WALTHAM, Mass.—BG Medicine announced the U.S. FDA has approved the first phase of its biomarker discovery project focusing on preclinical analysis of liver toxicity. Working with the National Center for Toxicological Research, the company will leverage its experiences in functional genomics, proteomics, metabolomics, and computational analysis to discover hepatotoxicity markers.
Liver toxicity has historically been a major contributor to late-stage failures of many drugs and therefore the rising costs associated with drug development. As such, it has been a target of the FDA's Critical Path Initiative and has fostered significant growth in the ADMET marketplace.
Representatives of seven pharmaceutical firms—Pfizer, Johnson & Johnson Pharmaceutical Research and Development, Mitsubishi Chemical Holdings, Orion, UCB, Sankyo, and Eisai—will sit on the project's scientific advisory board and provide funding. Applied Biosystems will likewise provide technology, service, and support, as well as in-kind contributions.