06/04/2026
Friends of Cancer Research has released a new policy white paper recommending ways to strengthen the FDA’s Biomarker Qualification Program (BQP), the primary pathway for qualifying tools to support the evaluation of drug safety and efficacy.
Biomarkers play a central role in modern drug development, enabling more efficient clinical trials, supporting precision medicine, and informing regulatory decision-making. However, as of July 2025, fewer than 15% of biomarkers accepted into the BQP have completed qualification, with the majority remaining stalled in the program for years. Issues related to transparency, review timelines, and limited ability to incorporate prior evidence have constrained the program’s effectiveness.
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.
Together, these recommendations aim to make the BQP a more practical and consistent pathway across modern drug development to help patients get safe and effective therapies faster. Read the full white paper: https://bit.ly/4u8ZdO8.
The conversation will continue at our June 9th virtual Hill briefing, featuring opening remarks from U.S. Senator Tim Kaine and an expert panel discussion about biomarker development and qualification to explore how FDA and Congress can make the BQP more efficient, consistent, and useful across drug development programs.
View the agenda and register: https://friendsofcancerresearch.org/event/virtual-hill-briefing-strengthening-fdas-biomarker-qualification-program/.
Thank you to our working group members for their time and contributions.