BG Medicine reports that the FDA approved the first phase of the Liver Toxicity Biomarker Study (LTBS). This discovery project aims at finding biomarkers related to human hepatotoxicity in standard preclinical tests.
It will be conducted under a CRADA with the FDA’s National Center for Toxicological Research (NCTR), as part of FDA’s Critical Path Initiative.
The scientific advisory board will consist of seven pharmaceutical companies—Pfizer, Johnson & Johnson Pharmaceutical Research and Development, Mitsubishi Chemical Holdings, Orion, UCB, Sankyo, and Eisai—providing project funding.
Additionally, Applied Biosystems will supply biomarker discovery systems based on mass spectrometry, including service, support, and in-kind contributions.