The main objective of the Phase II proposal is to commercialize the SBS standard format microfluidic bioreactor array developed in Phase I for high throughput physiologic cell-based screening in the pharmaceutical and biotechnology industry, with special focus on predictive hepatotoxicity screening, which has been included as one of the Critical Path Initiatives by the FDA since 2005 in order to provide better pre-clinical drug screening tools other than animal models. The value of this proposition is to improve prediction of drug toxicity before the expensive and time consuming human clinical trials using a more physiological in vitro human liver culture model. The Phase II award will enable us to optimize the bioreactor design and initiate the product beta testing with pharmaceutical companies on drug compounds that passed animal studies yet still caused liver injuries during human clinical trials. The Phase II proposal is to continue the awarded Phase I project (1R43DK076325-01) under program announcement PA-06-019 Molecular Libraries Screening Instrumentation , more specifically, to the commercialization of an SBS standard microfluidic bioreactor array to provide a better in vitro human model to predict drug toxicity effect during clinical trials, especially liver toxicity. The successful completion of the project will provide the pharmaceutical and biotechnology industry a better and more cost-effective platform on high throughput liver toxicity screening.
