Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program.

BACKGROUND

The Biomarker Qualification Program (BQP), formally established in 2016 under the 21st Century Cures Act, is a key pathway for developing novel biomarkers for regulatory use. We evaluated eight years of BQP experience to assess whether it has facilitated the qualification of novel biomarkers.

METHODS

We collected characteristics and submission dates for accepted biomarker qualification projects from the FDA's Drug Development Tool Qualification Project Search database.

RESULTS

As of July 1, 2025, 61 projects were accepted into the BQP. Safety (30%), Diagnostic (21%), and PD Response (20%) biomarkers were the most common. Projects primarily used molecular (46%) and radiologic/imaging (39%) methods and were split between measures of a disease/condition or drug response/effect of exposure. Few projects included surrogate endpoint biomarkers (n = 5). Half of the accepted projects remained at the initial Letter of Intent (LOI) stage, and only eight biomarkers were qualified through the program. LOI and Qualification Plan (QP) reviews frequently exceeded FDA targets by three months and seven months, respectively. For projects reaching the QP stage, QP development took a median of 32 months, with surrogate endpoints taking 47 months.

CONCLUSION

The BQP supports the development of certain biomarkers but has seen limited use for biomarkers intended as surrogate endpoints. Coupled with longer timelines for their QP development, these trends demonstrate the program may not be well-suited for advancing novel response biomarkers. Given significant stakeholder interest in novel surrogate measures, a dedicated program may better support novel response biomarker development, particularly for biomarkers with applicability across multiple drug development programs.