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.
What will you learn?
- 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
Who may this interest?
- Bioanalytical scientists
- Clinical scientists/chemists
- Tranlational scientists in Pharma and Biotech
- Research scientists in Pharma and Biotech
Nann is the Principal Scientist at Eurofins’ St Charles, Missouri site, where her role is to serve as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements particularly in the area of biomarkers. She received her PhD (Physiology of Reproduction) in 1999 from Texas A&M University. Nann has over 15 years of experience in the development, validation and implementation of immunoassay methods, holding positions with Linco Research and EMD Millipore.
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.
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