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 - Workshop: Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification

This workshop aimed at creating alignment among scientific stakeholders including the FDA, the NIH, the biopharmaceutical industry, academic researchers and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development.

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 - Carotid MRI Development and Validation via an AIMHIGH Sub-Study

The goal of this project was to conduct a 75-patient study at a total of 15 centers to determine the reproducibility of the non-invasive technique of carotid magnetic resonance imaging (CMRI). Results established a standardized carotid MRI protocol and determined, for the first time, that kinetic parameters of carotid atherosclerotic plaque are reproducible and can be used for multi-center studies.

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.