The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) was formed in 2006 in collaboration with the National Institutes of Health (NIH), the FDA, the Centers for Medicare and Medicaid Services (CMS), the Biotechnology Industry Organization (BIO) and the Pharmaceuticals Research and Manufacturers Association (PhRMA). The BC is set up to address specific biomarker projects in the precompetitive space, and its focus is on developing biomarkers for specific applications that accelerate drug development, inform regulatory decision-making and improve clinical practice. These open and collaborative projects foster precompetitive exchange of knowledge and expertise, with all stakeholders having a voice in the direction of projects. The spirit of collaboration extends beyond individual projects; an important aspect of all the BC projects is that the project results and data are made available to the entire scientific community. In this article, which is based on a recent strategic review of the BC, we discuss the achievements so far, as well as new opportunities created by challenges that have developed in the last 12 years, including the need to expand the scope of the BC to formally include projects beyond biomarkers such as patient-reported outcomes and clinical outcome assessments (COAs).
The authors acknowledge the contribution of J. Altshuler and S. Staats from Altshuler and Staats for their work on the strategic analysis, as well as the support and feedback from the members of the Biomarkers Consortium executive committee, particularly P. Herrling, chair of the executive committee and FNIH board member.
J.A.W. is an employee of Takeda Pharmaceuticals. J.P.M., C.A., L.S.B., G.E., C.L. and A.M. declare no conflicts.