Global perspectives for cellular and gene therapy development and regulatory expectations: a conference report from the 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies

The 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies, held in Seoul, South Korea, brought together global regulators, industry representatives, and United States Pharmacopeia to discuss the development and regulatory expectations of cellular and gene therapies. These therapies are transforming regenerative medicine and the treatment of cancer and hereditary disorders, necessitating adaptable and flexible regulatory frameworks. The workshop emphasized the importance of inter-agency consensus to accelerate market access for advanced therapies, highlighting challenges and solutions in product quality management, regulatory science, and drug approval processes. To foster scientific advancements and guide the creation of unified regulatory standards, organizers selected topics such as CAR-T therapy, advanced 3D bioprinting, and iPSC-derived cardiomyocyte patches. These sessions focused on quality control strategies, manufacturing comparability, and pre-clinical safety studies. The event underscored the need for ongoing dialogue and collaboration to ensure the safe and effective delivery of these innovative treatments globally.

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