企業におけるバイオマーカーを活用した創薬・個別化医療への取り組み

概要

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Low success rates of research and development (R&D) are a serious issue in pharmaceutical industries. This is attributed to the dramatic decline (from 88% in 1994, <55% in 1998, 40% in 2000, to nearly 30% in 2005) in phase II stage of drug development, also known as the proof of concept (POC) stage, partly because of the lack of predictive animal models and no previous human knowledge on drug candidates with novel targets and/or mechanisms. New technologies, such as global omics (genomics, transcriptomics, proteomics, and metabolomics), systems biology, and in vivo imaging tools (magnetic resonance imaging: MRI, positron emission tomography: PET, single photon emission computed tomography: SPECT, computed tomography: CT), are being developed and used for advancing molecular understanding of human diseases. Application of these biomarkers would increase confidence in drug candidates, enhance cost-effective decision making in exploratory development, and increase the success rate of the POC stage. In this study, our principle and examples of biomarkers research as well as general information on biomarkers including the definition and factors that affect the R&D paradigm are described.
2009-06-01