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Clin Pharmacol Ther. 2019 Apr;105(4):829-843. doi: 10.1002/cpt.1362.

The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.

Author information

1
Foundation for the National Institutes of Health, North Bethesda, Maryland, USA.
2
National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USA.
3
Foundation for the National Institutes of Health, Bethesda, Maryland, USA.
4
Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA.

Abstract

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) is a public-private partnership that aims to facilitate drug development with biomarkers across a range of therapeutic areas. The BC is organized to address specific precompetitive biomarker projects, giving participating stakeholders a role in the design and conduct of projects and making the results freely public. Ultimately, the goals of the BC are to accelerate the development of new medicines, inform regulatory decision making, and improve patient care. Here, we describe how the BC works and briefly highlight its accomplishments. The BC has had many notable successful biomarker projects in the past 12 years, including I-SPY2, which has improved clinical trials and biomarker use for breast cancer, and an evidentiary framework for biomarker qualification. Recently, the BC has undergone a strategic expansion of its scope to include related drug development tools along the lines of the Biomarkers, Endpoints, and other Tools (BEST) resource.

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