Programs

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.

Support of Ebola Research by NIAID

In response to the critical Ebola Virus Disease (EVD) outbreak in 2014, the FNIH has established a fund that supports the Division of Clinical Research of the National Institute of Allergy and Infectious Diseases (NIAID) in its efforts to prevent, treat and research the EVD in West Africa.

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 - Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Clinical Endpoint Development (HABP/VABP)

The Biomarkers Consortium’s Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) Project aims to develop clinically relevant endpoints in clinical trials to improve antibacterial trial feasibility.

Biomarkers Consortium - Developing Endpoints for Clinical Trials in Community Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Infections (ABSSSI)

The Biomarkers Consortium’s Developing Endpoints for Clinical Trials in CABP and Skin Infections aims to develop approaches that will help the U.S. Food and Drug Administration develop efficacy outcome measures (endpoints) for modern-day clinical trials of investigational agents for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Biomarkers Consortium - Diabetes Drug Development: Identification and Validation of Markers That Predict Long-Term Beta Cell Function and Mass

This is the first project in a two-stage strategy that seeks to characterize beta cell function for predicting long-term beta cell response to an intervention based on short-term measures. The first stage’s goal is to characterize key methodological issues in the assessment of beta cell function by evaluating Mixed Meal Tolerance (MTT) and Arginine Stimulation Tests against the standard Frequently Sampled Intravenous Glucose Tolerance (FSIGT) Test in a series of clinical 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.

Biomarkers Consortium - Evaluation of the Utility of Adiponectin as a Biomarker for Predicting Glycemic Efficacy

The primary objective of this project was to determine whether a 30kDa adipocyte-secreted protein, adiponectin, has utility as predictive serum biomarker of glycemic control in normal non-diabetic subjects and patients with type 2 diabetes, following treatment with a novel and promising new class of compounds, PPARγ agonists. Results confirmed previous relationships between adiponectin levels and metabolic parameters, and support the robust and predictive utility of adiponectin across the spectrum of glucose tolerance.