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CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme
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Keyword Search Criteria: regulatory returned 22 record(s)
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Monday, 07/31/2017
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Surrogacy for Regulatory Approval: The Follicular Lymphoma Analysis of Surrogate Hypothesis (FLASH) Project
Qian Shi, Mayo Clinic
9:00 AM
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Patient-Reported Outcomes: Observations of Regulatory Approvals by the Center for Biologics Evaluation and Research
Hussein Ezzeldin, FDA/CBER; Megan Moncur, FDA/CBER; Yuqun Abigail Luo, FDA/CBER; Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
9:35 AM
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Bayesian and Frequentist Partial Extrapolation Approaches in Organ Transplantation to Support the Pediatric Plan for European Health Authorities
Steffen Ballerstedt, Novartis Pharma AG; Jennifer Ng, Novartis Pharmaceuticals Inc
11:15 AM
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ODE Reconstruction of High-Dimensional Genetic Networks Through Game Theory
Rongling Wu, Pennsylvania State University; Libo Jiang, Beijing Forestry University
11:25 AM
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Graph Constrained Regularization for Nonparametric Instrumental Variable Regression in Genetical Genomic Analysis
Bin Gao, Janssen Research & Development, LLC; Yuehua Cui, Michigan State University
3:20 PM
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Tuesday, 08/01/2017
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Current Policies and Landscape for Bayesian Methods in Drug Approval
Fanni Natanegara, Eli Lilly and Company
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Use of Visual Analytics in Regulatory Submissions
Vipin Arora, Eli Lilly and Company
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GPU-Based Approximate Bayesian Computation Algorithms for Network Reverse-Engineering
Myriam Maumy, Universite de Strasbourg; Frederic Bertrand, University of Strasbourg
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Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs
Elizabeth Colantuoni, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University; Aidan McDermott, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University
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Accounting for Baseline Covariates and Missing Data in Regulatory Trials with Longitudinal Designs
Elizabeth Colantuoni, Johns Hopkins University; Jon Steingrimsson, Johns Hopkins University; Aidan McDermott, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University
8:45 AM
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Earning Regulatory Approval for a Phase II/III Design: a Case Study from Start to Finish
Adam Hamm, Cytel, Inc.
9:20 AM
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Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology and Cross-Disciplinary Scientific Engagement
Greg Ball, Merck; Frank Rockhold, Retired; Janet Wittes, Statistics Collaborative, Inc. (SCI); Ana Szarfman, CDER, FDA; William W Wang, Merck & Co Inc
10:35 AM
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PRO-CTCAE in Oncology Clinical Trials: a U.S. Regulatory Perspective
Paul Kluetz, U.S. Food and Drug Administration
2:45 PM
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Understanding the Differences in Regulatory Tax Sampling and Estimation Methodologies by Federal and State Jurisdictions
Roger Carl Pfaffenberger, Ryan LLC; Zac Rhyne, Ryan LLC
3:05 PM
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Wednesday, 08/02/2017
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Considerations in Transitioning from Proprietary to Non-Proprietary Statistical Software to Support Regulatory Submissions
Theodore Lystig, Medtronic, Inc.
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Estimating Causal Effects from Using Augmented Inverse Probability Weighted Estimators When Noncompliance Is Measured with Error
David Vock, University of Minnesota; Jeffrey Boatman; Joseph Koopmeiners, University of Minnesota
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Estimating Causal Effects from Using Augmented Inverse Probability Weighted Estimators When Noncompliance Is Measured with Error
David Vock, University of Minnesota; Jeffrey Boatman; Joseph Koopmeiners, University of Minnesota
8:55 AM
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Statistical Considerations in Clinical and Analytical Validations for Next Generation Sequencing Based GeneticTests
Jincao Wu, Food and Drug Administration; Meijuan Li, CDRH/FDA
9:35 AM
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Practical Considerations for Designing Pediatric Trials
Jerry Weaver, Celgene
9:50 AM
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Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance
Kefei Zhou, Theravance Biopharma; Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:35 AM
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