title: Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development.
abstract: The aim of this review is to discuss the potential usefulness of a novel class of biochemical markers, neoepitopes, in the context of the US Food and Drug Administration (FDA) Critical Path Initiative, which emphasizes biomarkers of safety and efficacy as areas of pivotal interest. Examples of protein degradation fragments--neoepitopes--that have proven useful for research on bone and cartilage are collagen type I and collagen type II degradation products, respectively. These markers have utility in the translational approach, as they can be used to estimate safety and efficacy in both preclinical models and clinical settings. Biochemical markers of tissue degradation may provide optimal tools, which in combination with other techniques, prove essential to drug discovery and development.
authors.affiliation: Nordic Bioscience A/S, Herlev Hovedgade 207, Herlev, Denmark. mk@nordicbioscience.com
authors.forename: M A
authors.initials: MA
authors.lastname: Karsdal
authors.forename: K
authors.initials: K
authors.lastname: Henriksen
authors.forename: D J
authors.initials: DJ
authors.lastname: Leeming
authors.forename: P
authors.initials: P
authors.lastname: Mitchell
authors.forename: K
authors.initials: K
authors.lastname: Duffin
authors.forename: N
authors.initials: N
authors.lastname: Barascuk
authors.forename: L
authors.initials: L
authors.lastname: Klickstein
authors.forename: P
authors.initials: P
authors.lastname: Aggarwal
authors.forename: O
authors.initials: O
authors.lastname: Nemirovskiy
authors.forename: I
authors.initials: I
authors.lastname: Byrjalsen
authors.forename: P
authors.initials: P
authors.lastname: Qvist
authors.forename: A C
authors.initials: AC
authors.lastname: Bay-Jensen
authors.forename: E B
authors.initials: EB
authors.lastname: Dam
authors.forename: S H
authors.initials: SH
authors.lastname: Madsen
authors.forename: C
authors.initials: C
authors.lastname: Christiansen
mesh_terms: D015415:Biomarkers; D019091:Critical Pathways; D015195:Drug Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers