Regulatory insights on advanced CAR-T cell products, AAV-based Gene therapies, and medical care/practice in cell and Gene therapies: Report from the 6th Asia partnership conference of regenerative medicine- April 20, 2023

Regulatory insights on advanced CAR-T cell products, AAV-based Gene therapies, and medical care/practice in cell and Gene therapies: Report from the 6th Asia partnership conference of regenerative medicine- April 20, 2023

The 6th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in person with online on April 20, 2023, to promote the regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region and the underly...

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Main Authors: Hiroshi Karasawa, Hirokuni Mizoguchi, Bryan Choi, Chia-Ling Hsieh, Masaaki Miyano, Yuu Moriya, Sasikumar Muthusamy, Koji Takakura, Kunihiko Suzuki, Yoshie Tsurumaki, Takeshi Watanabe, Karen Wen, Tomohiro Yoneda, Ta-Tung Yuan, Masayuki Nomura
Format: Article
Language:English
Published: Elsevier 2024-06-01
Series:Regenerative Therapy
Subjects:
APACRM
Cell and gene therapy product
AAV-Based gene therapies
Non-clinical
Quality
Regulatory guideline
Online Access:http://www.sciencedirect.com/science/article/pii/S2352320424001767
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Summary:The 6th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in person with online on April 20, 2023, to promote the regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region and the underlying rationales are important initial steps toward harmonizing regulations. The 6th APACRM featured an open dialog regarding non-clinical evaluation for advanced CAR-T products, regulation of clinical trials for AAV-based gene therapies, and cell and gene therapies provided to patients as medical care/medical practices without market authorization through presentations from the industry and panel discussions with regulatory agencies. The latest updates on regenerative medicine in each country and region are introduced. This paper summarizes the proceedings of the 6th APACRM for public dissemination to foster future discussions.
ISSN:2352-3204

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