Monthly Archives: May 2025

In recent years the FDA has taken significant steps toward reducing the reliance on animal testing in drug development. Through the endorsement of New Approach Methodologies (NAMs) the agency is encouraging the use of human-relevant models that can offer faster, safer and more predictive insights into drug safety and efficacy.

Rheumatoid arthritis (RA) remains a significant unmet clinical need, with a high attrition rate for drug candidates in early development. Traditional preclinical models often fall short in capturing the complexity and heterogeneity of human disease. In this context, ex vivo models using synovial fibroblasts directly derived from RA patients offer a powerful translational platform to assess drug efficacy, explore mechanisms of action, and identify early biomarkers of therapeutic response.