Fit-for-Purpose Biomarker Assay Development and Validation

Venue: San Diego

Location: San Diego, California, United States

Event Date/Time: Jan 26, 2009 End Date/Time: Jan 26, 2009
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Description

Instructors:
Jean Lee, Ph.D., Scientific Director, PKDM, Amgen
Viswanath Devanarayan, Ph.D., Director, Statistics, Biomarker Research, Abbott Laboratories
John Allinson, FIBMS, Laboratory Director, Veeda Clinical Research
This tutorial 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 the 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.
Outline:

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.

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