title: Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.
abstract: Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24-25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved among the participants on topics from nomenclature to best practices. For example, it was agreed that because reliable and accurate data provide the basis for sound decision making, biomarker assays must be validated in a manner that enables the creation of such data. The nature of biomarker measurements often precludes direct application of regulatory guidelines established for clinical diagnostics or drug bioanalysis, and future guidance on biomarker assay validation should therefore be adaptable enough that validation criteria do not stifle creative biomarker solutions.
authors.affiliation: MDS Pharma Services, Lincoln, Nebraska, USA. jean.lee@mdsinc.com
authors.forename: Jean W
authors.initials: JW
authors.lastname: Lee
authors.forename: Russ S
authors.initials: RS
authors.lastname: Weiner
authors.forename: Jeff M
authors.initials: JM
authors.lastname: Sailstad
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bowsher
authors.forename: Dean W
authors.initials: DW
authors.lastname: Knuth
authors.forename: Peter J
authors.initials: PJ
authors.lastname: O'Brien
authors.forename: Jean L
authors.initials: JL
authors.lastname: Fourcroy
authors.forename: Rakesh
authors.initials: R
authors.lastname: Dixit
authors.forename: Lini
authors.initials: L
authors.lastname: Pandite
authors.forename: Robert G
authors.initials: RG
authors.lastname: Pietrusko
authors.forename: Holly D
authors.initials: HD
authors.lastname: Soares
authors.forename: Valerie
authors.initials: V
authors.lastname: Quarmby
authors.forename: Ole L
authors.initials: OL
authors.lastname: Vesterqvist
authors.forename: David M
authors.initials: DM
authors.lastname: Potter
authors.forename: James L
authors.initials: JL
authors.lastname: Witliff
authors.forename: Herbert A
authors.initials: HA
authors.lastname: Fritche
authors.forename: Timothy
authors.initials: T
authors.lastname: O'Leary
authors.forename: Lorah
authors.initials: L
authors.lastname: Perlee
authors.forename: Sunil
authors.initials: S
authors.lastname: Kadam
authors.forename: John A
authors.initials: JA
authors.lastname: Wagner
mesh_terms: D001681:Biological Assay / Q000379:methods* / Q000592:standards; D015415:Biomarkers / Q000032:analysis; D002626:Chemistry, Pharmaceutical / Q000639:trends*; D002986:Clinical Trials as Topic; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers