BioSeek: Economic Impact of BioMAP® Profiling - Bridging the Gap from In Vitro to In Vivo

BioSeek: Economic Impact of BioMAP® Profiling - Bridging the Gap from In Vitro to In Vivo
Version:
V1

Year:
2013

CHALLENGE
The client identified a novel IL-17 inhibitor as its lead compound to treat an autoimmune disease. Specifically, it had identified the compound in a phenotypic screen of mouse cells and tested it in a rodent model for Collagen-Induced Arthritis. At this point, our client had collected valuable pre-clinical insights about the efficacy of the compound based on cellular and biochemical assays. However, these assays did not provide any insight into the mechanism of action (MOA) of the compound. Our client had already invested two years of preclinical research and up to $2 million in R&D to move the compound to this stage. The client also previously engaged the services of a contract research organization, but the results were uninformative. The client sought a new approach that could yield insights on MOA that may have been missed by earlier studies.

The client hoped to introduce the drug into clinical trials, and this would require validation of MOA in the discovery phase in order to reduce the safety risk from an unknown mechanism. Launching a drug in the international market costs more than $1 billion in annualized costs (DiMasi, J. & Grabowski, H. (2007) Manage. Decis. Econ. 28: 469-479) and requires six to nine years of clinical development. Hence, collecting accurate preclinical data for safety and efficacy with appropriate benchmarks, and knowing the MOA, would position the client to identify a suitable market and develop appropriate clinical trials.