Abstract
Cell-based regenerative medicine is an innovative field that can potentially alter the overall survival and quality of life of patients with devastating diseases. Several cell therapy products (CTPs) have been approved within the last two decades, and more are under development. The establishment of an effective developmental strategy in accordance with the regulatory bodies of each country/region is crucial for fast delivery of each respective CTP. In particular, facilitating investigational new drug (IND) approval is important for accelerating the transition from non-clinical to clinical research/trial phases. Here the authors compared the non-clinical prerequisites for initiating clinical studies in five Asian countries/regions (India, China, Korea, Taiwan and Japan) from an industry viewpoint. The authors first identified the differences and tried to clarify the perspectives/considerations underpinning the different requirements. The authors' findings revealed that differences in regulations and development experiences, especially with CTPs, have led to clear differences in the non-clinical study package and its corresponding study design. By sharing experiences of the research and development of CTPs among Asian countries/...Continue Reading
References
Nov 24, 2007·Cell·Kazutoshi TakahashiShinya Yamanaka
Aug 1, 2014·Expert Opinion on Biological Therapy·Chaomei ChenMeen Chul Kim
Jan 16, 2016·Immunopharmacology and Immunotoxicology·Samra Sardar, Åsa Andersson
Dec 17, 2016·Nature Reviews. Drug Discovery·Yanhong ShiShinya Yamanaka
Sep 11, 2017·Biologicals : Journal of the International Association of Biological Standardization·John PetriccianiIvana Knezevic
Dec 12, 2017·Frontiers in Immunology·Paul LohanAideen E Ryan
Dec 24, 2017·Stem Cell Research & Therapy·Alix K BerglundLauren V Schnabel
Sep 14, 2018·Stem Cells International·Ross E B FitzsimmonsCraig A Simmons
Oct 28, 2018·Cytotherapy·Natividad CuendeLaertis Ikonomou
May 6, 2019·Cells·Michael Xavier Doss, Agapios Sachinidis
May 6, 2019·Cellular and Molecular Life Sciences : CMLS·Abderrahim NajiNarufumi Suganuma
Dec 14, 2015·Regenerative Therapy·Takao HayakawaMasayuki Yamato
Dec 14, 2015·Regenerative Therapy·Takao HayakawaMasayuki Yamato
Nov 24, 2015·Regenerative Therapy·Takao HayakawaMasayuki Yamato
Dec 14, 2015·Regenerative Therapy·Takao HayakawaMasayuki Yamato
Dec 14, 2015·Regenerative Therapy·Takao HayakawaMasayuki Yamato
Mar 1, 2016·Regenerative Therapy·Kentaro Azuma, Shinya Yamanaka
Sep 24, 2019·Frontiers in Pharmacology·Carolina Iglesias-LópezAntonio Vallano
Jan 23, 2020·Cellular and Molecular Life Sciences : CMLS·Xing-Liang FanQing-Ling Fu
Apr 9, 2020·Frontiers in Bioengineering and Biotechnology·Fengxuan HanBin Li