Registration for ASGCT's 28th Annual Meeting is NOW OPEN! Join us May 13-17 in New Orleans for the premier event in CGT.
This Jan. 22-23 event brings together thought leaders and regulatory experts for two half-days of in-depth discussion on pressing challenges and emerging solutions in the field.
Join ASGCT and FDA for a virtual workshop exploring crucial developments in AAV gene therapy immunogenicity. Class Considerations on Immunogenicity for AAV Gene Therapy Products: Assessing Current Practice and New Data brings together thought leaders and regulatory experts for two half-days of in-depth discussion on pressing challenges and emerging solutions in the field. The event is free and open to the public, and will take place January 22-23, 2025 from 11 a.m. - 1 p.m. ET both days.
The agenda tackles critical topics that impact both academic research and industry development. Each session includes an interactive panel Q&A, providing attendees with direct access to expert insights and answers to their most pressing questions. Check out our full agenda for a complete list of expert speakers.
Day 1 will cover:
Immunogenicity in AAV Gene Therapy Products: Explore strategies for overcoming challenges like preexisting immunity and assay validation, with insights from leaders such as Dr. Terence Flotte (University of Massachusetts) and Dr. Andrew Byrnes (FDA).
Integration of Clinical and Preclinical Data: Learn how clinical observations can improve preclinical model design and regulatory approaches, featuring Dr. Margaret Benny Klimek (FDA) and Dr. Allison Keeler-Klunk (University of Massachusetts).
Challenges in Animal Models: Discuss resource constraints and innovative solutions with experts like Dr. Juliette Hordeaux (GEMMABio) and Dr. David Cantu (FDA).
On day 2, the focus shifts to:
Antibody Testing and Companion Diagnostics: Examine strategies to streamline efforts with thought leaders such as Dr. Johnny Lam (FDA) and Dr. Emily Coonrod (ARUP Laboratories).
Redosing Strategies: Gain insights into overcoming neutralizing antibodies from Dr. Barry Byrne (University of Florida) and Dr. Louise Rodino-Klapac (Sarepta).
Immunosuppression in AAV Therapies: Hear phase-appropriate, evidence-based approaches from Dr. Rosa Sherafat-Kazemzadeh (FDA) and Dr. Kevin Flanigan (Nationwide Children’s Hospital).
This workshop represents a valuable opportunity to engage directly with FDA reviewers on issues that impact the entire AAV development field, gain insights from cutting-edge research, and address practical solutions. Whether you're working in academia, industry, or regulatory affairs, these sessions will provide essential perspectives into the evolving landscape of AAV gene therapy development. Register now to secure your spot in this free workshop and contribute to advancing the field of AAV gene therapies.
Andrew is ASGCT's Regulatory Affairs Manager.
January 22-23, 2025 | Virtual
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