Transcript Stronger together

Evolution from IMI1 to IMI2:
challenges ahead
Elmar Nimmesgern, PhD
DG Research & Innovation
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Research &
Innovation
Public-private partnerships under FP7
• Public-Private Partnerships between EU and industry
in sectors of key strategic importance
• Innovative Medicines Initiative (IMI1) in health
research
• Largest PPP in pharmaceutical research in the world
set up under FP7 with €1b contribution each from
the EU and from the European pharmaceutical
industry represented by EFPIA
• Successes: has become a model for open innovation,
research breakthroughs in diabetes, brain research,
antimicrobial resistance
Research &
Innovation
Key figures IMI calls 1-10
Academia, Research
Organisations
622
Others,
including
regulators
84
Patient
organisations
26
SMEs
142
IMI contribution: 790 mil
EFPIA contribution: 771 mil
Call 10, 1st stage deadline 28 January 2014, 17:00:00 Brussels time
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Call 11, 1st stage deadline 8 April 2014, 17:00:00 Brussels time (CEST)
Research &
Innovation
Some IMI achievements
Innovation
• Faster development of diabetes drugs through the first
ever human pancreatic beta-cell line
• New models to better predict drug toxicity
• New definition of severe asthma which promises to
unlock new therapies
• The world’s largest database of schizophrenia studies to
develop targeted treatments
• Better understanding of the mechanisms of chronic pain
Research
• 440 academic publications - Average citation impact
double the world average – on par with Wellcome Trust
• 30% rank in the top quartile of journals in their specific
research fields
Research &
Innovation
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Evolution
Expanding scope of research addressed
• Research agenda initially focussed on overcoming
hurdles in early stages of drug development through 4
pillars: efficacy, safety, knowledge management,
education & training
• Revision of research agenda in 2011 to address drug
research and innovation value chain more broadly
• Research supported in 7 areas of interest: patients in the
focus, diseases and drug efficacy, tools and techniques,
development in regulatory framework, strategies in R&D,
knowledge management and science communication
More flexibility
• Initially one call per year – now calls launched when
topics are ready
• Call for exploitation of new scientific opportunities to
quickly valorise outcomes from IMI project
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Research &
Innovation
In the pipeline: IMI2
• Commission proposal adopted on 10 July as part
of the Innovation Investment Package
• Mission: create an even more powerful research
and innovation machine – with broader objectives
and a wider range of activities and partners
• Proposed budget from public and private
partners: 3.45 Billion Euro; 1.725 Billion Euro EU
contribution:
 Up to EUR 1 500 million to match EFPIA's contribution
 Up to EUR 225 million to match additional contributions
from other future Members or Associated Partners
• All EU funding goes to SMEs, academia, patient
organisations and regulatory agencies
Research &
Innovation
Scope and objectives
• IMI2 will expand the scope of IMI1 to cover the
entire medical research and innovation value chain:
 Actively involve life science industries other than
pharmaceuticals; for example the vaccine, the animal health
or the biomedical imaging industry
• Enable top quality research and innovations with
great public health benefits and commercial
possibilities
• Pave the way for the breakthrough vaccines,
medicines and treatments which we will need in the
near future:
 Develop new therapies for diseases with high unmet need,
such as Alzheimer's disease, and limited market incentives,
such as antimicrobial resistance
Research &
Innovation
Way forward for IMI2: legal framework
•
Final adoption of Horizon 2020 package on 3 December
forms the basis for moving forward with IMI2
•
Legislative process for the IMI2 Regulation ongoing in
the European Parliament and the Council:
− Agreement of the Member States on a common position
reached under the Lithuanian presidency at recent meeting
of the Competitiveness Council on 3 December
− Discussion in the European Parliament ongoing at the level
of the relevant committee (ITRE), plenary opinion
expected in spring 2014
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Research &
Innovation
Scientific research agenda for IMI2
•
Is being developed under the leadership of
EFPIA
•
Based on the WHO Report: Innovative Medicines
for Europe and the World
•
Goal: The right prevention and treatment, to the
right patient, at the right time
Research &
Innovation
Challenges moving from IMI to IMI2
•
We still have the ongoing IMI calls, will lead to
funding projects addressing important public health
needs
•
Calendar for legislative process is tight, ahead of the
end of May elections of the European Parliament
•
In addition to the "basic act" (the Council Regulation
setting up IMI2), a number of documents will have to
be adopted – we can benefit from experience setting
up IMI
•
New organisational structure to be established
Research &
Innovation
Practical aspects
Council
adopts
Regulation
20
days
Entry
into
force
JU
Establishing
GB
Nomination
of SC
members
Criteria
for SC
candidates
Establishing
SRG
SRG
proposes
candidates
Consultation
on annual
work plan
Call
topics
Consultation
on topics
Establishing
SC
Processes take time
•
Annual
Work
Plan
Commission has strong interest in seeing IMI-2 calls
launched as early as possible
Detailed planning is being worked out; will require
many steps to be taken in parallel and/or 'at risk'
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Research &
Innovation