本論文的研究主題乃是針對生技產業中新藥廠商的獲利模式進行實務研究分析。由於生技產業的特性為研發時間長，且投入研發資金龐大，加上新藥產品線過少，以及營運獲利模式過於單調，如僅以自有專利技術所開發出來的新藥標的對外授權，並取得授權金的獲利模式做為主要獲利來源，如此將大幅提高公司整體的營運風險，也無法有效提升獲利績效。因此本論文研究為如何在原有的獲利模式基礎之上，再增加其他有利於加快授權並收取權利金收入，或者找出多樣化的管道來增加公司的獲利，強化本身的競爭優勢。 本研究分析將針對實務案例公司所處產業現況與特性、及其整體營運狀況、潛在風險及獲利方式做探討。配合外部資料與訪談資料加以歸納整理，並利用SWOT分析各種可能的營運獲利模式，來發掘適合該公司的可行方案。藉由分析結果，本研究提出了三項強化的獲利模式，第一為共同研究開發模式，與國際大藥廠合作，可快速提升營運績效。第二為委託研究開發模式，可帶來更多的獲利機會。第三為向外取得新藥標的再轉授權模式，如此可縮短開發時程，以利增加未來提前再轉授權，並加速收益實現。 本研究期望能提供給生技產業中的新藥公司做為訂定公司中長期策略目標與獲利模式方針的參考。 / The featured company for this research is Case Study Company, which specializes in the research and development of new biotech medications. Case Study Company possesses its own technological platform for the development of new monoclonal antibody (mAb) medicines, and said platform embodies the highest level of fully human mAb technologies available in the field. Due to the company’s characteristics of long R&D periods and substantial investments in research, coupled with the fact that the company has few product lines for new medications and its simple model of profit generation, Case Study Company would stand to face significant operational risks and an inability to effectively improve its performance and earnings. This will continue if it only relies on the licensing out of new drugs that it has developed with its exclusive technologies and banking on the royalties as its primary source of profit. And as such, this research shall attempt to explore other solutions that would accelerate the pace of licensing and the generation of royalties based on the company’s existing business model or to seek other means for the company to boost its earnings more rapidly and effectively. The goal of this research is to enhance the company’s business model and expand the company’s sources of profit so as to achieve profit channel diversification without being confined to specific type or format of profit generation. From the analysis of the primary data (from the interviews) and secondary data, together with the findings, this research proposed three solutions that would help the company to strengthen its business model. First, adopt a joint-development model. Currently, major international pharmaceutical companies are pre-emptively seeking suitable partners for collaboration in the new drug market and with opportunities for advance cooperation; the company will be able to rapidly improve its operational performance. Second, adopt a commissioned-R&D model. A model whereby the company commissions another organization to handle relevant design and development will be able to create more opportunities for profit for the company in question. Third, adopt a re-licensing model by acquiring new target drugs externally and relicensing said drugs to clients. Such a model would help the company to shorten its development lead-time and thereby improve the odds that it will be able to re-license the new drugs at an earlier time. This would accelerate the collection of royalties and profit generation for the company.

生技產業乃高複雜、高風險及高獲利性產業，大部分生技公司目前皆尚處於虧損階段。因此就創投觀點來看，如何避免投資到有可能泡沫化之生技公司，皆需仰賴一套良好之評價模式。 基於本研究是以創投觀點看待投資性，且目標產業是生技產業，本研究建議投資人應該選擇製藥次產業切入投資，並以財務構面作為主決策構面，同時輔以本研究所提出之定量評價因子（銷售成長率、邊際利潤率、盈餘成長率、再投資率、WACC、ROIC）及定性評價因子（研發人員人數、碩博士比例、研發費用、新產品及新發明件數）作為輔助評價。另外，本研究藉由相關文獻及研究方法之探討，建立並確認目標公司相關的評價模式。 依據此評價模式，並考量數據取得難易度及可類比否，故選擇已上市櫃之公司－台灣東洋及濟生化學為樣本分析公司。實證結果顯示，東洋的合理價值區間為每股8.97~30.83元之間；濟生的合理價值區間為每股4.37~24.74元之間。除用股價淨值比計算出濟生之評估價值較實際股價略高以外，其他皆低於實際股價，故本評價模式具實用性。 / What is a biotech company really worth? The question is often faced by corporation, venture capitals, and investors alike who may be putting their capital at risk in a biotechnology company. Unfortunately, there is no definitive answer to the question; no standardized valuation methodology can be applied universally in order to determine investment value. Additionally, there is no method to isolate any specific scenario or state with a reasonable degree of certainty, valuation of a biotech company appears to be a challengeing endeavour. The objectives of the research are to analyze and investigate the value of biotech company from venture capital perspective. From the assessment of the research, an evaluation model to identify any potential investment opportunities in the biotech industry is considered to be effective.

電子高科技產業的全球市場變化快速，產業位移的趨勢已然成形，電子產業已進入成長動力趨緩的階段，且現今台灣電子產業面臨中國經濟趨緩、紅色供應鏈的威脅，使得台灣一直賴以為生的電子產業重挫，大家熟悉的電子產業已經不再亮眼。加上全球人口老化已成趨勢，醫療保健逐漸受到重視，生技醫療產業是目前最具投資價值的產業，由電子產業跨領域至生技，進而建立與醫管服務跨領域互補互利的合作機制，有機會發揮雙向連動國際行銷的效益。 生技產業是一個和電子產業完全不同的產業，電子產業為尋求快速獲利，商業模式就是降低生產成本，生技產業講究的是價值，並非以「量」取勝，價值經營遠大於成本控制。電子產業進入門檻低，產品變化快，電子產品生命週期往往都不到一年，而醫療產品剛好相反，進入門檻高，需要經過很多年的認證，但產品生命週期也很長。生技產業是一個資金、技術、專業相當密集的產業。 轉投資行為是企業在業務拓展或轉型的重要策略之一，轉投資與本業相關或非相關產業，分散經營風險並提升企業競爭力。本研究個案公司所處產業為印刷電路板產業，該產業在電子業中已是成熟產業，且外部環境深受中國紅色供應鏈的進逼，其供應鏈影響層面，不僅僅是台灣與中國大陸之間的問題，全球市場都有被中國大陸取代的威脅。公司在如此嚴峻的經營環境下，雖依然維持獲利，但營收卻無法突破成長，在財務資金方面，因本業成長趨緩，使得資金應用上保守穩健。本研究從產業的經營環境，再透過公司現況SWOT、財務狀況及公司各事業部門成長能力分析後，選擇轉投資電子非相關產業—生技產業。轉投資除了善用財務資源外，也藉由透過進入不同的產業領域，建立新的事業版圖尋求成長機會，使企業績效成長、永續經營下去。

本研究主要目的是驗證台灣生技公司的創新能力對公司績效有無正 面顯著影響，並且與美國市場的結果做比較。希望藉由證明創新能力能對 公司績效有貢獻並能增加有利的投資機會使投資人對此新興產業的公司 更有信心願意投入更多資金，以解決生技公司普遍研發經費和資金不足的 困擾。關於公司績效的衡量指標，我們選取了與市場價值相關的績效指標 Tobin’s q 和以會計帳面盈餘為基礎的績效指標資產報酬率(ROA)；創新能 力則以公司的研發密集度和專利數目作為衡量的代理變數。雖然過去有很 多研究發現企業的創新能力對公司績效有顯著的正面影響，但是關於台灣 市場的相關研究卻很少。本研究針對台灣生技產業探討此結論是否同樣成 立，並與世界生技產業領導地位美國的結果做比較。 研究結果發現：美國生技公司對於研發活動的投入明顯高於台灣的公 司，但是在研究期間台灣生技公司有逐年增加對研發活動之投入的趨勢。 整體來說，創新能力對於公司與市場價值相關的績效指標Tobin’s q 的 影響在美國與台灣市場皆顯著正相關。而研發密集度對於公司以會計盈餘 為基礎的績效指標之影響只在美國是顯著負相關，在台灣的影響不顯著。 專利對於公司會計盈餘為基礎的績效在台灣與美國皆為顯著正相關。 此外，因為每個國家及產業的現況、產業發展的階段、相關的法規不 盡相同，而使得創新能力對公司財務績效的影響效果也有所差異。 雖然對創新的投入可能暫時會對會計盈餘有負面影響，但是創新能力 卻能為公司帶來更多有利的投資機會及提昇公司與市場價值相關的財務 績效。因此台灣投資人不應該短視近利，要對有良好創新能力的公司有信 心進而願意投資更多資金，如此公司募得足夠資金去提升其創新能力後， 將能在市場上更有競爭力轉而回報給投資人更好的報酬。 另一方面政府也應更積極改進和簡化對於這個新興產業和無形資產相 關的法令規章。在健全且有效率的法規環境保護之下，公司將能更順利發 展其創新能力，並能更有效率的將研發結果商品化及上市。如此，台灣生 技產業的競爭力將能逐漸提升。 / The purpose of this study is to prove that firm’s innovation ability has a significantly positive effect on firm’s performance in Taiwan biotechnology and compare the results to those in US biotechnology industry. Through this study, we want to show investors that firm’s innovation ability can contribute to firm’s financial performance and increase profitable investment opportunities. Then investors can be more confident that firm’s innovation ability can contribute to financial performance and bring more profitable investment opportunities. Therefore, investors would be willing to invest more capital in this industry and firms can have enough capital to do R&D and develop innovation abilities. Tobin’s q and ROA are used to represent the market-based performance and accounting-based performance respectively. As for the innovation, we adopt R&D intensity and the number of patents as the proxy variables. Although previous studies prove that innovation has a positive effect on firm’s performance, fewer of them focus on such relationship in Taiwan biotechnology industry. This study fills the gap by providing empirical results to examine if this relationship is held in biotechnology industry in Taiwan. The empirical results show that US biotechnology firms place significantly more emphasis on R&D investment than Taiwan firms do but Taiwan firms tend to invest more and more in R&D during the research period. As a whole, innovation has a significant and positive effect on Tobin’s q in Taiwan and in US, and patent also has significant and positive effect on Tobin’s q in both regions. However, R&D intensity is negatively related to ROA only significant in US. Patent is significantly positive related to ROA in Taiwan and in US. In addition, the impacts of innovation on firm’s performance vary in different countries and industries because of different development stages, degree of competition and related regulations and so on.

生命科學產業常被視作將來的明星產業，亦被選為台灣產業轉型政策中之策略性產業。新創生技公司如何取得成功，是台灣接下來需特別關注的重要議題。 本研究以2015年時新創生技公司中最具代表性的案例－Theranos公司為分析標的。先藉「策略行銷分析4C架構」和「策略形態分析法」分析該公司在危機事件爆發前的策略形貌以及成功關鍵因素。再就危機事件對該公司帶來的影響、其處理方式是否合宜，以及該公司未來可能採取的發展策略進行探討。期望相關研究結果可供台灣的生技公司作為參考借鏡，從中學習應如何訂定公司的發展策略、該投注資源的重點項目為何，並了解在處理危機時應注意那些事項。 結果發現，危機事件爆發前該公司的血液檢驗服務因擁有較低的外顯單位效益成本，而使其整體交易成本應優於同業。整體而言，該公司採取了高度垂直整合的策略，且十分仰賴背書代言效果以及合作關係所帶來的獨特通路。該公司於此時期的關鍵成功因素包括：產業趨勢與市場需求、研發能力、檢驗能力、行銷能力、團隊成員與合作夥伴和資金。危機事件爆發後其檢驗能力、行銷、檢驗通路均受明顯影響，該公司危機處理行動之成效目前尚無法定論，但其聲譽已因溝通行動的缺失而嚴重受損。目前外界仍無法得知部分可能影響該公司未來發展的關鍵因素之相關訊息，依該公司的實際狀況，倒閉清算、限縮業務範圍或持續擴張都是其未來可能的發展。 此案例分析結果可提供台灣新創生技廠商參考學習，除可藉此案例了解技術基礎與行銷活動的重要性外，亦可從中學習到：把握市場機會、運用優勢爭取合作機會、注重行銷的整合性、善用背書效果與媒體、注意法律規範風險、確保關鍵技術的可信度、注意危機溝通，及注意團隊成員選擇...等事項之重要性。 / Life sciences industry has been seen as the star industry in the future and has been selected as the centerpiece of Taiwan's industrial transformation policy. How can a biotechnology startup company develop successful is going to be an important issue we must concern about. In this study, the most representative and controversial case in biotechnology startup companies in 2015 - Theranos, Inc. has been chosen as the research subject. "4C Framework of Strategic Marketing Analysis" and "Strategic Pattern Analysis" are used to analyze the company's strategic pattern and key success factors during the period before the critical incidents happened. The critical incidents' effects upon the company, the appropriateness of its crisis management actions, and its future development strategies are also discussed in this study. The purpose of this study is to provide information for Taiwan's biotechnology companies as a reference for strategy development, resource allocation and crisis management. We found that before the critical incidents happened, the company's blood examination service had lower overall transaction cost due to its lower cost of utility. The company was highly vertically integrated, relied on endorsement effects, and owned unique partnership which contributed to its special distribution channels. In this period of time, its key success factors included: industry trend and market demand, research ability, examination ability, marketing ability, team member and business partner, and finance. After the critical incidents happened, the company's examination ability, marketing activities, and distribution channels have been adversely affected. And although we cannot make a final conclusion about the effects of its crisis management actions now, its deficiencies in communication has already resulted in huge damage to its reputation. Until today, some information about key factors which might affect the company's future development still remains unknown to the public. Depends on the actual status of the company, its possible development strategies include: go bankrupt, narrow down the scope of business, or keep expanding. This case study shows the importance of both technology and marketing in biotechnology companies. And the study results provide some practical suggestions to Taiwan's biotechnology companies, which include: seize the market opportunities, use company's specialty to build up partnership, the importance of integrated marketing, usage of endorsement effect and media, beware of the legal risk, make sure of the reliability of company's key technology, the importance of crisis communication, and the importance of choose the team members.

食品業競爭激烈，眾多業者紛紛進入生技產業，在此歷程中發現擁有充沛的資源並非讓各大食品公司不敗的原因，因此希望可以藉由本研究瞭解食品業者如何適應環境，並發展出新的能力轉向生技領域。 研究目的有三：1.瞭解台灣食品業之廠商，面臨產業環境變化的思考方向，包含轉向動機及轉向策略選擇。2.以「動態能耐」觀點探討台灣「食品業轉向生技產業發展」之廠商轉型之過程。3.歸納「食品業轉向生技產業發展」之轉型歷程，並據以提出相關措施方向建議供產、官、學、研各界參考。 本文以多角化作為轉向之定義，並以Teece et al.（1997）提出之動態能耐架構分析研究個案轉向歷程。研究方式採用個案研究法以及質化研究法，深度訪談味全、黑松、卜蜂和金車四家企業的高階經理人，獲得以下五點結論： 1.食品業轉型至生技產業之動機是具有積極的思考方向，為了為提升企業價值而轉型。且食品業轉向之腳步較為穩健，會先仔細考量市場動向與缺口，再回頭評估自有能耐與方向，決定轉向之領域與方式。 2.食品業轉型至領域類似的食品生技產業，企業選擇的路線較為保守，少有其他領域的拓展。而食品業轉型至農業生技產業，所涉及的領域較廣，也比較勇於嘗試不同類型生技產業。 3.食品業轉向至生技產業之企業重新配置和轉化的動作相當頻繁，可以視情況隨時調整，適應企業及環境需求，具有靈活性及彈性，符合動態能耐之觀點。 4.食品業轉向生技產業時，因為與本業的共通性不多，大多歸類為非相關性多角化。在轉向過程中，原企業僅轉移部分共通的資源至新的企業或事業部門，如：財務性資源與管理能力，其餘資源大多為新企業從頭開始累積。 5.新企業在建構新事業的過程中，大多利用與外界的合作關係，迅速建立企業之能力，亦可快速學習與累積知識。

生技產業為典型的高附加價值、知識導向型產業。由政策面來看，生技產業是我國兩兆雙星計畫中所勾畫出的新興產業之一；近年來，國際間生技產業發展迅速，帶領生技產業走向多元化的發展。然而，我國在這股趨勢洪流中，整體生技產業的發展上並不蓬勃。本研究針對國內從事生物技術研發的重要的研究機構，對於該研究機構在生物技術的智慧財產權保護與技術移轉機制上進行探討，其目的不在於比較各研究機構獲得了多少件專利，技術移轉了多少件項目，而是著重於我國生技產業發展的過程中，產、官、學、研之間的互動及分工關係上的探討。 本研究中的每個研究機構在組織定位、發展歷程、技術類型、組織文化等皆不盡相同，但在我國生技產業發展上皆扮演重要且關鍵角色。希望能藉由個案研究比較分析出各單位在運作機制上的相似處與不同處，更加釐清各研究機構在整個國家創新體系及產業發展的角色與位置。研究目的包括：1. 瞭解研究機構在智慧財產權保護和技術移轉上的運作機制。 2. 探討推動國內生物技術產業發展過程中，研究機構與產業界間連結互動有的關鍵因素。 3. 在研究機構的策略發展和遇到的困難，對於機構內部組織上與政府生技產業政策的推動上給予適當建議。 本研究以研究機構技術移轉單位的『運作流程』、『產研連結』、『技轉策略與個案』三個主要構面來探討我國研究機構在生物技術移轉上的機制。研究方式採用個案研究法以及質化研究法，深度訪談中央研究院、國家衛生研究院、工業技術研究院與生物技術開發中心，四間研究機構的技轉單位主管與技轉專員，獲得以下結論： 1. 技轉單位需要得到機構高層的支持，同時很多重要的技轉案會採跨單位的專案形式為之，整個技轉過程需要跨領域的團隊合作。 2. 在技轉單位內部的運作上，近年開始有將專利業務與技術推廣業務分開之改變，這樣的改變效果短時間還不是很明顯。 3. 專利申請維護的預算也普遍成為技轉單位當下遇到的問題之一。研究機構著重於專利品質，以更貼近產業與市場需求，進而強化技術移轉之成效。 4. 國內在技術移轉後的相互回饋機制略顯不足，仍須再建立更細緻的互動機制來強化後續的技術商品化。 5. 現階段國內生技產業發展不蓬勃，也沒有成功的個案公司，廠商普遍經營困難。研究機構在生物技術移轉會給予比較大的彈性，讓技術繼續開發下去為原則。 6. 技術移轉是相當複雜與專業性高的領域，與市場互動至關密切。而政府在政策上應放在著眼於公平交易與經濟發展方面。現今經濟部已經廢除研發成果『專屬授權』限制的相關規定。然而，在研發成果『境外實施』上的政策法令，仍有許多爭議有待政府重視與鬆綁法令。

近年來，生物技術的快速進步，逐漸被公認為是繼資訊產業之後最具發展潛力的產業。生技產業不同於傳統的製造業或電子產業，前者之進入障礙高、產品研發時程長及研發投入成本高。雖然生技產品開發成功後，投資報酬率高、產品的生命週期長，但由於其研發過程較長，具有相當高的不確定性，加上研發的失敗率高，致使生技產業成為投資風險極高的產業。 生技產業屬於知識密集的知識型產業，其主要價值來自於研發創新的無形資產，而難以傳統的評價方法及標的來估算。因此，探討如何評估生技公司的價值，是本研究之主要目的。 本研究範圍以「生技醫藥產業」為研究重點，生技產業的應用範圍包括醫藥開發、醫療器材、診斷試劑、農業生技、健康食品及生技服務業等領域。醫藥品的開發是生物技術最早應用的領域，目前全球生技產業中，也以生技醫藥領域的市場最大，是目前發展較為成熟且成功的領域。 但因生技醫藥公司之投資的評估考量與傳統評價模式有差異，生技醫藥公司之營運，通常需要先投入數年的研發，開發出具有市場潛力的產品或技術、並取得專利後，再透過授權或合作方式，向有意承接之單位或藥廠收取前期金(up-front payment)或研究經費(research fund)，以及收取各階段的里程金(milestone payment)，待產品成功上市後，生技醫藥公司再依銷售金額，分配到一定比率的授權金。上述的收入或獲利過程，往往長達4到7年，而其收入結構因合作模式的差別而有不同的組合變化。如果依一般公認的會計原則認列損益，將造成公司某一年有一大筆收入，但接下來幾年收入可能都掛零的現象。不但無法反映生技公司的真正營運狀況，亦可能造成投資人或主管單位的誤解，這正是生技公司價值無法依傳統評價模式進行評估的原因。 然而，究竟應該如何對一生技公司進行評價？本研究使用目前最佳的生技公司評價方法：風險調整淨現值法(rNPV)，並以一個案公司為題，探索生技醫藥產業的投資與評價過程。此法的評估結果，對生技公司的現有價值，即使仍在R&D的早期階段，仍能運用於生技公司投資、授權、取得等交易之需要。 關鍵字：生技產業、公司評價、風險調整淨現值、折現率 / Due to the rapid growth of the biotechnology industry, it is now considered the hottest industry after the information technology industry. Unlike the traditional production industry (the labor intensive) or the electronic industry, the biotechnology requires higher R&D costs, and usually the life span of its product lasts longer, which leads to a certain barrier in this particular field. Although the return of investment tends to be profitable if the product succeeds, yet the lengthy R&D process still makes the business highly risky. The innovation of intangible assets is the main value of biotechnology; in other words, this is a knowledge-intensive industry, and it is hard to measure the potential risks and returns through traditional evaluation models. Hence, the main purpose of this study is to evaluate how a biotechnology company is worth. This study will be mainly focus on “Bio-Pharmaceutical”, which includes New Drugs, Medical Devices and Instruments, Diagnostic Reagents and Platforms, Agricultural Biotech, Health Care Products, and Contract Services. A large number of biotechnology companies have viewed pharmaceuticals as their target market since 1997. Cleary, the Bio-Pharmaceutical is regarded as the mainstream of this industry. Owing to the different models of evaluation as mentioned earlier, biotechnology industry is different from the traditional ones. Biotech companies usually need to go through a long-range research process before developing a success product or technique, and they will usually authorize the selling rights to a partner in order to demand the up-front payment, research funds, and the follow up milestone payments. If the product hits the market, the companies will be paid with a certain ratio royalty. The process generally takes about 4 to 7 years, and the revenue varies depending on the partnership. It is possible for a company to have a huge gain in one particular year and then a deficit for the coming years if the financial condition is viewed from the general accepted accounting principles. Not only does it not reflect the real situation of a biotech company, but also misleads investors and regulatory authorities. This is why the value of a biotech company needs to be reconsidered in different ways, not the traditional ones. How, then, can we put a price tag on biotechnology? The best solution is to evaluate a biotechnology by estimating its risk-adjusted net present value (rNPV). To illustrate the rNPV method, the study has created a hypothetical scenario. Through the case study, we have arrived at a realistic value of a bio-company even at early R&D stages. Using the rNPV, researchers and potential investors can price the bio-company that they are considering selling, investing in or acquiring. Keywords：Biotechnology Industry、Evaluation、rNPV、Discount Rate

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.

「雙星產業」其中的一星--生技產業為我國經濟發展很重要的一環，但在投注了大量資源的今日，卻未見明顯成功企業標的。以台灣經營環境而言，企業多半規模不大，在研發起步較晚、創新能力不足的狀態之下，若要與大型廠商競爭是不智的，中小企業發展生技是否有較適宜的發展方向？即使如此，台灣仍有成功商品化且獲益的生技公司出現。因此，本研究藉由個案深入研究，探討台灣生技產業可能的關鍵成功因素，並分析個案公司成功之創新點，進而提出對廠商在發展上的建議。 個案公司--邰港科技由原本經營傳統水族產業而透過生物技術轉型成功，其創新商品螢光魚，正代表著生技產品從技術研發到商品化而後成功進入市場的典範，其成功因素不外乎掌握了現代人的寂寞商機，在研發創新上邰港投入大量研發經費(占營業額6%)，透過與學界合作技術移轉的方式讓研發及技術取得更有效率；在技術方面也掌握到了不孕性處理的先驅以及量產的技術；資源方面由於邰港在水族產業的深耕，能作為其創新價值的後盾。 本研究透過對邰港科技的深入研究後，對於欲轉型或跨入生技業者提出建議如下： 一、 找出與公司既有核心能力相關的發展方向。 二、 積極運用產學合作培植有發展潛力的技術。 三、 發展自有品牌、透過結盟方式加強行銷通道的建構。 四、 採取以小養大、以短養長的模式轉型或發展生技產業較適宜。