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

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

Regenerative Therapy (Jun 2024)

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

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

Affiliations

Hiroshi Karasawa: Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan; Corresponding author.
Hirokuni Mizoguchi: Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan; Corresponding author.
Bryan Choi: Inha University College of Medicine, 100 Inha-ro, Nam-gu, Incheon 22212, South Korea
Chia-Ling Hsieh: Development Center for Biotechnology, No.107, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City, 11571, Taiwan
Masaaki Miyano: Chugai Pharmaceutical Co., Ltd., 5-1, Ukima 5-Chome, Kita-ku, Tokyo, 115-8543, Japan
Yuu Moriya: Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-Chome Fujisawa, Kanagawa, 251-8555, Japan
Sasikumar Muthusamy: Novartis Healthcare Private Limited, Salarpuria Sattva, Sy. No. 83/1, Plot No.2 Near Inorbit Mall, Raidurg, Hyderabad, 500081, India
Koji Takakura: Astellas Pharma Inc., 21, Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan
Kunihiko Suzuki: MEDINET Co., Ltd., 6-1-1 Heiwajima, Ota-ku, Tokyo, 143-0006, Japan
Yoshie Tsurumaki: Novartis Pharma K.K., 1-23-1, Toranomon, Minato-ku, Tokyo, 105-6333, Japan
Takeshi Watanabe: Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-Chome Fujisawa, Kanagawa, 251-8555, Japan
Karen Wen: GenomeFrontier Therapeutics, Inc., 23F., No. 95, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City, 221416, Taiwan
Tomohiro Yoneda: Novartis Pharma K.K., 1-23-1, Toranomon, Minato-ku, Tokyo, 105-6333, Japan
Ta-Tung Yuan: TFBS Bioscience Inc., 3F., No.103, Ln. 169, Kangning St., Xizhi Dist., New Taipei City, Taiwan
Masayuki Nomura: Asahi Kasei Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan

Journal volume & issue: Vol. 26
pp. 967 – 980

Abstract

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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.

Published in Regenerative Therapy

ISSN: 2352-3204 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Medicine (General); Science: Biology (General): Cytology
Website: http://www.journals.elsevier.com/regenerative-therapy/

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