Opportunities for Funding of Clinical Trials in Framework Programme VI Ian A. McKay PhD Practice Leader Medical Engineering and Biotechnology

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Opportunities for Funding of Clinical Trials
in Framework Programme VI Ian A. McKay
PhDPractice LeaderMedical Engineering and
Biotechnology
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Framework Programme VI

• A 16.5 Billion pot of gold in Brussels
• Opened in November 2003
• Will continue for four years
• One particular aim is to stimulate activity of
  Small and Medium-sized Enterprises (SMEs)
• Many biotechnology companies qualify as SMEs

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Framework Programme VI

• Divided into three Thematic Priorities and
  Horizontal activities
• Most relevant to this audience is TP1 Life
  sciences, genomics and biotechnology for health
• LifeSciHealth - Research and development
  offering opportunities to improve human health is
  the major focus of this Thematic Priority.

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The ECs Take on Clinical Trials

• Emphasis will be put on "translational" research,
  i.e. research aimed at translating basic research
  discoveries into successful clinical
  applications, to enable real, consistent and
  co-ordinated progress at European level in the
  health sector and improve the quality of life.
• Substantial funding will therefore be available
  for clinical research, including clinical trials.
• A Community contribution (up to 50 of the costs)
  will in general only be available for Phase I and
  II clinical trials. However, within the context
  of the European and Developing countries Clinical
  Trials Partnership (EDCTP), funding will be
  considered for Phase II and III trials.

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Funding Instruments in FP6

• Horizontal activities
• Cooperative (CRAFT)
• Collective
• Thematically restricted activities
• Specifically targeted research projects (STREPs)
• Networks of Excellence (NoEs)
• Integrated projects (IPs)

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Cooperative Projects

• The EC wants to get between 1M and 2M of
• RD resource for an SMEs innovative concept
  -
• Five or six SMEs provide In Kind work
• SMEs form a supply chain that brings the
  product/service to market
• The EC matches the In Kind contribution with
  cash
• The cash goes to the Research and Technology
  Development (RTD) performers who do the work...

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MATCHING CASH FROM THE E.C.
Cooperative
IN KIND CONTRIBUTION
SME 1
120k
720k
720k
SME 2
120k
SME 3
120k
RTD Performer 1 PERA
SME 4
120k
RTD Performer 2 iNET MEMBER
SME 5
120k
LE 1
120k
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Opportunities in FP6

• COLLECTIVE PROJECTS
• Like CRAFT but double the potential funding
• Consortium includes Trade Associations, SMEs,
  etc.
• Aims to encourage pan-European technology
  transfer
• Example - Nanomed

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Opportunities in FP6

• STREPS
• Highly targeted to e.g. cancer, TB, malaria
• There must be a specific call
• 50 funded like the old Collaborative projects of
  FP5
• Universities, RTOs, SMEs and LEs can participate
• Next deadline November 13th

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Opportunities in FP6

• NETWORKS OF EXCELLENCE
• Designed to enable world leadership in a thematic
  priority area
• Based on sharing intellectual property from
  organisations right across the spectrum
• Require SME participation disappointing
  response thus far

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Opportunities in FP6

• INTEGRATED PROJECTS
• Much bigger projects 10s of millions with the
  aim of producing world leadership in specific
  technologies
• Involve organisations from right across the
  spectrum including potential competitors
• Possibility of pooling patents/know-how
• Example SafeHose

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The Integrated Project Opportunity

• SME participation the objective
• Target of 15 of Integrating Research Budget to
  SMEs
• 25 in Stairway (10 SMEs) Gives 2.5
• 15 in NOEs (Tend to Zero SMEs) Gives 1 Max
• 60 in IPs (Make up Difference) Need 11.5
• Requires An Average of 20 in Individual IPs

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SME Participation in FP6

• As full partners in CRAFT, Collectives, IPs,
  NoEs, STREPS, etc.
• As members of EIGs
• As members of Trade Associations (IAGs)
• As members of Enterprise Groups e.g. EurExcel

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Timetable for Applications
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SUMMARY

• There is a wide range of opportunities to exploit
  the 16.5 Billion pot of gold in Brussels for
• Clinical Trials
• Start planning (and lobbying) now
• for November 2004 !

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The Advert

• Need help ?
• Pera and its iNET EurExcel partners can offer
  exceptional expertise in
• gaining grant support
• all fields of biotechnology and medical
  engineering
• product and process innovation
• introducing SMEs
• project management
• med.eng_at_pera.com