Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
Review Article
Current Status and Future Prospects of Biomarker Strategy for Drug Development
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2020 Volume 51 Issue 3 Pages 151-160


In recent years, large-scale genome analysis technology and information processing technology are rapidly progressing in the medical field, which leads a global-wide transformation of the entire medical care. The advancement of technologies also promotes utilization of clinical biomarkers, which play an important role in precision medicine, and clinical biomarker-based medical innovation is currently taking place in various fields in drug development.

This article discusses the efficient biomarker strategy to achieve precision medicine, and seeks the solutions of addressed issues. The development process of clinical biomarkers is divided into three phases: Discovery, Translational, and Qualification. Discovery section introduces the latest approaches which led to identification of clinical biomarker candidates through omics, and gap between utilization of clinical biomarker in clinical development and clinical application. Translational section introduces points to consider for analytical methods validation, and statistical points such as clinical sensitivity, specificity, and false discovery rate (FDR), for biomarker selection. This section also refers to the importance of genomic cohort studies, as well as the issues related to genome-wide association analysis. Qualification section discusses approaches to show clinical utility of biomarkers, by introducing enrichment strategies, master protocol strategies, etc. In addition, this section refers to new drug application and accelerated review led by biomarker strategies.

This article describes the current status and prospect of drug development based on the utilization of clinical biomarkers, which is an issue imposed on stakeholders who promote biomarker strategies, and we expect that it will help realize personalized therapy in the future.

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© 2020 The Japanese Society of Clinical Pharmacology and Therapeutics
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