Biomedical Engineering Reference
In-Depth Information
4.1
INTRODUCTION
Over the past decade there has been an enormous increase in the number and
range of precompetitive collaborations between pharmaceutical companies,
biotechnology companies, non - for - profi t organizations, and academia. Yet pre-
competitive research still represents only a small fraction of the research effort
and funding that are expended by pharmaceutical and biotechnology compa-
nies. In part this is because traditionally pharmaceutical companies were
fi ercely competitive and many of these precompetitive collaborations are rela-
tively recent. It is timely to assess what the drivers for change were, what
obstacles may still be present, what lessons can be learnt from existing pre-
competitive efforts, and what the future of precompetitive research might be.
4.1.1
Defi nition of Precompetitive Research
It is useful to have an agreed-upon defi nition of precompetitive research
together with an appreciation of how it differs from other approaches in a
more open pharmaceutical research and development (R&D) framework.
Although precompetitive research has been defi ned as competitors sharing
early stages of research that benefi t all [1], Janet Woodcock has more recently
defi ned precompetitive research as “a subset of translational research that is
focused on improving the tools and techniques needed for successful transla-
tion, and not on development of a specifi c product ” [2] .
A comparison of various forms of collaborative sourcing efforts is shown
in Table 4.1. It can be seen from this that there are clear distinctions between
these approaches and that the working defi nition proposed above for precom-
petitive research is a useful one that distinguishes it from some of the other
types of collaborative activity, such as crowdsourcing. It also follows from this
that some areas, such as safety science, can adopt a precompetitive agenda
more readily than others, for example, developing new targets in a particular
disease area. However, in looking to the future, the areas for precompetitive
collaboration could be greatly expanded (see Section 4.4 ).
4.1.2
Drivers for Change
Ten years ago there were far fewer precompetitive collaborations than at
present. Pharmaceutical companies were still yielding high profi ts and growth
for their investors, the biotechnology bubble had yet to burst, and academic
biomedical research was, in general, well funded in the United States and
Europe. In the last decade, there has been a dramatic change in the fi nances
of large pharmaceutical companies and biotechnology companies. The need
for increased spending on pharmaceutical R&D, aligned with a lack of con-
comitant success in terms of new product approvals, has been well documented
and discussed earlier in this volume. The cost of developing a new drug, includ-
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