Forecasts suggest that personalised medicine will become the future disease management model; a model where treatments will be tailored to a person’s genetic profile. Currently, most available drugs on the market are developed by targeting the patient’s population as a single entity, with limited differentiation of the patient’s genetic make-up. Nostrapharmus asks, how can we change our drug development approach in order to yield the medicines of the future?
Pharmacogenetic vs. Pharmacogenomic approaches
A pharmacogenetic approach demonstrates the development of drugs that are targeted to specific genes. A good example of this approach is research at the University of Southern California where they have identified genetic markers in cancer cells that are able to predict the benefit of a novel cancer drug, PTK/ZK*. The focus of this study was understanding the mechanisms of candidate genes. These genes are associated with a specific group of patients that exhibited significant improvement to PTK/ZK. This approach, if successful, would significantly increase the drug effectiveness in a specific patient group; that is, those who have the correct form of the candidate genes. It may, however, carry a higher risk of commercial failure, because of the increased effort and cost in development, and the risk of investigating the wrong candidate genes.
A Pharmacogenomic approach could be an alternative in developing personalised medicines. With the advance in gene sequencing techniques, it now only takes ten days to sequence all protein-coding genes (about 1 per cent of the genome), which forms a person’s genomic profile, or fingerprint. With this information, researchers could determine association between treatment outcomes and the pattern in the genetic fingerprint. Here, investigators focus on searching for an association between variations in the genome and treatment outcome. No candidate genes are isolated for investigation. To succeed, one must develop powerful analytic tools, using custom built IT solutions and, perhaps, adapting statistical solutions, such as SPSS and multi-level modelling. The tools should be able to effectively group genes into various levels of subgenome, a subset of a genome, which may have a specific function, and determine which subgenome, at which level, are associated with treatment outcomes.
The future model could be a mixture of both pharmacogenetic and pharmacogenomic approaches, dependent on the identification of the candidate gene(s) associated with diseases under investigation and the availability of analytic tools to investigate our genome. Nostrapharmus looks at what we can do now.
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*PTK/ZK, is a VEGF receptor tyrosine kinase inhibitor that is currently under development by Novartis AG and Schering AG as an inhibitor of angiogenesis for the potential treatment of various cancers.
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