the innovative medicines initiative structure and operations
TRANSCRIPT
The Innovative Medicines Initiative
Structure and Operations
Pierre Meulien
ECSEL-IMI workshop – 5 July 2017
IMI mission
IMI facilitates open collaboration in research to
advance the development of, and accelerate
patient access to, personalised medicines for the
health and wellbeing of all, especially in areas of
unmet medical need.
IMI – Europe’s partnership for health
IMI 2 Strategic Research Agenda Antimicrobial resistance Osteoarthritis Cardiovascular diseases Diabetes Neurodegenerative diseases Psychiatric diseases Respiratory diseases Immune-mediated diseases Ageing-associated diseases Cancer Rare/Orphan Diseases Vaccines
Molecular Medicine Continuum
Health
Maintenance and
Disease Prevention
Early Detection Treatment of
Disease
Increasing Knowledge of Underlying Disease Mechanisms
Environment Behaviour Lifestyle
“Big” Health Data
Genomic data
Population registries,
Clinical trials databases
Bio-sensors
Clinical
applications
Care pathways,
decision support,
trends and alerts
Mobile devices Environmental data
Social networks
IMI 2 budget (2014 – 2020)
€1.638 bn
€1.425 bn
Other
€213 m
IMI 2 total budget
€3.276 billion
EU funding goes to:
Universities
SMEs
Mid-sized companies
Patient groups
etc…
EFPIA companies
receive no funding
contribute to projects ‘in kind’
Associated Partners e.g. charities, non-EFPIA companies
Associated
Partners
IMI2 Governance
Executive Director | Day-to-day management
Programme Office | Day-to-day implementation
Scientific Committee Advice on scientific issues
States
Representatives
Group Consultation, opinions
Stakeholder
Forum Input, Information
& feedback
Strategic
Governing Groups Identify specific priority
areas
Governing Board (EC + EFPIA) Overall strategic orientation & operations
Industrial partners align themselves around a real challenge for
industry and agree to work together and commit resources
New ideas from public sector, universities, SMEs etc. are needed to
address the challenge
Scale is a key to success and is provided through IMI funding
IMI key concepts
Outcomes should be transformative for the industry as well as
having a clear “public” value
Participation of new players
We need to be more inclusive as regards who partners with IMI
We need other sectors to get involved (Dx, Imaging, ICT, Nutrition,
MedTech etc)
Evolution of Generics space (repurposing of existing drugs,
combinations etc)
Smaller EU Countries
Involvement of more SMEs
Associated Partners of IMI and EFPIA Partners in Research
Partnerships with European infrastructures and or other initiatives
like EIT-Health for example
Partnerships with other funders
10 www.efpia.eu www.efpia.eu
Why a ECSEL-IMI collaboration?
~ 100 public and private partners involved both in IMI and ECSEL
covering all scientific areas of IMI (1st/2nd phases) DKM, Neurodegeneration, Metabolic disorders, Translational safety,
Drug discovery, Lung diseases, Oncology
ECSEL is a provider of cutting edge solutions in many applications
of electronics
Health sector can articulate problems where there will be
technology solutions and may offer new market opportunities - but
a collective approach is needed
IMI cannot achieve it’s ambitious goals with Pharma alone
The JU mechanism should provide a more dynamic ecosystem
notably by bridging the gap between the health and electronics
components/systems areas
Main Differences between ECSEL and IMI
In IMI- industry partners do not receive funding but
contribute “in kind”
Process of creating consortia is different
In ECSEL- States representatives are part of the decision
making process (advisory body in IMI)
Different IP regime
From IMI annual priorities to projects
Drawing on the annual priorities, a consortium of EFPIA companies and, in
some cases, other large companies or organisations active in health research,
agree on the need to work together and with other stakeholders on a specific
issue. A topic text is drafted.
Following consultation with various groups (including the IMI Scientific
Committee and the States Representatives Group),
the Call text is sent to the IMI Governing Board for approval.
Following the Governing Board’s green light, IMI launches a Call for proposals on
its website and the European Commission’s Participant Portal.
Following an open, competitive process involving independent
experts and Governing Board approval, the project is launched.
Topic definition
phase
How does IMI work? Two stage procedure
Granting phase Stage 1
Definition of topic by
industry consortium
(potentially incl
Associated Partners)
Signature of
Consortium and
Grant Agreements
Short proposal
Submission &
Evaluation
Patients’
organisations
Academic
research
teams
Regulators
Hospitals
SMEs
Mid-size
enterprises
Industry
consortium
Stage 2
Full proposal
Submission &
Evaluation
industry
consortium
Applicant
consortium
Call launch
Selected stage 1 team merges with industry
team
Start of the Granting
phase
Project
launch!
Industry partners AC Immune, Switzerland ▪ GE Healthcare Ltd, United Kingdom
Biogen, United Kingdom ▪ Janssen, Belgium
Eli Lilly, United Kingdom ▪ Novartis, Switzerland
F. Hoffman-La Roche, Switzerland
Public consortium partners Aarhus Universitet, Denmark
Agentschap College ter Beoordeling van Geneesmiddelen, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam, Netherlands
Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina,
Spain
Goeteborgs Universitet, Sweden
Københavns Universitet, Denmark
London School of Economics and Political Science, United Kingdom
National Institute for Health and Care Excellence, United Kingdom
Rijksuniversiteit Groningen, Netherlands
University of Oxford, United Kingdom
The University of Edinburgh, United Kingdom
Universiteit Maastricht, Netherlands
SMEs IXICO Technologies Ltd, United Kingdom
Synapse Research Management Partners S.L, Spain
What does a IMI project look like?
Patients organisation Alzheimer Europe
One set of rules for multiple interests
Support to industry
Freedom of access
Compensation for IP
Dissemination of information
Incentive to participate flexibility
+
trusted
party
Background and sideground assets protected
Results owned by the generator(s) who decide(s) on the best protection
modalities
Access rights for project implementation on royalty-free basis
Opportunity of further development and/or validation of background
assets and results generated
Access rights for further R&D on fair/reasonable conditions (incl. royalty-free
approach)
Access rights to Affiliates under the same conditions than beneficiaries
Access rights to third parties for further R&D after project’s end
Access rights for exploitation purposes to be negotiated on a case-by-case
basis
Dissemination subject to conditions, such as respect of the legitimate
interests
Structuring an IP policy to support innovation
Stay in touch with IMI
Visit our website
www.imi.europa.eu
Sign up to our newsletter
bit.ly/IMInewsletter
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@IMI_JU
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bit.ly/LinkedInIMI
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