Premium
PhRMA Survey of Pharmacogenomic and Pharmacodynamic Evaluations: What Next?
Author(s) -
Grecco N,
Cohen N,
Warner A W,
LopezCorrea C,
Truter S L,
Snapir A,
Piccoli S P,
Wang D,
Westelinck A,
Hinman L,
Franc M A
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.334
Subject(s) - pharmacogenomics , pharmacodynamics , clinical pharmacology , pharmaceutical industry , drug development , pharmacology , drug , medicine , pharmacokinetics
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