ASGCT and FDA will host a virtual scientific workshop over two half days on January 22 and 23, 2025 (9a.m. - 1 p.m. ET on both days). This free, public event will explore key immunology-related topics that have implications across the class of AAV gene therapies, including immune responses, antibody testing, and redosing strategies.
The workshop will provide valuable insights for professionals in both academia and industry as it addresses pressing challenges in AAV gene therapies and new approaches.
Additionally, attendees will gain important regulatory perspectives from the FDA, offering guidance on how these ongoing issues are being addressed within the regulatory landscape.
Agenda
Wednesday January 22, 2025
9 - 9:05 a.m.
Welcome & Introduction
9:05 - 10:20 a.m.
Immunogenicity in AAV Gene Therapy Products: Identifying Areas That May Benefit from Convergence
10:20 - 11:35 a.m.
Integration of Clinical and Preclinical Data: Making Preclinical Models More Predictive of Clinical Observed Toxicity
11:35 - 11:45 a.m.
Break
11:45 a.m. - 1 p.m.
Challenges in Animal Models: Overcoming Resource Constraints, Long Timelines, and Limitations of Models
Thursday January 23, 2025
9 - 9:05 a.m.
Welcome
9:05 - 10:20 a.m.
Antibody Testing and Companion Diagnostics: Avoiding Duplication of Efforts When Possible
10:20 - 11:35 a.m.
Redosing Strategies in AAV Gene Therapies: Overcoming Neutralizing Antibodies
11:35 - 11:45 a.m.
Break
11:45 a.m. - 1 p.m.
Immunosuppression in AAV Gene Therapies: What Does the Clinical Evidence Support?