Addressing Regulatory Challenges Associated With AAVs

In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists cover the regulatory landscape, including working with regulatory agencies, addressing regulatory challenges for common diseases, long-term follow-up studies, beneficial regulatory pathways, establishing appropriate endpoints, vector shedding studies, anticipated regulatory guidance, and the cost burden of co-developing companion diagnostics.