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.
Speakers
John Allinson
FIBMS
Biologics Development Services (now Immunologix Laboratories) Tampa Bay, FL
Mr. Allinson is vice president of Biomarker Sciences and leads the Biomarker Services group at Biologics Development Services (now Immunologix Laboratories) 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.
Protein biology
- Protein quantitation
Duration:24min
Language:English
Session 1:presented September 12, 2018
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