•Regenerative medicine product overview
•Assessment of the Factors Affecting the Commercialization of Cellular Based Therapeutics
•Biomanufacturing Processes: immunotherapy, CAR-T, exosome, gene vector
•CAR-T: Product, Process and Patents
•Clinical Trials and Regulation: How do they apply to Regen Med?
Cell-based immunotherapies have the potential to transform current medical practice and offer an opportunity to effectively manage what were once considered untreatable diseases. Despite a large increase in basic science activity in the cell therapy arena, alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity – with the number of cell based therapeutics in mainstream use remaining comparatively low. This course serves to incorporate key aspects of the commercialization process and examines how therapeutic candidates can be successfully translated from basic science into commercially viable products. The course will address fundamental translational barriers spanning the so-called "valley of death" and delineate sustainable and efficient mechanisms that can support the commercialization process. Topic coverage will include preclinical, clinical, manufacturing, intellectual property, regulation and market components.
Monday, September 25:
Refreshment Break: 10:15-10:45
Refreshment Break: 2:45-3:15