根據2009年IMS生物技術開發中心統計，國內藥廠前十大銷售排名均為外商企業，且在健保藥品給付進口外國藥廠的購買金額也高達70%。由此可見外商製藥公司在台灣藥品市場所佔有的舉足輕重地位。而以往有關製藥產業的論文研究中，較多著重於其行銷業務、策略以及研發模式等方面的分析，很少針對製藥公司的知識管理來加以探討。就知識密集的製藥業來說，此為明顯的研究缺口，因此，本研究以製藥產業為主軸，選定在台灣藥品市占率高的外商藥廠為研究對象，探討其知識管理作為，以及知識管理影響因素如何影響知識管理活動。 本研究同時從知識管理影響因素與知識管理活動兩構面來探討我國外商藥廠的知識管理。研究方法上採用多重個案研究法，研究者首先結合研究問題與文獻回顧，結果導出實證研究的觀念性架構，再以此理論觀念模式為主軸進行個案的訪談與資料的收集，實地深入訪談四家我國外商藥廠，瞭解其知識管理影響因素以及知識管理活動主要作為。 本研究所得到的結論如下： 1. 外商藥廠的知識管理目標若越明確、且與人員的工作流程結合度越高，則其知識蓄積活動越容易進行，且知識保護活動也越能確實執行。 2. 外商藥廠會透過企業內部環境的建構，來促進其知識的擴散。 3. 外商藥廠的科技設備若越完備，則其知識蓄積越容易進行，也因而強化了其知識的創造與擴散。 4. 外商藥廠的績效評估制度之設計與衡量指標之搭配，有助於其知識創造及知識擴散的進行。 5. 外商藥廠知識的結構化程度會影響知識蓄積以及擴散方式。知識的結構化程度越高，則越容易透過文件式的蓄積方式、並經由資訊系統來擴散知識；而知識的結構化程度越低，則越容易透過人員式的蓄積方式、並仰賴面對面接觸來擴散知識。 6. 外商藥廠會藉由成功經驗的分享，來創造組織與各部門的知識，也因而促進了知識的擴散。 7. 外商藥廠會藉由師徒制度來擴散經驗型的知識。 8. 外商藥廠會積極主動並重視知識保護的活動，且使之成為日常作業流程的一部分。 本論文最後說明本研究結果在學術上的貢獻，同時對實務研究上與後續研究上提出一些建議。 / According to IMS Health Global Pharma Forecast in 2009, the top ten sales volumes of pharmaceutical enterprises in Taiwan are all international enterprises. Under the National Health Insurance reimbursement, the international enterprises occupy only 30% of all the pharmaceuticals volumes, but occupy up to 70% of all the pharmaceuticals sales, which shows that the international pharmaceutical enterprises play a decisive role in Taiwan pharmaceutical market. Most of the past studies of pharmaceutical industry focus on the aspects of marketing, strategy, and research and development. Few specifically inrestigate the issues of knowledge management and knowledge management influential factors. Consequently, a research gap can be found as pharmaceutical industry in a knowledge-intensive one. This research focuses on the pharmaceutical industry, explores the knowledge management activities of international pharmaceutical enterprise in Taiwan from both the view of knowledge management influential factors and knowledge management activities, and aims to discover the key factors that influence knowledge management. This research adopts four international pharmaceutical enterprises in Taiwan as case studies and conducts interviews with managers to understand knowledge management influential factors and knowledge management activities. By knowing inside information of knowledge management of the four companies, this research can deliver a more practical and well-organized point of view, giving examples and facts to the future implementation of knowledge management for Taiwan pharmaceutical enterprise. The conclusions of this research are as bellow. 1. The clearer of the goal in knowledge management and the stronger of connection to the daily process in the company allow knowledge researving and protection activities implemented. 2. Higher level of organization cooperation and sharing culture leads to higher level of reliance of knowledge among each department, facilitating knowledge to spread more effectively in the company. 3. The completeness of technolocial facilities helps knowledge researving activities more convenient, knowledge creation activities more smoothing , and knowledge difussion activities more efficient. 4. The design of performance appraisal influences the knowledge creation and knowledge difussion activities. 5. The degree of knowledge structure influences the knowledge researving and difussion activities. 6. Sharing the best practice ficilitates knowledge creation and knowledge difussion activities . This method had gradually become a well-known practice in international pharmaceutical enterprise. 7. 「Mentor program」 is an important way to extend experienced knowledge. Each company has different approach to conduct 「Mentor program」. 8. The knowledge protection activity includes intellectual property rights、information system、contracts、data reserved management and data destroyed process, and the degree of compulsory execution is in accordance with the principles of the companies.

新藥研發是台灣生技發展的重點產業。新藥研發一般具有高投資、高風險與研發期長的特性。因此，有些公司會透過多角化的策略來分散風險。不過，在有限的資源與人力下，發展多角化的產品通常是個極具挑戰的任務。因此，本研究針對新藥研發公司，就其採取多角化的動機與策略來加以探討。 此外，在知識經濟的時代，知識已成為企業最重要的資產，如何透過有效的知識管理以提昇組織知識的價值，則是企業所重視的關鍵性議題之一。新藥研發屬知識密集產業，知識管理對於公司相當重要。因此本研究亦從知識特性的觀點（路徑相依度、不確定程度與競爭衝擊程度）來探討其對知識管理的影響。 本研究在方法上採取多重個案研究的方式，透過深入個案訪談與次級資料收集，所得到的結論如下： 1. 台灣新藥研發公司選擇多角化策略的動機相當多元。 2. 台灣新藥研發公司多角化的動機與多角化目標領域之路徑相依度有關。 3. 台灣新藥研發公司多角化目標領域技術知識的路徑相依度與競爭衝擊程度會影響其技術知識吸收的方式。 4. 台灣新藥研發公司多角化目標領域技術知識的路徑相依度會影響其組織設計、分工與人員式知識擴散的對象。 5. 台灣新藥研發公司進行多角化產品研發時，其知識蓄積活動上傾向於採取「機械-整合式」的蓄積方式。 / New drug development industry is one of the key biotech development areas in Taiwan. The nature of new drug development involves high investment, high risk and long development time. As a result, some companies develop diversification as a strategy to reduce the risk. However, the scarcity of resource and manpower makes developing diversified products particularly challenging. This study would focus on why these companies choose diversification strategy and which strategies they develop. Knowledge management is very important for companies in research-intensive industry. This study would also explore how the companies practice knowledge management on its diversified projects. In addition, this study uses technological knowledge characteristics (path dependence, degree of uncertainty, and competitive position) to analyze the effect upon knowledge management process. In this study, multiple case study method to take the way through in-depth case interviews and secondary data collection, the conclusion is as follows: 1.The reasons why new drug development companies in Taiwan underwent diversification vary a lot. 2.Synergy motivation of new drug development companies in Taiwan will affect the path dependence of technological knowledge in target areas for diversification. 3.Path dependence and competitive intensity of technological knowledge in target areas for diversification will affect the way of technical knowledge acquired in Taiwan’s new drug development companies. 4.Path dependence of technological knowledge will affect the organizational design, the division of labor and object of personnel-type knowledge diffusion 5.New drug development companies in Taiwan tend to choose 「Mechanical-Integrated」mode of knowledge Storage when the diversification activities.

本研究旨在如何透過創新的營銷模式，如電子醫藥行銷及電子醫藥平台，來解決跨國製藥廠在台灣面臨的困境。本研究以個案公司為研究對象，透過傳統策略規劃流程來做策略分析、策略擬定及策略執行。策略分析主要在分析內外部環境，外部環境，先透過五力分析來確認製藥產業的吸引力及哪一項競爭力是跨國製藥廠最需重視的，接著討論醫業環境的演變及對傳統營銷模式的衝擊。內部分析，主要針對個案公司做情勢分析，透過個案公司的組織目標、BCG矩陣分析模型、核心競爭力、品牌權益市場調查、高涉入購買決策過程分析、SWOT分析、商業模式和4C（四種交換成本）處分析來判斷情勢。從分析的結果來確認主要問題及機會，然後根據主要問題及機會來擬定相對策略，最後分析執行行動方案的成效來驗證策略的正確性。 / This study explores how the innovative marketing and sales model (such as eDetailing and Physician Digital Platform) can help to overcome the obstacles that international pharmaceutical company has been facing in Taiwan. This research is a case study for an international pharmaceutical company. The study is mainly focused on Taiwan’s pharma division. They study is structured in 3 major sections – strategy analysis, strategy defining and strategy execution. For the analysis, it focuses on analyzing external and internal environment. For the external environment, first apply the 5-force theory to identify the attractiveness of the industry and which competitive forces should be focused on. Then it discusses the evolution of the pharmaceutical industry in Taiwan and how it impacts the traditional sales model. The internal analysis focuses on the case study of the company. Use tools and models such as BCG Matrix, core competency, brand equity market research, buying process, SWOT, business model and 4 Costs model to analyze the studied company’s situation. Through the analysis, identify the key problem and opportunity and make corresponding strategies. At the final section, validate the strategy’s effectiveness through analyzing the execution of the innovative marketing and sales model initiatives.

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

生物科技產業，是一個被預期將於未來使人類在醫學、製藥、材料、糧食乃至於能源、生態等各方面所面臨的問題，獲得重大突破的產業；也是被公認為二十一世紀最具發展潛力的重點產業！世界上各個先進國家莫不競相投入大量資源，積極進行生技產業的培植與發展。研究單位與大專院校，一向被稱為所謂的「知識引擎」。照理說，在良好的智財管理之下，理當成為智慧財產生產之重鎮，並經由技術轉移實際地應用在產業界，協助提昇企業的競爭力，進而強化國家整體的經濟能量。 本研究藉由各方相關之文獻、著作加以分析，先從美國與我國在科技或技術移轉相關法規的介紹，再整理生物技術與生技製藥產業的特性，和我國目前的現況與問題，最後由商品化角度歸納出技術移轉在各階段的組成要素，再參考美國麻省理工學院技術移轉中心實例。與國內產學成功之案例-「寶齡富錦PBF1681專案」及「陽明大學新藥中心」對照，從中比較出國內學校與產業之間的交流，哪一環節出了問題？在探討我國大學生技製藥產學合作機制上，本研究採用的架構主要是從國內外大學負責產學合作單位的「運作流程」開始瞭解在智慧財產權、技術推廣、技術移轉過程與移轉後的回饋監控機制等。 交相比較之後，建議國內大學之技術移轉中心需擬定明瞭易懂之政策 設計簡單易填之表格、重視商品化流程、經驗豐富之授權人才引進、設置「成功故事」區，來激勵想要新創公司之人。另外，也對國內生技製藥產業建議，台灣的切入點以植物藥為迅速且花費少、成功機會高，這是值得投入之領域。而產業之結構也應有所調整，台灣藥廠規模小，無法與國外大廠競爭開發新藥。開發新藥需投入大量時間及金錢，故國外藥廠之產業結構為垂直整合，亦即是將上市前所有試驗及上市後行銷一手包辦。國內藥廠需仿照科技業一般，將整個產業作水平分工，將核心能力保留，其餘皆可外包。這樣不但節省時間，也可減少對不熟悉領域之摸索，由仿製之學名藥廠，走向新藥開發，進而與國外大廠相互抗衡。 / The universities are long taken as the “knowledge engine” for industries. Through a well-designed cooperation or licensing system, that is, the academic-industry liaison, those intellectual property produced from academic researches should be applied in the industry and industrial competency can thus be improved. However, the academic-industry liaison concerning biotechnology and drug in Taiwan is deficient. This thesis compares the cases of “Panion & BF Biotech Inc. PBF1681 Project,” “Research Center for Drug Discovery in National Yang-Ming University” in Taiwan with the Technology Licensing Office (TLO) of MIT in the U.S. Through the comparison, it can be found that techonology transfer office of universities in Taiwan needs to design a more friendly procedesure for licensee applicants and focuses on technology commercialization. Moreover, the pharmaceutical industry needs to invest more in herbal drug development. The industry itself needs corporate reengineering. The structure of the industry should be a horizontal division instead of the vertical integration. They should focus on their core competency and strengthen the mutual cooperation between companies to form a network of efficient production divisions. Key word: academic-industry liaison, biotechnology, drug discovery, pharmaceutical, Technology Licensing Office (TLO)

近年來在相關產業與政府的努力及人才培育之下，我國許多生技研究已有初步的規模且可說是居於亞洲領先地位。然而，這些技術在商品化應用的階段卻一直沒有重大突破與發展，難以將研發成果的實質效益挹注到產業中。研發成果商品化的過程中，必須兼備技術面、法律面、財務面、管理面的考量，面面俱到才能將初萌的技術逐步發展為成熟的商品，進而在市場上獲取實質利潤，再將獲得的資源挹注於研發活動，形成良性循環。 研發成果商品化的策略視產業特性而截然不同，在「生技醫療產業」中，因其具有「受衛生主管機關高度管制」、「商業化認證需時」、「行銷國際化」的特性，在法規面的複雜度較高，且為專案成功與否的關鍵因素之一，進行商品化評估時必須熟悉相關醫藥法規，才能著手為專案發展做正確的規畫 ，極度仰賴「跨領域」、「高度技術」與「熟稔特殊商業技巧」的人才。依各國藥物法規的不同，商品化的開發時程也受此影響，生技製藥產業之技術及研發成果必須將為達到法規規範的要求而必須投入的時間、資金、人力等各項資源納入總體可行性評估之考量依據。。因法規具有地域性，本研究無法齊備全球各國，將以美國及台灣為研究主體，台灣的法規深受世界公認醫藥法規先進的美國影響，熟知美國的法規可以預估台灣法規機構的思路；且美國藥品市場佔全世界最大規模，此外，美國也極有可能成為潛在合作廠商之所在地，因此本研究將比較美國與台灣之醫藥法規，並評估在技術研發的過程中，衛生主管機關之要求對於技術商品化過程中所產生的影響。 明確、具科學性、可預期性的法規環境能降低製藥產業於研發過程中的不確定性，提高廠商投入的意願。衛生醫療政策及藥政管理政策直接影響到醫藥法規的訂立，政府制定的法規將引導產業發展的方向，對於藥品市場有極重要的影響。一個好的政策應該能夠與國家的總體背景相匹配，法規要求應與國家發展程度及國家內需市場成比例。台灣生技製藥產業目前的困境之一，就是國內廠商在開發新藥時，為了符合台灣衛生主管機關訂定的高標準法規必須投入更多的成本，但台灣卻沒有足夠的內需市場得以支撐，造成擁有豐厚資源的國外廠商可以將符合世界（十大先進國）高標準的藥品進入台灣市場，但國內廠商卻無法立足。為解決此困境，台灣廠商一定要設法將業務範圍擴大到外需市場，以獲取足以支持藥物發展所需的資金成本。因此，了解國內、外之藥物相關法規，做出能符合各國法規要求的產品，為踏出國際外銷市場的第一步；此外，各國的智財法以及與商業相關的法律，還有其之間的互相關聯，都是技術商品化是否能夠成功至為重要的關鍵因素。本文擬就藥物法規面為討論之主軸，其間輔以智財、商業相關構面，對生技製藥產業之技術商品化之過程做一探討。在本研究所選的個案—核子醫學藥物，是眾多創新產品的一種，如果能把握技術、智財、法規、法律、國際商業運作，很有可能為台灣的藥業打開另一片天。 / In recent years, we have already developed some achievements in biotech researches in Taiwan and are in a leading position in Asia under the efforts of government and industries. However, these technologies still are slowly developed to the commercialized phase. Thus, the achievement of these researches does not benefit industry substantially. In the process of commercialization of biotech research, we have to consider all the aspects, including technology and regulation, intellectual property, finance and management. With a well-rounded development plan, technologies in the bud will gradually develop to a mature commodity, and earn fiscal profit in the market. The profit will consequently contribute to research activity. A virtuous circle will be formed. The strategies of commercialization differ considerably among industries. Regarding biopharmaceutical industry which has the properties of highly regulated by competent authorities, time consuming, heavy capital, and global marketing, the regulation assessment is not only complicate but also critical to project implementation. The required documents according by regional authorities will be a decisive factor to consider the development plan including the estimated timetable, needed resources. Due to the regulation system in US affected a lot legislation for laws in Taiwan , America and Taiwan will be the prior topics in this research. A well-developed legal framework and protection of intellectual property rights is the prerequisite for building an ideal environment where the biotechnology and pharmaceutical industries can flourish. In order to improve the environment for these industries, in recent years the government has approved the amendment and execution of related laws and regulations. Amendments have been made to related tax benefit and incentive measures of investment. Other amendments have been made which have allowed R&D results to be more easily transferred to academia and industry. Looking into the future, under the joint cooperation of industry, academia and research institutes, and with the government’s policy to fully promote the sector, it is believed that Taiwan will have well developed in the near future.

二十一世紀是知識經濟的時代，傳統製造業所看重的有形資本已不足以維持企業優勢，無形的智慧資本在新型態的企業競爭中所扮演的角色日顯重要。各行各業都有無形資產，種類性質因產業而異，傳統製造業重視營業秘密、商譽，高科技產業的專利則是公司競爭力的核心，而屬於知識高度密集產業的生技產業更需要重視智慧資本的管理。生技產業的結構複雜，價值鏈長、分工專業、產品開發期漫長，在產品成功上市之前的開發時期中，公司資產多屬於無形的智慧資本，無法從傳統的財務報表觀察其真正的企業價值。相較於其他產業，生技公司更必須訴求於正確的無形資產管理方式，方能成功兌現其智慧資本。 本研究先藉由文獻回顧統整台灣生技產業的相關現況、過去相關智慧資本管理研究以及研發管理等議題，歸納出一般性共識與管理原則。接著依循這些重點，訪談三家台灣生技公司的經理人，包括台灣微脂體、中裕新藥與因華生技，深入了解台灣產業經營實務與現況，探討其智慧資本中的人力、組織與關係資本在個案公司內的蓄積方式，從研發管理模式、組織制度設計與智財管理等面向進行綜合比較。 本研究認為研發能量與知識管理在組織制度中的蓄積，是台灣業界經營管理上常見的盲點，台灣生技新藥業者多重視新技術的研發，普遍對智慧資本其他面向的重視程度不高，但對生技產業而言，扣除資金與技術後，公司的長期競爭力往往都是在組織發展的過程中累積而來的，忽視知識管理與組織制度的養成，對於企業長久發展有關鍵性的負面影響。研究中的個案最終都必須往累積組織資本的方向邁進，若不針對組織資本的蓄積設計恰當的管理方法，為研發人才設計合適的制度與生涯發展管道，將研發團隊的知識能量內化為企業自有資產，只期望以短期的數據績效取得資金支持，忽視智慧資本的管理與培養，並非生技產業長久經營之道。建議生技公司除了聘僱專業經理人處理資金與股東的關係外，也要重視研發長與策略長在組織中的地位，大膽給予權利，調整組織的運作模式，設計出能累積公司能量的專案管理流程，才是生技公司創造競爭力之本。 / In the era of knowledge-based economy, the tangible assets highly-valued by traditional manufacturing industry is no more enough solely to maintain industrial competency. Intangible intellectual assets become more and more important in modern commercial competitions. The intangible assets exist and vary according to different industries. Traditional manufacturing industry looks highly upon trade secrets and brand reputation while patent is the core competency to high-tech companies. Biotech industry belongs to a high knowledge-intensive business and should emphasize more on the management of intellectual assets. Biotech industry is characterized of a complicated system, a long value chain, specialized divisions of labor, and a prolonged timeline of product development. The company assets before the successful commercialization of a product are usually intangible intellectual property and a biotech company during this period cannot be accurately evaluated from traditional financial reports. Hence, compared to other business, biotech companies should resort more actively to appropriate intangible intellectual asset management to achieve a successful redemption of its intellectual assets. This thesis will firstly through the literature study depict the current condition of Taiwan biotech industry and important issues on intellectual asset management and R&D management, inducing several principles of management. Further, the study proceeds with the principles induced to examine three new ventures in Taiwan, Taiwan Liposome Company (TLO), TaiMed Biologics, and InnoPharmax. The discussion will elaborate the practice of intellectual asset management of biotech industry in Taiwan, analyzing and comparing the accumulation of human capital, organizational capital, and relationship capital in the three cases. The study proposes that Taiwan biotech companies usually neglect the accumulation and management of R&D capacity and knowledge in the enterprise organization system. The companies in question invest their resources mostly on the development of new technology and less on other intellectual assets. However, in the long run, the competency of a biotech company accumulates while the organization develops, other than the financial capital and technology. The depreciation of knowledge management and organization system will cause fatal influences on the company. The cases in the thesis must eventually develop their own organizational capital. Biotech companies need to devise appropriate management for organizational capital and preferable career paths for researchers and engineers, to internalize the knowledge capacity of the research team into the company assets. It is not beneficial to a biotech company in the long run to expect financial supports with short-termed achievements, instead of the management and cultivation of intellectual assets. It is advised that other than hiring professional manager for investor relations, the biotech company should pay more attention to the function of CRO and CSO in the organization and sufficiently authorize them into full play. It should also focus on the operation of the organization, adjusting and devising program management to accumulate knowledge capacity, to firmly establish the core competency in a biotech company.

專利權具有獨占性，對一國產業發展具有重要影響，為了平衡該權利，各國專利法在給予發明人專利權的同時也加諸某些限制，以我國為例，於專利法第五十七條第一項列舉專利權效力所不及之情形有：(一)為研究、教學或試驗，實施其發明，而無營利行為者。此即所謂之「實驗例外」 (experimental use exception)條款。 實驗例外條款在各國司法實務運作上，最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。因為學名藥廠為了能夠盡早進入市場，不免須在專利期間屆滿前實施原廠專利進行必要之研究、試驗，以符合各國對於藥物上市管理法令之要求。 雖然我國專利法與其他國家一樣也有試驗例外條款，但其中要件嚴格限定為「非營利行為」，從比較法之方式分析，該規定係受美國普通法之影響。美國普通法關於試驗例外係採取嚴格路線，必須行為人之試驗係出於非營利目的，單純追求真相、探求知識理論，或為滿足好奇心，才可主張普通法上之實驗例外，即始係不具營利色彩之公家機關、學術單位從事之試驗，只要背後具有實質的商業目的亦不得主張試驗例外。如此造成要成功適用試驗例外是愈來愈不可能。 國際間對於試驗例外之立法，除美國外，尚存在許多形式值得我國借鏡，以歐洲共同體專利規則草案(Proposal for a Council Regulation on a Community Patent)為例，其區分「私人且非商業性目的之行為」，以及「為試驗目的之行為」，後者要求必須係針對系爭專利技術本身所進行之試驗始非專利權效力所及，若係將該專利技術作為研究工具之用，仍非法之所許。這種區分方法不僅層次分明、無觀念上混淆之虞，判斷上也較具有可預測性。 美國於1984年通過Hatch-Waxman 法案鼓勵學名藥之發展，對於為滿足主管機關關於醫藥品上市要求之試驗，在專利法271(e)(1)明文規定排除在專利權效力之外，即所謂之「Bolar例外」。我國於九十四年二月五日亦增訂藥事法第四十條之二第五項：「新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗」關於Bolar例外之規定。惟或因立法匆促，致法條要件不符合實際狀況，例如限定「申請查驗登記前」之行為，實際上藥廠於提出查驗登記之申請後，往往在主管機關之要求下須進行其他試驗，這些行為均在立法者原欲保護之範圍內，僅因立法用語之不當，造成實務運用之困擾。 筆者最後從法律及商業管理觀點著眼，對國內立法提出下列修法建議，作為本研究之最終成果： 壹、對於專利法第五十七條第一項第一款修法之建議 一、刪除「教學」之行為態樣 二、刪除「而無營利行為」之要件 三、增列關於研究工具之專利則無本條之適用 四、放寬適用範圍為符合主管機關法規要求而實施他人專利亦有實驗例外之適用。 贰、對於藥事法修法之建議 一、刪除「申請查驗登記前」之要件，改以行為目的來限定範圍，即「為通過藥品查驗登記所進行之研究或試驗」，始有本款之適用。 二、明定「物品專利」及「方法專利」均有本條之適用

策略的目的是在特定的競爭環境中，憑藉企業的特質條件為它創造競爭地位或發展的方向，也就是創造具競爭性的差異優勢，使企業得以順利發展和持續成長。在競爭的環境中，組織能耐常會隨著時間經過而演化；演化的方式會隨著技術本身的特性、外部市場競爭強弱、與內部的組織與管理特性的差異，而有所不同。除此之外，體制環境會影響整個產業內的創新速率，因而對廠商的能耐演化造成影響。但是在環境急速變動的情況下，組織能耐要完全由內部產生不但不可能，而且其速度亦嫌過於緩慢，再加上現代企業的專業分工網絡，企業必須與客戶、供應商、甚至競爭同業合作，以獲得相關的資訊與技術；在企業的發展歷程中，如何有效提升內部經營管理及促進組織之間的知識交流與能耐移轉，便成為組織管理的重要課題。 本研究以一家台灣本土醫藥公司，在台灣生技製藥產業的架構下，創業、轉型、成長的發展歷程，仔細描述影響企業發展的關鍵因素 ─ 企業策略轉變、環境變動、能耐演化，以及企業內部管理提升，彼此之間如何相互配適，並塑造出企業的獨特發展路徑；茲藉由個案公司過去的回顧，描繪其成長的軌跡，作為其未來發展路徑的參考。 / Under the favorable government policy support and a well-established regulatory environment, there are more and more new start-up companies established in Taiwan biotechnology and pharmaceutical industry in the past dacade. However, most of the new emerging companies are still facing very difficult situation. New drug discovery is one kind of long-term time-consuming and heavily cash-investment-needed business. Besides, Taiwan is a small market in the world. The market potential can not afford to develop a R&D based local pharmaceutical company. However, biotechnology and pharmaceutical industry is a very diversified and versatile industry. Under such circumstances, how does a biotech and pharmaceutical company make use of the limited resources and scarce capital assets to identify the niche market, create a new business model, develop the corporate competence, and construct the internal operation to strengthen the core business and secure a sustainable growth in the industry? Besides, due to the evolution of the modern tools including genomic science, bioinformatics, high-through-put screening machine, and gene therapy, the speed of new drug discovery becomes much faster and much more efficient, but the product life cycle also becomes much shorter. How does a local company play in such a highly competitive, technically professional, and dramatically changed environment? This study tracks the growth path of a local pharmaceutical company to show how the key factors, which are, environmental uncertainty, the development of core competence in the firm, and the choice of a successful strategy by top management and the organization, can be manipulated in the entrepreneurial firm that grows rapidly and formalizes its structure and internal operation. The growth path of the company in the past years could be interpretated as the mutual interactions (dynamic fit) of those key factors. Evenmore, the interaction consequences influence the strategic intent to confront the changing environment, and facilitate the practice of the law and the establishment of a government policy. Besides, in order to improve the whole healthcare system in certain medical care, the company develops a new operation model to run the specific business. Traditionally, most pharmaceutical companies are pursuing market-oriented product management, instead of sales-oriented business management. Nowadays, most multi-national firms are actively involved in disease management to expand the market share of certain disease. However, how to integrate the healthcare system and strengthen individual disease management under the specific healthcare system has become a new operation model of a pharmaceutical company to a specific market segment. The company has to work together and closely with the stakeholders, such as health authorities, medical societies, patient associations, healthcare personnel, and the patients themselves to improve the whole healthcare system and even the policy of the law, regulatory, social, and welfare system in the specific medical care, as well.