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BIOTEC OPEN FORUM
Practical Biomarker Assay Development, Validation and Sample Results for Drug Exposure – Effect Assessment
Thursday, November 15
1:30 pm – 5:00 pm
Co-sponsored with the Ligand Binding Assays Bioanalytical Focus Group
An overview of fit-for-purpose biomarker method development, validation and sample analysis for exploratory and advanced applications with case studies will be presented. The focus will be on the basic and practical elements of biomarker quantification using statistical thinking to select and develop methods (platforms, single and multiplex reagents, measuring free or bound forms) to assess assay performance and for implementation that aid decision-making in drug development. The challenges of validating a large multiplex method, mining the mountains of data, and overcoming technical problems will be presented in a case study to support a therapeutic monoclonal antibody drug candidate. Statistical considerations such as multi-factorial methods for assay optimization, evaluation of calibration curves, analytical precision and sensitivity will be addressed. Impact of biomarker analytical variability in relation to biological variability on clinical study design and sample evaluations will be discussed.
Moderator
Yuchen Barrett, Ph.D.
Bristol-Myers Squibb Company
"Fit-for-Purpose" Biomarker Method Validations: From Concept to Practices
Jean Lee, Ph.D.
Amgen, Inc.
The Life Cycle of a Multiplex Biomarker Method
Steve Keller
Protein Design Labs
Some Statistical Considerations in Biomarker Assays and Their Impact on Clinical Sample Evaluations
Viswanath Devanarayan
Abbott Laboratories