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.

Eliminate Dengue

This program is field testing a new self-sustaining biocontrol technology to prevent transmission of dengue, zika and chikungunya viruses by vector mosquitoes.

Alzheimer's Disease Neuroimaging Initiative 2

ADNI was established to facilitate the development of effective treatments for Alzheimer’s disease by validating biomarkers for clinical trials and determining the relationships between the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of AD.  

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.

Genome Research Fund

The Genome Research Fund supports genetics and genomics research at the National Human Genome Research Institute (NHGRI).

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 - Single Cell Mass Accumulation Rate as a Biomarker for Drug Efficacy in Multiple Myeloma and Leukemia

The FNIH is seeking funding to support the Single Cell Mass Accumulation Rate as a Biomarker for Drug Efficacy in Multiple Myeloma and Leukemia (MAR) project, to develop a predictive response biomarker that directly measures drug effects on single living tumor cells to allow for rapid therapeutic adaptation for patients facing treatment resistance.

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 - Identification and Validation of ctDNA Quality Control Materials

The ctDNA Quality Control Materials project seeks to develop a set of nationally recognized standards to enable the production of suitable quality control materials that can be submitted for FDA clearance for widespread use in ctDNA testing. Once successfully developed and disseminated, these quality control materials will provide confidence in interpretation of ctDNA biomarker assay results, paving the way for more effective clinical research, therapeutic decision-making, regulatory evaluation, and reimbursement applications.

Biomarkers Consortium - Chemotherapeutic Impact on the Immune MicroEnvironment

Project results will help determine the effect of chemotherapy on malignant and non-malignant cells including immune cells. New biomarkers characterizing the TME before and after chemotherapy may be discovered that reflect cell composition, cell states, and cell-cell interaction.

Biomarkers Consortium - Inflammatory Markers for Early Detection and Subtyping of Neurodegenerative and Mood Disorders

This project will aim to standardize and validate measurement methods for inflammatory markers associated with Alzheimer’s Disease and/or Major Depressive Disorder to ultimately identify a unique biosignature of disease. The identified biosignature would greatly assist with medication development, patient diagnosing, and patient selection for clinical trials.