Abstract

Symposium Sessions

Day 2, June 11（Tue.）　9:39-10:01　Room C (Conference Room 201)

Biomarker is defined as "an indicator of pharmacological response to a normal biological process, pathological process, or therapeutic intervention. In drug development, biomarkers are expected to facilitate drug development as indicators that can evaluate efficacy and safety of drugs. Metabolomics (including lipidomics, which focuses on lipids) is an exhaustive analysis of metabolites. With the dramatic advances in analytical chemistry over the past two decades, metabolomics has increased the number of metabolites that can be analyzed from biological samples. The advantages of using metabolomics to search for biomarkers are that metabolite variation is the downstream of protein expression and is considered to have the highest association with phenotype among various targets of omics. When employing biomarkers identified through metabolomics for drug development and regulatory submissions, it is crucial to go beyond merely confirming the reproducibility of biomarker discovery. It is essential to perform both analytical method validation, which ensures the analytical soundness of the biomarkers, and clinical validation, which confirms their clinical relevance and utility. These steps are vital for the biomarkers to be considered reliable tools in the drug approval process. The integration of metabolite biomarkers into drug development necessitates rigorous verification to ensure their validity. My presentation will explore the utilization of metabolite biomarkers in advancing drug discovery and development.

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