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Virtual

Dec 08, 2021 9:50 AM - Dec 09, 2021 4:30 PM

(US Eastern Standard Time)

Diagnostics and Personalized Medicine Conference

This event is now offered in a new entirely virtual format.

Session 3: Expediting Companion Diagnostics for Accelerated Therapies and Beyond Breakthrough

Session Chair(s)

Megan  Doyle, JD, MPH

Megan Doyle, JD, MPH

Associate Vice President, Assistant General Counsel - Diagnostics

Eli Lilly & Company, United States

Mark  Stewart, PhD

Mark Stewart, PhD

Vice President, Science Policy

Friends of Cancer Research, United States

In recent years, we’ve seen an explosion in the development of novel therapies targeting rare mutations or biomarkers, particularly in cancer. The unmet need for these treatments is high, and thus many of these therapies have been approved for marketing via expedited regulatory programs. Developing a companion diagnostic for these therapies is challenging given the expedited timeframe and the rarity of samples needed for development. This session will discuss this challenge and brainstorm potential solutions.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss current challenges in developing companion diagnostics for rare biomarkers/diseases/mutations
  • Identify flexibilities that could be applied or options to consider addressing these challenges
  • Discuss methods for advancing the development of companion diagnostics in areas of high unmet need

Speaker(s)

Jeff  Allen, PhD

Speaker

Jeff Allen, PhD

Friends of Cancer Research, United States

President and Chief Executive Officer

Wendy  Rubinstein, MD, PhD, FACP

Speaker

Wendy Rubinstein, MD, PhD, FACP

FDA, United States

Director, Personalized Medicine, OIR, CDRH

Anthony  Sireci, MD, MSc

Speaker

Anthony Sireci, MD, MSc

Loxo Oncology at Lilly, United States

Vice President, Diagnostics Development and Medical Affairs

Ivana  Silva, MBA, MPharm

Speaker

Ivana Silva, MBA, MPharm

European Medicines Agency, Netherlands

Healthcare Professionals Relations Coordinator

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