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研究生:簡珮如
研究生(外文):Pei-Ju Chien
論文名稱:細胞治療之創業計畫
論文名稱(外文):The Business Plan of Cell Therapy
指導教授:曾智揚曾智揚引用關係
指導教授(外文):Chih-Yang Tseng
口試委員:陳耀宗戴怡蕙
口試委員(外文):Yaw-Chung ChenYi-Hui Tai
口試日期:2020-06-10
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:創業創新管理碩士在職專班
學門:商業及管理學門
學類:企業管理學類
論文種類:學術論文
論文出版年:2020
畢業學年度:108
語文別:中文
論文頁數:47
中文關鍵詞:細胞治療資本預算淨現值法內部報酬率法
外文關鍵詞:Cell therapyCapital budgetingNet present valueInternal rate of return
DOI:10.6342/NTU202004079
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細胞治療是屬於再生醫學的範疇。再生醫學是利用細胞來修復受損的組織或器官,以治療各種疾病,而這些疾病在常規藥物和醫療程序中得不到很好的管理。細胞治療依細胞種類分成自然殺手細胞、T細胞、樹突細胞、間質幹細胞 、造血幹細胞、CD34+細胞、細胞激素激活殺手細胞及腫瘤浸潤淋巴細胞等等的免疫細胞,來治療疾病。衛生福利部於2018年9月6日公告『特定醫療技術檢查檢驗儀器施行或使用管理辦法』,將自體(autologous)的六大項安全性可確定、成效可預期的細胞治療項目,納入特定醫療技術管理,對台灣的細胞治療發展將產生顯著的影響。台灣為亞洲第二個合法使用細胞治療技術的國家。製造真正具有效性及安全性細胞醫療產品需遵守細胞製備場所人體細胞組織優良操作規範(Good tissue practices; GTP)或優良製造標準(Good manufacturing practice; GMP)。由於生技產業產品開發期長、投資通常較龐大,風險較高,不僅需要技術支持及事前良好的規劃,才能擁有高的回報率。本創業計畫重點在於不影響院所的運營的行情況下,規劃2個資本投資方案,方案一: GTP建置六間細胞操作實驗室; 方案二: GTP建置2間細胞操作實驗室,預留空間使用自行開發的UJ癌細胞培養系統設備(商品名)。依照資本預算規劃方案一及及方案二,以淨現值法、內部報酬率法及收回期限法比較兩方案。經規劃及計算後,方案一及方案二皆能投資,其中方案二更優於方案一的獲利性及未來擴充性。
Cell therapy is listed in the category of regenerative medicine. Regenerative medicine aims to repair damaged, tissues or organs, using cells for the treatment of various diseases, which have been poorly managed with conventional drugs and medical procedures. Cells used for cell therapy include but not limited to natural killer (NK) cell, T Cell, dendritic cell, mesenchymal stem cell (MSC), hematopoietic stem cells (HSC), CD34+ cell, cytokine-induced killer (CIK) cell, and tumor-infiltrating lymphocyte (TIL). September 6, 2018, Ministry of Health and Welfare has amended the “Regulations governing implementation or use of specific medical technology, examination, laboratory testing and medical devices”. Six regulatory items of autologous cellular therapy to consider with ascertain safety and expectable efficacy were listed. High expectation of this new regulation could significantly impact the cell therapies development. Taiwan is the second country passed regulations for producing cell medicinal products in Asia. Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) are the core Taiwan Food and Drug Administration (TFDA) requirements for manufacturing merchandise involving human cells, tissues and cellular and tissue-based products for cell therapies. Due to the nature of biomedical product bearing long developing period, heavy investment and high risk, it requires technical supporting and well planning to ensure its high rewarding. Two business plans are proposed aiming not causing negative impacts on hospital/clinical daily practice and to pursuit cell therapy investment. Plan I is to build six, and plan II is to build two GTP labs with reserved space for an original design manufacture, ODM, UJ cell culture equipment. The capital budget plan of these two proposes has been compared based on the net present value (NPV), internal rate of return (IRR), and the payback period. The conclusion indicates both plans are working and investment worthy. The reward and future expansion favor the plan II.
中文摘要…………………………………………………………………………………………i
英文摘要………………………………………………………………………………………ii
第一章 前言………………………………………………………………………………1
第二章 文獻討論……………………………………………………………………2
第一節 細胞治療產業文獻討論…………………………………………2
第二節 台灣細胞治療的技術及法令規範…………………… 6
第三節 癌症細胞產業之現況與發展………………………………10
第四節 幹細胞產業之現況與發展……………………………………14
第五節 醫療器材產業之現況與發展………………………………15
第三章 創業計畫……………………………………………………………………22
第一節 創業構想………………………………………………………………………22
第二節 癌症細胞治療服務流程(含院所)………………………25
第三節 創業構想的SWOT分析………………………………………………26
第四章 資本投資方案……………………………………………………………31
第一節 GTP實驗室資本投資方案…………………………………………31
第二節 GTP實驗室資本投資方案比較…………………………33
第五章 資本預算…………………………………………………………………………34
第一節 兩種資本投資方案現金流量估計……………………………34
第二節 淨現值法(NPV) ………………………………………………………………35
第三節 內部報酬率法(IRR) ………………………………………………………37
第四節 收回期限法…………………………………………………………………………37
第五節 資本預算分析比較及非財務因素………………………………38
第六章 結論………………………………………………………………………………………39
參考文獻…………………………………………………………………………………………………40
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