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.

Dr. Edward T. Rancic Memorial Fund for Cancer Research

The Dr. Edward T. Rancic Memorial Fund for Cancer Research supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

Dean R. O'Neill Renal Cell Cancer Research Fund

The Dean R. O'Neill Renal Cell Cancer Research Fund supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

Accelerating Medicines Partnership: Rheumatoid Arthritis, Systemic Lupus Erythematosus & Related Autoimmune Disorders

Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus & Related Autoimmune Disorders is an initiative of the Accelerating Medicines Partnership (AMP), which 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: 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 - PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers

The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.

Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.

Biomarkers Consortium - Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers

The Biomarkers Consortium’s Kidney Safety Project aims to advance clinical regulatory qualification and broader acceptance of new translational biomarkers that outperform sCr and BUN for monitoring kidney safety to support early clinical 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.