Pharmacogenomics: Drug Development, Drug Response, and Precision Medicines
Michelle A. Penny, Duncan McHale · 2008
Abstract In its broadest sense, pharmacogenomics can be defined as the investigation of variations of DNA and RNA characteristics as related to drug response. The last decade has seen a large increase in the amount of genomics data generated and, with it, increased the expectations of how improved understanding of disease will lead to the development of more effective therapies and personalized medicines. Despite the regular media reports of novel genes being identified in a range of disorders, by 2007 the much-heralded promise of the human genome project has yet to materialize. However, it is important to realize that this does not represent a failure of the science to deliver but is a reflection of the length of time it takes to develop new drugs. The 1980s and 1990s saw a boom time for the pharmaceuticals industry producing many highly effective new classes of drugs from statins to proton-pump inhibitors and quinolone antibiotics. All were novel therapeutic approaches offering significant benefit to individuals and society. The science that drove many of these advances was based on the greater understanding of biochemistry and pharmacology that emerged during the 1970s and early 1980s. This 10–15-year time-lag from gaining scientific knowledge to developing therapies is typical for the pharmaceutical industry, and reflects the complexity of drug discovery and the time required for preclinical and clinical testing to ensure safety and efficacy. This chapter will introduce the major concepts of drug discovery and development and give a broad overview of how genetics and genomics is used across the whole drug discovery and development pipeline, from pretarget identification to postmarketing surveillance to help discover and develop improved medicines.