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.

The Biomedical Research Community Responds to the Opioids Crisis

As part of a larger national effort to address the opioid crisis, the FNIH is leading the planning effort for a potential public-private scientific partnership that includes the NIH, FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA) and more than 30 biopharmaceutical companies.

Accelerating Medicines Partnership (AMP)

The goal of the Accelerating Medicines Partnership (AMP) is to bring together the resources of NIH and industry to improve our understanding of disease pathways and facilitate better selection of targets for treatment.

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.

Sports and Health Research Program

The Sports and Health Research Program (SHRP) sought to help accelerate research that enhances the health of athletes at all ages and levels, and to extend the research’s impact beyond the playing field to benefit others in the general population, including members of the military.

Sports and Health Research Program: Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research

Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research was a component of the Sports and Health Research Program (SHRP) that funds pilot projects for research on sports-related traumatic brain injury and spinal cord injury research.

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 - 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 - 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.