AGENDA – DAY 1: Charting the Path for ctDNA as an Early Endpoint

12:00 PM – Welcoming Remarks

• Jeff Allen, Friends of Cancer Research

12:05 PM – Keynote Conversation

• Janet Woodcock, Acting Commissioner, U.S. FDA
• Ellen Sigal, Friends of Cancer Research

12:25 PM – Session 1: Charting the Path for ctDNA as an Early Endpoint

Overview: The Value of ctDNA Monitoring in Cancer

• Matthew Hellmann, Memorial Sloan Kettering Cancer Center

12:35 PM – Panel Discussion

• Kathleen Winson, Genentech, A Member of the Roche Group (Moderator)
• Chris Abbosh, AstraZeneca
• Valsamo Anagnostou, Johns Hopkins School of Medicine
• Jonathan Baden, Bristol Myers Squibb
• Reena Philip, CDRH, U.S. FDA
• Mark Sausen, Personal Genome Diagnostics
• Paz Vellanki, CDER, U.S. FDA

1:05PM – Closing Remarks

• Jeff Allen, Friends of Cancer Research

AGENDA – DAY 2: Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization

12:00 PM – Welcoming Remarks

• Jeff Allen, Friends of Cancer Research

12:05 PM – Session 2: Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization

Overview: Optimizing Dosing of Oncology Drugs

• Atik Rahman, U.S. FDA

12:15 PM – Panel Discussion

• Mark Ratain, University of Chicago (Moderator)
• Lokesh Jain, Merck
• Anne Loeser, Patient Advocate
• Mirat Shah, CDER, U.S. FDA
• Laurie Strawn, Pfizer

12:45 PM – Fireside Chat with the Oncology Center of Excellence

• Richard Pazdur, Director, Oncology Center of Excellence, U.S. FDA
• Julia Beaver, Chief of Medical Oncology, Oncology Center of Excellence, U.S. FDA
• Tamy Kim, Director for Regulatory Affairs and Regulatory Policy, Oncology Center of Excellence, U.S. FDA
• Paul G. Kluetz, Deputy Center Director, Oncology Center of Excellence, U.S. FDA
• Marc Theoret, Deputy Center Director, Oncology Center of Excellence, U.S. FDA

1:10 PM – Closing Remarks

• Jeff Allen, Friends of Cancer Research