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Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?
Session Chair(s)
Megan Doyle, JD, MPH
Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly and Company, 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
President and Chief Executive Officer, Friends of Cancer Research, United States
Panelist
Alberto Gutierrez, PHD
Partner, NDA Partners, United States
Panelist
Wendy Rubinstein, MD, PHD, FACP
Director, Personalized Medicine, OIR, CDRH, FDA, United States
Panelist
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