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Abstract:
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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. |
