To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.
The Neuroscience Steering Committee, led by the FNIH and its co-chairs Dr. Linda Brady, Dr. Hartmuth Kolb, and the emeritus co-chair Dr. Bill Potter, is bringing together experts in the field of neuroscience from industry, NIH, FDA, and academia to present progress to date, next steps, and key obstacles that need to be addressed in order to drive biomarker development in a multitude of neuroscience focus areas.
As part of a larger national effort to address the opioid crisis, the FNIH is leading the planning effort for a potential public-private scientific partnership that includes the NIH, FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA) and more than 30 biopharmaceutical companies.
The Undiagnosed Diseases Program (UDP) at the National Institutes of Health assists with diagnosing patients who have long been unable to find any diagnosis for their symptoms.
The Jayne Koskinas Ted Giovanis (JKTG) Foundation for Health and Policy established two NIH Intramural Research Training Awards (IRTAs) for deserving young scholars in the NIH Intramural Training program. Through this IRTA, the JKTG Foundation aims to fund fellows whose basic research could help to expand the understanding of disease and could ultimately result in clinical applications.
The goal of the Accelerating Medicines Partnership (AMP) is to bring together the resources of NIH and industry to improve our understanding of disease pathways and facilitate better selection of targets for treatment.
The Clinical Center In-Kind Drug Donation Program provides pharmaceuticals that are donated through the public-private partnership coordinated by the FNIH to the NIH Clinical Center.
In 2015, the NIH became one of 17 leading institutions taking part in the Amgen Scholars Program, a training program that enables undergraduates to participate in cutting-edge research opportunities at world-class institutions.
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus & Related Autoimmune Disorders is an initiative of the Accelerating Medicines Partnership (AMP), which is a multi-sector, pre-competitive partnership among government, industry, and nonprofit organizations, the goal of which is to harness collective capabilities, scale and resources toward improving current efforts to develop new therapies for complex, heterogeneous diseases.
The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.
The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.