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

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.

Figure 1

Stages of biomarkers discovery and development. Different stages of biomarker discovery and development are expected to produce different results and therefore expected impact and success. FDA, US Food and Drug Administration.

Figure 2

Timeline of projects that were approved and initiated in the Biomarkers Consortium. The projects that have been approved in the Biomarkers Consortium are shown as a function of year of Executive Committee approval. The size to the marker is proportional to the number of projects approved during that calendar year (4 is the largest). The color of the marker sectors represents the highest level of success that the project has attained as of the writing of this review. FDA, US Food and Drug Administration.

Figure 3

Project flow for the antibacterial clinical outcome measure project. ABSSSI, acute skin and skin structure infection; BC, Biomarkers Consortium; CABP, community‐acquired bacterial pneumonia; FDA, US Food and Drug Administration; FNIH, Foundation for the National Institutes of Health; HABP, hospital‐acquired bacterial pneumonia; IDSA, Infectious Diseases Society of America; KOLs, key opinion leaders; NIH, National Institutes of Health; PRO, patient‐reported outcome; VABP, ventilator‐associated bacterial pneumonia.

Figure 4

Project flow for the osteoarthritis (OA) biomarker project. BL, baseline; FDA, US Food and Drug Administration; FNIH, Foundation for the National Institutes of Health; KOLs, key opinion leaders; MCID, minimal clinically important difference; minJSW, minimal joint space width; MRI, magnetic resonance imaging; NIH, National Institutes of Health; OAI, Osteoarthritis Initiative; OARSI, Osteoarthritis Research Society International; WOMAC, Western Ontario and McMaster Universities.

Figure 5

Project flow for the Sarcopenia biomarker project. BC, Biomarkers Consortium; FDA, US Food and Drug Administration; FNIH, Foundation for the National Institutes of Health; HRS, Health and Retirement Study; KOLs, key opinion leaders; NHATS, National Health and Aging Trends Study; NIH, National Institutes of Health; RCTs, randomized controlled trials.

Figure 6

Evidentiary criteria framework for safety biomarkers qualification. COU, context of use.

Figure 7

Results of Biomarkers Consortium (BC) Committee Member Survey. The Biomarkers Consortium Executive and Steering Committee members were asked to provide a perceived level of importance on different areas of drug discovery tool development. The results of this survey are shown and are reported a percent of members that thought that the particular area was important for the consortium to address.