As therapeutic modalities have become more complex, such as cell and gene therapies, so too have the bioanalytical methods become more complex for characterizing these therapies. In particular, immunogenicity testing has begun to incorporate more aspects of the patient immune response than what was previously measured. For most protein-based biotherapeutics, immunogenicity measurements focused on anti-drug antibody detection and cytokine production. However, with advanced modalities there is an increase in the use of tools to measure cellular immunogenicity and in particular the use of the enzyme-linked immune absorbent spot (ELISpot). ELISpot measures activated cells by stimulating samples with peptides generated from a protein of interest to determine if the patient’s immune cells are specific for that (potentially) antigenic epitope.
This webinar will provide an overview of the ELISpot platform, assay development, regulatory concerns and data analysis/reporting. A live Q&A session with the featured speakers will follow the presentation to answer attendee questions.
Jim McNally, PhD, Chief Scientific Officer, BioAgilytix
Jim McNally offers 20 years of experience in bioanalytical assay development and program leadership in pharmaceuticals and biotechnology. At BioAgilytix, he advises on emerging scientific developments and provides scientific and regulatory guidance. Prior to BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, with previous roles at Genzyme, Pfizer, EMD Serono and Shire.
Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and progression of biotherapeutics from research through clinical development. He has special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. Dr. McNally earned his BSc in Biology from Mississippi State University, his PhD in Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.
Michelle Miller, PhD, DABT, Associate Director, BioAgilytix
Dr. Michelle Miller has over a decade of experience working in the fields of immunology and toxicology. She has a strong background in project management, previously serving as a bioanalytical project manager at BioAgilytix. Prior to BioAgilytix, Michelle worked as a study director leading GLP toxicology and immunotoxicology studies, as a lead investigator in the toxicology field developing high-throughput screening assays, and as an R&D scientist in the pharmaceutical industry. She is a current Diplomate of the American Board of Toxicology.
In her role at BioAgilytix, Michelle works closely with clients and operational staff to assure successful on-time execution of assays, validation and sample analysis under GxP, supporting preclinical, clinical and product release studies. Michelle earned a BA in Chemistry, BSc in Zoology, and PhD in Immunology with a minor in Biochemistry from North Carolina State University.
Who Should Attend?
This webinar will appeal to:
- Bioanalytical Scientists
- Non-clinical study directors
- Clinical operations
- Clinical Pharmacologists
What You Will Learn
Register for this webinar to learn about:
- Use case for measuring cellular immunogenicity
- An overview of the ELISpot platform
- Assay design and implementation on ELISpot
- Data analysis
- Regulatory expectations for ELISpot assays
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states.
BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.