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.

Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE)

The NIMBLE Project is a comprehensive, five-year collaborative effort to standardize, compare and appropriately validate imaging and circulating biomarkers for NASH to: 1. Diagnose and stage the disease and; 2. Measure response to therapeutic intervention.

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.