Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme
Activity Details
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493 * !
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Wed, 7/31/2019,
10:30 AM -
12:20 PM
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CC-506
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Leveraging Historical Data and Real World Evidence in Drug Development Program Evaluation — Topic Contributed Papers
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Health Policy Statistics Section, Biopharmaceutical Section, International Chinese Statistical Association
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Organizer(s): Freda Cooner, Amgen Inc.
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Chair(s): Yang Wang, Amgen
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10:35 AM
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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
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10:55 AM
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Leveraging Historical Data in Diabetes Cardiovascular Outcome Trials
Shuang Li, Southern Methodist University; Freda Cooner, Amgen
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11:15 AM
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Sources of Data and Statistical Strategies for Design and Analysis: Real World Insights
Olga Marchenko, Bayer
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11:35 AM
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Real World Evidence Use in CBER
Jennifer Kirk, FDA, Center for Biologics Evaluation and Research (CBER)
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11:55 AM
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Discussant: Freda Cooner, Amgen Inc.
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12:15 PM
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Floor Discussion
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