title: European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development.
abstract: Biomarkers have become increasingly important in drug development and many bioanalysts are getting involved. Consequently, different views on how to approach the bioanalysis of biomarkers have been published or are being developed. The European Bioanalysis Forum has intensively discussed this topic since 2010 and is ready with their recommendation on method establishment and bioanalysis of biomarkers. Acknowledging that the challenges step outside the bioanalytical laboratory is a cornerstone of our recommendation. The importance of integrating all scientific aspects, from purely analytical aspects, all the way to understanding the biology and effects of the biomarker, prior to embarking on method establishment or sample analysis, cannot be underestimated. Close and iterative interactions with the teams requesting the data is imperative to develop a bioanalytical strategy that combines science, analytical performance and regulations. The European Bioanalysis Forum developed a straightforward decision tree to help the scientific community in developing a bioanalytical strategy for any biomarker in drug development.
authors.affiliation: Janssen Research & Development. ptimmerm@its.jnj.com
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
authors.forename: Christian
authors.initials: C
authors.lastname: Herling
authors.forename: Daniela
authors.initials: D
authors.lastname: Stoellner
authors.forename: Birgit
authors.initials: B
authors.lastname: Jaitner
authors.forename: Susanne
authors.initials: S
authors.lastname: Pihl
authors.forename: Karen
authors.initials: K
authors.lastname: Elsby
authors.forename: Neil
authors.initials: N
authors.lastname: Henderson
authors.forename: Begona
authors.initials: B
authors.lastname: Barroso
authors.forename: Stephanie
authors.initials: S
authors.lastname: Fischmann
authors.forename: Arjen
authors.initials: A
authors.lastname: Companjen
authors.forename: Amanda
authors.initials: A
authors.lastname: Versteilen
authors.forename: Stewart
authors.initials: S
authors.lastname: Bates
authors.forename: Clare
authors.initials: C
authors.lastname: Kingsley
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kunz
mesh_terms: D000818:Animals; D054316:Biomarkers, Pharmacological / Q000032:analysis* / Q000378:metabolism; D055808:Drug Discovery / Q000592:standards*; D005060:Europe; D005069:Evaluation Studies as Topic; D033161:Government Regulation; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D054316:Biomarkers, Pharmacological