title: Industry perspectives on biomarker qualification.
abstract: Biomarkers have the potential to expedite drug development, increase patient safety, and optimize clinical response. Yet few have achieved regulatory qualification. A survey was conducted to clarify industry's perspective on biomarker qualification and identify the most promising biomarkers for drug development. The results across toxicities/clinical areas highlight challenges in regulatory qualification, although early prioritization and alignment on an evidentiary standard framework are key factors in facilitating biomarker development and qualification.
authors.affiliation: Pharmaceutical Research and Manufacturers of America, Washington, DC, USA.
authors.forename: G
authors.initials: G
authors.lastname: Lavezzari
authors.affiliation: Biotechnology Industry Organization, Washington, DC, USA.
authors.forename: A W
authors.initials: AW
authors.lastname: Womack
mesh_terms: D015415:Biomarkers; D054316:Biomarkers, Pharmacological; D004345:Drug Industry / Q000592:standards / Q000639:trends; D019981:Health Care Sector / Q000592:standards* / Q000639:trends*; D006801:Humans; D061214:Patient Safety; D004364:Pharmaceutical Preparations; D010600:Pharmacology / Q000592:standards / Q000639:trends; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations