Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
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BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, shares scientific insight focused on the assessment of pre-existing antibodies to the AAV viral capsid and the implications for their impact on the successful dosing (and potential re-dosing) of gene therapy drug candidates.
During the webinar, Dr. McNally shares:
- Multiple case studies from across the industry showing how the thought process about pre-existing antibodies is evolving
- Tools used to measure and characterize pre-existing antibodies against the viral capsid and their utilization for screening patients and as exclusion criteria for entry into clinical studies
- Strategies for implementation & execution of these important assays
About the Presenter
Jim McNally, Ph.D. has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry.
Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics.
Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance.