title: The role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG).
abstract: Genetic polymorphisms in metabolizing enzymes and drug transporters have been shown to significantly impact the exposure of drugs having a high dependence on a single mechanism for their absorption, distribution or clearance, such that genotyping can lead to actionable steps in disease treatment. Recently, global regulatory agencies have provided guidance for assessment of pharmacogenomics during early stages of drug development, both in the form of formal guidance and perspectives published in scientific journals. The Industry Pharmacogenomics Working Group (I-PWG), conducted a survey among member companies to assess the practices relating to absorption, distribution, metabolism, excretion pharmacogenomics) during early stages of clinical development, to assess the impact of the recent Regulatory Guidance issued by the US FDA and EMA on Industry practices.
authors.affiliation: Pfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Tremaine
authors.affiliation: Sanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA.
authors.forename: William
authors.initials: W
authors.lastname: Brian
authors.affiliation: Bristol Myers Squibb, Clinical Sample Strategy & Operations, Exploratory & Clinical Translational Research, 311 Pennington Rocky Hill Rd, Pennington, NJ 08534, USA.
authors.forename: Terrye
authors.initials: T
authors.lastname: DelMonte
authors.affiliation: Janssen Research & Development, 1400 McKean Rd, PO Box 776, Spring House, PA 19477, USA.
authors.forename: Stephan
authors.initials: S
authors.lastname: Francke
authors.affiliation: Actelion Pharmaceuticals Ltd, Translational Science, Gewerbestrasse 16, 4102 Allschwil, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Groenen
authors.affiliation: Veritas Genetics Inc., 99 Conifer Hill Drive, Danvers, MA 01923, USA.|Novartis Institutes for Bio Medical Research, Inc., 250 Massachusetts Avenue, Cambridge, MA 02139, USA.
authors.forename: Keith
authors.initials: K
authors.lastname: Johnson
authors.affiliation: Veritas Genetics Inc., 99 Conifer Hill Drive, Danvers, MA 01923, USA.|Novartis Institutes for Bio Medical Research, Inc., 250 Massachusetts Avenue, Cambridge, MA 02139, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Li
authors.affiliation: Sanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Pearson
authors.affiliation: Pfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Marshall
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D010599:Pharmacokinetics; D011110:Polymorphism, Genetic; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
keywords: ADME; Regulatory Guidance; absorption, distribution, metabolism and excretion; drug metabolism; drug transporters; pharmacogenomics; pharmacokinetics