CONFERENCE SERIES: Biomarkers & Diagnostics
Recorded at: ADAPT Congress
Digital Course: Fit-for-Purpose Biomarker Assay Development and Validation
Instructor: John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions
This digital course will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for the intended exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in method development and validation will be illustrated with examples, including reference to standard material, sample stability and collection integrity, validation and QC samples, validity of reference standards, calibration curve fitting methods, method optimization and method feasibility studies. The special challenges in protein biomarker assays will be discussed, including strategies for moving from biomarker panels in the exploratory phase to the few markers chosen to support clinical trials.
Introduction: Nomenclature, types of biomarker methods/assays, biomarker method development & validation road map, fundamental validity, similarity and differences from PK assays & diagnostic application
Pre-analytical and Bioanalytical elements: Target range, standards, validation & QC samples, stability, matrix effect, specificity, and relative selectivity
Calibration curve model selection, evaluation, and weighting
Method feasibility and optimization with precision profiles
Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits
Use of Sample Controls for in-study performance monitoring and conformance testing among laboratories
John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions
John Allinson is a Fellow of the Institute of Biomedical Sciences and has experience in all fields of clinical pathology, having spent 22 years in diagnostic laboratories in the National Health Service in the United Kingdom where he managed and developed specialist laboratory services for drug monitoring, trace metals and immunoassays. Moving to Contract Research in 1992, he developed analytical and bespoke Biomarker services for a large central clinical laboratory in the UK conducting all phases of pre-clinical and clinical trials, which included validation of more than 150 immunoassays on a variety of analytical platforms. John has led the development of the biomarkers laboratory and other analytical services at other CRO’s before joining ICON as part of a recent acquisition of his Biomarker Laboratory in Oxford, UK. He now has 37 years experience in working with Biomarkers. John has been a respected speaker at many International Biomarker meetings, and was a member of the AAPS Ligand Binding Assay Bioanalytical Focus Group’s Biomarker Committee that published the first White Paper on Biomarker Assay Validation requirements for the drug development industry in 2006.
Pharm Res. 2006 Feb;23(2):312-28.
Fit-for-purpose method development and validation for successful biomarker measurement.Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA.
This digital course was recorded at:
ADAPT 2009: Accelerating Development & Advancing Personalized Therapy Congress
September 22-25, 2009, Washington, DC