圣泰公司金森脑泰产品的项目管理
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摘要
近几年来,随着国家宏观对医药企业实施与国际WTO接轨的药品GMP、GSP认证管理,药品招标的逐步推广、医疗保障机制的逐步完善、药品价格管理的增强,致使我国制药企业的经营利润空间将会逐年下降,而经营成本却居高不下,许多医药企业步入了难以为继的困境。在这种情况下,保持产品的不断创新是提高竞争实力的有效途径。大力发展具有民族品牌的中药,就成为圣泰公司发展战略的必然选择之一。
本文首先对圣泰公司的发展现状、企业的发展战略、研发能力、产品状况和金森脑泰产品作了介绍;从国内医药市场的需求状况、政策环境、中药市场的环境变化、医药市场的竞争状况、项目开发的必要性五个方面客观叙述了金森脑泰项目的实施背景;对金森脑泰项目的实施过程和具体现状进行了阐述,介绍了项目的来源、可行性分析的过程、项目的目标和开发计划以及项目的组织。
在对金森脑泰项目案例具体描述的基础上,从金森脑泰项目选择过程、可行性分析过程、项目合作伙伴、风险管理、组织管理、计划和控制以及项目沟通这几个方面对金森脑泰项目管理实施过程中存在的问题进行了分析。金森脑泰项目在实施过程由于缺乏医药项目的管理经验,对医药项目从研发到产业化的整个过程缺乏足够的认识;项目的选择和立项还缺乏科学性;对项目的风险认识不足,没有良好的风险管理机制;缺乏对项目合作伙伴控制的良好机制;没有专门的项目团队:未建立项目经理人制度;项目中的成员素质有所欠缺;缺乏对项目有效的计划和控制;没有建立项目团队的绩效考核和激励体系;项目的沟通存在缺陷。最终导致了项目未按预定计划完成目标。在问题分析的基础上,根据项目管理的科学理论,本文也针对性地提出了改进的措施和方案。希望这些建议能够对金森脑泰项目的后续工作和其他制药企业的项目研发工作提供借鉴和指导。
Recent years, government has executed GMP and GSP attestation management on pharmacy enterprises according to WTO, spread medicine bid, consummated medical ensuring system , strengthened medicine price management. All these make profit of pharmacy enterprise decreased but high operation cost. Many enterprises fall into hot water. Under this circumstance, keeping continuous innovation of product is a effective way to improve competence. Developing native brand of Chinese traditional medicine is one of necessary choices to carry on Shengtai strategy.This dissertation introduces development actuality, development strategy, R&D plan, products of Shengtai Company first. Then, project development background, including demand of native medical market, policy environment, environment variety of Chinese traditional medical, compete of medical market and necessity of project development, is described. It also clarifies execution and actuality of Jinsen Naotai such as project source, feasibility analysis, project development target and plan, project organization.Based on description to Jinsen Naotai project, the dissertation analyzes the problems during project selection, feasibility, project cooperation partners, risk management, organization management, plan and control, project communication. The conclusions are absence of project management experience during project management and industrialization, lack of scientific management of project selection and establishment, short of acquisition to project adventure and without good risk management system, devoid of specialize project team, un-employ project manager, poor education and research experience, un-build performance assessment and inspiration system , limitation of project communication. The problems above mentioned leads to delay the total period of project development. Based on the analysis, according to the scientific theory of project management, the dissertation puts forward to improvement measures and schemes of problems. These suggestions should be advisable and directed to nt follow-up process and other pharmacy enterprises.
本文首先对圣泰公司的发展现状、企业的发展战略、研发能力、产品状况和金森脑泰产品作了介绍;从国内医药市场的需求状况、政策环境、中药市场的环境变化、医药市场的竞争状况、项目开发的必要性五个方面客观叙述了金森脑泰项目的实施背景;对金森脑泰项目的实施过程和具体现状进行了阐述,介绍了项目的来源、可行性分析的过程、项目的目标和开发计划以及项目的组织。
在对金森脑泰项目案例具体描述的基础上,从金森脑泰项目选择过程、可行性分析过程、项目合作伙伴、风险管理、组织管理、计划和控制以及项目沟通这几个方面对金森脑泰项目管理实施过程中存在的问题进行了分析。金森脑泰项目在实施过程由于缺乏医药项目的管理经验,对医药项目从研发到产业化的整个过程缺乏足够的认识;项目的选择和立项还缺乏科学性;对项目的风险认识不足,没有良好的风险管理机制;缺乏对项目合作伙伴控制的良好机制;没有专门的项目团队:未建立项目经理人制度;项目中的成员素质有所欠缺;缺乏对项目有效的计划和控制;没有建立项目团队的绩效考核和激励体系;项目的沟通存在缺陷。最终导致了项目未按预定计划完成目标。在问题分析的基础上,根据项目管理的科学理论,本文也针对性地提出了改进的措施和方案。希望这些建议能够对金森脑泰项目的后续工作和其他制药企业的项目研发工作提供借鉴和指导。
Recent years, government has executed GMP and GSP attestation management on pharmacy enterprises according to WTO, spread medicine bid, consummated medical ensuring system , strengthened medicine price management. All these make profit of pharmacy enterprise decreased but high operation cost. Many enterprises fall into hot water. Under this circumstance, keeping continuous innovation of product is a effective way to improve competence. Developing native brand of Chinese traditional medicine is one of necessary choices to carry on Shengtai strategy.This dissertation introduces development actuality, development strategy, R&D plan, products of Shengtai Company first. Then, project development background, including demand of native medical market, policy environment, environment variety of Chinese traditional medical, compete of medical market and necessity of project development, is described. It also clarifies execution and actuality of Jinsen Naotai such as project source, feasibility analysis, project development target and plan, project organization.Based on description to Jinsen Naotai project, the dissertation analyzes the problems during project selection, feasibility, project cooperation partners, risk management, organization management, plan and control, project communication. The conclusions are absence of project management experience during project management and industrialization, lack of scientific management of project selection and establishment, short of acquisition to project adventure and without good risk management system, devoid of specialize project team, un-employ project manager, poor education and research experience, un-build performance assessment and inspiration system , limitation of project communication. The problems above mentioned leads to delay the total period of project development. Based on the analysis, according to the scientific theory of project management, the dissertation puts forward to improvement measures and schemes of problems. These suggestions should be advisable and directed to nt follow-up process and other pharmacy enterprises.
引文
[1] 卢有杰,卢家仪.项目风险管理.清华大学出版社,1998:37-38
[2] 吴之明,卢有杰.项目管理引论.清华大学出版社,2000:102-107
[3] 杰克吉多,詹姆斯.P.克莱门斯著.张金成译成功的项目管理.机械工业出版社,1999:135-150
[4] 蔡希贤.现代企业战略管理.武汉:华中理工大学出版社,1998:43-76,103-104
[5] WM.E.舒德尔,J·丹尼尔·舍曼.新技术开发管理.北京:中信出版社,2001:17-82
[6] 刘京城.无形资产的价格形成及评估方法.北京审计出版社,1998
[7] 辛希娅,罗宾斯.罗思.生物技术企业资本运营.机械工业出版社,2001:228-234
[8] 中国医药市场研究报告.深圳共好商业资讯有限公司出版,2004:77
[9] 北京生物工程和新医药产业发展报告.时代资源(香港)出版有限公司,2004:39
[10] 国际技术和医药研讨会资料.上海,2004.3.28
[11] 国家药品监督管理局.新药审评办法,1999-05-01
[12] 国家药品监督管理局.药品注册管理办法(征求意见稿),2002-08-15
[13] 谢建平,王洪海.我国中小型医药高技术公司专利战略的制定.研究与发展管理,2004,13(1):51-56
[14] 刘昌孝.美国新药研究开发与药物安全性评价研究概况.中国药学杂志,2003,34(11):785-787
[15] 刘景江,王勇等.R&D项目管理模式的实证研究.研究与发展管理,2004,13(1):25-30
[16] 宋逢明,陈涛涛.高科技投资项目评价指标体系的研究.中国软科学,2003,1:90-94
[17] 曾衍霖.我国新药研发值得商榷的四个问题.中国新药杂志, 2004,11(3):185-187
[18] 胡永忠.解读“三高”医药经济报,2004.5.10
[19] 蒋伟民,陈金林等.医药创新研制和专利战略研究.科技管理研究,2003:16
[20] 汤旦林,张建方.新药临床试验的原理与操作(一).中国新药杂志,2003,9(1):19-20
[21] 张清江.研究开发新药的实践与体会.中国新药杂志,2004,8(2):76-78
[22] 钟武,贾暖.浅谈新药研究开发的过程和基本策略.中国新药杂志,2001,10(12):881-883
[23] 陶勇,邵元福.美国罕用药管理的历史与现状.中国药学杂志,2001,36(9):634-636
[24] 蔡小惠.新药开发研究的新战略.医药导报,2004,20(11):718-719
[25] 沈虹,齐欢.浅谈生物技术商业化系统及未来.高科技与产业化,2004,1
[26] 曹文忠.我国新药研究与产业化开发进展情况医药经济信息,2004,总第290期:21-22
[27] 王毅,毛义华.新产品开发管理新范式:基于核心能力的平台方法.科研管理,1999,20(4):6-12
[28] 紫兴.新产品研发推进紫竹药业发展.经济世界,2003(07)
[29] 郑晓波.哈药集团新品种研发成果显着.上海医药,2004(02)
[30] 杨育谋.研发机构落户中国.跨国药企步步为营.医药世界,2004(03)
[31] 单孟渤.抗血栓约——生化药物研发的一个热点.山东食品科技,2004(10)
[32] 易安.构建现代化中药和生物工程药物研发平台——记吉林修正药业集团技术中心.中国创业投资与高科技,2004(10)
[33] 李正越.与中国药业携手走向世界——访罗氏中国研发总监安德利博士.国际市场,2004(05)
[34] 林华.跨国药企研发东渐.中国外资,2004(11)
[35] 余坚.我国中药产业国际化市场战略分析.经济问题探索,2003(12)
[36] 新华.中药出口应具有灵活的市场定位.国际医药卫生导报,2003(15)
[37] 蔡茜.中药市场发展潜力展望.科技情报开发与经济,2003(12)
[38] 黎羽,陈刚.企业项目管理七要素.商业研究,2003(14)
[39] 戚国胜.项目管理建设模式探索.国际经济合作,2003(07)
[40] 谈凤奎.基于并行工程的项目管理模式研究.航空制造技术,2003(05)
[41] Nelson. Blair. Tufts center for the study of drug development: pegs cost of a new prescriptionmedicine at $802 million. Prince Hall Incor Press, 2004: 30
[42] Thomson. Keller. Convergence: The Biotechnology Industry Report, Millennium Edition. Ernst & Young LLP, 2000: 48-49
[43] Aflred muller. Evolution: Emst & Young's Seventh Annual European Life Sciences Report. Ernst & Young LLP, 2000: 52-54
[44] S W. Morrison & G, T. Giovanneti. Ernst & Young's Biotech '13th Biotechnology Industry Annual Report. Emst & Young LLP, 1998, 11: 39-40
[45] Richert JM. News pharmacenticals in the USA: Trends in development and marketing approvals 1995-1999[J]. Feature, 2000, 18: 364
[46] Kazoo Katao. The present state, and view for the policy of medicial industry. Pharmacentical Industry, 2000, 17
[47] R. Ducan. The Guide to The Project Management Body of knowledge. Project Management, 2003, 18
[48] Lientz, B. P, &Rea, K. P. Project Management for the 21st Century. San Diego: Academic Press, 2002, 9
[49] Edison. Muller. U. S. Congress, Office of Technology Assessment. Pharmaceutical R&D: Costs, Risks, and Rewards, 2003, 12
[50] Richert JM. News biopharmacenticals in the USA: Trends in development and marketing approvals 1995-2001[J]. Feature, 2002, 18
[51] Thayer A M. Great ezpectations-biopharmaceuticel industry expects success from new drug therapies and a full product development pipeline. Chemical Engineering News, 1999, 19
[52] Dibner MD. Medical technology and pharmaceuticals 10 year later, Biopharm, 2001, 10
[2] 吴之明,卢有杰.项目管理引论.清华大学出版社,2000:102-107
[3] 杰克吉多,詹姆斯.P.克莱门斯著.张金成译成功的项目管理.机械工业出版社,1999:135-150
[4] 蔡希贤.现代企业战略管理.武汉:华中理工大学出版社,1998:43-76,103-104
[5] WM.E.舒德尔,J·丹尼尔·舍曼.新技术开发管理.北京:中信出版社,2001:17-82
[6] 刘京城.无形资产的价格形成及评估方法.北京审计出版社,1998
[7] 辛希娅,罗宾斯.罗思.生物技术企业资本运营.机械工业出版社,2001:228-234
[8] 中国医药市场研究报告.深圳共好商业资讯有限公司出版,2004:77
[9] 北京生物工程和新医药产业发展报告.时代资源(香港)出版有限公司,2004:39
[10] 国际技术和医药研讨会资料.上海,2004.3.28
[11] 国家药品监督管理局.新药审评办法,1999-05-01
[12] 国家药品监督管理局.药品注册管理办法(征求意见稿),2002-08-15
[13] 谢建平,王洪海.我国中小型医药高技术公司专利战略的制定.研究与发展管理,2004,13(1):51-56
[14] 刘昌孝.美国新药研究开发与药物安全性评价研究概况.中国药学杂志,2003,34(11):785-787
[15] 刘景江,王勇等.R&D项目管理模式的实证研究.研究与发展管理,2004,13(1):25-30
[16] 宋逢明,陈涛涛.高科技投资项目评价指标体系的研究.中国软科学,2003,1:90-94
[17] 曾衍霖.我国新药研发值得商榷的四个问题.中国新药杂志, 2004,11(3):185-187
[18] 胡永忠.解读“三高”医药经济报,2004.5.10
[19] 蒋伟民,陈金林等.医药创新研制和专利战略研究.科技管理研究,2003:16
[20] 汤旦林,张建方.新药临床试验的原理与操作(一).中国新药杂志,2003,9(1):19-20
[21] 张清江.研究开发新药的实践与体会.中国新药杂志,2004,8(2):76-78
[22] 钟武,贾暖.浅谈新药研究开发的过程和基本策略.中国新药杂志,2001,10(12):881-883
[23] 陶勇,邵元福.美国罕用药管理的历史与现状.中国药学杂志,2001,36(9):634-636
[24] 蔡小惠.新药开发研究的新战略.医药导报,2004,20(11):718-719
[25] 沈虹,齐欢.浅谈生物技术商业化系统及未来.高科技与产业化,2004,1
[26] 曹文忠.我国新药研究与产业化开发进展情况医药经济信息,2004,总第290期:21-22
[27] 王毅,毛义华.新产品开发管理新范式:基于核心能力的平台方法.科研管理,1999,20(4):6-12
[28] 紫兴.新产品研发推进紫竹药业发展.经济世界,2003(07)
[29] 郑晓波.哈药集团新品种研发成果显着.上海医药,2004(02)
[30] 杨育谋.研发机构落户中国.跨国药企步步为营.医药世界,2004(03)
[31] 单孟渤.抗血栓约——生化药物研发的一个热点.山东食品科技,2004(10)
[32] 易安.构建现代化中药和生物工程药物研发平台——记吉林修正药业集团技术中心.中国创业投资与高科技,2004(10)
[33] 李正越.与中国药业携手走向世界——访罗氏中国研发总监安德利博士.国际市场,2004(05)
[34] 林华.跨国药企研发东渐.中国外资,2004(11)
[35] 余坚.我国中药产业国际化市场战略分析.经济问题探索,2003(12)
[36] 新华.中药出口应具有灵活的市场定位.国际医药卫生导报,2003(15)
[37] 蔡茜.中药市场发展潜力展望.科技情报开发与经济,2003(12)
[38] 黎羽,陈刚.企业项目管理七要素.商业研究,2003(14)
[39] 戚国胜.项目管理建设模式探索.国际经济合作,2003(07)
[40] 谈凤奎.基于并行工程的项目管理模式研究.航空制造技术,2003(05)
[41] Nelson. Blair. Tufts center for the study of drug development: pegs cost of a new prescriptionmedicine at $802 million. Prince Hall Incor Press, 2004: 30
[42] Thomson. Keller. Convergence: The Biotechnology Industry Report, Millennium Edition. Ernst & Young LLP, 2000: 48-49
[43] Aflred muller. Evolution: Emst & Young's Seventh Annual European Life Sciences Report. Ernst & Young LLP, 2000: 52-54
[44] S W. Morrison & G, T. Giovanneti. Ernst & Young's Biotech '13th Biotechnology Industry Annual Report. Emst & Young LLP, 1998, 11: 39-40
[45] Richert JM. News pharmacenticals in the USA: Trends in development and marketing approvals 1995-1999[J]. Feature, 2000, 18: 364
[46] Kazoo Katao. The present state, and view for the policy of medicial industry. Pharmacentical Industry, 2000, 17
[47] R. Ducan. The Guide to The Project Management Body of knowledge. Project Management, 2003, 18
[48] Lientz, B. P, &Rea, K. P. Project Management for the 21st Century. San Diego: Academic Press, 2002, 9
[49] Edison. Muller. U. S. Congress, Office of Technology Assessment. Pharmaceutical R&D: Costs, Risks, and Rewards, 2003, 12
[50] Richert JM. News biopharmacenticals in the USA: Trends in development and marketing approvals 1995-2001[J]. Feature, 2002, 18
[51] Thayer A M. Great ezpectations-biopharmaceuticel industry expects success from new drug therapies and a full product development pipeline. Chemical Engineering News, 1999, 19
[52] Dibner MD. Medical technology and pharmaceuticals 10 year later, Biopharm, 2001, 10