SC3: Fit-for-Purpose Biomarker Assay Development – Performance Characterization and Validation to “Context of Use”

MONDAY, JUNE 2 | 8:00 – 10:45 AM

ABOUT THIS COURSE: This tutorial will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in the method of 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 feasibility studies. 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, cross-validation of biomarker assays, etc.


  • Introduction: Nomenclature, types of biomarker methods/assays, method development and validation roadmap, fundamental validity, similarity and differences from PK assays and diagnostic applications
  • Pre-analytical and bioanalytical elements: Target range, standards, validation and 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
  • Special considerations for multiplex assays, cross validation of assays, etc.
  • Method comparisons


Allinson_JohnJohn L. Allinson, FIBMS, Vice President, Biomarker Services, Immunologix Labs

John Allinson, Leads the Biomarker Services at Immunologix in Tampa Bay, Florida. He was previously the Head of Biomarker Strategy of LGC and brings over 40 years of experience in developing and working with biomarkers including their use in drug development across all therapeutic categories and phases of development. Before joining LGC, Mr. Allinson spent 22 years in NHS Clinical Pathology services before moving into the CRO industry where he managed Central, Bioanalytical and Biomarker Laboratories at a number of CRO’s.

Mr. Allinson was part of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) Biomarker Committee which published the first consensus white paper on biomarker assay validation requirements in Drug Development, and was also co-author of the first white paper on the Validation of Multiplexed Biomarker assays as well as other leading Biomarker white papers on the subject.

Devanarayan_ViswanathViswanath Devanarayan, PhD, Global Health of Statistics & Data Sciences, Charles River Laboratories

Dr. Devanarayan has 23 years of pharmaceutical research experience from Eli Lilly, Merck, and AbbVie. In addition to leading global teams for over 15 years, his scientific contributions cover a wide variety of statistical methods and applications across basic science, drug discovery and clinical research. He has filed ten patent applications, given over 100 invited talks, and co-authored over 65 manuscripts, which include several white papers with regulatory, academic and industry scientists on compound screening, genomics, predictive modeling, machine learning, bioanalytical methods, and clinical biomarker qualification. He was inducted as a Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2014. He is currently employed at Charles River Laboratories and is also serving as an Adjunct Professor at the University of Illinois in Chicago.