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    Title: 台灣臨床試驗服務公司 (CRO) 營運模式之探討- 以藥品研發為例
    A study of business model of contract research organizations in Taiwan: case study on drug development
    Authors: 鍾曉芬
    Jung, Shiau Fen
    Contributors: 溫肇東
    Wen, Chao Tung
    鍾曉芬
    Jung, Shiau Fen
    Keywords: 臨床試驗服務公司
    臨床試驗
    營運模式
    藥物研發
    生物技術
    製藥
    白地策略
    Contract Research Organization
    CRO
    Clinical Trial
    Business Model
    Drug Development
    Biotechnology
    Pharmaceutical
    Seizing the White Space
    Date: 2010
    Issue Date: 2011-09-29 16:55:09 (UTC+8)
    Abstract: 生物醫藥產業對人類健康福祉影響甚鉅，同時也屬於技術、資本密集、開發期長、風險偏高的產業，在新藥開發的歷程中，臨床試驗是開發中藥品自「試驗階段」邁向「市場階段」的絕對關鍵過程，其重要性不言而喻。對藥廠而言，臨床試驗若能有效率地被執行，一方面可縮短試驗時間減少花費；另一方面則是搶得先機佔據市場，及早實現獲利。因應臨床試驗重要且繁複需求的臨床試驗服務公司（Contract Research Organization, CRO）便應蘊而生。

    CRO產業在美國的發展已逾40年，在奠基於過去的競爭基礎之外，其CRO產業已朝向「便利性」與「客製化」等利基市場佈局，以滿足新的顧客價值主張，並創新商業模式，追求新的成長機會。本研究在介紹美國CRO之產業市場營運模式之外，也以個案分析方式，自國內CRO公司與藥廠/生技公司的互動、合作，探討CRO的營運模式是否符合客戶需求，並嘗試以<白地策略>書中四個核心市場要素：顧客價值主張、利潤公式、關鍵流程與關鍵資源，思索CRO公司應如何經營市場白地。希望借鏡國外CRO公司的演進，反饋予國內CRO產業的未來發展及策略調整參考。
    Bio-pharmaceutical industry on human health well-being highly influential, but also a industry of technical, capital intensive, long development periods, and high risk. Among the course of drug development, clinical trials are absolute the key to the process, and advance the development process from the pilot phase to the market phase. For pharmaceutical companies, if the clinical trial can be executed efficiently, they can shorten the test time and spending; seize the market in advance, and reap profits as soon as possible. In response to the important and complex clinical trial requirements, the Contract Research Organization (CRO) prospers and takes advantage of a favorable situation.

    The evolvement of the CRO industry in US is more than 40 years. In the foundation base in the past, the CRO industry has been towards convenience and customization and other niche market distribution, to meet new customer value propositions, innovative business models and pursue new growth opportunities. In this thesis, the author not only introduces the CRO’s business models in US, but also explores the CRO’s business models in Taiwan by way of case studies. Through the interaction and cooperation between domestic pharmaceutical companies and CROs, the author wants to find out if the business models of CROs are in line with customer needs. The author also wants to quest if the CROs can learn how to manage and operate a white space which the CROs hope to seize by way of the book Seizing the White Space lists four fundamental building blocks including customer value proposition, profit formula, key resources, and key processes that make a company business model works. The domestic CROs can adjust their strategy and business model for fitting customer’s value proposition.
    第一章 緒論 1
    第一節 研究動機與目的 1
    第二節 研究架構與研究途徑或研究方法 3
    第二章 臨床試驗的意義與全球執行現況 9
    第一節 臨床試驗的意義與過程 11
    第二節 全球臨床試驗執行現況 21
    第三章 臨床試驗服務產業的發展與營運模式 25
    第一節 定義 25
    第二節 供給與需求間的落差 32
    第三節 產業發展趨勢 38
    第四節 小結 73
    第四章 台灣臨床試驗服務公司個案探討 77
    第五章 綜合討論與主要發現 89
    第一節 綜合討論 89
    第二節 個案研析 96
    第三節 合作模式之探討 103
    第四節 產業環境的比較 105
    第五節 小結 108
    第六章 結論與建議 110
    第一節 結論 110
    第二節 建議 112
    參考文獻 114
    Reference: 一、英文參考資料：
    1. A New Approach to CRO Partnerships, InPharm, June 4, 2009. http://www.inpharm.com
    2. Anderson Brad, CRO Market view, Contract Pharma, March 2008.
    3. Anderson Brad, How We Fail to Use CROs Effectively? Applied Clinical Trials Online, August 1, 2008.
    4. Calaprice-Whitty Denise, The State of Clinical Outsourcing, Applied Clinical Trials Online, March 1, 2010.
    5. Calaprice-Whitty Denise, Mismatched Expectations Between Sponsors and Service Providers, Monitor, February 2009.
    6. Carroll John, CRO：Crowing About Their Growth, Biotechnology Healthcare, December 2005, pp. 46-50.
    7. CRO Management: Why Sponsors Don’t Do a Better Job and What They Can Do About It, Campbell Alliance Group Inc., 2009.
    8. CRO Survey: A Troubled Marriage, ClinPage, April 13, 2007. http://www.clinpage.com/article/
    9. CROs and Clinical Trials: Strategic Partnerships Driving Future Growth, Frost & Sullivan slides, December 4, 2010. http://www.slideshare.net/FrostandSullivan/cros-and-clinical-trials-strategic-partnerships-driving-future-growth
    10. CROs Shift Focus as Drug Industry Adds to Demands, Triangle Business Journal, March 8, 2010.
    11. Daemmarch A. Arthur, A Managerial Perspective on Clinical Trials, Harvard Business Review, July 17, 2009.
    12. Dimasi A. Joseph & Grabowski G. Henry, The Cost of Biopahrmaceutical R&D: Is Biotech Different? Managerial and Decision Economics, 28: 469-479 (2007).
    13. Doyle Eleanore, The Changing Role of CRAs, Applied Clinical Trials Online, November 1, 2008.
    14. Getz A. Kenneth, Vogel R. John, Successful Outsourcing: Tracking Global CRO Usage, Applied Clinical Trials Online, August 17, 2009.
    15. Getz A. Kenneth, Vogel R. John, Successful Outsourcing: Tracking the Evolving Use of Full-Service and Niche-Service CROs, Applied Clinical Trials Online, June 1, 2005.
    16. Getz A. Kenneth, CRO Shifts in the Outsourcing Market, Applied Clinical Trials Online, May 1, 2007.
    17. Getz A. Kenneth & Zuckerman Rachael, Anticipating Structural change in the CRO Market, Contract Pharma, October 2010.
    18. Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008, Cipher Company, April 2008, http://www.cliniminds.com/presentation/GLOBAL%20CRO%20REPORT.pdf.
    19. Greeff Oppel, The Role of CROs in CNS Pre-clinical Development, presentation ppt file. http://www.worldeventsforum.com/addf/presentations/Greef,%20Oppel.pdf. 3/19/2011.
    20. Henderson Lisa, Competitive Pressures for CROs, Applied Clinical Trials Online, November 1, 2010.
    21. Henderson Lisa, CRO and AMC Collaboration, Applied Clinical Trials Online, February 1, 2009.
    22. Henke Frank, Outsourcing the Biotech Trial, Applied Clinical Trials Online, June 1, 2008.
    23. Hindin Jane Toby, Looking Back, Moving Forward: A CRO Retrospective, Applied Clinical Trials Online , August 2, 2004. http://license.icopyright.net, 2010/9/21.
    24. Hintze Todd, Why Life-Science Companies Need to Change How They Outsource to Create Greater Value, Outsourcing Center, Everest Group, December 1, 2007. http://www.outsourcing-cnter.com
    25. Hong Qi, Coughlin M. Margaret, Techniques for Managing Projects Outsourced to Offshore CRO, NESUG 2009.
    26. http://www.hoovers.com/, 2010/9/20。
    27. Industry Standards Research, A CRO’s Project Manager is Often the Key to Successful Business Procurement, Applied Clinical Trials Online, September 1, 2010.
    28. Kreger John, CRO Industry Update, Results from Survey of Pharm and Biotech Sponsors. William Blair & Company, LLC., 312.364.8597. 2006.
    29. Lake Eric, Improve the Business of Science, Applied Clinical Trials Online, October 1, 2010.
    30. Levin David, Why Emerging Pharmas and CROs Need Each Other, Applied Clinical Trials Online, April 1, 2010.
    31. Lipp Elizabeth, CRO Relationships Get More Serious, Genetic Engineering & Biotechnology News, vol. 30, No. 13, July 1, 2010.
    32. Miller George, Relationship Management, Pharmaceutical Formulation & Quality, September 2007. http://www.phamaquality.com/ME2
    33. Miller Jim, Stall Out in R&D Outsourcing, Pharmaceutical Technology, July 2, 2007. http://license.icopyright.net.
    34. Mirowski Philip and Horn Van Robert, The Contract Research Organization and the Commercialization of Scientific Research, Social Studies of Science, 2005; 35; pp. 503-548.
    35. Morrison Trista, New Business Models Offer up More Products, Not Companies, BioWorld Financial Watch, April 12, 2010.
    36. Numerof E. Rita, Morgan Mark, Considerations for Outsourcing, Applied Clinical Trials Online, April 2, 2008.
    37. Nussenblatt B Robert & Meinert L Curtist, The Status of Clinical trials: Cause for Concern, Journal of Translational Medicine, 8:65, 2010.
    38. Overview of clinical Trials, CnterWatch, http://www.centerwatch.com/clinical-trials/overview, 2010/9/17. http://www.centerwatch.com/clinical-trials/overview.aspx. 2010/9/17.
    39. Reese Brenda, RN, Top 5 Partnering Mistakes, Applied Clinical Trials Online, April 1, 2010.
    40. Schwed Joel , Contract Research Organizations Buddy Up with Big Pharma, July 12, 2010. http://www.valueline.com/Stocks/Commentaries/, 3/20/2011.
    41. Shuchman Miriam,Commercializing Clinical Trials- Risks and Benefits of the CRO Boom, The New England Journal of Medicine, p. 1365.
    42. Smyth Michael, The China Experience, Applied Clinical Trials Online, June 1, 2010.
    43. Sponsorship, Authorship, and Accountability, The New England Journal of Medicine, 345: 825-827, September 13, 2001.
    44. Tufts 2010 Outlook，Tufts Center for the Study of Drug Development, Tufts University, p.8. http://csdd.tufts.edu/_documents/www/Outlook2010.pdf.
    45. Twyman Richard, A Brief History of Clinical Trials, The Human Genome, September 22, 2004. http://genome.wellcome.ac.uk
    46. Tyson Gary, Working with CROs, Pharmaceutical Executive, Campbell Alliance, June 2004.
    47. Voisin M. Emmanuelle, Anticipating New Regulatory Hurdles, Applied Clinical Trials Online, May 1, 2004.
    48. Ware Mark, Transactional vs. Strategic Sourcing, Applied Clinical Trials Online, September 1, 2010.
    49. Wechsler Jill, Clinical trials Face New Enforcement Models, Applied Clinical Trials Online, June 1, 2010.
    50. Ylisaari Maria Anne, Developing Successful Partnership With a Clinical CRO, October 2010. http://www.cphi.com/c/document_library/get_file?uuid=9a6eec6c-6a04-4f53-810c-4f2943c6d2b1&groupId=118224. 2010/12/25.
    51. Trends in Asia Clinical Outsourcing, Insights from 2009-10 Industry Survey, PRTM 2010.
    二、 中文參考資料：
    1. 2010生技產業白皮書，經濟部工業局，中華民國99年7月。
    2. Robert S. Kaplan, David P. Norton, Bjarne Rugelsjoen, <善用平衡計分卡- 管理你的企業夥伴>，哈佛商業評論，2010年2月。
    3. 生技中心衍生公司 招標，經濟日報，2010年9月17日。（http://udn.com/NEWS/FINANCE/FIN9/5854519.shtml）
    4. 生技新視野－藥省成本 找上CRO代工，工商時報，2009/12/14。
    5. 百度百科，「合同研究組織」，http://baike.baidu.com/view/491725.htm.
    6. 洪錫娟，台灣發展醫藥研發服務產業之探討-以臨床試驗部分為例，國立政治大學科技管理研究所碩士論文，民國93年。
    7. 馬克強生，白地策略，天下遠見出版股份有限公司，2010年11月初版。
    8. 郭亭玉，<新藥上市前臨床試驗委外市場概況-新藥物開發之流程及全球生技醫藥產業之委外市廠概況>，生醫知識網， 2004/3/25。
    9. 麥克喬治、詹姆斯沃克斯、金柏利華生漢普菲爾，創新者的實踐，美商麥格羅希爾國際股份有限公司台灣分公司，2006年1月初版。
    10. 彭嚴燕，<全球藥品委外代工(CRO)的現況與未來>，科技產業資訊室，2009年10月27日。
    11. 彭嚴燕撰稿，<全球藥品委外代工(CRO)的現況與未來>，市場報導，財團法人國家實驗研究院科技政策研究與資訊中心資訊服務處科技產業資訊室， 2009/10/14。http://cdnet.stpi.org.tw/techroom/market/bio/2009/bio_09_004.htm. 2010/11/21.
    12. 新藥研發費時，CRO趁勢崛起，工商時報，2010年12月27日。
    13. 董珮真，<生技醫藥產業商機龐大，取得國際舞台競技權~ 總論篇：台灣生技醫療產業發展現況>，貿易雜誌電子報，200期，2008年2月1日。http://www.ieatpe.org.tw/magazine/200-1.htm.
    14. 藥物臨床試驗品質管理規範，中國國家食品藥品監督管理局，2003年8月6日。
    15. 藥品非臨床試驗安全性規範第三版(Guideline for the Nonclinical Pharmacology/Toxicology Studies for Medicinal Products Applications), p. 10.
    16. 藥品優良臨床試驗準則。
    Description: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    97932074
    99
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0097932074
    Data Type: thesis
    Appears in Collections:[Executive Master of Business Administration] Theses

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