Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis

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Cell and gene therapies (CGT) are rapidly emerging and evolving as promising therapies for a variety of disease indications. It is important to understand the distribution, persistence and clearance of these products in vivo from the site of administration to target and non-target tissues and biofluids by conducting biodistribution studies. In addition, with the use of viral vectors, it is important to understand the release of virus-based therapy products from patients by evaluating viral shedding in different matrices. Biodistribution and shedding assays are commonly conducted via qPCR, however, there is limited information and guidance on how to develop these assays in regulated bioanalysis. In this webinar, we will discuss the challenges and considerations for developing and validating biodistribution and vector shedding assays in regulated studies.

About the Speakers

Amanda Hays, Ph.D., Scientific Officer, Senior Director, offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR. She has particular expertise leading programs through all stages in the drug development process.

In her current role, Amanda serves as a Scientific Officer and provides global scientific leadership and technical guidance at BioAgilytix (NC, USA). Dr Hays is the Chair of the AAPS biomarkers and precision medicine community and the AAPS qPCR working group, among other volunteer leadership positions. She earned her Ph.D. in Pharmacology from the University of Kansas Medical Center (KS, USA).

Bryan Gullick, Ph.D., Director, Bioanalytical Operations, offers more than 16 years of GLP and GMP-regulated experience in quality control, process development, bioanalysis and pharmacokinetic applications.

Prior to BioAgilytix, he served as an Associate Director of Bioanalysis for Lovelace Biomedical (NM, USA), where he managed the small molecule LC-MS and molecular biology bioanalytical laboratories, overseeing process improvement, assay development, regulatory compliance and customer satisfaction. He earned his Ph.D. in Chemistry, with an emphasis on Biochemistry, from the University of Alabama in Tuscaloosa (AL, USA).

Jennifer T. Durham, Ph.D., Associate Director, Scientific Services, leads a team that develops, qualifies and validates fit for purpose molecular biology assays in accordance with applicable regulatory guidelines and supports a variety of client projects from early discovery stages to fully regulated clinical trials. Jennifer earned her BA in Biology at Boston University (MA, USA), where she contributed to the understanding of muscle development by studying the transcriptional regulation of novel gene myospryn.

Her Ph.D. at Tufts University Graduate School of Biomedical Sciences (MA, USA) focused on a novel cytoskeletal capping protein in modulating angiogenesis and wound healing in diabetic retinopathy. As a post-doctoral fellow at Tufts University School of Medicine (MA, USA), she studied how mechanical forces in muscle cells influenced cellular growth, migration and angiogenic processes.