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DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Session 1: PDUFA VI Pilot Program and Discussion

Session Chair(s)

Dionne Price, PhD

Dionne Price, PhD

  • Deputy Director, Office of Biostatistics, OTS, CDER
  • FDA, United States
Karen Lynn Price, PhD

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)

Dionne Price, PhD

The Complex Innovative Trial Design Pilot Program: Setting the Stage

Dionne Price, PhD

  • Deputy Director, Office of Biostatistics, OTS, CDER
  • FDA, United States
William H. Dunn, MD

Panelist

William H. Dunn, MD

  • Office Director, Office of Neuroscience, OND, CDER
  • FDA, United States
Danise Subramaniam, PhD

Panelist

Danise Subramaniam, PhD

  • Senior Director -- Global Regulatory Affairs
  • Eli Lilly and Company, United States
Abby Bronson, MBA

Panelist

Abby Bronson, MBA

  • Vice President, Patient Advocacy and External Innovation
  • Edgewise Therapeutics, United States
Representative Invited

Panelist

Representative Invited

  • Amgen Inc, United States

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Additional Information

Complex Innovative Clinical Trial Designs Resource Kit

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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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