製薬企業におけるトランスレーショナルリサーチの役割 : パラダイムシフトによる医薬品研究開発の生産性向上を目指して
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概要
- 論文の詳細を見る
Current drug discovery, clinical development, and approval process is long, expensive, and inefficient. Less than 1 in 10 promising drug candidates entering phase I clinical trials eventually receive regulatory approval. This is an alarming statistic for the pharmaceutical industry, and the traditional drug development paradigm is no longer sustainable in the face of high attrition risk and increasing development cost. The core problem is lack of innovation in developing effective new therapies for unmet medical needs. There is an urgent need to improve productivity in pharmaceutical research & development (R & D) by closing the gap between bench and bedside and making much earlier and more accurate go/no-go decisions. A paradigm shift that will reinvent the process of R & D is emerging in the pharmaceutical industry. It is time for pharmaceutical companies to introduce new innovative thinking into current drug development strategies.Translational research in the pharmaceutical industry is intended to facilitate the transition of new ideas in basic science to patient cure through improvement of R & D productivity. Exploratory clinical trials, targeted medicine, and biomarkers are major tools for translational research. Simple introduction of new technologies and sciences into the current system/organization is not sufficient. We must change the current paradigm (business model) and, more importantly, our way of thinking (mindset). In this article, the potential roles of translational research in pharmaceutical R & D are discussed, focusing on early drug development (from discovery to proof of concept).
- 日本質量分析学会の論文
- 2009-06-01