我国制药企业技术创新战略选择问题探讨
|
摘要
技术创新是医药企业竞争力的核心，技术创新战略统领制药企业创新的具体行为。本研究的目的在于探讨我国医药企业技术创新战略选择的思路和原则。
本文综合运用了文献调研、专家咨询、战略分析和典型案例研究等方法，主要研究了如下问题：制药技术创新中的理论问题和基本概念界定；全球制药技术创新环境的演变、现状与趋势；制药技术创新影响因素；技术创新模式与策略；我国技术创新的逻辑起点及创新战略选择的思路和原则。
主要研究结论是：新药产出率呈下降趋势，新药研发突破尚等时日；新药研发费用增加成为制约新药开发效率的瓶颈因素，药品价格控制以及鼓励通用名药品的竞争减少对创新的激励作用，专利保护、数据保护促进制药的创新。各国政府也在不断调整创新的战略以提高创新的效率，我国制药业面临新的发展机遇和环境。模仿创新是我国现阶段制药企业的主要模式，合作创新是技术创新的必要路径，制药核心技术唯有立足自主创新。我国制药业技术创新战略模式选择中要以改进技术为逻辑起点。化学、生物制药技术创新战略在全局上以模仿创新为切入点，重视局部技术环节的突破。中药制药企业技术创新战略以自主创新为战略模式重点。
Technology innovation is the core of competence in pharmaceutical companies, technology innovation strategy command the innovative behavior. The pupose of this reaearch is to discuss the way and principles in the selection of technology innovation strategies in pharmaceutical companies.
The methods used in this paper are literature review, expert consultanting, strategy analysis and case study. The issues studied included: the theory issues in the pharmaceutical innovation, the evolution, status and trend of the environment of global phmarmaceutical innovation, the influential factors and modes of pharmaceutical innovation, the starting point and the principles of selection of innovation strategies in pharmaceutical companies in our country.
The main concluation are as follows. The productivity of new drug is descending; there is still some time to break through in new drug research and development; the increasing of development cost has become the bottleneck restraining the yield of drug development; the controlling of drug price and the encouraging competition of generics reduce the incentive effect to innovation; the protection of patent and test data promote innovation. Most governments are adjusting innovation strategy to raise innovation efficiency. The pharmaceutical industry of our country faces new opportunity and environment to develop. Imitative innovation is our main innovation mode at present, collaborating innovation is a essential path of innovation in our country, and the core pharmaceutical technology must depend on independent innovation. The innovation strategy selection in pharmaceutical companies in our country should base on the stage of improving technology. From overall situation, chemical and biopharmaceutical industry should apply Imitative innovation mode and think highly of breakthrough in important part. The companies of traditional Chinese medicine should emphasize the mode of independent innovation.
本文综合运用了文献调研、专家咨询、战略分析和典型案例研究等方法，主要研究了如下问题：制药技术创新中的理论问题和基本概念界定；全球制药技术创新环境的演变、现状与趋势；制药技术创新影响因素；技术创新模式与策略；我国技术创新的逻辑起点及创新战略选择的思路和原则。
主要研究结论是：新药产出率呈下降趋势，新药研发突破尚等时日；新药研发费用增加成为制约新药开发效率的瓶颈因素，药品价格控制以及鼓励通用名药品的竞争减少对创新的激励作用，专利保护、数据保护促进制药的创新。各国政府也在不断调整创新的战略以提高创新的效率，我国制药业面临新的发展机遇和环境。模仿创新是我国现阶段制药企业的主要模式，合作创新是技术创新的必要路径，制药核心技术唯有立足自主创新。我国制药业技术创新战略模式选择中要以改进技术为逻辑起点。化学、生物制药技术创新战略在全局上以模仿创新为切入点，重视局部技术环节的突破。中药制药企业技术创新战略以自主创新为战略模式重点。
Technology innovation is the core of competence in pharmaceutical companies, technology innovation strategy command the innovative behavior. The pupose of this reaearch is to discuss the way and principles in the selection of technology innovation strategies in pharmaceutical companies.
The methods used in this paper are literature review, expert consultanting, strategy analysis and case study. The issues studied included: the theory issues in the pharmaceutical innovation, the evolution, status and trend of the environment of global phmarmaceutical innovation, the influential factors and modes of pharmaceutical innovation, the starting point and the principles of selection of innovation strategies in pharmaceutical companies in our country.
The main concluation are as follows. The productivity of new drug is descending; there is still some time to break through in new drug research and development; the increasing of development cost has become the bottleneck restraining the yield of drug development; the controlling of drug price and the encouraging competition of generics reduce the incentive effect to innovation; the protection of patent and test data promote innovation. Most governments are adjusting innovation strategy to raise innovation efficiency. The pharmaceutical industry of our country faces new opportunity and environment to develop. Imitative innovation is our main innovation mode at present, collaborating innovation is a essential path of innovation in our country, and the core pharmaceutical technology must depend on independent innovation. The innovation strategy selection in pharmaceutical companies in our country should base on the stage of improving technology. From overall situation, chemical and biopharmaceutical industry should apply Imitative innovation mode and think highly of breakthrough in important part. The companies of traditional Chinese medicine should emphasize the mode of independent innovation.
引文
[1] Pharmaceutical R&D: Costs, Risks, and Rewards. Office of Technology Assessment(OTA). 1993
[2] Changing Patterns of Pharmaceutical Innovation. The National Institute for Health Care Management Research and Educational Foundation.2002
[3] Pharmocoevolution: the benefits of incremental innovation. IPN Working Papers On Intellectual Property, Innovation And Health.2005
[4] Challenge and Opportunity on the Critical Path to New Medical Products. U.S. Department of Health and Human Services Food and Drug Administration. 2004
[5] Profile 2007.PhRMA.2007.http://www.phrma.org
[6] Innovation in the pharmaceutical sector Charles River Associates.2004
[7] The Many Faces Of Innovation.Office of Health Economics.2005
[8] Barriers To Innovation In The Development Of New Medicines In Europe And Possible Solutions To Address These Barriers.The European Federation Of Pharmaceutical Industry Associations(EFPIA).2004
[9] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2006(volum4)
[10] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2004(volum2)
[11] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2005(volum3)
[12] Encouraging Pharmaceutical R&D In Developing Countries.International Federation of Pharmaceutical Manufacturers Associations.2003
[13] The Pharmaceutical Innovation Platform. International Federation of Pharmaceutical Manufacturers Associations.2004
[14] 张飞燕，王英．我国医药产业合作技术创新问题分析．中国药房，2002；13(10)：580-582
[15] 李建敏．我国医药企业的技术创新战略及R&D模式．中国药房，2002；13(7)：388-389
[16] 杨舒杰．论我国政府在医药企业技术创新中的激励政策．中国药房，2002；13(11)：644-646
[17] 刘皓，杨悦，王永春．降低医药企业技术创新风险的对策研究．中国药业，2004；13(4)：22-24
[18] 孙利华，左根永，黄泰康．制药企业品牌管理与持续技术创新的整合战略．中国新药杂志，2004；13(7)：577-579
[19] 茅宁莹．医药企业技术创新能力评价方法探析．中国药房，2005；16(13)：970-972
[20] 孟光兴，邱家学．论模仿创新在我国新药研究和开发中的应用．上海医药，2003；24(8)：343-344
[21] 曹阳．医药产业技术创新风险与政府政策支持．上海医药，2002；23(10)：443-444
[22] 张景|JIE|，张宗益等．全球与中国医药领先企业技术创新战略模式比较研究．医学与哲学，2005；26(2)：58-60
[23] Linda A Hall, Sharmistha Bagchi-Sen.An analysis of firm-leval innovation strategies in the US biotechnology industry.Techovation 27(2007):4-14
[24] Gelijns A, Moskowitz A. Capturing the Unexpected Benefits of Medical Research, Office of Health Economics, 2000,London
[25] Pritchard C., Towse A., Owen I. Results of a review of leading NHS medicines, in Capturing the Unexpected Benefits of Medical Research, Office of Health Economics, 2000 London
[26] Rosen A.,Beerman B. Rating innovative therapeutic benefits of medicines licensed in Sweden 1987-1997, Int J Pharmaceutical Medicine, 1999,13:123-126
[27] Schoffski O., Diffusion of Medicines in Europe. University of Erlangen-Nuremberg, 2002
[28] The Pharmaceutical Innovation Platform. International Federation of Pharmaceutical Manufacturers Associations,2004
[29] Lichtenberg F. R.. The Impact of New Drug Launches on Longevity: Evidence from Longitudinal, Disease-Level Data from 52 Countries, 1982-2001, National Bureau of Economic Research Working Paper No. 9754(Cambridge, MA: NBER, June 2003).
[30] CASCADE Collaboration.Determinants of Survival Following HIV-1Seroconversion After Introduction of HAART. The Lancet 2003; 363:1267-1274.
[31] Lichtenberg F. R.. The Expanding Pharmaceutical Arsenal in the War on Cancer, National Bureau of Economic Research Working Paper No. 10328(Cambridge, MA: NBER, February 2004).
[32] The Value of Investment in Health Care: Better Care, Better Lives, Bethesda, MD: MEDTAP, 2003. http://www.unitedbiosource.com/pdfs/HP_FullReport.pdf(accessed2 November 2006).
[33] Manton K. G., X. L. Gu. Changes in Prevalence of Chronic Disability in the United States Black and Nonblack Population Above Age 65 from 1982 to 1999. Proceedings of the National Academy of Sciences 98, No. 11(2001): 6354-6359.
[34] Sokol M. C. et al. Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost. Med Care, 2005; 43: 6521-530.
[35] Improving Innovation in Medical Technology: Beyond 2002. FDA, 2003.
[36] Genomics and the world health. Report of the Advisory Committee on Health Research.World Health Organisation(WHO), Geneva 2002
[37] The Pharmaceutical Industry in Figures. The European Federation of Pharmaceutical Industries and Associations(EFPIA), 2006
[38] Post-approval R&D raises total drug development costs to $897 million, Impact Report.Tufts Center for the Study of Drug Development.2003
[39] DiMasi, J, Ronald H, Henry G.The Price of Innovation:New Estimates of Drug Development Costs. J of Health Econ, 2003; 22:151-185.
[40] 2004 Industry Profile. www.phrma.org. 2005
[41] Therapeutic Class is a Critical Determinant of Drug Development Cost and Time.Tufts Center for the Study of Drug Development,2004.
[42] Danzon E Sean N, Nuno P. Productivity in Pharmaceutical-Biotechnology R&D: The Role of Experience and Alliance. NBER Working Paper 9615, April 2003.
[43] The Importance of Innovation in Pharmaceutical Research.The Pfizer Journal, 1999 Summer,3(20)
[44] Innovation in the Pharmaceutical Sector, a Study Undertaken for the European Commission Charles River Associates, London,November 2004.
[45] Understanding the Development of the Clinical Study Budget While Avoiding Bumps and Pitfalls.Temple University, Philadelphia, 2004
[46] Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,FDA, March 2004
[47] Obstacles and Opportunities for Collaboration Among Academia, Industry and Government The Association of American Medical Colleges, Food and Drug Administration, Center for Drug Development Science at the University of California San Francisco, Drug Development Science: January 2005.
[48] Assessing the Current and Future Impact of Genomics on R&D Costs, Complexity, and Success Rates,Lehman Borthers,2001
[49] Troyer J, Alexander K. The effect of price regulation on innovation in the pharmaceutical industry. J Appl Bus Res, 2002; 18(4)
[50] Delivering on the Promise of Pharmaceutical Innovation: The Need to Maintain Strong and Predictable Intellectual Property Rights, PhRMA White Paper, 2002.
[51] Danzon P, Sean N, Nuno P. Productivity in Pharmaceutical Biotechnology R&D: The Role of Experience and Alliance, NBER Working Paper 2003.
[52] DiMasi J. New Drug Innovation and Pharmaceutical Industry Structure:Trends in the Output of Pharmaceutical Firms.Drug Inform J, 2000; 34:1169-1194
[53] Henderson R, Iain C. Scale, scope and spillovers: the determinants of research productivity in drug discovery. Rand J of Econ,1996; 27(1):32-59.
[54] Bixia Xu. Market differential evaluations of strategic alliances in the pharmaceutical/biotech industry. J High Technol Manage Res, 2006;17:43-52
[55] Swinbanks D. Single Amino-acid Makes Big Difference in Patent Court.Nature 1994;372 :123.
[56] FilmoreD. It's a GPCR World. Modern Drug Discov, 2004; 7(11): 24-28
[57] Arnold K, Coia A et. al. Value drivers in licensing deals. Nat Biotechnol, 2002; 20 (11) : 1085-1089.
[58] Schmid E.F, Smith D.A. Discovery, innovation and the cyclical nature of the business - a bright future for the pharmaceutical industry. Drug Discov Today , 2002; 7:563-568
[59] Danzon P, Ketcham, J. Reference pricing of Pharmaceuticals for Medicare: evidence from Germany, the Netherlands and New Zealand. NBER Working Paper, 2003
[60] DiMasi J, Mark A. Seibring, and Louisa Lasagna. New Drug Development in the United States from 1963 to 1992. Clin Pharmacol Ther, 1994; 55 (6)
[61] DiMasi J. New Drug Innovation and Pharmaceutical Industry Structure: Trends in the Output of Pharmaceutical Firms. Drug Inform J, 2000; 34:1169-1194.
[62] DiMasi J, Ronald H, Henry G The Price of Innovation: New Estimates of Drug Development Costs. J of Health Econ, 2003; 22:151-185.
[63] Dodds-Smith I, Grant B. Cost effectiveness - the fourth hurdle to market entry. Global Counsel Life Sciences Handbook, 2003:43-50.
[64] The Pharmaceutical Industry in Figures 2003, EFPIA (2003)
[65] Review of the EU pharmaceutical legislation: EFPIA comment on outcome of EP final vote EFPIA (2004) , http://www.efpia.org/
[66] Improving Innovation in Medical Technology: Beyond 2002, FDA ,2003. http://www.fda.gov/
[67] Innovation - Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, FDA, 2004. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf.
[68] Ganslandt M, Keith M. Parallel imports and the pricing of pharmaceutical products: evidence from the European Union. J Health Econ, 2004; 23:1035-1057.
[69] Grabowski H,, John V, DiMasi. J. Returns on Research and Development for 1990s New Drug Introductions. Pharmacoeconomics,2002;20 (Suppl. 3) : 11-29.
[70] Kanavos P. Overview of Pharmaceutical Pricing and Reimbursement Regulation in Europe. 2001. http://pharmacos.eudra.Org/F3/g10/docs/synthesis.pdf.
[71] The many faces of innovation. OHE consulting for the European federation of pharmaceutical industries and associations (EFPIA) ,2005.
[72] Medicines for Mankind: Today's Research, Tomorrow's Cures. European Federation Of Pharmaceutical Industries And Associations, 2006 (volum4)
[73] Pharmaceutical R&D: Costs, Risks, andRewards. U.S. Congress, Office of Technology Assessment(OTA), 1993
[74] Innovation in the pharmaceutical sector, A study undertaken for the European Commission. Charles River Associates, 2004
[75] Innovation In Parmaceutical Biotechnology:Comparing National Innovation Systems At The Sectoral Level. Organisation For Economic Co-Operation And Development, 2006
[76] The Pharmaceutical Industry in Figures.European Federation Of Pharmaceutical Industries And Associations, 2006
[77] Ulrich K.Betz How many genomics targets can a portfolio afford? DDT, 2005; 10(15): 1057-1063
[78] Jürgen D. Strategic trends in the drug industry. DDT, 2003; 8(9): 411-420
[79] Bryan G. et al. Pharmaceutical R&D Productivity: The Path to Innovation. Cambridge Healthtech Associates Life Sciences Reports.2005
[80] Esther S, Dennis S. Is pharmaceutical R&D just a game of chance or can strategy make a difference? DDT, 2004; 9(1): 18-26
[81] Esther S, Dennis S. Is declining innovation in the pharmaceutical industry a myth? DDT,2005; 10(15):1031-1039
[82] Esther S, Dennis S. Discovery, innovation and the cyclical nature of the pharmaceutical business.DDT,2002; 7(10):563-568
[83] CDER Number Of Active Inds At The Close Of The Calendar Year: Calendar Years 1986-2006. http://www.fda.gov/
[84] CDER Original Inds Received Calendar Years 1986-2006. http://www.fda.gov/
[85] Lars S.Knowledge transfer and R&D in pharmaceutical companies: A case study. J Eng Technol Manage, 2005; 22:315-331
[86] Robert A. drug discovery in Japanese pharmaceutical companies:insights into national differences in industrial innovation.Res Policy,2003;32:1805-1827
[87] Jiirgen D, Stefan R. Pharmaceutical innovation between scientific opportunities and economic constraints. DDT,1997; 2(9):365-372
[88] New Drug Development:Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts.United States Government Accountability Office,2006
[89] Innovation or Stagnation: Critical Path Opportunities List, FDA, March 2006
[90] Innovation or Stagnation: Critical Path Opportunities Report, FDA, March 2006
[91] Lyles A. Creating alternative incentives for pharmaceutical innovation. Clin Ther, 2006; 28(1):126-128
[92] Tice B. Pharmaceutical care: a necessary"disruptive innovation" in health care.J Am Pharm Assoc(Wash),2002;42(3):381-382.
[93] Drews J. Research & development. Basic science and pharmaceutical innovation. Nat Biotechnol, 1999; 17(5):406.
[94] Cohen J. Macro trends in pharmaceutical innovation. Nat Rev Drug Discov, 2005; 4(1):78-84.
[95] 傅家骥，仝允恒等．技术创新学．北京：清华大学出版社，1998
[96] 凌云，王立军．技术创新的理论与实践．北京：中国经济出版社，2004
[97] 阎军印，孙班军．企业技术创新的系统分析与评价．北京：中国财政经济出版社，2002
[98] 吴贵生．技术创新管理．北京：清华大学出版社，2000
[2] Changing Patterns of Pharmaceutical Innovation. The National Institute for Health Care Management Research and Educational Foundation.2002
[3] Pharmocoevolution: the benefits of incremental innovation. IPN Working Papers On Intellectual Property, Innovation And Health.2005
[4] Challenge and Opportunity on the Critical Path to New Medical Products. U.S. Department of Health and Human Services Food and Drug Administration. 2004
[5] Profile 2007.PhRMA.2007.http://www.phrma.org
[6] Innovation in the pharmaceutical sector Charles River Associates.2004
[7] The Many Faces Of Innovation.Office of Health Economics.2005
[8] Barriers To Innovation In The Development Of New Medicines In Europe And Possible Solutions To Address These Barriers.The European Federation Of Pharmaceutical Industry Associations(EFPIA).2004
[9] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2006(volum4)
[10] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2004(volum2)
[11] Medicines for Mankind: Today'S Research, Tomorrow'S Cures. The European Federation Of Pharmaceutical Industry Associations(EFPIA).2005(volum3)
[12] Encouraging Pharmaceutical R&D In Developing Countries.International Federation of Pharmaceutical Manufacturers Associations.2003
[13] The Pharmaceutical Innovation Platform. International Federation of Pharmaceutical Manufacturers Associations.2004
[14] 张飞燕，王英．我国医药产业合作技术创新问题分析．中国药房，2002；13(10)：580-582
[15] 李建敏．我国医药企业的技术创新战略及R&D模式．中国药房，2002；13(7)：388-389
[16] 杨舒杰．论我国政府在医药企业技术创新中的激励政策．中国药房，2002；13(11)：644-646
[17] 刘皓，杨悦，王永春．降低医药企业技术创新风险的对策研究．中国药业，2004；13(4)：22-24
[18] 孙利华，左根永，黄泰康．制药企业品牌管理与持续技术创新的整合战略．中国新药杂志，2004；13(7)：577-579
[19] 茅宁莹．医药企业技术创新能力评价方法探析．中国药房，2005；16(13)：970-972
[20] 孟光兴，邱家学．论模仿创新在我国新药研究和开发中的应用．上海医药，2003；24(8)：343-344
[21] 曹阳．医药产业技术创新风险与政府政策支持．上海医药，2002；23(10)：443-444
[22] 张景|JIE|，张宗益等．全球与中国医药领先企业技术创新战略模式比较研究．医学与哲学，2005；26(2)：58-60
[23] Linda A Hall, Sharmistha Bagchi-Sen.An analysis of firm-leval innovation strategies in the US biotechnology industry.Techovation 27(2007):4-14
[24] Gelijns A, Moskowitz A. Capturing the Unexpected Benefits of Medical Research, Office of Health Economics, 2000,London
[25] Pritchard C., Towse A., Owen I. Results of a review of leading NHS medicines, in Capturing the Unexpected Benefits of Medical Research, Office of Health Economics, 2000 London
[26] Rosen A.,Beerman B. Rating innovative therapeutic benefits of medicines licensed in Sweden 1987-1997, Int J Pharmaceutical Medicine, 1999,13:123-126
[27] Schoffski O., Diffusion of Medicines in Europe. University of Erlangen-Nuremberg, 2002
[28] The Pharmaceutical Innovation Platform. International Federation of Pharmaceutical Manufacturers Associations,2004
[29] Lichtenberg F. R.. The Impact of New Drug Launches on Longevity: Evidence from Longitudinal, Disease-Level Data from 52 Countries, 1982-2001, National Bureau of Economic Research Working Paper No. 9754(Cambridge, MA: NBER, June 2003).
[30] CASCADE Collaboration.Determinants of Survival Following HIV-1Seroconversion After Introduction of HAART. The Lancet 2003; 363:1267-1274.
[31] Lichtenberg F. R.. The Expanding Pharmaceutical Arsenal in the War on Cancer, National Bureau of Economic Research Working Paper No. 10328(Cambridge, MA: NBER, February 2004).
[32] The Value of Investment in Health Care: Better Care, Better Lives, Bethesda, MD: MEDTAP, 2003. http://www.unitedbiosource.com/pdfs/HP_FullReport.pdf(accessed2 November 2006).
[33] Manton K. G., X. L. Gu. Changes in Prevalence of Chronic Disability in the United States Black and Nonblack Population Above Age 65 from 1982 to 1999. Proceedings of the National Academy of Sciences 98, No. 11(2001): 6354-6359.
[34] Sokol M. C. et al. Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost. Med Care, 2005; 43: 6521-530.
[35] Improving Innovation in Medical Technology: Beyond 2002. FDA, 2003.
[36] Genomics and the world health. Report of the Advisory Committee on Health Research.World Health Organisation(WHO), Geneva 2002
[37] The Pharmaceutical Industry in Figures. The European Federation of Pharmaceutical Industries and Associations(EFPIA), 2006
[38] Post-approval R&D raises total drug development costs to $897 million, Impact Report.Tufts Center for the Study of Drug Development.2003
[39] DiMasi, J, Ronald H, Henry G.The Price of Innovation:New Estimates of Drug Development Costs. J of Health Econ, 2003; 22:151-185.
[40] 2004 Industry Profile. www.phrma.org. 2005
[41] Therapeutic Class is a Critical Determinant of Drug Development Cost and Time.Tufts Center for the Study of Drug Development,2004.
[42] Danzon E Sean N, Nuno P. Productivity in Pharmaceutical-Biotechnology R&D: The Role of Experience and Alliance. NBER Working Paper 9615, April 2003.
[43] The Importance of Innovation in Pharmaceutical Research.The Pfizer Journal, 1999 Summer,3(20)
[44] Innovation in the Pharmaceutical Sector, a Study Undertaken for the European Commission Charles River Associates, London,November 2004.
[45] Understanding the Development of the Clinical Study Budget While Avoiding Bumps and Pitfalls.Temple University, Philadelphia, 2004
[46] Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,FDA, March 2004
[47] Obstacles and Opportunities for Collaboration Among Academia, Industry and Government The Association of American Medical Colleges, Food and Drug Administration, Center for Drug Development Science at the University of California San Francisco, Drug Development Science: January 2005.
[48] Assessing the Current and Future Impact of Genomics on R&D Costs, Complexity, and Success Rates,Lehman Borthers,2001
[49] Troyer J, Alexander K. The effect of price regulation on innovation in the pharmaceutical industry. J Appl Bus Res, 2002; 18(4)
[50] Delivering on the Promise of Pharmaceutical Innovation: The Need to Maintain Strong and Predictable Intellectual Property Rights, PhRMA White Paper, 2002.
[51] Danzon P, Sean N, Nuno P. Productivity in Pharmaceutical Biotechnology R&D: The Role of Experience and Alliance, NBER Working Paper 2003.
[52] DiMasi J. New Drug Innovation and Pharmaceutical Industry Structure:Trends in the Output of Pharmaceutical Firms.Drug Inform J, 2000; 34:1169-1194
[53] Henderson R, Iain C. Scale, scope and spillovers: the determinants of research productivity in drug discovery. Rand J of Econ,1996; 27(1):32-59.
[54] Bixia Xu. Market differential evaluations of strategic alliances in the pharmaceutical/biotech industry. J High Technol Manage Res, 2006;17:43-52
[55] Swinbanks D. Single Amino-acid Makes Big Difference in Patent Court.Nature 1994;372 :123.
[56] FilmoreD. It's a GPCR World. Modern Drug Discov, 2004; 7(11): 24-28
[57] Arnold K, Coia A et. al. Value drivers in licensing deals. Nat Biotechnol, 2002; 20 (11) : 1085-1089.
[58] Schmid E.F, Smith D.A. Discovery, innovation and the cyclical nature of the business - a bright future for the pharmaceutical industry. Drug Discov Today , 2002; 7:563-568
[59] Danzon P, Ketcham, J. Reference pricing of Pharmaceuticals for Medicare: evidence from Germany, the Netherlands and New Zealand. NBER Working Paper, 2003
[60] DiMasi J, Mark A. Seibring, and Louisa Lasagna. New Drug Development in the United States from 1963 to 1992. Clin Pharmacol Ther, 1994; 55 (6)
[61] DiMasi J. New Drug Innovation and Pharmaceutical Industry Structure: Trends in the Output of Pharmaceutical Firms. Drug Inform J, 2000; 34:1169-1194.
[62] DiMasi J, Ronald H, Henry G The Price of Innovation: New Estimates of Drug Development Costs. J of Health Econ, 2003; 22:151-185.
[63] Dodds-Smith I, Grant B. Cost effectiveness - the fourth hurdle to market entry. Global Counsel Life Sciences Handbook, 2003:43-50.
[64] The Pharmaceutical Industry in Figures 2003, EFPIA (2003)
[65] Review of the EU pharmaceutical legislation: EFPIA comment on outcome of EP final vote EFPIA (2004) , http://www.efpia.org/
[66] Improving Innovation in Medical Technology: Beyond 2002, FDA ,2003. http://www.fda.gov/
[67] Innovation - Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, FDA, 2004. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf.
[68] Ganslandt M, Keith M. Parallel imports and the pricing of pharmaceutical products: evidence from the European Union. J Health Econ, 2004; 23:1035-1057.
[69] Grabowski H,, John V, DiMasi. J. Returns on Research and Development for 1990s New Drug Introductions. Pharmacoeconomics,2002;20 (Suppl. 3) : 11-29.
[70] Kanavos P. Overview of Pharmaceutical Pricing and Reimbursement Regulation in Europe. 2001. http://pharmacos.eudra.Org/F3/g10/docs/synthesis.pdf.
[71] The many faces of innovation. OHE consulting for the European federation of pharmaceutical industries and associations (EFPIA) ,2005.
[72] Medicines for Mankind: Today's Research, Tomorrow's Cures. European Federation Of Pharmaceutical Industries And Associations, 2006 (volum4)
[73] Pharmaceutical R&D: Costs, Risks, andRewards. U.S. Congress, Office of Technology Assessment(OTA), 1993
[74] Innovation in the pharmaceutical sector, A study undertaken for the European Commission. Charles River Associates, 2004
[75] Innovation In Parmaceutical Biotechnology:Comparing National Innovation Systems At The Sectoral Level. Organisation For Economic Co-Operation And Development, 2006
[76] The Pharmaceutical Industry in Figures.European Federation Of Pharmaceutical Industries And Associations, 2006
[77] Ulrich K.Betz How many genomics targets can a portfolio afford? DDT, 2005; 10(15): 1057-1063
[78] Jürgen D. Strategic trends in the drug industry. DDT, 2003; 8(9): 411-420
[79] Bryan G. et al. Pharmaceutical R&D Productivity: The Path to Innovation. Cambridge Healthtech Associates Life Sciences Reports.2005
[80] Esther S, Dennis S. Is pharmaceutical R&D just a game of chance or can strategy make a difference? DDT, 2004; 9(1): 18-26
[81] Esther S, Dennis S. Is declining innovation in the pharmaceutical industry a myth? DDT,2005; 10(15):1031-1039
[82] Esther S, Dennis S. Discovery, innovation and the cyclical nature of the pharmaceutical business.DDT,2002; 7(10):563-568
[83] CDER Number Of Active Inds At The Close Of The Calendar Year: Calendar Years 1986-2006. http://www.fda.gov/
[84] CDER Original Inds Received Calendar Years 1986-2006. http://www.fda.gov/
[85] Lars S.Knowledge transfer and R&D in pharmaceutical companies: A case study. J Eng Technol Manage, 2005; 22:315-331
[86] Robert A. drug discovery in Japanese pharmaceutical companies:insights into national differences in industrial innovation.Res Policy,2003;32:1805-1827
[87] Jiirgen D, Stefan R. Pharmaceutical innovation between scientific opportunities and economic constraints. DDT,1997; 2(9):365-372
[88] New Drug Development:Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts.United States Government Accountability Office,2006
[89] Innovation or Stagnation: Critical Path Opportunities List, FDA, March 2006
[90] Innovation or Stagnation: Critical Path Opportunities Report, FDA, March 2006
[91] Lyles A. Creating alternative incentives for pharmaceutical innovation. Clin Ther, 2006; 28(1):126-128
[92] Tice B. Pharmaceutical care: a necessary"disruptive innovation" in health care.J Am Pharm Assoc(Wash),2002;42(3):381-382.
[93] Drews J. Research & development. Basic science and pharmaceutical innovation. Nat Biotechnol, 1999; 17(5):406.
[94] Cohen J. Macro trends in pharmaceutical innovation. Nat Rev Drug Discov, 2005; 4(1):78-84.
[95] 傅家骥，仝允恒等．技术创新学．北京：清华大学出版社，1998
[96] 凌云，王立军．技术创新的理论与实践．北京：中国经济出版社，2004
[97] 阎军印，孙班军．企业技术创新的系统分析与评价．北京：中国财政经济出版社，2002
[98] 吴贵生．技术创新管理．北京：清华大学出版社，2000