Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 283-297 |
| Number of pages | 15 |
| Journal | Biologicals |
| Volume | 43 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 01-09-2015 |
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All Science Journal Classification (ASJC) codes
- Biotechnology
- Bioengineering
- Applied Microbiology and Biotechnology
- Immunology and Microbiology(all)
- Pharmacology
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}
Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products. / Hayakawa, Takao; Aoi, Takashi; Bravery, Christopher; Hoogendoorn, Karin; Knezevic, Ivana; Koga, Junichi; Maeda, Daisuke; Matsuyama, Akifumi; McBlane, James; Morio, Tomohiro; Petricciani, John; Rao, Mahendra; Ridgway, Anthony; Sato, Daisaku; Sato, Yoji; Stacey, Glyn; Sakamoto, Norihisa; Trouvin, Jean Hugues; Umezawa, Akihiro; Yamato, Masayuki; Yano, Kazuo; Yokote, Hiroyuki; Yoshimatsu, Kentaro; Zorzi-Morre, Pierrette.
In: Biologicals, Vol. 43, No. 5, 01.09.2015, p. 283-297.Research output: Contribution to journal › Article
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
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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UR - http://www.scopus.com/inward/citedby.url?scp=84941314513&partnerID=8YFLogxK
U2 - 10.1016/j.biologicals.2015.07.009
DO - 10.1016/j.biologicals.2015.07.009
M3 - Article
VL - 43
SP - 283
EP - 297
JO - Biologicals
JF - Biologicals
SN - 1045-1056
IS - 5
ER -