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.

Single-Cell Transcriptomic Analysis of HIV Reservoirs before and After Systemic Interleukin-2 (IL-2) Therapy
Epidemiology of Visceral Leishmaniasis in Bihar, India

In India, the sand fly vector Phlebotomus argentipes is responsible for the transmission of the protozoan parasite Leishmania donovani, which causes a disease called visceral leishmaniasis (VL), from one human to another. 

Rapid identification of individuals with viable adult female worms of Onchocerca volvulus: a means to the end

To identify host- and parasite-specific biomarker(s) present in human subjects with viable adult females of Onchocerca volvulus (Ov) and to develop and configure rapid point of care methods to detect (or sense) these biomarkers.

Identification of high-quality HITs for tuberculosis (HIT-TB)

To produce high-quality chemical hit series with defined, tractable targets as drug leads for tuberculosis.

Centralized Envelope Comparative Immunogenicity Study

The Centralized Envelope Comparative Immunogenicity Study is an HIV/AIDS vaccine development project that seeks to answer a central question that has blocked the development of a successful HIV vaccine: how can we design vaccine immunogens that address the broad genetic diversity of HIV?

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

The project seeks to analyze volumetric CT imaging trial data from completed industry phase II solid tumor trials to improve quantitative prediction of phase III results.

Biomarkers Consortium - Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability

Sarcopenia 2 seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death); evaluate relative strength as a discriminator for mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials.

Biomarkers Consortium - Establish Guidelines for Initial Diagnostic Criteria for “Sarcopenia with Clinically Important Weakness” and Associated Evidence for Treatment Benefit

The Sarcopenia 1 project launched in 2010 and aimed to establish the first evidence-based definition of sarcopenia (muscle weakness), which is still not recognized as a medical condition.

Biomarkers Consortium - Minimal Residual Disease (MRD) Detection in Adult Acute Lymphoblastic Leukemia (ALL)

Minimal residual disease (MRD) is the amount of disease detected by molecular or cellular means when the patient is in a clinical and pathological state of remission after treatment of leukemia. The goals of this project are to assess whether MRD may be an endpoint for use as a DDT and to standardize MRD measurement in adult precursor B-lineage ALL.