BG Medicine has announced that the US Food and Drug Administration (FDA) has approved the first phase of a biomarker discovery project to be conducted under a Cooperative Research and Development Agreement (CRADA) with the FDA’s National Center for Toxicological Research (NCTR).
As part of FDA’s Critical Path Initiative, the Liver Toxicity Biomarker Study (LTBS) aims to discover biomarkers of human hepatotoxicity in the standard pre-clinical test used by pharmaceutical companies in the initial stages of drug development.
The NCTR and BG Medicine will jointly conduct a toxicity study designed to overcome one of the primary obstacles to the efficient development of safe and effective drugs.
The first phase of the LTBS, which will last approximately nine months, has been designed by the FDA and BG Medicine with input from leading academic and industry scientists.
Seven participating pharmaceutical companies - Pfizer, Johnson & Johnson Pharmaceutical Research and Development LLC, Mitsubishi Chemical Holdings Corporation, Orion, UCB, Sankyo Co. and Eisai - will participate on the Scientific Advisory Board (SAB) and provide project funding.
Additionally, life science technology provider Applied Biosystems, an Applera Corporation business, will provide biomarker discovery systems based on mass spectrometry, including service and support as well as in-kind contributions.
Liver toxicity is the most common biological reason for drug failure in the development of new pharmaceuticals, affecting one in six drugs in development. The toxicity tests currently accepted by the regulatory agencies for use by drug companies have been unchanged for at least 40 years.
The LTBS will be conducted at the FDA’s NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. The research project leverages NCTR’s and BG Medicine’s systems biology platforms for functional genomics, proteomics, metabolomics and computational analysis.