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Wednesday, June 26 • 2:00pm - 3:15pm
#367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-691-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss the status and share experience of the MIDD and CID programs; Summarize high level insights on the scope and process of the programs.

Chair

Rajanikanth Madabushi, PhD

Speaker

Update on PDUFA VI MIDD Pilot Program
Rajanikanth Madabushi, PhD

Update on the PDUFA VI CID Pilot Program
Dionne Price, PhD

Moderator
Issam Zineh, PharmD, MPH

Panelist
Yaning Wang, PhD

Panelist
Cristiana Mayer, DrSc, PhD

Panelist
Brian Corrigan, PhD


Speakers
BC

Brian Corrigan

Global Head, Clinical Pharmacology, Pfizer Inc
Brian Corrigan is Vice President and Global Head of Clinical Pharmacology and Head of Clinical Pharmacology for Global Product Development at Pfizer in Groton, Connecticut. In these roles, Brian directly oversees the Global Clinical Assay Group, the Global Pharmacometrics Group, and... Read More →
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →
avatar for Cristiana Mayer

Cristiana Mayer

Director, Statistics and Decision Sciences, Janssen Research & Development, LLC
Cristiana Mayer is Director at Statistics and Decision Sciences, at Janssen R&D, Johnson & Johnson, with 20+ years of experience in the pharmaceutical industry. Cristiana is also the Head of the Adaptive Clinical Trials Center of Excellence at Janssen, and Vice-Chair of the DIA Adaptive... Read More →
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial... Read More →
avatar for Yaning Wang

Yaning Wang

Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA
Dr. Yaning Wang is the Director of the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained... Read More →
avatar for Issam Zineh

Issam Zineh

Director, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum