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December 3, 2021 This café begins with an introduction to CMC issues for gene and cell therapy products and will also help attendees understand the critical CMC development issues from a regulatory perspective. 🔒
January 26, 2023 ASGCT members presented in collaboration with the bipartisan House Cancer Caucus. Speakers touched on the pipeline of CAR T therapies and its exponential growth in recent years, the potential for immunotherapies to treat rare cancers and solid tumors, and the patient experience. 🔒
July 15, 2022 This month’s café focuses on Good Manufacturing Practices (GMPs). While these regulations are governed by the FDA, their applications to the field of gene and cell therapy are still being developed. During this event, speakers present pre-recorded pieces on their views of GMPs. 🔒
February 23, 2023 Speakers focused on gene therapy approvals in 2022 including Skysona (for CALD), Zynteglo (for beta thalassemia), and Hemgenix (for hemophilia B). 🔒
March 30, 2023 This session explored some of the areas where treatments can get stopped while en route to an approval. 🔒
September 30, 2022 Speakers explore the clinical pathway for getting a therapy through a clinical trial and into the approval phase, and thoughts on cost and access once a therapy is approved. 🔒
February 8, 2023 Although regulatory approvals seem to indicate a lag in innovation, they represent an important proof of principle that the technical, regulatory, and commercial hurdles can be cleared for new modalities. This event provides an overview of some of the exciting developments in this area. 🔒
April 11, 2024 This presentation focuses on recent CMC guidance for cell and gene therapies, specifically the Manufacturing Changes and Comparability and Potency Assurance guidance documents. 🔒
February 28, 2024 2023 was an exciting year for the field, but what do all these approvals mean for access, safety, and long-term outcomes in the communities they affect? 🔒
February 16, 2024 Explore the roles of AI and automation in propelling the latest advances in genetics and regenerative medicine and the rapid pace of progress. 🔒
September 23-24, 2024 | Washington, D.C.
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