Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
While the use of biomarkers in drug development will lead to the realization of drugs with high therapeutic efficacy and few side effects, their use without the sufficient consideration may bring about wrong decisions. Therefore, it is essential to verify the qualification before the official use in drug development. Qualification is a conclusion that, within the stated context of use, the results of assessment with a biomarker can be relied upon to adequately reflect a biological process, response or event, and support use of the biomarker during drug development, ranging from discovery through post-approval (ICH E16).
In 2009, Pharmaceuticals and Medical Devices Agency (PMDA) launched Omics Project Team to internally unify the way of thinking about biomarkers. The team has dealt with pharmacogenomics / biomarker consultation to evaluate and interpret data unrelated to particular pharmaceutical candidates, playing a role in the preparation of administrative notifications related to pharmacogenomics in cooperation with the Ministry of Health, Labour and Welfare (MHLW). Appropriately setting and revising the context of use will lead to the appropriate use and expansion of qualification, and the continuous and stepwise efforts will result in the realization of drugs with high therapeutic efficacy and few side effects guided by truly clinically meaningful biomarkers.
In this presentation, I would like to introduce points to consider when considering drug development using safety biomarker candidates found in non-clinical studies.
