Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a disorder. Often it can be a combination of cell and gene therapies, which is the case for chimeric antigen receptor T (CAR T) cells. As of March 2022, there are 20 US Food and Drug Administration (FDA) approved cell and gene therapy (CGT) licensed products from the Office of Tissues and Advanced Therapies (OTAT) and according to clinicaltrials.gov over 2,000 active CGT clinical trials.
But what does it mean for bioanalysis? In this webinar, the featured speakers explore the challenges with bioanalytical method development and qualification/validation for support of CGTs. They will take a deep dive into the following bioanalytical assays and the platforms to support them:
- Pharmacokinetics (PK) – quantitative PCR (qPCR), digital droplet PCR (ddPCR), flow cytometry, ligand binding assays (LBAs)
- Biodistribution – qPCR, ddPCR, flow cytometry, LBAs
- Immunogenicity – LBAs, flow cytometry cell-based assays (neutralizing antibody) against transgene, viral vectors, etc.
- Pharmacodynamic markers – qPCR, ddPCR, flow cytometry, enzyme-linked immunosorbent spot (ELISpot) assay, LBAs
- Viral shedding (outcomes and safety) – ddPCR, qPCR, cell-based infectivity assays
Additionally, the speakers will discuss how the demand for GLP bioanalytical analysis for support of CGTs has exploded.
Join this webinar to explore what the advent of cell and gene therapies mean for bioanalysis.
Dominic Warrino, Senior Scientific Advisor, KCAS Bioanalytical and Biomarker Services
Dominic Warrino, PhD, is a Senior Scientific Advisor. His role is to serve as scientific and technical advisor for both clients and internal teams for development, validation and application of bioanalytical, immunogenicity and biomarker methods for large molecule therapeutics. Dominic joined the company in 2013 and brought expertise in a full range of bioanalytical techniques including ECL, ELISA, RIA, flow cytometry, ELISpot, cell-based assays and Luminex. He has over 28 years’ experience developing and validating immunological assays for biotechnology and pharmaceutical companies. Most recently, he spent several years in the Biopharma Services department at Viracor-IBT (formally IBT), and previously worked for Cytogen (formally Cellcor), Eligix and Streck Laboratories developing novel compounds for treatment of various cancers. Dominic has worked on over 100 large molecule compounds developing and validating PK, PD, ADA and biomarker assays in support of preclinical to Phase IV testing.
Jeff D. Hester, PhD, Senior Director, Cell & Gene Therapy Services
Jeff D. Hester, PhD is the Senior Director of the Cell and Gene Therapy Program at KCAS Bioanalytical and Biomarker Services based in Shawnee, Kansas, USA. With over 20 years of experience in the CRO industry, Dr Hester has a successful track record of developing innovative solutions to solve complex business challenges and executing strategies that dramatically improve organizational performance, increase customer satisfaction and accelerate business growth. Previously, Dr Hester was the Vice President of Research and Development at Eurofins ViraCor, Inc., based in Lee’s Summit, Missouri, USA where he was a member of the executive team with P&L responsibility for BioPharma custom bioassays and clinical diagnostics development programs. Dr Hester earned both his BS and PhD in Chemistry from the University of Cincinnati (OH, USA) and has held appointments as both an Adjunct Assistant Professor and Assistant Professor in the Department of Pathology and Laboratory Medicine at the University of Kansas School of Medicine (KS, USA).
Who Should Attend:
- Cell and gene therapy (CGT) drug developers
- Pharma and biopharma individuals
- Sr. Scientists/Managers
- CEO/Executive level
What You Will Learn:
- The types of methods needed for bioanalytical support of cell and gene therapies (CGTs)
- The platforms used to support CGTs and the regulatory challenges
- The challenges of development and qualification/validation of method for support of CGTs
- The increased demand for CTG bioanalysis and the paucity of bioanalytical GLP CROs
If you’d like to hear more about our Cell & Gene Therapy Services, please Register Now for this webinar or contact KCAS directly using the form below.