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.

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.