Thursday, February 5, 2026
9:00AM – 2:00PM ET
Friends of Cancer Research (Friends) hosted a public meeting, Modernizing Oncology Endpoints: Pathways for Evidence and Policy, to review the current landscape and application of evolving early endpoints—such as ctDNA and (AI)-enabled tumor assessments—and explore how they may improve trial efficiency and inform regulatory decision-making. The meeting featured dedicated sessions on ctDNA and AI-enabled tumor assessment tools, as well as a broader discussion on the regulatory and policy considerations needed to support modernization of oncology endpoints.
AGENDA
8:30AM | Networking Breakfast
9:00AM | Welcome & Opening Remarks
9:05AM | Keynote Address
- The Honorable Diana DeGette, U.S. Representative (CO-01)
9:15AM | Keynote Fireside
- Richard Pazdur, Former Director, Oncology Center of Excellence, FDA
- Janet Woodcock, Former Principal Deputy Commissioner of the FDA
- Kate Rawson, Prevision Policy – Moderator
9:45AM | Session 1 – ctDNA: Lessons Learned and Future Directions
Session 1 provided an overview of new results from the ctMoniTR Project, examine how ctDNA may function as an early endpoint in oncology trials, and discuss evidence needs for integration into drug development.
- Névine Zariffa, NMD Group – Moderator
- Jon Baden, Bristol Myers Squibb
- Shibing Deng, Pfizer Inc.
- Minetta Liu, Natera Inc.
- Paz Vellanki, FDA
11:00AM | Break
11:15AM | Session 2 – AI-Enabled Tumor Assessments: Opportunities and Challenges for Incorporation into Clinical Trials
Session 2 discussed insights from Friends ai.RECIST Project and evaluate opportunities to incorporate AI-enabled tumor assessment tools into clinical trials, including how automated imaging tools could support more efficient trial operations and the development of novel endpoints.
- Ariel Bourla, Johnson & Johnson – Moderator
- Felix Baldauf-Lenschen, Altis Labs
- Lauren Brady, Genmab
- Nathaniel Braman, Picture Health
- Lia Ridout, Friends Advisory Advocate
- Larry Schwartz, Memorial Sloan Kettering Cancer Center
- Alain Silk, Tempus AI
12:30PM | Lunch & Networking
1:15PM | Session 3 – Modernizing Regulatory Frameworks: Future Policies & Priorities
Session 3 explored regulatory and policy implications of integrating novel measurement tools and endpoints into clinical development programs and examine opportunities to advance frameworks that support their use.
- Jeff Allen, Friends of Cancer Research – Moderator
- Tala Fakhouri, Parexel
- Michael Montalto, Amgen Inc.
- John Stone, BGR Group
- Lowell Zeta, FDA
1:55PM | Closing Remarks
2:00PM | Meeting Adjourned