Participants in the FDA's Biomarker Qualification Program

Abstract

The US FDA's Biomarker Qualification Program (BQP) aims to validate biomarkers for use in the therapeutic development process. Applicants to this program are not restricted to just pharmaceutical firms and a variety of incentives may underlie applicants' decision to participate. Of the 80 biomarker qualification programs that were initiated through February 2025, we find that academic organizations (70.0%) are the most common applicants, followed by pharmaceuticals-related industries (55%), government entities (51.25%), and pharmaceutical firms (50%), although much of this activity is in the context of multi-party consortia. With respect to stage of development, all phase-I-related biomarkers are developed in some form of partnership, while academic institutions alone and foundations devote slightly more attention to trial endpoints as a total share of BQP activities. These findings shed light on the incentives at play and the types of stakeholders that have been active in the development of these tools to date.