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Session 3: Expediting Companion Diagnostics for Accelerated Therapies and Beyond Breakthrough
Session Chair(s)
Megan Doyle, JD, MPH
Global Policy Lead, Digital Health, Diagnostics, Oncology
Amgen, 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)
Speaker
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
Speaker
Wendy Rubinstein, MD, PhD, FACP
FDA, United States
Director, Personalized Medicine, OIR, CDRH
Speaker
Anthony Sireci, MD, MSc
Loxo Oncology at Lilly, United States
Vice President, Diagnostics Development and Medical Affairs
Speaker
Ivana Silva, MBA, MPharm
European Medicines Agency, Netherlands
Healthcare Professionals Relations Coordinator