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Session 3: Expediting Companion Diagnostics for Accelerated Therapies and Beyond Breakthrough
Session Chair(s)
Megan Doyle, JD, MPH
Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly and Company, United States
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
President and Chief Executive Officer, Friends of Cancer Research, United States
Speaker
Wendy Rubinstein, MD, PHD, FACP
Director, Personalized Medicine, OIR, CDRH, FDA, United States
Speaker
Anthony Sireci, MD, MSC
Vice President, Diagnostics Development and Medical Affairs, Loxo Oncology at Lilly, United States
Speaker
Ivana Silva, MBA, MPHARM
Healthcare Professionals Relations Coordinator, European Medicines Agency, Netherlands
Speaker
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