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DIA 2021 Global Annual Meeting
Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?
Megan Doyle, JD, MPH
- Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
- 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.
Jeff Allen, PhD
- President and Chief Executive Officer
- Friends of Cancer Research, United States
Alberto Gutierrez, PhD
- NDA Partners, United States
Wendy Rubinstein, MD, PhD, FACP
- Director, Personalized Medicine, OIR, CDRH
- FDA, United States