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.

Dr. Edward T. Rancic Memorial Fund for Cancer Research

The Dr. Edward T. Rancic Memorial Fund for Cancer Research supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

Dean R. O'Neill Renal Cell Cancer Research Fund

The Dean R. O'Neill Renal Cell Cancer Research Fund supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

Osteoarthritis Initiative

The Osteoarthritis Initiative was a public-private collaboration to improve the efficiency of drug development and clinical trials for the treatment of osteoarthritis, which affects more than 30 million adults in the United States.

Accelerating Medicines Partnership: Rheumatoid Arthritis, Systemic Lupus Erythematosus & Related Autoimmune Disorders

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.

Biomarkers Consortium - Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

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.

Biomarkers Consortium - PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers

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.

Biomarkers Consortium - The Performance of Novel Cardiac Biomarkers in the General U.S. Population

The Biomarkers Consortium’s Novel Cardiac Biomarkers in the General US Population (the Cardiac Troponin Project) seeks to define the reference ranges and to generate the epidemiologic basis for the use of several significant novel cardiac and related biomarkers for cardiovascular risk stratification in the general U.S. population. The program will measure a panel of biomarkers in almost 30,000 individuals in a national study. The project will provide key reference data regarding novel biomarkers for cardiovascular risk stratification and inform U.S. clinical and laboratory guidelines.

Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.

Biomarkers Consortium - Establish Guidelines for Initial Diagnostic Criteria for “Sarcopenia with Clinically Important Weakness” and Associated Evidence for Treatment Benefit

The Sarcopenia 1 project launched in 2010 and aimed to establish the first evidence-based definition of sarcopenia (muscle weakness), which is still not recognized as a medical condition.

Biomarkers Consortium - Osteoarthritis Biomarkers Project

The Biomarkers Consortium - Osteoarthritis Biomarkers Project is a $3.4 million study aimed at determining which biomarkers have greater prognostic ability to measure early progression of structural and symptomatic changes in the joint over time and which are likely to predict treatment response better than the radiographic measurement of narrowing of joint space in knee OA patients. These new biomarkers are candidates for follow-on studies for evaluation and use in regulatory decision-making.