Biomedical Engineering Reference
In-Depth Information
3.1
INTRODUCTION
Over the last decade the biomedical research community has undergone sig-
nifi cant changes with respect to the mechanisms and models used to conduct
scientifi c research. These changes have been spurred largely by the shift in the
research paradigm that drives drug research and development (R&D) coupled
with the accelerated pace of emerging technologies.
For several decades the pharmaceutical industry has employed a “closed
model” which was underpinned by two premises: (1) discovering and develop-
ing new drugs and (2) patenting those drugs in order to gain a monopoly on
the profi ts of the newly developed drug. Since the development of a monopoly
is based on capturing exclusive intellectual property right (e.g., patent exclusiv-
ity or exclusive licenses), this traditional model is competitive and inherently
discourages the use of collaborative mechanisms.
While historically yielding high rates of return on investment, this closed
model of R&D has been encumbered by increasing development costs and
regulatory hurdles. For example, the average cost of developing a new drug in
2002 was $800 million, while the 2006 study from the U.S. Federal Trade
Commission estimated costs of new drug development ranging from $500
million to $2 billion [1].
The decline in the U.S. economic status coupled with the escalating cost of
drug development has forced the pharmaceutical industry, as well as the bio-
technology and diagnostic industries, to reevaluate the traditional “solo”
model of conducting research—and has led to the emergence of nontraditional
partnerships and collaborative models. This chapter will introduce the con-
cepts of modern partnerships and will describe some of the current partnership
models that are being used to conduct collaborative scientifi c research.
3.2
IMPORTANCE OF PARTNERSHIPS
The concept of working collaboratively to advance scientifi c research efforts
is not a new idea. However, the notion of collaborating within the scientifi c
research arena through the twentieth century had been limited to the sharing
of reagents and/or tools—mice, cell lines, antibodies, and so on. These tradi-
tional “partnerships” were generally the result of scientists sharing their curi-
osity for a particular scientifi c question and recognition that there may be
some value in sharing controlled amounts of information to advance that
shared research interest.
While traditional partnerships were successful in bringing together research-
ers sharing common research goals, they were limited in both scope and out-
comes. Additionally, these early efforts to collaborate were limited to academic
researchers and rarely, if ever, involved the industry sector.
Multisector partnerships are relatively new and are still largely competitive
versus precompetitive (see Section 3.3.1) in their structure. However, many of
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