Biomedical Engineering Reference
In-Depth Information
projects to obtain in-kind contribution from industry has meant that they are
very focused on things that could make a real difference to the drug discovery
and development process. However, this did cause some diffi culties early on
in the review process as reviewers, primarily from academic backgrounds, were
more used to reviewing very early, more blue-sky projects. Likewise in the
discussions around the IP policy, it was much easier to defi ne the boundaries
in safety projects than in effi cacy projects, although there were no IP issues
that precluded projects from the fi rst call progressing. Effi cacy projects also
had challenges as they are very much dependent on the long-term commit-
ment of a company to the particular therapeutic area in question. In 2010 a
number of companies exited aspects of neuroscience research, which meant
that there had to be some changes to consortia involved in the neuroscience
effi cacy projects.
Another lesson from the IMI was the importance of providing subject
matter experts within companies to drive forward the IMI centrally. This
included people from fi nance, legal, IP, and project management functions.
With such a large program of work there is clearly a need for dedicated tools
for data sharing and knowledge management and the IMI offi ce will have to
make sure that there is suffi cient cross talk across programs and projects to
ensure data can be transferred and stored in an accessible way with little
duplication. The IMI offi ce is also working with groups globally, such as the
Biomarkers Consortium, to reduce overlap and duplication and ensure efforts
are synergistic where possible. Indeed there is a clear requirement going
forward for the IMI to complement rather than compete with other initiatives
globally. Resources within the industry will continue to be constrained, and as
large companies are global, they will seek to avoid duplication of effort in
precompetitive collaborations.
Leadership from the industry participants was also important in moving the
IMI agenda forward. The RDG developed a good working relationship that
allowed the industry to agree on the bottlenecks that needed to be solved and
show a clear commitment to the precompetitive agenda. Such open and honest
communication takes time to develop but is necessary to tackle the inevitable
issues that arise.
There do remain a number of challenges going forward. There needs to
be greater involvement of patients and lay persons to maximize their input
and ensure the aims and achievements of the IMI are communicated widely.
The need to consider contributions from outside Europe and from pharma-
ceutical companies not in the EFPIA or from related industries (e.g., diag-
nostics) is also a challenge that remains despite being fl agged as an issue very
early on in the process. There are also other fi nancial challenges such as the
differences between the IMI and other Framework VII funding programs in
funding parameters such as overheads. However, the IMI has clearly shown
that precompetitive research can happen on a grand scale and has largely
been successful in its original aim of stimulating more pharmaceutical R&D
in Europe.
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