Ways to Improve Biomarker Qualification
A Friends of Cancer Research white paper makes the case for improving FDA’s Biomarker Qualification Program (BQP) and suggests three ways the program could be strengthened. “More than a decade after its establishment,” the paper says, “the BQP has not consistently functioned as a predictable or broadly used pathway for biomarker qualification. Relatively few biomarkers have achieved FDA qualification, reflecting both the scientific complexity of biomarker development and structural and operational limitations in the current framework…. In practice, many biomarkers achieve regulatory acceptance through program-specific pathways, including Investigational New Drug-based development and product-specific regulatory review. While these pathways support biomarker use within individual development programs, they often lack transparency, consistency, and mechanisms for broader adoption. They also operate largely in parallel with the BQP, with limited exchange of evidence across pathways. This fragmentation reduces efficiency, limits shared regulatory learnings, and constrains the broader impact of biomarkers.”
The paper says that while modernizing the BQP is necessary, the goal is not to rethink the purpose of qualification, but to operationalize that purpose more effectively, connecting evolving biomarker evidence to broader regulatory use, enabling regulatory confidence to build as evidence matures, and ensuring qualification provides a clear and useful signal for decision-making across drug development programs.
To develop its recommendations, Friends of Cancer Research convened a multi-stakeholder working group of regulatory, industry, and scientific experts with direct experience developing biomarkers and other drug development tools and navigating the qualification process.
The paper says the working group identified two root issues limiting the program’s effectiveness: (1) misalignment between the structure of the qualification pathway and the way biomarker evidence is generated and applied to practice; and (2) uncertainty regarding whether qualification provides a clear and predictable signal of regulatory acceptance beyond a single product or review context.
The group’s three targeted recommendations to strengthen the BQP are:
- establish predictable processes and clear accountability mechanisms;
- strengthen institutional and regulatory alignment; and
- modernize the BQP to align with evidence maturity.
The Friends of Cancer Research says near-term improvements could be advanced through FDA guidance, internal policy, and structured engagement to better operationalize the intended role of qualification. It says longer-term reforms may require legislative action, particularly to support formal tiered recognition, dedicated resourcing mechanisms, and clearer accountability for program performance.
“Together, these actions would help ensure qualification functions as a practical and reliable pathway for modern drug development, supporting more efficient translation of biomarker science into regulatory use and, ultimately, improved outcomes for patients,” the paper concludes.