"Era of personalized therapy" has come, bringing big changes for actual clinical practice as we can see in cancer therapy. Pharmacogenomic strategy for cancer therapy started with diagnostic markers based on genetic polymorphism by SNPs variations, passed through genome panel diagnosis as group CDx markers, and make it possible to maximize individual patient's benefit by comprehensive genome profiling including single cell RNA sequencing, and genome size enrichment, with global-wide genomic and healthcare records.When implementing this innovation, development strategies of new medicinal products in pharmaceutical industries are required to be applicable of several innovative technologies. Model Informed Drug Development integrating systems biology / systems pharmacology / exposure-response modeling should be used to optimize the right objective related to signal pathways / target molecule / treatment / dose / patient by the development stage of discovery / translation / qualification to guide the way to the personalized therapeutics. With developments of analytical technologies such as digital cytometry and several RNAi techniques, quantitative systems pharmacology can be essential tools with real world data during discovery to translational stages. Not only master protocol projects including basket / umbrella / platform design and/or several adaptation techniques, but also newly updating of biomarker-driven clinical study designs such as mendelian randomization and meta n-of-1 clinical trials could be developed in the clinical qualification stage, intensive biomarker-driven evolution focusing on coming of "Era of personalized therapy" can be seen. We believe this personalized therapy concept give an impulse to mutually enhance personalized treatment / preventive therapy / predictive diagnosis / patient involvement, being closer to each goal.