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.

Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in LMICs - (A-PLUS Trial)
Gene Drive Research-Related Activities

Gene drive is a mechanism that can promote the preferential inheritance of a beneficial genetic trait, thereby increasing its prevalence in a population. A variety of gene drive mechanisms occur in nature that can cause specific genetic elements to spread throughout populations in varying degrees. Researchers have long sought to harness these naturally occurring gene drive mechanisms to prevent the transmission of mosquito or other insect-borne diseases that pose some of society's most intractable public health problems.

Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED)

The study was implemented using shared and harmonized protocols across the eight sites to gather an enormous amount of data (physical, cognitive assessments, diet, illness and enteric infection, socio-economic status, etc.) to enable identification and characterization of factors associated with negative impacts on a child’s growth, development and vaccine response early in life.

Age-Related Eye Disease Study 2 (AREDS2) Ancillary Study

The Age-Related Eye Disease Study 2 (AREDS2) examined the effects of vitamin and mineral supplementation on the progression of age-related macular degeneration (AMD), which is one of the leading causes of blindness in the United States. Funds raised by the FNIH support the development of a genetic repository for the study, facilitating deeper analyses of the results.

Global Health Fund

The Global Health Fund supports FNIH programs that are designed to alleviate widespread suffering in the developing world. Program focus includes research and training on diseases such as malaria and HIV, as well as conditions like malnutrition that afflict hundreds of millions of people globally.

Accelerating Medicines Partnership: Type 2 Diabetes Project

https://www.nature.com/articles/s41586-019-1231-2The Accelerating Medicines Partnership Type 2 Diabetes Project (AMP T2D), 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: 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 - 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 - 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.

Biomarkers Consortium - The Autism Biomarkers Consortium for Clinical Trials (ABC-CT)

The Consortium will establish a technical and data infrastructure for reliably measuring social function, allowing the collaborating sites to work together as a single unit. The goal is to create a set of measures that can be used in clinical trials to determine which treatments are best for which patients and who will benefit from a particular treatment. The ultimate goal is to further develop and validate a set of measures that can be used as stratification biomarkers and/or sensitive and reliable objective measures of social impairment in autism spectrum disorders that could serve as indicative markers of long term clinical outcome.