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.

在各大藥廠明星藥品專利到期、新藥開發數量銳減的當下，全球首例植物新藥MediGene Veregen™ 的核准上市為製藥產業帶來新的希望，雖然製藥價值鏈與商品化模式已為人所熟知，但針對植物新藥特殊性所架構之商品化模式還是一個全新的議題，為了架構一個適合台灣中小型藥廠的植物新藥開發模式，本研究嘗試以技術層面為根基，從法規面、產品面與產業面深入探討MediGene Veregen™ 關鍵的成功因素，從中獲取值得台灣藥廠參考的經驗，同時考量台灣植物新藥開發的大環境限制因素，包括法規與健保，給予台灣藥廠一些植物新藥商品化策略建議。 本研究之架構以實務觀點出發，首先整理參考文獻以探討植物新藥包含的範圍與藥品開發流程，幫助藥廠了解植物新藥商品化需要具備的條件與資訊；接著針對台灣與美國在植物新藥方面審查上市之法規、流程與審核成果進行研究，結果顯示目前台灣有兩種植物新藥審查系統「中藥新藥」與「植物抽取新藥」，對廠商而言並不如美國單一系統來得便利；再者藉由探討植物新藥的價值鏈結構、法規結構、產品結構與產業結構，試圖架構植物新藥商品化模式；接下來以兩家新藥開發廠商為例進行實際個案研究，一家為成功推出植物新藥商品的德國藥廠MediGene AG，一家為台灣藥廠中天生技/合一生技，主要藉由分析MediGene Veregen™ 商品化過程的關鍵成功因素，比較中天生技/合一生技WH-1商品化模式的異同，探討是否有足以借鏡與改進之處。最後，歸納整理上述的研究做出結論，並且對於台灣藥廠提出策略建議，希望能對於台灣新藥開發公司有實質上的幫助。 / While the star drug patents of each big pharmaceutical company are expired one after another and the quantity of their newly developed drugs sharply declines in these years, MediGene Veregen™, the first botanical new drug in the world, enters the market and therefore brings a new hope for the pharmaceutical industry. Although the value chain and the commercialization model of pharmaceutical industry have been known and researched a lot, the specific construction of commercialization model for botanical drugs is still a brand new subject. In older to construct the model that is suitable for Taiwanese middle and small pharmaceutical companies for the process from development to commercialization of botanical new drugs, this research, based on the technical analysis, attempts to discuss the key success factors of MediGene Veregen™ through analyzing the aspects of the laws, regulations, industry and product itself. With the case study about the environmental limited factors of new drug development in Taiwan, including the laws and regulations as well as the health insurance, this research tries to offer Taiwan pharmaceutical companies some strategic suggestions for the development and commercialization of botanical new drugs. The structure of this research is based on the practical viewpoints. First, we reorganize the reference in order to define the scope of botanical new drugs and the processes of drug development. It can help pharmaceutical companies understand the conditions and information needed for botanical new drug commercialization. Then, our studies focus on the laws and regulations in Taiwan and the United States, as well as the application processes and approvals for botanical new drugs. The results show that there are two evaluation systems in Taiwan for botanical new drug applications. For those pharmaceutical companies, the dual system is not as convenient as the sole evaluation system in the States. Furthermore; based on the discussion on the structure of the value chain, laws, regulations, product and industry, this paper makes an attempt to construct a better commercialization model of botanical new drugs. Next, two pharmaceutical companies are chosen as case study in this paper. One is a German pharmaceutical company, MediGene AG, which launched the first botanical new drug. The other is a Taiwan pharmaceutical company, MicroBio Co., Ltd/Oneness Bio-Tech Co., Ltd. By analyzing the key success factors in the commercialization process of MediGene Veregen™ and comparing its commercialization model with MicroBio Co., Ltd/Oneness Bio-Tech Co. WH-1, we try to get any valuable idea and insight. Finally, our conclusion and strategic suggestions may have solid help for Taiwan botanical new drug pharmaceutical companies.

八零年代起，我國政府即對生技新藥產業寄予厚望，為促使生技醫藥產業成為明星產業，行政院也自1982年起，將生物技術列為國內八大重點科技產業之一，並投入相當大的金額補助產業之發展；至今已歷經35年，卻仍僅極少由台灣本土研發之新藥成功上市。 本研究主要採用文獻探討以及個案訪談作為主要的研究方法，先藉由文獻探討建立起論文整體之架構，之後再透過兩間國內本土新藥研發公司的訪談加以實證。本研究探討衛生福利部中央健康保險署現行之藥價政策對於國內本土研發新藥上市策略之影響，以及《全民健康保險藥物給付項目及支付標準》第17-1條實施後，是否有助於國內本土研發新藥上市的問題，進行深入分析與探討。而可得到以下初步之研究結論： 一、我國政府的鼓勵措施對於台灣的新藥發展之影響 我國政府多以科技專案補助臨床試驗的形式協助國產新藥公司研發新藥。 二、比較在台灣及其他國家研發新藥的鼓勵措施 我國與日本政府皆有提供新藥不同形式之新藥相關加成給付；本研究未發現韓國政府有針對新藥提供相關加成給付措施。 三、台灣健保藥價制度與台灣研發的新藥藥價 1.對新藥開發類型之國產新藥公司而言，期望政府在設定參考藥品之藥價時，可以選擇使用參考藥品之初始藥價作為reference price。 2.對新藥開發類型之國產新藥公司而言，期望在選擇參考藥品時，可以鼓勵創新藥理作用之新藥、跳脫侷限治療相同疾病用藥之思維。 3. 對新藥開發類型之國產新藥公司而言，全民健康保險藥物給付項目及支付標準第17-1條規範參考類似藥品之十國藥價不合理，因為若以台灣為第一上市國，則尚未在其他國家取得藥價，此法規自相矛盾。 四、我國藥品政策與台灣研發新藥上市策略 對新藥開發類型之國產新藥公司而言，健保給付國產新藥之藥價無法符合國產新藥公司期望之藥價，國產新藥公司改採取由病患自費購買藥品的方式銷售。 / Since the 1980s, our government has placed great hopes toward the industry of biotech and new drugs in order to take such industry to a booming stage. The Executive Yuan has also listed biotechnology as one of the eight key technological industries in the country since 1982. Furthermore, large amounts of subsidies have aided the development of this industry. This industry has been in development for 35 years, however, very few new drugs developed by domestic pharmaceutical companies have been launched successfully in Taiwan. This study mainly used literature review and case interview as the main research methods. Firstly, the structural development of the thesis was built on reviewing past literature. Then, the empirical study was conducted through interviews with two domestic new drug research and development pharmaceutical companies. This study examined the impact of the current drug pricing policy of the National Health Insurance Administration on the domestic market for research and development of new drugs. Moreover, the effectiveness of implementation of Article 17-1 of the "National Health Insurance Drug Payment Program and Payment Standards" was investigated in relations to the development of domestic new drugs in the country. In-depth analysis was employed to explore and discuss our research. The following preliminary conclusions were obtained: First, the influence of the government's encouragement measures on the development of Taiwan's new drugs was examined. Results revealed that the government have mainly been funding domestic new drug companies to research and develop new drugs through subsidized clinical trials of technological projects. Second, the encouragement measures for developing new drugs in Taiwan and other countries were compared. Results showed that both Taiwan and the Japanese government have been providing new forms of new-drug-related premiums for new drugs. However, in this study, we did not find the Korean government providing relevant premiums measures for new drugs. Third, we explored the drug price system of Taiwan's national health insurance and the prices of new drugs that were developed domestically. We found that 1) for domestic pharmaceutical companies that specializes in developing new drugs, they anticipate the government to use the initial drug prices of the reference drugs as reference prices when setting the prices of reference drugs; 2) for domestic pharmaceutical companies that specializes in developing new drugs, they anticipate the government to encourage innovations of new drugs leading to new pharmacological effects and overcoming the idea of limiting treatment to the same illness or conditions when they are selecting reference drugs; 3) for domestic pharmaceutical companies that specializes in developing new drugs, under Article 17-1 of the "National Health Insurance Drug Payment Program and Payment Standards", the statement that drug prices should be referenced from ten countries is unresonalbe because prices cannot be obtained from other countries if Taiwan is the first country to launch the new drug. Thus, the regulation is contradictory in itself. Fourth, we examined Taiwan’s pharmaceutical policy and the marketing strategy of new drugs developed domestically. Findings showed that for domestic drug companies that specializes in developing new drugs, when the drug payment provided by the national health insurance does not meet the drug prices set by the new drug companies, these companies employ a strategy that the patient pay for the drugs instead of the national insurance system.

在學術領域之中，其過去對於新藥產業的研究大多集中於「新藥發展策略」、「產業環境分析」與「智慧財產權策略」等領域，而探討新藥研發各階段之團隊組成與運作模式的研究仍然極少。 本研究以個案訪談法為主要研究方式，深入探討兩家台灣新藥研發公司（包括基亞生技、台灣微脂體），並以『新藥研發流程』與『技術知識特質』兩個構面來探索其對於『新藥研發專案團隊運作』之影響。 所得到的初步研究發現包括： 1. 新藥研發專案各階段中，技術知識路徑相依程度與技術知識系統複雜程度呈現負相關，當路徑相依程度越高時，系統複雜程度則越低。 2. 新藥研發專案隨著階段的推進，專案團隊的組成與結構也會隨之產生變化，臨床前與臨床試驗皆有不同的團隊組成與結構。 3. 技術知識系統複雜程度會影響新藥研發團隊組成的異質/多元程度：技術知識系統複雜程度越高，其團隊組成的異質/多元程度越高。 4. 技術知識路徑相依程度會影響團隊採取何種團隊運作策略：（1）路徑相依程度愈「高」或是愈「低」，專案團隊會傾向採取「自行發展」的團隊運作模式；（2）路徑相依程度為「中」時，專案團隊會傾向採取先執行「初步研發」活動之後，再與外部廠商進行「合作研發」。 5. 技術知識路徑相依程度會影響新藥研發專案各階段的團隊類型：（1）技術知識路徑相依程度愈低，專案團隊會傾向採用「重量級」、「自主型」的團隊運作模式；（2）技術知識路徑相依程度愈高會傾向採用「功能型」、「輕量級」的團隊運作模式。 6. 技術知識內隱化程度愈高，該專案在團隊運作上愈容易將外部成員視為內部團隊，甚至在團隊組成上直接將外部成員納入內部團隊之中。 7. 在臨床試驗階段，試驗主持人的過往經驗為成功關鍵之一。 8. 新藥研發廠商若擁有先導研發的能力，可以減短研發時程與成本。 / Most of previous the studies on pharmaceutical industry have been focused on the development strategy, environmental analysis and intellectual property. Very few of them emphasize the stage of new drug development concerning the project team management. This study uses technological knowledge characteristics (path dependence, complexity, and explicitness) and drug development process (drug discovery, non-clinical, pre-clinical, and clinical ) to explore the effect upon project team management. The result of this study： 1. In every stage of new drug development, the path dependence and the complexity of technological knowledge have significantly negative correlation. 2. When the new drug development project evolves into the clinical stage, the structure of project team will be different. 3. The complexity of technological knowledge can affect the composition of team members. If the complexity of technological knowledge is higher, the complexity of members is higher. 4. The path dependence of technological knowledge can affect the development strategy. If the path dependence is higher or lower, the team members prefer “inner development”. If the path dependence is medium degree, the team members prefer “primary inner development” and then “cooperative research and development”. 5. The path dependence of technological knowledge can affect the team structure. If the path dependence is higher, the enterprise prefers “Heavyweight team structure” or “Autonomous team structure”. If the path dependence is lower, the enterprise prefers “Lightweight team structure” or “Functional team structure”. 6. If the explicitness of technological knowledge is higher, the enterprise intends to recruit team member from outside. 7. In clinical stage, the practice investigator can be key person of the success. 8. If the enterprise has the ability of “primary inner development”, the time and the cost of the new drug development can be reduced.

在一般定義上，新藥通常指稱「新發明之成分」，也就是所謂專利藥或品牌藥。值得關注的是，1990年代起，歐美傳統製藥公司將新藥研究開發活動委外，或以合作研發方式與小型專業生技公司或學術機構合作，使得全球製藥產業結構走向專業分工，這些小型專業生技公司專注於新藥探索階段及新藥早期開發階段，例如尋找創新的藥物標的、快速自動化篩選先導化合物、進行臨床前研究，本研究將其定義為「生技新藥研發公司」，傳統製藥公司則有機會購買、引進授權或以併購方式取得其先導化合物、候選藥物進行較晚期開發及臨床試驗，最後通過審核許可上市行銷。 智慧財產權策略，實為企業考量其規模大小、技術水準等因素後，所訂定專利權、商標權、營業秘密、著作權四項法定權利「取得」、「授權」、「訴訟」的指導性原則，擬訂合適有效的智慧財產權策略，將有助於排除喜擅模仿的競爭對手、增加營業外收益，及保護企業受到不當攻擊及榨取。 本研究訪談三家我國生技新藥研發公司，首先初步了解其智慧財產權管理概況，並且以較有系統的方式描述出企業策略、智慧財產權策略的形貌，並對企業策略與智慧財產權策略互動進行整理與分析。 事實上，我國新藥研發公司的目標市場大致相當類似，但企業策略則略有差異，主要受到其切入產業價值鏈位置之影響。在企業策略與智慧財產權策略互動方面，早期布局的卡位申請策略，有助於放眼國際成長性市場；不倚靠單一內部來源取得智慧財產權，更能加速整合互補性資源；積極尋求向外授權、不排除權利共享，能使企業有機會爭取短、中期資金收益，幫助企業建立較為穩定的基礎。

新藥研發為一高風險、高報酬的產業，股票或債券投資人通常不願承擔那麼高的風險。本研究利用類似Mortgage Backed Securities的概念，發行RBO（Research Backed Obligation），募集50億美金的Megafunds，投資在200個藥物上。RBO包含了Senior bond、Junior bond，以及Equity三個tranche。Senior與Junior的利率分別為5%與8%，在4年與6年後到期，Equity不發利息或股利，而是於投資期間結束後，領回基金總額扣除Bond後的價值。 本研究使用2003-2011年共5820個新藥臨床實驗結果，依照藥物型式、對應疾病分為59類，將各種藥物於各階段臨床實驗的成功機率帶入模型。每種藥物模擬5000次。最後得到投資各種藥物時，Senior bond與Junior bond的違約機率與違約時的期望損失，以及Equity報酬率的期望值與標準差。 分析模擬的結果，可得到除了其中三種藥物之外，Senior與Junior bond的違約機率皆分別在5 bp與2.5 %以下。至於Equity的部分，除了其中四種藥物的報酬率較低外，多數藥物年化報酬率的期望值在8-16%間、標準差在14-15.5%間。各藥物的風險並不會差太多，然而各種藥物報酬率的期望值彼此間有所差距。故以RBO投資新藥產業時，仍需注意投資的藥物種類。 / Biomedical innovation has become riskier and more difficult to finance with traditional sources such as private and public equity. Here we propose a financial structure called RBO (Research Backed Obligations) which is similar to Mortgage Backed Securities. In RBO structure, a $5 billion ‘Megafunds’ is financed by issuing Senior bonds, Junior bonds, and Equity. Senior bond and Junior bond tranches yield 5% and 8% annually, due within 4 and 6 years, respectively. Equity tranche does not pay any interest and obtain the residual asset after all debt obligations have been satisfied. ‘Megafunds’ will be invested on the 200 biomedical programs at various development stage to reduce the portfolio’s risk. We use the historical clinical trail data of 5820 new drug programs from 2003 to 2011. These drugs are classified into 59 groups by molecular type and disease area. Success rates of each development stage are imported into our simulation model, 5000 simulations for each drug group. The simulation result included the default rate of the Senior bonds and Junior bonds, loss of the bonds when the bonds default, and the expected value and standard deviation of the Equity return. We show that except for 3 drug groups, the default rate of Senior bond and Junior bond are less than 5 bp and 2.5% respectively for all the drugs. The expected return of Equity are between 8-16% of almost all the drug, although 4 drug groups show poorer performance. The standard deviations are between 14-15.5% for all drug groups. Consequently, almost all the drug groups have similar risks, but the expected return of the Equity tranche of these drug groups are quite different.

生技新藥產業是指使用於人類及動植物用之新藥及高風險醫療器材之產業。而生技新藥產業與醫藥產業，在目的上均與人類及動植物用藥或醫療儀器相關；差異之處在於目前的生技醫藥產業相較於20餘年前的醫藥產業，多了生物技術的應用，產業結構由大型藥廠垂直整合演變為非營利組織、生物技術公司、大型藥廠分工的形態。總結來說，生物技術是生技新藥產業的重要組成要素，而生物技術的興起，則改變了過去醫藥產業產品與技術的組成，也改變了產業結構。 生物技術產業或醫藥產業是全球各國競相發展的產業類別，我國亦不例外；其中，美國無論於生物技術或醫藥產業的發展，均居於全球領先的地位，其成功必然有可以提供我們討論或學習之處。而在知識價值鏈的體系中，美國大學更扮演著提供創新以及產學合作的重要角色，對於全球生技新藥產業的進步有重要的貢獻。從而本研究以美國為標的，研究產業的發展歷程，並進一步以產業之觀點，探討大學產學合作的模式以及智慧財產管理，希望能供我國大學與產業實務發展的參考。 從美國生物技術與醫藥產業發展的歷史與經驗，本研究歸納出生物技術產業興起的因素，與1980年代發生的基礎科學上的突破性發展、拜杜法案的通過、專利法將生物技術的發明納入保護範圍，三項因素有關。另外，由大學所提供的創新，透過密切的產學合作、授權與技術移轉、企業間的策略聯盟等方式，於知識的價值鏈中流動並增加價值，而大學提供創新的人才，往往也是創業者和重要的經營者。 本研究認為，美國大學對生物技術發展具有重要性的貢獻，其中，大學內部創業與大學智慧財產的管理特別值得討論。在大學內部創業方面，美國大學不但鼓勵創業，並制定股權政策，允許新創公司以股權取代部分的授權報酬，給予新創公司實際的協助。透過限制大學持股比例與禁止大學擔任董事或參與董事投票活動之原則，則可兼顧大學避免利益衝突與公司專業經營的需求。 在大學智慧財產管理的部份，本研究認為加州大學系統的智慧財產管理方式，採用網路式的授權與技術移轉組織，將各校區共同的需求如政策、法務、資訊技術與通訊等活動統籌處理，而將需與發明人和企業密切交流的活動如授權與技術移轉的活動交由各校區的授權與技術移轉中心負責。透過此種統籌與分工管理的方式，能夠兼顧減少營運成本與增加授權效率的功能。 經由本研究節果，建議我國的大學可採用網路式的授權與技術移轉組織之概念，除各校之授權與技轉中心外，聯合設一統籌政策、法務、智慧財產資料庫之管理機構，並對大學持有公司股份、鼓勵創業、避免利益迴避等議題制定一致的政策，方能有效利用資源並發揮大學創新的價值。 / Biotech and new drug development industry are targeted toward the development of drugs for human, animal, or plant use. This also includes the high-risk industry in medical devices. Although the pharmaceutical industry shares common objectives, the biotech and new drug industry emphasizes on applications in biotechnology and its industrial structure is composed by non-profit organizations and biotech dedicated firms. While biotechnology forms the basis to the biotech and new drug industry, the improvement of biotechnology also changed the interaction between the pharmaceutical products and technologies as well as its industrial structure. Biotechnology and pharmaceutical industry have received considerable attention around the world, including Taiwan. Since U.S. has been the leading country in the development of biotechnology and pharmaceutical industry, we can surely learn from its success. In particular, universities in the U.S. have played a crucial role in providing innovation and promoting university-industry cooperation and resulted in significant contributions to the progress of global biotech and new drug industry. Thus, this study will investigate the development of the industry within the U.S. by dissecting the various university-industry cooperation models and the management of intellectual property rights. Results from this study will hopefully shed some light on bridging our university with industry for further practice operation. By examining the U.S. biotech and pharmaceutical industry, this study has concluded that breakthroughs in fundamental, the passage of Bayh-Dole Act, and the inclusion of biotechnology into patent law science in 1980s are responsible for the rise of biotechnology industry. In addition, active university-industry cooperation along with licensing, technology transfer, strategic alliance among enterprises and information flowing in the knowledge value chain added the value of the innovation provided by universities. In many cases, the university has not only provided innovation, but also a source for future leaders that would take on role of the founders or head of project management. The U.S. universities have made significant contributions to the development of biotechnology by establishing entrepreneurship programs, intellectual property rights management, and often providing substantial assistance in business start-up. One type of assistance is rendered through regulating policies on equity that allows start-up companies to provide equity in place of part of license fee. In order to avoid a “conflict of interest”, universities should be limited of their possession of industry equity, which can prevents them from taking part in the company as the board director or members. In terms of the management of intellectual property rights, the measures of management of the University of California system can help diminish operation cost and enhance licensing efficiency. University of California system resorts to Technology transfer in a distributed institutional network that feed the common needs from each campus such as patent policies, general counsel, and information technology and communications. A licensing and technology transfer center (OTT) on each campus will follow a system wide license and technology transfer process between the inventor and the enterprise. In conclusion, it is recommended that our university could adopt the concept of network licensing and technology transfer. Through an overall arrangement, a management institute can be established to regulate the planning of policies, provide general counseling, and build a database of intellectual property rights aside from the existing licensing and technology center of each university. In the best interest of the developing biotech and new drug industry, universities should initiate policies with regard to equity holding limitation, encouragement of start-up business, and the avoidance in the “conflict of interest” so the industry may effectively utilize university resources and demonstrate its innovative values.

近年來全球醫藥市場競爭越來越激烈，歐美製藥產業面臨：1.暢銷藥品專利即將到期、2.新藥產品生命週期縮短、3. 研發支出與產出不成比例、4. 健保藥價之削減，過去傳統藥廠以垂直整合方式開發新藥的方式已無法負荷艱困的產業環境。因此，開發新藥方式已從過去垂直整合轉向產業分工的方式，減低風險，提升新藥開發成功機會。因此，吾人可以預測這些廠商必須借用大量的外部資源才能快速地推出新藥。 目前我國新藥開發處於萌芽期，廠商規模小且較無經驗，加上國內過去以學名藥為主，因此，開發新藥一直是國內廠商的一個夢，也是製藥產業獲利最高的一項產品。然而，過去的研究重點往往著重在製藥產業相關業者發展策略、關鍵成功因素、營運模式或生技公司之創新管理、智財管理等層面探討，對於新藥開發流程的實務歷程的研究較少著墨。故本研究針對我國新藥開發公司的「新藥開發流程」進行研究，試圖以開放式創新觀點，探討其新藥開發流程中，專案團隊的外部技術網路與內部專案管理的關係，期能對於「團隊間之開放式創新管理」方面，提供一些實務上與學理上的貢獻。 本研究方法採個案分析法，文獻探討部分包含新藥開發流程、開放式創新、外部技術網路、專案管理，導出本研究之觀念性架構，以此理論架構發展出個案訪談問題，在研究中實地訪談四家之我國新藥開發廠商，並從中分析我國新藥開發流程中外部技術網路與專案管理之關係，透過個案分析推論我國新藥開發流程內、外部合作的關鍵成功因素。 本研究發現，新藥開發流程中，各階段技術不同，新藥開發專案團隊須清楚地界定本身的研發能力，才能有效連結外部技術資源。同時，專案團隊要能有效連結外部技術資源，團隊成員須擔任技術中介人，以促進適當的技術流進、流出，達成開放式創新。因此，選擇適當的技術中介人是新藥開發成功的關鍵因素。

有鑑於生物科技成為科技趨勢，以及其創造出的龐大價值，近年來台灣也開始大力推動生技產業的發展。產業是企業的組合，企業的成長與否正是驅動產業生態變化的主要原因。本研究主要探討台灣生技藥物研發公司的創業過程，希望透過研究成果對台灣生技公司的發展有所貢獻。 　　本研究的研究架構以Timmons Model做為主軸，以機會、資源、團隊做為主要的研究構面，先對個案公司進行靜態的研究構面探討，然後分析其發展的動態平衡過程。 / Because biotechnology sets a trend and creates great value, Taiwan government tries to develop his own biotechnology industry. However, an industry will bloom if most of companies related to the industry are operated well. The objective of this study is to observe and analyze the entrepreneurial process of biomedical R&D companies in Taiwan. 　　The research bases on Timmons Model that was developed by Timmons for analyzing an entrepreneurial process of a company and consists of three driving forces, opportunity, resource, and team. Every entrepreneurial process of companies in the thesis is observed first according to the three driving forces. Then it is analyzed by using the idea of constant balancing.

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)