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