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.

Baby Connectome Project

The Baby Connectome Project (BCP) is a four-year study of children from birth through five years of age, intended to provide a better understanding of how the brain develops from infancy through early childhood and the factors that contribute to healthy brain development.

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 - 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 - The Performance of Novel Cardiac Biomarkers in the General U.S. Population

The Biomarkers Consortium’s Novel Cardiac Biomarkers in the General US Population (the Cardiac Troponin Project) seeks to define the reference ranges and to generate the epidemiologic basis for the use of several significant novel cardiac and related biomarkers for cardiovascular risk stratification in the general U.S. population. The program will measure a panel of biomarkers in almost 30,000 individuals in a national study. The project will provide key reference data regarding novel biomarkers for cardiovascular risk stratification and inform U.S. clinical and laboratory guidelines.

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 - Comparison of Two PET Radioligands to Quantify the Peripheral Benzodiazepine Receptor

The Biomarkers Consortium’s PET Radioligand Project, completed in December 2012, developed improved, more sensitive PET radioligands with higher binding to the peripheral benzodiazepine receptor. Findings from this study suggest that the [11C]PBR38 ligand, in particular, may be useful in detecting progression from mild cognitive impairment or treatment response in Alzheimer’s Disease.

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 - Diabetes Drug Development: Identification and Validation of Markers That Predict Long-Term Beta Cell Function and Mass

This is the first project in a two-stage strategy that seeks to characterize beta cell function for predicting long-term beta cell response to an intervention based on short-term measures. The first stage’s goal is to characterize key methodological issues in the assessment of beta cell function by evaluating Mixed Meal Tolerance (MTT) and Arginine Stimulation Tests against the standard Frequently Sampled Intravenous Glucose Tolerance (FSIGT) Test in a series of clinical studies.

Biomarkers Consortium - Evaluation of the Utility of Adiponectin as a Biomarker for Predicting Glycemic Efficacy

The primary objective of this project was to determine whether a 30kDa adipocyte-secreted protein, adiponectin, has utility as predictive serum biomarker of glycemic control in normal non-diabetic subjects and patients with type 2 diabetes, following treatment with a novel and promising new class of compounds, PPARγ agonists. Results confirmed previous relationships between adiponectin levels and metabolic parameters, and support the robust and predictive utility of adiponectin across the spectrum of glucose tolerance.

Biomarkers Consortium - Longitudinal Proteomic Changes in CSF from ADNI: Towards Better Defining the Trajectory of Prodromal and Early Alzheimer’s Disease

The Biomarkers Consortium Longitudinal CSF Proteomics Project addresses the need for tools for early diagnosis and measurement of disease progression in Alzheimer’s disease. This longitudinal study will measure the rate of change of five protein biomarkers within patients from the Alzheimer’s Disease Neuroimaging Initiative Cohort with Mild Cognitive Impairment (MCI), AD and healthy controls, utilizing a multiplexed mass spectrometry-based approach.