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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Published inRegenerative therapy Vol. 26; pp. 967 - 980
Main Authors Karasawa, Hiroshi, Mizoguchi, Hirokuni, Choi, Bryan, Hsieh, Chia-Ling, Miyano, Masaaki, Moriya, Yuu, Muthusamy, Sasikumar, Takakura, Koji, Suzuki, Kunihiko, Tsurumaki, Yoshie, Watanabe, Takeshi, Wen, Karen, Yoneda, Tomohiro, Yuan, Ta-Tung, Nomura, Masayuki
Format Journal Article
LanguageEnglish
Published Elsevier B.V 01.06.2024
Japanese Society for Regenerative Medicine
Subjects
AAV-Based gene therapies
APACRM
Asia
Cell and gene therapy product
Non-clinical
Quality
Regulatory guideline
Review
Regulatory guideline
FDA
ABLE
CARM
Cell and gene therapy product
MFDS
WG
Quality
FIRM
PMDA
SAPI
CTGTP
iPSC
GMO
GvHD
GMP
CDSCO
CGT
Non-clinical
ISSCR
Asia
CAR-T
scFv
AAV
CMBA
ISCT
TACT
AAV-Based gene therapies
RM
APACRM
BPIPO
IND
MPA
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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.
Bibliography:These authors contributed equally to this work.
ISSN:2352-3204
2352-3204
DOI:10.1016/j.reth.2024.09.015