The Institute for Integrated Cell-Material Sciences (iCeMS), Kyoto University, Yoshida-Ushinomiyacho, Sakyo-ku, Kyoto, 606-8501, Japan.
Stem Cell Rev Rep. 2011 Jun;7(2):221-6. doi: 10.1007/s12015-010-9204-8.
In this report we review the concept of standardization and propose an exhaustive framework for the proper management of technology on pluripotent stem cells based on studies of global and regional initiatives. We demonstrated detailed observational analysis on global initiatives for the standardization of related technologies as well as regional attempts with particular interest in the cases of the UK, the US and Japan. Consequently, we came up two fundamental issues: first, these initiatives and attempts tend to be limited to each of currently existing categories of pluripotent stem cells, whereas the technological opportunity to enable clinical/commercial application is equally open to all stem cell types. Second, the subject to be examined for standardization is set to a quite narrow range compared to precedent practices in other industrial sectors. To address these issues, we propose a strategic framework for standardization with an emphasis on comprehensiveness covering various technological opportunities and consistency to learning in the management science. By utilizing this framework development of intellectual property rights not only through patents but through taking leadership in standardization can be considered as means for improving research and development competence. Of particular concerns is the formation of quality standards for final products/services and core elemental technology, especially specific pluripotent stem cell lines. Furthermore, we inferred two stages of the standardization process, individualization where a particular product/service is qualified by the market, then standardization where the elemental technology is subsequently established as compatibility standards.
在本报告中,我们回顾了标准化的概念,并基于全球和区域倡议的研究,提出了一个全面的多能干细胞技术管理框架。我们详细观察分析了全球标准化相关技术的倡议,以及英国、美国和日本等地区的特别关注的区域尝试。因此,我们发现了两个基本问题:首先,这些倡议和尝试往往仅限于目前现有的多能干细胞类别,而使临床/商业应用成为可能的技术机会对所有干细胞类型都是开放的。其次,与其他工业部门的先例相比,标准化的审查对象被设定在相当狭窄的范围内。为了解决这些问题,我们提出了一个标准化的战略框架,重点是全面涵盖各种技术机会,并与管理科学中的学习保持一致。通过利用这个框架,知识产权的发展不仅可以通过专利,还可以通过在标准化方面的领导地位来考虑,这是提高研发能力的一种手段。特别关注的是最终产品/服务和核心基本技术的质量标准的形成,特别是特定的多能干细胞系。此外,我们推断出标准化过程的两个阶段,个性化阶段是市场认可特定产品/服务的阶段,然后是标准化阶段,基本技术随后被确立为兼容性标准。
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