title: PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?
abstract: 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 serves 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.
authors.affiliation: Department of Pharmacogenomics, Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, USA.
authors.forename: N
authors.initials: N
authors.lastname: Grecco
authors.forename: N
authors.initials: N
authors.lastname: Cohen
authors.forename: A W
authors.initials: AW
authors.lastname: Warner
authors.forename: C
authors.initials: C
authors.lastname: Lopez-Correa
authors.forename: S L
authors.initials: SL
authors.lastname: Truter
authors.forename: A
authors.initials: A
authors.lastname: Snapir
authors.forename: S P
authors.initials: SP
authors.lastname: Piccoli
authors.forename: D
authors.initials: D
authors.lastname: Wang
authors.forename: A
authors.initials: A
authors.lastname: Westelinck
authors.forename: L
authors.initials: L
authors.lastname: Hinman
authors.forename: M A
authors.initials: MA
authors.lastname: Franc
mesh_terms: D002986:Clinical Trials as Topic; D004247:DNA / Q000235:genetics; D003625:Data Collection; D003627:Data Interpretation, Statistical; D004345:Drug Industry; D005060:Europe; D020407:Internet; D007753:Laboratories / Q000592:standards; D007880:Legislation, Drug; D010597:Pharmacogenetics / Q000639:trends*; D010600:Pharmacology / Q000639:trends*; D057285:Precision Medicine; D011786:Quality Control; D013048:Specimen Handling / Q000592:standards; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D004247:DNA