PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?

Interindividual variation in pharmacodynamic (PD) response to drugs is an ongoing area of research for drugs in clinical development, pre- and postapproval. To characterize how pharmacogenomic (PG) variations can serve as a predictor of differences in PD outcomes, the pharmaceutical industry has incorporated PG/PD analysis into clinical drug development. The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey of 16 pharmaceutical companies to ascertain to what extent PG/PD research is being incorporated into drug development. The survey results showed that, while the industry has made some attempt to incorporate PG/PD studies into drug development, application has been inconsistent. Nevertheless, several valid PG/PD markers have since emerged in drug labels. The I-PWG considers PG/PD research an important approach to improving success rates in drug development. This article reports the results of the survey and proposes steps toward increasing the use of PG/PD research by the industry. Clinical Pharmacology & Therapeutics (2012); 91 6, 1035–1043. doi:10.1038/clpt.2011.334