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

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

Keyword Search Criteria: regulatory returned 19 record(s)

Sunday, 07/29/2018

Statistical Evaluation of Oncology Drug Trial Portfolios and the Potential for Inappropriate Regulatory Approval: a Simulation Study
Renee Gennarelli, Memorial Sloan Kettering Cancer Center; Peter Bach, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
3:20 PM

Modeling and Simulation Strategies in Tobacco Regulatory Science
George Rochester, FDA Center for Tobacco Products
4:05 PM

A Glimpse into Industry Experience with RWE to Transform Pharmaceutical Research and Development
James Harnett
4:25 PM

Models for Sensory Discrimination with Application to Tobacco Regulatory Science
Ghideon Solomon, FDA; George Rochester, FDA Center for Tobacco Products
5:25 PM

Monday, 07/30/2018

The Role of Real World Evidence in a Regulatory Environment: Focus on Safety
Estelle Russek-Cohen, US FDA CDER
8:35 AM

Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges
Lilly Yue, U.S. Food and Drug Administration; Nelson Lu, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:35 AM

Tuesday, 07/31/2018

Differences Between Telomerase Activation and ALT Based on the Theory of G-Networks
Kyung Hyun Lee, Rice University; Marek Kimmel, Rice University

Response to Regulatory Issues in an Adaptive Medical Device Study
Jill Stankowski, ICON Plc

Proteomics and Genomics Integration and Ovarian Cancer Survival
Umut Ozbek, Icahn School of Medicine at Mount Sinai; Christopher Conley, University of California at Davis; Jie Peng, UC Davis; Pei Wang, Icahn School of Medicine at Mount Sinai

Quantitative Regulatory Landscape
Lothar Tremmel, CSL Behring
8:35 AM

Inferring Gene Regulatory Networks from a Population of Yeast Segregants
Dabao Zhang, Purdue University
9:35 AM

Constructing Tumor-Specific Gene Regulatory Networks Based on Sample with Tumor Purity Heterogeneity
Pei Wang, Icahn School of Medicine at Mount Sinai ; Francesca Petralia, Icahn School of Medicine at Mount Sinai; Li Wang, Icahn School of Medicine at Mount Sinai; Jie Peng, UC Davis
2:05 PM

Inferring the Impact of Genetic Variation on Regulatory Networks
Sara Mostafavi
2:45 PM

Wednesday, 08/01/2018

Bayes in Drug Development for Rare Diseases
John Scott, FDA
11:35 AM

Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices
Martin Ho, FDA
2:25 PM

Achieving Regulatory Approvals Without a Randomized Control Study in Rare Infectious Disease
Masanori Ito, Astellas Pharma; Misun Yu Lee, Astellas Pharma
2:30 PM

Thursday, 08/02/2018

Utility and Challenges of Applying Quantitative Benefit-Risk Assessment for Regulatory Decision Making
Weili He, AbbVie; Bo Fu, Astellas Pharma Inc.; John Scott, FDA
8:50 AM

Statistical Challenges and Opportunities in Drug Development for Rare Diseases
Guowen Sun, BioMarin; Keith Gregg, BioMarin; Peter Slasor, BioMarin; Chito Hernandez, BioMarin Pharmaceutical Inc.
9:50 AM

Statistical Arguments for Regulatory Negotiation on Promising Subgroup Results
Ming-Xiu Hu, Nektar Therapeutics
11:35 AM

JSM 2018 Online Program

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American Statistical Association