title: Fit-for-purpose method development and validation for successful biomarker measurement.
abstract: Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are employed in an attempt to speed new drugs to market. Still, widespread adoption of biomarkers is impeded by limited experience interpreting biomarker data and an unclear regulatory climate. Key differences preclude the direct application of existing validation paradigms for drug analysis to biomarker research. Following the AAPS 2003 Biomarker Workshop (J. W. Lee, R. S. Weiner, J. M. Sailstad, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report. Pharm Res 22:499-511, 2005), these and other critical issues were addressed. A practical, iterative, "fit-for-purpose" approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use. Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development.
authors.affiliation: Formerly MDS Pharma Services, Lincoln, Nebraska, USA. jwlee@amgen.com
authors.forename: Jean W
authors.initials: JW
authors.lastname: Lee
authors.forename: Viswanath
authors.initials: V
authors.lastname: Devanarayan
authors.forename: Yu Chen
authors.initials: YC
authors.lastname: Barrett
authors.forename: Russell
authors.initials: R
authors.lastname: Weiner
authors.forename: John
authors.initials: J
authors.lastname: Allinson
authors.forename: Scott
authors.initials: S
authors.lastname: Fountain
authors.forename: Stephen
authors.initials: S
authors.lastname: Keller
authors.forename: Ira
authors.initials: I
authors.lastname: Weinryb
authors.forename: Marie
authors.initials: M
authors.lastname: Green
authors.forename: Larry
authors.initials: L
authors.lastname: Duan
authors.forename: James A
authors.initials: JA
authors.lastname: Rogers
authors.forename: Robert
authors.initials: R
authors.lastname: Millham
authors.forename: Peter J
authors.initials: PJ
authors.lastname: O'Brien
authors.forename: Jeff
authors.initials: J
authors.lastname: Sailstad
authors.forename: Masood
authors.initials: M
authors.lastname: Khan
authors.forename: Chad
authors.initials: C
authors.lastname: Ray
authors.forename: John A
authors.initials: JA
authors.lastname: Wagner
mesh_terms: D015415:Biomarkers / Q000032:analysis* / Q000737:chemistry; D002138:Calibration; D003627:Data Interpretation, Statistical; D015195:Drug Design; D015233:Models, Statistical; D011786:Quality Control; D015203:Reproducibility of Results; D009626:Terminology as Topic
chemical_list: D015415:Biomarkers