Name: 2019 Joint Statistical Meetings
Start: 2019-07-27T07:00:00+00:00
End: 2019-08-01
Location: Colorado Convention Center

Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme

Activity Details

77	Sun, 7/28/2019, 4:00 PM - 5:50 PM	CC-111
Complex Designs and Composite Endpoints of Medical Device Clinical Studies and Benefit-Risk Analysis of Diagnostic Tests — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Jianjin Xu, FDA/CDRH
4:05 PM	Survey of Composite Endpoints in Therapeutic PMA Submissions Presentation Rajesh Nair, CDRH/FDA; Natasha Sahr, St. Jude's Children's Hospital; Ja-An Lin, FDA/CDRH
4:20 PM	A Simulation of Various Missing Data Imputation Methods in the Application of Composite Endpoint Presentation Ja-An Lin, FDA/CDRH; Rajesh Nair, CDRH/FDA; Natasha Sahr, St. Jude's Children's Hospital
4:35 PM	A Practical Perspective: Application of the Generalized Approach for Adaptive Design Jin Wang, Abbott Vascular; juanjuan li, abbott; Yu Shu, Abbott; xiaolu su, abbott
4:50 PM	Survival Analysis of Hierarchical Learning Curves in Assessment of Cardiac Device and Procedural Safety Presentation Usha Govindarajulu, SUNY Downstate Medical Center; Sandeep Bedi, SUNY Downstate; Aaron Kluger, Baylor University; Frederic Resnic, Lahey Hospital and Medical Center
5:05 PM	Proposing How to Establish Analytical Measuring Range When the Comparator’s Range Is Shorter in Method Comparison Studies Kyungsook Kim, FDA; Meijuan Li, FDA
5:20 PM	Benefit-Risk (BR) Evaluation for Diagnostic Tests Presentation Jeng Mah, Beckman Coulter
5:35 PM	Floor Discussion

111 * !	Mon, 7/29/2019, 8:30 AM - 10:20 AM	CC-102
Evidence Beyond Traditional Clinical Trials — Invited Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Health Policy Statistics Section
Organizer(s): Martin Ho, FDA
Chair(s): Chava Zibman, FDA Center for Devices and Radiological Health
8:35 AM	Recent Statistical Developments in Considering Real World Evidence for Regulatory Decisioin Making Martin Ho, FDA; Weili He, AbbVie
8:55 AM	Propensity Score-Integrated Approaches for Incorporating Real-World Evidence in Clinical Studies Presentation Chenguang Wang, John Hopkins University
9:15 AM	External Evidence: Latest Developments from the Eponymous Medical Device Innovation Consortium Working Group Presentation Theodore Lystig, Medtronic
9:35 AM	Use of Past Control Observations Within a Perpetual Platform Trial Presentation Kert Viele, Berry Consultants; Scott Berry, Berry Consultants
9:55 AM	Discussant: Telba Irony, FDA CBER
10:15 AM	Floor Discussion

159 * !	Mon, 7/29/2019, 10:30 AM - 12:20 PM	CC-302
Novel Approaches for Diagnostics and Prediction with Complex Data — Topic Contributed Papers
International Chinese Statistical Association, Biometrics Section, Section on Medical Devices and Diagnostics
Organizer(s): Wei Zhang, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
Chair(s): Aiyi Liu, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
10:35 AM	Assessing the Incremental Value of New Biomarkers Based on or Rules Ying Huang, Fred Hutchinson Cancer Research Center; Lu Wang, Fred Hutchinson Cancer Research Center; Alex R. Luedtke, Dept. of Statistics- University of Washington
10:55 AM	Statistical Monitoring of Hemodialysis Treatments via Raman Spectral Analysis Pang Du, Virginia Tech; Yunnan Xu, Virginia Tech
11:15 AM	Recent Advances in Statistical Methods for Biomarker Evaluation: Naïve Pooling Vs Umbrella Ordering Presentation Lili Tian, SUNY at Buffalo; Yingdong Feng, SUNY at Buffalo; Dan Wang, Eli Lilly
11:35 AM	A Resample-Replace Lasso Procedure for Combining High-Dimensional Markers with Limit of Detection Presentation Yunpeng Zhao, Arizona State Univ; Jinjuan Wang, University of Chinese Academy of Sciences; Larry Tang, George Mason University; Claudius Mueller, George Mason University; Qizhai Li, Academy of Mathematics and Systems Science, Chinese Academy of Science
11:55 AM	A Joint Prediction Model with Partial Network Data with Informative Cluster Size Danping Liu, National Cancer Institute
12:15 PM	Floor Discussion

219005	Mon, 7/29/2019, 2:00 PM - 3:00 PM	H-Limestone Boardroom
SMDD Officer Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Zhen Zhang, Abbott

227 *	Mon, 7/29/2019, 2:00 PM - 3:50 PM	CC-709
Recent Advances in the Design and Analysis of Multi-Reader Imaging Studies — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biometrics Section, ENAR
Organizer(s): Joanna H Shih, National Cancer Institute
Chair(s): Joanna H Shih, National Cancer Institute
2:05 PM	Relationship Between Obuchowski-Rockette and Gallas U-Statistic Methods for Analyzing Multi-Reader Diagnostic Imaging Data Stephen Hillis, University of Iowa
2:25 PM	Assigning Readers to Cases in Multi-Reader Multi-Case Imaging Studies Using Balanced Incomplete Block Designs Presentation Erich Huang, National Cancer Institute
2:45 PM	Analyzing Readers’ Performance in Detection-Localization Tasks Andriy Bandos, University of Pittsburgh
3:05 PM	Adaptive Design and Analysis of Multi-Reader Multi-Case Studies Weijie Chen, Food and Drug Administration; Zhipeng Huang, FDA/CDER; Frank Samuelson, FDA/CDRH; Lucas Tcheuko, FDA/CTP
3:25 PM	Discussant: Alicia Toledano, Biostatistics Consulting, LLC
3:45 PM	Floor Discussion

219006	Mon, 7/29/2019, 6:00 PM - 7:30 PM	CC-301
SMDD Business Meeting — Other Cmte/Business
Section on Medical Devices and Diagnostics
Chair(s): Zhen Zhang, Abbott

338	Tue, 7/30/2019, 10:30 AM - 12:20 PM	CC-103
SPEED: Biostatistical Methods, Application, and Education, Part 1 — Contributed Speed
ENAR, Section on Medical Devices and Diagnostics, Mental Health Statistics Section, Quality and Productivity Section, Section on Statistics in Epidemiology, Section on Bayesian Statistical Science, Section on Risk Analysis, Section on Statistical Graphics, Section on Teaching of Statistics in the Health Sciences
Chair(s): Loren Cobb, University of Colorado Denver
Poster Presentations for this session.
10:35 AM	Impact of Approaches for Clinical and Radiological Monitoring on Predicting of Short-Term and Long-Term Disability Outcomes in Multiple Sclerosis Presentation Brian Healy, Biostatistics Center/Massachusetts General Hospital
10:40 AM	Assessment of Biomarker Strategies in Lung Cancer Management via Net Reclassification Indices Piper Williams, University of Colorado Anschutz Medical Campus; Alexander Kaizer, University of Colorado Anschutz Medical Campus; Anna Barón, University of Colorado Anschutz Medical Campus
10:45 AM	New Results on the Weighted Generalized Score for Comparing Two Correlated Means Presentation Aaron Douglas Jones, Duke University; Andrzej Stanislaw Kosinski, Duke University
10:50 AM	Developing Year-Long Mobile Health Interventions to Improve Mental Health Outcomes Among Medical Interns: Experimental Design and Statistical Methods Presentation Timothy NeCamp, University of Michigan; Zhenke Wu, University of Michigan; Srijan Sen, University of Michigan
10:55 AM	Lowering Sample Size Requirements for Mixture Modeling in Mental Health Research Alessandro De Nadai, Texas State University; Kate Fitzgerald, University of Michigan; Ryan Zamora, Texas State University; Luke Norman, University of Michigan; Tara Little, Texas State University; Joseph Himle, University of Michigan; Kristin Mannella, University of Michigan; Stephan Taylor, University of Michigan
11:00 AM	Psychotherapy Outcomes for Adults with Autism Spectrum Disorder in a University Counseling Setting E. Neeley Tass, Brigham Young University
11:05 AM	Sample Size Calculations in Single-Case Designs Jiabei Yang, Brown School of Public Health; Christopher Schmid, Brown University; Jon Steingrimsson, Brown University
11:10 AM	Importance of Data Quality for National HIV Prevention Program Monitoring and Evaluation Presentation Guoshen Wang, Centers for Disease Control and Prevention; Shubha Rao, The Centers for Disease Control and Prevention ; Hui Zhao, The Centers for Disease Control and Prevention ; Wei Song, The Centers for Disease Control and Prevention ; Carolyn Wright, The Centers for Disease Control and Prevention ; Marc Wiehn, Luther Consulting LLC
11:15 AM	Coffee and Cardiovascular Disease Prevention Anna Wu; Patrick Giuliano, Abbott
11:20 AM	Tolerance Intervals for Autoregressive Models, with an Application to Hospital Waiting Lists Presentation Kedai Cheng; Derek Young, University of Kentucky
11:30 AM	Temporal Association of Prostate and Colon Cancer with World Trade Center Rescue/Recovery Work: a 14 Year Cohort Study Presentation Charles Hall, Albert Einstein College of Medicine; David Goldfarb, Montefiore Medical Center ; Rachel Zeig-Owens, Montefiore Medical Center ; David Prezant, Fire Department of the City of New York
11:35 AM	Age-Period-Cohort Analysis of Lead Body Burden in the United States, 1976-2016 Yutaka Aoki, National Center for Health Statistics
11:40 AM	Optimality in Group Testing Estimation with Misclassification Md. S. Sarker, Radford University
11:45 AM	Joint Valid Moments Bayesian Marginal Logistic Regression Model with Time Dependent Covariates Presentation Maria Vazquez; Jeffrey Wilson, W. P. Carey School of Business, ASU
11:50 AM	A Bayesian Zero Inflated Binomial Model for Repeated Measures Count Data Benjamin W. Rogers, UCLA
11:55 AM	Predicting the Absolute Risk of Undetected Uterine Cancer in a Matched Case-Control Study Catherine Lee, Kaiser Permanente Division of Research; Scott E. Lentz, , The Southern California Permanente Medical Group, Los Angeles; Eve Zaritsky, The Permanente Medical Group, Oakland California; Lue-Yen Tucker, The Division of Research, Kaiser Permanente Northern California; Tina Raine-Bennett, Oakland California and The Division of Research, Kaiser Permanente Northern California
12:00 PM	Experiences with Incorporating R into a Second-Level Biostatistics Course for MPH Students Presentation Christine Mauro, Columbia University; Nicholas Williams, Columbia University; Anjile An, Columbia University
12:05 PM	Rank-Based Approach for Estimating Correlations in Mixed Ordinal Data Xiaoyun Quan; James Booth, Cornell University; Martin Wells, Cornell University
12:10 PM	Pre-Conceptions of Statistical Inference in Biostatistics Presentation Aimee Schwab-McCoy, Creighton University

359	Tue, 7/30/2019, 10:30 AM - 12:20 PM	CC-Hall C
Contributed Poster Presentations: Section on Medical Devices and Diagnostics — Contributed Poster Presentations
Section on Medical Devices and Diagnostics, Text Analysis Interest Group
Chair(s): Wendy Meiring, University of California At Santa Barbara
90:	Modeling Concordance of Beta-Amyloid Images Under a Mixed Model Framework Katelyn A. McKenzie, University of Kansas Medical Center; Jonathan D. Mahnken, University of Kansas Medical Center
91:	ROC and C: Time-Dependent Relationships Between ROC Curve Methods and Concordance Measures Norberto Pantoja Galicia, U.S. Food and Drug Administration; Rebecca Betensky, NYU
92:	Application of Calibration Estimator in Comparison of TVR-MACE Survival Rate Between IntraVascular UltraSound Guided PCI and Angiography Guided PCI Within Complex Lesion Population Cheng Zhang
93:	Missing Data and Sensitivity Analyzes: a Methodology Evolution in Medical Device Studies Scott Mollan, ICON plc
94:	A Wavelet Decomposition Based Analysis of Physical Activity and Using Accelerometer Data Margaret Banker, University of Michigan
95:	Prediction of Pediatric Emergency Department X-Ray and CT Utilization in the United States Xingyu Zhang, University of Michigan; Sheng Yang, University of Michigan; Pau Medrano-Gracia, University of Auckland; Konrad Werys, University of Oxford; Prashant Mahajan, University of Michigan

410	Tue, 7/30/2019, 2:00 PM - 3:50 PM	CC-104
Diagnostic Tests: Regulatory Considerations of Intermediate Outputs and Oncology Screening, and Optimal Point of Heterogeneous ROC Curves — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Alan M. Zaslavsky, Harvard Medical School
2:05 PM	Evaluation of Diagnostic Tests with Binary/Dichotomous Output: a Decision Analytic Approach Arianna Simonetti, U.S. Food and Drug Administration - CDRH; Bipasa Biswas, U.S. Food and Drug Administration - CDRH
2:20 PM	Diagnostic Devices with Intermediate/Gray Zone Output Bipasa Biswas, U.S. Food and Drug Administration - CDRH
2:35 PM	ROC Analysis for Multistage Diagnostic Testing Procedures in the Presence of Indeterminate Results Ziqiang Chen, State University of New York At Buffalo; Gregory Wilding, SUNY at Buffalo
2:50 PM	Statistical Methods to Address Verification Bias for Evaluating Screening Tests Presentation Changhong Song, FDA
3:05 PM	Uncertainty of the Reported Results in Molecular Diagnostics Presentation Jeffrey Vaks, Roche Molecular Diagnostics
3:20 PM	The Optimal Point of the ROC Curve When Disease Distribution Is a Mixture of Normals Donna McClish, VCU
3:35 PM	Floor Discussion

418	Tue, 7/30/2019, 2:00 PM - 2:45 PM	CC-Hall C
SPEED: Biostatistical Methods, Application, and Education, Part 2 — Contributed Poster Presentations
Section on Medical Devices and Diagnostics, ENAR, Mental Health Statistics Section, Quality and Productivity Section, General Methodology, Section on Bayesian Statistical Science, Section on Risk Analysis, Section on Statistical Graphics, Section on Teaching of Statistics in the Health Sciences
Chair(s): Loren Cobb, University of Colorado Denver
Oral Presentations for this session.
20:	Importance of Data Quality for National HIV Prevention Program Monitoring and Evaluation Guoshen Wang, Centers for Disease Control and Prevention; Shubha Rao, The Centers for Disease Control and Prevention ; Hui Zhao, The Centers for Disease Control and Prevention ; Wei Song, The Centers for Disease Control and Prevention ; Carolyn Wright, The Centers for Disease Control and Prevention ; Marc Wiehn, Luther Consulting LLC
21:	Pre-Conceptions of Statistical Inference in Biostatistics Aimee Schwab-McCoy, Creighton University
22:	Impact of Approaches for Clinical and Radiological Monitoring on Predicting of Short-Term and Long-Term Disability Outcomes in Multiple Sclerosis Brian Healy, Biostatistics Center/Massachusetts General Hospital
23:	Developing Year-Long Mobile Health Interventions to Improve Mental Health Outcomes Among Medical Interns: Experimental Design and Statistical Methods Timothy NeCamp, University of Michigan; Zhenke Wu, University of Michigan; Srijan Sen, University of Michigan
24:	Tolerance Intervals for Autoregressive Models, with an Application to Hospital Waiting Lists Kedai Cheng; Derek Young, University of Kentucky
25:	Coffee and Cardiovascular Disease Prevention Anna Wu; Patrick Giuliano, Abbott
26:	Lowering Sample Size Requirements for Mixture Modeling in Mental Health Research Alessandro De Nadai, Texas State University; Kate Fitzgerald, University of Michigan; Ryan Zamora, Texas State University; Luke Norman, University of Michigan; Tara Little, Texas State University; Joseph Himle, University of Michigan; Kristin Mannella, University of Michigan; Stephan Taylor, University of Michigan
27:	Rank-Based Approach for Estimating Correlations in Mixed Ordinal Data Xiaoyun Quan; James Booth, Cornell University; Martin Wells, Cornell University
28:	Age-Period-Cohort Analysis of Lead Body Burden in the United States, 1976-2016 Yutaka Aoki, National Center for Health Statistics
29:	Psychotherapy Outcomes for Adults with Autism Spectrum Disorder in a University Counseling Setting E. Neeley Tass, Brigham Young University
30:	Assessment of Biomarker Strategies in Lung Cancer Management via Net Reclassification Indices Piper Williams, University of Colorado Anschutz Medical Campus; Alexander Kaizer, University of Colorado Anschutz Medical Campus; Anna Barón, University of Colorado Anschutz Medical Campus
31:	Experiences with Incorporating R into a Second-Level Biostatistics Course for MPH Students Christine Mauro, Columbia University; Nicholas Williams, Columbia University; Anjile An, Columbia University
32:	Joint Valid Moments Bayesian Marginal Logistic Regression Model with Time Dependent Covariates Maria Vazquez; Jeffrey Wilson, W. P. Carey School of Business, ASU
33:	Temporal Association of Prostate and Colon Cancer with World Trade Center Rescue/Recovery Work: a 14 Year Cohort Study Charles Hall, Albert Einstein College of Medicine; David Goldfarb, Montefiore Medical Center ; Rachel Zeig-Owens, Montefiore Medical Center ; David Prezant, Fire Department of the City of New York
34:	Predicting the Absolute Risk of Undetected Uterine Cancer in a Matched Case-Control Study Catherine Lee, Kaiser Permanente Division of Research; Scott E. Lentz, , The Southern California Permanente Medical Group, Los Angeles; Eve Zaritsky, The Permanente Medical Group, Oakland California; Lue-Yen Tucker, The Division of Research, Kaiser Permanente Northern California; Tina Raine-Bennett, Oakland California and The Division of Research, Kaiser Permanente Northern California
35:	New Results on the Weighted Generalized Score for Comparing Two Correlated Means Aaron Douglas Jones, Duke University; Andrzej Stanislaw Kosinski, Duke University
36:	Sample Size Calculations in Single-Case Designs Jiabei Yang, Brown School of Public Health; Christopher Schmid, Brown University; Jon Steingrimsson, Brown University
37:	A Bayesian Zero Inflated Binomial Model for Repeated Measures Count Data Benjamin W. Rogers, UCLA
38:	Optimality in Group Testing Estimation with Misclassification Md. S. Sarker, Radford University
Oral Presentations for this session.

443 * !	Wed, 7/31/2019, 8:30 AM - 10:20 AM	CC-301
Making an Impact on Physical Activity and Sleep Research by Developing New Statistical Methods — Invited Papers
Korean International Statistical Society, Section on Statistics in Epidemiology, Section on Medical Devices and Diagnostics
Organizer(s): Jungwha Julia Lee, Northwestern University
Chair(s): Kwang-Youn Kim, Northwestern University
8:35 AM	Processing Accelerometer Data with an Automated Algorithm – an R Package ‘PhysicalActivity’ Presentation Leena Choi, Vanderbilt University Medical Center; Cole Beck, Vanderbilt University Medical Center; Zhouwen Liu, Vanderbilt University Medical Center; Maciej S Buchowski, Vanderbilt University Medical Center
8:50 AM	Sample Integrity in Physical Activity Experiments: R 'Accelmissing' Jung Ae Lee, University of Arkansas
9:05 AM	Accelerometry Data: From Millivolts to Counts Jiawei Bai, Johns Hopkins University
9:20 AM	New Methodology for Characterizing Circadian Rhythms in Actigraphy Data Collected from a Wearable Device Presentation Paul Albert , National Cancer Insititute; Sungduk Kim, NIH
9:35 AM	Integrative Analysis of Domains of Physical Activity, Sleep, and Circadian Rhythmicity Collected by Wearables Junrui Di, Johns Hopkins Bloomberg School of Public Health; Vadim Zipunnikov, Johns Hopkins University
9:50 AM	Improving Sleep Classification Using Multivariate Actigraphy Measures Haochang Shou, University of Pennsylvania
10:05 AM	Floor Discussion

470	Wed, 7/31/2019, 8:30 AM - 10:20 AM	CC-108
Biomarker Evaluation and Winning Student Papers on Medical Devices and Diagnostics — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Barbara Wendelberger, Berry Consultants, LLC
8:35 AM	Shock Prediction Using Vital Sign Time Series Iris Bennett, North Carolina State University; Bill Rand, North Carolina State University
8:50 AM	Combining Biomarker Trajectories to Improve Diagnostic Accuracy in Prospective Cohort Studies with Verification Bias Presentation Hong Li, Medical University of South Carolina; Constantine Gatsonis, Brown University
9:05 AM	Bayesian Hierarchical Models for Voxel-Wise Classification of Prostate Cancer Accounting for Spatial Correlation and Between-Patient Heterogeneity in the Multi-Parametric MRI Data Jin Jin, Division of Biostatistics, University of Minnesota; Joseph Koopmeiners, University of Minnesota; Lin Zhang, Division of Biostatistics, University of Minnesota; Ethan Leng, Center for Magnetic Resonance Research, Department of Radiology, University of Minnesota; Gregory Metzger, Center for Magnetic Resonance Research, Department of Radiology, University of Minnesota
9:20 AM	Smoothed Empirical Likelihood Inference for the Youden Index Subject to Limit of Detection Dongliang Wang, SUNY Upstate Medical University
9:35 AM	Analyzing Wearable Device Data Using Marked Point Processes Yuchen Yang, Johns Hopkins University; Mei-Cheng Wang, Johns Hopkins University
9:50 AM	BayesCT: a Tool for Simulation and Analysis of Adaptive Bayesian Clinical Trials Presentation Thevaa Chandereng, University of Wisconsin-Madison; Donald Musgrave, Medtronic; Tarek Haddad, Medtronic ; Graeme Hickey, Medtronic; Tim Hanson, Medtronic ; Theodore Lystig, Medtronic; Rick Chappell, University of Wisconsin-Madison
10:05 AM	Constructed Composite Response: a Framework for Constructing Targeted Latent Variables Christopher Barbour, National Institutes of Health; Mark Greenwood, Montana State University; Dominique Zosso, Montana State University; Bibiana Bielekova, National Institute of Allergy and Infectious Diseses

596 * !	Thu, 8/1/2019, 8:30 AM - 10:20 AM	CC-605
Statistical and Mathematical Methods in Cancer Etiology and Cancer Early Detection — Invited Papers
ENAR, Section on Statistics in Genomics and Genetics, Section on Medical Devices and Diagnostics
Organizer(s): Cristian Tomasetti, Johsn Hopkins University
Chair(s): Cristian Tomasetti, Johsn Hopkins University
8:35 AM	Statistical Methods Behind the CancerSEEK Blood Test and the DYNAMICS Study Kamel Lahouel, Johns Hopkins University
9:05 AM	Statistical and Mathematical Approaches to Cancer Etiology Cristian Tomasetti, Johsn Hopkins University; Lu Li, Johns Hopkins University
9:35 AM	Mutational Signatures and Cancer Etiology Presentation Bahman Afsari, Johns Hopkins University
10:05 AM	Floor Discussion

605 * !	Thu, 8/1/2019, 8:30 AM - 10:20 AM	CC-603
Innovations in Use of Historical Control Data in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Biometrics Section, Section on Statistical Consulting, Statistics and Pharmacometrics Interest Group
Organizer(s): Steven Schwager, Cornell University
Chair(s): Steven Schwager, Cornell University
8:35 AM	Exploring External Controls Using Prior Clinical Trial Data Presentation Pallavi Mishra-Kalyani, US Food and Drug Administration
8:55 AM	Composite Likelihood Approach for Incorporating the Entropy Balance Weighting of Real World Data (RWD) in Uncontrolled and Randomized-Controlled Trials (RCTs) Guanglei Yu, Eli Lilly and Company; Margaret Gamalo-Siebers, Eli Lilly; Yuanyuan Bian, Eli Lilly and Company
9:15 AM	Incorporation of Historical Information in Pediatric Trials Presentation James Travis, FDA
9:35 AM	Real World Data for Oncology Drug Development: Promise and Pitfalls Presentation Catherine Tuglus, Amgen; Qui Tran, Amgen; Chris Holland, Immunocore
9:55 AM	Strengthening Clinical Trials Through Synthetic Control Arms Antara Majumdar, Medidata Solutions; Ruthie Davi, Medidata Solutions; Steven Schwager, Medidata Solutions
10:15 AM	Floor Discussion

644 * !	Thu, 8/1/2019, 10:30 AM - 12:20 PM	CC-607
Statistical Methods for the Co-Development of Drug and Companion Diagnostic in Oncology — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Society for Medical Decision Making
Organizer(s): Rong Liu, Celgene
Chair(s): Frank Shen, Celgene Co.
10:35 AM	Evaluation of Biomarker Threshold Designs in Cancer Therapy Kui Shen, Bayer U.S. LLC; Xiaowen Tian, University of Washington; Jonathan Siegel, Bayer HealthCare Pharmaceuticals Inc.
10:55 AM	A Case Study in Bridging for Companion Diagnostic Development: Pembrolizumab and PD-L1 Selected 2nd Line NSCLC Patients Jared Lunceford, Merck & Co., Inc.; Ellie Corigliano, Merck & Co., Inc.; Siddhartha Mathur, Merck & Co., Inc.; Ziwen Wei, Merck & Co., Inc.; Yue Shentu, Merck & Co., Inc.
11:15 AM	Drug-Device Co-Development in the Era of Precision Medicine: Industry Perspectives on Statistical Challenges Shunguang Wang, Novartis Institutes for BioMedical Research Inc.
11:35 AM	Logical Inference on Treatment Efficacy When Subgroups Exist Presentation Ying Ding, University of Pittsburgh
11:55 AM	Innovative Designs for Drug-Device Co-Development in the Area of Precision Medicine Rui Tang, Servier
12:15 PM	Floor Discussion

JSM 2019 Online Program

Activity Details

American Statistical Association