Biomarker Qualification Project
Modernizing Biomarker Qualification to Advance Drug Development
What is the unmet need and why does it matter?
Biomarkers are central to modern drug development, enabling more efficient clinical trials, supporting precision medicine, and informing regulatory decision-making. The FDA’s Biomarker Qualification Program (BQP) was established to provide a structured pathway for evaluating biomarkers for a defined context of use. Once qualified, the biomarker can be used across multiple development programs within the specified context of use without repeated evidentiary review.
More than a decade after its establishment, relatively few biomarkers have achieved qualification. The BQP remains less predictable and broadly used than intended, reflected by both the scientific complexity of biomarker development and challenges in the current framework, including unclear evidentiary expectations, lengthy and variable review timelines, and limited clarity on how qualified biomarkers are applied across FDA review divisions. As a result, many biomarkers advance through program-specific pathways that limit opportunities to translate evidence generated in one development program into broader regulatory use.
How is Friends helping to find solutions?
Through Friends’ broader work to advance biomarkers, early endpoints, and other drug development tools for regulatory decision-making, we identified a need to ensure we have a functional and modern biomarker qualification pathway.
Friends Early Endpoint Portfolio focuses on developing early endpoints for regulatory decision-making. Through discussions with these working groups and an evaluation of BQP’s performance and experience to date, we recognized a need for updated processes to qualify biomarkers and ensure their use could go beyond a single program.
Friends first evaluated the BQP’s performance and experience to date to assess how effectively the program has functioned, which identified challenges related to biomarker qualification project uptake and progression through the qualification process, as well as review timelines that can make the program difficult to navigate. Building on those findings, Friends convened a multi-stakeholder working group of regulatory, industry, and scientific experts with direct experience developing biomarkers and navigating the qualification process.
Together, the group developed targeted recommendations to modernize the program, including establishing more predictable processes and clearer accountability mechanisms, strengthening institutional and regulatory alignment across FDA review divisions, and better aligning the BQP with how evidence supporting the use of biomarkers, novel endpoints, and other drug development tools evolves over time. This includes a proposed tiered, risk-based qualification framework to better characterize the acceptable uses of a biomarker at different stages of its development and allow its regulatory use to expand as additional evidence is generated.
This work aims to help ensure qualification functions as a practical, reliable pathway for advancing biomarker evidence to broader regulatory use.
How does this impact patients?
A modernized BQP could help move scientifically validated biomarkers from individual development programs into broader regulatory use more efficiently, reducing duplicative evidence generation and supporting more consistent application across programs.
For patients, broader use of well-validated biomarkers can support more efficient and interpretable clinical trials, including by helping identify patients most likely to benefit from a treatment, inform dosage selection, assess treatment response, and monitor safety.
Project Outcomes
Friends prioritizes sharing findings from our projects with the public to inform policy:
Friends Led Peer-Reviewed Literature
Collins G, Allen J, Andrews HS, Navarro-Serer B, Stewart MD. Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program. Springer Nature V60 (2025). DOI:10.1007/s43441-025-00889-6
Friends Public Meetings
In June 2026, Friends held a Virtual Hill Briefing exploring opportunities to strengthen the FDA’s BQP. 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.