Biomedical Engineering Reference
In-Depth Information
Surely, some aspects of the drug innovation process are well-known and widely
discussed. The industry is perhaps less of an enigma these days due to the unfaltering
attention given it in the media. But creating effi cacious drugs is also a multibillion
dollar business, and there is a need to integrate the abundant yet rather compartmen-
talized extant knowledge about drug innovation. Such synthesis can enable us to
view the process systematically and discuss it in more depth, richer detail, and with
a clear emphasis on its business aspects.
It is well known that drug creation fi nds itself on the leading edge of the latest
scientifi c and technological breakthroughs. Revolutionary discoveries in various
disciplines are often employed to assist in the selection among myriads of naturally
occurring compounds, in the design of new ones, or in the transformation of exist-
ing ones. The economic aspects related to the colossal amounts of effort and dedica-
tion germane to drug innovation are no less deserving of attention.
Drug innovation emerges at the confl uence of state-of-the-art discoveries in the
life sciences, aided by cutting-edge advancements in other fi elds such as engineer-
ing, informatics, and optimization. Thriving in the wake of the latest achievements
in these disciplines, it often brings them together to intersect and interact in a way
geared to ultimately improve human health and extend human life. In the process of
fi nding the most effective structures and the most effi cient strategies, novel decision
opportunities and challenges arise, and new organizational forms and arrangements
emerge to address them.
Inventing novel drugs is ultimately a business process in need of strict fi scal
discipline and effective strategic, organizational, and managerial decisions. Various
aspects of pharmaceutical innovation have been the object of intense scrutiny in
diverse fi elds such as economics, business strategy, and marketing. Still, the obtained
fi ndings and inferences have remained somewhat insular, limited to the originating
discipline despite their broader applicability and signifi cance. There are many areas
that warrant further analysis and optimization. This is why a comprehensive over-
view of the business processes, strategies, and practices related to pharmaceutical
innovation seems necessary and timely. A compilation of this kind can be a useful
reference source for various future streams and areas of research.
Hence, the intention with this chapter is to present recent fi ndings related to the
organization and the outcomes of the innovation process in the pharmaceutical indus-
try, and concisely yet systematically review them from a business perspective. We
hope that a more integrated and informative picture of the currently dispersed frag-
ments of knowledge will arise in this process. Such an outlook will be of interest to
business students, fellow researchers, and pharmaceutical executives alike, as well as
to anybody with a keen curiosity about the exciting domain of drug innovation.
We start by presenting some facts and fi gures related to the economics of drug
innovation, and briefl y describe the evolution of drug discovery from a historical per-
spective. We proceed with a comprehensive overview of the modern process of drug
innovation. To highlight the nature and the sources of its inherent complexity, we pro-
vide succinct but hopefully informative descriptions of some of the latest technologies
involved. Next, we discuss the mechanisms of intellectual property protection perti-
nent to the industry, and outline the distinction between patents and market exclusivity.
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