臺灣幹細胞產業技術策略與商業化之探討- 以生技新藥G公司為例

Technological Strategy And Commercialisation Of Taiwan Stem Cell Industry-A Case Study Of G Company.

劉雅雯(Ya-Wen Liu)

指導教授 ： 蔡文鈞

中原大學/商學院/企業管理研究所/碩士(2016年)

https://doi.org/10.6840/cycu201600305

摘要

生物技術產業是21世紀的明星產業，我國為鼓勵生物技術相關產業發展，增進人民健康與社會福祉，陸續推動多項重大措施，近年來，幹細胞的應用技術也不斷突破，在我國國民所得和生活水準不斷提升之下，健康議題也愈來愈受重視，慢性和嚴重疾病治癒更寄託於未來幹細胞醫療技術的突破性應用。然生物技術和幹細胞產業具有產品研發時程長、投入成本高、產品附加價值高、產品生命週期長、財務風險性高等特性，所以各企業為實現其經營理念，進行與技術有關的重大決策，包括發展方向、資源配置、能力水準、實現方法、以及與技術研發相關的組織管理等的技術策略制定能力更顯重要。
文獻探討得知實際上技術的各個研發里程都可創造階段性的價值，重點在於能否清楚定位切入與退場的時機及階段，而所謂的「商業化關鍵時刻」是只要察覺有「賣點」，即關注技術的「優點」是否能被強化突顯，再加上商業的包裝，就可以開始進行商業化的買賣，陳桂恒(2011)表示要以客觀的實驗數據顯現技術的優點，因此使用細胞或適當的動物模式進行實驗所取得的數據，皆可作為技術優良的佐證，當然能提供人體實驗的數據是最有力的證明。要落實在各個研發里程中創造階段性的價值，將有價值且符合市場的技術進行商業化，並將產品上市行銷，以獲得資金投注繼續後續的研究與開發，邁向企業永續經營之目標。
本研究採取質化方式中的個案研究和深度訪談兩種研究方法，以通過生技新藥產業發展條例之生技新藥公司為對象，個案公司以研發幹細胞新藥為主，積極落實在各個研發里程中創造階段性的價值，並成功將階段性產品上市行銷創造營收，以支持新藥開發的龐大研發支出，透過訪談個案公司高層核心主管及相關的次級資料作為研究觀察以及發現的依據，探討個案公司在企業願景目標下如何展開技術策略實現「成為幹細胞產業的領航者」的目標，又如何將核心技術進行技術商業化創造獲利。
本研究發現個案公司在企業願景下技術策略的選擇模式以可延伸核心技術策略發展且重視市場與產品功能性的策略為主，而技術來源可簡單分為自行創新研發和移轉外部技術，其移轉外部技術多為技術移轉、技術授權、技術策略聯盟及產學合作等方式， 而商業化是將技術從研究發展到設計和製造並轉化成有價產品的一連串加值過程或技術本身成為流通性的有價商品之過程，包含可量產銷售之產品、專利或技術移轉皆算是技術商業化，個案公司有部分的技術策略有產出產品，但一定會申請專利，不僅可透過專利保護技術，亦可作為產品的功效保證，可知個案公司很重視市場變化，技術策略多以商業化為主，研發型公司重視市場和商業化，努力創造營業額，以支持目標核心幹細胞新藥開發，是一個良好的正向循環，企業也可朝永續經營邁進。
因個案公司企業願景目標為「成為幹細胞產業的領航者」，以目前技術策略多為「應用改良型」而言，似乎尚不足以擔任「領航者」角色，本研究建議應多增加「領先創新型」技術，強化自行創新研發能力，此外，建議技術來源不僅侷限於產學合作也可增加其他外部技術的來源，讓技術策略與技術商業化更多元性，成為研發實力堅強的「領頭羊」。

關鍵字

幹細胞 ； 技術策略 ； 技術商業化 ； 生技新藥

並列摘要

Biotechnology industry is a star industry of the 21st century. In order to encourage the development of biotechnology industry and improve people's health and social welfare, Taiwan has been promoting a number of significant measures in succession. In the recent years, due to the constant breakthrough of application technology of stem cell as well as the continuous improvement of national income and living standard, health issues are also increasingly valued. In addition, chronic and severe disease cure rely on the breakthrough application of future stem cell medical technology. However, as biotechnology and stem cell industry have characteristics such as long product development schedule, high cost of invest, high product added-value, long product life cycle and high financial risk etc., for enterprises to realize their business philosophy, it is significant to have the capabilities regarding development direction, resource allocation, competence level, realization measures and the technical strategy development of organization management related to technical research and development.
Literature review shows that actually each milestone during technology research and development can create transitional value, while the key lies on whether the timing and phase for getting in and out the business can be clearly identified or not. The so-called "commercialization crucial moment" means once the "selling point" is noticed, the "advantage" of the technology is immediately focused to see whether it can be strengthen and highlighted and with commercial packaging it is ready for commercial business. Queiyuan Chen (2011) said the advantages of technique require objective experimental data for verification, therefore, using cells or appropriate animal model for experimental data requisition could be taken as an evidence of good technology. Of course, providing human experimental data is the most powerful proof. It is necessary to realize transitional value at each research milestone and commercialize the technology with value and market demand by promoting the related products to the market in order to obtain capital for follow-up research and development and head to the goal of sustainable operation of the company.
This research adopted two research methods in qualitative research method, the case study and the depth interview, and targeted a new biotech drug company who passed the "Biotech industry development regulation" as the research object. The object company focuses on developing new stem cell drugs and actively realizes transitional value at each research milestone and successfully promoted stage products to the market to create revenue that supports huge research expense on new drug development. Through interviewing the top core management of the object company as well as related supportive information as the basis for research observation and discovery, we explored how the object company deployed its technical strategies to realize the goal of "becoming the leader of the stem cell industry" under the company's vision and how to commercialize its core technology for revenue creation.

In this research it is found that the object company's technical strategy under the company's vision is established on expandable core technical strategy development and valuing market and product functionality. As for the source of technology, it could be divided into self innovative research and development and external technology transfer. The external technology transfer is mostly of technology transfer, technology authorization, strategically technology alliance and industry-academia cooperation etc., while commercialization denotes a series of value-adding processes that turn the technology into a valued product from research and development to design and manufacturing, or the process of turning the technology itself into a purchasable valued product. Mass-produced sellable products, patent or technology transfer also belong to technology commercialization. A part of technology strategies of the object company were made into products, however, patent application is a must as it not only protects developed technologies but guarantee the effectiveness of products, from which it could be seen that the object company values market change and focuses on commercialization for technical strategy. It is a good and positive circulation for a research and development type of company to value the market and commercialization and endeavor in creating revenue to support the goal of new stem cell drug development as well as lead the company on the way of sustainable operation.
The object company's goal of vision is "becoming the leader of the stem cell industry", but with current technical strategy focusing mostly on "application improvement" it is a little behind being a role of "leader". From this research it is suggested that more "leading innovative" technology shall be incorporated to strengthen self innovative research ability. Besides, it is also recommended not to limited the source of technology in industry-academia cooperation only but increase more sources of external technology to diversify its technical strategy and technology commercialization and become the "bellwether" with strong research and development capability.

並列關鍵字

Stem Cell ； Technological Strategy ； Commercialisation ； New Biotechnology Drug

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