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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)
Matthew Raymond, PhD
Director, Science and Regulatory Policy, Astellas, United States
Moderator
Rajanikanth Madabushi, PhD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Model-Informed Drug Development Pilot Program: FDA Perspective
Daniele Ouellet, PhD
Global Head Pharmacometrics, Pfizer Inc, United States
Industry Perspective on MIDD
Samantha Roberts, PhD
Senior Director, Regulatory Intelligence, AstraZeneca, United States
MIDD Pilot Program: Lessons Learned
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