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.

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 - 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 - 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.