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Session 1: PDUFA VI Pilot Program and Discussion
Session Chair(s)
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
Karen Lynn Price, PhD
Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
The Complex Innovative Trial Design (CID) Pilot Program was launched in August 2018 with the goal of advancing the use of novel designs when appropriate. The CID Pilot Program will achieve this goal through increased interactions between regulatory staff, industry, and public discussion of case examples for learning and information sharing. In this session, we will discuss the goals and progress of the program and set the stage for subsequent sessions by introducing case examples.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the hallmarks of the CID Pilot Program
- Discuss the progress of the CID Pilot Program
- Summarize examples of innovative designs in a regulatory environment
Speaker(s)
The Complex Innovative Trial Design Pilot Program: Setting the Stage
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
Panelist
William H. Dunn, MD
FDA, United States
Office Director, Office of Neuroscience, OND, CDER
Panelist
Danise Subramaniam, PhD
Regeneron, United States
Senior Director
Panelist
Abby Bronson, MBA
Edgewise Therapeutics, United States
Vice President, Patient Advocacy and External Innovation
Panelist
Representative Invited
Amgen, United States