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Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

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Participants in the FDA's Biomarker Qualification Program.

Mahnum Shahzad^1,2, Ariel D Stern^2,3

¹Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, Massachusetts, USA.

Clinical Pharmacology and Therapeutics

|April 9, 2025

Summary

Academic organizations, not just pharmaceutical firms, are the primary applicants to the US Food and Drug Administration's Biomarker Qualification Program (BQP). This program validates biomarkers for drug development, with diverse stakeholders participating.

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Area of Science:

Biomedical research
Drug development
Regulatory science

Background:

The US Food and Drug Administration's (FDA) Biomarker Qualification Program (BQP) validates biomarkers for therapeutic development.
Applicant diversity extends beyond pharmaceutical firms, with various incentives driving participation.

Purpose of the Study:

To analyze the types of organizations applying to the BQP.
To understand stakeholder involvement and incentives in biomarker development.

Main Methods:

Analysis of 80 biomarker qualification programs initiated through February 2025.
Categorization of applicants including academic organizations, pharmaceutical industries, government entities, and pharmaceutical firms.
Examination of development stages and partnership structures.

Main Results:

Academic organizations are the most frequent applicants (70.0%), followed by pharmaceutical-related industries (55%), government entities (51.25%), and pharmaceutical firms (50%).
Much of the activity involves multi-party consortia.
Phase-I biomarkers are exclusively developed in partnerships; academic institutions and foundations focus more on trial endpoints.

Conclusions:

Biomarker development within the BQP involves a diverse range of stakeholders, with academic institutions playing a leading role.
Partnership models are crucial, especially for early-stage biomarker development.
Understanding stakeholder incentives is key to the successful advancement of biomarker tools.