Pharmacogenomics and Clinical R&D

Abstract

Genetic variation in drug metabolism, disposition, and sensitivity may influence the risk for adverse drug reactions and poor responsiveness of patients. The study of the influence of genetic variations on drug response is the objective of pharmacogenomics (PG, also covering pharmacogenetics). The promise of PG (and other biomarker methodologies such as proteomics) lies in its potential to help identify, and respond to, sources of interindividual variability in drug response from both an efficacy and a safety perspective. This information will make it possible to develop drug therapies for particular groups of patients with the intent of maximizing effectiveness and minimizing risk. However, the field of PG is currently still at a relatively early stage in its life cycle and the promise has yet to be realized, albeit with some notable exceptions, in the field of oncology in particular. Despite major advances in basic biomedical research, including the study of gene structures and activities (genomics) and protein expression (proteomics), there has been a downward trend in the number of new drug and biologic marketing applications and approvals. This is in sharp contrast to the budget spend by the pharmaceutical industry for drug research and development, which has been steadily increasing over the last decade with current estimates as high as US$0.8–1.7 billion [1]. The emerging techniques of PG and proteomics show great potential for contributing biomarkers to target responders, monitoring clinical response and serving as determinants of drug effectiveness. However, much developmental work and standardization of the biologic, statistical and bioinformatics methods is required before these techniques can be routinely used and successfully applied. The 2nd Annual Conference on Pharmacogenomics and Clinical RD however, it should not be considered an exhaustive summary of each of the topics or the subsequent discussions.