oregon State University ; Luis Leon Novelo, The University of Texas Health Science Center at Houston ; Sarah Emerson, Oregon State University
11:35 AM	Moving Beyond the Single Gene: Integrative Pathway Analysis for RNA-Seq — Andrew Aschenbrenner, The University of Texas Health Science Center at Houston ; Yun-Xin Fu, The University of Texas Health Science Center at Houston ; David Loose, The University of Texas Health Science Center at Houston
11:50 AM	Improving the Power of the Benjamini-Hochberg Procedure for Discrete Data — Sebastian Doehler, Darmstadt University of Applied Sciences
12:05 PM	Analysis Pipeline to Investigate Diversity and Dynamics of Next-Generation Sequencing--Based T Cell Repertoire Data — Li Zhang, University of California at San Francisco ; Jason Cham, University of California at San Francisco ; Nadeem Sheikh, Dendreon Corporation ; Lawrence Fong, University of California at San Francisco

357 *	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W194a
Advances in Statistical Genetics and Genomics — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Chao Xing, The University of Texas Southwestern Medical Center
10:35 AM	Integrative Analysis of Omics Data Across Multiple Conditions Using Tensor Decomposition and Regularization — Eun Jeong Min, Emory University ; Yijuan Hu, Emory University ; Qi Long, Emory University
10:50 AM	Detecting Low Allele Fraction Variants Using Targeted DNA Sequencing with Molecular Barcodes — Chang Xu, Qiagen Sciences ; Mohammad R. Nezami Ranjbar, Qiagen Sciences ; John Dicarlo, Qiagen Sciences ; Yexun Wang, Qiagen Sciences
11:05 AM	Inferring Spatial Organizations of Chromosomes from Hi-C Data via Poly-Helix Model — Rongrong Zhang, Purdue University ; Ming Hu, New York University ; Yu Zhu, Purdue University
11:20 AM	Analysis of Variance Components for Genetic Markers with Unphased Genotypes — Tao Wang, Medical College of Wisconsin
11:35 AM	Powerful Test Based on Multivariate Joint Effect for Genome-Wide Screening — Yaowu Liu, Purdue University ; Jun Xie, Purdue University
11:50 AM	Robust Approaches for the Analysis of High-Throughput Proteomic Data — Naim Rashid
12:05 PM	Genomic Prediction Models on Wheat Doubled Haploid Population — Xiaowei Hu, Oklahoma State University ; Lan Zhu, Oklahoma State University ; Charles Chen, Oklahoma State University

362 * !	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W192c
Biomarkers and Endpoint Validation — Contributed Papers
Biopharmaceutical Section , Section on Statistics in Imaging , International Chinese Statistical Association
Chair(s): Geng Chen, GlaxoSmithKline
10:35 AM	Biomarker Analyses in Phase II Dose-Ranging Study — Xiwen Ma, Sanofi US ; Yuefeng Lu, Sanofi US ; Zheng Wei, Sanofi US
10:50 AM	Evaluation of Magnetic Resonance Imaging (MRI) Parameters as Biomarkers in Alzheimer's Disease — Leacky Muchene, Hasselt University ; Ziv Shkedy, Hasselt University ; Luc Kamau Bijnens, Janssen ; Nikolay Manyakov, Janssen ; Tom Van De Kasteel, Janssen ; Tom Jacobs, Janssen ; Marleen Kamau Verhoye, Antwerp University ; Jelle Praet, Antwerp University ; Annemie Van der Linden, Antwerp University ; Astrid Bottelbergs, Janssen ; Mark Schmidt, Janssen ; Darrel Pemberton, Janssen
11:05 AM	Link-Free Identification of Simple Index Variables for the Prediction of Differential Treatment Response — Hongjie Zhu, Sanofi
11:20 AM	Searching for Correlates of Protection for Ebola Vaccine — Jin Xu, Merck ; Kenneth Liu, Merck ; Ivan S. F. Chan, Merck
11:50 AM	Bias Correction for Biomarker Threshold Studies — Li Liu, Sanofi ; Glen Laird, Sanofi
12:05 PM	Floor Discussion

363 *	Tue, 8/2/2016, 10:30 AM - 12:20 PM	CC-W191
Statistical Methods with Applications in Pharmacology, Toxicology, and Pharmacovigilance — Contributed Papers
Biopharmaceutical Section , Section on Risk Analysis
Chair(s): John A. Wass, Quantum Cat Consultants
10:35 AM	On the Perils and Pitfalls of PRR Analysis as Applied to Social Media Safety Surveillance — Jeffery Painter, GlaxoSmithKline
10:50 AM	Robust Ridge Regression Estimators for Nonlinear Models with Applications to High-Throughput Screening Assay Data — Changwon Lim
11:05 AM	The Estimation of Absolute IC50 and Its 95% Confidence Interval — Qin Liu, The Wistar Institute ; Xiangfan Yin, The Wistar Institute ; Quentin McAfee, University of Pennsylvania ; Ravi Amaravadi, University of Pennsylvania ; Jeffery Winkler, University of Pennsylvania ; Meenhard Herlyn, The Wistar Institute
11:20 AM	Alternatives to Nonproportional Hazards — Ramin Arani, AstraZeneca ; Yifan Huang , AstraZeneca ; Andrew Stone, AstraZeneca
11:35 AM	An Exposition to Integrated System Modeling of Patients' Safety Risk — D. Purkayastha ; Sadhvi Khanna, Novartis
11:50 AM	Performance Improvement of Parameter Estimation by Two-Step Analysis Incorporating Generalized Log-Rank Statistics — Junji Moriya, Kyowa Kirin Pharmaceutical Development ; June Li, Kyowa Kirin Pharmaceutical Development
12:05 PM	Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach — Junshan Qiu, FDA ; Marilyn Martinez, FDA ; Ram Tiwari, FDA/CDER/OT/OB

380	Tue, 8/2/2016, 10:30 AM - 11:15 AM	CC-Hall F1 West
SPEED: Advances in Biopharmaceutical Research, Part 2A — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
1:	Generalizing Results from Randomized Trials to Target Population via Weighting Methods Using Propensity Score — Ziyue Chen, The Ohio State University ; Eloise Kaizar, The Ohio State University
2:	Bone Marrow Stromal Cell Therapy for Ischemic Stroke: A Meta-Analysis of Randomized Control Animal Trials — Qing Wu, Nevada Institute of Personalized Medicine ; Yuexiang Wang, Mayo Clinic ; Bart Demaerschalk, Mayo Clinic ; Saruna Ghimire, Nevada Institute of Personalized Medicine ; Kay Wellik, Mayo Clinic ; Wenchun Qu, Mayo Clinic
4:	Stepped Wedge Cluster Randomized Controlled Trials with Two Layers of Clustering: Designs and Comparisons of Power — Ranran Dong, The Ohio State University ; Abigail Shoben, The Ohio State University
5:	On the Use of Nonparametric Tests for Comparing Immunological Reverse Cumulative Distribution Curves (RCDCs) — Lihan Yan, FDA ; Bob Small, Sanofi Pasteur ; Ayca Ozol-Godfrey, Sunovion Pharmaceuticals
7:	Impact of Mis-Specified Prior on the Bayesian Dose-Finding Method in Phase I Cancer Trials — Lixia Pei, Janssen R&D ; Kevin Liu, Janssen R&D ; Hong Tian, Janssen R&D
8:	Covariate Adjustment for Logistic Regression Analysis of Binary Clinical Trial Data — Honghua Jiang ; Pandurang Kulkarni, Eli Lilly and Company ; Craig Mallinckrodt, Eli Lilly and Company ; Linda Shurzinske, Eli Lilly and Company ; Geert Molenberghs, Universiteit Hasselt ; Ilya Lipkovich, Quintiles
9:	Improving Vaccine Inventory Utilization Using R-Based Statistical Heuristic Algorithm — Hesham Fahmy, Merck
10:	Value-Driven Decision Making at Late Stage of Drug Development: Statistical Simulation Approach — Masanori Ito, Astellas Pharma ; Hideki Hirooka, Astellas Pharma
The oral portion will take place during Session 213148

383	Tue, 8/2/2016, 11:35 AM - 12:20 PM	CC-Hall F1 West
SPEED: Advances in Biopharmaceutical Research, Part 2B — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
1:	D-Optimal Designs for Multinomial Logistic Models — Xianwei Bu, UIC ; Jie Yang, University of Illinois at Chicago
2:	Finding Minimum Effective Dose With Multiple Testing Procedures — Lucy Kerns, Youngstown State University ; Flora Opoku Asantewaa, Youngstown State University
4:	Comparisons of Statistical Approaches and Procedures in Building Predicting Models to Drug Response from SNPs Through Simulation — Wencan Zhang, Takeda Development Center ; Pingye Zhang, University of Southern California ; Feng Gao, Takeda
5:	Finding the 'Missing Heritability' in Combined Phase 2 and Subset Phase 3 Analyses — Knut Wittkowski, Rockefeller University ; Benedetta Bigio, Rockefeller University
6:	The Analysis of Impact of Difference in Duration of Treatment — Jiejun Du, Merck
8:	Multiple Testing Procedures Under Group Sequential Design — Aiying Chen, Temple University
9:	Use of the Treatment-Free Interval in Driving Decision Making in Cancer Care: A Late-Phase Example — Suddhasatta Acharyya, Novartis ; Ashok Panneerselvam, Novartis Oncology ; Sofia Paul, Novartis
The oral portion will take place during Session 213148

388	Tue, 8/2/2016, 12:30 PM - 1:50 PM	CC-W375a
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Jennifer Gauvin, Novartis
TL12:	Statistical Issues in the Design and Analysis of Rheumatology Trials — Yongman Kim, FDA
TL13:	Unmet Medical Needs: Can We Accelerate Drug Approval and Marketing Through Expansion Cohort Trials? — Soumi Lahiri, GlaxoSmithKline ; Teri Ashton, GlaxoSmithKline ; Ohad Amit, GlaxoSmithKline

397 *	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W196b
Innovative Trial Designs and Data Analysis Models in Rare Diseases — Invited Papers
Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Freda Cooner, FDA/CDER/OTS/OB/DB2
Chair(s): Freda Cooner, FDA/CDER/OTS/OB/DB2
2:05 PM	Efficient Use of Deficient (Limited) Information: A Rare Disease Perspective — Sandeep M. Menon, Pfizer
2:20 PM	The Statisticians Role as a Strategic Drug Developer in Rare Disease Indications — Jeff Palmer, Pfizer
2:35 PM	Case Studies for Biologics Trials in Very Rare Diseases — John Scott, FDA
2:50 PM	Issues and Solutions Encountered in the Design of Trials for Rare Diseases — Brenda Gaydos, Eli Lilly and Company ; Karen Price, Eli Lilly and Company ; Bill Prucka, Eli Lilly and Company
3:05 PM	Hierarchical Bayesian Approaches for Clinical Trials in Orphan and Pediatric Diseases — Cynthia Basu, University of Minnesota ; Freda Cooner, FDA/CDER/OTS/OB/DB2 ; Ram Tiwari, FDA/CDER/OT/OB ; Bradley Carlin, University of Minnesota
3:20 PM	Discussant: Amy Xia, Amgen
3:35 PM	Floor Discussion

413 * !	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W178a
Bayesian Approaches to Modeling Complex Phenomena in Health Applications — Topic Contributed Papers
Health Policy Statistics Section , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science
Organizer(s): Mark Glickman, Harvard
Chair(s): Yang Chen, Harvard
2:05 PM	Measuring the Effects of Time-Varying Medication Adherence on Health Outcomes Through Latent States — Mark Glickman, Harvard
2:25 PM	Bayesian Modeling of Between- and Within-Subject Variances Using Mixed Effects Location Scale Models for Intensive Longitudinal Data — Donald Hedeker, The University of Chicago ; Robin J. Mermelstein, University of Illinois at Chicago ; Xiaolei Lin, The University of Chicago
2:45 PM	Bayesian Approaches to Modeling Complex Phenomena in Health Applications — Jennifer L. Hill, New York University ; Vincent Dorie, New York University ; Nicole Carnegie, University of Wisconsin - Milwaukee ; Masataka Harada, National Graduate Institute for Policy Studies
3:05 PM	Estimating Number of Founder Lineages and Infection Duration of Multivariant HIV-1 Transmissions — Tanzy Love, University of Rochester ; Sung Yong Park, University of Southern California ; Elena E. Giorgi, Los Alamos National Laboratory ; Wendy Mack, University of Southern California ; Alan S. Perelson, Los Alamos National Laboratory ; Ha Youn Lee, University of Southern California
3:25 PM	A Novel Bayesian Multiple Imputation Framework for Massive Multivariate Data with Mixed Types of Marginals — Hakan Demirtas, University of Illinois at Chicago
3:45 PM	Floor Discussion

418 * !	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W193a
Biometrics Section Student Paper Award Session 2 — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Dipankar Bandyopadhyay, Virginia Commonwealth University
Chair(s): Ronald Gangnon, University of Wisconsin
2:05 PM	A Class of Semiparametric Tests of Treatment Effect Robust to Measurement Error of a Confounder — Caleb Miles, University of California at Berkeley ; Eric Tchetgen Tchetgen, Harvard
2:45 PM	Sure Screening for Transelliptical Graphical Models — Yuxiang Xie, University of Washington ; Chengchun Shi, North Carolina State University ; Rui Song, North Carolina State University ; Daniela Witten, University of Washington
3:05 PM	Nonparametric Bayesian Learning of Heterogeneous Dynamic Transcription Factor Networks — Xiangyu Luo, The Chinese University of Hong Kong ; Yingying Wei, The Chinese University of Hong Kong
3:25 PM	ScDD: A Statistical Approach for Identifying Differential Distributions in Single-Cell RNA-Seq Experiments — Keegan Korthauer, Dana-Farber Cancer Institute ; Michael Newton, University of Wisconsin - Madison ; Christina Kendziorski, University of Wisconsin
3:45 PM	Floor Discussion

422 * !	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W194b
Methodological and Practical Aspects of Adaptive Model-Based Design of Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Sergei Leonov, ICON Clinical Research
Chair(s): Sergei Leonov, ICON Clinical Research
2:05 PM	Practical Experiences with Adaptive Dose-Escalation Designs in Early-Phase Oncology Trials — Inna Perevozskaya, Pfizer
2:25 PM	Application of Adaptive Designs to Optimize a Compound Development Program — Yevgen Tymofyeyev, J & J PRD
2:45 PM	Interim Timing in Adaptive Two-Stage Dose-Finding Studies: What Happens to the Expected Benefit? — Tobias Mielke, ICON PLC
3:05 PM	Discussant: William Rosenberger, George Mason University
3:25 PM	Discussant: Cristiana Mayer, Janssen R&D
3:45 PM	Floor Discussion

428 *	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W193b
Recent Challenges in -Omics Sciences — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Sheng Luo, The University of Texas at Houston
2:05 PM	Robust Heritability and Predictive Accuracy Estimation in Plant Breeding — Vanda Lourenco, Universidade Nova de Lisboa ; Hans-Peter Piepho, University of Hohenheim ; Joseph Ochieng Ogutu, University of Hohenheim
2:20 PM	Using IMRE and Dual KS to Select MicroRNAs for Predicting Prostate Cancer — Yarong Yang, North Dakota State University
2:35 PM	Module-Based Reconstruction of Gene Regulatory Network into Predictive Modeling for High-Dimensional Genomic Data — Rui Zhong, AbbVie ; Xin Huang, AbbVie ; Viswanath Devanarayan, AbbVie
2:50 PM	PROMISE-ME: A Robust Method for Integrated Analysis of DNA Methylation, Gene Expression, and Multiple Biologically Related Clinical and Pharmacological Outcomes — Stanley Pounds, St. Jude Children's Research Hospital ; Xueyuan Cao, St. Jude Children's Research Hospital ; Tong Lin, St. Jude Children's Research Hospital
3:05 PM	Relative Quantification of mRNA Expression Based on Dynamics of QRT-PCR Efficiency — Inna Chervoneva, Thomas Jefferson University
3:35 PM	Evaluating Imputation Methods for Integrating Proteomics Data Sets — Yian Chen, Moffitt Cancer Center ; Kate Fisher, PAREXEL ; Eric A. Welsh, Moffitt Cancer Center ; Steven Eschrich, Moffitt Cancer Center

430 *	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W191
Longitudinal Data Analysis — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Charles Smith, North Carolina State University
2:05 PM	Detecting Treatment Differences in Group Sequential Longitudinal Studies with Covariate Adjustment — Neal Jeffries, National Heart, Lung, and Blood Institute ; James Troendle, National Institutes of Health ; Nancy L. Geller, National Heart, Lung, and Blood Institute
2:20 PM	Inference for Nonlinear Panel/Longitudinal Data — Carles Breto, University of Michigan ; Edward L. Ionides, University of Michigan ; Aaron A. King, University of Michigan
2:35 PM	Estimating Onset Time from Longitudinal Data with Application to Estimating Gestational Age from Maternal Anthropometry During Pregnancy — Ana Maria Ortega-Villa, Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Paul Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development
2:50 PM	Power Analysis for Longitudinal Data — Niloofar Ramezani, University of Northern Colorado
3:05 PM	Multivariate Copula-Based Regression Models for Longitudinal Data — Xin Tian, National Heart, Lung, and Blood Institute ; Colin O. Wu, National Heart, Lung, and Blood Institute
3:20 PM	Generalized Semiparametric Varying-Coefficient Models for Longitudinal Data — Li Qi, Sanofi US ; Yanqing Sun, The University of North Carolina at Charlotte ; Peter Gilbert, Fred Hutchinson Cancer Research Center
3:35 PM	Model Estimation and Dynamic Prediction for Subject-Specific Event Probability in Joint Modeling Using Longitudinal Quantile Regression — Ming Yang, The University of Texas Health Science Center at Houston ; Sheng Luo, The University of Texas at Houston ; Stacia DeSantis, The University of Texas Health Science Center at Houston

434 * !	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W194a
Statistical Modeling of RNA-Seq Data — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Yuchao Jiang, University of Pennsylvania
2:05 PM	Detection of Differential Gene Expressions from Tumor RNA-Seq and Copy Number Data in the Presence of Tumor Heterogeneity — Jaeil Ahn, Georgetown University ; Wenyi Wang, MD Anderson Cancer Center ; Ying Yuan, MD Anderson Cancer Center
2:20 PM	TSCAN: Pseudo-Time Reconstruction and Evaluation in Single-Cell RNA-Seq Analysis — Zhicheng Ji, Johns Hopkins Bloomberg School of Public Health ; Hongkai Ji, Johns Hopkins Bloomberg School of Public Health
2:35 PM	NMFP: A Non-Negative Matrix Factorization--Based Preselection Method to Increase Accuracy of Identifying mRNA Isoforms from RNA-Seq Data — Yuting Ye, University of California at Berkeley ; Jingyi (Jessica) Li, University of California at Los Angeles
2:50 PM	A Statistical Method for Cross-Species Analysis of RNA-Seq Data — Yered Pita-Juarez, Harvard ; Rafael A. Irizarry, Dana-Farber Cancer Institute ; Michael I. Love, Harvard T.H. Chan School of Public Health
3:05 PM	Model-Based Clustering and Visualization of RNA-Seq Data — Kushal Dey, The University of Chicago ; Matthew Stephens, The University of Chicago
3:20 PM	Modeling the Ordering of Cell-Cycle Phase in Single-Cell RNA-Seq Data — Chiaowen Joyce Hsiao, The University of Chicago ; Kushal Dey, The University of Chicago ; PoYuan Tung, The University of Chicago ; Yoav Gilad, The University of Chicago ; Matthew Stephens, The University of Chicago
3:35 PM	Nonparametric Hypothesis Testing of the Human Microbiome Using Evolutionary Trees — Martina Mincheva, Temple University ; Hongzhe Li, University of Pennsylvania ; Jun Chen, Mayo Clinic

435 *	Tue, 8/2/2016, 2:00 PM - 3:50 PM	CC-W195
Power, Sample Size, and Practical Considerations in Clinical Trials — Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Daniel He Li, Juno Therapeutics
2:20 PM	Sample Size Estimation Using a Hybrid Classical and Bayesian Procedure — Maria Ciarleglio, Yale University ; Christopher Arendt, Air Force Office of Scientific Research
2:35 PM	Using Power Contours to Assess the Sensitivity of Clinical Trial Design Assumptions — Richard C. Zink, JMP Life Sciences, SAS Institute ; Xiaotong Jiang, The University of North Carolina at Chapel Hill
2:50 PM	On Power and Sample Size of the ANOVA-Type Rank Test — Chunpeng Fan, Sanofi US ; Donghui Zhang, Sanofi US
3:05 PM	Identifying Main Effects in Multi-Factor Clinical Trials — Abhishek Bhattacharjee, University of Florida ; Samuel S. Wu, University of Florida
3:20 PM	Two-Stage Procedure for Fixed-Width Confidence Intervals of the Risk Ratio — Hokwon Cho, University of Nevada, Las Vegas
3:35 PM	Practical Considerations in Clinical Trial Design — Kerry Go, Sanofi Pasteur

213618	Tue, 8/2/2016, 5:30 PM - 7:30 PM	H-Marquette
Biopharmaceutical Section Mixer and Open Business Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): B Christine Clark

456	Wed, 8/3/2016, 7:00 AM - 8:15 AM	CC-W375a
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Jennifer Gauvin, Novartis
WL01:	Assessing Safety of Rare Events for Sparse, Limited, or Extreme Data — Mike Wright Colopy, UCB Bioscience

473 *	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W178a
Subgroups Analyses: Planned Versus Ad-Hoc: How Many Are Too Many? — Invited Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Vipin Arora, Eli Lilly and Company
Chair(s): Lisa LaVange, Office of Biostatistics Organization
8:35 AM	Subgroup Analyses in Early-Phase Clinical Trials: Challenges and Opportunities — Björn Bornkamp, Novartis ; Marius Thomas, Novartis
8:55 AM	Visualizing the Limitations of Subgroup Analyses — Kevin Andrew Buhr, University of Wisconsin - Madison
9:15 AM	Subgroup Analysis in Regulatory Decision Making — Lilly Yue, FDA/CDRH/OSB
9:35 AM	Visualization vs traditional presentation of data - what is there in subgroups? — Vipin Arora, Eli Lilly and Company
9:55 AM	Discussant: Judith D. Goldberg, New York University School of Medicine
10:15 AM	Floor Discussion

481 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W179a
Small Clinical Trials: Challenging Traditional Thinking — Topic Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians
Organizer(s): Satrajit Roychoudhury, Novartis
Chair(s): Satrajit Roychoudhury, Novartis
8:35 AM	Impact of Adaptive Design on Optimization of Pharmaceutical Portfolios — Zoran Antonijevic
8:55 AM	Maximizing the Efficiency of Proof-of-Concept Studies and of Arrays of Proof-of-Concept Studies for Multiple Drugs or Indications — Robert Beckman, Georgetown University Medical Center
9:15 AM	Challenges and Experience in Designing Small Clinical Trials — Christopher Coffey, University of Iowa
9:35 AM	An Extrapolation Framework to Specify Requirements for Drug Development in Children — Gerald Hlavin, Medical University of Vienna ; Franz Koenig, Medical University of Vienna ; Christoph Male, Medical University of Vienna ; Martin Posch, Medical University of Vienna ; Peter Bauer, Medical University of Vienna
9:55 AM	Discussant: Pandurang Kulkarni, Eli Lilly and Company
10:15 AM	Floor Discussion

484 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W176a
Recent Advances in Computer-Intensive Methods for Analyzing Oral Health Data — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Elizabeth G. Hill, Medical University of South Carolina
Chair(s): Tanujit Dey, Cleveland Clinic
8:35 AM	Nonparametric Spatial Models for Clustered Ordered Periodontal Data — Dipankar Bandyopadhyay, Virginia Commonwealth University ; Antonio Canale, University of Turin/Collegio Carlo Alberto
8:55 AM	A Bayesian Multiscale Ordinal Latent Class Model for Dysphagia Severity — Elizabeth G. Hill, Medical University of South Carolina ; Kent Armeson, Medical University of South Carolina ; Elizabeth Slate, Florida State University ; Bonnie Martin-Harris, Medical University of South Carolina
9:15 AM	Cluster-Adjusted Regression for Displaced Subject Data (CARDS): Marginal Inference Under Potentially Informative Temporal Cluster Size Profiles — Somnath Datta, University of Florida ; JOE BIBLE, National Institutes of Health ; JAMES BECK, The University of North Carolina at Chapel Hill
9:35 AM	Continuous Time Causal Mediation Analysis with Application to Longitudinal Dental Caries Data — Jeffrey Albert, Case Western Reserve University ; Yiying Liu, Case Western Reserve University ; Suchitra Nelson, Case Western Reserve University
9:55 AM	Marginal Mean Models for Zero-Inflated Count Data with Spline-Based Semiparametric Estimation — David Todem, Michigan State University ; Yifan Yang, Michigan State University
10:15 AM	Floor Discussion

487 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W182
Novel Statistical Methodologies for Neuroimaging Data — Topic Contributed Papers
ENAR , Biopharmaceutical Section , Section on Statistics in Imaging , International Chinese Statistical Association
Organizer(s): Ranjan Maitra, Iowa State University
Chair(s): Adam Ciarleglio, Columbia University
8:35 AM	An Assessment of Statistical Models of Complex-Valued fMRI Data — Daniel Adrian, Grand Valley State University ; Ranjan Maitra, Iowa State University ; Daniel Rowe, Marquette University
8:55 AM	Quantifying Functional Connectivity with Data-Adaptive Covariance Matrices for Multivariate Functional Data — Alexander Petersen, University of California at Davis ; Hans-Georg Mueller, University of California at Davis
9:15 AM	A Joint Modeling Approach for Treatment Response and Baseline Imaging Data — Bei Jiang ; Eva Petkova, New York University ; Thaddeus Tarpey, Wright State University ; Robert Todd Ogden, Columbia University
9:35 AM	HPRM: Hierarchical Principal Regression Model of Diffusion Tensor Bundle Statistics — Jingwen Zhang ; Hongtu Zhu, The University of North Carolina at Chapel Hill ; Joseph G. Ibrahim, The University of North Carolina at Chapel Hill
9:55 AM	SENSE-Induced Correlation in Simultaneous Multi-Slice fMRI — Daniel Rowe, Marquette University

490	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W181a
SPEED: Statistical Methods for Clinical Trials and Longitudinal Analysis — Contributed Speed
Biopharmaceutical Section , Biometrics Section
Chair(s): Kevin Lawson, PPD
8:35 AM	Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials — Wanying Zhao, The George Washington University
8:45 AM	Adaptive Estimation of Personalized Maximum Tolerated Doses in Cancer Phase I Clinical Trials According to All Toxicities and Individual Characteristics — Zhengjia Chen, Emory University ; Zheng Li, Penn State University ; Ying Yuan, MD Anderson Cancer Center ; Michael Kutner, Emory University ; Taofeek Owonikoko, Emory University ; Walter J. Curran, Emory University ; Jeanne Kowalski, Emory University
8:50 AM	Small Sample Inference in Imbalanced Cluster Randomized Clinical Trials with Binary Outcomes — Dong Hyun Ahn, New York University ; Judith D. Goldberg, New York University School of Medicine
8:55 AM	Robust Generalized Multivariate Bioequivalence — Srinand Ponnathapura Nandakumar, Quintiles
9:00 AM	Explore Methodologies for Extrapolation of Efficacy from the Adult to the Specific Pediatric Population — Yao Li, AbbVie ; Bidan Huang, AbbVie
9:05 AM	A Clinical Trial Design Based on the Concept of Relative Time Using the Generalized Gamma Ratio Distribution — Milind Phadnis, University of Kansas Medical Center
9:10 AM	Improved Methods for the Marginal Analysis of Longitudinal Data in the Presence of Time-Dependent Covariates — I-Chen Chen, University of Kentucky ; Philip Westgate, University of Kentucky
9:15 AM	Proportional Likelihood Ratio Mixed Model — Hongqian Wu, University of Iowa ; Michael Jones, University of Iowa
9:20 AM	Simultaneous Confidence Intervals for Assessing SNP Effects on Treatment Efficacy — Yushi Liu ; Jason C. Hsu, Eli Lilly and Company/The Ohio State University
9:30 AM	Dangers of Misusing Ordinal Data — Ivy Liu, Victoria University of Wellington ; Daniel Fernandez Martinez, New York University ; Peter Yongqi Gu, Victoria University of Wellington
9:35 AM	A Simulation-Based Method for Detecting the Best Treatment in Clinical Trials — Yan Zhao, University of Oklahoma Health Sciences Center ; Roy Tamura, University of South Florida ; Michael Brown, Oklahoma Medical Research Foundation
9:45 AM	A Small N Sequential Multiple Assignment Randomized Trial for Use in Rare Disease Research — Roy Tamura, University of South Florida
9:50 AM	The Impact of Model Misspecification on Repeated Measures Analysis — Yingmei Xi, Vertex Pharmaceuticals ; John Jiang, Vertex Pharmaceuticals
9:55 AM	Correlates of Time to Sexual Debut in 15--19-Year-Olds in the Jamaica Youth Risk and Resiliency Survey 2006: A Survival Analysis — Tamika Royal-Thomas, University of the West Indies ; Novie Younger-Coleman, University of the West Indies ; Jan Van den Broeck, University of Bergen ; Debajyoti Sinha, Florida State University ; Daniel McGee , Florida State University ; Shelly McFarlane, University of the West Indies ; Damian Francis, University of the West Indies ; Rainford Wilks, University of the West Indies
10:05 AM	Applying Statistical Design to Improve Target Selection: An Example from Whole-Genome SiRNA Screens — Mandy Bergquist ; Katja Remlinger, GlaxoSmithKline
10:10 AM	Good Practices and Implementation Methods for Optimally Stratified Randomization — Jonathan Chipman, Vanderbilt University ; Cole Beck, Vanderbilt University ; Robert Greevy, Vanderbilt University

495 *	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W176b
Random Effects and Mixed Models — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Yifei Sun, The Johns Hopkins University
8:35 AM	A Computationally Efficient Algorithm for Random Effects Selection in Linear Mixed Models — Mihye Ahn, University of Nevada, Reno ; Helen Zhang, University of Arizona ; Wenbin Lu, North Carolina State University
8:50 AM	Random-Effects Models in Genetics: Theoretical and Computational Tools for Modern Applications — Lee Dicker, Rutgers University
9:05 AM	Restricted Maximum Likelihood Approaches for Linear Mixed Models: AREML and BREML — Erning Li, University of Iowa ; Dale Zimmerman, University of Iowa
9:20 AM	Confidence Intervals for Variance Components in Mixed-Effects Models: A Likelihood-Based Approach — Gaurav Sharma, The EMMES Corporation ; Lihan Yan, FDA
9:35 AM	Drug Interaction Assessment with Repeated Measurements in Fixed Ray Design — Shouhao Zhou, MD Anderson Cancer Center
9:50 AM	Multidimensional Latent Trait Linear Mixed Model with an Application in Clinical Trials — Jue Wang, The University of Texas Health Science Center at Houston ; Sheng Luo, The University of Texas at Houston
10:05 AM	Floor Discussion

496 *	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W177
New Methods for Competing Risks and Multistate Models — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Chiung-Yu Huang, The Johns Hopkins University
8:35 AM	A Bivariate Lehmann Model for Semi-Competing Risks Data — David Oakes, University of Rochester Medical Center
8:50 AM	Semiparametric Models of Bivariate Times-to-Event Data with a Semi-Competing Risk — Ran Liao, Indiana University ; Sujuan Gao, Indiana University
9:05 AM	Semiparametric Regression Analysis of Recurrent Gap Times in the Presence of Competing Risks — Chia-Hui Huang, National Taipei University ; Yi-Hau Chen, Academia Sinica
9:20 AM	Instrumental Variable with Competing Risk Model — Cheng Zheng, University of Wisconsin - Milwaukee ; Ran Dai, The University of Chicago ; Parameswaran Hari, Medical College of Wisconsin ; Mei-Jie Zhang, Medical College of Wisconsin
9:35 AM	Doubly Robust Regression Trees Under Competing Risks — Youngjoo Cho, University of Rochester Medical Center ; Robert Strawderman, University of Rochester Medical Center
9:50 AM	On the Choice of Time Scales in Competing Risks Predictions — Minjung Lee, Kangwon National University ; Natalia A. Gouskova, The University of North Carolina at Chapel Hill ; Eric J. Feuer, National Cancer Institute ; Jason Fine, The University of North Carolina at Chapel Hill
10:05 AM	A Semiparametric Multi-State Survival Model for Correlated Interval-Censored Life History Data in Caries Research — Daewoo Pak, Michigan State University ; Chenxi Li, Michigan State University ; David Todem, Michigan State University

500 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W175c
Adaptive Designs: Interim Decision Making — Contributed Papers
Biopharmaceutical Section
Chair(s): Weili He, Merck
8:35 AM	Unblinded Sample Size Re-Estimation in Bioequivalence Trials with Small Sample Sizes — Sam Hsiao, Cytel ; Lingyun Liu, Cytel
8:50 AM	Multiple Testing Procedures for Adaptive Enrichment Designs: Combining Group Sequential and Reallocation Approaches — Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health ; Tianchen Qian, Johns Hopkins Bloomberg School of Public Health ; Yu Du, Johns Hopkins Bloomberg School of Public Health ; Huitong Qiu, Johns Hopkins Bloomberg School of Public Health ; Aaron Fisher, The Johns Hopkins University
9:05 AM	Blinded Sample Size Re-Estimation in Demonstrating Biosimilarity — Lingyun Liu, Cytel ; Emmanuelle Vincent, Cytel
9:20 AM	Sample Size Re-Estimation in a Two-Stage Cross-Over Trial for Testing for Average Bioequivalence — Byron Jones, Novartis Pharma ; Will Maurer, Novartis Pharma AG ; Ying Chen, Shanghai University of Finance and Economics
9:35 AM	Adaptive Enrichment with Subpopulation Selection at Interim — Xiang Ling, FDA/CDER ; Sue-Jane Wang, FDA ; Kun Jin, FDA/CDER ; Hsien-Ming James Hung, FDA
9:50 AM	Improved Group Sequential Clinical Trial Designs with Multiple Co-Primary Endpoints — Koko Asakura, National Cerebral and Cardiovascular Center ; Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Franz Koenig, Medical University of Vienna ; Martin Posch, Medical University of Vienna
10:05 AM	Arm Dropping in Clinical Trials: An In-Depth Look at Statistical Considerations and Implications — JonDavid Sparks, Eli Lilly and Company ; Brian Millen, Eli Lilly and Company ; Qi Zhang, Eli Lilly and Company

501 * !	Wed, 8/3/2016, 8:30 AM - 10:20 AM	CC-W178b
Analysis of Gene Expression, Genomics, and Next-Generation Sequencing Data — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Cheng Jia, University of Pennsylvania
8:35 AM	Efficient Bayesian Model-Based Clustering Method for Identification of Transcription Factor--Binding Sites for ChIA-PET Data — Ioannis Vardaxis, Norwegian University of Science and Technology ; Bo Henry Lindqvist, Norwegian University of Science and Technology ; Finn Drabløs, Norwegian University of Science and Technology ; Morten Beck Rye, Norwegian University of Science and Technology
8:50 AM	Adaptive Models for Profiling Tumor Evolution and Drug Response in Cancer Cell Subpopulations — Evan Johnson, Boston University
9:05 AM	Detecting EQTLs: A Fast Analysis Protocol Using High-Dimensional Sequencing Data — Kai Kammers, Johns Hopkins Bloomberg School of Public Health ; Ingo Ruczinski, Johns Hopkins Bloomberg School of Public Health ; Margaret A. Taub, Johns Hopkins Bloomberg School of Public Health ; Joshua Martin, The GeneSTAR Program ; Lisa R. Yanek, The GeneSTAR Program ; Lewis Becker, The GeneSTAR Program ; Rasika A. Mathias, The GeneSTAR Program ; Jeffrey Leek, Johns Hopkins Bloomberg School of Public Health
9:20 AM	Analysis of Paired Mitochondrial DNA Data Set by Using Bivariate Poisson Models — Pei-Fang Su, National Cheng Kung University ; Yan Guo, Vanderbilt University ; John D. Boice, National Council on Radiation Protection and Measurements ; Yu Shyr, Vanderbilt University
9:35 AM	BatchQC: Interactive Software Framework for Evaluating Sample and Batch Effects in Genomic Data — Solaiappan Manimaran, Boston University ; Evan Johnson, Boston University
9:50 AM	Dirichlet Process Mixture Model for High-Dimensional Gene Expression Data — Eric Mittman, Iowa State University ; Jarad Niemi, Iowa State University
10:05 AM	A Dirichlet Process Mixture Model for Clustering Longitudinal Gene Expression Data — Jiehuan Sun, Yale University ; Jose D. Herazo-Maya, Yale School of Medicine ; Naftali Kaminski, Yale School of Medicine ; Hongyu Zhao, Yale University ; Joshua Warren, Yale University

528 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W183b
The NSF/NIH/SAMSI Workshop on Interdisciplinary Approaches to Biomedical Data Science Challenges — Topic Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section
Organizer(s): Richard L. Smith, Statistical and Applied Mathematical Sciences Institute
Chair(s): Arni Rao, Augusta University
10:35 AM	The Innovations Lab: A New Model for Research Collaborations — Richard Smith, The University of North Carolina at Chapel Hill
10:55 AM	Interactive Ensemble Clustering for Mixed Data with Application to Mood Disorders — Ellen Eischen, University of Oregon ; David Gotz, The University of North Carolina at Chapel Hill ; Rachael Hageman Blair, University of Buffalo ; Arianna Di Florio, The University of North Carolina at Chapel Hill ; Mathews Jacob, University of Iowa ; Brian Chapman, University of Utah
11:15 AM	Statistical and Dynamical Systems Modeling of Real-Time Adaptive M-Intervention for Pain — Chaeryon Kang, University of Pittsburgh ; Daniel M. Abrams, Northwestern University ; Jingyi (Jessica) Li, University of California at Los Angeles ; Qi Long, Emory University ; Nirmish R. Shah, Duke University
11:35 AM	Using Machine Learning Algorithms for Handling Missingness: Application to Predicting Drug-Disease and Drug-Drug Interactions — Ruoshui Zhai, Brown University ; Roee Gutman, Brown University
11:55 AM	Spatial-Nonspatial Multidimensional Adaptive Radiotherapy Treatment — David Vock, University of Minnesota School of Public Health ; Guadalupe M. Canahuate, University of Iowa ; G.Elisabeta Marai, University of Illinois at Chicago ; C. David Fuller, MD Anderson Cancer Center
12:15 PM	Floor Discussion

529 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W190b
Using Statistics to Understand Health Care Quality: New Methods and Applications — Topic Contributed Papers
Health Policy Statistics Section , Biopharmaceutical Section , Scientific and Public Affairs Advisory Committee , Committee on Applied Statisticians
Organizer(s): Amelia M. Haviland, Carnegie Mellon University
Chair(s): Maria Cuellar, Carnegie Mellon University
10:35 AM	Varying Relationships Between Beneficiary Traits and Quality Measures Affect Comparisons in Medicare Advantage — Laura Anne Hatfield, Harvard Medical School ; Alan M. Zaslavsky, Harvard Medical School
10:55 AM	Insurance Premiums and Patient Experience: Do You Get What You Pay for in Medicare Advantage Plans? — Amelia M. Haviland, Carnegie Mellon University ; Sai MA, Centers for Medicare and Medicaid Services ; Katrin Hambarsoomian, RAND Corporation ; Marc N. Elliott, RAND Corporation
11:15 AM	Extension to the Bayesian Improved Surname Geocoding (BISG) Method — Marc N. Elliott, RAND Corporation ; Amelia M. Haviland, Carnegie Mellon University ; Ann Haas, RAND Corporation ; John Adams, Kaiser Permanente ; Joshua Mallet, RAND Corporation ; Jake Dembosky, RAND Corporation ; Sarah Gaillot, Centers for Medicare and Medicaid Services ; Samuel "Chris" Haffer, Centers for Medicare and Medicaid Services
11:35 AM	Methodological Considerations When Adjusting Quality Measures for Socioeconomic Status — Susan M. Paddock, RAND Corporation ; Melony E. Sorbero, RAND Corporation ; Cheryl L. Damberg, RAND Corporation ; Ann Haas, RAND Corporation ; Marc N. Elliott, RAND Corporation
11:55 AM	Discussant: John Adams, Kaiser Permanente
12:15 PM	Floor Discussion

530 *	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W187a
The Promise and Perils of External Patient-Level Data: Applications in Drug Development — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Greg Hather, Takeda
Chair(s): Ray Liu, Takeda
10:35 AM	Leveraging Individual Patient Data Meta-Analysis to Support a Go or No-Go Decision — Alan Chiang, Eli Lilly and Company ; Ann Cleverly, Eli Lilly and Company
10:55 AM	Boosting the Power of Phase II and III Oncology Studies Using Project Data Sphere — Greg Hather, Takeda ; Ray Liu, Takeda
11:15 AM	Facilitating Clinical Trial Simulation in Alzheimer's Disease Using the CAMD IPD, Literature Summary Level Data, and the 'adsim' R Package — Daniel Polhamus, Metrum Research Group
11:35 AM	Using External Patient Data in Clinical Trial Simulation — Forrest Williamson, Eli Lilly and Company
11:55 AM	Discussant: Jeffry Florian, FDA/CDER
12:15 PM	Floor Discussion

531 *	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W186c
Time-to-Event Models for Studies with Informative Censoring, Truncation, or Drop-Out — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Michael Pennell, The Ohio State University
Chair(s): Brittney Bailey, The Ohio State University
10:35 AM	Bayesian Threshold Regression for Multivariate Current Status Data with Informative Censoring — Michael Pennell, The Ohio State University ; Tao Xiao, Shenzhen University
10:55 AM	Analyzing Semi-Competing Risks Data with Missing Cause of Informative Terminal Event — Hong Zhu, The University of Texas Southwestern Medical Center ; Renke Zhou, Baylor College of Medicine ; Melissa Bondy, Baylor College of Medicine ; Jing Ning, MD Anderson Cancer Center
11:15 AM	Model Diagnostics of a Class of Joint Dynamic Models of Recurrent Competing Risks and a Terminal Event — Piaomu Liu, Bentley University ; Edsel Aldea Pena, University of South Carolina
11:35 AM	Adjusting for Dependent Truncation with Inverse Probability Weighting — Jing Qian, University of Massachusetts - Amherst ; Rebecca Betensky, Harvard
11:55 AM	Joint Partially Linear Model for Longitudinal Data with Informative Drop-Outs — Sehee Kim, University of Michigan ; Donglin Zeng, The University of North Carolina at Chapel Hill ; Jeremy M. G. Taylor, University of Michigan
12:15 PM	Floor Discussion

535 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W183a
Global Challenges and Collaboration in Biopharmaceutical Statistics — Topic Contributed Panel
Biopharmaceutical Section , International Chinese Statistical Association , Committee on Applied Statisticians , Statistics Without Borders , Committee on International Relations in Statistics
Organizer(s): Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center
Chair(s): Geert Molenberghs, Universiteit Hasselt
10:35 AM	Global Challenges and Collaboration in Biopharmaceutical Statistics
Panelists:	Jose Pinheiro, Johnson & Johnson Yuki Ando, Pharmaceutical and Medical Device Agency, Japan Frank Bretz, Novartis Pharma Estelle Russek-Cohen, FDA Abdus S. Wahed, University of Pittsburgh

538 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W186a
Methods for Risk Prediction — Contributed Papers
Biometrics Section , Biopharmaceutical Section , Section on Risk Analysis
Chair(s): Rebecca Scherzer, University of California at San Francisco
10:35 AM	Dynamic Scheduling of the Next Exam in Cancer Screening — Dongfeng Wu, University of Louisville
10:50 AM	Evaluating Probability Forecasts — Shulamith Gross, Baruch College
11:05 AM	Comparisons of Statistical Methods for Determining Gene Expression Signatures to Predict Prostate Cancer Response — Dirk Moore, Rutgers School of Public Health ; Qian Dong, Celgene
11:20 AM	Estimating HIV Relative Risk in India Using CAR Models — Kaushik Ghosh, University of Nevada, Las Vegas ; Chandrasekaran Kandhasamy, National Institute for Research in Tuberculosis
11:35 AM	A Latent-Variable Approach to Derive a Pediatric Cardiac Inotrope Score Associated with Congenital Heart Surgery — Mallikarjuna Rettiganti, University of Arkansas for Medical Sciences ; Avishek Chakraborty, University of Arkansas ; Punkaj Gupta, University of Arkansas for Medical Sciences
11:50 AM	Semiparametric Estimation and Inference for Partial AUC of Biomarkers Subject to Limit of Detection — Lixuan Yin, George Mason University ; Guoqing Diao, George Mason University ; Aiyi Liu, Eunice Kennedy Shriver National Institute of Child Health and Human Development
12:05 PM	Missing Data and Prediction Models — Sarah Fletcher, Vanderbilt University School of Medicine ; Jeffrey David Blume, Vanderbilt University School of Medicine

542 *	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W186b
Semiparametric Methods for Longitudinal and Event Time Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Jing Wang, St. Louis University
10:35 AM	A Semiparametric Joint Model for Terminal Trend of Quality of Life and Survival in Palliative Care Research — Zhigang Li ; H. Rob Frost, Dartmouth College ; Lihui Zhao, Northwestern University ; Lei Liu, Northwestern University ; Kathleen Lyons, Dartmouth College ; Huaihou Chen, University of Florida ; Bernard Cole, University of Vermont ; David Currow, Flinders University ; Marie Bakitas, University of Alabama at Birmingham ; Tor Tosteson, Dartmouth College
10:50 AM	Semiparametric Structural Equation Models with Latent Variables for Right-Censored Data — Kin Yau Wong, The University of North Carolina at Chapel Hill ; Donglin Zeng, The University of North Carolina at Chapel Hill ; Danyu Lin, The University of North Carolina at Chapel Hill
11:05 AM	Classification of Longitudinal Data Using P-Splines and Correlated Mixed-Effects Models Applied to Predict Pregnancy Outcomes — Cristian Meza, Universidad de Valparaiso ; Ana Arribas-Gil, Universidad Carlos III de Madrid ; Rolando De la Cruz, P. Universidad Católica de Valparaíso ; Claudio Fuentes, Oregon State University
11:20 AM	Semiparametric Spatial Model for Interval-Censored Data with Time-Varying Covariate Effect — YUE ZHANG, University of Cincinnati ; Xia Wang, University of Cincinnati ; Bin Zhang, Cincinnati Children's Hospital Medical Center
11:35 AM	Pseudo-Value Method for Ultra-High-Dimensional Semiparametric Models with Life-Time Data — Tony Sit, The Chinese University of Hong Kong
11:50 AM	A Semiparametric Survival Model with a Time-Dependent Cure Process — Sophie Yu-Pu Chen, University of Michigan ; Alex Tsodikov, University of Michigan
12:05 PM	A General Semiparametric Accelerated Failure Time Model Imputation Approach for Censored Covariate — Shengchun Kong, Gilead Sciences ; Ying Ding, University of Pittsburgh ; Shan Kang, Robert Bosch LLC

545 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W184a
Variable Selection and Risk Prediction in Genomics — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Simon Vandekar, University of Pennsylvania
10:35 AM	Multi-Tuning Parameter Lasso for Sample Classification — Kimberly Siegmund, University of Southern California ; Jie Liu, University of Southern California ; Juan Pablo Lewinger, University of Southern California
10:50 AM	A Permanental Approach in Predicting the Relapse Risk of Breast Cancer — Haipeng Liu, University of Illinois at Chicago ; Jie Yang, University of Illinois at Chicago
11:05 AM	Expandable Factor Analysis — Sanvesh Srivastava, University of Iowa ; Barbara E. Engelhardt, Princeton ; David Dunson, Duke University
11:20 AM	Random Forest for Paired Data — Matthew Mitchell, Metabolon ; Jacob Edward Wulff, Metabolon ; Philip Ross Gunst, Metabolon
11:35 AM	Predicting Pathologic Complete Response Using Clinical and Microarray Data in the Presence of a Dominating Class — Jonathon Abernethy, University of Illinois at Chicago ; Jie Yang, University of Illinois at Chicago
11:50 AM	Analysis of Ultra-High-Dimensional Polycystic Ovary Syndrome Genome Using DC-RR — Jill Lundell, Utah State University ; Guifang Fu, Utah State University

546 * !	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W184d
Noninferiority Studies — Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Pilar Lim, Janssen R&D
10:35 AM	Clinical Trial Design of Authorized Biosimilars in Europe — Johanna Mielke, Novartis Pharma AG ; Bernd Jilma, Medical University of Vienna ; Byron Jones, Novartis Pharma ; Franz Koenig, Medical University of Vienna
10:50 AM	Average Inferiority Measure and Standardized Margins to Address Issues in Biosimilar Trials — Gang Li, Johnson & Johnson ; Weichung J. Shih, Rutgers University
11:05 AM	Various Approaches to Calculate 95% CIs of Treatment Difference from a Stratified Noninferiority Trial — Qiaoyang Lu, Astellas Pharma ; Misun Lee, Astellas Pharma
11:20 AM	Bayesian Design of Phase II Noninferiority (NI) Safety Clinical Trial — Lu-May Chiang, Novartis Pharma ; David Ohlssen, Novartis ; Dong Xi, Novartis
11:35 AM	The Role of Multiple Imputation in Noninferiority Trials — Brian Wiens, Portola Pharmaceuticals ; Ilya Lipkovich, Quintiles
11:50 AM	Is It Valid to Claim Superiority in a Noninferiority Trial? — Jitendra Ganju, Global Blood Therapeutics
12:05 PM	Noninferiority Tests for Anti-Infective Drugs Using Control Quantiles — Michael Fay, National Institute of Allergy and Infectious Diseases ; Dean Follmann, National Institute of Allergy and Infectious Diseases

548 *	Wed, 8/3/2016, 10:30 AM - 12:20 PM	CC-W187c
Clinical Trial Monitoring — Contributed Papers
Biopharmaceutical Section
Chair(s): Theodore Lystig, Medtronic
10:35 AM	The Three Pillars of a Successful Data Monitoring Committee Organizational Meeting and Interim Monitoring of a Randomized Clinical Trial and the Eventual Impact on Public Health — Navneet Ram Hakhu, Axio Research
10:50 AM	Group-Sequential Clinical Trials for Comparing Two Interventions Using Two Time-to-Event Outcomes — Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center ; Tomoyuki Sugimoto, Hirosaki University ; Koko Asakura, National Cerebral and Cardiovascular Center ; Scott Evans, Harvard
11:05 AM	Enhanced Conditional Power and Predictive Power Using Auxiliary Information — Libo Sun, Janssen R&D ; Ying Wan, Janssen R&D
11:20 AM	Best Practices for Reporting Adverse Event Data to Data-Monitoring Committees — Hengrui Sun, The University of North Carolina at Chapel Hill ; Kwanhye Jung, The University of North Carolina at Chapel Hill ; Sonia Davis, The University of North Carolina at Chapel Hill
11:35 AM	Statistical Issues for Safety Monitoring of Recurrent Adverse Events in Clinical Trials — LiAn Lin, Merck Research Laboratories ; Greg Ball, Merck Research Laboratories ; William William Wang, Merck Research Laboratories
11:50 AM	Modeling Events and Early Terminations to Predict — John Johnson, PPD
12:05 PM	Collection of Adverse Events Data for the Supplemental Indications in Cancer Clinical Trials: Is It Needed? — Sirisha Mushti, FDA ; Huanyu Chen, FDA ; Yun Wang, FDA ; Rajeshwari Sridhara, FDA

559	Wed, 8/3/2016, 10:30 AM - 11:15 AM	CC-Hall F1 West
SPEED: Statistical Methods for Clinical Trials and Longitudinal Analysis, Part 2A — Contributed Poster Presentations
Biometrics Section , Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
1:	Statistical Inference of Covariate-Adjusted Response-Adaptive Randomized Clinical Trials — Wanying Zhao, The George Washington University
3:	Adaptive Estimation of Personalized Maximum Tolerated Doses in Cancer Phase I Clinical Trials According to All Toxicities and Individual Characteristics — Zhengjia Chen, Emory University ; Zheng Li, Penn State University ; Ying Yuan, MD Anderson Cancer Center ; Michael Kutner, Emory University ; Taofeek Owonikoko, Emory University ; Walter J. Curran, Emory University ; Jeanne Kowalski, Emory University
4:	Small Sample Inference in Imbalanced Cluster Randomized Clinical Trials with Binary Outcomes — Dong Hyun Ahn, New York University ; Judith D. Goldberg, New York University School of Medicine
5:	Robust Generalized Multivariate Bioequivalence — Srinand Ponnathapura Nandakumar, Quintiles
6:	Explore Methodologies for Extrapolation of Efficacy from the Adult to the Specific Pediatric Population — Yao Li, AbbVie ; Bidan Huang, AbbVie
7:	A Clinical Trial Design Based on the Concept of Relative Time Using the Generalized Gamma Ratio Distribution — Milind Phadnis, University of Kansas Medical Center
8:	Improved Methods for the Marginal Analysis of Longitudinal Data in the Presence of Time-Dependent Covariates — I-Chen Chen, University of Kentucky ; Philip Westgate, University of Kentucky
9:	Proportional Likelihood Ratio Mixed Model — Hongqian Wu, University of Iowa ; Michael Jones, University of Iowa
10:	Simultaneous Confidence Intervals for Assessing SNP Effects on Treatment Efficacy — Yushi Liu ; Jason C. Hsu, Eli Lilly and Company/The Ohio State University
The oral portion will take place during Session 213149

562	Wed, 8/3/2016, 11:35 AM - 12:20 PM	CC-Hall F1 West
SPEED: Statistical Methods for Clinical Trials and Longitudinal Analysis, Part 2B — Contributed Poster Presentations
Biometrics Section , Biopharmaceutical Section
Chair(s): Genevera Allen, Rice University
1:	Dangers of Misusing Ordinal Data — Ivy Liu, Victoria University of Wellington ; Daniel Fernandez Martinez, New York University ; Peter Yongqi Gu, Victoria University of Wellington
2:	A Simulation-Based Method for Detecting the Best Treatment in Clinical Trials — Yan Zhao, University of Oklahoma Health Sciences Center ; Roy Tamura, University of South Florida ; Michael Brown, Oklahoma Medical Research Foundation
4:	A Small N Sequential Multiple Assignment Randomized Trial for Use in Rare Disease Research — Roy Tamura, University of South Florida
5:	The Impact of Model Misspecification on Repeated Measures Analysis — Yingmei Xi, Vertex Pharmaceuticals ; John Jiang, Vertex Pharmaceuticals
6:	Correlates of Time to Sexual Debut in 15--19-Year-Olds in the Jamaica Youth Risk and Resiliency Survey 2006: A Survival Analysis — Tamika Royal-Thomas, University of the West Indies ; Novie Younger-Coleman, University of the West Indies ; Jan Van den Broeck, University of Bergen ; Debajyoti Sinha, Florida State University ; Daniel McGee , Florida State University ; Shelly McFarlane, University of the West Indies ; Damian Francis, University of the West Indies ; Rainford Wilks, University of the West Indies
8:	Applying Statistical Design to Improve Target Selection: An Example from Whole-Genome SiRNA Screens — Mandy Bergquist ; Katja Remlinger, GlaxoSmithKline
9:	Good Practices and Implementation Methods for Optimally Stratified Randomization — Jonathan Chipman, Vanderbilt University ; Cole Beck, Vanderbilt University ; Robert Greevy, Vanderbilt University
The oral portion will take place during Session 213149

566	Wed, 8/3/2016, 12:30 PM - 1:50 PM	CC-W375a
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
Organizer(s): Jennifer Gauvin, Novartis
WL11:	Consulting: Building Relationships and Skills — Jason Connor, Berry Consultants
WL12:	Best Practices for Discussing/Negotiating Endpoints, Hypotheses, Sample Size, and Other Study Design Aspects of Clinical Studies with FDA Reviewers — Jennifer Mischke, NAMSA ; Tyson Rogers, NAMSA
WL13:	Challenges Implementing CDISC — William Coar, Axio Research ; Amber Randall, Axio Research

593 * !	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W187b
Batch Effects in Genomics Data — Topic Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Organizer(s): Johann Gagnon-Bartsch, University of Michigan
Chair(s): Johann Gagnon-Bartsch, University of Michigan
2:05 PM	Batch Effects in Network Inference — Claire Ruberman
2:25 PM	Confounder Adjustment in Multiple Hypotheses Testing — Jingshu Wang ; Qingyuan Zhao, Stanford University
2:45 PM	Correction for Confounding Factors in Genome and Epigenome-Wide Association Studies — Jennifer Listgarten, Microsoft Research
3:05 PM	Accounting for Sample Quality and Other Unwanted Effects in Single-Cell RNA-Seq Data — Davide Risso, University of California at Berkeley ; Michael Cole, University of California at Berkeley ; John Ngai, University of California at Berkeley ; Nir Yosef, University of California at Berkeley ; Sandrine Dudoit, University of California at Berkeley
3:25 PM	Batch Effects in Genomics Data — Florian Buettner ; Oliver Stegle, EMBL-European Bioinformatics Institute
3:45 PM	Floor Discussion

596 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W185d
Statistical Challenges in Drug Development in the Era of Immuno-Oncology — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistical Consulting , Committee on Applied Statisticians
Organizer(s): Ji Lin, Eli Lilly and Company
Chair(s): Jingyi Liu, Eli Lilly and Company
2:05 PM	How Many Birds Can Be Killed with One Stone? The KEYNOTE-001 Experience — Cong Chen, Merck ; Nicole Li, Merck ; Jin Zhang, Merck
2:25 PM	Measures of Clinical Benefit in Immuno-Oncology Studies — Luping Zhao ; Pralay Mukhopadhyay, AstraZeneca
2:45 PM	Generalized Pairwise Comparisons for Several Complex Outcome Measures — Marc Buyse
3:05 PM	Combination Studies with Immuno-Oncology Drugs — Jonathan Denne, Eli Lilly and Company ; Yanping Wang, Eli Lilly and Company
3:25 PM	Improved Designs and Analyses of Safety and Efficacy in Immuno-Oncology — Bo Huang, Pfizer ; Margarida Geraldes, Pfizer
3:45 PM	Floor Discussion

597 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W185bc
Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians , Section on Risk Analysis
Organizer(s): Weili He, Merck
Chair(s): Jonathan Norton, MedImmune
2:05 PM	Practical Considerations for Benefit Risk Assessment and Implementation: Vorapaxar TRA-2P TIMI 50 Case Study — Weili He, Merck
2:25 PM	Patient Preference in Benefit-Risk Analysis in Medical Device Trials — Xuefeng Li, FDA
2:45 PM	Benefit-Risk Assessment via Case Studies — George Quartey, Genentech ; Qi Jiang, Amgen ; Weili He, Merck
3:05 PM	Some Consideration on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment in Pharmaceutical Drug Development — Haijun Ma ; Qi Jiang, Amgen
3:25 PM	Discussant: Martin Ho, FDA/CDRH
3:45 PM	Floor Discussion

598 * !	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W175b
Innovative Bayesian Methods in Biostatistics — Topic Contributed Papers
Section on Bayesian Statistical Science , Biopharmaceutical Section , International Society for Bayesian Analysis (ISBA) , International Chinese Statistical Association
Organizer(s): Samiran Sinha, Texas A&M University
Chair(s): Michael Longnecker, Texas A&M University
2:05 PM	Flexible Link Functions in Nonparametric Binary Regression with Gaussian Process Priors — Xia Wang, University of Cincinnati ; Dan Li, University of Cincinnati ; Lizhen Lin, The University of Texas ; Dipak Dey, University of Connecticut
2:25 PM	A Multi-Scale Spatial Model for Stroke Lesion Segmentation — Huiyan Sang, Texas A&M University ; Ciprian Crainiceanu, The Johns Hopkins University ; Elizabeth M. Sweeney, Johns Hopkins Bloomberg School of Public Health ; John Muschelli, The Johns Hopkins University
3:05 PM	Quantile Graphical Models: An Approximate Bayesian Approach — Nilabja Guha, Texas A&M University ; Bani K. Mallick, Texas A&M University
3:25 PM	Floor Discussion

599 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W184a
Bayesian Nonparametric and Semiparametric Methods for Causal Inference — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section , Section on Nonparametric Statistics , International Society for Bayesian Analysis (ISBA) , Section on Bayesian Statistical Science , International Chinese Statistical Association
Organizer(s): Kirsten J. Lum, University of Pennsylvania
Chair(s): Jason Roy, University of Pennsylvania
2:05 PM	Accounting for Uncertainty in Confounder and Effect Modifier Selection When Estimating Average Causal Effects in Generalized Linear Models — Chi Wang, University of Kentucky ; Francesca Dominici, Harvard T.H. Chan School of Public Health ; Giovanni Parmigiani, Dana-Farber Cancer Institute/Harvard T.H. Chan School of Public Health ; Corwin Zigler, Harvard T.H. Chan School of Public Health
2:25 PM	A Dirichlet Process Functional Approach to Heteroscedastic-Consistent Covariance Estimation and Sensitivity Analysis of Causal Effects — George Karabatsos, University of Illinois at Chicago
2:45 PM	A Bayesian Nonparametric Causal Inference Model for Comparative Effectiveness Research — Chenguang Wang, The Johns Hopkins University
3:05 PM	Bayesian Semiparametric Latent Mediation Model — Chanmin Kim, Harvard ; Michael Daniels, The University of Texas at Austin ; Yisheng Li, MD Anderson Cancer Center
3:25 PM	Floor Discussion

603 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W186c
Missing Data Methodology — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Vered Madar, Statistical and Applied Mathematical Sciences Institute
2:05 PM	Testing for Missing Always at Random and Row Exchangeability in Multivariate Data with Missing Values — Iavor Bojinov, Harvard ; Natesh Pillai, Harvard ; Donald B. Rubin, Harvard
2:20 PM	Testing Treatment Effect in Clinical Trials with Patient Dropout Using Latent Mixture Models — Fanhui Kong, FDA ; Yeh-Fong Chen, FDA
2:35 PM	Design of Primary and Sensitivity Analyses for Handling Nonfuture Dependence Missing Data in Clinical Trials with an Emphasis on the Type I Error Rate Using Pattern Mixture Model — Lixian Peng, Celgene ; Weichung J. Shih, Rutgers University
2:50 PM	A Multivariate Selection Model for Cluster-Level Outcome-Dependent Missing Data — Jiebiao Wang, The University of Chicago ; Pei Wang, Icahn School of Medicine at Mount Sinai ; Lin Chen, The University of Chicago
3:20 PM	Missing Data Approaches in Categorical Latent Growth and Multilevel Proportional Odds Models — Karen Traxler, University of Northern Colorado ; Niloofar Ramezani, University of Northern Colorado
3:35 PM	Floor Discussion

607 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W186b
New Frontiers in Survival Analysis, Copula, and Clustered Data — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Usha Govindarajulu, SUNY Downstate
2:05 PM	Latent Promotion Time Cure Rate Model Using Dependent Tail-Free Mixtures — Li Li, University of New Mexico
2:20 PM	Hierarchical Archimedian Copula Models for the Analysis of Familial Binary Data — Yihao Deng, Indiana University Purdue University Fort Wayne
2:35 PM	Improved Computation of Full Data Likelihood Estimates in the Cox Proportional Hazards Model — Xiao Fang, The University of Texas Medical Branch ; Kristofer Jennings, The University of Texas Medical Branch
2:50 PM	Reversed Hazard Parametric Regression Model to Analyze Left-Censored HIV Data — Md Akhtar Hossain, University of South Carolina ; Hrishikesh Chakraborty, University of South Carolina
3:05 PM	Estimation of Rank Correlation for Clustered Data — Bernard Rosner, Harvard Medical School ; Robert Glynn, Harvard Medical School
3:20 PM	Considerations for Analysis of Time-to-Event Outcomes Measured with Error — Eric Oh, University of Pennsylvania ; Pamela A. Shaw, University of Pennsylvania
3:35 PM	Model Validation for Regression with Covariates Subject to Fixed or Random Censoring — Paul Bernhardt, Villanova University

611 * !	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W185a
Missing Data Imputations — Contributed Papers
Biopharmaceutical Section
Chair(s): Isaac Nuamah, Janssen R&D
2:05 PM	Missing Data Imputation in Phase III Study with Time-to-Event Outcome — Gang Jia, Merck ; Paul DeLucca, Merck ; Steven Bird, Merck ; Bruce Binkowitz, Merck ; Weichung J. Shih, Rutgers University
2:20 PM	On the Use of the Treatment Effect in the Imputation Model for Multiple Imputation Analyses of Missing Data — Robert Small, Sanofi Pasteur
2:35 PM	An Extended Kaplan-Meier Estimator for Time-to-Event Data with Informative Censoring — Misun Yu Lee, Astellas Pharma ; Wei Li, Astellas Pharma
2:50 PM	Handling Missing Data in Multiple-Attack Migraine Studies — Kaifeng Lu, Allergan
3:05 PM	Bias Reduction in Logistic Regression with Missing Responses When the Missing-Data Mechanism Is Nonignorable — Vivek Pradhan, Pfizer ; Arnab Maity, Northern Illinois University
3:20 PM	A Simulation Study to Compare Multiple Imputation Methods Under Missing Not-at-Random Assumption — David Li, Pfizer ; Lingfeng Yang, BMS
3:35 PM	Inverse Probability Weighting (IPW) Estimator for Comparing Two Proportions Under Nonignorable Missingness Mechanism — Madan Gopal Kundu, Novartis Oncology

612 *	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W187a
Biopharmaceutical Section Student Papers — Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Richard McNally, Covance
2:05 PM	Multi-Arm Group Sequential Designs with Simultaneous Stopping Rule — Susanne Urach, Medical University of Vienna ; Martin Posch, Medical University of Vienna
2:20 PM	Prediction-Oriented Marker Selection (PROMISE) with Application to High-Dimensional Regression — Soyeon Kim, MD Anderson Cancer Center ; J. Jack Lee, MD Anderson Cancer Center ; Veera Baladandayuthapani, MD Anderson Cancer Center
2:35 PM	Adaptive Dose Modification for Phase I Clinical Trials — Yiyi Chu, The University of Texas School of Public Health ; Haitao Pan, MD Anderson Cancer Center ; Ying Yuan, MD Anderson Cancer Center
2:50 PM	Optimizing Dynamic Treatment Regimes via Quality-Adjusted Q-Learning and Threshold Utility Analysis for Subgroup Analysis in Clinical Trials — Geoffrey Johnson ; Andrew Topp, University of Pittsburgh ; Abdus S. Wahed, University of Pittsburgh
3:05 PM	Evaluating the Effect of Delayed PEG Insertion in Patients Diagnosed with ALS via Adaptive Treatment Length Regimes — Xin Lu, Sanofi ; Brent Johnson, University of Rochester
3:20 PM	Change-Plane Analysis for Subgroup Detection and Sample Size Calculation — Ailin Fan, North Carolina State University ; Rui Song, North Carolina State University ; Wenbin Lu, North Carolina State University
3:35 PM	Estimating Individualized Treatment Rules for Ordinal Treatments — Jingxiang Chen ; Yufeng Liu, The University of North Carolina at Chapel Hill ; Michael R. Kosorok, The University of North Carolina at Chapel Hill ; Haoda Fu, Eli Lilly and Company ; Xuanyao He, Eli Lilly and Company

615	Wed, 8/3/2016, 2:00 PM - 3:50 PM	CC-W186a
Methods for Analyzing High-Dimensional Sequencing Data — Contributed Papers
ENAR , Biopharmaceutical Section
Chair(s): Shengchun Kong, Gilead Sciences
2:05 PM	Simulation Studies for Comparison of Gene-Based Association Tests — Hung-Chih Ku, DePaul University ; Chao Xing, The University of Texas Southwestern Medical Center
2:20 PM	Geometrical and Symbolic Transformation of Sequential Data — Rainhard Bengez
2:35 PM	Flexible Prior Specification Through Empirical Reparameterization in Hierarchical Models for RNA-Seq Experiments — Andrew Lithio, Iowa State University ; Dan Nettleton, Iowa State University
2:50 PM	Identify Host Genetic Variants Associated with Microbiome Composition in Large-Scale Studies — Jianxin Shi, National Cancer Institute ; Xing Hua, National Cancer Institute
3:05 PM	Conditional Inference for the Kernel Association Tests — Kai Wang, University of Iowa
3:20 PM	Cross-Validated STEPP Analysis for Biomarker Subgroup Determination Problems — Gu Mi, Eli Lilly and Company ; Tuan Stevon Nguyen, Eli Lilly and Company ; Jonathan Denne, Eli Lilly and Company
3:35 PM	Floor Discussion

639 * !	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W184bc
Development and Application of Practical and Advanced Dose-Finding Designs — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yuan Ji, NorthShore University HealthSystem
Chair(s): Sue-Jane Wang, FDA
8:35 AM	Practical Considerations for the Implementation of the Modified Toxicity Probability Interval (MTPI) Design and Associated Change Management — Erik Pulkstenis, MedImmune
8:55 AM	A Flexible Model for Dose Escalation in Phase I Trials — Ying Lu, Palo Alto VA Health Care System/Stanford University ; Shenghua Kelly Fan, California State University at East Bay ; Bee Leng Lee, San Jose State University ; Yanyan Song, Shanghai Jiao Tong University
9:15 AM	Toxicity and Efficacy Probability Intervals Design for Phase I Dose Finding in Oncology Trials — Daniel He Li, Juno Therapeutics ; Jim Whitmore, Juno Therapeutics ; Yuan Ji, NorthShore University HealthSystem
9:35 AM	Optimal Design for Dose-Finding Study with Delayed Responses — Min Yang, University of Illinois at Chicago ; Tian Tian, University of Illinois at Chicago
9:55 AM	Discussant: Milan Stehlik, University of Valparaiso, Chile and Johannes Kepler University, Austria
10:15 AM	Floor Discussion

641 * !	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W180
Advancing Precision Medicine Using Innovative Subgroup Identification Methods — Topic Contributed Papers
Section on Statistical Learning and Data Science , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Qi Tang, AbbVie
Chair(s): Richard A. Rode, AbbVie
8:35 AM	Use of the VG (Virtual Twins Combined with GUIDE) Method in the Development of Precision Medicines — Jia Jia ; Qi Tang, AbbVie ; Wangang Xie, AbbVie ; Richard A. Rode, AbbVie
8:55 AM	Comparison of Some Subgroup Identification Algorithms for Precision Medicine in Drug Development — Xin Huang ; Yan Sun, AbbVie ; Saptarshi Chatterjee, AbbVie ; Viswanath Devanarayan, AbbVie
9:15 AM	Subgroup Identification Based on Multiple Outcomes — Chensheng Kuang, University of Wisconsin - Madison ; Menggang Yu, University of Wisconsin - Madison ; Sijian Wang, University of Wisconsin - Madison
9:35 AM	Development of Predictive Signature to Identify Patient Subgroups with Differential Treatment Effect — Yu-Chuan Chen ; James Chen, FDA/NCTR ; Un Jung Lee, FDA/NCTR
9:55 AM	Subgroup Identification in a Learn-and-Confirm Setting — Lei Shen, Eli Lilly and Company
10:15 AM	Floor Discussion

644 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W186c
Integrative Approaches for Genomics Data — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Marinela Capanu, Memorial Sloan Kettering Cancer Center
Chair(s): Marinela Capanu, Memorial Sloan Kettering Cancer Center
8:35 AM	Meta-Analysis for Discovering Rare-Variant Associations — Zheng-Zheng Tang, Vanderbilt University
8:55 AM	Integrative Analysis of Sequencing and Array Genotype Data for Discovering Disease Associations with Rare Mutations — Yijuan Hu, Emory University ; Yun Li, The University of North Carolina at Chapel Hill ; Paul Auer, University of Wisconsin - Milwaukee ; Danyu Lin, The University of North Carolina at Chapel Hill
9:15 AM	Pedigree-Based Imputation from Sequencing Data and Its Applications — Dan Nicolae, The University of Chicago
9:35 AM	Integrated Analysis of Germline, Omic, and Disease Data — David Conti, University of Southern California ; Zhao Yang, University of Southern California ; Duncan Thomas, University of Southern California
9:55 AM	Discussant: Colin Begg, Memorial Sloan Kettering Cancer Center
10:15 AM	Floor Discussion

646 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W187c
Multiplicity in Diagnostic Device Development and Validation — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Section on Statistics in Imaging
Organizer(s): Gene Pennello, FDA/CDRH/OSB/DBS
Chair(s): Alicia Y. Toledano, Biostatistics Consulting, LLC
8:35 AM	Identifying Optimal Approaches to Early Termination in Two-Stage Biomarker Validation Studies — Alexander Kaizer, University of Minnesota ; Joseph S. Koopmeiners, University of Minnesota
8:55 AM	Statistical Considerations in Evaluating Radiological Imaging Devices in FDA/CDRH — Qin Li, FDA/CDRH
9:15 AM	Different Success Criteria in the Performance Evaluation of Diagnostic Devices — Norberto Pantoja-Galicia, FDA/CDRH ; Gene Pennello, FDA/CDRH/OSB/DBS
9:35 AM	Creating a Biomarker Signature for a Companion Diagnostic Using Bootstrapping and Aggregating Thresholds from Tree-Based Models — Raj Chandran
9:55 AM	Multiple Endpoint Evaluation in Diagnostic Medical Imaging: Analyses, Labeling, and Claims — Camille Vidal, GE Healthcare
10:15 AM	Floor Discussion

648 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W183a
Outside the Closed Door: Industry Statisticians Discuss the DMC Process — Topic Contributed Panel
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): David Kerr, Axio Research
Chair(s): David Kerr, Axio Research
8:35 AM	Outside the Closed Door: Industry Statisticians Discuss the DMC Process
Panelists:	Paul Gallo, Novartis Walt Offen, AbbVie Markus Abt, Roche/Genentech Gordon Sun, BioMarin Gary Aras, Amgen
8:55 AM	Floor Discussion

649 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W186a
Clustering, Classification, and Dimension Reduction Techniques — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Susheela Singh, North Carolina State University
8:35 AM	Integrative Subtype Analysis of Ovarian Cancer Using Non-Negative Matrix Factorization — Prabhakar Chalise, University of Kansas Medical Center ; Ellen L. Goode, Mayo Clinic ; Brooke L. Fridley, University of Kansas Medical Center
8:50 AM	Dynamic Functional Classification and Clustering — J. Richard Landis, University of Pennsylvania ; Wensheng Guo, University of Pennsylvania Perelman School of Medicine ; Xiaoling Hou, University of Pennsylvania
9:05 AM	Clustering with Non-Convex Penalized Gaussian Graphical Models for Simultaneous Parameter Estimation and Pursuit of Sparseness — Chen Gao, University of Minnesota ; Wei Pan, University of Minnesota ; Xiaotong Shen, University of Minnesota ; Yunzhang Zhu, The Ohio State University
9:20 AM	Methods for Joint Clustering of Longitudinal HIV Biomarker Trajectories in the Presence of Missing and Censored Observations — Miranda Lynch, University of Connecticut Health Center ; Marianna Baum, Florida International University ; Vladimir Novitsky, Harvard T.H. Chan School of Public Health ; Victor De Gruttola, Harvard
9:35 AM	Classification of Multivariate Time Series Data with Applications to ECIS — Laura Tupper, Cornell University ; David Matteson, Cornell University
9:50 AM	Classification of Mixed Binary Outcomes Using Biomarker Information — Feng-Chang Lin, The University of North Carolina at Chapel Hill ; Quefeng Li, The University of North Carolina at Chapel Hill
10:05 AM	Optimal Decision Rule for Multiple Biomarkers Combined as Tree-Based Classifiers — Yuxin Zhu, The Johns Hopkins University ; Mei-Cheng Wang, The Johns Hopkins University

653	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W185a
Longitudinal and Survival Analysis in Observational Studies — Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section
Chair(s): Sujuan Gao, Indiana University
8:35 AM	Joint Modeling of Longitudinal Cognitive Responses and Survival Time in an Alzheimer's Disease Cohort Study — Eveleen Darby, Baylor College of Medicine ; Wenyaw Chan, The University of Texas Health Science Center at Houston ; Elaine Symanski, The University of Texas Health Science Center at Houston ; Rachelle S. Doody, Baylor College of Medicine
8:50 AM	Clustering Alzheimer's Patients into 'Syndrome Groups' Using Longitudinal Biomarker and Cognitive Trajectories — Teresa Filshtein, University of California at Davis ; Laurel A. Beckett, University of California at Davis
9:05 AM	A Hidden Markov Model Approach to Analyzing Longitudinal Alzheimer's Disease Stages Subject to Possible Misclassification — Julia Benoit, University of Houston ; Wenyaw Chan, The University of Texas Health Science Center at Houston ; Linda Piller, The University of Texas Health Science Center at Houston ; Rachelle S. Doody, Baylor College of Medicine
9:20 AM	Predicting Alzheimer's Disease with Mixture of Regression Modeling — Frank Appiah ; David Fardo, University of Kentucky ; Erin L. Abner, University of Kentucky ; Glen Mays, University of Kentucky ; Richard Charnigo, University of Kentucky
9:50 AM	Clustering Longitudinal Unbalanced Data: An Application to the Early Childhood Growth Pattern — Md Hossain, Nemours Biomedical Research, A.I. DuPont Children's Hospital
10:05 AM	Prediction of Invasive Group A Streptococcus Infections in Non-ABCs Areas in the United States — Yongping Hao, CDC

654 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W186b
Survival Analysis with Health Applications — Contributed Papers
Biometrics Section , Biopharmaceutical Section
Chair(s): Jack Follis, University of St. Thomas
8:35 AM	Attributable Excess Time Function for Censored Time-to-Event — Yixin Wang, Fred Hutchinson Cancer Research Center ; Ying Qing Chen, Fred Hutchinson Cancer Research Center
8:50 AM	The Reflected-Shifted-Truncated Gamma Distribution with Application to Left-Skewed Survival Data — Sophia Waymyers, University of South Carolina ; Hrishikesh Chakraborty, University of South Carolina ; Sanku Dey, St. Anthony's College
9:05 AM	A New Estimator of Baseline Hazard Function in Bivariate Frailty Models — Antai Wang, New Jersey Institute of Technology ; Xieyang Jia, New Jersey Institute of Technology
9:20 AM	Two-Step Parsimonious Variable Selection for Right-Censored Survival Time Models — Anju Menon, University of Wyoming ; A. Gregory DiRienzo
9:35 AM	Subgroup Identification and Sample-Size Calculation for the Proportional Hazard Model — Suhyun Kang, North Carolina State University ; Wenbin Lu, North Carolina State University
9:50 AM	Efficient Methods for Fitting Bayesian Semiparametric Models to Partly Interval-Censored Data — Haiming Zhou, Northern Illinois University ; Timothy Hanson, University of South Carolina
10:05 AM	Generalized Estimating Equations for Restricted Mean Survival Time Under General Censoring Mechanisms — Xin Wang, University of Michigan ; Douglas Schaubel, University of Michigan

657 * !	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W185d
Statistical Methods for Integration of Omics Data — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Xinglei Chai, University of Pennsylvania
8:35 AM	An Analysis of Variation-Based Procedure for PCA on Multiple Groups — Zi Yang, University of Michigan ; George Michailidis, University of Florida
8:50 AM	Quadratically Regularized Functional Canonical Correlation Analysis and Its Application to Genetic Pleiotropic Analysis of Multiple Phenotypes — Nan Lin ; Yun Zhu, Tulane University ; Fen Peng, The University of Texas Health Science Center at Houston ; Jinying Zhao, Tulane University ; Momiao Xiong, The University of Texas Health Science Center at Houston
9:05 AM	Locally Adaptive Bayesian Nonparametric Inference for Phylodynamics — James R. Faulkner, University of Washington ; Vladimir Minin, University of Washington
9:20 AM	Improved Environmental Modeling in Statistical Genetics and Genomics — Claus Ekstrom, University of Copenhagen
9:35 AM	The Functional False Discovery Rate Methodology and Applications to Genomics — Xiongzhi Chen, Princeton ; David G. Robinson, Stack Overflow ; John D. Storey, Princeton
9:50 AM	Floor Discussion

658 *	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W187a
Statistical Learning in Various Areas of Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Ugochi A. Emeribe, AstraZeneca
8:35 AM	Is Q-Learning a Valid Method of Knowing? — Francisco Diaz, University of Kansas Medical Center
8:50 AM	Finding Common Support for Causal Inference Through Largest Connected Components — Sharif Mahmood, Kansas State University ; Michael Higgins, Kansas State University
9:05 AM	Application of Classification and Clustering Methods on MVoC (Medical Voice of Customer) Data for Scientific Engagement — Yingzi Xu, North Carolina State University ; Jeffery Painter, GlaxoSmithKline
9:20 AM	Imaging Information Chaos: The Consequences of More Complete Imaging and Less Complete Understanding — David Raunig, ICON Medical Imaging
9:35 AM	A Versatile Multi-Domain Test with Adaptive Weighting — Yang Zhao, Sanofi Genzyme ; Stephen Lake, Sanofi Genzyme
9:50 AM	Patient Subgroup Identification in Clinical Trials Where Overall Treatment Response Is Suboptimal — Isaac Nuamah, Janssen R&D ; Youping Huang, Janssen R&D
10:05 AM	Deconstructing the Measure of Vaccine Efficacy Against Disease Irrespective of HPV in HPV Vaccine Clinical Trials — Oliver Bautista, Merck ; Alain Luxembourg, Merck

660 * !	Thu, 8/4/2016, 8:30 AM - 10:20 AM	CC-W184a
Deep Dive: Exploring Testing Procedures in the Biopharmaceutical Statistician's Toolbox — Contributed Papers
Biopharmaceutical Section , Royal Statistical Society
Chair(s): Thomas Kelleher, Bristol-Myers Squibb
8:35 AM	Efficient Study Designs in Clinical Research — Steven Julious, University of Sheffield
8:50 AM	Statistical Testing in the Presence of Nonproportional Hazards — Amarjot Kaur, Merck ; Yabing Mai, Merck Research Laboratories ; Ziliang Li, MRL ; Xia Xu, MRL ; Wen-Chi Wu, MRL
9:05 AM	The Impact of Sensitivity and Specificity of Case Definition on Vaccine Efficacy Trial Design — Xiaohua Sheng, Sanofi Pasteur ; Steven Self, Fred Hutchinson Cancer Research Center ; Ehab Bassily, Sanofi Pasteur ; Joshua Chen, Sanofi Pasteur
9:20 AM	Evaluation of Logistic and Cox Regression Models Using Simulated Survival Data and Clinical Practice Research Datalink — Jessica Kim , FDA ; Chenyi Pan, University of Virginia ; Clara Y. Kim, FDA/CDER ; Esther Zhou, FDA/CDER
9:35 AM	Challenges in Disease Prevention Studies That Utilize Continuous Diagnostic Endpoints — Norman Bohidar, Johnson & Johnson ; George Capuano, Johnson & Johnson
9:50 AM	Why the Likelihood Ratio Test Is Inappropriate to Test Dose-Response and Sharing of Information Among Antibody Therapies for Dose Selection — Russell Reeve, Quintiles
10:05 AM	Asymmetric Margins for Equivalence Tests — Somesh Chattopadhyay

682 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W186a
Modern Inference for Selected Models — Topic Contributed Papers
ENAR , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Yuval Benjamini, Hebrew University
Chair(s): Nancy Zhang, University of Pennsylvania
10:35 AM	Adaptive Sequential Model Selection — William Fithian, University of California at Berkeley ; Jonathan Taylor, Stanford University ; Robert Tibshirani, Stanford University ; Ryan Tibshirani, Carnegie Mellon University
10:55 AM	Measuring Bumps: Intervals for Effect Size of Selected Regions in Genomic Signal — Yuval Benjamini, Hebrew University ; Rafael A. Irizarry, Dana-Farber Cancer Institute ; Jonathan Taylor, Stanford University
11:15 AM	Selection-Adjusted Bayesian Inference in the Linear Model — Asaf Weinstein ; Jonathan Taylor, Stanford University ; Snigdha Panigrahi, Stanford University
11:35 AM	No Assumptions? No Problem! — Ryan Tibshirani, Carnegie Mellon University ; Sangwon Hyun, Carnegie Mellon University
11:55 AM	Floor Discussion

685 *	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W185d
Integrated Analysis of Transcriptomics Data in Drug Discovery: The QSTAR Framework — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Ziv Shkedy, Hasselt University
Chair(s): Bruce Basson, Quintiles
10:35 AM	Introduction to the QSTAR Modeling Framework in Drug Discovery — Willem Talloen, Janssen ; Hinrich Göhlmann, Janssen
10:55 AM	Multiple Factor Analysis for QSTAR Data Integration — Nolen Joy Parualila, Hasselt University
11:15 AM	Construction of Genetic Biomarkers in Drug Discovery Experiments Using Joint Modeling Methods — Ziv Shkedy, Hasselt University
11:35 AM	Integrated Analysis Based on Cluster Analysis and Analysis of Differential Expression — Adetayo Kasim, Durham University
11:55 AM	Discussant: Javier Cabrera, Rutgers University
12:15 PM	Floor Discussion

687 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W185bc
The Power of Historical Data-Borrowing Methods in Increasing Clinical Trial Efficiencies — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Qi Tang, AbbVie
Chair(s): Ran Liu, AbbVie
10:35 AM	Covariate-Adjusted Borrowing of Historical Data for Clinical Development — John Zhong, Biogen ; Baoguang Han, Biogen ; Peng Sun, Biogen ; Stacy Lindborg, Biogen ; Guochen Song, Quintiles
10:55 AM	Utilization of Historical Patient-Level Data for Efficient Trial Design — Zachary Thomas, Eli Lilly and Company ; Tianle Hu, Eli Lilly and Company ; Nathan Enas, Eli Lilly and Company ; Honglu Liu, Eli Lilly and Company
11:15 AM	Using Clustered Historical Borrowing in Clinical Trials — Michelle Detry, Berry Consultants ; Kert Viele, Berry Consultants
11:35 AM	Use of Co-Data in Clinical Trials with Time-to-Event Endpoint — Satrajit Roychoudhury, Novartis
11:55 AM	How to Decide When to Borrow Historical Data for a Clinical Trial — Qi Tang, AbbVie ; Martin King, AbbVie ; Ran Liu, AbbVie ; Bo Fu, AbbVie ; Sandra Lovell, AbbVie ; Alan Hartford, AbbVie
12:15 PM	Floor Discussion

688	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W193a
Personalized Intervention Based on Health Care Big Data Research — Topic Contributed Papers
Health Policy Statistics Section , Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Douglas Faries, Eli Lilly and Company
Chair(s): Douglas Faries, Eli Lilly and Company
10:35 AM	Build Individualized Treatment Rule on Scale Using Health Care Data with Genomic Information — Jin Zhou, University of Arizona ; Haoda Fu ; Kevin Doubleday, University of Arizona
10:55 AM	Multicategory Personalized Treatment Rule with Application to Diabetes Data Analysis — Xuanyao He, Eli Lilly and Company ; Haoda Fu
11:15 AM	Optimal Treatment Regime in Inhomogeneous Data — Chengchun Shi, North Carolina State University
11:35 AM	On the Impact of Informative Nonresponse in Logistic Regression — Joanna Wang, University of Technology Sydney
11:55 AM	Floor Discussion

689 *	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W184d
Recent Developments in Restricted Mean Survival Time — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Lihui Zhao, Northwestern University
Chair(s): Lei Liu, Northwestern University
10:35 AM	Restricted Mean Survival Time: Does Covariate Adjustment Improve Precision in Randomized Clinical Trials? — Theodore Karrison, The University of Chicago ; Masha Kocherginsky, The University of Chicago
10:55 AM	Issues of Conventional Meta-Analysis for Time-to-Event Outcomes Using Reported Hazard Ratios or Relative Risks from Independent Studies — Hajime Uno, Dana-Farber Cancer Institute ; Masayuki Kaneko, Kitasato University
11:15 AM	Estimating the Optimal Treatment Regime for Time-to-Event Data — Min Zhang, University of Michigan ; Baqun Zhang, Renmin University of China
11:35 AM	Restricted Mean Event Time in the Presence of Multiple Endpoints — Lihui Zhao, Northwestern University ; Lu Tian, Stanford University ; Lee-Jen Wei, Harvard
11:55 AM	Discussant: Lu Tian, Stanford University
12:15 PM	Floor Discussion

690 *	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W193b
Working with Statistically Trained Nonstatistician Scientists: Conflicts and Possible Resolutions — Topic Contributed Papers
Section on Teaching of Statistics in the Health Sciences , Pharmacometrics Interest Group , Biopharmaceutical Section
Organizer(s): Alan Hartford, AbbVie
Chair(s): Alan Hartford, AbbVie
10:35 AM	I Was a Statistician Before I Was a Pharmacometrician, I Swear! — Kevin Dykstra, Qpharmetra
10:55 AM	Statistics for Nonstatisticians: A Mixed Bag Is Better Than a String Bag — Felicity Enders, Mayo Clinic
11:15 AM	Overlap Between Statisticians and Pharmacometricians in Clinical Drug Development: Conflicts and Possible Resolutions — Ken Kowalski, Kowalski PMetrics Consulting
11:35 AM	How to Train Both Statisticians and Nonstatisticians, Including Pharmacokineticists and Pharmacometricians, to Develop a Good Consulting Environment — Balakrishna Hosmane, Northern Illinois University (Retired)
11:55 AM	Discussant: Heather Bush, University of Kentucky
11:55 AM	Floor Discussion

696 *	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W184a
Novel Applications of Statistical Methods to Epidemiologic Data — Contributed Papers
Section on Statistics in Epidemiology , Biopharmaceutical Section
Chair(s): Allen Heller, University of Southern California
10:35 AM	Longitudinal Study of NHDS Data Using NFCA for Aging Population — Junheng Ma, Case Western Reserve University ; Jiayang Sun, Case Western Reserve University ; Neal Dawson, Case Western Reserve University/MetroHealth Medical Center
10:50 AM	Better Use of Family History Data to Predict Breast Cancer Risk — Shanshan Zhao, National Institute of Environmental Health Sciences ; Clare Weinberg, National Institute of Environmental Health Sciences ; Yue Jiang, The University of North Carolina at Chapel Hill
11:05 AM	Projected Outcomes of Six-Month Delay in Exception Points vs. an Equivalent MELD Score for HCC Liver Transplant Candidates — Guy N. Brock, The Ohio State University ; Douglas J. Lorenz, University of Louisville ; Sarah K. Alver, University of Louisville ; Michael R. Marvin, Geisinger Medical Center
11:20 AM	Comparing Results from Two National Surveys: How Survey Methodologies May Influence the Observed Association Between Physical Activity and Diabetes by Mobility Disability Status — Qing Zhang, CDC/NCBDDD ; Dianna D. Carroll, CDC
11:35 AM	Projection of Acute Gastroenteritis Illness Rates on Cruise Ships in the United States Through 2050 — Shailendra Banerjee, CDC ; Amy L. Freeland, CDC
11:50 AM	Distinguishing Hospital Performance Using Health Care--Associated Infection Survival Functions — Jonathan R. Edwards, CDC
12:05 PM	Alcohol Consumption, BMI, and Colorectal Cancer — Negasi Beyene, CDC/NCHS

698 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W186c
New Challenges in Complex Data Modeling II — Contributed Papers
Biometrics Section , Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Gu Mi, Eli Lilly and Company
10:35 AM	Inference of an Additive Transient Binding Model — Jason Bernstein
10:50 AM	Stable Balancing Weights for Marginal Structural Models — Maria de los Angeles Resa Juarez, Columbia University ; Jose Zubizarreta, Columbia University
11:05 AM	Constrained Inference for Double Cone Alternatives — Xuechan Li, Duke University ; Janice McCarthy, Duke University ; Zhiguo Li, Duke University ; Andrew Allen, Duke University ; Kouros Owzar, Duke University
11:20 AM	An Instrumental Variable Approach to Generalizing Experimental Results — Chaitra Nagaraja, Fordham University ; Dylan Small, University of Pennsylvania
11:35 AM	A Factor Analysis Model for Estimating the Structure of Related Covariance Matrices — Teal Guidici ; George Michailidis, University of Florida
11:50 AM	Quantification of Imbalances in Baseline Covariates in Observational Studies — Adin-Cristian Andrei, Northwestern University
12:05 PM	Floor Discussion

699 !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W187a
General Methodology and Applications in Biostatistics — Contributed Papers
Biometrics Section , Biopharmaceutical Section , Section for Statistical Programmers and Analysts
Chair(s): Mallikarjuna Rettiganti, University of Arkansas for Medical Sciences
10:35 AM	False Discovery Rate Control for Identifying Simultaneous Signals — Sihai Zhao, University of Illinois at Urbana-Champaign
10:50 AM	Pearson's Chi-Square Test and Rank Correlation Inferences for Clustered Data — Joanna Shih, National Cancer Institute ; Michael Fay, National Institute of Allergy and Infectious Diseases
11:05 AM	Increasing the Power of the Mann-Whitney Test in Randomized Experiments Through Flexible Covariate Adjustment — Karel Vermeulen, Ghent University ; Olivier Thas, Ghent University ; Stijn Vansteelandt, Ghent University
11:20 AM	Power Calculations for Statistics Based on Orthogonal Components of Pearson's Chi-Square — Maduranga Dassanayake, Arizona State University ; Mark Reiser, Arizona State University
11:35 AM	Covariate-Adjusted ROC Analysis Using Covariate Balancing Propensity Score — Seungbong Han, Gachon University
11:50 AM	HIV kit lot related shifts in RNA using external control samples: the Virology Quality Assurance Program — Daniel Zaccaro, RTI International ; Amy Couzens, RTI International ; Donald Brambilla, RTI International ; Cheryl Jennings, Rush University Medical Center ; James Bremer, Rush University Medical Center
12:05 PM	Floor Discussion

700 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W187b
Survival Data: New Directions — Contributed Papers
Biometrics Section , Biopharmaceutical Section , Statistics Without Borders
Chair(s): Shouhao Zhou, MD Anderson Cancer Center
10:35 AM	Concordance Index for Composite Disease Outcomes — Li Cheung, The George Washington University ; Qing Pan, The George Washington University ; Hormuzd Katki, National Cancer Institute
10:50 AM	Study Design for Interval-Censored Outcomes — Yibai Zhao, University of Massachusetts - Amherst ; Xiangdong Gu, University of Massachusetts - Amherst ; Raji Balasubramanian, University of Massachusetts - Amherst
11:05 AM	Sample Size Methods for Validating Treatment Selection Cancer Biomarkers from Right-Censored Survival Data — Kevin Dobbin, University of Georgia ; Lisa M. McShane, National Cancer Institute
11:20 AM	An Empirical Saddlepoint Approximation--Based Method for Smoothing Survival Functions Under Right Censoring — Pratheepa Jeganathan, Texas Tech University ; Alexandre Trindade, Texas Tech University ; Robert Paige, Missouri University of Science and Technology
11:35 AM	How to Control for Unmeasured Confounding in an Observational Time-to-Event Study with Exposure Incidence Information: The Treatment Choice Cox Model — James Troendle, National Institutes of Health ; Zhiwei Zhang, FDA/CDRH ; Eric Leifer, National Heart, Lung, and Blood Institute ; Song Yang, National Heart, Lung, and Blood Institute ; Michael Sklar, University of Pennsylvania ; Heather Jerry, Nebraska Department of Health and Human Services
11:50 AM	On Propensity Score Weighting Approaches to Observational Studies with Survival Outcome — Huzhang Mao ; Liang Li, MD Anderson Cancer Center
12:05 PM	Estimating Mortality Hazard Ratios Using Cross-Sectional Data from Maternal Birth Histories — Philimon Gona, University of Massachusetts ; Janet Dzangare, Ministry of Health and Child Welfare ; Vasco Chikwasha, University of Zimbabwe College of Health Sciences ; Sowmya Rao, Boston University

702 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W186b
Longitudinal Analysis in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Chris Barker, Statistical Planning and Analysis Services
10:35 AM	Bayesian Joint Modeling of Longitudinal Data on Frequency and Intensity of Drinking in Alcoholism Trials — Eugenia Buta, Yale University ; Stephanie O'Malley, Yale University ; Ralitza Gueorguieva, Yale University
10:50 AM	Individualizing Drug Dosage with Longitudinal Data — Xiaolu Zhu, University of Illinois at Urbana-Champaign ; Annie Qu, University of Illinois at Urbana-Champaign
11:05 AM	Population-Averaged Model Versus Subject-Specific Model in the Longitudinal Binary Data Analysis — Hua Li, Novartis ; Biswajit Sen , Novartis ; David Ohlssen, Novartis
11:20 AM	Using the Latent Correlations to Measure the Association Between Continuous and Binary Markers with Repeated Measurements — Dai Feng, Merck ; Vladimir Svetnik, Merck
11:35 AM	Improved Power in Crossover Designs Through Linear Combinations of Baselines — Thomas Jemielita ; Mary Putt, University of Pennsylvania ; Devan V. Mehrotra, Merck
11:50 AM	On Analysis of Longitudinal Clinical Trials with Missing Data Using Reference-Based Imputation — Lei Pang, Merck ; Guanghan Liu, Merck Research Laboratories
12:05 PM	A Comparison of Model-Based and Data-Driven Methods for Clustering of Multivariate Longitudinal Data — Dawei Liu, Biogen ; Ih Chang, Biogen ; Donald Johns, Biogen ; Stacy Lindborg, Biogen

703 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W183c
Novel Approaches for Large-Scale Genetic Association Studies — Contributed Papers
Section on Statistics in Genomics and Genetics , Biopharmaceutical Section
Chair(s): Weiqiang Zhou, Johns Hopkins Bloomberg School of Public Health
10:35 AM	SNP-Set Tests Using Generalized Berk-Jones Statistics in Genetic Association Studies — Ryan Sun, Harvard ; Xihong Lin, Harvard T.H. Chan School of Public Health
10:50 AM	A Genomically Informed High-Dimensional Predictor for Microbial Community Metabolic Profiles — Himel Mallick, Harvard ; Eric Franzosa, Harvard ; Lauren Mclver, Harvard ; Soumya Banerjee, Harvard ; Alexandra Sirota-Madi, Broad Institute ; Aleksandar Kostic, Broad Institute ; Clary B. Clish, Broad Institute ; Hera Vlamakis, Broad Institute ; Ramnik Xavier, Broad Institute ; Curtis Huttenhower, Harvard
11:05 AM	Multiplicity-Adjusted Evidence Weights for Characterizing Associations of Phenotypes with Genotypes — Wenjian Bi ; Stanley Pounds, St. Jude Children's Research Hospital ; Guolian Kang, St. Jude Children's Research Hospital
11:20 AM	A Clustering Algorithm for Human Genetic Data — Jae Brodsky, Thermo Fisher Scientific ; Teresa Webster, Thermo Fisher Scientific ; Dorothy Oliver, Thermo Fisher Scientific ; Jeremy Gollub, Thermo Fisher Scientific ; Barry Eynon, Thermo Fisher Scientific
11:35 AM	Integrated Analysis of Cell Survival Data with Family-Based Genetic Studies to Treat Neurodegenerative Diseases — Daisy Philtron, Penn State University
12:05 PM	Modeling Maternal-Offspring Gene-Gene Interactions at Multiple Loci Using the Quantitative-MFG Test with an Application to Human Birth Weight — Michelle M. Clark, University of California at Los Angeles ; Olympe Chazara, University of Cambridge ; Eric M. Sobel, University of California at Los Angeles ; Ashley Moffett, University of Cambridge ; Janet S. Sinsheimer, University of California at Los Angeles

704 * !	Thu, 8/4/2016, 10:30 AM - 12:20 PM	CC-W185a
Topics in Late-Phase Clinical Trial Research: Randomization, Group Sequential Designs, and Comparing Adverse Event Profiles — Contributed Papers
Biopharmaceutical Section
Chair(s): Katherine Monti, Rho
10:35 AM	A Class of Semiparametric Models in Analysis of Adverse Events in Drug Safety — Richard Entsuah, Merck
10:50 AM	Defensive Efficacy Interim Design: Dynamic Benefit/Risk Ratio View Using Probability of Success — Zhongwen Tang, Novartis
11:05 AM	Comparison Beyond Power: Sample Size Re-Estimation vs. Group Sequential Design — Lei Shu, Astellas Pharma ; Charles Liu, Astellas Pharma ; Matt Rosales, Astellas Pharma
11:20 AM	Multiple Comparisons in Truncated Group Sequential Experiments with Applications in Clinical Trials — Tian Zhao
11:35 AM	Joint Modeling of Time-to-Event and Laboratory Test Data — Kao-Tai Tsai
11:50 AM	Properties of the Blocked Randomization with the Biased Coin Design — Victoria Plamadeala Johnson
12:05 PM	Comparing Randomization Methods for Clinical Trials — Steven Schwager, Medidata Solutions

JSM 2016 Online Program

Activity Details

ASA Meetings Department

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