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5 - Outsourcing, fragmentation, and integration

The pharmaceutical industry

Published online by Cambridge University Press:  10 January 2011

Janis K. Kapler
Affiliation:
University of Massachusetts, Boston
Kimberly A. Puhala
Affiliation:
University of Massachusetts, Boston
Farok J. Contractor
Affiliation:
Rutgers University, New Jersey
Vikas Kumar
Affiliation:
University of Sydney
Sumit K. Kundu
Affiliation:
Florida International University
Torben Pedersen
Affiliation:
Copenhagen Business School
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Summary

Introduction

The outsourcing of non-core standardized tasks and processes which permit relatively easy measurement of performance and quality is a well-known story. Outsourcing is presented as an opportunity resulting from technological changes that permit the springing up of thick intermediate markets (Langlois, 2003; Milberg, 2004; Narula, 2001; Williamson, 1981). This allows firms to use markets to obtain intermediate products and services, with the associated benefits from specialization, economies of scale, and competition, resulting in lower costs and better quality intermediate products (Langlois, 2003). This is treated as a dynamic transaction cost story. Advances in the standardization and codification of production processes promotes a smooth interface between vertical stages of production. This allows principal firms to concentrate on core competence activities, with few coordination costs required to maintain the vertical relationship. Coordination costs are low because the outsourced intermediate product is the result of rote labor which can be easily measured and monitored by the new technology embodied in production equipment. In addition, the principal firm benefits from conservation of capital, diminishing uncertainty, and the spreading of risk. In this story, the principal firm retains knowledge-process core competences within the firm, not only because these competences rely on tacit information and ongoing knowledge creation (and are thus difficult to transfer to an outside entity), but also because they are the sources of the firm's competitive advantages, requiring protection from appropriation (Dosi et al., 2006; Kogut and Zander, 1993; Sen, 2006). Langlois (2003: 347) describes the pre-conditions for this organizational transformation:

Decentralization implies an ability to cut apart the stages of production cleanly enough that they can be placed into separate hands without high costs of coordination…decentralization implies some degree of standardization of “interfaces” between stages.

Type
Chapter
Information
Global Outsourcing and Offshoring
An Integrated Approach to Theory and Corporate Strategy
, pp. 137 - 167
Publisher: Cambridge University Press
Print publication year: 2010

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References

Angell, M. 2004. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York: Random House.Google Scholar
Azoulay, P. 2003. “Agents of embeddedness,” NBER Working Paper 10142.CrossRef
Balconi, M. 2002. “Tacitness, codification of technological knowledge and the organisation of industry,” Research Policy 31: 357–79.CrossRefGoogle Scholar
Balconi, M., Pozzali, A., and Viale, R. 2007. “The ‘codification debate’ revisited: a conceptual framework to analyze the role of tacit knowledge in economics,” Industrial and Corporate Change 16(5): 823– 49.CrossRefGoogle Scholar
Bhatt, N.A. 2005. “Dynamics of India's life sciences outsourcing industry,” Pharmaceutical Technology. Accessed at http://license.icopyright.net/user/viewFreeUse.act?fuid=NjAwNzM3.
Boswell, C. 2005. “Discovery outsourcing increases,” Chemical Market Reporter 267: 14–15.Google Scholar
Cantwell, J. 1991. “A survey of theories of international production,” in Pitelis, C. and Sugden, R. (eds.), The Nature of the Transnational Firm. London: Routledge, pp. 16–63.Google Scholar
Cantwell, J. and Santangelo, G.D. 1999. “The frontier of international technology networks: sourcing abroad the most highly tacit capabilities,” Information Economics and Policy 11(1): 101–23.CrossRefGoogle Scholar
,CDISC (Clinical Data Interchange Standards Consortium). 2008a. Accessed at CDISC, “Strategy & Goals,” “CDISC 2008+5 strategy document,” at www.cdisc.org/about/about_strategy.html.
,CDISC (Clinical Data Interchange Standards Consortium) 2008b. “FDA information/documents relevant to CDISC.” Accessed at www.cdisc.org/publications/regdoc.html.
Clark, D.E. 2007. “Outsourcing lead optimization: constant change is here to stay,” Drug Discovery Today 12(1–2): 62–70.CrossRefGoogle Scholar
Clark, D.E. and Newton, C.G. 2004. “Outsourcing lead optimization – the quiet revolution,” Drug Discovery Today 9(11): 492–500.CrossRefGoogle Scholar
Cline, J. 2007. “The state of E-Clinical technology: E-Solutions are on the rise and gaining favor with FDA, as resistance finally gives way,” Applied Clinical Trials. Accessed at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=431921.
Cline, J. 2008. “FDA information/documents relevant to CDISC.” Accessed at www.cdisc.org/publications/regdoc.html.
Cockburn, I.M. 2004. “The changing structure of the pharmaceutical industry,” Health Affairs 23(1): 10–22.CrossRefGoogle ScholarPubMed
Cockburn, I.M. 2006. “Is the pharmaceutical industry in a productivity crisis?” Paper prepared for the NBER Innovation Policy and the Economy Conference, Washington, DC.
,CTTI (Clinical Trials Transformation Initiative). 2007. “FDA and Duke collaborate to modernize clinical trials.” Accessed at www.trialstransformation.org/fda-and-duke-collaborate-to-modernize-clinical-trials.
Daniel, D.A., Nanette, N., James, K., and Sue, A.S. 1997. “Outsourcing management in the pharmaceutical industry: the early stages at four United States companies,” Drug Information Journal 31: 111–18.CrossRefGoogle Scholar
DiMasi, J.A., Ronald, W.H., and Henry, G.G. 2003. “The price of innovation: new estimates of drug development costs,” Journal of Health Economics 22: 151–85.CrossRefGoogle Scholar
Doshi, K. 2004. “Pharmaceutical outsourcing: the next wave,” Indian Journal of Economics and Business Special Issue: 125–35.
Dosi, G., Franco, M., Giovanni, B.R., and Francesco, S. 2006. “Information, apropriability, and the generation of innovative knowledge four decades after Arrow and Nelson: an introduction,” Industrial and Corporate Change 15(6): 891–901.CrossRefGoogle Scholar
Ernst, D. 2006. “Innovation offshoring: Asia's emerging role in global innovation Nnetworks,” East-West Center Special Reports 10.Google Scholar
Finkelstein, S. and Temin, P. 2008. Reasonable Rx: Solving the Drug Price Crisis. Upper Saddle River, NJ: FT Press.Google Scholar
,Future Pharmaceuticals. 2006. “The holy grail of clinical trials”: 40–42. Accessed at www.futurepharmaus.com/?mc=holy-grail&page=ct-viewresearch.
Galambos, L. and Sturchio, J.L. 1998. “Pharmaceutical firms and the transition to biotechnology: a study in strategic innovation,” The Business History Review 72(2): 250–78.CrossRefGoogle Scholar
Gassman, O., Reepmeyer, G., and Zedtwitz, M. 2004. Leading Pharmaceutical Innovation: Trends and Drivers for Growth in the Pharmaceutical Industry. Berlin: Springer.CrossRefGoogle Scholar
Getz, K.A. 2006. “Insights from today's CRO renaissance,” Applied Clinical Trials Online. Accessed at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=334568.
Getz, K.A. 2007. “CRO shifts in the outsourcing market,” Applied Clinical Trials Online. Accessed at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=424918.
Gilbert, J., Henske, P., and Singh, A. 2003. “Rebuilding big pharma's business model,” IN VIVO: The Business & Medicine Report (21)10. Accessed at www.windhover.com/windhover/content/publications/ index.aspx.Google Scholar
Gopalan, S. 2007. “CPP: an emerging trend in intellectual partnering,” Specialty Chemicals 27(4): 22–23.Google Scholar
Gradwell, T. 2003. “Outsourcing knowledge creation: don't give the game away,” Specialty Chemicals 23(8): 24–25.Google Scholar
Grant, R.M. 1996. “Prospering in dynamically-competitive environments: organizational capability as knowledge integration,” Organization Science 7(4): 375–87.CrossRefGoogle Scholar
Hall, J.M. 2000. “The future role of CROs,” Drug Discovery World: 13–16. Accessed at www.ddw-online.com.
Harris, G. 2008. “British balance benefit vs. cost of latest drugs,” The New York Times. Accessed at www.nytimes.com/2008/12/03/health/03nice.html?
,HHS (US Department of Health and Human Services). 2006. “Statement of regulatory priorities.” Accessed at CDISC, “Regulatory Documents,” www.cdisc.org/publications/regdoc.html.
Higgins, M.J. and Rodriguez, D.R. 2006. “The outsourcing of R&D through acquisitions in the pharmaceutical industry,” Journal of Financial Economics 80: 351–83.CrossRef
Hindin, T.J. 2004. “Looking back, moving forward: a CRO retrospective,” Applied Clinical Trials Online. Accessed at http://actmagazine.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=109371.
,ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) (n.d.). “History and future of ICH.” Accessed at www.ich.org/cache/compo/276–254-1.html.
,ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) “ICH Guidelines” (n.d.). Accessed at www.ich.org/cache/compo/276–254-1.html.
Ietto-Gillies, G. 2002. Transnational Corporations: Fragmentation Amidst Integration. Routledge Studies in International Business and the World Economy. London: Routledge.CrossRefGoogle Scholar
John, S. 2006. “Leadership and strategic change in outsourcing core competencies: lessons from the pharmaceutical industry,” Human Systems Management 25: 135–43.Google Scholar
Kapler, J.K. 2007. “The theory of the firm, the theory of competition, and the transnational corporation,” Competition and Change 11(4): 287–306.CrossRefGoogle Scholar
Kermani, F. and Langer, E.S. 2007. “Outsourcing is key to future pharmaceutical R&D strategy,” Pharmaceutical Technology Europe 19(3): 14–17. Accessed from Business Source Premier database.Google Scholar
King, J. 2004. “Today's drug discovery: unlocking greater potential,” R&D Directions 10(2): 28–36.Google Scholar
Kleyn, D., Kitney, R., and Atun, R.A. 2007. “Partnership and innovation in the life sciences,” International Journal of Innovation Management 11(2): 323–47.CrossRefGoogle Scholar
Kogut, B. and Zander, Z. 1993. “Knowledge of the firm and the evolutionary theory of the multinational corporation,” Journal of International Business Studies 24: 625–45.CrossRefGoogle Scholar
Kush, R., Newby, F., Iberson-Hurst, D., and Montjoie, A.M. 2008. “The future of ODM, SDTM, and CDISC.” Accessed at http://clinpage.com/article/the_future_of_odm_sdtm_and_cdisc/C12.
Lamoreaux, N.R., Raff, D.M.G., and Temin, P. 2003. “Beyond markets and hierarchies: toward a new synthesis of American business history,” American Historical Review 108: 404–33.CrossRefGoogle Scholar
Langlois, R.N. 2003. “The vanishing hand: the changing dynamics of industrial capitalism,” Industrial and Corporate Change 12(2): 351– 85.CrossRefGoogle Scholar
Lazonick, W. 1991. Business Organization and the Myth of the Market Economy. Cambridge University Press.Google Scholar
Levina, N. and Vaast, E. 2008. “Innovating or doing as told? Status differences and overlapping boundaries in offshore collaboration,” MIS Quarterly 32(2): 307–32.CrossRefGoogle Scholar
Martinez, B. and Goldstein, J. 2007. “Big pharma faces grim prognosis; industry fails to find new drugs to replace wonders like Lipitor,” The Wall Street Journal, December 6. Accessed at http://proquest.umi.com/pqdlink?index=0&sid=1&srchmode=1&vinst=PROD&fmt=4&startpage=1&clientid=46815&vname=PQD&RQT=309&did=1393817541&scaling.
Maskell, P., Pedersen, T., Petersen, B., and Nielsen, J. 2007. “Learning paths to offshore outsourcing: from cost reduction to knowledge seeking,” Industry and Innovation 14(3): 239–57.CrossRefGoogle Scholar
Mattingly, S. 2003. “What does the future hold for CROs?Good Clinical Practice Journal 10(4). Accessed at www.GCPj.com.Google Scholar
McCoy, M. and Tremblay, J.F. 2003. “Tapping foreign brains for profit,” Chemical and Engineering News 81: 15–23. Accessed at http://pubs.acs.org/cen/.Google Scholar
Mehta, S. and Peters, S.F. 2007. “Outsourcing a core competency,” Research Technology Management 50(3): 28–34.CrossRefGoogle Scholar
Milberg, W. 2004. “The changing structure of trade linked to global production systems: what are the policy implications?International Labor Review 142(1–2): 45–90.CrossRefGoogle Scholar
Miller, J. 2007a. “Stall out in R&D outsourcing,” Pharmaceutical Technology 31(7): 108–10.Google Scholar
Miller, J. 2007b. “Strong demand versus strained capacity,” Pharmaceutical Technology 32 (Supplement): 14–22.Google Scholar
Mitchel, A., Jules, T., Kim, Y., Choi, J., Hays, V., Langendorf, J., and Cappi, S. 2006. “Impact of IBCTs on clinical trial efficiency,” Applied Clinical Trials Online. Accessed at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=363641.
Narula, R. 2001. “Choosing between internal and non-internal R&D activities: some technological and economic factors,” Technology Analysis & Strategic Management 13(3): 365–87.CrossRefGoogle Scholar
Nolan, P., Sutherland, D., and Zhang, J. 2002. “The challenge of the global business revolution,” Contributions to Political Economy 21: 91–110.CrossRefGoogle Scholar
Parexel, . 2007. Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008. Boston: Parexel.Google Scholar
Pedersen, T. 2008. “Offshoring of high value-added activities – what is this about?” Paper presented at Conference on Offshoring and Outsourcing: The Organizational and Geographical Relocation of High-Value Company Functions. Milan, Italy.
,Pharmaceutical Executive. 2006. “A question of ethics?” 26 (Supplement): 16–16.
Piachaud, B. 2004. Outsourcing R&D in the Pharmaceutical Industry: From Conceptualisation to Implementation of the Strategic Sourcing Process. Houndmills: Palgrave Macmillan.CrossRefGoogle Scholar
,Public Citizen (Congress Watch). 2003. “2002 drug industry profits: hefty pharmaceutical company margins dwarf other industries.” Accessed at www.citizen.org/documents/Pharma_Report.pdf.
Rogers, M.J., Maranas, C.D., and Ding, M. 2004. “Valuation and design of pharmaceutical R&D licensing deals,” AIChE [American Institute of Chemical Engineers]Journal 51(1): 198–209.Google Scholar
Scherer, F.M. 2004. “The pharmaceutical industry – prices and progress,” New England Journal of Medicine 351(9): 927–32.CrossRefGoogle ScholarPubMed
Sen, F. 2006. “Special issue on outsourcing,” Human Systems Management 25: 89–90.Google Scholar
Sen, F. and Shiel, M. 2006. “From Business Process Outsourcing (BPO) to Knowledge Process Outsourcing (KPO): some issues,” Human Systems Management 25: 145–55.Google Scholar
Souza, T., Kush, R., and Evans, J.P. 2007. “Global clinical data interchange standards are here!Drug Discovery Today 12(3–4): 174–81.CrossRefGoogle Scholar
Takeishi, A. 2002. “Knowledge partitioning in the interfirm division of labor: the case of automative product development,” Organization Science 13(3): 321–38.CrossRefGoogle Scholar
Thakur, P. 2009. “Externalization of clinical trials and their geographical coverage: in-house versus outsourcing versus offshoring,” Rutgers University. Dissertation, forthcoming.
Thiers, F.A., Sinskey, A.J., and Berndt, E.R. 2007. “Trends in the globalization of clinical trials,” Nature Reviews Drug Discovery. Accessed at www.nature.com/reviews/drugdisc.
,Tufts Center for the Study of Drug Development (TCSDD). 2006. “New approaches to assessing drug safety will help reduce development time and costs.” Accessed at http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=64.
Ulset, S. 2008. “The rise and fall of global network alliances,” Industrial and Corporate Change 17(2): 267–300.CrossRefGoogle Scholar
,UNCTAD. 2005. World Investment Report 2005: Transnational Corporations and the Internationalization of R&D. New York and Geneva: United Nations.Google Scholar
,UNCTAD 2007. “Memorandum of understanding between the Food and Drug Administration and Duke University,” Federal Register 72: 65745.Google Scholar
,FDA (US Food and Drug Administration). 2004. “Stagnation/innovation: challenge and opportunity on the critical path to new medical products,” White Paper. Accessed at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.
Williamson, O.E. 1981. “The modern corporation: Origins, evolution, attributes,” Journal of Economic Literature 19: 1537–68.Google Scholar
Wood, F. and Guinter, F. 2007. “Evolution and implementation of the CDISC Study Data Tabulation Model (SDTM),…” The Pharmaceutical Industry SAS Users Group. Accessed at www.lexjansen.com/pharmasug/2007/fc/fc08.pdf.

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