Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024
The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each co...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Regenerative Therapy |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352320425000331 |
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| author | Yoshie Tsurumaki Yusuke Kagawa Shigeaki Hayashi Hirokuni Mizoguchi Masaaki Miyano Masaki Fujii Ruriko Shinozaki Srinivasan N. Kellathur Alex J. Zhang Kunihiko Suzuki Masayuki Nomura |
| author_facet | Yoshie Tsurumaki Yusuke Kagawa Shigeaki Hayashi Hirokuni Mizoguchi Masaaki Miyano Masaki Fujii Ruriko Shinozaki Srinivasan N. Kellathur Alex J. Zhang Kunihiko Suzuki Masayuki Nomura |
| author_sort | Yoshie Tsurumaki |
| collection | DOAJ |
| description | The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of cell and gene therapies as medical practices without market authorization. These discussions included presentations by industry experts and panel discussions with regulatory agencies. The latest updates on regenerative medicine from each country and region were also introduced. This paper summarizes the proceedings of the 7th APACRM to foster future discussions and disseminate information to the public. |
| format | Article |
| id | doaj-art-a186d1d7060a4e3aa10072a680081271 |
| institution | OA Journals |
| issn | 2352-3204 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Regenerative Therapy |
| spelling | doaj-art-a186d1d7060a4e3aa10072a6800812712025-08-20T01:51:16ZengElsevierRegenerative Therapy2352-32042025-06-012940441810.1016/j.reth.2025.02.007Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024Yoshie Tsurumaki0Yusuke Kagawa1Shigeaki Hayashi2Hirokuni Mizoguchi3Masaaki Miyano4Masaki Fujii5Ruriko Shinozaki6Srinivasan N. Kellathur7Alex J. Zhang8Kunihiko Suzuki9Masayuki Nomura10Novartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan; Corresponding author.Novartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, JapanJapan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi, 443-0022, JapanAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Tokyo, JapanChugai Pharmaceutical Co., Ltd., 5-1, Ukima 5-Chome, Kita-ku, Tokyo, 115-8543, JapanMitsui-Soko HOLDINGS Co., Ltd., 20-1 Nishi-Shimbashi 3-chome, Minato-ku, Tokyo, 105-0003, JapanAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Tokyo, JapanRoche Singapore Technical Operations, #10-01/09 Aperia Tower 1, 8 Kallang Avenue, Singapore, 339509, SingaporeHELP Therapeutics Co., Ltd., 568 Longmian Avenue, Jiangning District, Nanjing, PR ChinaMEDINET Co., Ltd., 6-1-1 Heiwajima, Ota-ku, Tokyo, 143-0006, JapanAsahi Kasei Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, JapanThe 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of cell and gene therapies as medical practices without market authorization. These discussions included presentations by industry experts and panel discussions with regulatory agencies. The latest updates on regenerative medicine from each country and region were also introduced. This paper summarizes the proceedings of the 7th APACRM to foster future discussions and disseminate information to the public.http://www.sciencedirect.com/science/article/pii/S2352320425000331APACRMCell and gene therapy productsAdeno-associated virus-based gene therapiesCell/Tissue-based productsNon-clinicalClinical |
| spellingShingle | Yoshie Tsurumaki Yusuke Kagawa Shigeaki Hayashi Hirokuni Mizoguchi Masaaki Miyano Masaki Fujii Ruriko Shinozaki Srinivasan N. Kellathur Alex J. Zhang Kunihiko Suzuki Masayuki Nomura Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 Regenerative Therapy APACRM Cell and gene therapy products Adeno-associated virus-based gene therapies Cell/Tissue-based products Non-clinical Clinical |
| title | Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 |
| title_full | Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 |
| title_fullStr | Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 |
| title_full_unstemmed | Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 |
| title_short | Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024 |
| title_sort | regulatory insights on gene therapies adeno associated virus based gene therapies cell tissue based products and medical care practice in cell and gene therapies report from the 7th asia partnership conference april 25 2024 |
| topic | APACRM Cell and gene therapy products Adeno-associated virus-based gene therapies Cell/Tissue-based products Non-clinical Clinical |
| url | http://www.sciencedirect.com/science/article/pii/S2352320425000331 |
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