生技產業產學合作模式之探討 ─以臺灣再生醫療產業為例

Abstract

隨著現代科技快速發展，醫療技術不斷推陳出新，國際公認的幹細胞及癌症生物學領導者哈佛大學教授喬治･戴利（George Q Daley）說：「如果說20世紀是藥物治療時代，而21世紀就是細胞治療時代！」，醫界常將「細胞治療」稱為繼小分子藥、生物製劑、醫療儀器後，現代醫療第四支柱。 廣義來說，臺灣最早接觸幹細胞治療是1983年、1984年由臺大陳耀昌醫師相繼完成第一例自體及異體骨髓移植開始，隨著醫藥科技發展，細胞治療、基因治療或組織工程技術陸續被驗證，衛福部2017年開始著手草擬「細胞及基因治療產品管理法」（草案），2018年衛福部醫事司根據《醫療法》授權及其第六十二條第二項授權，發布《特定醫療技術檢查檢驗醫療儀器或用管理辦法》（以下簡稱《特管法》）開放醫院申請六大項目的自體細胞治療計畫，而再生醫療技術係依《特管法》管理，而再生醫療製劑歸類為生物藥品，以藥事法管理，訂定相關審查基準等規範。 本文藉由四螺旋價值創造模型（A Conceptual Model of Principal Investigators as Quadruple Helix Value Creators），透過產業技術分析目前再生醫療幹細胞、外泌體、iPSC及CAR-T四大重要技術；並採美國專利商標局（USPTO）資料以Python抓取數據創建資料庫，使用社交網路分析軟體UCINET繪製網路連接圖進行專利趨勢分析；另外，本文也訪談臺灣細胞醫療協會會長、幹細胞學會會長、醫院細胞治療中心的醫師主管、細胞製備生技公司負責人，了解《特管法》下的臺灣再生醫療技術構面、合作構面、產業發展構面及臨床構面的現況；最後再爬梳近10年臺灣產學合作計畫，探討學研界研究能量與社會資本的關聯性，勾勒再生醫療產業的產學合作模式中計畫主持人（Principal Investigator）扮演的角色、社會連帶（Simmelian Ties）如何成為產學合作關鍵成功因素及跨域工作（Boundary Work）等外部因素如何影響產學合作運行。 細胞治療提供了一種新的治療選擇：個體化治療，患者將適應症、先期的治療選擇、體能狀態等需要滿足臨床及特定的健康標準及接受製造細胞產品的時間透過醫療院所進行費用高昂的客製化醫療模式，這個過程需要多方利益相關者的溝通、醫療決策、個人、財務決策以及資金流、細胞產品的標準化和系統支持各方面都存在挑戰。如何提高生物技術商業化應用，孕育臺灣再生醫療產業的發展，也是本文關注的重點。

With the rapid development of modern technology and the continuous progress of medical technology, Professor George Q Daley of Harvard University, who is internationally recognized as a leader in stem cell and cancer biology, said: "If the 20th century is the era of drug treatment, the 21st century is the era of cell therapy!" The medical community often refers to "cell therapy" as the fourth pillar of modern medical care after small molecule drugs, biological agents and medical devices. Broadly speaking, the earliest history of stem cell therapy in Taiwan started in the year of 1983, and in 1984 when Dr. Yiu-chang Chen of National Taiwan University successively completed the first case of autologous and allogeneic bone marrow transplantation. Along with the development of medical technology, cell therapy, gene therapy and tissue engineering technology has been verified one after another. The Ministry of Health and Welfare passed the "Cell and Gene Therapy Products Management Law" (draft) in 2017, and then in 2018, the Medical Affairs Department of the Ministry of Health and Welfare issued the " Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices" (hereinafter referred to as the "Regulations of Special Medical Techniques"), which allowed hospitals to apply for six major autologous cell therapy programs, while regenerative medicine technology is to be managed in accordance with the "Regulations of Special Medical Techniques", and regenerative medicine preparations are classified as biological drugs, which are managed by the Pharmaceutical Affairs Law and accompanied with relevant review standards and other norms. Based on the Conceptual Model of Principal Investigators as Quadruple Helix Value Creators, this article will analyze the four important technologies of regenerative medical stem cells, exosomes, iPSC and CAR-T through industrial technology. The data of the United States Patent and Trademark Office (USPTO) was used to create a database by Python, and the social net work anaylasis software UCINET was also used to draw network connection diagrams for patent trend analysis. In addition, this paper interviewed the president of the Taiwan Cell Medicine Association, who is also the president of the Stem Cell Society, the physician supervisor of the cell therapy center of the hospital, and the person in charge of the cell preparation biotechnology company, to understand the aspects of the regenerative medicine technology, cooperation, current status of industrial development and clinical aspects under the Regulations of Special Medical Techniques in Taiwan. Finally, we will review the industry-academia cooperation projects in Taiwan in the past 10 years and explore the correlation between R&D capabilities and social capital in the academic-research circles, and outline the role played by the Principal Investigator (Principal Investigator) and social solidarity in the industry-academia cooperation model of the regenerative medical industry, to see how Simmelian Ties became a key success factor of industry-academia cooperation and how external factors such as cross-domain work (Boundary Work) affect the operation of industry-academia cooperation. Cell therapy provides a new treatment option: personalized cell therapies, in particular autologous, ex vivo cell and gene therapies, with costly customized medical models offered by medical institution, while the patients need to meet the clinical and specific health standards, and acceptance of manufacturing cell products, which all require multi-stakeholder communication touchpoints: treatment decision making, personal and financial decision-making, as well as funding flows, standardization of cell products and system support. In contrast, the commercial delivery of pills and biologics primarily involves one-way decision making among few stakeholders, and much of the regulation and standards in development and manufacturing occur outside of the patient journey. However, how to improve the commercial application of biotechnology and nurture the development of the regenerative medicine industry in Taiwan is also the focus of this article.