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DIA 2021 Global Annual Meeting

Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?

Session Chair(s)

Megan Doyle, JD, MPH

Megan Doyle, JD, MPH

  • Global Policy Lead, Digital Health, Diagnostics, and Combination Products
  • Amgen, United States
Novel targeted therapies can reach patients faster than ever before. Many require development of a companion diagnostic. Novel solutions for expedited co-development and review practices is needed for CDx that are paired with accelerated therapeutics.
Learning Objective : Discuss methods to accelerate CDx co-development to enable earlier patient access to novel, innovative therapies; Describe current challenges in companion diagnostic co-development for accelerated therapies; Identify possible approaches to address this problem.

Speaker(s)

Jeff Allen, PhD

Panelist

Jeff Allen, PhD

  • President and Chief Executive Officer
  • Friends of Cancer Research, United States
Alberto Gutierrez, PhD

Panelist

Alberto Gutierrez, PhD

  • Partner
  • NDA Partners, United States
Wendy Rubinstein, MD, PhD, FACP

Panelist

Wendy Rubinstein, MD, PhD, FACP

  • Director, Personalized Medicine, OIR, CDRH
  • FDA, United States