Tuesday, June 9, 2026
1:00PM – 2:00PM ET  (10 AM – 11 AM in Arizona)
Location: Virtual

Register Today

 

Friends of Cancer Research (Friends) is hosting a Virtual Hill Briefing exploring opportunities to strengthen the FDA’s Biomarker Qualification Program (BQP). Biomarkers and early endpoints have the potential to modernize drug development, but the policies and processes to validate, qualify, and support broader adoption have not kept pace with scientific progress.

The BQP was designed to support broader use of biomarkers across development programs, but its impact has been limited. A streamlined pathway for predictable, efficient, and evidence-driven biomarker development will yield critical tools to aid safety assessment and accelerate clinical trials.

More predictable biomarker development matters for researchers, FDA, and ultimately for patients waiting on the next generation of precision therapies.

The briefing will highlight practical opportunities for the FDA and Congress to strengthen the regulatory pathways needed to support more efficient development, qualification, and broader adoption of biomarkers and novel endpoints. Access the agenda below.

 

Agenda

Opening Keynote (To Be Announced)

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 – Moderator
• Steve Hoffmann, Foundation for the NIH
• Mike Montalto, Amgen
• Lauren Oliva, Biogen
• Katy Wack, PathAI
• Meeting Adjourned

Agenda is subject to change.