خطرات نوآوری برون سپاری در توسعه محصول جدید دارویی
|کد مقاله||سال انتشار||مقاله انگلیسی||ترجمه فارسی||تعداد کلمات|
|646||2012||11 صفحه PDF||سفارش دهید||10200 کلمه|
Publisher : Elsevier - Science Direct (الزویر - ساینس دایرکت)
Journal : Technovation, Volume 32, Issue 2, February 2012, Pages 99–109
New product development, which until relatively recently was a core activity within the pharmaceutical industry, is increasingly being outsourced (Howells et al., 2008). This is symptomatic of the transformation of product development towards a more decentralised, network-based and alliance-rich function. We have selected the pharmaceutical industry for this paper because it offers an excellent example of a research and technology intensive industry where outsourcing has led to problems in the innovation and new product development process. We examine the impact of the increase in outsourcing on the way firms manage the clinical trials process. The increasing role of Clinical Research Organisations (CROs) has dramatically changed the nature of the innovation process. CROs initially provided a limited service in clinical trials management, but have gradually evolved into organisations that have expertise across a much wider spectrum of the clinical development process. The fragmentation of the innovation process, which has arisen from the increased role of CROs, creates innovation risks for the pharmaceutical companies. In this paper we discuss the risks associated with knowledge losses for research and technology intensive industries that may arise from lack of integration of new product development activities and develop a number of propositions for further research.
The pharmaceutical industry is facing major productivity challenges. For example, over a 10 year period the number of new drugs reaching the market declined by 20%, while research and development (R&D) expenditure increased by 60% (CMR International, 2006). The cost of bringing a new drug to market has increased dramatically and is estimated to be in excess of $1.2 billion (DiMasi et al., 2003 and DiMasi and Grabowski, 2007). Competition remains high and lead times have fallen, with the average period of market exclusivity down to less than two years (DiMasi and Paquette, 2004). A key development has been the rise of the importance of the contract research organisations in response to large scale outsourcing of research activities around clinical trials. The pharmaceutical industry provides lessons for other research and technology intensive industries that have not yet developed their outsourcing activities to the same extent. The purpose of this paper is to examine the impact of the increase in outsourcing on the way research and technology intensive firms manage their new product development process and to discuss the potential harm that this may have for such industries. Discovery research, the scientific laboratory research aimed at identifying new drug targets and novel pharmaceutical agents, is seen as the main driver of innovation. Indeed, much attention has been given to renewing technologies in this area, particularly in the fields of biotechnology, genomics and associated technology platforms (Siedlok et al., 2010). Organisational changes occurring as part of this transformation of the discovery research base are well described in the literature, with networks (Powell et al., 1996 and Huston and Sakkab, 2006), clusters (Chiaroni and Chiesa, 2006 and Casper, 2007) and strategic alliances (Deeds and Hill, 2006 and Gutierrez de Mesa Vazquez et al., 2006) all contributing to a move towards ‘virtual’ research forms (Chesbrough and Teece, 1996, Jones, 2000 and Gassmann and Reepmeyer, 2005). As argued by Chesbrough, 2003a, Chesbrough, 2003b, Chesbrough, 2003c and Chesbrough, 2006, the process of innovation has shifted from one of closed systems, internal to the firm, to a new mode of open systems involving a range of players distributed up and down the supply chain.
نتیجه گیری انگلیسی
This paper has explored the outsourcing of clinical development to innovation service providers within the pharmaceutical industry. Our exploratory research provides support for the proposition that the scale and scope of outsourcing to innovation service providers (here termed CROs) has reached a level where they have become key drivers of product development success. We find no evidence to support the fact that firms are beginning to take back development activities in-house (Zirpoli and Becker, 2011). Large-scale outsourcing is apparent at the level of individual functional tasks, clinical trial projects and drug development programmes. Also, there is an emerging trend for ‘preferred supplier’ relationships with smaller numbers of CROs, and global outsourcing of particular functional disciplines such as clinical trials management. Time and costs were not seen as critical to the outsourcing decision, but rather flexible resourcing to cope with the changing capacity requirements arising from the technology uncertainty in new product development programmes was a major factor. There were also clear indications of pharmaceutical companies making strategic outsourcing decisions with the aim of developing new areas of technological know-how (Coombs et al., 2003 and Gassmann et al., 2010). We do find some support for the proposition that the absorptive capacity of pharmaceutical firms is the key to their success in product development in a business environment where the CROs have taken on many of the key tasks. The CROs appear to vary in terms of innovation potential, from those preferring to operate within strict parameters established by the client pharmaceutical company to those, often smaller CROs and partner biotechnology companies, where greater operational autonomy is used to stimulate innovations in service provision. This supports the idea that such project-based firms may not always be sources of innovation (Blindenbach-Driessen and van den Ende, 2010). It would be important to understand the factors influencing the creative climate within and between these organisations (Sundgren et al., 2005) but this is beyond the scope of this exploratory study. We found some indication that loss of technological know-how (Hoecht and Trott, 2006) might be an emerging problem as a result of full-scale functional outsourcing of particular role and task areas, often on a global basis. In such situations the innovative capacity of the service providers would be even more critical. The scope of outsourcing was widespread, with a high degree of internationalisation (Tijssen, 2009). The highly structured and regulated nature of the clinical development process seems to allow a degree of modularisation (Mikkola, 2006), and there is, as might be expected, a high level of focus on objectified knowledge in the form of databases of trial outputs. Information and communication technologies are increasingly global, but remain most well developed within single organisations and within particular functional areas (Howells, 2002). There was, however, a relatively low level of understanding between informants concerning how the broad-based knowledge of the overall product ‘architecture’ is maintained (Baldwin and Clark, 2000 and Zirpoli and Becker, 2011).