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ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development
Session Chair(s)
Samantha Roberts, PHD
Senior Director, Regulatory Intelligence, AstraZeneca, United States
This forum will present case studies from FDA’s Model-Informed Drug Development pilot program. A panel of experts will provide their perspectives on how key learnings from the pilot can be used to advance the acceptability and use of modeling.
Learning Objective : Describe potential applications of modeling to inform and accelerate drug development; Discuss lessons from FDA's Model-Informed Drug Development (MIDD) pilot program; Identify opportunities to use learnings from pilot program to facilitate more routine adoption of MIDD in the future.
Speaker(s)
Moderator
Director, Science and Regulatory Policy, Astellas, United States
Model-Informed Drug Development Pilot Program: FDA Perspective
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Industry Perspective on MIDD
Global Head Pharmacometrics, Pfizer Inc, United States
MIDD Pilot Program: Lessons Learned
Senior Director, Regulatory Intelligence, AstraZeneca, United States
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