The press release....
Yesterday, BG Medicine, a Massachusetts-based biotechnology research company, 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 state-of-the-art, 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. As a result of the shortcomings of the current preclinical tests liver toxicity is often first detected in the late stages of clinical development after incurring most of the product development costs.
On March 16, 2004 the FDA released a report, "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," describing the "urgent need to modernize the medical product development process -- the Critical Path -- to make product development more predictable and less costly." The proposed project addresses the liver toxicity issue highlighted in the Critical Path document as one of the obvious and priority areas for innovation.
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.
