2011 Anniversary Yearbook - EUFEPS today and history

• NeuroMed, which will develop and
validate novel surrogate markers based
upon in vitro and in vivo models in
animal and humans, using Alzheimer´s
disease as a testing platform.
• PredTox will deliver new biomarkers
of toxicity and a greater understanding
of mechanisms of toxicity.
The experience gained here will be used
in the Joint Technology Initiative for
Innovative Medicines in Europe under
FP7.
EU Joint Technology Initiative
(JTI)
A Joint Technology Initiative, via Art.
171 of the EC Treaty, should finance
the Innovative Medicines Initiative,
with its SRA and ETP. However, this
does not happen automatically as 6 JTIs
are currently competing; Innovative
Medicines, Aeronotics, Hydrogen and
Fuel Cells, Embedded Systems, Nano
Electronics, GMES (Global Monitoring
for Environment and Security).
The decision will be taken by
a “Competitiveness Council” of all
European Research Ministries, later this
year. Their decision will be based on;
• European added value
• Inability of existing instruments to
achieve their objectives
• Degree and clarity of definition of
objectives to be pursued
• Strength of financial/resource
commitment by industry
• Contribution to broader policy
objectives
• Scale of the impact on industrial
competitiveness and growth
The IMI JTI is high on the priority list, but
nothing is certain. Therefore it needs your
support, see Mirror Platforms below.
The overall intentions for the JTI on
Innovative Medicines are to;
• provide a mechanism for rapid and
systematic take up, evaluation and
translation of research results into new
methods and techniques for use in the
medicines development process
• facilitate the provision of advice by
regulators for setting up “tailor made”
validations
• provide “neutral ground” for the necessary
collaboration between all
stakeholders, thereby removing the
suspicions of “biased collaborations”
that undermine collaborations today
• foster the development of a new «tool-
box» (toxicology tests, biomarkers,
clinical trials protocols, etc.) for drug
developers to reduce the risk of failure
during clinical trials
• provide the infrastructure for validation
of the new tools in view of rapid uptake
into regulatory and industry practice
• set up ‘knowledge platforms’ pooling
data from toxicology testing and
biomarker validation, which will be
available to all researchers (industry
and academic)
Since the necessary R&D cannot be done
by any one member of the stakeholders
group alone, the IMI will facilitate the
participation of all stakeholder groups
in the research, following open calls and
peer review. Research can be done by
“anybody” as long as it is carried out in
Europe.
At the present stage, March 2006, the
EU money allocated to FP7 are expected
to be considerably less than originally
anticipated. So instead of 400 Mio. Euro
per year, the Commission works with a
plan where they allocate 50 Mio. Euro in
the first year, followed by an increase in
subsequent years, when money becomes
more abundant in the EU system. The
money will be given to public-private
partnerships where industry pays for all of
their own costs and the Commission pays
for the rest. The industry has bound itself
to spend the same amount of money as the
Commission per year.
Proposed governance structure of
the IMI JTI
The IMI JTI Board shall be composed by
the Founding Members (EC and EFPIA)
and by potential new funding members.
The Executive Office is responsible
for day-to-day management regarding the
implementation of the SRA.
The Scientific Committee is an
advisory body to the Board. Collectively
it shall have the competencies to cover the
complete drug development process and
have a balance composition of academia,
patients, industry and regulatory
representatives. In particular it shall advise
on the continued relevance of the SRA
and review the scientific achievements of
the SRA implementation and advise the
board accordingly. Finally it shall advise
on the composition of the peer review
committees.
The Stakeholder Forum should be
LI
open to all stakeholders and convene
annually. It shall ensure the openness and
transparency of IMI and it can provide
strategic advice to the Board.
The Member States Group shall
approve the composition of Scientific
Committee. It shall facilitate rapid
dissemination of information and ensure
co-ordination with national activities.
Especially it shall be responsible for
the implementation of Education and
Training.
It is noteworthy that the organisation
of the Stakeholder Forum is so vaguely
presented. This leaves room for European
organisations linked to the drug
development process to act on this stage.
Conventional support through FP7
If the JTI for Innovative Medicines is
adopted at its intended scale, one should
not expect to see many calls specifically
related to the pharmaceutical research in
the ordinary FP7. However, it will still be
possible to apply for general instruments
like Marie Curie fellowships etc.
Mirror Technological Platforms
In parallel to the European Innovative
Medicines Initiative, corresponding
regional and national platforms have been
established in Denmark-Sweden, The
Netherlands, Spain, France and Romania.
In this connection, it is important that
all researchers engaged in pharma in one
way or another support these initiatives;
indicating to the national governments that
there are local researchers, who will step
in, if their respective ministers support the
JTI on Innovative Medicines. In this way,
your personal effort can strengthen the
pharmaceutical sciences in Europe and
vice versa.
Conclusion
The NSMF initiative has grown in size
and importance, but it has also been
substantially added to and changed
branding, appearing under a new name:
Innovative Medicines Initiative (IMI).
Still the decisive step of significant funding
has not yet been taken, for which reason
I appeal to all EUFEPS membership not
to lose any opportunity to promote and
support the idea in your local environment:
namely that Europe needs the Innovative
Medicines Initiative to compete in the
global arena for pharmaceuticals.
Together we can do it!