Cellular therapies offer great promise as a cancer therapy. They are living biological drugs, and often personalized, which gives them unique properties, characteristics, and great variability. These factors have made adhering to existing regulatory requirements challenging and requires significant collaboration and interactions with the FDA and other health authorities. Commercializing approved cellular therapies requires novel strategies for adoption, patient access, and cost. Though in early stages, new paradigms for manufacturing and delivery of autologous cell therapies, namely point of care manufacturing, have emerged that may reduce cost to manufacture and increase patient access. Collaboration with health authorities is critical for point of care manufacturing to have regulatory success. This session will first provide an update on SITC’s Release Criteria Summit. During the one-day virtual summit, topics include stakeholder feedback, summaries, current state, and future directions identified during the one-day virtual summit. The session will then expand upon some of the concepts discussed during the release criteria summit and we will hear about Iovance Biotherapeutics’s experience with regulatory approval of the first and only FDA-approved T cell therapy for a solid tumor indication. Finally, we will hear about how new manufacturing strategies are being developed to reduce costs and increase access for patients and discussion on regulatory perspectives. This session and the rest of the SITC annual meeting can be registered for and accessed virtually HERE.
#SITC2024