title: Plasma Fibrinogen Qualification as a Drug Development Tool in Chronic Obstructive Pulmonary Disease. Perspective of the Chronic Obstructive Pulmonary Disease Biomarker Qualification Consortium.
abstract: The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on qualification of drug development tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support qualification of several tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the qualification. This led to the FDA qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development tool qualified for use in COPD under the FDA's drug development tool qualification program. This perspective summarizes the FDA's qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker qualification efforts.
authors.affiliation: 1 Respiratory Therapy Area Unit, GlaxoSmithKline Research and Development, King of Prussia, Pennsylvania.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Miller
authors.affiliation: 1 Respiratory Therapy Area Unit, GlaxoSmithKline Research and Development, King of Prussia, Pennsylvania.
authors.forename: Ruth
authors.initials: R
authors.lastname: Tal-Singer
authors.affiliation: 2 Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Nebraska Medical Center, Omaha, Nebraska.|3 Clinical Discovery Unit, AstraZeneca LP, Cambridge, United Kingdom.
authors.forename: Stephen I
authors.initials: SI
authors.lastname: Rennard
authors.affiliation: 4 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Armin
authors.initials: A
authors.lastname: Furtwaengler
authors.affiliation: 5 Outcomes Research, Evidera, Bethesda, Maryland.
authors.forename: Nancy
authors.initials: N
authors.lastname: Leidy
authors.affiliation: 6 Global Regulatory Affairs, GlaxoSmithKline Research and Development, Middlesex, United Kingdom.
authors.forename: Michael
authors.initials: M
authors.lastname: Lowings
authors.affiliation: 7 Global Medicine Development, AstraZeneca LP, Gaithersburg, Maryland.
authors.forename: Ubaldo J
authors.initials: UJ
authors.lastname: Martin
authors.affiliation: 8 Novartis Pharmaceuticals, East Hanover, New Jersey.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Martin
authors.affiliation: 9 COPD Foundation, Washington, DC.
authors.forename: Debora D
authors.initials: DD
authors.lastname: Merrill
authors.affiliation: 10 Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut; and.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Snyder
authors.affiliation: 9 COPD Foundation, Washington, DC.
authors.forename: John
authors.initials: J
authors.lastname: Walsh
authors.affiliation: 11 Department of Preventive Medicine and Environmental Health, University of Kentucky, College of Public Health, Lexington, Kentucky.
authors.forename: David M
authors.initials: DM
authors.lastname: Mannino
mesh_terms: D015415:Biomarkers / Q000097:blood; D055808:Drug Discovery / Q000379:methods*; D005340:Fibrinogen / Q000378:metabolism*; D006801:Humans; D004364:Pharmaceutical Preparations; D055818:Public-Private Sector Partnerships; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood* / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations; D005340:Fibrinogen
keywords: Food and Drug Administration; biomarkers; chronic obstructive pulmonary disease; drug development tools; fibrinogen