医薬品の臨床開発におけるバイオマーカー活用の現状

抄録

In the course of drug development, it’s important to find an effective dose in a defined group of patients with the fewest side effects. In recent years, it has become difficult to proceed with drug development without exploring the relationship between biomarkers representing genetic characteristics, environmental factors and detailed characteristics of diseases, and efficacy and safety. Utilization of biomarkers lead the shift change from a “one-drug-fits-all” to a “personalized approach”, placing the drug development industry in a highly dynamic landscape, having to navigate such disruptive trends. In response to this, innovative clinical trial designs have been key in realizing biomarker-driven drug development. Regulatory approvals of cancer genome sequencing panels and associated targeted therapies have brought personalized medicines to the clinic. 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, and clinical biomarker-based medical innovation is currently taking place in various fields in drug development. The presentation will include an overview of biomarker-driven drug development and summarizes the current state of biomarker utilization in drug development. I will also touch on the development phases of clinical biomarkers divided into Discovery, Translational and Qualification.