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.

The Science of Caregiving, Bringing Voices Together

The National Institute of Nursing Research hosted a two-day Summit to gather a variety of stakeholder perspectives on the spectrum of caregiving issues and research for conditions and illnesses that may occur across the lifespan.

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 - 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 - 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.