

OUTSOURCING MODEL OF DRUG DEVELOPMENT IN PHARMACEUTICAL INDUSTRY
Abstract
In recent times health-care budget constraints have been responsible for the mounting pressure on the profitability and growth prospects of the pharmaceutical industry. The performance in the past decade has not been able to boost the confidence levels of patients, health-care professionals, sponsors, and stakeholders. At the crux of the matter is that in the midst of the ever growing market for new drug molecules, loss of revenue due to patent expirations can only be sustained by igniting the R&D productivity. This paper attempts to focus on the service providers in clinical research which have over the past two decades turned into a specialized global industry providing niche services. This expanding industry may include patient recruitment firms, site management organizations, academic research organizations, data capture software vendors, and commercialized institutional review boards.
Keywords
References
Danzon PM, Nicholson S, and Pereira NS. (2005). “Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliances”, J. Health Econ, Vol.24, pp.317-339.
Drews J. (2000). “Drug Discovery: a historical perspective”, Science, Vol.287, pp.1960-1964.
Enlight Biosciences. (2008). [press release] http://www.enlightbio.com/news/enlight-biosciences-launched-in-collaboration-with-merck-andco-inc-pfizer-and-eli-lilly-pharmaceutical-and-academic-luminaries-combineforces-to-addressinnovation-bottleneck-33
FDA Amendments Act. Pub. L. No. 110-85, 121 Stat. 823.
Getz KA, Wenger J, Campo RA, Seguine ES, and Kaitin KI. (2008). “Assessing the impact of protocol design changes on clinical trial performance”, Am. J. Ther, Vol.15, pp.450-457. [PubMed: 18806521]
Grabowski HG, Vernon JM, and DiMasi JA. (2002). “Returns on research and development for 1990s new drug introductions”, Pharmacoeconomics, Vol.20, pp.11-29. [PubMed: 12457422]
Lilly sells its Greenfield, Indiana, operations to Covance; expands existing collaboration between the two companies. (2008). [press release] http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=326599
Lilly sings a new tune: Chorus unit brings high efficiency note to early R&D; The Pink Sheet. [online], http://www.choruspharma.com/p070226_26.pdf (2007).
Maloff BL. (1999). “Partnering for Success—Performance Measurements for Sponsors, Contract Research Organizations, and Site Management Organizations”, Drug Information Journal, Vol.33, p.656.
Paul SM, Mytelka DS, and Dunwiddie CT. (2000). “How to improve R&D productivity: the pharmaceutical industry’s grand challenge”, Nature reviews, Vol.9, pp.203-214.
Resisting NICE. (2007). “BioCentury: The Bernstein Report on BioBusiness”, October 8, Vol.15(45), pp.A1-A11.
Rettig RA. (2000). “The industrialization of Clinical Research”, Health affairs, Vol.19, pp.129-146.
Refbacks
- There are currently no refbacks.
Send mail to ijmpr@ijmpr.com with questions or comments about this web site.
International Journal of Medical and Pharma Research, All rights reserved.