Applying pharmacogenomics in drug development: Call for collaborative efforts

Personalized medicine remains the long-awaited next revolution in medicine. So far, progress towards this change has been much slower than hoped, given that our entire DNA sequence has been publicly available since April 2001. Three years down the road, it has become clear that the expectations for fast progress in medicine were excessive, and that our genome is by far more complex than originally perceived. Moreover, it seems that both the medical profession and health care systems, as well as pharmaceutical companies, are too conservative for modifying diagnostic and treatment protocols following the gain of new pharmacogenomics knowledge that has the potential to drastically reduce the incidence rates of adverse drug reactions. The next few years may well be a crucial turning point for the use of pharmacogenomics data in drug development. The transformation will hopefully begin with the availability of FDA approved rapid and reliable diagnostic screening tools for CYP450 alleles, along with new FDA guidelines favoring the approval process for drug applications supported by valuable genomic information related to toxic reactions. The current theme issue, a focused snapshot for mid-2004, highlights some of the vital topics in clinical genetics and informatics that together will hopefully form a platform for future joint efforts to identify the most valuable genotype/drug response phenotype correlations. Dialogue and collaboration between regulatory agencies and the pharmaceutical industry, as well as within the pharmaceutical sector, will be indispensable for advancing beyond this turning point towards genuine personalized medicine.