Webinar Technology

Getting it right: The importance of rigorous validation for high-sensitivity immunoassays

This webinar is brought to you by the Science/AAAS Custom Publishing Office

Getting it right: The importance of rigorous validation for high-sensitivity immunoassays

12 September 2018

12:00 p.m. ET

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Finding robust, reliable biomarkers for potential clinical application is an ongoing challenge. Equally challenging is proper validation of assays for detection and measurement of these biomarkers. During this webinar, our expert speaker will discuss how to optimize the collection of validation data for the ultrahigh sensitivity measurement of cytokines interleukin-17A and IL-17F, and describe the use of validation samples prepared with endogenous molecules generated using whole-blood ex vivo stimulation.

Other critical topics covered will include:

  • The importance of parallelism, including minimum required dilution (MRD) confirmation
  • Precision and proposed confidence limits for acceptance criteria
  • Comparison of performance using endogenous vs. surrogate validation samples
  • The matrix effect and MRD—comparing results from endogenous vs. spiked samples
  • An explanation of the ex vivo stimulation method protocol.

Viewers will be able to submit questions during the live broadcast.

This webinar will last for approximately 60 minutes.

Speaker bios

John Allinson

Biologics Development Services
Tampa Bay, FL

Mr. Allinson is vice president of Biomarker Sciences and leads the Biomarker Services group at Biologics Development Services in Tampa Bay, Florida. He was previously the head of Biomarker Strategy at LGC in the United Kingdom 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 the United Kingdom’s National Health Service clinical pathology services before moving into the contract research industry where he managed central, bioanalytical, and biomarker laboratories at a number of contract research organizations. He was part of the American Association of Pharmaceutical Scientists Ligand Binding Assay Bioanalytical Focus Group (LBABFG) Biomarker Committee, which published the first consensus white paper on biomarker assay validation requirements in drug development. He also coauthored the first white paper on the validation of multiplexed biomarker assays as well as other leading white papers on the subject.

Sean Sanders, Ph.D.

Washington, DC

Dr. Sanders did his undergraduate training at the University of Cape Town, South Africa, and his Ph.D. at the University of Cambridge, UK, supported by the Wellcome Trust. Following postdoctoral training at the National Institutes of Health and Georgetown University, Dr. Sanders joined TranXenoGen, a startup biotechnology company in Massachusetts working on avian transgenics. Pursuing his parallel passion for writing and editing, Dr. Sanders joined BioTechniques as an editor, before joining Science/AAAS in 2006. Currently Dr. Sanders is the Senior Editor for Custom Publishing for the journal Science and Program Director for Outreach.

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