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.

Precision Medicine Initiative Survey

Informing the development of the Precision Medicine Initiative.

Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED)

The study was implemented using shared and harmonized protocols across the eight sites to gather an enormous amount of data (physical, cognitive assessments, diet, illness and enteric infection, socio-economic status, etc.) to enable identification and characterization of factors associated with negative impacts on a child’s growth, development and vaccine response early in life.

Development & Production of Endotoxin under GMP for Human Clinical Research

Development & Production of Endotoxin under GMP for Human Clinical Research is a program enabling NIH to develop and produce a new strain of endotoxin under good manufacturing practices (GMP) conditions.

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 - Use of Targeted Multiplex Proteomic Strategies to Identify Plasma-Based Biomarkers in Alzheimer’s Disease

The Biomarkers Consortium’s Targeted Plasma-Based Biomarkers in Alzheimer’s Disease (AD), completed in July 2012, was the first part of a multi-phased effort utilizing samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) to validate multiplex panels in both plasma and cerebrospinal fluid (CSF), to diagnose patients with AD and to monitor disease progression.

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.

Biomarkers Consortium - High Definition Single Cell Analysis of Blood and Tissue Biopsies in Patients with Colorectal Cancer Undergoing Hepatic Metastasectomy

The project seeks to show that a liquid biopsy can serve as a source of rare circulating cells (CTCs) to comprehensively represent the traditional solid biopsy. The project is designed in two stages to demonstrate the correlation between liquid and solid biopsies in an observational clinical study with metastatic colorectal cancer (mCRC) patients undergoing resection of liver metastases.

Biomarkers Consortium - Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma

Build the case for FDA incorporation of FDG-PET into outcome measures for lung cancer and lymphoma.