The future of the pharmaceutical R&D process

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The future of the pharmaceutical R&D process

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Title: The future of the pharmaceutical R&D process
Author: Andersson, Pernille; Hallager, Morten
Abstract: Changes in factors such as income distributions, population demographics, and epidemiological trends gives rise to unique market opportunities, by shifting demand into new therapeutic areas. However, decreasing R&D productivity causes industry experts to argue that the pharmaceutical industry must reinvent it self, in order to capitalize on these emerging opportunities. This motivates present thesis to explore future trends of the pharmaceutical R&D process. The thesis initially investigates the current R&D productivity ‘crisis’ and, by defining input as total industry R&D expenditure and output as approved New Molecular Entities by the Food and Drug Administration, a sevenfold decrease in R&D productivity from 1970-2008 is identified, which is driven primarily from a vast increase in cost related to late-stage drug failures. Hereafter, the analysis proceed to an analysis of five selected pharmaceutical companies; Pfizer, GlaxoSmithKline, Daiichi Sankyo, Bristol-Myers Squibb and Sanofi-aventis, to identify current R&D trends. The analysis establishes that the traditional blockbuster product centric strategy makes companies vulnerable to generic competition, due to the over-reliance on sales generated by only a few products. On this foundation the contours of the future seem to be therapeutic diversification into the market for biologics. Furthermore, the analysis finds evidence that a shift from the traditional blockbuster product centric strategy to a more personalized drug development is apparent. The thesis proceeds to an examination of future trends, and finds that alterations of the present organizational configurations are essential, in order to create a more effective R&D process, however, these alterations are influenced by a long time horizon. Three main areas of alterations were identified: enhanced focus on niche markets, change from the traditional topdown management approach, and an increased importance and utilization of external scientific affairs. Especially external scientific affairs is found to be of great significance to the evolvement of personalized medicine, and therefore, an in-depth analysis examines how these affairs will materialize in the future. Gaining access to the patient data to identify biomarkers, is identified as the primary driver of the personalization of medications, however, this must be incorporated in the conventional pharmaceutical research via the utilization of supporting technologies. Acknowledging that these supporting technologies, to a large extend are discovered and developed external to most pharmaceutical companies, the thesis forecast an increase in collaboration between pharmaceutical companies and external partners. Based on this analysis, the thesis provides a series of recommendations on the generation of successful partnerships, how to ensure quality and safety in medicine development in partnerships, and the thesis recommend a new R&D process that possess advantages for developing personalized medicine. The thesis concludes by stating that the transition towards, and development of, personalized medicine is extremely complex, hence, pharmaceutical companies are advised to ‘take it easy’ by employing a logical incremental implementation plan, by gradually changing visions, strategy and the R&D process towards discovering and developing personalized medicine.
URI: http://hdl.handle.net/10417/788
Date: 2009-12-10
Pages: 170 s.
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