在生技服務產業中，臨床試驗服務業(CRO)為收益最佳且最具發展價值的項目，2009年全球CRO總營收中，臨床試驗服務業營收就約占總營收的一半，加上近來全球各國開始加速醫藥產業的發展，國際藥廠也逐漸加重臨床試驗外包比例，整體全球臨床試驗服務產業需求大增。 台灣自1997年起，本土企業就開始努力耕耘於臨床試驗服務領域，直至今日，已累積許多成功的經驗與案例，然而在面對國際大廠寡占市場，以及亞洲新興國家CRO企業如雨後春筍般盛出的環境下，台灣CRO企業於發展上仍飽受壓力，不過，這些在多年的經營下，事實上也已累積了相當的能力，若能針對自身核心能耐進行統整分析、經營及拓展，相信仍將有辦法面對全球之競爭環境。此外，由於臨床試驗服務業屬知識密集之服務性產業，經驗累積、專業性及外部關係資產等智慧資本皆較有形資本更能代表企業所具之價值，因此，本研究主要從智慧資本的角度來探討臨床試驗服務企業所具有之核心能耐，並依不同經營時期比較核心能耐之變化，以了解企業所具有之競爭優勢及優勢變化。一方面期望透過本論文之架構，提供企業有關自身核心能耐之分析方式的參考，協助其進行自我核心能耐之統整分析，另一方面，也期望藉由本論文之CRO企業核心能耐之個案分析，提供企業在選擇經營或拓展核心能耐時作為參考。 本研究所得到的結論如下： 1. 運用外部關係資本-與其他企業進行聯盟合作，是臨床試驗服務公司用以提升服務能力、擴大服務範圍，及拓展核心能耐的重要方式。 2. 臨床試驗服務公司所具明確的企業價值與文化，有助於其營運上的發展以及獨有特色的創造。 3. 發展較成熟的臨床試驗服務公司會具備涵蓋人力資本、組織結構資本及顧客關係資本之核心能耐，所具備之核心能耐較不易再進行拓展，反之，較新進的臨床試驗服務公司則較易拓展其核心能耐。 4. 臨床試驗服務公司所擁有的「教育」及「品牌」智慧資本，有助於提升公司其他的智慧資本。 5. 我國本土臨床試驗服務公司較重視發展具差異性之核心能耐，而我國外商臨床試驗服務公司則較重視員工專案執行之能力。 關鍵詞：臨床試驗服務產業、CRO、核心能耐、智慧資本 / In the Bio-service Industry, clinical trial service is the most profitable and valuable item. In 2009, the revenue of clinical trial service accounted for about half of the revenue of CRO Industry. Recently, since all the countries in the world are speeding up developing Pharmaceutical Industry and pharmaceutical companies are gradually raising the proportion of clinical trial outsourcing, the demand of clinical trial service are grately increasing. From 1997, Taiwan local companies have been working so hard in the clinical trial service area. Till now, Taiwan local companies have accumulated lots of successful experience. But when facing the oligopoly market of CRO Industry and competition of Asia new CRO companies, Taiwan CRO companies still have big stress on operation. However, since Taiwan CRO companies have had great competence in clinical trial service, we believe that if Taiwan CRO companies can tidy up, analyze and expand their own core competence, the competitive strength of Taiwan CRO companies will get improved to face the global competition. Besides, intellectual capital of CRO companies which are knowledge intensive business services (KIBS) shows real value of the CRO companies. Hence, this study is trying to investigate the core competence of clinical trial service companies from intellectual capital aspect, and also trying to compare the differences of the core competence in the different timing. We hope this study can on the one hand provide CRO companies a way to analyze their core competence, and on the other hand can provide the successful core competence information of the study cases for CRO companies as a reference. There are several conclusions from this study: 1. Using relationship capital-business collaboration is an important way for the clinical trial service companies to improve their service ability, broaden their service area, and develop their core competence. 2. The clear values and culture of clinical trial service companies can help the development and operation of the companies, and create the characteristic of the companies. 3. A mature clinical trial service company has accumulated plentiful core competence in human capital, organizational capital and customer capital, and it’s hard for the company to deepen and broaden its core competence. Relatively, it’s easier for a young clinical trial service company to develop its core competence. 4. The intellectual capital of “Education” and “Brands” of clinical trial service companies can upgrade other intellectual capital of the companies. 5. Taiwan local clinical trial service companies emphasize the core competence with differenciation while foreign clinical trial service companies in Taiwan emphasize good executive ability of the employee. Keywords: Clinical trial services, CRO, Core competence, Intellectual capital

2010 年全球藥品銷售額約8800 億美金，並預估未來五年內，全球藥品市場規模可再成長3000 億美元，龐大的市場吸引許多生技製藥公司積極投入新藥的開發，但是製藥與審批程序日趨複雜，因此新藥上市必須仰賴專業分工。本研究臨床試驗委託研究機構，由於其提供生技製藥業臨床試驗研究支援，可加速新藥上市時程，是新藥開發價值鏈重要環節。 台灣的臨床試驗委託研究機構自 1996 年至今，歷經產業環境從導入期進入成長期之外部環境變化快速，本研究採用個案研究法，以深入訪談、觀察等方式探討企業如何因應外部環境不斷調整策略方向，如何設計價值單元以及具備哪些內部及外部資源優勢，並據此提出未來實務建議。依據本研究提出的三個研究問題，經個案研究結果分析所得結論如下： 一、 台灣臨床試驗委託研究機構產業環境變化，主要來自兩大因素：各國競爭及科技發展、成本考量造成的全球位移趨勢，以及臨床試驗相關法規的變更。因此策略方向初期以國內學名藥業務作為主力，隨著亞太區、生技醫藥技術發展與政府輔導等因素，策略轉向新藥開發臨床試驗的國際案件，並以策略聯盟方式加快開發業務速度。長期策略方向則是持續佈局國際市場並建立新的技術平台。 二、 臨床試驗委託研究機構以九項價值單元組合完成嚴謹的臨床試驗經營流程，包括「業務開發」、「法規諮詢」、「專案管理」、「醫學撰寫」、「臨床監測」、「專業檢驗」、「資料管理」、「統計分析」、「結案報告」。不同階段的臨床試驗程序可能整合在同一價值單元，以創造最終價值。 三、 各項價值單元之內部、外部資源分析結果顯示，臨床試驗委託研究機構歷經產業環境變化與策略調整，累積資源形成現有實體設備、關係、人力與經驗，可提供國際新藥開發臨床試驗案件服務，為企業策略發展基礎。 / In 2010, global pharmaceutical sales is estimated to reach 880 billion US dollars and the market is expected to expand 300 billion US dollars further within 5 years. Such a huge market has attracted many bio-pharmaceutical companies to invest their assets in new drug research and development (ND R&D). However, the procedure of new drug production and application is getting more and more complicated, thus it depends on professional services to assist launching new drugs. A contract research organization, also called a clinical research organization (CRO), is an organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services to speed up launch timeline, and has played an important role in ND R&D value chain. Taiwan CRO industrial environment has went through from introduction period to growing period since 1996. External environment changes rapidly. This study adopts case study method, by in-depth interviews, observation etc. to explore how CRO companies continue to adjust strategy in response to the external environment, how to design value units and what internal and external resource advantages they have. The study also proposes future practice recommendations for CRO companies based on the results. To answer three research questions, the study result is concluded as follows: 1. Taiwan CRO industry environment changes mainly from two factors: one is global displacement trend attributed to international competition, technology and cost. The other is changes in laws and regulations related to clinical trials. Therefore, the initial strategic direction focused on the domestic generic drug business. With the Asia Pacific biotechnology development and government guidance etc., it shifted to new drug international cases and strategic alliances. Long-term strategic direction is to focus on international market and to establish new technology platforms. 2. Taiwan CRO uses 9 value units to constitute whole management process of clinical trials. These value units include: "sales development", "regulatory consulting", "project management", "medical writing", "clinical monitoring", "sample testing", "data management", "statistical analysis" and “final report". Different stages of clinical trial procedures may be integrated in the same value unit, in order to create the ultimate value. 3. All value units’ internal and external resource analysis shows that Taiwan CRO accumulated resources such as physical facilities, relationships, human resources and experiences through industrial environment changes and strategy adjustment. These resources enable Taiwan CRO to provide new drug development services for international cases and this ability eventually became the foundation of corporate strategy.

昂貴的藥物研發成本，促使製藥生技產業的委外營運模式，以合約方式提供在藥物研發過程中專業化服務的產業，而近年來由於委外研發服務的高效率，已明顯縮短了新藥開發的時程；同時，在全球醫藥研發服務產業的市場中，約有超過七成的收益來自於臨床試驗服務；由此顯見醫藥研發服務產業中的臨床試驗部分的重要性。 醫藥研發服務是個高度國際性競爭的產業，如何找到發展的核心利基以突破重圍，是許多後進企業或國家所必需面對的嚴峻考驗。因此，本研究主要描述台灣目前的醫藥研發服務產業以及臨床試驗產業發展概況，並探討台灣是否具備發展臨床試驗產業的實力。透過本研究，希望對於台灣發展臨床試驗產業，或是推動台灣成為亞太臨床試驗中心，都能提供作為規劃與執行時的參考資訊。 本研究重要結論與建議如下： 1. 以新藥研發價值鏈而言，台灣目前在每一個階段的工作均已佈局，其中又以臨床試驗階段最有潛力加入國際的競爭市場；長期而言，為追求醫藥產業最大的經濟效益，應強化國內的基礎研發工作，進而刺激與培養國內醫藥研發服務產業的能量。 2. 產業政策的落實不能只談邏輯架構或觀念，應該設定明確的推動方案、目標與達成時間表，要推動產業必須貫徹以管理的觀念；同時也應加速業者與官方之間的溝通協調，其中包括藥政主管單位對於產業發展應由被動轉為積極主動的角色，另外，政府部門跨部會的整合也是相當重要的。 3. 國內的全民健保制度涵蓋了所有醫療資源的運用，而健保制度的設計缺乏鼓勵預防與醫藥研發的投入的機制。因此建議應深入分析與探討健保對於產業的影響，進而能以更積極正面的態度促進製藥生技或醫藥研發服務產業的發展。 4. 建議國內可以由政府與製藥產業界共同出資，成立具有公信力且目標明確的教育訓練組織，提供以實務為導向且有系統的在職教育，用以規劃與培植國家未來所需要的專業臨床試驗人才。 5. 建議國內應就醫療院所執行臨床試驗相關作業訂定管理原則，包括臨床試驗贊助款的管理與運用規範、相關執行人員的權利義務等，藉由透明化的標準與明確的獎勵制度，提高醫師與醫院參與臨床試驗的動機；同時也應鼓勵醫院設立專責的臨床試驗辦公室，執行各項協調、整合與管理的工作，並促進與產業界間的互動。 / The cost of drug research and development has soared during the past years. And this compels pharmaceutical and biotechnology companies to look for new, smarter ways of running their businesses. One of their strategies is trying to accelerate drug development by outsourcing. The size of the outsourcing market for Contract Research Organizations (CROs) is rising. Clinical-trial operations hold over 70% of the revenue in the CRO industry. Competition in the CRO industry is extremely international in scope. The key issues for the catching-up company or country is to find their own niche. This study goes on to identify and profile the development of clinical trials and the CRO industry in Taiwan. It also seeks to identify ways of showcasing Taiwan as an Asia-Pacific Clinical Trail Service Center. There are several conclusions from this study: 1. In the value chain of new drug discovery and development, the current status in Taiwan has the potential to join the international market by conducting the clinical trials. In the long term, we should consolidate our basic medical research to pursue the maximum benefit of biotechnology and pharmaceutical industry, and then to enhance the capability of CRO in Taiwan. 2. The policy for improving industry must be set up after the explicit acting plans, goals and time schedule. It should go through with management, not just a structure or concept. We have to hasten the communication between industry and government. The medical legal authorities need to be more active. Ultimate integration of the functions of the related government departments is exceedingly important. 3. The National Health Insurance (NHI) system covers all of the medical resources in Taiwan, but it lack for the incentive to encourage the medical research. It is recommended that NHI Program should probe into the impact of the biotechnology and pharmaceutical industry, and then try to revise it with more positive thinking. 4. It is very important for Taiwan to improve the professional in clinical trials. Setting up a training center funded by both government and industries is strongly recommended. The organization will have the definite goals and accountability, and provide practical training and systematic continuing education. 5. We need more regulating operations of clinical trials of hospitals in Taiwan. These operations should include the usage of the fees from sponsors, and the rights and responsibilities of all staff. We should set up a transparent standard and obviously encourage a mechanism to enhance the motivation of physicians and hospitals to participate in clinical trials. Hospitals should be encouraged to establish an independent office for clinical trials to perform all the details. This office will promote the interaction within the industries.

國際經濟環境的變遷脈動與發展趨勢，牽動我國產業未來發展方向，在全球產業環境日益變遷下，台灣未來將朝「製造業服務化、服務業科技化與國際化、傳產業特色化」之「三業四化」產業策略來發展，其中在「製造業服務化」，則以產品為中心的製造轉為以服務為中心導向的思考模式，製造業者不再只是單一產品供應者，而是提供一系列滿足客戶需求的服務，透過服務來凸顯產品差異化，進而增加客戶的黏密度，創造更高的附加價值。製造業服務化就是製造業為了獲取競爭優勢，將價值鏈由以製造為中心向以服務為中心轉變。 面對愈來愈多企業重視「服務化」的議題，台灣製造業也應改變經營策略，從產品製造導向轉變為服務導向，才能在激烈的全球化競爭中永續生存。趕上產業升級轉型的世界潮流，台灣已有不少成功執行製造業服務化的業者，在高科技產業中最為成功的案例，就是從10幾年前就力行服務化的台積電。而製藥業中，葡萄王生技從傳統製藥業，一路走向生機飲料生產到成為生物科技公司，也是非常成功的例子。再看傳統工業製造中，素有扣件王國之稱的台灣，在握有全球龐大扣件市場之後，更有多家公司積極轉型為服務業，成功跨入醫療器材產業。 本論文以T藥廠為例，分析從傳統學名藥製造廠，經歷了毛利下降導致虧損的改組轉型，初步降低成本，對藥證、客戶、業務員、工廠原物料、包材去蕪存菁留存重點，轉虧為盈，進一步朝服務化轉型，建立品牌學名藥、強化研發實力、拓展各項專注領域、人文與科技平衡、開創國際化新局，成就穩定的營收金流，現今以落實藥品劑型便民化、藥品便民包裝、製造搭配業務、行銷、跟診服務、專業代工接單製造、In-licensing & out-licensing、建立大客戶關係管理體系提供客戶全面解決方案及產業一條龍的再造：研發、製造、銷售、服務的服務化作為，未來進一步全面轉型製造業服務化的願景為佈局全球市場，包含製造國內自營或外銷產品、代理國外藥品進口或出口、接單國際藥廠委製訂單，同時朝新藥研發邁進，以T藥廠既有強項著手新劑型平台藥品開發、新覆方藥品開發及臨床試驗、新療效適應症臨床試驗查登等，最終朝新成分新藥開發邁進，成為一全球性大藥廠。

本研究之目的在探討台灣生技產業科技政策推動過程中所引發之爭議：臨床試驗(clinical trials)產業化，並以台灣地區自1960年代末期至2010年臨床試驗發展的制度變遷為研究標的，尤其是其中之生技產業政策推動及臨床試驗制度變遷，以說明該爭議如何發生及為何發生。 為發展台灣生物技術產業，行政院於2005年起推動生醫科技島(biomedical technology island)計畫，將原先為生物技術產業發展基礎設施的臨床試驗作為政策推動的主體，引發臨床試驗產業化的爭議。一般認為，此爭議是來自於促進產業發展與維護國民健康之間的利益衝突。 本研究經由制度變遷(institutional change)的觀點，探索台灣地區臨床試驗發展的歷程，認為上述臨床試驗產業化的爭議不只是產業推動與國民健康間的衝突，而是與台灣地區自1960年代末期至2010年生技產業政策推動與臨床試驗制度變遷有關。 台灣地區推動生物技術的科技政策始於1982年行政院修訂「科學技術發展方案(science technology development program」，明訂生物技術為八大重點科技之一，而後有1995年的行政院「加強生物技術產業推動方案(biotechnology industry promotion program」，2005年的行政院「生醫科技島計畫」等科技政策，本研究發現不同時期的科技政策賦予臨床試驗不同的意義，而不同時期臨床試驗的發展，其不同時期的行動者【產、官、學、研、醫】-- 包含政策決策者與政策參與者 -- 在臨床試驗制度變遷的過程中產生行動的差異；而在不同時期臨床試驗的發展階段，不同的官方行動者 -- 治理機構（governance agency）【衛生署、國科會、經濟部、科技顧問組等】，對於臨床試驗議題有不同程度的涉入。 台灣地區臨床試驗的發展在生技產業政策的型塑下，由原先之學術研究，階段性轉向協助產業發展。2005年行政院生醫科技島計畫，將臨床試驗作為政策推動的主體，擴大醫界參與生物技術產業發展，而醫界主要以醫療服務為主的制度邏輯（institutional logics）與科技政策形塑下產業發展的制度邏輯不一致（contradictions），因而引發臨床試驗產業化的爭議。 本研究發現對於科技政策的意涵為：在制訂與推動科技政策的過程中，唯有同時瞭解產業發展的歷史脈絡，才能避免產生非預期的結果（例如爭議）。本研究除探討生技產業政策推動過程中臨床試驗的制度變遷與變遷過程中所衍生的爭議，並將探討未來可能的研究方向。 / The study is intended to explore a controversy derived from the Taiwan biotechnology industry promotion by government policies, industrialization of clinical trials. The study targets the institutional change of the clinical trials and the policies for biotechnology industry promotion in Taiwan from the late 1960’s through 2010 to explain why and how the controversy was incurred. In order to develop the Taiwan biotechnology industry, the Executive Yuan implemented a Biomedical Technology Island program beginning 2005 to focus on clinical trials -- supposedly the infrastructure of biotechnology technology development -- but resulted in the controversy about the initiative of industrialization of clinical trials. It is reputedly because there is a conflict of interest between industry development promotion and how to maintain national healthcare. From the perspective of institutional change, the study explores the evolution of clinical trials in Taiwan, holding that the aforementioned controversy is not only a conflict of interest between industry development promotion and how to maintain national healthcare but also a consequence of the institutional change of the clinical trials and biotechnology promotion by government policies from the late 1960’s through 2010. The biotechnology industry promotion in Taiwan began with the Executive Yuan’s revision of its Science Technology Development program in 1982, designating the biotechnology as one of the eight strategic industries. The Executive Yuan followed through with a Biotechnology Industry Promotion program in 1995 and the Biomedical Technology Island program in 2005. The study finds that science and technology policies in different periods of time endowed clinical trials with different meanings while discrepant actions on clinical trials were taken by both policy makers and policy executors including the industry, government organizations, academia, research institutes and the medical community in different periods of time. The study also finds that different governance agencies, such as the Department of Health, Ministry of Economic Affairs, National Science Council as well as Science and Technology Advisory Group of the Executive Yuan, had different levels of involvement with the development of clinical trials in different periods of time. Molded by the government’s biotechnology policies, clinical trials in Taiwan have evolved from the nature of academic research to assistance to industry development. The Biomedical Technology Island program beginning 2005 focuses on clinical trials and strengthens the medical community’s participation in biotechnology development, but the institutional logics of the medical community is primarily about medical service and its contradictions with the institutional logics of biotechnology industry development have resulted in the controversy about industrialization of clinical trials. A science and technology policy implication identified by the study is that unexpected outcomes, such as the controversy dealt with herein, can only be avoided by understanding the historical context of an industry when the government develops and promotes the relevant policies for the industry. Moreover, the study will explore possible research directions in the future.

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.

繼人體基因圖譜於2000年解碼後，基因解讀及研究初期均在競爭解讀基因序列(Gene sequences)，然而了解基因序列是一件事，如何從序列中來了解基因功能所賦予之生理生化意義，比如每段基因所產生之蛋白質產物、及蛋白質與細胞之間的相互關係等資訊，進而應用於藥物標的之尋找，才是未來生物醫學發展之主要方向。同理，藉由基因功能學(Functional Genomics)領域來研究新發現之基因的功能、基因表現、與蛋白質產物，進而辨識有用的藥物標的(Drug target)及尋找新的疾病治療方法，才是基因解讀後最主要之生技醫療市場。全球生物科技之應用中以醫療用的生技產品所帶來的產值最為可觀，佔總體生技產業約七成以上之產值，其中又以重組蛋白藥品、單株抗體、疫苗及檢驗試劑之研發為主要重心，其中行政院更在“加強生物技術產業推動方案”裡，特別將蛋白藥物、抗癌藥物開發及檢驗試劑等領域列為重點推動項目，國內外許多生物科技公司研發專長及主軸亦座落於全球最熱門的生技製藥發展脈絡上。目前由於許多癌症、代謝失常疾病、遺傳性疾病及自體免疫疾病等，臨床之治療藥物仍舊是付之闕如或是供不應求，其中特別是各種癌症以及自體免疫疾病，如類風濕性關節炎、多發性硬化症、牛皮癬及過敏等，都是生技醫藥開發非常重要之疾病研究領域。現今臨床上所常用的藥物，普遍有特異性不佳、副作用大的缺點，因此國內外許多生物科技公司正戮力於針對上述疾病類別找尋合適之生技藥物或是小分子藥物，已達到標的治療(Target therapy)為目的；然而在生技醫藥公司草創初期，大都以技術掛帥，且由於藥品開發時間冗長，因此鮮少有生技醫藥公司能於設立初期10年內有產品上市，因此導致初期營運風險居高不下，令投資者裹足不前，所以如何評估具有成長潛力之生技醫藥公司頗為困難，因此本論文擬從生技藥品著手，除了傳統從技術面、產品面、市場面、競爭者、人力資源、策略經營等構面著手分析成長中之生技醫藥公司外，由於生技醫藥產業之特殊屬性，所以更特別注重產業成長時針對生物倫理面的考量，以做為生技醫藥公司具成長潛力之指標之一。希望透過多元的評估分析，能夠歸納出生技醫藥公司的成功要素，並藉此分析能夠有系統的篩選出具成長性、具社會責任之生技醫藥公司，才能擘畫生技醫藥公司維持長期競爭力、獲得永續發展的遠景，並藉此做為投資者長期投資評估之參考依據。 / The completion of the human genome project is regarded as a turning point in biotechnology and medicine. This project is expected to produce sequence of DNA representing the functional blueprint and evolutionary history of the human species. As we entered the postgenomic era, what we faced is the explosion of new information, which is leading to dramatic changes in the way we are able to study and manipulation of life. At the first few years, many groups were competing in sequence decoding. However, the findings of the functions of genes and the interactions of different gene products are the main issues helping us exploit the new biotechnology markets. Through the research of functional genomics to explore the function, expression, and protein products of novel genes is helpful in identifying new drug targets and developing therapeutic strategies in treating various diseases. This is what we emphasized in biotech market after entering the postgenomic era. The most valuable branch of biotechnology industry is the medical products in global biotechnology market. The medical products take up to 70% of total sales in biotechnology markets. Among the medical biotechnology field, recombinant protein drugs, monoclonal antibodies, vaccines, and detection kits have been focused in pharmaceutical R&D investment. Executive yuan of the Republic of China decided to emphasized in protein drugs, anti-cancer drug development and detection kits in their “ The promotion plan of improving biotechnology industry”. Currently, the drugs against cancers, metabolic diseases, inherited diseases, and autoimmune diseases are still unavailable. Especially the drugs for various cancers, and autoimmune diseases including rheumatoid arthritis, multiple sclerosis, psoriasis, and allergy are under intensive investment in global biotechnology industry. This is because the drugs used today have the deficiencies including low specificity and adverse side effects. Thus, target therapy using monoclonal antibodies and small molecular drugs are the goals for worldwide biotech companies. However, the development in research has been considered as the most important thing in the starting stage of newly founded biotech companies and the long time needed for putting a new drug to market make very few biotech companies have salable products. Thus, the newly biotechnology company has been considered has high risk in the beginning stage. This makes investors to hesitate in putting their money in this field. To evaluate the potential of a new biotechnology companies is difficult since the complex of this industry. This study will try evaluating a newly founded biotechnology company not only through technology, product, market, competitors, human resources, strategies, but also from the consideration in bioethics. Hopefully, through the evaluation of multiple markers, we can conclude the essential factors for a successful company and screen out the company with high growing potential via this study. Finally, this study might serve as a reference for investors in evaluating a promising company for long-term investment.

近年來，病人自主權意識高漲，醫療糾紛頻傳，每個醫師無不戒慎恐懼，而醫療爭議之處理模式與醫師專門職業之道德責任都受到社會高度的檢視及廣泛的討論。事實上，醫學的進步需要依賴不斷地創新與大膽地試驗研究，因此人體試驗相關的問題也受到大眾的關注。 由於人體試驗所面對的是複雜而變化多端的情境，所以參與人體試驗之受試者將會面對甚而遭到危險或傷害。我國人體試驗的相關法規，多散置於醫療法、醫師法、藥事法、藥品優良臨床試驗準則、藥品優良臨床試驗規範等，除了無整體之法規範外，且多為行政法令，在法律位階上均較低，加上衛生署主管機關無法落實對試驗過程中之管理與監控，因此參與人體試驗之受試者往往會受到損害而無法得到應有的保障。因為人體試驗的特殊性與常規醫療是不同的，如果僅由既有的傳統醫療糾紛處理方式，如醫療契約於受試者的關係、侵權行為於違反保護他人法律的標準、醫療倫理不傷害原則於人體試驗規範等，這些恐怕都是必須的，但是仍嫌不足。 本文參考國外人體試驗規範包括紐倫堡法則、赫爾辛基宣言、美國貝爾蒙特報告、美國聯邦法規、CIOMS國際生物醫學研究人體試驗倫理準則、國際醫藥法規協和會之優良人體臨床試驗準則等等，然後針對個別議題如受試者保護之告知後同意，受試者權益之醫療契約關係及侵權行為責任，受試者受傷害之損害賠償責任，作一整理分析與檢討，並進一步配合我國現行法律制度與社會倫理規範做出建議。 本文共分為七章，分別為「序論」、「人體試驗」、「人體試驗告知後同意法則」、「國外人體試驗之民事責任」、「我國人體試驗之民事責任」、「人體試驗之賠償責任及機制」及「結論」。 / In recent years, patients’ consciousness of self-determination has raised and many medical disputes occurred; doctors feel discomfort and developed the high intensity of self-defense. The solution of medical malpractice and professional liability of doctors have became the major public issues and received many discussions. We are quite sure that the medical progress is based on innovative and intensive clinical study on human subjects. Under this background, the topics on human subject research have been attracted more attention than ever. Since the situations in human research are complex and variable. If relative clinical standards and legal protections are not adequately provided, the human subjects involved in clinical researches may face many risks and even injured. In Taiwan, we don’t have a systemic regulations on human subject research, all regulations are distributed in different code, act, proceeding, and agreement. Furthermore, the government does not have enough resource and manpower to monitor or inspect the processes of human research, the issues of protection of human rights and benefits of testee has raised serious concern. The human subject research is not exactly the same as the clinical medical treatment, it’s impossible for legislators or institutions to regulate research through traditional medical regulations such as medical ethics doctor-involved informed consent, medical agreement (contract), tort laws, and compensation for injury. In this thesis, firstly, I reviewed the most important publications related to human subject research include Nuremberg Code, Declaration of Helsinki, USA’s Belmont Report and Code of Federal Regulations, CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and ICH-GCP; secondly, focus on each specific topics especially the value of informed consent, the importance of medical agreement, the liabilities of torts and the policy of compensation for injury. Finally, I’ll make my comments and suggestions to the health care authorities to update and implement new regulating policies to protect human rights of subjects involved in clinical researches. My thesis is restricted to discuss the impact of civil liability on human subjects research focus on drug clinical trial and divided into seven chapters as follows: “Introduction”, “Human subject research”, “Principles of informed consent”, “International liability of civil law on human subject research”, “Liability of Taiwan civil law on human subject research”, “Policy of compensation for injured human research subject” and “Conclusion”.