1. Members

Project Leader	Hiroshi Yamada
Researcher	Noriyuki Nakatsu
Researcher	Yoshinobu Igarashi
Researcher	Yuki Yamagata
Technical Assistant	Seiko Ueda

2. Background and objectives

Rapid progress in basic sciences related to genomics, proteomics and metabolomics (commonly called omics technology) has lead to advances in the implementation of omics technology in drug development. Since safety is always a major concern in drug development, ongoing our research is focused on toxicogenomics technology and actively conducted to develop new safety biomarkers. The toxicogenomics database used in our research was established by a collaborative project among National Institute of Biomedical Innovation (NIBIO), National Institute of Health Sciences (NIHS) and major Japanese pharmaceutical companies. The first 5-year project (2002-2007), named the Toxicogenomics Project(TGP1), established a large-scale, high-quality and well-designed toxicogenomics database comprising approximately 150 chemicals, mainly medical drugs. The second 5-year project (2007-2012), named the Toxicogenomics Informatics Project(TGP2), identified 30 and more potential safety biomarkers related to hepatotoxicity and nephrotoxicity, and demonstrated that toxicogenomics data combined with a large-scale integrated database were useful for assessing drug safety. To date, Our project (TGIP) are adding supplemental toxicogenomics data to the database, and also developing new safety biomarkers

3. Overview of our research

Toxicogenomics represents the utilization of genetic information for toxicological investigations. Our main goals are as follows:

1) Establishment of biomarker gene lists for prediction of toxicity for drug candidates in the early stage of drug development
2) Development of new safety assessment systems
3) Clarification of toxicological mechanisms