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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)
Update on PDUFA VI MIDD Pilot Program
Rajanikanth Madabushi, PhD
FDA, United States
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
Update on the PDUFA VI CID Pilot Program
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
Moderator
Issam Zineh, PharmD, MPH
FDA, United States
Director, Office of Clinical Pharmacology, OTS, CDER
Panelist
Yaning Wang, PhD
FDA, United States
Director, Division of Pharmacometrics, OCP, OTS, CDER
Panelist
Cristiana Mayer, DrSc, PhD
Johnson & Johnson Vision, United States
Head of Biostatistics
Panelist
Brian Corrigan, PhD
Pfizer Inc, United States
Global Head, Clinical Pharmacology
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