FP7 Health presentation Jan' 07

1
FP7 Health theme
Ludovica SerafiniSME InnovationDirectorate
HealthDG Research European Commission
FP7 Health 16th July 2007 - Brussels The
Italian Bio-Metacluster a key industry and
research sector in three local areas
2
The Health Theme in Framework programme 7

• FP7 Health Theme
• Health related industry participation SME focus
  in FP6 FP7
• Calls, budgets and specificities
• Supports available
• Contacts
• News flash on RSFF

3
FP7 main elements

• Budget to be increased 50.5 billion over 7
  years 40
• Human potential and science careers (People )
• European Research Council (Ideas programme )
  ERC
• Infrastructures, SME, regions potential
  (Research Capacities )
• Collaborative research (Cooperation )
• continuity in themes funding modalities.
• funding levels to be raised in some cases, 50
  ? 75
• Joint Technology Initiatives, eg the Innovative
  Medicines Initiative IMI

4
Cooperation Collaborative research in FP7

• Thematic Priorities
• Health 6.1
• Food, agriculture, fisheries and
  biotechnology 1.9
• Information and communication technologies 9.1
• Nanosciences, nanotechnologies, materials and
  new production technologies 3.5
• Energy 2.3
• Environment (including climate change) 1.9
• Transport (including aeronautics) 4.2
• Socio-economic sciences and the humanities 0.6
• Security 10. Space 2.8
• Total for collaborative research
  32.4 billion

5
Scope of research in the Health Theme in FP6
FP7

• In the Health theme, the Framework programme
  supports basic and applied collaborative research
• This includes discovery activities, translational
  research and early clinical trials (normally only
  phase I and II)

6
What was funded in FP6 in the Health priority
(2003-06)

• 2.4 billion in research grants 604 projects in
  4 years
• Average success rate 25.4

• Total number of participants 7,426

7
SME participationin FP6 Health is overall 14
of contribution
SME STREP call

• Calculated on requested contribution, excluding
  NoEs

8
SME participation in FP6 (2003-2006)

• Main features of SME-STREP call
• only small projects (STREPS)
• very open topics (based on consultations with
  industrial associations)
• required participation of research intensive SMEs
• Proposals had to be SME-driven
• Proposals had to be designed to support SME
  efforts towards research and innovation
• Results should be of interest/benefit to SMEs
• 30-50 of the EU contribution had to go to the
  SME partners
• Research-intensive SMEs were expected to play
  leading roles (although not necessarily
  coordinate)

9
Outcome of SME-STREP call

• Key figures on the 86 selected proposals
• 43 of budget is going to SMEs 94 million
  out of 200 million
• 40.6 of participants are SMEs ( 276)
• Average budget requested per SME 342,000
• 46 (40 projects) are coordinated by SMEs
• More then 90 of SMEs are research intensive
• The SME-STREP call has been a major success ?
• Research Intensive SMEs were key players
• driving forces
• in the project
• See some examples

10
Multi-parametric quantum dot bioassay for point
of care diagnosis

• To provide clinicians with multi-parametric
  measurement of the 4/5 essential markers and
  support decision-making with a software tool.
• EC contribution 2.5m over 3 years ? 44 to
  SMEs
• 3 SMEs involved (out of 9 participants)
• Coordinator is an SME all SMEs play key
  scientific roles development of photonic and
  electro-optics immunoassay development
  production of monoclonal antibodies and
  recombinant proteins.

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Fully automated and integrated Microfluidic
Platform for Real-time Molecular Diagnosis of
Methicillin-resistant Staphylococcus aureus

• to develop a new diagnostics platform for a
  fast, simple and accurate identification of MrSa,
  responsible for most nosocomial and
  community-acquired infections
• EC contribution 2.1mill over 3 years ? 45 to
  SMEs
• 4 SMEs involved (out of 6 participants)
• Coordinator is an SME.
• All SMEs play key scientific roles design the
  microchip and Magnetic Phase platform provide
  quadruplex real-time quantitative PCR for gene
  expression analysis develop and manufacture
  appropriate magnetic particles

12
Development of multi-step improved
epidermic-specific vaccine candidate against
HIV1/AIDS

• to develop genetic vaccine candidate for
  therapeutic and preventive use against HIV/AIDS
  .
• EC contribution 2.4mill. over 3 years ? 50 to
  SMEs
• 4 SMEs involved (out of 7 participants)
• Coordinator is an SME.All SMEs play key roles in
  the development of a complex new vaccine
  technology that will combine restricted
  expression of the multi-epitope/multivalent HIV
  antigens in specific cells of the epidermis
  segregation/partitioning function of the Bovine
  papillomavirus type 1 immunogens expression
  within and onto virus-like-particles the
  adjuvant effect of different cytokines
  development of micro-needle array

13
Multi-parametric quantum dot bioassay for point
of care diagnosis

• To provide clinicians with multi-parametric
  measurement of the 4/5 essential markers and
  support decision-making with a software tool.
• EC contribution 2.5m over 3 years ? 44 to
  SMEs
• 3 SMEs involved (out of 9 participants)
• Coordinator is an SME all SMEs play key
  scientific roles development of photonic and
  electro-optics immunoassay development
  production of monoclonal antibodies and
  recombinant proteins.

14
FP7 Health

• Main policy drivers
• Improving health of European citizens
• Increasing competitiveness of European
  health-related industries and businesses
• Addressing global health issues, including
  emerging epidemics

• Budget
• 6.1 billion over 7 years (2007-2013)

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FP7 Health

• Out of the 6 billion
• dedicated to the Health Theme
• the share going to SMEs
• is expected to be at least 15,
• or 900 million.

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FP7 IS MORE FAVORABLE TO SME PARTICIPATION. Why?

• Broader approach to health research than FP6
  (including medical technologies and public
  health)
• 7 year programme(long term continuity of
  structure, rules and procedures)
• Better funding Up to 75 for research and
  development activities of SMEs (vs 50 for other
  industry) Management and training activities are
  funded up to 100
• Reduced need for financial checks and bank
  guaranteesA guarantee fund (replacing the
  'collective financial responsibility) covers the
  financial risks of defaulting project
  participants
• Better, more flexible, protection of intellectual
  property

17
SME Definition
less than 250 employees, annual turnover less or
equal to 50 million and balance sheet less or
equal to 43 million the company has to be
"independent" For more details see
http//ec.europa.eu/enterprise/enterprise_policy/s
me_definition/index_en.htm An available help to
see if an company fits in the SME definition, is
available at http//ec.europa.eu/research/sme-te
chweb/index_en.cfm But, in FP7, participating
company respondence to the SME definition is
assessed during negotiation
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EU contribution provided through call for
proposals

• Proposals go through a pair review evaluation.
• Evaluation main objectives? proposals selected
  for funding must demonstrate a high scientific,
  technical and managerial quality.? all the
  proposals should be treated alike, considering
  only their merits.

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General Overview Evaluation Process
Panel
Submission
Consensus meeting in Brussels
Remote individual evaluation
Finalisation
Final decision and procedures
Eligibility
Evaluation
COMMISSION
EXPERTS
COMMISSION
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FP7 Callspublished documents

• Rules on submission and evaluation
• Same for all FP7
• Consistency vs flexibility!
• Guide for applicants (annexes 1 and 2)
• How the rules will be applied for a certain call
• The work programme
• The topics and criteria against which the
  proposals will be judged

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Information for proposal preparation in Health
Theme

• http//cordis.europa.eu/fp7/cooperation/health_en.
  html
• Where to get help to prepare a proposal
• National Contact Points in the Member States and
  Associated States, provides guidance, practical
  information and assistance on all aspects of
  participation in the Framework Programmes
  http//cordis.europa.eu/fp7/ncp_en.html
• SME-go-Health, an FP6 EU-funded project,
  specifically supporting the participation of
  SMEs, provides several services, including a
  matchmaking database for proposals preparation.
  Contact them at http//www.smesgohealth.org/

22
FP7 first calls for the Health theme

• New rules for FP7
• page number limitation for proposals
• new provisions for ethics
• ceilings for EU contribution
• Specificities of Health theme
• one-step submission
• no Networks of Excellence
• 1 ERA-NET (cancer registries) with deadline 30
  July 2007

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Funding levels in the Health theme

• Maximum (and minimum) funding levels for funding
  schemes
• min. max.
• Small- or medium-scale focussed research
  project (FP) 3m
• Large-scale integrating project (IP) 6m 12m
• Coordination action (CA)
• Support action (SA)
• ERA-Net (for cancer topic) 2m
  
• except where otherwise stated in work
  programme.
• Warning this is an eligibility criteria !

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FP7 first calls for the Health theme

• for 2007-2008 (year 1 2 of FP7)
• work programme published 22 December 2006
• Call A - first deadline 19 April 2007
  637 million for 87 topics
• Call B - second deadline 18 September 2007
• 549 million for 89 topics (draft
  available since 22/12/2006 call published on
  18/6/2007)
• JTI IMI publication expected by year-end,
  pending approval by Council

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Health in FP7Opportunities for Industry

• Health Theme aims at increasing competitiveness
  and innovative capacity of European related
  enterprises
• Political objective to give 15 of contribution
  to SMEs
• Industry in general, and SMEs in particular, are
  encouraged to participate in all projects,
  wherever appropriate
• SME driven topics, designed for SMEs, with higher
  of contribution to SMEs, significant/leading
  role of SMEs in research activities
• Innovative Medicine Initiative, a public-private
  partnership, aims at accelerate drug development
  in Europe, is proposed as a Joint Technology
  Initiative (JTI) under FP7 with calls for
  proposals and peer evaluations

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Innovative Medicines Initiative (IMI)

• The Commissions Proposal for a Council Regulation
  to set up the Innovative Medicines Initiative
  Joint Undertaking
• presented to the Competiveness Council 22 May
  2007
• Foreseen to become operational by end 2007/early
  2008 pending the Councils Decision with the
  opinion of the European Parliament and the
  Economic and Social Committee

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Innovative Medicines Initiative (IMI)

• Public-Private Partnership
• Work Programme to be developed from
  Strategic Research Agenda
• Dedicated structure to support research
  through calls for proposals

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Scenario for IMI Call for proposals
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Health research in FP7
NEW!
Pillar 1 Biotechnology, generic tools and
medical technologies for human health
Pillar 2 Translating research for human health
Pillar 3 Optimising the delivery of health
care to European citizens
Funding schemes targeted at Small and
Medium-sized Enterprises
Child Health
Health of the Ageing population
Funding schemes targeted at International
Cooperation SICA
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Cross-cutting aspectsfor the Health theme in FP7

• Special emphasis and measures for
• SMEs
• Participation encouraged in all areas
• Special topics for SMEs
• Support actions
• International Cooperation
• Participation possible in all areas
• Special International Cooperation Actions (SICA)
• Coordination or Support actions

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Collaborative researchin the Health theme

• 1 Biotechnology, generic tools and technologies
• High-throughput research enhancing data
  generation, standardisation, acquisition
  analysis
• Detection, diagnosis and monitoring with
  emphasis on non-invasive or minimally invasive
  approaches
• Predicting suitability, safety and efficacy of
  therapies develop and validate parameters, tools,
  methods and standards (mainly through IMI) and
  alternatives to animal testing
• Innovative therapeutic approaches and
  interventionsgene and cell therapy, regenerative
  medicine, immunotherapy and vaccines.

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Collaborative researchon the Health theme

• 2 Translating research for human health
• Integrating biological data and processes
  large-scale data gathering, systems biology
• Research on the brain and related diseases,
  human development and ageing
• Translational research in major infectious
  diseasesto confront major threats to public
  health antimicrobial drug resistance, HIV/AIDS,
  malaria and TB, emerging epidemics, neglected
  infectious diseases
• Translational research in other major diseases
  cancer, cardiovascular disease, diabetes and
  obesity, rare diseases, and other chronic
  diseases

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Collaborative researchin the Health theme

• 3 Optimising the delivery of health care to
  citizens
• Translating clinical research into clinical
  practice patient safety, better use of
  medicines, benchmarking, pharmacovigilance, etc.
• Quality, efficiency and solidarity of health care
  systems organisational and financial aspects,
  health systems, etc.
• Enhanced health promotion and disease prevention
  providing evidence of best public health measures
  life styles, interventions, special focus on
  mental health, etc.

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Contacts Information
Innovative Medicines Initiative (IMI) Irene
NorstedtTel. 32 2 296 9527 Email
irene.norstedt_at_ec.europa.eu http//ec.europa.eu/re
search/health/imi/index_en.html SME
participation Ludovica SerafiniTel. 32 2 295
6759 Email ludovica.serafini_at_ec.europa.eu Inte
rnational Cooperation Dr. Indridi
BenediktssonTel. 32 2 299 3137 Email
indridi.benediktsson_at_ec.europa.eu Framework
Programme 7 http//cordis.europa.eu/fp7
Experts http//cordis.europa.eu/research_opening
s/
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Contacts in the Health Directorate
Director Dr. Octavi Quintana-Trias Medical and
Public Health Research unit Manuel
HallenEmail manuel.hallen_at_ec.europa.eu Cancer
Maria Vidal Email maria-jose.vidal-ragout_at_ec.e
uropa.eu Public Health sector Kevin
McCarthy Email kevin.mccarthy_at_ec.europa.eu Infec
tious Diseases unit Bernard MulliganEmail
bernard.mulligan_at_ec.europa.eu Emerging
Infectious diseases Anna Lönnroth Email
anna.lonnroth_at_ec.europa.eu Genomics and Systems
Biology unit Patrik KolarEmail
patrik.kolar_at_ec.europa.eu Health Biotechnology
unit Arnd HoevelerEmail arnd.hoeveler_at_ec.europ
a.eu Coordination unit Stéphane Hogan Email
stephane.hogan_at_ec.europa.eu
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Information for project results valorisation

• Bioentrepreneur boot camp ?business plan
  development, training, coaching, consulting
  www.eurobiobiz.com/bioentrepreneur/bbc-executives.
  php
• European Council of Bioregions (CEBR) ?
  networking, incubation, partnering and cluster
  promotion www.cebr.net
• Innovation Rely Centers ?
• support innovation and transnational
  technological co-operation in Europe
  www.innovationrelay.net

37
Other useful info

• Funding opportunities for Biotech companies
• Article published in "nature biotechnology"
• from Bioenterpreneur
• How EU can fund your company
• http//www.nature.com/nbt/journal/v25/n1/pdf/nbt01
  07-21.pdf

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Risk-Sharing Finance Facility (RSFF)

• The European Commission and the European
  Investment Bank (EIB) have launched a new 
• 2 billion instrument to finance
  'riskier' research and innovation projects in
  Europe
• Agreement signed on 5/6

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EIB/EC Partnership
EU FP7
EIB i2i
Contribution of up to EUR 1 billion
Contribution of up to EUR 1 billion

RISK-SHARING FINANCE FACILITY reserve to cover
risk of EIB (and its partners) lending
40
Doing more with lessthe leverage effect
Matching contributions
Provisioning and capital Allocation representing
15 to 25 (average 20) of volume of
individual loan
Loans representing on average one third of total
cost of financed research projects
FP7 Contribution up to 1 billion
EIB loans and guaranties 8 to 12
billions (average 10)
Additional private investments in research 16
to 48 billions (Average 30)
X 4 to 6 (average 5)
X 2
X 2 to 4 (average 3)
EIB Contribution up to 1 billion
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A large spectrum of loans
For loans of EUR 7.5 million or more - direct
involvement by the EIB
EIB
Borrower
For all loans where borrowers wish to work with
their own banks, in particular those of less
than EUR 7.5 million - sharing of RSFF
benefits with intermediaries (e.g. through
guarantees)
EIB
Intermediary
guarantee
Borrower
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RSFF INFO

• DG RTD - Unit B.04  Regions of Knowledge
  Research Potential 
• RSFF Team
• Jean-David MALO jean-david.malo_at_ec.europa.eu
• Martin KOCH martin.koch_at_ec.europa.eu
• Anna KRZYZANOWSKA anna.krzyzanowska_at_ec.europa.eu
  
• Telephone [phone]
• EIB web-site http//www.eib.org/rsff