Tuesday, June 9, 2026
1:00PM – 2:00PM ET
Location: Virtual
White Paper Panelist Biographies
Friends of Cancer Research (Friends) hosted a Virtual Hill Briefing exploring opportunities to strengthen the FDA’s Biomarker Qualification Program (BQP). The BQP was designed to support broader use of biomarkers across development programs, but experience to date shows the pathway has not worked as reliably or predictably as intended. Strengthening the program is critical to ensuring promising biomarkers can be used more consistently in clinical trials and regulatory decision-making.
The briefing opened with remarks from U.S. Senator Tim Kaine (D-VA) and a presentation from Jeff Allen, Friends of Cancer Research President and CEO. An expert panel discussed challenges with the current BQP and policy opportunities for Congress and the FDA to strengthen biomarker pathways to support more efficient clinical trials, faster development of new therapies, and better regulatory decision-making. More predictable biomarker development matters for researchers, the FDA, and ultimately, for patients waiting on the next generation of precision therapies.
Agenda
Opening Remarks
- Ellen Sigal, Friends of Cancer Research
Opening Keynote
- The Honorable Tim Kaine, U.S. Senator (D-VA)
Setting the Stage: The Role of Biomarkers and the FDA’s Qualification Program
- Jeff Allen, Friends of Cancer Research
Panel Discussion: Strengthening the Biomarker Qualification Framework
- Rasika Kalamegham, Genentech, a member of the Roche group – Moderator
- Steve Hoffmann, Foundation for the NIH
- Michael Montalto, Amgen Inc.
- Lauren Oliva, Biogen
- Katy Wack, PathAI