Clinical translation of biomedical materials and the key factors towards product registration
Clinical translation of biomedical materials and the key factors towards product registration
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生物医用材料的临床转化及产品注册的关键因素
DOI：
10.1016/j.jot.2013.12.002
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发表时间：
2014-04-01
影响因子：
6.6
通讯作者：
Liu, Changsheng
中科院分区：
文献类型：
--
作者：
Yuan, Yuan;Lin, Dan;Liu, Changsheng
生物医学材料已被开发用于促进组织再生和增强愈合。虽然生物医用材料的研究在材料创新和临床前试验方面取得了很大进展，但瓶颈在于从研发到临床应用的转化；也就是说，目前的产品注册和产业化速度较低，这直接影响了它们的临床应用。本文介绍了医用材料的基本特点，以及近年来我组在骨组织再生生物材料的研究和临床转化方面的经验。根据我们的经验，我们提出转化医学平台（TMP）是促进生物医学材料从实验室到床边进步的有效途径。并从科学技术和管理的角度阐述了TMP的功能。并从技术创新、化工一体化、资金筹措和管理等方面探讨了TMP与科研机构、企业和政府的关系。为生物医学资料的临床翻译提供理论和实践参考。版权所有，作者。爱思唯尔（新加坡）私人有限公司出版
Biomedical materials have been developed for facilitating tissue regeneration and healing enhancement. Although research on biomedical materials has made great progress in material innovation and preclinical testing, the bottleneck is their translation from research and development to clinical applications; that is, the current rate of product registration and industrialization is low, which directly affects their clinical applications. In this paper, we introduce the basic features of biomedical materials towards the making of medical products and the experiences of our group in research and clinical translation of biomaterials for bone-tissue regeneration in the last few years. Based on our experience, we propose that the translational medicine platform (TMP) is an effective route to facilitate the progress of biomedical materials from bench to bedside. Moreover, from the viewpoints of scientific technology and management, the functions of TMP were also addressed. Relationships among TMP, research institution, enterprise, and government were also explored from the viewpoints of technological innovation, chemical engineering integration, fund raising, and management. This paper provides a theoretical and practical reference for clinical translation of biomedical materials. Copyright (C) 2013, The Authors. Published by Elsevier (Singapore) Pte Ltd.