title: Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'.
abstract: Over the past four years, the annual US FDA-DIA pharmacogenomic workshops have brought together attendees with wide-ranging expertise spanning industry, regulatory authorities and academia. This special report summarizes a breakout session using a novel, interactive case format as a way to engage participants, raise awareness and share diverse learnings via 'real life' decisions that project teams might face in developing a new medicine. This case was situated just prior to approval by a Regulatory Authority as a project team is finalizing a new medicine label. To effectively integrate new biomarkers such as pharmacogenomics into developing new medicines, this session highlighted the importance in considering medical practice implications as relevant (or not) to information or actions by a prescriber; progressing validation beyond assay to clinical; and fitting pharmacogenomics into context with other evidence often built over decades during a drug's development. All converge onto a label that must communicate evidence-based use of a new medicine that is effective and safe.
authors.affiliation: CEDD, Global Regulatory Affairs, Neurology & Pharmacogenetics, GlaxoSmithKline, Greenford Road, Greenford, Middlesex, UB6 OHE, UK. lcs29779@gsk.com
authors.forename: Linda C
authors.initials: LC
authors.lastname: Surh
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Lesko
authors.forename: Stuart
authors.initials: S
authors.lastname: Hobbs
authors.forename: Steve
authors.initials: S
authors.lastname: Gutman
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
authors.forename: Oscar E
authors.initials: OE
authors.lastname: Della Pasqua
authors.forename: M J Finley
authors.initials: MJ
authors.lastname: Austin
authors.forename: Kan
authors.initials: K
authors.lastname: Lu
mesh_terms: D054316:Biomarkers, Pharmacological / Q000032:analysis; D003657:Decision Making; D015195:Drug Design; D004345:Drug Industry / Q000592:standards; D006801:Humans; D010597:Pharmacogenetics / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054316:Biomarkers, Pharmacological