Short Course Events*
Thursday, September 20
Using next-generation sequencing for clinical research and diagnostic medicine requires the adoption of procedures such as CLIA/CAP certification, standards for reference materials for proficiency testing, and questions regarding informed consent. The session will cover these topics including challenges with clinical interpretation and incidental findings. In addition, the session will include an interactive discussion on the impediments and opportunities for the potential use of genome-scale profiling in drug development.
- Nazneen Aziz, Ph.D., Director of Molecular Medicine, Transformation Program Office, College of American Pathologists
- Birgit Funke, Ph.D., Director, Clinical Research and Development, Laboratory for Molecular Medicine, PCPGM; Assistant Professor, Pathology, MGH/Harvard Medical School
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.
1. Introduction: Nomenclature, types of biomarker methods/assays, method development and validation road-map, fundamental validity, similarity and differences from PK assays and diagnostic applications
2. Pre-analytical and bioanalytical elements: Target range, standards, validation and QC samples, stability, matrix effect, specificity and relative selectivity
3. Calibration curve model selection, evaluation and weighting
4. Method feasibility and optimization with precision profiles
5. Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits
6. Use of sample controls for in-study performance monitoring and conformance testing among laboratories
7. Special considerations for multiplex assays, cross-validation of assays, etc.
8. Method comparisons
- John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions
- Viswanath Devanarayan, Ph.D., Director, Exploratory Statistics, Abbott Laboratories
*Separate Registration Required