Challenges Faced in the Integration of Pharmacogenetics/Genomics into Drug Development

Pharmacogenetics and pharmacogenomics are rapidly developing areas of research, with potentially enormous clinical implications and an increasing number of requests for inclusion of pharmacogenetic discoveries in drug labels. While academic centers have been central to the development of research in this area, the need for collaboration amongst academia, industry and regulators is important in order to proceed with high quality and utmost speed. As a number of issues need to be addressed jointly by the different parties, the Group for the Respect of Ethics and Excellence in Science, a not-for-profit organization that constitutes an interface between regulators, academic scientists and representative of the pharmaceutical industry in Europe, organized a meeting to discuss the use of pharmacogenetics/genomics in drug development. The areas for discussion amongst the participants included design of pharmacogenetic studies, regulatory requirements in the European Union, pharmacokinetic and pharmacodynamic aspects with a proposal on future prospects for recognition of pharmacogenetic biomarkers in Europe. A common principle agreed by the group was that there was a need to discover much earlier areas that would have an impact on the safety or efficacy of a new drug. Future guidelines should offer guidance using different scenarios with the common goal of improving the process of drug development.