我国医药企业创新药合作研发风险治理

Try to Promote the Risk Governance of Chinese Pharmaceutical Enterprises Innovative Drug Cooperation Research and Development

我国药物研发和产业发展进入跨越式创新阶段,越来越多医药企业与高校、科研机构、合同外包研究机构(contract research organization,CRO)进行研发合作,合作研发的每一环节都面临着较大风险。结合创新药研发历程识别各环节组织合作情况,分析我国医药企业创新药合作研发面临的风险;基于Rasmussen社会系统层次模型,建立5层级创新药合作研发风险框架,通过对百济神州创新药合作研发项目案例分析,构建合作研发风险Accimap模型,结合信息流传递途径,厘清我国创新药合作研发风险层次间致因因素的影响路径。采用PSR(pressure-state-response,压力-状态-响应)模型,针对我国创新药合作研发风险提出对策与建议。

Chinese drug R&D and industrial development has entered a leap-forward stage of innovation.More and more pharmaceutical enterprises cooperate with universities,scientific Research institutions,CRO(contract research organization)contract outsourcing service agencies for R&D.Each link of cooperative research is faced with great risks.Combined with the process of innovative drug research and development,the organization and cooperation of each link were identified,and the risks faced by Chinese pharmaceutical enterprises were analyzed.Based on the Rasmussen social system hierarchy model,a 5-level risk framework for cooperative R&D of innovative drugs was established.Through the case analysis of Beigene cooperative R&D project,the Accimap model of cooperative R&D risk was constructed,and the influence path of the factors among the levels of risk of cooperative R&D of innovative drugs in China was clarified with the combination of information flow transmission channels.Based on the PSR(pressure-state-response)model,the countermeasures and suggestions are put forward according to the risks of our innovative drug cooperative R&D.