Celebrating Two Decades of Biomarker Innovation
NIH’s Pivotal Role in the FNIH Biomarkers Consortium
Nearly 20 years ago, the Foundation for the National Institutes of Health (FNIH) launched the Biomarkers Consortium, together with NIH, FDA, the nonprofit PhRMA and other key contributors from the public and private sectors.
From the beginning, NIH’s leadership and scientific expertise have been at the heart of the Biomarkers Consortium’s progress and have guided the development of biomarker science from promising ideas to regulatory-grade tools and solutions that improve patient care.
The FNIH Biomarkers Consortium has been instrumental in driving innovation and transforming how biomarkers are developed, validated and applied in clinical and regulatory settings. Among the consortium’s accomplishments are 35 scientifically validated methods, materials or measures for use in clinical trials and patient care; 26 therapeutics advanced based on the tools generated; support for 10 FDA guidance documents and more than 200 publications.
In February, FNIH will host a symposium celebrating 20 years of biomarker innovation and impact—highlighting groundbreaking achievements and cultivating new cross-sector collaborations for the future.
Keynote speakers will discuss the role of biomarkers from the perspectives of government regulators, drug developers and patients in need of better outcomes.
- Dr. Janet Woodcock, former principal deputy commissioner, FDA, will reflect on the evolution and promise of biomarkers in transforming drug development and clinical care. She will explore how biomarkers enable more precise, patient-centered approaches to treatment, support regulatory decision-making, and foster innovation across therapeutic areas.
- Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer at Merck, will discuss what’s next in biomarker science: How do we ensure biomarker discovery keeps pace with therapeutic innovation? What new frontiers—scientific, technical and ethical—must we navigate to realize the full promise of precision medicine? And how can the field work collectively to accelerate validation, standardization and equitable implementation?
- Dr. David Fajgenbaum, co-founder and president of Every Cure, will share his inspiring journey going from a healthy third-year medical student to a critically ill patient diagnosed with a rare and deadly disease, before discovering a drug that saved his life. This talk will illustrate the power of biomarkers not only to guide precision medicine, but also to unlock hidden cures for patients in need.
The two-day agenda will also feature panel sessions exploring development of reasonably likely surrogate endpoints, the future of epigenomic and blood-based biomarkers, and the application of artificial intelligence to clinical imaging and pathology data—all with NIH colleagues providing expertise and perspective.
The Biomarkers Consortium Symposium will be held February 9-10, 2026. Due to limited in-person seating, all NIH’ers are welcome to attend via videocast, with opportunities to pose questions virtually. See the full agenda and updated information at: bit.ly/3K97cde.
To watch the videocast, see Day 1: https://videocast.nih.gov/watch=57168 and Day 2: https://videocast.nih.gov/watch=57169.