The Liver Toxicity Biomarker Study (LTBS)

BG Medicine, in collaboration with the FDA's National Center for Toxicological Research and with the support of seven international bio-pharmaceutical companies, is leading a Critical Path Initiative to discover a new biomarker for liver toxicity. Operating under a Collaborative Research and Development Agreement (CRADA), the project is applying modern technologies including proteomics, metabolomics and transcriptomics to solve the leading cause of clinical failure in the drug development process. 

Project Goal

To discover preclinical biomarkers of clinical drug-induced hepatic effects that are not detected with current routine preclinical testing.

Outline

• Characterize molecular effects of drugs that were shown to have clinical liver toxicity leading to late-stage attrition
• Perform cross-omics analyses of samples obtained from a 28-day oral repeat-dose rat study
• Identify hepatic molecular profiles and circulating biomarkers which will enable pharmaceutical and biotechnology companies to make better-informed decisions in the drug discovery and development process

Participating Organizations

Pfizer, Johnson & Johnson Pharmaceutical Research and Development LLC, Mitsubishi Chemical Holdings Corporation, Orion, UCB, DaiichiSankyo, Eisai

Technology Partner