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Wednesday, June 30 • 4:00pm - 5:00pm
#359 SL: Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-633-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Megan Doyle, JD, MPH


Jeff Allen, PhD

Alberto Gutierrez, PhD

Wendy Rubinstein, MD, PhD, FACP

avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
avatar for Alberto Gutierrez

Alberto Gutierrez

Partner, NDA Partners, United States
Alberto Gutierrez, PhD is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2017. He is an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, premarket notifications of devices, applications... Read More →
avatar for Wendy Rubinstein

Wendy Rubinstein

Director, Personalized Medicine, OIR, CDRH, FDA, United States
Dr. Wendy Rubinstein is a physician-scientist who is Director of Personalized Medicine at FDA / CDRH. She co-discovered the SDHD gene for hereditary paraganglioma syndrome and directed academic cancer genetics programs for 15 years at three NCI-designated Comprehensive Cancer Centers... Read More →

Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum