Fit-For-Purpose Biomarker Validation to Support Clinical Trials Webinar
Learning Objectives
- Understand the regulatory Fit for Purpose validation requirements for protein biomarkers
- Understand the difference between assays validated specifically to meet the needs of clinical trials vs those used in a reference laboratory setting
- Learn about optimal approaches to the validation of biomarker assays on a variety of commonly used and specialized analytical platforms
Webinar Description
The increased use of protein biomarker signatures during the drug development path for new pharmaceuticals, from exploratory to clinical subject decision-making has led to an increasing scrutiny of the data being generated. The revised FDA guideline on Bioanalytical Method Validation is the first regulatory document to specifically address how to validate assays for biomarker assessment, following the 'fit for purpose' approach. This talk will discuss some of the major challenges that need to be overcome to ensure that biomarker assays are 'fit for purpose' and compare assays tailored specifically for clinical trials with assays developed for diagnostic or reference laboratories.
Meet the Speakers
 |
Nann Green, PhD. Dr. Green is Principal Investigator 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. Dr. Green has over 15 years of experience in the development, validation and implementation of immunoassay methods, holding positions with Linco Research and EMD Millipore. |
