title: The triad of success in personalised medicine: pharmacogenomics, biotechnology and regulatory issues from a Central European perspective.
abstract: The population of the world has recently passed the 7 billion milestone and as the cost of human genome sequencing is rapidly declining, sequence data of billions of people should be accessible much sooner than anyone would have predicted 10 years ago. This will form the basis of personalised medicine. However it is still not clear, even in principle, whether these data, combined with data of the expression of one's genome in various cells and tissues relevant to different diseases, could be used effectively in clinical medicine and healthcare, or in predicting responses to different therapies. Therefore this is an important issue which needs to be addressed before more resources are wasted on less than informative studies and surveys simply because technologies exist. As a typical example, we have selected and summarise here key studies from the biomedical literature that focus on gene expression profiling of the response to biologic therapies in peripheral blood and biopsy samples in autoimmune diseases such as rheumatoid arthritis, spondylarthropathy, inflammatory bowel diseases and psoriasis. We also present the state of the biotechnology market from a European perspective, discuss how spin-offs leverage the power of genomic technologies and describe how they might contribute to personalised medicine. As ethical, legal and social issues are essential in the area of genomics, we analysed these aspects and present here the European situation with a special focus on Hungary. We propose that the synergy of these three issues: pharmacogenomics, biotechnology and regulatory issues should be considered a triad necessary to succeed in personalised medicine.
authors.affiliation: Department of Biochemistry and Molecular Biology, Research Center for Molecular Medicine, University of Debrecen, Medical and Health Science Center, Debrecen, Hungary.
authors.forename: Bertalan
authors.initials: B
authors.lastname: Mesko
authors.forename: Gabor
authors.initials: G
authors.lastname: Zahuczky
authors.forename: Laszlo
authors.initials: L
authors.lastname: Nagy
mesh_terms: D001709:Biotechnology / Q000941:ethics / Q000331:legislation & jurisprudence*; D005060:Europe; D023281:Genomics / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D010597:Pharmacogenetics / Q000941:ethics / Q000331:legislation & jurisprudence*; D057285:Precision Medicine / Q000941:ethics; D012926:Social Control, Formal