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Tommy Douglas Conference Center

02 mar 2020 7:00 a.m. - 03 mar 2020 5:15 p.m.

10000 New Hampshire Ave, Silver Spring, MD 20903

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

FDA, United States

Deputy Director, Office of Biostatistics, OTS, CDER

William  H.  Dunn, MD

Panelist

William H. Dunn, MD

FDA, United States

Office Director, Office of Neuroscience, OND, CDER

Danise  Subramaniam, PhD

Panelist

Danise Subramaniam, PhD

Regeneron, United States

Senior Director

Abby  Bronson, MBA

Panelist

Abby Bronson, MBA

Edgewise Therapeutics, United States

Vice President, Patient Advocacy and External Innovation

Representative Invited

Panelist

Representative Invited

Amgen, United States

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