Module 7 - Case Study 3: Acceleration of Phase 2 Study through the MIDD Pilot Program

Dr. Dinko Rekic of Astra-Zeneca shows how the FDA MIDD Pilot Program enabled a Phase 2 trial start prior to multiple standing dose (MAD) study completion and therefore resulted in a 6-month time gain without compromising the probability of success.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.