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A new publication entitled "Pharmacogenetics: Opportunities and Challenges for Health Innovation" will be available in late 2009. The book will examine the challenges facing pharmacogenetics at across the health innovation cycle and into the clinic. It reviews the impact to date of pharmacogenetics on both pharmaceutical R&D and clinical care, and concludes that the widespread adoption of pharmacogenetics is not yet guaranteed and that governments have a role to play in creating an “enabling” environment.
Pharmacogenetics can improve both the drug discovery process. It is useful in both identifying and validating new drug targets. In clinical trials, pharmacogenetics can help stratify patients who respond to a new potential medicine appropriately, adversely or not at all. It can also improve the quality and efficacy of the medicines ultimately developed. In clinical care, pharmacogenetics may enable doctors to prescribe more effective interventions and improve their use of evidence-based medicine. Pharmacogenetics can help identify those individuals most likely to benefit from a therapy and those most likely have an adverse reaction, allowing doctors to optimise treatments for individuals.
However, the number of pharmacogenetics-based diagnostics on the market is still limited with less than a dozen products commercially available. A number of scientific, regulatory, and economic challenges need to be overcome if pharmacogenetics is to be taken up more widely by healthcare systems.
Public policy and coordinated international action may be necessary to:
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validate biomarkers
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run the prospective studies necessary to apply pharmacogenetics to existing medicines
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create the incentives to apply pharmacogenetics broadly in the drug development process
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increase transparency about how pharmacogenetics will be accepted by regulatory authorities
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understand the economic and health impacts of pharmacogenetics on health care systems
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educate and make information available to health care providers about pharmacogenetic assays, their interpretation and treatment options.
The book is scheduled for publication in late 2009.
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