基于“先进合同研究组织”的生物医药产业创新模式探讨

Advanced Contract Research Organization-Based Innovated Pattern of Biopharmaceutical Industry

目的:探索我国的生物医药产业创新模式。方法:分析我国生物医药产业的核心——新药研发中存在的研发基地建设薄弱、资金不足、成果转化难三大问题,基于"合同研究组织(CRO)"建立产业创新模式。结果:提出由"多并发CRO"的研发模式、风险投资与专利/新药证书对接的融资形式以及新药证书为导向的研发过程管理组成的产业创新模式,并整合为"先进合同研究组织(CRO+)"。结论:该模式是一种开放性集成服务体系,有利于缩短生物医药研发周期,降低研发成本与研发风险,促进我国生物医药产业发展。

OBJECTIVE： To explore the innovation pattern of biopharmaceutical industry in China. METHODS： Three major problems encountered by the research and development （R＆D） of new drug, the core of Chinese biopharmaceutical industry, including the weak construction of operation base for R＆D of new drug, insufficient fund, difficulty in the transformation of achievements were analyzed. An innovation pattern of biopharmaceutical industry was founded based on the ＂Contract Research Organization（CRO）＂ . RESULTS： An innovation industry pattern consisting of multiple-concurrent CRO R＆D mode, venture capital and patent/new drug certificate tie - in financing form and new drug certificate oriented R＆ D process management has been put forward, which was integrated into an ＂advanced CRO＂（CRO ＋ ） mode. CONCLUSION： The CRO ＋ mode is an open and integrative service system which can help shorten the R＆D cycle, lower the cost and risk of R＆D and promote the development of biopharmaceutical industry in China.