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| Title: | 跨國藥廠臨床研究組織在亞洲營運的成功因素—以臺灣及韓國為例 |
| Authors: | 李宜珊 |
| Contributors: | 李仁芳
李宜珊 |
| Keywords: | 新藥開發
臨床研究
研究委託服務機
臨床研究組織策略
臨床研究中心 |
| Date: | 2010 |
| Issue Date: | 2013-09-02 16:08:14 (UTC+8) |
| Abstract: | 當新藥發展的趨勢顯示不斷增加的研發費用已無法提高新藥上市的速度與品質時，同時日益嚴峻的法規環境，第三世界專利的損失，棘手的醫療市場管理，政府控制日益上升的藥價以及學名藥的競爭因素，讓各大藥廠面無不絞盡腦汁找尋新的新藥開發模式以加速讓新藥在全世界同步上市。
然而新藥開發是一個非常耗費時間與成本卻不得不經歷的過程，而其中尤以臨床研究最為複雜、耗時與耗成本。於是全球化的方向讓各大藥廠開始轉往新興國家進行臨床研究。其原因除了在新興國家有足夠的病人數外，法規環境漸與國際標準接軌，以及如何藉由臨床研究在新興市場的執行，累積新藥開發的能耐，進而發展出本國或區域性疾病需求的藥品，讓需要的病人可早日使用到適當的藥品亦是原因之一。
而新興市場中，其中尤以亞洲市場最看好，因許多亞洲國家在臨床研究的技術上，與病人的人數以及未來市場的潛力上最為看好。而亞洲國家中，近年來由以韓國成長最為顯著，本論文將以一跨國製藥公司內外的角度來探討臺灣與韓國在臨床研究上法規環境面與內在策略與組織發展構面，來瞭解臨床研究組織的成功因素。結果顯示臺灣多年來的法規發展與國家生技政策規劃已使得臺灣在亞洲各國表現傑出。然而韓國在政府的政策推動執行下積極的進行產、官、學跨國合作，其法規的調整速度，以及各醫院臨床研究中心積極的朝世界級的研究中心標準改善的方向，讓韓國成為全球臨床研究成長最快速的國家。而韓國A公司的臨床研究組織也在管理階層支持下，持續展現優秀的執行力，使其成為總公司研發團隊選擇參與國家的首要選擇。
為讓臺灣可持續在全球臨床研究領域扮演重要角色，本研究建議在政策法規方面，可針對全球新藥開發的發展，瞭解成熟之臨床研究環境與國人需求，調整臺灣臨床研究的定位與方向。並成立專責機構，統籌各部會之發展協調，讓政府與民間的投資可以發揮縱效。在政策法規方面，在臨床研究中心方面應持續強化臨床研究的能耐，改善其流程，並藉由各醫院間的聯盟與專業疾病領域專攻的方式，爭取參與早期臨床研究，進而進一步主導藥品開發計畫的進行。在人員培育方面則建議作專業人才需求分析，將臨床研究研究的教育訓練計畫，推廣從大學基礎教育學程開始，同時強化專業認證的重要性。同時負責執行的臨床研究組織策略、是否主動爭取總公司支持、能否快速因應組織轉型營運模式以及人才訓練與培育亦是組織可否成功的關鍵因素。
When the new drug development trend shown that increasing R&D investment can not speed up and enhance the quality for new drug on the market. At the same time, more stringent regulatory environment, patent expiration, medical market management challenges, pricing control by government and generic drug competition also make the international R&D pharmaceutical company think about how to find new development model to speed up the process and enable the drug on global market simultaneously.
Drug development is a complex undertaking, with many steps and hurdles. And Clinical trial is the most complex, time and cost consuming component during this process. Therefore, clinical trial globalization had driven the study placement shifted to emerging countries since they have enough patients pool, their regulatory environment are aligned with international standard, and they would like to nurture their drug development capability through participating global development, so they can start to develop their own drug based on their own country/area need. In addition, how to help patient to access the new drug earlier is one of the factors to drive for the studies conducted in those countries.
Among those emergency countries, Asia countries are more attractive in clinical research area due to their improved infrastructures, abundant patient pool and great market potential. And Korea had become one of the top growing countries for clinical research within Asia countries.
This thesis is to understand the successful factors for a clinical research organization in an international pharmaceutical company in Asia via investigating in the external clinical research environment, and internal R&D strategy and organization construction in Korea and Taiwan. The result shown Taiwan had demonstrated outstanding performance in clinical research development via clear government strategy in biopharmaceutical area and regulatory environment evolving. Korea had surpassed all other Asia countries and become one of the fastest growing countries in the world in clinical research area after their government’s dedicated efforts in fostering regulatory, academic institute, industry collaboration to make rapid regulatory change and their clinical trial center are striving to align with world class clinical research standard. And with the strong support from senior management team in international pharmaceutical company, the local clinical research organization had also become the first choice for its own headquarter R&D team to place the global study in Korea.
"摘要 ..................................................... I
ABSTRACT .................................................IV
致謝詞 ....................................................VI
第壹章 緒論 ................................................1
第一節研究背景與動機..........................................1
第二節研究問題與目的 .........................................6
第三節研究架構與流程 ........................................ 7
第貳章文獻探討 ..............................................9
第一節全球新藥發展趨勢及臨床研究定義.............................9
第二節亞洲國家參與新藥開發的機會與挑戰及選擇新藥發展研
究參與國家的因素 ........................................... 20
第三節跨國藥廠與臨床研究委託公司的策略合作模式....................34
第參章研究方法與架構........................................ 44
第一節研究架構 ............................................ 44
第二節研究方法與流程........................................ 45
第肆章韓國臨床研究組織個案研究.................................46
第一節外在環境 .............................................46
第二節CRO在韓國發展狀況......................................65
第三節內在環境 .............................................68
第伍章臺灣臨床研究組織個案研究.................................90
第一節外在環境 ............................................ 90
第二節CRO在臺灣的發展狀況 .................................. 120
第三節內在環境 ............................................127
第陸章結論與建議............................................135
第一節個案比較 ........................................... 135
第二節結論 ...............................................144
第三節建議 .............................................. 148
參考文獻 .................................................153
中文參考文獻.............................................. 153
英文參考文獻.............................................. 154
網路資料 ................................................ 156 |
| Reference: | 中文參考文獻
吳文俊(2007)，生技代工業經營策略之研究，高雄，國立中山大學高階經營碩士班。
何玉婷(2004)，「勇闖生技路：12家台灣生技產業的明日之星」，台灣，聯經出版公司。
李芝瑩(2010)，「亞洲新藥發展之策略與執行之異同」，RegMed 2011 Vol.3，pp6-8
邱青萸(2005)，「臺灣藥物臨床試驗申請廠商對此環境觀點探討」，台中，臺中健康暨管理學院健康管理研究所碩士論文。
林明定(2004)，台灣生技醫藥產業中國佈局策略之研究，高雄市，國立中山大學國際高階經營管理碩士班。
陳如如(2002)，「展現台灣生技醫藥產業發展整體競爭裡之對策思考與檢討」，財團法人醫藥檢查中心。
趙玲珠(2005)，「臨床試驗委託研究機構競爭策略之探討─ 以國際精鼎科技股份有限公司為例"」，台中，臺中健康暨管理學院健康管理研究所碩士論文。
英文參考文獻
Albert Liou(2009) “The value and challenges of including Asia for global drug development,” presentation slide, PAREXEL APEX International.
Andrew C. Chang(2010), “Regulatory Environment for Clinical Studies in Asia Pacific,” presentation slide, PharmaNet Development Group.
BUSINESS INSIGHTS(2010), "Pharmaceutical R&D Outsourcing Strategies," An analysis of market drivers and resistors, working paper, BUSINESS INSIGHTS.
Clinical Trials (2011), “Asian Clinical Trial Trends by Type of Sponsor, Trial Phase, Disease Area and Country. ,“working paper, CLINICAL TRIAL MAGNIFIER, Vol. 4, pp64-94
Deepa Elizabeth Oommen (2007), “Clinical Research Career Opportunities in Asia,” working paper, pp.58-60
Guilin Huang, Qihong Xu, Li Zang, Laurie A. Halloran, Joan Q. Zhong (2009), ”Conducting Global Clinical Trials in Asia,” working paper, pp.42-46
PhRMA(2010), “Pharmaceutical industry Profile 2010,” working paper, Pharmaceutical Research and Manufacturers of America. Washington, DC.
PhRMA(2010) “Drug Discovery and Development,” RD brochure, Pharmaceutical Research and Manufacturers of America. Washington, DC.
Jessica Liu(2010), “Demystifying the Intricacies of Asian Clinical Trials” Foresight, Vol.3.
Jong Ran Kim, Clin Ops Director (2010), “Clinical Trial Environment in Korea” ICON slide.
Johan PE Karlberg(2011), “Globalization of Industry-Sponsored Clinical Trials and Challenges and Opportunities for Asia,” presentation slide, Clinical Trials Centre, The University of Hong Kong.
Kenneth I Kaitin, Christopher-Paul Milne (2010),“Tufts Center for the Study of Drug Development,” Working paper, Tufts University, Boston
Liebowitz J. and Suen C. Y.(2000), “Developing Knowledge Management Metrics for Measuring Intellectual Capital,” Journal of Intellectual Capital Vol.1 No.1, pp54-67
Min Jung Park, Young-Ok Kim, and Yun-Hong Noh (2011), “CLINICAL TRIALS IN SOUTH KOREA: Becoming a Leader in Asia’s Life Science Arena,” GLOBAL FORUM, Vol.3, pp8-9.
MIN SOO PARK(2010), “HUMAN RESOURCES MANAGEMENT FOR GLOBAL TRIALS CONDUCTED IN ASIA,” DIA(2010) Presentation slide.
Ms Mi-Yang Kim(Sep,2008) “interview,” CoverStory, pp45-46.
Sang-Goo Shin (2008), “status quo of Korea: “Clinical Drug Development,”Working paper, Seoul National University Hospital & School of Medicine,”
Scrip Market Data(2010), "CRO Watch-Global industry-sponsored clinical trials work secured by the world’s major CROs," working paper, Market Data, 16/07/2010, pp28-29
Soon-wook Hong (2010) “The Current Status and Regulations on MRCT in Korea” presentation slide, Pharmaceutical Safety Policy Division Korea Food and Drug Administration
Young Jack Lee(2005), "Clinical Trials in Korea: Why Korea?" working paper, LSK Global Pharma Services.
網路資料
Lee Ji-yoon (2010), “Korea emerging as global drug trial hub,” http://www.asianewsnet.net/home/news.php?id=12175
慧典市場研究報告網 (2010) 「发展的韩国医药市场 CRO市场异军突起」，慧典市場研究報告網，中國大陸，http://news.pharmnet.com.cn/news/2010/06/28/301678.html
百度文庫(2011)，「CRO在全球的发展与在我国的前景」，中國大陸，http://wenku.baidu.com/view/0b394d7e5acfa1c7aa00cc7d.html
吳俊億(2008)，「台灣發展生技產業分析」，MBAtics，台灣，http://www.mbatics.com/2008/04/blog-post_30.html
Pai(2005)，「生技製藥CRO所扮演之角色」，科技產業資訊室，台灣，http://cdnet.stpi.org.tw/techroom/market/bio/bio038.htm
文靜波(2004)，「全球合同研發外包（CRO）服務業發展動態與趨勢」，上海情報服務平台，中國大陸，http://www.istis.sh.cn/list/list.aspx?id=801
統一證券(2002)，「臨床委外服務產業概況，DJ財經知識庫-MoneyDJ理財網」，台灣，http://www.moneydj.com/KMDJ/Report/ReportViewer.aspx?a=26d1df8c-d5ff-4fa5-9b5b-dfe2d0d61685 |
| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
92932924
99 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0092932924 |
| Data Type: | thesis |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
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