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.

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 - Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability

Sarcopenia 2 seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death); evaluate relative strength as a discriminator for mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials.

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.

Biomarkers Consortium - Bone Quality Project

The Biomarkers Consortium’s Bone Quality Project aims to evaluate and to identify biomarkers of bone strength and quality changes by analyzing pooled imaging and biochemical data from multiple clinical studies to allow definition of better clinical endpoints.

Biomarkers Consortium - In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk from Statin Therapy

The Biomarkers Consortium’s In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk From Statin Therapy’s goal was to identify a time-dependent, dynamically-responsive panel of extant markers that change in response to Phase II intervention and predict Phase III clinical cardiovascular outcomes to build the model. This model would support cardiovascular drug development decision-making and assessment of atherosclerotic risk in the development of drugs for other indications.