oa Editorial [Hot Topic: Pharmacogenomics: Achievements, Challenges and Prospects, for Patients, Pharmaceutical Industries and Healthcare Systems (Guest Editor: Despina Sanoudou)]

Pharmacogenomics represents one of the leading emerging translational sciences. It has been rapidly expanding over the past 20 years and especially following the completion of the Human Genome Project and the advent of high-throughput technologies (e.g. microarrays). This has led to a significant accumulation of new information (Fig. 1). Pharmacogenomics, has much to offer to faster drug target identification and evaluation, increasing drug specificity, reducing adverse drug reactions (ADRs) and improving genome-based patient stratification, with direct implications in patient quality of life and viability, clinical practice, drug development and pharmacoeconomics. The U.S.A. Food and Drug Administration (FDA) has already approved a number of pharmacogenomic tests and includes pharmacogenomic information in the labels of ˜10% of its approved drugs, many of which are anti-tumor agents [1]. Indeed, the significant role of pharmacogenomically guided selection of patient treatments is best exemplified in the oncology clinic, such as in the case of molecular targeted therapies. The latest advances in this rapidly evolving area and their clinical implications are presented in this Special Issue by Mountzios et al. [2]. Numerous other patient groups are starting to benefit from the advances in pharmacogenetics. Heart disease is a representative example of an area where significant work on pharmacogenetics is under way and promising findings are arising. For example, numerous genetic variants have been associated with presence/absence or levels of patient response as well as different ADRs to medications for heart disease. However, the biological complexity and multifactorial nature of heart disease together with current limitations in the pharmacogenomic research setting have hindered the transition of pharmacogenomic research findings to the clinic. Vafiadaki et al. are summarizing the latest advances in the field focusing on antihypertensive, antiarrhythmic, anticoagulant, and cholesterol-lowering drugs [3]. Representative large- and small-scale studies are included, the contradictory findings presented and ethnicity is introduced as an important additional parameter to be considered during the integration of pharmacogenetic tests to the cardiology clinic. As our understanding of the drug-genome interplay increases it is likely that environmental parameters will start being introduced to the drug-genome equation. In addition to an individual's ethnic background, sex is emerging as a key component especially in conditions differentially affecting males and females. Pitychoutis et al. are discussing the impact sex could have in pharmacogenetics using the example of depression and antidepressant response [4]. The rapidly accumulating data from phramacogenomic studies raise the need for the establishment of well structured, high-capacity, international pharmacogenomic databases along with clear, globally accepted guidelines. This will not only ensure high quality and comparability of datasets generated across the board, but will further enable easy access to those datasets and form the basis for future large scale metanalysis, ultimately expediting the generation of robust and clinically useful findings. Lagoumintzis et al. are presenting how the existing genetic databases can serve towards this direction [5]. Together with the need for large, carefully selected and well characterized patient cohorts, pharmacogenomic studies must be suitably designed to allow for sufficient statistical power and potentially seek the use of innovative statistical methodologies. Sato et al. highlight some of the important aspects related to the design and statistical analysis for pharmacogenomics studies or clinical trials incorporating biomarkers [6].