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DIA 2021 Global Annual Meeting


Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years

Session Chair(s)

Bonnie  Brennan, PharmD

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

Experience and Impact of Model-Informed Drug Development (MIDD) Pilot Program: FDA Perspective

Rajanikanth Madabushi, PhD

  • Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
  • FDA, United States
Spyros  Stamatelos, PhD

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

  • Group Leader
  • Sanofi, United States
Patrick  Smith, PharmD

Industry Update

Patrick Smith, PharmD

  • Senior Vice President, Integrated Drug Development
  • Certara, United States