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Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years
Session Chair(s)
Bonnie Brennan, PHARMD
Senior Director, Clinical Pharmacology Lead, Bayer, United States
We will share experience with Model Informed Drug Development (MIDD) Pilot Program over the past three years from the perspective of FDA and pharma industry experts including a discussion of key learnings, best practices, and impact on the development and regulatory strategy.
Learning Objective : Summarize experience with the Model Informed Drug Development (MIDD) Pilot Program over the past three years from FDA and pharma industry perspective; Evaluate detailed MIDD case studies from experts in the field including key learnings and impact on the development and regulatory strategy; Discuss best practices for the future.
Speaker(s)
Rajanikanth Madabushi, PHD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Experience and Impact of Model-Informed Drug Development (MIDD) Pilot Program: FDA Perspective
Spyros Stamatelos, PHD
Group Leader, Sanofi, United States
Prediction of Cytokine Release and Active Dose of a CD3-CD28-CD38 Trispecific Antibody for Multiple Myeloma: Utilization of a Systems Pharmacology Platform for Multispecific T Cell Engagers
Patrick Smith, PHARMD
Senior Vice President, Integrated Drug Development , Certara, United States
Industry Update
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