Personalised Medicine


Figure 2: Major challenges identified by participants in the field of personalised medicine 21%


Other


Reducing the size of pharmaceutical markets – since they are carved up – hence smaller patient populations


Tools and technologies do not exist for targeted therapeutics Adds complexity to the drug development process Unclear future regulatory considerations


Difficult to associate diseases with molecular markers as yet comprehensively Not required as yet by the FDA


Biomarkers do not exist for characterising/stratifying patient populations 0% Source: Select Biosciences Industry Report 10% 20% 30% 40% Percent of respondent pool 50% 37% 60%


56% 60%


70% 31% 41% 53% 49%


active investigation. In fact in the academic litera- ture in the past several years, there are tens of thousands of biomarkers that have been described. Only a few of these markers can be validated, how- ever, in that their association with a biological phe- notype (disease) is strong, robustly-detected using commercially-available assays, and their frequency in the target patient population is significantly high


such that they can be effectively used as bona fide biomarkers. These are significant hurdles from a scientific perspective, notwithstanding the regula- tory and economic barriers for deployment. For these reasons, there are currently very few companion diagnostic-therapeutic combinations that have made it to the drug label – ie, providing prescribing guidelines to the physician. Figure 3


Figure 3: Dawn of personalised medicine: tests recommended/required in US drug labels


Source: US FDA Presentation at Select Biosciences European Biomarkers Summit 2009 (EBS2009), Barcelona, Spain, November 2009. 2D6 and 2C9 refer to the cytochrome P450 drug metabolising enzymes (CYP450 DMEs)


Drug Discovery World Summer 2010 87


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