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.

Adam J. Berry Memorial Fund

The Adam J. Berry Memorial Fund assists early career Australian scientists with travel between Australia and the United States to work at the NIH.

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI 3)

The Alzheimer’s Disease Neuroimaging Initiative (ADNI), is a landmark study that has profoundly influenced our understanding of Alzheimer’s disease by identifying the earliest changes in brain structure and function that signal its onset and progression.

Lung-MAP: Master Protocol for Treatment of Non-Small Cell Lung Cancer

Lung-MAP is an umbrella protocol which contains a screening component and multiple independently conducted and analyzed treatment sub-studies. The overarching hypothesis is that the umbrella master protocol will establish genomic screening for a large population of previously treated Non-small cell Lung Cancer (NSCLC) patients and evaluate targeted therapies (or combinations) in biomarker-driven sub-studies and immunotherapy combinations in patients previously exposed to standard checkpoint inhibitor therapy and lead to regulatory approval of efficacious regimens.

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.  

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 - 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.

Biomarkers Consortium – CSC Scientific Symposium

The Cancer Steering Committee (CSC) Scientific Symposium reviews advances in the field of biomarker and regulatory science that are relevant to the development of new public-private partnerships for precompetitive biomarkers. This review assists the CSC with planning future public- private partnerships in this area.

Biomarkers Consortium - Vol-PACT Phase II: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

Vol-PACT is designed to analyze volumetric CT imaging trial data from completed industry phase II/III solid tumor trials to improve quantitative prediction of phase III trial results. The project seeks to develop novel imaging methods to more accurately measure cancer response and progression