從分析歐美生技製藥及新技術發展 探討台灣生技製藥產業發展方向

Abstract

論文摘要 生技製藥乃未來黃金產業，全球已開發國家更全力以赴力爭一席之地。50年代科學家發現DNA雙螺旋型結構，揭開生命科學的序幕。90年代初期全球專注基因解碼研究，2000年在多國合作下，人類基因解碼計畫順利完成。提供全球科學界，重新思考21世紀生技製藥產業發展的新方向。 生技製藥乃全球性產業，各國對此產業發展方向，仍在摸索中。如何從歐美主導生技製藥發展的國家中，學習成功經驗，進而推動本土生技製藥產業，乃本論文重點。 本研究蒐集過去五年全球生技製藥產業發展資訊，藉由第一、系統化的分類，探討新藥開發過程及新技術衍生在醫學研究上的貢獻。第二、逐一分析問題癥結，並推敲成功關鍵技術，評估未來產業發展方向。第三、提供本土生技製藥產業發展的目標與策略。 從探討四種疾病藥物開發過程及六種新技術的應用中發現，第一、大藥廠目前以開發癌症藥物，並專注以小分子及單株抗體為製藥主流。第二、善用知識經濟提昇藥物附加價值，如分析臨床試驗數據，設計新給藥模式及儀器設備等。第三、從基因組及蛋白組的研究中，尋找生物標定物，並開發相關儀器設備。第四、幹細胞及干擾RNA，將提供嶄新研究方式。第五、基因改造作物將是未來必得面對的議題。 從研究歐美成功案例及國內最近十年發展過程中，發現台灣生技產業面臨的瓶頸在於，並未充分了解推動生技製藥產業的模式、缺乏國際大藥廠長期進駐的條件、研發資源分散且創投資金供給鏈不足。本研究建議台灣未來生技製藥，應朝以下方向推動。第一、學名藥的國際化及差異化，並開發以單株抗體為主的抗癌藥物。第二、利用國內基因組及蛋白質組的研究團隊，發現生物標定物，開發體外檢驗試劑(in vitro Diagnostics，簡稱IVD)及儀器。第三、善用台灣臨床試驗水平及CRO技術，建立亞洲臨床試驗中心。第四、推動再生醫學的研究與發展。第五、引進國外人才及技術平台，帶動國內研發、製造及行銷水平。第六、培育領導及管理人才，領導者必須了解產業界的需求、學界的技術及政府的政策，建立平台以整合基礎研究及臨床試驗的界面。 總而言之，生技製藥產業千變萬化充滿挑戰，未來仍將以知識經濟為主軸，如何面對(一)開放性研發架構，(二)開發新生物能源，(三)有效掌握知識經濟，更值得慎思。 關鍵詞：生物科技、生技製藥、學名藥、生物標定物、體外檢驗試劑、臨床試驗

Abstract Biopharmaceutical industry is the golden industry in the twenty first century. All nations have endeavored to achieve the best. In fifties, scientists discovered the structure of DNA; in nineties, scientists started gene hunting. In 2000, human genome was deciphered. The results have prompted the industry to rethink the new direction of biopharmaceutical development. Whilst Biopharmaceutical is a global industry, most of the nations are still looking for their directions. The main purposes of this thesis are to figure out how we learn from the experiences of leading nations in biopharmaceutical development and promote our domestic biopharmaceutical industry. The methodology is to collect the global biopharmaceutical information within the last five years, adopt systematic grouping, investigate the process of new drug development and emerging techniques and evaluate their medical contributions. Subsequently, analyze the problems and key successful factors, and predict the future development trends. From investigating the drug development for four different diseases and the six cutting edge techniques, we conclude: First, big pharmaceutical companies are concentrating on developing new cancer drugs, using small molecules and monoclonal antibodies. Second, make the most of knowledge based economy, such as analyzing the clinical trial data to promote the value added drugs and designing new deliver systems and devices. Third, discover biomarkers through basic genomic and proteomic research and develop related devices. Forth, stem cells and RNAi will play important roles in the near future. Fifth, GMO will be the next major issue. The bottlenecks of Taiwan biopharmaceutical industry development include: lack of efficient model, lack of global big pharma’s sustainable support, fragmented R&D resources and insufficient capital. In comparison to western pharmaceutical industry, Taiwan shall promote its biopharmaceutical industry through following directions: First, develop generic drugs through international alliances and differentiation; apply monoclonal antibodies techniques to develop new cancer drugs. Second, discover biomarkers and develop in vitro diagnostic (IVD) kits and devices. Third, make the most of our clinical trials facilities, human resources and CRO techniques to establish the Asia clinical trial center. Forth, promote regeneration medical research and development. Fifth, recruit more leading scientists and techniques to drive R&D, manufacture and marketing standard. Sixth, develop human capital with leadership and management skills and establish the platform to integrate the academic advantages, industry needs and government policies. Biopharmaceutical industry is versatile and challenging. Knowledge based economy is its key character. Looking forward, (1) open sources management, (2) bioenergy development and (3) knowledge based economy management remain key subjects.

Key Words: biotechnology, biopharmaceutical, generic drug, biomarker, in vitro diagnostic, clinical trial.