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...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-06-01
|
| Series: | Regenerative Therapy |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352320424001767 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850219129305300992 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Hiroshi Karasawa |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4806501293ea499390e9c584ceec36b2 |
| institution | OA Journals |
| issn | 2352-3204 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Regenerative Therapy |
| spelling | doaj-art-4806501293ea499390e9c584ceec36b22025-08-20T02:07:30ZengElsevierRegenerative Therapy2352-32042024-06-012696798010.1016/j.reth.2024.09.015Regulatory 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, 2023Hiroshi Karasawa0Hirokuni Mizoguchi1Bryan Choi2Chia-Ling Hsieh3Masaaki Miyano4Yuu Moriya5Sasikumar Muthusamy6Koji Takakura7Kunihiko Suzuki8Yoshie Tsurumaki9Takeshi Watanabe10Karen Wen11Tomohiro Yoneda12Ta-Tung Yuan13Masayuki Nomura14Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan; Corresponding author.Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan; Corresponding author.Inha University College of Medicine, 100 Inha-ro, Nam-gu, Incheon 22212, South KoreaDevelopment Center for Biotechnology, No.107, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City, 11571, TaiwanChugai Pharmaceutical Co., Ltd., 5-1, Ukima 5-Chome, Kita-ku, Tokyo, 115-8543, JapanTakeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-Chome Fujisawa, Kanagawa, 251-8555, JapanNovartis Healthcare Private Limited, Salarpuria Sattva, Sy. No. 83/1, Plot No.2 Near Inorbit Mall, Raidurg, Hyderabad, 500081, IndiaAstellas Pharma Inc., 21, Miyukigaoka, Tsukuba, Ibaraki, 305-8585, JapanMEDINET Co., Ltd., 6-1-1 Heiwajima, Ota-ku, Tokyo, 143-0006, JapanNovartis Pharma K.K., 1-23-1, Toranomon, Minato-ku, Tokyo, 105-6333, JapanTakeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-Chome Fujisawa, Kanagawa, 251-8555, JapanGenomeFrontier Therapeutics, Inc., 23F., No. 95, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City, 221416, TaiwanNovartis Pharma K.K., 1-23-1, Toranomon, Minato-ku, Tokyo, 105-6333, JapanTFBS Bioscience Inc., 3F., No.103, Ln. 169, Kangning St., Xizhi Dist., New Taipei City, TaiwanAsahi Kasei Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, JapanThe 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.http://www.sciencedirect.com/science/article/pii/S2352320424001767APACRMCell and gene therapy productAAV-Based gene therapiesNon-clinicalQualityRegulatory guideline |
| spellingShingle | 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 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 Regenerative Therapy APACRM Cell and gene therapy product AAV-Based gene therapies Non-clinical Quality Regulatory guideline |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | APACRM Cell and gene therapy product AAV-Based gene therapies Non-clinical Quality Regulatory guideline |
| url | http://www.sciencedirect.com/science/article/pii/S2352320424001767 |
| work_keys_str_mv | AT hiroshikarasawa regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT hirokunimizoguchi regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT bryanchoi regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT chialinghsieh regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT masaakimiyano regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT yuumoriya regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT sasikumarmuthusamy regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT kojitakakura regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT kunihikosuzuki regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT yoshietsurumaki regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT takeshiwatanabe regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT karenwen regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT tomohiroyoneda regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT tatungyuan regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 AT masayukinomura regulatoryinsightsonadvancedcartcellproductsaavbasedgenetherapiesandmedicalcarepracticeincellandgenetherapiesreportfromthe6thasiapartnershipconferenceofregenerativemedicineapril202023 |