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.
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus & Related Autoimmune Disorders is an initiative of the Accelerating Medicines Partnership (AMP), which is a multi-sector, pre-competitive partnership among government, industry, and nonprofit organizations, the goal of which is to harness collective capabilities, scale and resources toward improving current efforts to develop new therapies for complex, heterogeneous diseases.
The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.
The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.
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.