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

Activity Details

150 * ! Mon, 7/30/2018, 10:30 AM - 12:20 PM CC-East 17
Lead with Statistics in Medical Device Innovations and Beyond — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal
Organizer(s): Yunling Xu, FDA/CDRH
Chair(s): Rajesh Nair, CDRH/FDA
10:35 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
10:55 AM A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies

Chenguang Wang, John Hopkins University; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
11:15 AM Bayesian Approach for Benefit-Risk Assessment with Examples

Ram Tiwari, Center for Devices and Radiologica Health, FDA
11:35 AM Statistics of Counting Molecules for Precision Medicine
Svilen Tzonev
11:55 AM Discussant: Gregory Campbell, GCStat Consulting
12:15 PM Floor Discussion