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论文编号：	8343
作者编号：	2220110838
上传时间：	2016/6/7 21:48:53
中文题目：	启德公司新药研发管理研究
英文题目：	Research on new drug R&D Management in Genequantum Co., Ltd.
指导老师：	周建教授
中文关键字：	新药研发 开放式创新 精益研发 启德公司
英文关键字：	new drug R&D, open innovation, Lean R&D，Genequantum compay
中文摘要：	新药研发是一项系统工程，在疾病与生命科学的基础研究、药物发现与开发、审批与评价、药品的生产销售和使用等诸多环节中，涉及众多的研发资源和利益相关方，形成了一个庞大的产业生态系统，这个生态系统的每一环都会对新药研发的产出和效率产生影响。中小型新药研发企业如何在庞杂的医药产业生态链中有效突破新药研发所面临的资金、人才、经验等方面的困境，提升新药研发效率？本文以启德公司为实例，探讨中小型新药研发企业加强新药研发管理，提升自主创新能力和新药产出效率的管理策略。 启德公司成立于2013年，在用于肿瘤靶向治疗的新型ADC药物研发方面拥有自主知识产权、国际领先的核心技术。但是，作为一家初创的小型生物医药公司，如何克服新药研发漫长周期、巨额投入的实际困难，快速有效的将自身核心技术优势转化为商业化的产品？ 启德公司创始团队结合公司实际情况，充分借鉴开放式创新模式的理论与方法，以核心技术为基础，充分整合、借助外部资源，同时通过精细化项目管理全面提升新药研发管理水平，建立以价值创造和认可导向为核心的绩效管理体系，迅速打开局面，开发与建立了一个通用性的技术平台，获得了首个具有良好应用前景的肿瘤靶向治疗药物GQ1001。 本论文通过对国内外新药研发现状的分析，开放式创新模式、精细化项目管理、价值创造和认可导向的绩效管理理论方法，结合启德公司的发展实际，探索我国初创型中小生物医药企业以核心技术为基础、采用开放式创新模式进行新药研发、强化精益研发和项目管理，推动企业迅速发展的策略选择，有一定的范式作用，具有重要的现实意义。
英文摘要：	New drug R&D is a systematic project, in which the basic research in life science and diseases, drug discovery and development, drug evaluation and approval, manufacutre, sale and use of drugs, involving many R & D resources and interest related parties, formaed a huge industry ecosystem. Each factor in the ecosystem has an impact on the output and efficiency of new drug research and development. Small and medium-sized pharmaceutical enterprise how to effective breakthrough the morass in funds, human resurce, experience, etc, improve efficiency of new drug research and development? In this paper, the GeneQuantum company as an example to explore new drug development for small and medium-sized enterprises to strengthen the management of drug development, enhance independent innovation capability and drug efficiency management strategies. GQ company was founded in 2013, focus on new ADC drug R&D for targeted cancer therapy with independent intellectual property, the world's leading core technology. However, as a small start-up biomedical companies, how to overcome the long cycle, large inputs of practical difficulties, will quickly and effectively transfer their core technology into a commercial product? GQ company founders according to the actual situation and the theory of open innovation, based on the core technology, fully integrated and leverage external resources, meticulous project management, the establishment of value guide the creation and recognition as the core of performance management system, rapidly develop and establish a common technology platform, obtain the first quite promising targeted cancer therapy GQ1001. In this paper, through the research and development of new drugs at home and abroad the status quo analysis, open innovation, meticulous project management, value creation and recognition of performance-oriented management theory, combined with the actual development of GeneQuantum explore our biomedical start-up of small and medium enterprises core technology, the use of open innovation model of drug development, and strengthen lean R&D and project management, and promote the rapid development of business strategy selection, have a certain role in the paradigm has important practical significance.
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