TY - JOUR
T1 - Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products
AU - Hayakawa, Takao
AU - Aoi, Takashi
AU - Bravery, Christopher
AU - Hoogendoorn, Karin
AU - Knezevic, Ivana
AU - Koga, Junichi
AU - Maeda, Daisuke
AU - Matsuyama, Akifumi
AU - McBlane, James
AU - Morio, Tomohiro
AU - Petricciani, John
AU - Rao, Mahendra
AU - Ridgway, Anthony
AU - Sato, Daisaku
AU - Sato, Yoji
AU - Stacey, Glyn
AU - Sakamoto, Norihisa
AU - Trouvin, Jean Hugues
AU - Umezawa, Akihiro
AU - Yamato, Masayuki
AU - Yano, Kazuo
AU - Yokote, Hiroyuki
AU - Yoshimatsu, Kentaro
AU - Zorzi-Morre, Pierrette
N1 - Funding Information:
The authors extend their sincere appreciation to all participants in the international conference for their contributions leading to the conclusions and recommendations. The members of the organizing and program committees (Takayuki Aoi, Mira Choi, Joyce Frey-Vasconcells, Takao Hayakawa, Karin Hoogendoorn, Surapol Issaragrilsil, Ivana Knezevic, Akifumi Matsuyama, James McBlane, John Petricciani, Matthias Renner, Anthony Ridgway, Daisaku Sato, Yoji Sato, Masayuki Shibasaki, Glenn Smith, Glyn Stacey, Yuzo Toda, Jean-Hugues Trouvin, Akihiro Umezawa, Masayki Yamato, Pierrette Zorzi) are acknowledged for their contributions to the planning of the workshop. All of the invited experts are acknowledged for their contributions to the conference and this report. Participating organizations ( World Health Organization , Pharmaceuticals and Medical Devices Agency , Japan Science and Technology Agency , Japanese National Institute of Biomedical Innovation , Japanese Ministry of Health, Labour and Welfare , Japanese Forum for Innovative Regenerative Medicine , Japan Pharmaceutical Manufacturers Association , and Japanese Society for Regenerative Medicine ) are gratefully acknowledged for their scientific contributions and financial support.
Publisher Copyright:
© 2015 .
PY - 2015/9/1
Y1 - 2015/9/1
N2 - The regulation of human cell therapy products is a key factor in their development and use to treat human diseases. In that regard, there is a recognized need for a global effort to develop a set of common principles that may serve to facilitate a convergence of regulatory approaches to ensure the smooth and efficient evaluation of products. This conference, with experts from regulatory agencies, industry, and academia, contributed to the process of developing such a document.Elements that could form a minimum consensus package of requirements for evaluating human cell therapy products were the overall focus of the conference. The important regulatory considerations that are unique to human cell therapy products were highlighted.Sessions addressed specific points that are different from those of traditional biological/biotechnological protein products. Panel discussions complemented the presentations.The conference concluded that most of the current regulatory framework is appropriate for cell therapy, but there are some areas where the application of the requirements for traditional biologicals is inappropriate. In addition, it was agreed that there is a need for international consensus on core regulatory elements, and that one of the major international organizations should take the lead in formulating such a consensus document.
AB - The regulation of human cell therapy products is a key factor in their development and use to treat human diseases. In that regard, there is a recognized need for a global effort to develop a set of common principles that may serve to facilitate a convergence of regulatory approaches to ensure the smooth and efficient evaluation of products. This conference, with experts from regulatory agencies, industry, and academia, contributed to the process of developing such a document.Elements that could form a minimum consensus package of requirements for evaluating human cell therapy products were the overall focus of the conference. The important regulatory considerations that are unique to human cell therapy products were highlighted.Sessions addressed specific points that are different from those of traditional biological/biotechnological protein products. Panel discussions complemented the presentations.The conference concluded that most of the current regulatory framework is appropriate for cell therapy, but there are some areas where the application of the requirements for traditional biologicals is inappropriate. In addition, it was agreed that there is a need for international consensus on core regulatory elements, and that one of the major international organizations should take the lead in formulating such a consensus document.
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U2 - 10.1016/j.biologicals.2015.07.009
DO - 10.1016/j.biologicals.2015.07.009
M3 - Article
C2 - 26315651
AN - SCOPUS:84941314513
VL - 43
SP - 283
EP - 297
JO - Journal of Biological Standardization
JF - Journal of Biological Standardization
SN - 1045-1056
IS - 5
ER -