制药企业对CRO的选择及管理研究
摘要
当今世界,制药企业新药研发“高投资、高风险及长周期”的特点日益突出,研发成本逐年增加,而上市新药数量却明显减少;传统的新药研发方式越来越受到挑战,完全自主进行新药研发所有阶段的理念也已不合时宜。现在,制药企业每研发一个创新药物平均约需8年～14年的时间和8亿～10亿美元的成本,而拥有创新药物又是其在激烈的市场竞争中制胜的关键。在此状况下,具有缩短研发周期、节省研发成本及专业化服务特长的CRO便应运而生。CRO是“Contract Research Organization”的英文缩写,直译为“合同研究组织”,是指以合同的方式在新药研发过程中提供药学研究技术服务的学术性或商业性科学机构。
随着全球医药外包服务业的迅速增长,世界范围内的大多数制药企业都在适应社会分工越来越细的趋势,走向联合协作、合同研究和共同发展的道路。如今,CRO已成为国际新药研发的新模式和现代制药企业研发外包的必然选择。那么,现代制药企业依据什么指标、采用什么方法选择满意的CRO,并怎样对所选的CRO进行管理,已成为其研发外包过程中不可避免并亟待解决的问题。
本文在具体分析制药企业选择CRO的原因的基础上,通过文献研究和逻辑推理的方法建立制药企业选择CRO的指标,然后结合层次分析法对制药企业选择CRO的过程进行具体的模拟,最后提出制药企业对所选CRO进行管理的措施,为制药企业选择及管理CRO提供指标、方法和措施上的借鉴及指导,同时为相关政府管理部门对CRO的规范管理及CRO的自我战略管理提供参考。
In today's world, the characteristics of "high investment, high risk and long-period" have become increasingly prominent during the pharmaceutical enterprises' new drugs R&D. New drugs R&D's cost is increasing year by year, but the number of new drugs is obviously reduced. The traditional new drugs R&D's way is increasingly being challenged, and the concept of completing independently new drugs R&D's all stages is also outdated. Today, pharmaceutical enterprises need about 8 to 14 years and 800 to 1000 million dollars in costs to have developed an innovative drug. We all know innovative drug is the key that modern pharmaceutical enterprises can win in fierce market competition. In this case, the CRO come into the pharmaceutical industry, which can reduce new drugs R&D's cycle, save new drugs R&D's cost and has professional technical services. CRO is the english abbreviation of the "Contract Research Organization" . It is a academic or commercial scientific institution which provides the new drugs R&D's some technical services for modern pharmaceutical enterprises and two sides must sign one contract before they cooperate.
With the rapid growth of global pharmaceutical outsourcing services, most pharmaceutical enterprises of the world are adapting to the trend of increasingly fine division. They have began to cooperate with CRO for the common development. Today, CRO has become an new international model of new drugs R&D and the nevitable choice of modern pharmaceutical enterprises' new drugs R&D outsourcing. So, modern pharmaceutical enterprises basing on what indexes, using what method to select the most satisfactory, or the most suitable CRO, and how to manage CRO have become inevitable issues during their new drugs R&D outsourcing. These issues require urgent solution.
Based of specificly analysing the causes of the modern pharmaceutical enterprises choosing CRO, this paper establishes the indexes of modern pharmaceutical enterprises choosing CRO through literature research and logical methods, and then makes a simulation analysis on the course of modern pharmaceutical enterprises choosing CRO by the method of AHP, finally gives some measures of modern pharmaceutical enterprises manageing CRO. This research will provide the reference and guidance of indexes, method and measures with modern pharmaceutical enterprises choosing and manageing CRO, and provide information with relevant government departments to supervise CRO as well as self-strategy management of CRO.
随着全球医药外包服务业的迅速增长,世界范围内的大多数制药企业都在适应社会分工越来越细的趋势,走向联合协作、合同研究和共同发展的道路。如今,CRO已成为国际新药研发的新模式和现代制药企业研发外包的必然选择。那么,现代制药企业依据什么指标、采用什么方法选择满意的CRO,并怎样对所选的CRO进行管理,已成为其研发外包过程中不可避免并亟待解决的问题。
本文在具体分析制药企业选择CRO的原因的基础上,通过文献研究和逻辑推理的方法建立制药企业选择CRO的指标,然后结合层次分析法对制药企业选择CRO的过程进行具体的模拟,最后提出制药企业对所选CRO进行管理的措施,为制药企业选择及管理CRO提供指标、方法和措施上的借鉴及指导,同时为相关政府管理部门对CRO的规范管理及CRO的自我战略管理提供参考。
In today's world, the characteristics of "high investment, high risk and long-period" have become increasingly prominent during the pharmaceutical enterprises' new drugs R&D. New drugs R&D's cost is increasing year by year, but the number of new drugs is obviously reduced. The traditional new drugs R&D's way is increasingly being challenged, and the concept of completing independently new drugs R&D's all stages is also outdated. Today, pharmaceutical enterprises need about 8 to 14 years and 800 to 1000 million dollars in costs to have developed an innovative drug. We all know innovative drug is the key that modern pharmaceutical enterprises can win in fierce market competition. In this case, the CRO come into the pharmaceutical industry, which can reduce new drugs R&D's cycle, save new drugs R&D's cost and has professional technical services. CRO is the english abbreviation of the "Contract Research Organization" . It is a academic or commercial scientific institution which provides the new drugs R&D's some technical services for modern pharmaceutical enterprises and two sides must sign one contract before they cooperate.
With the rapid growth of global pharmaceutical outsourcing services, most pharmaceutical enterprises of the world are adapting to the trend of increasingly fine division. They have began to cooperate with CRO for the common development. Today, CRO has become an new international model of new drugs R&D and the nevitable choice of modern pharmaceutical enterprises' new drugs R&D outsourcing. So, modern pharmaceutical enterprises basing on what indexes, using what method to select the most satisfactory, or the most suitable CRO, and how to manage CRO have become inevitable issues during their new drugs R&D outsourcing. These issues require urgent solution.
Based of specificly analysing the causes of the modern pharmaceutical enterprises choosing CRO, this paper establishes the indexes of modern pharmaceutical enterprises choosing CRO through literature research and logical methods, and then makes a simulation analysis on the course of modern pharmaceutical enterprises choosing CRO by the method of AHP, finally gives some measures of modern pharmaceutical enterprises manageing CRO. This research will provide the reference and guidance of indexes, method and measures with modern pharmaceutical enterprises choosing and manageing CRO, and provide information with relevant government departments to supervise CRO as well as self-strategy management of CRO.
引文
[1]陈宁.美国的生物医药产业合同研究机构的概况及启示[J].全球科技经济嘹望,2007,5:45-49
[2]李娜,诸黎星,邹栩.1996年～2005年全球上市新药研发趋势及分析[J].药学进展,2007,31(5):228
[3]国际制药行业发展态势:外包转移[EB/OL].上海情报服务平台.2006-08-14
[4]王静波.全球合同研发外包服务业发展动态与趋势[EB/OL].http://www.tigermed.net/zxDetails.asp?newsid=564.2006-09-06
[5]Vogel John R.,Getz Kenneth A..Successful outsourcing:tracking the evolving use of full-service and niche-service CROs[J].Applied Clinical Trials,2005,14(6):54-60
[6]Schaub Wolfgang.Searching for a CRO-can the intemet help[J].Applied Clinical Trials,2003,12(4):45-48
[7]Joseph Jamila.Entering the contract research industry in India[J].Contemporary Clinical Trials,2008,29(3):311-313
[8]Boericke Kim M..What is the role of the project management in a contract research organization[EB/OL].www.socra.org/pdf/200311_RoleOfProjMgrCRO.pdf
[9]Shuchman Miriam.Commercializing clinical trials-risks and benefits of the CRO boom[J].New England Journal of Medicine,2007,357(14):1365-1368
[10]谢琪,黄卫平,崔天红.浅谈合同研究组织对我国制药业的作用[J].中国中医药信息杂志,2004,11(5):377-378
[11]赵健,邱家学.合同研究组织的现状和未来[J].药学进展,2007,31(2):86-90
[12]唐玲,晁阳.探析CRO在我国的发展前景[J].中国药业,2006,15(3):16-17
[13]廖子兵.制药行业国内CRO的战略管理研究[D].天津大学硕士学位论文,2004:12-14,17,26-27
[14]李军.我国新药合同研究组织(CRO)发展战略研究[D].天津大学硕士学位论文,2006:2-3,7-9,31-34
[15]美国联邦法规(2006版)第21篇第1章第312.3部分(21 CFR Ch.Ⅰ.§312.3)[EB/OL].http://edocket.access.gpo.gov/cfr_2006/aprqtr/pdf/21cfr312.6.pdf
[16]国家食品药品监督管理局.药物临床试验质量管理规范[S].2003
[17]李中华.中国CRO的现状及所面临的挑战[J].中国医药技术经济与管理,2008,2(1):43-46
[18]John Allinson,Steve Brooks.Biomarkers in drug development-a CRO perspective[J].Current Separations,2004,21(1):15-19
[19]左丽华.基于COR模式的制药企业产品开发研究[D].天津大学硕士学位论文,2004:7,34
[20]Getz Kenneth A..CRO shifts in the Outsourcing Market[J].Applied Clinical Trials,2007,16(5):35-38
[21]Covance:2007 Annual Report[R].http://ir.covance.corn/phoenix.zhtml
[22]Pharmaceutical Product Development:2007 Annual Report[R].http://www.ppdi.com/events_speakers/presentations/
[23]Charles River Lab:2007 Annual Report[R].www.criver.com
[24]MDS:2007 Annual Report[R].http://www.mdsintl.com/investors/index.asp
[25]Parexel:2007 Annual Report[R].http://investor.parexel.com/phoenix.zhtml
[26]倪静云,卞鹰,王一涛.国内外CRO发展现状的比较分析[J].科技进步与对策,2007,24(4):199-200
[27]綦开军.产学研合作交易费用理论研究[J].商业时代.理论,2005,20:17-18
[28]王立明,刘丽文.外包的起源、发展及研究现状综述[J].科学学与科学技术管理,2007,3:151-156
[29]吴宗颐.CRO——制药业外包研究[D].沈阳药科大学硕士学位论文,2004:9-16
[30]安景玲,齐二石,李中阳,等.基于资源与能力的竞争力理论研究综述[J].天津大学学报(社会科学版),2003,5(4):338
[31]Barney Jay B..Firm resources and sustained competitive advantage[J].Advances in Strategic Management,2000,17:203-227
[32]魏洁.外包使医药企业获得竞争新优势[J].上海医药,2004,25(9):402-403
[33]Gwynne Peter.Specialist CROs aid pharmas with better R&D efficiency[J].Drug Discovery &Development,2002,5(9):81-83
[34]陈洁.药物经济学[M].第1版.北京:人民卫生出版社,2006:202
[35]Sollecito William A.,Kaluzny Arnold D..Continuous quality improvement in contract research organizations-the customer focus[J].Quality Management in Health Care,1999,7(3):7-21
[36]童利忠,丁胜利,马继征.企业核心竞争力新论——理论与案例[M].第1版.北京:人民邮电出版社,2006:189-190
[37]魏颖,毛军文,易凌.药研机构核心竞争力评价指标体系研究[J].中国药房,2008,19(7):484-485
[38]贺红燕,朱军勇,许丽红,等.供应商选择方法综述[J].河北工业科技,2005,22(5):308-310
[39]杨土保.现代卫生管理学[M].第1版.北京:化学工业出版社,2006:287-288
[40]吴祈宗.运筹学与最优方法[M].第1版.北京:机械工业出版社,2003:230-249
[41]吴贵生.技术创新管理[M].第1版.北京:清华大学出版社,2000.63
[42]Things to consider when selecting a CRO[EB/OL].www.promedica-intl.com/SELECTING%20A%20CRO%20and%20CHECKLIST.pdf
[43]安德鲁·克里斯,马丁·费伊.服务共享[M].郭蓓译.北京:中国人民大学出版社,2005:98-101
[44]吴宗颐.制药企业如何利用CRO提高竞争力[J].中国药业,2004,13(6):18-19
[45]Hindin Toby Jane.Looking back,moving forward:a CRO retrospective[J].Applied Clinical Trials,2004,Supplement:9-18
[2]李娜,诸黎星,邹栩.1996年～2005年全球上市新药研发趋势及分析[J].药学进展,2007,31(5):228
[3]国际制药行业发展态势:外包转移[EB/OL].上海情报服务平台.2006-08-14
[4]王静波.全球合同研发外包服务业发展动态与趋势[EB/OL].http://www.tigermed.net/zxDetails.asp?newsid=564.2006-09-06
[5]Vogel John R.,Getz Kenneth A..Successful outsourcing:tracking the evolving use of full-service and niche-service CROs[J].Applied Clinical Trials,2005,14(6):54-60
[6]Schaub Wolfgang.Searching for a CRO-can the intemet help[J].Applied Clinical Trials,2003,12(4):45-48
[7]Joseph Jamila.Entering the contract research industry in India[J].Contemporary Clinical Trials,2008,29(3):311-313
[8]Boericke Kim M..What is the role of the project management in a contract research organization[EB/OL].www.socra.org/pdf/200311_RoleOfProjMgrCRO.pdf
[9]Shuchman Miriam.Commercializing clinical trials-risks and benefits of the CRO boom[J].New England Journal of Medicine,2007,357(14):1365-1368
[10]谢琪,黄卫平,崔天红.浅谈合同研究组织对我国制药业的作用[J].中国中医药信息杂志,2004,11(5):377-378
[11]赵健,邱家学.合同研究组织的现状和未来[J].药学进展,2007,31(2):86-90
[12]唐玲,晁阳.探析CRO在我国的发展前景[J].中国药业,2006,15(3):16-17
[13]廖子兵.制药行业国内CRO的战略管理研究[D].天津大学硕士学位论文,2004:12-14,17,26-27
[14]李军.我国新药合同研究组织(CRO)发展战略研究[D].天津大学硕士学位论文,2006:2-3,7-9,31-34
[15]美国联邦法规(2006版)第21篇第1章第312.3部分(21 CFR Ch.Ⅰ.§312.3)[EB/OL].http://edocket.access.gpo.gov/cfr_2006/aprqtr/pdf/21cfr312.6.pdf
[16]国家食品药品监督管理局.药物临床试验质量管理规范[S].2003
[17]李中华.中国CRO的现状及所面临的挑战[J].中国医药技术经济与管理,2008,2(1):43-46
[18]John Allinson,Steve Brooks.Biomarkers in drug development-a CRO perspective[J].Current Separations,2004,21(1):15-19
[19]左丽华.基于COR模式的制药企业产品开发研究[D].天津大学硕士学位论文,2004:7,34
[20]Getz Kenneth A..CRO shifts in the Outsourcing Market[J].Applied Clinical Trials,2007,16(5):35-38
[21]Covance:2007 Annual Report[R].http://ir.covance.corn/phoenix.zhtml
[22]Pharmaceutical Product Development:2007 Annual Report[R].http://www.ppdi.com/events_speakers/presentations/
[23]Charles River Lab:2007 Annual Report[R].www.criver.com
[24]MDS:2007 Annual Report[R].http://www.mdsintl.com/investors/index.asp
[25]Parexel:2007 Annual Report[R].http://investor.parexel.com/phoenix.zhtml
[26]倪静云,卞鹰,王一涛.国内外CRO发展现状的比较分析[J].科技进步与对策,2007,24(4):199-200
[27]綦开军.产学研合作交易费用理论研究[J].商业时代.理论,2005,20:17-18
[28]王立明,刘丽文.外包的起源、发展及研究现状综述[J].科学学与科学技术管理,2007,3:151-156
[29]吴宗颐.CRO——制药业外包研究[D].沈阳药科大学硕士学位论文,2004:9-16
[30]安景玲,齐二石,李中阳,等.基于资源与能力的竞争力理论研究综述[J].天津大学学报(社会科学版),2003,5(4):338
[31]Barney Jay B..Firm resources and sustained competitive advantage[J].Advances in Strategic Management,2000,17:203-227
[32]魏洁.外包使医药企业获得竞争新优势[J].上海医药,2004,25(9):402-403
[33]Gwynne Peter.Specialist CROs aid pharmas with better R&D efficiency[J].Drug Discovery &Development,2002,5(9):81-83
[34]陈洁.药物经济学[M].第1版.北京:人民卫生出版社,2006:202
[35]Sollecito William A.,Kaluzny Arnold D..Continuous quality improvement in contract research organizations-the customer focus[J].Quality Management in Health Care,1999,7(3):7-21
[36]童利忠,丁胜利,马继征.企业核心竞争力新论——理论与案例[M].第1版.北京:人民邮电出版社,2006:189-190
[37]魏颖,毛军文,易凌.药研机构核心竞争力评价指标体系研究[J].中国药房,2008,19(7):484-485
[38]贺红燕,朱军勇,许丽红,等.供应商选择方法综述[J].河北工业科技,2005,22(5):308-310
[39]杨土保.现代卫生管理学[M].第1版.北京:化学工业出版社,2006:287-288
[40]吴祈宗.运筹学与最优方法[M].第1版.北京:机械工业出版社,2003:230-249
[41]吴贵生.技术创新管理[M].第1版.北京:清华大学出版社,2000.63
[42]Things to consider when selecting a CRO[EB/OL].www.promedica-intl.com/SELECTING%20A%20CRO%20and%20CHECKLIST.pdf
[43]安德鲁·克里斯,马丁·费伊.服务共享[M].郭蓓译.北京:中国人民大学出版社,2005:98-101
[44]吴宗颐.制药企业如何利用CRO提高竞争力[J].中国药业,2004,13(6):18-19
[45]Hindin Toby Jane.Looking back,moving forward:a CRO retrospective[J].Applied Clinical Trials,2004,Supplement:9-18