All Times EDT
Legend:
Activity Details
25
Sun, 8/8/2021,
1:30 PM -
3:20 PM
Virtual
Medical Devices and Diagnostics Speed Session — Contributed Speed
Section on Medical Devices and Diagnostics
Chair(s): Bipasa Biswas, FDA
1:35 PM
The Multistage Diagnostic Testing Algorithm for Accommodating Indeterminate Results and Its Associated Inference
Ziqiang Chen, Merck ; Gregory Wilding, University at Buffalo
1:40 PM
An Approach to Evaluating Treatment Selection-Biomarker for Observational Studies
Hulya Kocyigit, University of Georgia ; Kevin K Dobbin, University of Georgia
1:45 PM
Bayesian and Frequentist Promising Zone Designs for Adaptive Sample Size Modification in Clinical Trials
Apurva C Bhingare, Cytel Inc. ; Cyrus Mehta, Cytel Inc; Pralay Senchaudhari, CYTEL INC; Lingyun Liu, Vertex
1:50 PM
Marginal, Conditional, and Pseudo-Likelihood Ratio Approaches for Biomarker Combination to Predict a Binary Disease Outcome
Danping Liu, National Cancer Institute/National Institutes of Health ; Yongli Han, National Cancer Institute/National Institutes of Health; Aiyi Liu, National Institute of Child Health and Human Development
1:55 PM
Implementing the Obuchowski-Rockette Procedure Using Conventional Linear Mixed Model Software
Stephen Hillis, University of Iowa
2:00 PM
Pathologist Agreement from Quantitative Measurements: A Pilot Study
Presentation
Brandon D Gallas, FDA/CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability ; Katherine Elfer, FDA/CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability
2:05 PM
On the Noninferiority McNemar Test
Zhigang Zhang, Memorial Sloan-Kettering Cancer Center
2:10 PM
One-Year Watch Use Patterns in the Electronic Framingham Heart Study
Chathurangi H. Pathiravasan, Department of Biostatistics, Boston University School of Public Health ; Yuankai Zhang, Department of Biostatistics, Boston University School of Public Health; Xuzhi Wang, Department of Biostatistics, Boston University School of Public Health; Ludovic Trinquart, Department of Biostatistics, Boston University School of Public Health; Emelia J. Benjamin, Department of Epidemiology, Boston University Schools of Medicine and Public Health; Belinda Borrelli, Boston University Henry M Goldman School of Dental Medicine; David D. McManus, Department of Medicine, University of Massachusetts Medical School; Vik Kheterpal, Care Evolution; Honghuang H. Lin, Department of Medicine, Boston University School of Medicine; Michael M. Hammond, Institute's Framingham Heart Study; Nicole L. Spartano, Section of Endocrinology, Diabetes, Nutrition, and Weight Management, Boston University; Eric Schramm, Care Evolution; Chris Nowak, Care Evolution; Jelena Kornej, Framingham Heart Study; Chunyu Liu, Department of Biostatistics, Boston University School of Public Health; Joanne M. Murabito, Department of Medicine, Boston University School of Medicine
2:15 PM
A Large-Scale Cohort Study of Wearable-Derived Resting Heart Rates, Lifestyle Factors, and Disease Risk
Catherine H. Weldon, 23andMe ; Teresa H. Filshtein Sonmez, 23andMe; Christophe H. Toukam Tchakouté, 23andMe; Stella Aslibekyan, 23andMe
2:20 PM
Model-Based Clustering of Multiple Two-Dimensional Functional Data Incorporating Covariates
Ying Cui, Emory University ; Jeong Hoon Jang, Indiana University; Amita K. Manatunga, Emory University
2:30 PM
Moving Beyond Total Lesion Volume: An Integrative Neuroimaging and Statistical Approach for Evaluating Neuroprotection During Surgical Aortic Valve Replacement (SAVR)
Lewis E Tomalin, Icahn School of Medicine at Mount Sinai ; Mayte Suárez-Fariñas, Icahn School of Medicine at Mount Sinai; Guray Erus, University of Pennsylvania; Jessica Overbey, Icahn School of Medicine at Mount Sinai; Amy Kuceyeski, Cornell; Steven R Messe, University of Pennsylvania; Emilia Bagiella, Icahn School of Medicine at Mount Sinai; Alan J Moskowitz, Icahn School of Medicine at Mount Sinai; Annetine C Gelijns, Icahn School of Medicine at Mount Sinai; Alex Iribarne, Dartmouth-Hitchcock Medical Center; Michael A Acker, University of Pennsylvania; Michael J Mack, Baylor Research Institute
2:35 PM
Correlating Cerebral Oxygenation and Postural Stability Using Functional Principal Component Analysis
David Rice, Western Washington University ; Jonathan Garber, Western Washington University; Mamiko Noguchi, University of Waterloo; Richard Hughson, Schlegel-University of Waterloo Research Institute for Aging; Kimihiro Noguchi, Department of Mathematics, Western Washington University; Laura K Fitzgibbon-Collins, Schlegel-University of Waterloo Research Institute for Aging?
2:40 PM
Quantile Index Protein Biomarkers Based on Cell-Level Immunohistochemistry Data
Misung Yi, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University ; Inna Chervoneva, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University
2:45 PM
Biomarker Evaluation Under Tree/Umbrella Ordering with Application to Lung Cancer
Yi Gao, State University of New York at Buffalo ; Lili Tian, State University of New York at Buffalo
2:50 PM
Feature Space Fusion for Heterogeneous Scattered Data
Jingyi Zhang, Center for Statistical Science, Tsinghua University ; Wenxuan Zhong, University of Georgia; Ping Ma, University of Georgia
2:55 PM
Floor Discussion
64 * !
Mon, 8/9/2021,
10:00 AM -
11:50 AM
Virtual
Innovative Practical Improvements in Biomarker Development and Evaluation — Invited Papers
Section on Medical Devices and Diagnostics , Biometrics Section, Biopharmaceutical Section, Caucus for Women in Statistics
Organizer(s): Laura Yee, National Cancer Institute, National Institutes of Health
Chair(s): Hari Sankaran, National Cancer Institute, National Institutes of Health
10:05 AM
Emulating a Target Trial to Evaluate the Clinical Utility of a Biomarker-Based Treatment Rule
Michael Charles Sachs, Karolinska Institutet
10:25 AM
Two-Stage Adaptive Design for Prognostic Biomarker Signatures with a Survival Endpoint
Mei-Yin C Polley, University of Chicago ; Biyue Dai, University of Iowa
10:45 AM
Biologically Informed Development of Treatment Selection Scores from High-Dimensional Omics Data
Lisa McShane, National Cancer Institute
11:05 AM
Sample Size Methods for Validation of Predictive Biomarkers
Kevin K Dobbin, University of Georgia ; Lisa McShane, National Cancer Institute
11:25 AM
Discussant: Ana Best, National Cancer Institute, National Institutes of Health
11:45 AM
Floor Discussion
104 * !
Mon, 8/9/2021,
1:30 PM -
3:20 PM
Virtual
Novel Methodology for the Analysis of Physical Activity Data Measured by Accelerometers — Invited Papers
Biometrics Section , Section on Nonparametric Statistics, Section on Medical Devices and Diagnostics
Organizer(s): Erjia Cui, Johns Hopkins Bloomberg School of Public Health
Chair(s): Erjia Cui, Johns Hopkins Bloomberg School of Public Health
1:35 PM
Compositional Data Analysis for the 24-Hour Activity Cycle: Methods Considerations and Applications to the Women’s Health Initiative
Chongzhi Di, Fred Hutchinson Cancer Research Center ; Yifan Zhu, Fred Hutchinson Cancer Research Center; Guangxing Wang, Fred Hutchinson Cancer Research Center
2:00 PM
A Case Study of the Micro-Randomized Trial of HeartSteps V2
Xiang Meng, Harvard University ; Peng Liao, Harvard University; Susan Murphy, Harvard University; Predrag Klasnja, University of Michigan; Walter Dempsey, University of Michigan; Nick Reid, University of Washington
2:25 PM
Establishing Population Reference Quantities of Interpretable Summaries of Physical Activity from Accelerometry Data
Andrew Leroux, University of Colorado Anschutz Medical Campus
2:50 PM
Complex Survey-Weighted Functional Regression Methods for Mortality Prediction in National Health and Nutrition Examination Studies (NHANES)
Ekaterina Smirnova, Virginia Commonwealth University ; Andrew Leroux, University of Colorado Anschutz Medical Campus; Erjia Cui, Johns Hopkins Bloomberg School of Public Health; Lucia Tabacu, Old Dominion University; Ciprian Crainiceanu, Johns Hopkins University
3:15 PM
Floor Discussion
157 *
Tue, 8/10/2021,
10:00 AM -
11:50 AM
Virtual
Advances in Analytic Methods and Novel Applications of the Use of Synthetic Control for Causal Estimation of Effects of Therapeutic Interventions — Topic-Contributed Papers
Biometrics Section , ENAR, Section on Medical Devices and Diagnostics
Organizer(s): Margaret Gamalo, Pfizer
Chair(s): Chao-Kang Jason Liang, National Institute of Allergy and Infectious Diseases
10:05 AM
Synthetic Control Trial Design with Enhanced Double Robust Estimate of Rx Effect
Ming Tan, Georgetown University
10:25 AM
Evaluation of Diagnostic Tests for Low Prevalence Diseases with Leveraging Real-World Data
Wei-Chen Chen, FDA/CDRH ; Heng Li, FDA/CDRH; Nelson Lu, FDA/CDRH; Changhong Song, FDA/CDRH; Chenguang Wang, JHU; Ram Tiwari, FDA/CDRH; Yunling Xu, CDRH/FDA; Lilly Q. Yue, FDA/CDRH
10:45 AM
Innovative Adaptive Design for Confirmatory Trials: A Case Study in Pediatrics
Junjing Lin, Takeda Pharmaceuticals ; Margaret Gamalo-Siebers, Pfizer Inc.; Ran Liao, Eli Lilly
11:05 AM
Some Practical Issues of Augmenting Concurrent Control Data with Synthetic Control
Binbing Yu, AstraZeneca, LLC
11:25 AM
Design and Analysis of Externally Controlled Trials: Regulatory Review Experience in Hematology and Oncology Drug Applications
Presentation
Haiyan Chen, FDA
11:45 AM
Floor Discussion
159 * !
Tue, 8/10/2021,
10:00 AM -
11:50 AM
Virtual
Teaching Undergraduates and High-School Students to Analyze Time Series Data — Topic-Contributed Papers
Section on Statistics and Data Science Education , Section on Statistics and the Environment, Section on Medical Devices and Diagnostics, Section on Teaching of Statistics in the Health Sciences
Organizer(s): Juana Sanchez, UCLA
Chair(s): Jeff Witmer, Oberlin College and Conservatory
10:05 AM
Time Series: Its Place in the Secondary School Curriculum
Rachel Passmore, University of Auckland
10:25 AM
Long-Term and Seasonal Trends of Wastewater Chemicals in Lake Mead: An Introduction to Time Series Decomposition
Rich Wildman, Geosyntec Consultants
10:45 AM
CGM and Insulin Pump Data to Introduce Classical and Machine Learning Time Series Analysis Concepts to Students.
Juana Sanchez, UCLA
11:05 AM
Discussant: Vera Ioudina, Texas State University
11:25 AM
Floor Discussion
219 * !
Wed, 8/11/2021,
10:00 AM -
11:50 AM
Virtual
Artificial Intelligence and Machine Learning in Medical Imaging for Drug Development — Invited Papers
Section on Statistics in Imaging , Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Bushi Wang, Boehringer Ingelheim Pharmaceuticals Inc.
Chair(s): Sue-Jane Wang, FDA
10:05 AM
Using Deep Learning on HRCT Scan to Predict Pulmonary Fibrosis Progression and Support Early Clinical Development Decision
Bushi Wang, Boehringer Ingelheim Pharmaceuticals Inc. ; Yi Liu, Boehringer Ingelheim; Hao Li, Boeringer-Ingelheim
10:25 AM
Application of Machine Learning in Medical Imaging: Overview of Novartis Radiomics Projects
Thibaud Coroller, Novartis
10:45 AM
Histopathology and AI for Cancer Subtype and Mutation Detection
Narges Razavian, New York University Langone Health
11:05 AM
Development and Clinical Evaluation of Quantitative Lung Fibrosis Scores on CT Images in Clinical Trials: Idiopathic Pulmonary Fibrosis and Scleroderma Lung Disease
Grace Hyun Kim, UCLA ; Jonathan Goldin, UCLA; Matthew Brown, UCLA
11:25 AM
Recent Advances in Machine Learning in Medical Image Analysis
Fei Wang, Weill Cornell Medicine
11:45 AM
Floor Discussion
237
Wed, 8/11/2021,
10:00 AM -
11:50 AM
Virtual
Statistical Challenges in Evaluating Molecular Diagnostic Assays Geared Toward Companion Diagnostics Devices — Topic-Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Qin Li, CDRH/FDA
Chair(s): Xiaoqin Xiong, CDRH/FDA
10:05 AM
Statistical Considerations in Bridging Study of Personalized Medicine with Biomarker-Based Prescreened Samples
Wei Wang, US Food and Drug Administration ; Rajesh R Nair, CDRH/FDA
10:25 AM
Challenges in the Bridging Study to Validate Companion Diagnostics for Rare Predictive Biomarkers
Dandan Xu, US Food and Drug Administration
10:45 AM
Statistical Considerations in Bridging Study for Companion Diagnostic Clinical Validation
Johan Surtihadi, Illumina ; Yaji Xu, Illumina; Kristen Meier, Illumina; Joanne Lin, Illumina
11:05 AM
Statistical Methods for PPV Confidence Interval Estimation for Clinical Bridging Studies When PPV Is Near or at 100%
Lei Yang, Foundation medicine ; Chang Xu, Foundation medicine; Cui Guo, Foundation medicine
11:25 AM
Discussant: Zhiwei Zhang, NIH
11:45 AM
Floor Discussion
346 * !
Thu, 8/12/2021,
10:00 AM -
11:50 AM
Virtual
Advances in Diagnostics and Reproducibility Research — Topic-Contributed Papers
Social Statistics Section , Section on Medical Devices and Diagnostics, Caucus for Women in Statistics
Organizer(s): Ananda Sen, University of Michigan
Chair(s): Parul Agarwal, Icahn School of Medicine, Mount Sinai
10:05 AM
Rank Correlation Inferences for Clustered Data with Small Sample Size
Sally Hunsberger, NIAID ; Joanna Shih, National Cancer Institute
10:25 AM
Assessing the Reproducibility of Microbiome Measurements Based on Concordance Correlation Coefficients
Limin Peng, Emory University ; Ying Cui, Emory University; Yijuan Hu, Emory University; HuiChuan Lai, University of Wisconsin-Madison
10:45 AM
A Paired Kappa for Comparing the Binary Classifications of Many Raters
Kerrie Nelson, Boston University ; Don Edwards, University of South Carolina
11:05 AM
A Bayesian Joint Model for Clustered Agreement Data
Ananda Sen, University of Michigan ; Wen Ye, University of Michigan ; Pin Li, University of Michigan ; Alfred Franzblau, University of Michigan
11:25 AM
Floor Discussion
360 * !
Thu, 8/12/2021,
12:00 PM -
1:50 PM
Virtual
Advances and Challenges in Recent Diagnostic Research — Invited Papers
Section on Medical Devices and Diagnostics , Biometrics Section, Health Policy Statistics Section, Caucus for Women in Statistics
Organizer(s): Zheyu Wang, Johns Hopkins
Chair(s): Yuxin Zhu, Johns Hopkins
12:05 PM
Assessing Misdiagnosis-Related Harm with Electronic Medical Records
Zheyu Wang, Johns Hopkins
12:30 PM
Strategies for Validating Biomarkers Using Data from a Reference Set
Ying Huang, Fred Hutchinson Cancer Research Center ; Lu Wang, Peking University; Ziding Feng, Fred Hutchinson Cancer Research Center
12:55 PM
Longitudinal Modeling of Disease Progression Biomarkers in the Latent Disease Timescale: Example of Alzheimer’s Disease and Related Disorders
Cécile Proust-Lima, University of Bordeaux ; Jérémie Lespinasse, Univ. Bordeaux, INSERM, BPH; Carole Dufouil, Univ. Bordeaux, INSERM, BPH
1:20 PM
Correcting for Imperfect Gold Standard and Verification Bias in Estimating Accuracy of Diagnostic Tests: An Application on COVID-19 Diagnosis with CT and RT-PCR
Xiao-Hua Zhou, Peking University
1:45 PM
Floor Discussion
378 *
Thu, 8/12/2021,
12:00 PM -
1:50 PM
Virtual
Study Design and Statistical Challenges for AI/ML Based Medical Tests — Topic-Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section
Organizer(s): Rajesh R Nair, CDRH/FDA
Chair(s): Sung Hee Kim, CDRH/FDA
12:05 PM
Statistical Challenges in the Design and Validation of Medical Deep Learning Models
Andrew Beam, Harvard
12:25 PM
Validation of a Breakthrough AI-Guided Echocardiography System: Overcoming Challenges in Testing AI-Based Medical Device
Ha Hong, Caption Health, Inc. ; Samuel Surette, Caption Health, Inc.; Yngvil Thomas, Caption Health, Inc.; Charles Cadieu, Caption Health, Inc.; Ali Chaudhry, Caption Health, Inc.; Randolph Martin, Caption Health, Inc.
12:45 PM
AI/ML Application and Challenges in Medical Diagnostic Tests
Bipasa Biswas, FDA
1:05 PM
DADP: Dynamic Abnormality Detection and Progression for Longitudinal Knee Magnetic Resonance Images from the Osteoarthritis Initiative
Chao Huang, Florida State University
1:25 PM
Statistical Consideration in Demonstrating Standalone Performance for AI/ML-Based Computer-Aided Detection Devices
Jessie Moon, FDA
1:45 PM
Floor Discussion
