摘要
目的:为构建具有我国特色的新药转化研究链保证体系提供参考。方法:分析当前转化研究链对新药研发过程凸显的制约作用,评述新药转化研究中的关键课题,探讨新药转化研究体系的构建与发展。结果:转化研究贯穿新药研发过程始终,生物标志物、动物实验模型、遗传药理学、网络药理学等的研究与应用是新药转化链中的关键课题。建议通过各层面综合配套的改革创新措施,对新药转化研究协作、转化型人才培养、资本风险投入、国际合作交流机制等加以规范化推进,建立健全以患者为中心的新药转化研究公共平台与切合我国实际情况的政策法规体系,以有效破解新药研发风险及其效率低下的困境,加快我国新药发展步伐。结论:践行转化医学理念,科学的顶层设计和统筹规划不可或缺;必须充分利用我国独特优势,着力优化新药转化研究工作环境,从而保障新药转化研究链的实效运行。
OBJECTIVE： To provide references for the construction of new drugs transformation chain assurance system with Chinese characteristics. METHODS：Current translational research chain＇s restriction on the process of new drug research and devel- opment were analyzed. The key topics in the new drug transformation were reviewed and the construction and development of trans- formation system for new drugs were discussed. RESULTS ： Transformation will run through the process of new drug research and development. There were some key topics in the transformation chain, including biomarkers, animal models, genetic pharmacolo- gy, network pharmacology and other research and application. The measures innovation were conducted by the adoption of compre- hensive reform at all levels to promote the new drug transformation collaboration, conversion personnel training, risk capital invest- ment, international cooperation and exchange mechanism, establish and improve common platform of transformation in new drugs of patient-centered and policies and regulations with the actual situation of China, crack drug development risks and inefficiencies they face effectively and accelerate the pace of new drugs development. CONCLUSIONS：The scientific top-level design and overall planning is indispensable for practicing theory of translational medicine. We must make full use of the unique advantages and focus on the optimization of transformation work environment for new drugs to ensure the effective operation of the new drug transforma- tion chain.
出处
《中国药房》
CAS
北大核心
2015年第4期433-436,共4页
China Pharmacy
基金
国家自然科学基金青年基金资助项目(No.21102003)
关键词
新药
生物标志物
转化医学
药物基因组学
网络药理学
New drugs
Biomarker
Translational medicine
Pharmacogenomics
Network pharmacology
