The Dynamic Landscape of Biomarker Validation
Learning Objectives
- Explore the continuum of early exploratory biomarker analysis from FDA GLP and CLIA GLP guidelines
- What applications people currently use for biomarker validation
- Latest techniques and guidelines to provide an individualized plan for biomarker validation services
Webinar Description
The use of biomarkers in clinical research is finally coming of age, with an ever-increasing importance in clinical studies, patient stratification, diagnosis and therapeutic monitoring, and requires a ‘fit-for-purpose’ validation approach. Instead of validation guidance becoming more unified and transparent with time, the continuum of fit-for-purpose validation is becoming more dynamic as the utilization of biomarkers broadens. Eurofins Pharma Bioanalytics Services provides specialized biomarker services and validation consultation to clients ranging from pre-clinical animal studies, as well as pharmaceutical clinical trials and therapeutic monitoring. We will share our guidelines in providing highly individualized fit-for-purpose biomarker testing and validation services, ensuring that a biomarker is scientifically and clinically meaningful for its specified purposes.
Meet the Speakers
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Jennifer Ohayon, PhD Jennifer has 20+ years of experience in biomarker discovery and novel biomarker assay development. She received her doctoral studies at the Joslin Diabetes Center at Harvard Medical School. During her post-doctoral training Jennifer continued to study growth factor signaling using proteomics approaches. Her professional expertise incorporates the use of nanotechnology in ultra-sensitive assay development. She brings a depth of understanding in the development and validation of laboratory-developed tests and novel biomarker assay development in the clinical chemistry setting. |
