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Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
Session Chair(s)
Rajanikanth Madabushi, PhD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
The PDUFA VI ‘goals letter’ identified MIDD and CID as enhancing regulatory decision tools. Starting in FY2018, the FDA committed to conduct pilot program for these. This session presents the experiences and learnings from the two pilot programs.
Learning Objective : Discuss the status and share experience of the MIDD and CID programs; Summarize high level insights on the scope and process of the programs.
Speaker(s)
Rajanikanth Madabushi, PhD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Update on PDUFA VI MIDD Pilot Program
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Update on the PDUFA VI CID Pilot Program
Issam Zineh, PharmD, MPH
Director, Office of Clinical Pharmacology, OTS, CDER, FDA, United States
Moderator
Yaning Wang, PhD
Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States
Panelist
Cristiana Mayer, DRSc, PhD
Head of Biostatistics, Johnson & Johnson Vision, United States
Panelist
Brian Corrigan, PhD
Global Head, Clinical Pharmacology, Pfizer Inc, United States
Panelist
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