This review starts with a brief history of drug discovery & development, and the place of Asia in this worldwide effort discussed. The conditions and constraints of a successful translational R&D involving aca...This review starts with a brief history of drug discovery & development, and the place of Asia in this worldwide effort discussed. The conditions and constraints of a successful translational R&D involving academic basic research and clinical research are discussed and the Singapore model for pursuit of open R&D described. The importance of well-characterized, validated drug targets for the search for novel targeted anti-cancer agents is emphasized, as well as a structured, high quality translational R&D. Furthermore, the characteristics of an attractive preclinical development drug candidate are discussed laying the foundation of a successful preclinical development. The most frequent sources of failures are described and risk management at every stage is highly recommended. Organizational factors are also considered to play an important role. The factors to consider before starting a new drug discovery & development project are described, and an example is given of a successful clinical project that has had its roots in local universities and was carried through preclinical development into phase I clinical trials.展开更多
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...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。展开更多
药物研发是一个多学科相互渗透和相互合作的过程,具有周期长、投入高、风险大的特点。将实验室信息管理系统(Laboratory Information Management System,LIMS)应用于药物研发实验室不仅能持续推进研究进度,降低相关成本,而且能保证实验...药物研发是一个多学科相互渗透和相互合作的过程,具有周期长、投入高、风险大的特点。将实验室信息管理系统(Laboratory Information Management System,LIMS)应用于药物研发实验室不仅能持续推进研究进度,降低相关成本,而且能保证实验流程符合相关的国际质量标准和规范。概述了LIMS的发展现状,并对LIMS在药物研发实验室的应用进行了分析,进一步探讨了实际应用中需要解决的几个关键问题,包括LIMS与仪器的集成、物联网技术的应用、生物信息数据库与LIMS的集成。展开更多
文摘This review starts with a brief history of drug discovery & development, and the place of Asia in this worldwide effort discussed. The conditions and constraints of a successful translational R&D involving academic basic research and clinical research are discussed and the Singapore model for pursuit of open R&D described. The importance of well-characterized, validated drug targets for the search for novel targeted anti-cancer agents is emphasized, as well as a structured, high quality translational R&D. Furthermore, the characteristics of an attractive preclinical development drug candidate are discussed laying the foundation of a successful preclinical development. The most frequent sources of failures are described and risk management at every stage is highly recommended. Organizational factors are also considered to play an important role. The factors to consider before starting a new drug discovery & development project are described, and an example is given of a successful clinical project that has had its roots in local universities and was carried through preclinical development into phase I clinical trials.
文摘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。
文摘药物研发是一个多学科相互渗透和相互合作的过程,具有周期长、投入高、风险大的特点。将实验室信息管理系统(Laboratory Information Management System,LIMS)应用于药物研发实验室不仅能持续推进研究进度,降低相关成本,而且能保证实验流程符合相关的国际质量标准和规范。概述了LIMS的发展现状,并对LIMS在药物研发实验室的应用进行了分析,进一步探讨了实际应用中需要解决的几个关键问题,包括LIMS与仪器的集成、物联网技术的应用、生物信息数据库与LIMS的集成。
