Pharmacogenetics and future drug development and delivery

A great medicine is one that effectively treats or prevents disease and has no adverse effects. Despite well-regulated registration environments for proving efficacy and safety, adverse events (eg, adverse drug reactions, ADRs) can be unpredictable and a medicine is rarely effective in all patients. Neither those who pay for medical care nor patients want drugs to be prescribed that do not benefit the recipient. Pharmacogenetics has the promise of removing much of the uncertainty. Physicians will be able to use a medicine response profile to predict an individual’s likely response before a medicine is prescribed. Although not immediately obvious, the pharmaceutical industry and the public should also benefit by faster and more efficient clinical trials, more treatments for more patients, reduced costs of drug development, expansion of research to cover more diseases, and improved drug surveillance. The first step is to acknowledge shortfalls in current regulatory systems and the potential of pharmacogenetics to meet those shortfalls. A phased system of regulatory change could be considered, as the anticipated scientific developments become available. It is therefore useful to define the terms and techniques that will allow this process to be designed, piloted, and established.