eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs

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The emergence of advanced therapeutic medicinal products (ATMPs), such as cell and gene therapies, has led to the increased utilization of specialized technology platforms in regulated bioanalysis. In this eChalk Talk, we will discuss platforms that are used in determining pharmacokinetics (PK) of ATMPs including qPCR, and flow cytometry. We will also highlight some of the key considerations for development and validation of these types of PK assays to support ATMP drug development.

About the Speakers

Amanda Hays, Ph.D., Scientific Officer - BioAgilytix
Dr. Amanda L. Hays is the Scientific Officer at BioAgilytix. She 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. Dr. Hays is the 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.

Grant Jones, Ph.D., Manager I - BioAgilytix
Grant is a manager at BioAgilytix where he leads a team of scientists in the flow cytometry and cell-based assay group. Grant has extensive experience in developing and qualifying immunophenotyping, receptor occupancy, ADA, cell therapy persistence, ADCC, and CDC assays using flow cytometry, as well as cell-based neutralizing antibody assays. Before joining BioAgilytix in April 2020, Grant held a position as Postdoctoral Research Associate at the University of North Carolina at Chapel Hill and was doing research in the fields of Microbiology and Immunology. Grant received his PhD from the University of Kentucky.