Biopartnering Seminar Series - Orencia: Making it Personal - By Proche Solutions
Abstract: Rheumatoid Arthritis (RA) is a chronic, highly heterogeneous autoimmune condition characterized by inflammation of synovial joints with a prevalence of 0.5-1% and an incidence of 41 per 100,000 annually. Bristol-Myers Squibb (BMS)’s Orencia (abatacept) is a IgG1/CTLA-4 fusion protein that blocks T cell activation and is indicated for adult patients with moderate to severely active RA. The treatment landscape for RA has many therapeutic options including conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), tumour necrosis factor inhibitors (TNFi) and other non-TNFi biologics including Orencia. As there are many treatments available to physicians, there is an uncertain treatment paradigm for second-line therapy where biologics are prescribed on a trial and error basis. The risk of biologic failure due to inefficacy and adverse events results in a delay in improved patient outcomes and imposes a financial burden on both the healthcare system and patients. This presentation explores how BMS can leverage immunophenotyping to improve the sales of Orencia and the treatment landscape of RA. We have proposed a three-step solution beginning with the establishment of valid biomarkers that can predict patient response to Orencia through ongoing clinical trials, and if successful, a larger validation trial will be conducted. This will be followed by selecting an appropriate vendor and the approval of a complementary in-vitro diagnostic test that predicts patient response to Orencia. The last part of our solution entails educating physicians and key opinion leaders through BMS’s medical science liaisons on the use and analysis of this complementary diagnostic.
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