ON-DEMAND Webinar
Best Practices for the Development and Validation of qPCR and ddPCR Assays
Now Streaming On-Demand
The emergence and evolution of cell and gene therapy has led many bioanalytical laboratories to implement qPCR and/or ddPCR to support preclinical and clinical assays. While there is a lack of regulatory guidance on how to approach these assays, discussions have already started in the community on harmonizing the approach on the development and validation of qPCR/ddPCR assays. This talk will cover best practices and what should be considered when developing and validating such assays.
Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.
Dr. Amanda L. Hays offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers and flow cytometry. She has particular expertise leading clients from pre-clinical through phase III clinical trials and post-marketing studies. Prior to joining BioAgilytix, she served as Director of Bioanalytical Science at PRA Health Sciences, where she provided global scientific leadership and technical guidance for PRA’s large molecule bioanalytical laboratory.
Dr. Hays is the Vice Chair of the AAPS Biomarkers and Precision Medicine Community and has held several volunteer leadership positions through the AAPS in the last several years. She earned her Ph.D. in Pharmacology from the University of Kansas Medical Center in Kansas City, KS.
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