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Cell and Gene Therapy Products (CGTP) have been in development for the last 30 years and the recent the advances in basic science, manufacturing technologies and supported by regulatory framework have paved the way commercialization of CGTPs. These advanced therapies have enabled the successful targeting of monogenic diseases using in vivo corrective technology (e.g., adeno-associated vector, AAV) and treat cancer using ex vivo therapies based on genetic engineering of patient cells prior to the re- infusion (e.g., CART products for blood cancers). This plenary will provide insight into the development these novel cutting edge CGTP therapies having the potential to further advance the targeted treatment of patients’ unmet medical needs. Specifically, the session will focus on innovative therapies based on genome editing, progress in regenerative medicine, and new viral vector design. In addition, the session will address the current regulatory expectation for these novel CGTP therapies.