新藥開發是需要大量的資金投入，同時需要專業的技術實驗人才、以及具產業經驗的管理團隊，但是其所獲取的價值和領域也是相對較大的。生技製藥產業包括新藥、學名藥、中草藥、基因及蛋白質製劑、遠距醫療、預防醫學、醫療器材等。台灣在生技製藥已經投入許多資源，但是所獲得的成果並不如預期，主要原因除了缺乏像國際大廠的充足資金之外、且沒有完整的生技製藥產業鏈，更重要的是缺少了對生技製藥智慧財產管理的經驗、沒有國際行銷能力去取得市場。起因點則為台灣生技製藥公司仿照國際成功的生技製藥大廠模式，卻沒有自己的價值創造和創新模式，為了替台灣生技製藥廠商尋找新的利基和成功模式，本文分析了國內與國外的生技製藥公司，以尋找適合台灣的價值創造模式。
台灣生技製藥廠商主要缺乏的並非是技術，而是結合智慧財產的法律議題、並且發展出市場導向的生物技術研發模式。智慧財產相關議題在生技製藥產業更是最關鍵的因素，因為新藥研發動輒10年，而一般資金來源的銀行和創投都無法忍受所投資的公司必須要十年才可以獲利退出，因此透過不同臨床時期開發的新藥，其價值也會有顯著的不同，再透過技術移轉、授權和相關合約的簽訂，才能促使台灣中小型的生技製藥公司可以生存。本文要提出價值創造模型之前，必須要針對生技製藥產業的技術研發特性進行分析，接著必須透過智慧資本與財務會計的方式計算生技製藥產業無形資產的價值，最後透過個案中不同公司的營運策略，找出最適合現今生物製藥產業發展的模式。
生技產業需要相當多的資金去做新藥研發與市場行銷，這也是生技產業特殊的供應鏈上最重要的一環。因為，創投公司不只會投資金錢，它還會幫忙被投資公司尋找人才、市場、和策略發展。因此，本文第三個個案公司Burrill&Company為美國生技創投公司，最近幾年也可以看到它在大中華地區尋求投資機會。Apex International公司選對人才創造出優良品質的委託臨床試驗、和NexMed透過技術授權所產生平台技術，三家公司所創造的價值，去印證本文所提出的生技製藥產業價值創新模式的適用性。
論文研究結果顯示生技製藥產業最成功的關鍵因素至少有兩點，第一點就是核心能耐(Core Competence)的建立、第二點就是選擇對的人才。由本論文的價值創造模式中心出發，便是透過紮實的研究發展技能；建立優良的管理技巧以降低研發風險；透過創造新的技術和產品價值的核心能力建立，再選擇正確的人才組合，創造出外部的價值，最後達到整體價值創造的綜效。希望台灣不光只是擁有科技基本法與生技新藥產業發展條例等政策，而是可以透過本論文提出之價值創造模式，有效提升整體生技製藥產業的環境，以期產生更多成功的故事。
關鍵字：生技製藥、智慧財產、實體審查、無形資產鑑價、價值創造、技術移轉。 / Biopharmaceutical is driving force of the global healthcare economy transformation. In order for a biopharmaceutical company to gain value from a new drug during its clinical development, capital investment, professional talents, and management team with industrial experience are needed. Biopharmaceutical industry are included of new drugs, generic drugs, Chinese herbal medicine or traditional Chinese medicine, genetic and protein preparations, tele-medicine, preventive medicine, medical devices and so on. Taiwan has invested a lot of resources at biopharmaceutical fields but the results are not as expectation. The main reason is the lack of adequate funding from international big pharma, and the operation is no integrity of the value chain at biopharmaceutical industry. More importantly is the lack of management experience on Intellectual Property, and no marketing ability to access to the global technology supply and demand market. The key point is that they copy of the format of big pharma but lack the spirit of the creativity and innovation. I analyzed the three cases in the thesis and tried to find a niche and successful model for the value-adding on the Taiwan’s Biopharmaceutical industry.
Taiwan does have the technology know-how, but most of the companies’ problems are the lack of market-oriented R&D model and the Intellectual Property issues. IP issues including management know-how related to biopharmaceutical industry are the most crucial factors. Most companies tends to spend ten years on developing a new drug. Most of the investment banking and venture capitals are hard to endure by the long-term exit mechanism. The value will be totally different if the investors can exit at various clinical stage of new drugs at various stages with the strategy of technology transfer and licensing agreement. Such business model can make Taiwan’s small and medium-sized biopharmaceutical companies easier to survive. To verify this value creation model, I analyzed the characteristics of the industrial research and development and calculate the value of intangible assets on the technology by the methodology of intellectual capital and financial accounting. Finally, I will identify the most suitable model by compared with the different business models in three representative cases.
The biotech industry needs a lot of funding to do R&D and marketing of new drugs which is the most important on this special supply chain. Not only to invest money, venture capitalist should help the company to recruit the talent, target the market, plan and execute the strategy. Therefore, the third case is the U.S. venture capital firm called Burrill & Company. In recent years, it moved to the Great China region to seek the investment opportunities. Apex International recruit the right talents to the right position and create a great world class quality project on the clinical trial, and NexMed bring their value through the platform technology and technology licensing. All the cases are selected to examine the availability and suitability of the value creation model.
At least two key successful factors for biopharmaceutical industry has been revealed by the research of the thesis study. The first one is the establishment of the core competence on the technology in their respective business, and the second one is the management know how in putting the right person on the correct position. Overall, the value creation model is build on a solid research and development skills, a great management know-how to reduce the risk, and the spirit of entrepreneurship to create the true innovative products or services. With all the core competences, we can integrate the team with multidisciplinary talents to expand the value with the outside resources, and give the synergy of the whole value-added model. Hope that with the recent enactment of the Basic Science and Technology law and New Pharmaceutical Development Act in Taiwan, more successful stories can be created by this value-added model discussed in this thesis.
| Identifer | oai:union.ndltd.org:CHENGCHI/G0095361005 |
| Creators | 林群倫, Lin, Chun Lun |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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