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    Title: 技術知識特質與團隊運作之探討-以台灣新藥研發專案為例
    Authors: 蔡宗儒
    Contributors: 吳豐祥
    蔡宗儒
    Keywords: 生技新藥
    新藥研發流程
    技術知識特質
    專案團隊運作
    New drug
    Drug development process
    Technological knowledge characteristics
    Project team management
    Date: 2008
    Issue Date: 2009-09-18 20:09:06 (UTC+8)
    Abstract: 在學術領域之中,其過去對於新藥產業的研究大多集中於「新藥發展策略」、「產業環境分析」與「智慧財產權策略」等領域,而探討新藥研發各階段之團隊組成與運作模式的研究仍然極少。
    本研究以個案訪談法為主要研究方式,深入探討兩家台灣新藥研發公司(包括基亞生技、台灣微脂體),並以『新藥研發流程』與『技術知識特質』兩個構面來探索其對於『新藥研發專案團隊運作』之影響。
    所得到的初步研究發現包括:
    1. 新藥研發專案各階段中,技術知識路徑相依程度與技術知識系統複雜程度呈現負相關,當路徑相依程度越高時,系統複雜程度則越低。
    2. 新藥研發專案隨著階段的推進,專案團隊的組成與結構也會隨之產生變化,臨床前與臨床試驗皆有不同的團隊組成與結構。
    3. 技術知識系統複雜程度會影響新藥研發團隊組成的異質/多元程度:技術知識系統複雜程度越高,其團隊組成的異質/多元程度越高。
    4. 技術知識路徑相依程度會影響團隊採取何種團隊運作策略:(1)路徑相依程度愈「高」或是愈「低」,專案團隊會傾向採取「自行發展」的團隊運作模式;(2)路徑相依程度為「中」時,專案團隊會傾向採取先執行「初步研發」活動之後,再與外部廠商進行「合作研發」。
    5. 技術知識路徑相依程度會影響新藥研發專案各階段的團隊類型:(1)技術知識路徑相依程度愈低,專案團隊會傾向採用「重量級」、「自主型」的團隊運作模式;(2)技術知識路徑相依程度愈高會傾向採用「功能型」、「輕量級」的團隊運作模式。
    6. 技術知識內隱化程度愈高,該專案在團隊運作上愈容易將外部成員視為內部團隊,甚至在團隊組成上直接將外部成員納入內部團隊之中。
    7. 在臨床試驗階段,試驗主持人的過往經驗為成功關鍵之一。
    8. 新藥研發廠商若擁有先導研發的能力,可以減短研發時程與成本。
    Most of previous the studies on pharmaceutical industry have been focused on the development strategy, environmental analysis and intellectual property. Very few of them emphasize the stage of new drug development concerning the project team management.
    This study uses technological knowledge characteristics (path dependence, complexity, and explicitness) and drug development process (drug discovery, non-clinical, pre-clinical, and clinical ) to explore the effect upon project team management.
    The result of this study:
    1. In every stage of new drug development, the path dependence and the complexity of technological knowledge have significantly negative correlation.
    2. When the new drug development project evolves into the clinical stage, the structure of project team will be different.
    3. The complexity of technological knowledge can affect the composition of team members. If the complexity of technological knowledge is higher, the complexity of members is higher.
    4. The path dependence of technological knowledge can affect the development strategy. If the path dependence is higher or lower, the team members prefer “inner development”. If the path dependence is medium degree, the team members prefer “primary inner development” and then “cooperative research and development”.
    5. The path dependence of technological knowledge can affect the team structure. If the path dependence is higher, the enterprise prefers “Heavyweight team structure” or “Autonomous team structure”. If the path dependence is lower, the enterprise prefers “Lightweight team structure” or “Functional team structure”.
    6. If the explicitness of technological knowledge is higher, the enterprise intends to recruit team member from outside.
    7. In clinical stage, the practice investigator can be key person of the success.
    8. If the enterprise has the ability of “primary inner development”, the time and the cost of the new drug development can be reduced.
    Reference: 一、 中文部分
    1. 王偉中(民88)。台灣軟體產業創新平台之研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    2. 生物技術開發中心(2007),醫藥產業年鑑2007。
    3. 江佳玶(民93)。我國生技新藥研發公司智慧財產權策略研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    4. 李仁芳 (民86)。「聚智分金-台灣企業技術網絡建構之探討」,第六屆產業管理研討會,ppl-36。
    5. 李仁芳、賴建男與賴威龍(民86)。「台灣IC設計業中技術知識特質與組織動態能耐之研究」,1997年科技管理研討會。
    6. 吳心慈(民89)。台灣生技製藥廠商之技術知識特質與技術網絡之研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    7. 吳豐祥、謝慶龍 (民91)「技術知識特質對知識管理作為的影響之實證研究」,2002知識經濟與科技創造力培育國際研討會,2002年4月19-21日,師範大學,台北市。
    8. 徐健銘(民91)。高科技中小企業產品創新與知識管理之研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    9. 涂瑞德(民87)。技術知識特質、產業開發團隊與組織動態能耐關係之研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    10. 黃雅苓(民90)。知識移轉機制與知識管理能力對知識移轉績效之研究。未出版之碩士論文,成功大學企業管理學系,台南市。
    11. 廖佑宗(民87)。技術知識特質與組織動態能耐之研究-以化工所為例。未出版之碩士論文,輔仁大學管理學研究所,台北縣。
    12. 劉昱岑(民93)。台灣生物科技公司創新行為之研究。未出版之碩士論文,政治大學科技管理研究所,台北市。
    13. 藥品非臨床試驗優良操作規範,行政院衛生署 編,中華民國八十九年六月三版。
    14. 藥品非臨床試驗安全性規範,行政院衛生署 編,中華民國八十九年六月三版。
    15. 藥品臨床試驗申請須知,行政院衛生署編印,中華民國八十九年九 月。
    二、 英文部分
    1. Booz, A. H. (1982), “New Product Management for 1980s”, New York: Booz, Allen & Hamilton.
    2. Clark, K. B and Wheelwright, S.C (1992), “Organizing and Leading `Heavyweight` Development Teams”, California Management Review 34, 9-28.
    3. Dosi, G. (1982), “Technological Paradigms and Technological Trajectories”, Research Policy Vol. 11, No. 3, 147-62.
    4. Dougherty, D. (1990), “Understanding New Markets for New Products”, Strategic Management Journal, 11, 59-78.
    5. Edvinsson, L and Sullivan, P (1996), “Developing A Model for Managing Intellectual Capital”, European Management Journal Vol. 14, No. 4, 356-364.
    6. Fleming Q. W. & Koppleman J. M. (1997), “Integrated Project Development Team: Another Fad or A Permanent Change”, Project Management 28(1), 4-11.
    7. Miyazaki, K. (1997), “Complex System - Toward a New Paradigm in Technology Management”, 7th International Forum on Technology Management, Tokyo, Japan.
    8. Gaurud, R.and Nayyer, P.R. (1994), “Transformative Capacity: Continual Structuring by Intertemporal Technology Transfer”, Strategic Management Journal Vol.15 No.5, 365-385.
    9. Nonaka and Takeuchi (1995), The Knowledge-Creating Company, New York, Oxford University Press.
    10. Polanyi, M. (1962), Personal Knowledge. London: Routledge.
    11. Simon, H. (1979), “The Architecture of Complexity”, The Science of the Artificial, Cambridge, 467-482.
    12. Teece, D. J. (1996), “Firm Organization, Industrial Structure and Technological Innovation”, Journal of Economic Behavior and Organization 31, 193-224.
    13. Tyre, M. (1991), “Managing The Introduction of New Process Technology: International Differences in A Multiplant Network”, Research Policy Vol. 20, 57-76.
    14. Utterback (1994), Mastering the Dynamics of Innovation, Boston (MA), Harvard University Press.
    15. Wheelwright, C. (1993), Managing New Product and Process Development, New York: Fress Press.
    16. Yin, R. k. (1989), Case Study Research: Design and Methods, London, Sage Publications.
    17. Zander, U., and B. Kogut (1995), “Knowledge and the Speed of the Transfer and Imitation of Organizational Capabilities: An Empirical Test”, Organization Science 11, 76-92.
    Description: 碩士
    國立政治大學
    科技管理研究所
    96359015
    97
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0096359015
    Data Type: thesis
    Appears in Collections:[Graduate Institute of Technology and Innovation Management] Theses

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