New Policy Recommendations
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New Policy White Paper Released: Strengthening FDA’s Biomarker Qualification Program 

Friends of Cancer Research (Friends) releases a new white paper outlining policy recommendations to strengthen FDA’s Biomarker Qualification Program (BQP), the primary pathway for evaluating and qualifying biomarkers for use across drug development programs. 

Biomarkers are central to modern drug development, supporting more efficient clinical trials, precision medicine, and regulatory decision-making. Yet persistent challenges related to transparency, review timelines, and the ability to build on prior evidence and regulatory experience have limited the BQP’s effectiveness as a predictable pathway for biomarker qualification.  

Developed with input from a multi-stakeholder working group, the white paper identifies opportunities to strengthen the BQP by: 

  • Improving predictability, transparency, and accountability throughout the qualification process
  • Strengthening alignment around how to interpret qualified biomarkers and apply them in regulatory decision-making 
  • Modernizing the BQP to support a more flexible, risk-based qualification framework that builds on prior knowledge, regulatory experience, and the maturity of available evidence


These recommendations will be discussed during Friends Virtual Hill briefing on June 9th, featuring an opening keynote from U.S. Senator Tim Kaine and a panel discussion on biomarker development and qualification with working group representatives.  

View the agenda below and explore panelist biographies.

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
  • Mike Montalto, Amgen Inc.
  • Lauren Oliva, Biogen
  • Katy Wack, PathAI 

About Friends of Cancer Research

Friends of Cancer Research (Friends) powers advances in science and policy that speed life-saving treatments to patients. Friends aims to accelerate cutting edge cancer care that both extends and improves quality of life for patients. To accomplish this, we leverage groundbreaking collaborations, generate scientific evidence, and integrate patient input to shape public policy. 
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