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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)
Experience and Impact of Model-Informed Drug Development (MIDD) Pilot Program: FDA Perspective
Rajanikanth Madabushi, PhD
FDA, United States
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
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
Spyros Stamatelos, PhD
Sanofi, United States
Group Leader
Industry Update
Patrick Smith, PharmD
Certara, United States
Senior Vice President, Integrated Drug Development
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