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

Activity Details

493 * ! Wed, 7/31/2019, 10:30 AM - 12:20 PM CC-506
Leveraging Historical Data and Real World Evidence in Drug Development Program Evaluation — Topic Contributed Papers
Health Policy Statistics Section, Biopharmaceutical Section, International Chinese Statistical Association
Organizer(s): Freda Cooner, Amgen Inc.
Chair(s): Yang Wang, Amgen
10:35 AM From Quantitative Drug Safety to Real-World Evidence: Activities at the US FDA
Hana Lee, U.S Food and Drug Administration; Mark Levenson, FDA CDER
10:55 AM Leveraging Historical Data in Diabetes Cardiovascular Outcome Trials
Shuang Li, Southern Methodist University; Freda Cooner, Amgen
11:15 AM Sources of Data and Statistical Strategies for Design and Analysis: Real World Insights

Olga Marchenko, Bayer
11:35 AM Real World Evidence Use in CBER
Jennifer Kirk, FDA, Center for Biologics Evaluation and Research (CBER)
11:55 AM Discussant: Freda Cooner, Amgen Inc.
12:15 PM Floor Discussion