
Legend:
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
|
|