ArticleTherapeutic innovation & regulatory science2026
Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- First-in-human to proof-of-concept: why experimental medicine studies remain essential in human physiology and drug development.Pflugers Archiv : European journal of physiology · 2026Review
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsWe collected characteristics and submission dates for accepted biomarker qualification projects from the FDA's Drug Development Tool Qualification Project Search database.
resultsAs 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.
conclusionThe 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.
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Registered trials
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