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AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group Meeting, 2006 Presentations: Metabonomics in preclinical assessment of hepatic toxicity

Donald G. Robertson, PhD, DABT
Metabonomics Evaluation Group, Worldwide Safety Sciences,
Pfizer, Global R&D
Metabonomics in preclinical assessment of hepatic toxicity [PDF]

Metabonomics is a technology for measuring the global metabolic response of an organism to physiologic change, disease, toxicity or genetic modification. The technology is in broad use in applications from plant and bacterial sciences all the way through human clinical trials. Within the field of safety assessment, the technology has shown promise in screening applications, biomarker discovery and the exploration of mechanisms of toxicity. Like other “omic” technologies, results need to be interpreted globally, and not necessarily restricted to one target organ. However, the comprehensive measurement of global metabolic responses often provides mechanistic clues and potential biomarkers, which can easily be missed by traditional approaches. This presentation will focus on the application of the technology in assessment of hepatic toxicity including necessary caveats, learnings from the COMET metabonomics consortium and real-world applications of the technology within the realm of preclinical pharmaceutical development.

Biographical Sketch

Dr. Robertson received a BA in biology from The King’s College (NY) as well as a Master’s degree in Environmental Health Sciences and a Ph.D. in Toxicology from the University of Michigan where he subsequently was appointed as a post-doctoral fellow. He is a diplomat of the American Board of Toxicology and past-president of the Michigan Society of Toxicology. He joined Pfizer (then Parke-Davis) in 1986 and currently holds the title of Director and Research Fellow in World-Wide Safety Sciences. Within Safety Sciences, he has served as Director of the Biochemical Toxicology Laboratory and Director of Anti-inflammatory Drug Development. His growing involvement in metabonomic sciences led to his full-time appointment as the Safety Sciences Leader of the Metabonomic Evaluation Group in 2003. He is a charter member of the COMET metabonomic consortium and was the first chair of the toxicology-working group of that consortium. His expertise in metabonomic technology led to various appointments to both industrial and regulatory groups interested in utilizing and understanding this emerging technology. He currently chairs the Biology Context Committee of the Metabolomics Standardization Effort. He serves on the editorial board of Cardiovascular Toxicology and is an ad hoc reviewer for numerous toxicology-oriented journals. He was senior editor of the volume entitled “Metabonomics in Toxicity Assessment” published in 2005 and has written and presented extensively on the topics of metabonomics and drug-induced toxicity.