Summary of FDA/Arthritis Foundation osteoarthritis drug development workshop published in Seminars in Arthritis and Rheumatism
The summary of last year’s FDA/Arthritis Foundation osteoarthritis drug development workshop has been published in Seminars in Arthritis and Rheumatism. Dr. Roemer of BICL’s management team was an invited participant of this event presenting on the role of imaging in DMOAD trials. Aim of the workshop was to discuss the current state of science in the disease of OA, identify the knowledge gaps, and examine the developmental and regulatory challenges in bringing these products to market.
The present study highlights the combination of biomarkers with potential prognostic utility in OA disease-modifying trials with imaging measures among the best predictors. These biomarkers could be used to enrich future trials with participants likely to experience progression of knee OA. The phase II of the OA Biomarkers Consortium is currently underway to externally validate the present findings and enable the submission of these biomarkers for regulatory review and formal qualification for use as prognostic biomarkers in disease-modifying OA trials.