Toshinori Yamamoto, PhD is currently VP and Head of Preclinical Research, RaQualia Pharma, Japan. He experienced broad range of Pharmaceutical R&D covering Discovery through Regulatory Filing, wherein mainly focusing on DMPK, toxicology and clinical development for more than 20 years. Before joining RaQualia in 2008, he worked at Chugai Pharmaceuticals and Pfizer, Japan. He was a visiting researcher at the University of Arizona and the University of Michigan. He was awarded the 2010 Incentive Award from the Japanese Society of Toxicology (JSOT), and the JSOT Tanabe Award in 2006, 2007 and 2008.


Drug toxicity observed in pre-/non-clinical animal studies sometimes leads to discontinuation of drug candidates. Understanding the phenomena or backgrounds surrounding toxicological events occurred must be a key element for attrition improvement in research and development (R&D) of new chemical entities (NCEs), often requiring mechanistic investigations to understand toxicological mechanism of actions and then to make “Go” or “No go” decisions. In the post-genomic era, a battery of “Omics” technologies was introduced and has been rapidly increasing utilization, among which is the prefix of “toxico-” added to each omics technology in toxicology field. Especially, metabolomics in toxicology, which is so-called “toxicometabolomics”, has been widely implemented in this area. The objectives are to identify and characterize the metabolites, both endogenous and exogenous, which are the end products of cellular metabolism and drug metabolism, respectively. Moreover, toxicometabolomics enables to capture the phenotypic changes in the events, which are generated by enzymatic proteins as resultants of gene expression, at the molecular level; therefore, smooth translation of the findings can be made into the clinic. The presentation in this session will review the usefulness of toxicometabolomics technologies which are generally nuclear magnetic resonance (NMR)-based and mass spectrometry (MS)-based, and other toxic-Omics technologies. Furthermore, today, newly introduced technology, MS imaging (MSI) is considered applicable in the toxicology field, hence its toxicological usability will be also reviewed.

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