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Session 2: Early Development Use Cases
Session Chair(s)
Charles Lee, MBA, MS
Executive Regulatory Science Director
AstraZeneca, United States
Session 2: Early Development Use Cases
Speaker(s)
Beyond External Control Arms: Utility of Real-World Data in Oncology Regulatory Applications
Ulka B Campbell, PhD
Aetion Inc, United States
Head of Scientific Strategy
Why and How: An External Control Used to Contextualize the Results of an Early Phase Single Arm Metastatic Pancreatic Study
Lisa Ensign, PhD, MSc
Medidata, a Dassault Systemes Company, United States
VP, Statistics and Regulatory Science Innovation
Endpoints Optimization for Clinical Trials in Myotonic Dystrophy Type 1 (DM1): A Real World Data-driven Approach
Representative Invited
Sanofi, France
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