Attend FDA & ASGCT's Immune Responses to AAV Vectors

Join ASGCT members and FDA speakers Jan. 24-25, 2023, for a free, public event about immune responses to AAV vectors.

During this event, which will be held 10 a.m.- 2 p.m. (CT) on both days, attendees will identify and discuss new and emerging topics in immunogenicity. The workshop is intended to inform clinicians, regulators, and developers about appropriate approaches to control immunogenicity during clinical development.

On the first day of the event, after an introduction from ASGCT Member Federico Mingozzi, PhD, Shari Gordon, PhD, will provide attendees with an overview of immunogenicity and talk about conducting clinical trials with healthy volunteers. J. Fraser Wright, PhD, will then discuss AAV vector and manufacturing process design and describe how those impact immunogenicity. Manuela Corti, PhD, will provide an overview of readministration approaches. Finally, the FDA’s Natasha Thorne, PhD, will talk about the regulatory pathway in the development of companion diagnostic anti-AAV assays. Drs. Gordon, Wright, Corti, Thorne, and FDA’s Lei Xu, MD, PhD, will close out the first day with a panel discussion moderated by Dr. Mingozzi.

Ying Kai Chan, PhD, will welcome attendees to the second day of the event Jan. 25. Then we’ll hear from Genevieve Laforet, MD, PhD, who will talk about complement-mediated thrombotic microangiopathy associated with AAV gene therapy. NIH’s Carsten Bonnemann, MD, will discuss serious adverse events, complement activation, and anti-dystrophin responses, and Terry Flotte, MD, will talk about clinical experiences with rAAV vector immune responses. Finally, Dave Copland, PhD, will cover intraocular AAV inflammation. Drs. Laforet, Flotte, Bonnemann, and Copland will participate in a panel discussion moderated by Dr. Chan.

Register for this ASGCT-FDA event

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