Considerations for biodistribution and viral shedding assays in regulated bioanalysis
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.
What will you learn?
- Participants will be able to understand the differences between biodistribution and shedding assays and their context of use
- Participants will be able to know the challenges in developing and qualifying biodistribution assays with different matrices
- Participants will be able to appreciate the regulatory expectations associated with these assays
Who may this interest?
- Bioanalytical scientists
- Clinical Pharmacologists
- Scientists working on gene and cell therapy programs
Speakers
Amanda Hays, PhD
Scientific Officer, Senior Director
BioAgilytix (NC, USA)
Dr Hays 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 PhD in Pharmacology from the University of Kansas Medical Center (KS, USA).
Bryan Gullick, PhD
Director, Bioanalytical Operations
BioAgilytix (NC, USA)
As Director of Bioanalytical Operations, Dr Gullick 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 PhD in Chemistry, with an emphasis on Biochemistry, from the University of Alabama in Tuscaloosa (AL, USA).
Jennifer T. Durham, PhD
Associate Director of Scientific Services
BioAgilytix (NC, USA)
Dr Durham is an Associate Director of Scientific Services at BioAgilytix (NC, USA), where she 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 PhD 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.
In association with
