How to Accelerate AAV Gene Therapy from Early Discovery to Commercialization
AAV gene therapy faces developmental challenges, including anticipating and addressing immune responses, as well as the underlying complexity of targeted diseases. The functionality of AAV vectors is impacted not only by their design, but also by their scaling and manufacturing processes.
This is why the design and development of new viral vectors should be approached as a continuum of interdependent activities, from understanding and controlling manufacturing procedures to analytical procedures used to determine purity and functionality.
This on-demand webinar explores how best to address challenges at each stage of in vivo AAV gene therapy discovery and development, from plasmid development and manufacture to clinical production and first-in-human studies with defined regulatory requirements around vector production and the testing/release of material.
Join an expert panel to learn:
- Major challenges in gene therapy early-stage discovery
- The connectivity between discovery and clinical manufacturing
- Considerations for leveraging a platform approach to simplify manufacturing and phase-appropriate QC testing
Presenters:
Dr. Christina Fuentes
Senior Consultant, Dark Horse Consulting
Christina Fuentes, PhD, is a Bioengineer with experience in gene and cell therapies. Dr. Fuentes' work with DHC clients has ranged from long-term embedded support to vendor management to technical lead from initial product design stages through to first-in-human/IND approval.
Dr. James J. Cody
Associate Director, Technical Sales and Evaluations, Charles River Laboratories
James has worked in the viral vector CDMO space since 2018 and is currently a member of Charles River’s gene therapy CDMO business development team. James obtained a PhD and completed postdoctoral training in cancer gene therapy at the University of Alabama at Birmingham (UAB), studying oncolytic viruses. Afterward, he worked as a research scientist in virology, cell biology, cancer, and parasitology. Based at the viral vector manufacturing site in Rockville, MD, James provides technical support to the business development team, helping to guide client discussions and onboard new projects by collaborating with subject matter experts across various functional groups.