臺灣博碩士論文加值系統

製藥產業是一個具有無窮商機與挑戰的獨特產業。面對著衛生主管機關的改變和醫藥市場內競爭的壓力；以及投資人對公司獲利的期許，都迫使製藥產業在新的世紀裡必須更快速的回應這些挑戰。因此製藥產業對新藥品開發及上市的要求也就更加急迫。
研究及開發（R&D）與行銷（Marketing）是新產品開發過程中主要的兩大核心任務。研究及開發與行銷之間的界面關係與新產品的成敗有著密不可分的關聯。Triple Stream Process（R&D, Marketing, Evaluation）可以用來檢測新產品開發及管理過程，進而對研究及開發與行銷之間的界面關係進行探討。本研究乃針對製藥產業產品開發的特性提出一個適合的Triple Stream Process，並從研究及開發與行銷兩個構面中對製藥產業的需求提出討論。
本研究接著以一個個案為例，針對該製藥公司的新產品開發過程中主要的兩大核心任務進行討論，並對觀察到的現象提出看法與可能的解決方案。
總結之，能夠成功地推出一個產品，其產品的開發過程應包含一個好的計畫、一個持續檢測的評估系統、一個有效能的組織、以及將所有成員組織起來為同一目標努力的企業文化。Triple Stream Process 應在技術層面上成為產品開發的骨架，而組織/文化則如同骨骼間的關節使計畫能夠平順地行動。兩者都是使產品開發成功不可或缺的必要條件。

Pharmaceutical industry is a unique industry with tremendous business opportunities and challenges. As changes from health authority, competing pressure within healthcare market, and expectations from shareholders increased, all of these have forced pharmaceutical industry to meet those challenges more rapidly in the new century. Therefore, the demand for new pharmaceutical products is getting more urgent.
R&D and marketing are two major tasks in new product development; the coordination between R&D and marketing has close relationship with the success of a new product. A Triple Stream Process has used to examining new product development management, and further evaluating. the interface between R&D and marketing. This research has proposed a modified Triple Stream Process for the new pharmaceutical product development management. Requests from R&D and marketing have also been discussed.
A case study has been raised for examining integration between R&D and marketing interface during new product development process. Observed phenomena have been analyzed and possible solutions have been proposed.
In summary, successfully executing a product development program includes a good plan, a continuous evaluation system, and an effective organization that brings all members together working for the same goal under a strong culture. Triple Stream Process should serve as the skeleton for the product development on technical level, while organization/culture will serve as the joint to make the firm move smoothly. Both of them are necessary for the success of a new product development.

CHAPTER 1 INTRODUCTION……………………………………………1
1.1. BACKGROUND OF PHARMACEUTICAL INDUSTRY………………1
1.2. DISCOVERY AND DEVELOPMENT PROCESS………………………2
1.2.1. DISCOVERY……………………………………………………2
1.2.2. DEVELOPMENT…………………………………………………2
1.3. MEDICAL MARKETING……………………………………………5
1.4. KEY CHARACTER FOR PHARMACEUTICAL INDUSTRY…………5
1.4.1. KNOWLEDGE-BASED INDUSTRY………………………………5
1.4.2. INVESTMENT RISK……………………………………………6
1.4.3. GOVERNMENT REGULATION…………………………………… 6
1.4.4. COMPLICATED PRODUCT LIFE CYCLE………………………7
1.5. THE CHALLENGES FACING PHARMACEUTICAL INDUSTRY……9
1.5.1. HIGH FINANCIAL EXPECTION………………………………9
1.5.2. CUSTOMER AWARENESS………………………………………10
1.5.3. R&D PRODUCTIVITY PRESSURE………………………………10
1.5.4. GOVERNMENT PRESSURE………………………………………11
1.6. STATEMENT OF THE PROBLEM…………………………………11
1.7. PROJECT MOTIVATION……………………………………………12
CHAPTER 2 MANAGEMENT OF NEW PRODUCT DEVELOPMENT PROCESS
…………………………………………………………13
2.1. FROM PROCESS’S PERSPECTIVES……………………………13
2.1.1. STRATEGIC PLANNING STAGE………………………………15
2.1.2 CONCEPT GENERATION STAGE…………………………………15
2.1.3. PRETECHNICAL EVALUATION STAGE…………………………16
2.1.4. TECHNICAL DEVELOPMENT STAGE……………………………17
2.1.5. COMMERCIALIZATION STAGE…………………………………18
2.2. FROM ORGANIZATION’S PERSPECTIVES………………………19
2.2.1. FUNCTIONAL ROLE……………………………………………19
2.2.2. TRAINING BACKGROUND………………………………………19
2.2.3. CULTURE………………………………………………………20
2.3. INTEGRATION OF R&D AND MARKETING INTERFACE…………22
2.3.1. TRIPLE STREAM PROCESS……………………………………23
2.3.1.1. PURPOSE OF EVALUATION…………………………………23
2.3.1.2. STRUCTURE AND PROCESS OF TRIPLE STREAM
PROCESS……………………………………………………24
2.3.1.3. EVALUATION PARTY…………………………………………26
2.3.2. ORGANIZATIONAL STRUCTURE.………………………………26
2.4. SUMMARY……………………………………………………………28
CHAPTER 3 INTEGRATION IN ACTION: THE PHARMACEUTICAL
INDUSTRY ………………………………………………29
3.1. R&D UNMET NEEDS………………………………………………29
3.2. MARKETING UNMET NEEDS………………………………………30
3.3. UNMET NEEDS FOR BOTH SIDES………………………………31
3.4. INTERFACE BETWEEN R&D AND MARKETING…………………32
CHAPTER 4 CASE STUDY: ROCHE……………………………………35
4.1. COMPANY HISTORY………………………………………………35
4.1.1. THE HOFFMANN ERA (1897-1919)…………………………35
4.1.2. GROWTH (1920-1952)…………………………………………36
4.1.3. EXPANSION (1953-1965)……………………………………37
4.1.4. BOOM AND BUST (1965-1978)………………………………38
4.1.5. SWEEPING CLEAN (1978-1985)……………………………39
4.1.6. RECAP SUCCESS (1986-1999)………………………………40
4.1.7. NEW CHALLENGE (2000-PRESENT)…………………………41
4.2. COMPANY BUSINESSES……………………………………………42
4.3. PHARMACEUTICALS DIVISION…………………………………46
4.3.1. PHARMACEUTICALS DIVISION ORGANIZATION……………49
4.4. LIFE CYCLE MENAGEMENT………………………………………53
4.5. CURRENT SITUATION ANALYSIS………………………………55
4.6. CONCLUSION………………………………………………………58
CHAPTER 5 CONCLUSION………………………………………………60
BIBLIOGRAPHY……………………………………………………………64

Aaker, D.A. (1998) in Strategic Market Management. 5th edition, John Wiley & Sins Inc.
Barrett, Amy. (1998) “The formula at Pfizer: Don’t run with the crowd.” Business Week, 3577, May 11, p.96,
Bastianelli, Enrico, Eckhardt, Jurg and Teirlynck Olivier. (2001) “Pharma: can the middle hold?” The McKinsey Quarterly, Number 1, pp.117-125.
Brown, Philip. (2000) “The trick is in managing R&D and human capital”. Scrip Magazine, December, pp.3-4.
Chaturvedi, Kalpana J. and Rajan, Y.S. (2000) “New Product Development: Challenges of Globalization.” International Journal of Technology Management. 19 (7/8), pp.788-805.
Crawford, C.Merle. (1996) New Product Management, 5th edition, McGraw-Hill, Inc., USA.
Gilmartin, Raymond V. (1998) “Winning in pharmaceutical research.” Research Technology Management. 41 (4), pp.9-12.
Grabowski, H.G. and Vernon, J.M. (2000) “Effective patent life in pharmaceuticals.” International Journal of Technology Management. 19 (1/2), pp.98-120.
Grabowski, Henry G. and Vernon, John M. (1994) “Returns to R&D on new drug introductions in the 1980s’.” J. Health Econ., 13, pp.383-406.
Griffin, Abbie and Hauser, John R. (1996) “Intergrating R&D and marketing: A review and analysis of the literature”. J. Prod. Innov. Manag., 13, pp.191-215.
Gupta, Ashok K., Raj, S. P., and Wilemon, David. (1986) “A model for studying R&D-marketing interface in the product innovatiion process.” Journal of Marketing, 50 (April), pp.7-17.
Hallahan, Mary. (2000) “Building business by therapeutic category.” Pharmaceutical Executive. 20(8), pp.106-107.
International Journal of Technology Management. 19, 788-805, 2000.
Guarino, R.A. (1993) Introduction in New Drug Approval Process. Marcel Dekker, Inc. New York.
James, Barrie G. (2000) “Is big pharma too tied to old business solutions?” Scrip Magazine, September, p.9.
Knight, Karl. (2000) “Opinion leader development: A neglected area?” International Journal of Medical Marketing 1, 2, pp142-147.
Koberstein, Wayne. (1998) “Evolution of value.” Pharmaceutical Executive 18 (7), pp.40-56.
Liyabage, Shantha, Greenfield, Paul F. and Don Robert. (1999) “Towards a fourth generation R&D management model-research networks in knowledge management.” International Journal of Technology Management. 18 (3/4), pp.372-393.
Magrath, A.J. (1990) “What marketing can learn from manufacturing.” Across the Board, pp.37-42.
MacLennan, J., and MacKenzie, D. (2000) “Strategic market segmentation: An opportunity to integrate medical and marketing activities.” International Journal of Medical Marketing 1(2), pp142-147.
Roche Group Annual Report and Group Accounts, 2000.
Rhodes, John D. (1999) “The challenges of governance in the global marketplace: Satisfying shareholders.” Pharmaceutical Executive. 19 (7), pp.86-91.
Saxberg, B and Slocum, J.W. (1968) “The management of scientific manpower.” Management Science 14(8), pp.B473-B489.
Scrip Magazine (2001). “Double-digit growth for world pharma sales for world pharma sales in 2000.” Scrip Magazine, February, pp.31-33.
Tellis, G. J. and Golder, P.N. (1996) “First to market, first to fail? Real causes of enduring market leadership” Sloan Management Review 37, pp.65-75.
Veverka, Mary Jo. (2000) “Delivering the drugs — the quest for better medicines.” Scrip Magazine, March, pp.26-28.
Welling, Peter G., Lasagna, Louis, and Banakar, Umesh V. (1996) The Drug Development Process: Increasing Efficiency and Cost-effectiveness. Marcel Dekker, Inc., New York.
Yeoh, Poh-Lin and Roth Kendall. (1999) “An empirical analysis of sustained advantage in the U.S. pharmaceutical industry: Impact of firm resources and capabilities.” Strategic Management Journal. 20 (7), pp.637-653.