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.

Biomarkers Consortium - Mucosal Healing in UC: Definition, Treatment Target and Clinical Endpoints

This project will establish a common methodology for a histologic measurement of a mucosal healing endpoint for treatment of UC that demonstrates clear prognostic value for long-term outcomes for patients that the scientific community can utilize when developing therapeutics for UC.

Deeda Blair Research Initiative for Disorders of the Brain

The Deeda Blair Research Initiative for Disorders of the Brain was established by FNIH Board member, Deeda Blair to create hope for millions of people who struggle with mental illness by transforming our existing knowledge of the brain and fostering the development of novel ways of thinking about the brain and its disorders. This initiative will allow forward-thinking scientists to accelerate advances in the diagnosis and treatment of mental health illness including anxiety, depression, bipolar disorder and other serious mood disorders.

Biomarkers Consortium - Neuroscience Symposium

The Neuroscience Steering Committee, led by the FNIH and its co-chairs Dr. Linda Brady, Dr. Hartmuth Kolb, and the emeritus co-chair Dr. Bill Potter, is bringing together experts in the field of neuroscience from industry, NIH, FDA, and academia to present progress to date, next steps, and key obstacles that need to be addressed in order to drive biomarker development in a multitude of neuroscience focus areas. 

Robert Whitney Newcomb Memorial Lecture and Internships

The Robert Whitney Newcomb Memorial Fund endows an annual lecture in neuroscience and one or more internships for high-school students at the National Institute of Neurological Disorders and Stroke (NINDS). 

Sayer Vision Research Lecture & Award

The Sayer Vision Research Lecture and Award funds an annual presentation delivered by an investigator conducting outstanding research in the area of vision research or related fields. It also provides a grant to support the research of a promising independent investigator in the early stage of his or her career in the Division of Intramural Research whose work is closely related to aspects of vision research.

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.

Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE)

The NIMBLE Project is a comprehensive, five-year collaborative effort to standardize, compare and appropriately validate imaging and circulating biomarkers for NASH to: 1. Diagnose and stage the disease and; 2. Measure response to therapeutic intervention.

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.