Life Sciences, Genomics and Biotechnology for Health

1
Life Sciences, Genomics and Biotechnology for
Health

• Dr. Martha Cahill
• National Contact Point ,
• Enterprise Ireland, Glasnevin

2
Presentation Overview

• FP6 4th Call
• Overview of thematic area
• A look at the instruments
• SME perspective
• Practical information on application procedures
• Available supports and information resources
• FP7 Developments, timing the proposed Budget.

3
Lisbon Strategy

• In March 2000, EU heads of state and government
  agreed on an ambitious goal
• The most competitive and dynamic and
  knowledge-based economy in the world
• Capable of sustainable economic growth
• With more and better jobs and
• Greater social cohesion and
• Respect for the environment.
• by 2010.
• Kok Report  -Facing the Challenge
• http//europa.eu.int/growthandjobs/pdf/kok_report_
  en.pdf

4

• FP6 4th Call

5
FP6 -4th call

• 4th Call in FP6 opened 8th July, closed in 9th
  Nov 05
• Budget for the 4th call.
• Total indicative budget 362 million , broken
  down as follows

6
FP6 4th Call Places an Emphasis on SME
Participation

• Life Science and biotechnology is a frontier
  technology that can contribute significantly to
  the Lisbon objective of Europe.
• EC believes that the key is the integration of
  SMEs.
• research new therapies clinical practice.
• Budget dedicated specifically to SME-STREPs
  
• 171 million.

7
Overview of the FP6 4th Call.

• Advanced genomics and its applications for health
• Fundamental knowledge and basic tools for
  functional genomics in all organisms
  (10 topics)
• b) Application of knowledge and technologies in
  the field of genomics and biotechnology for
  health. (22 topics)

8
Overview of the FP6 4th Call.

• Combating major diseases
• Application-orientated genomic approaches to
  medical knowledge and technologies. (30 topics)
• Combating cancer (9 topics)
• Confronting the major communicable diseased
  linked to poverty (12 topics)
• SSAs across Thematic Priority 1 (12 topics)

9
Breakdown of Thematic Area

• Fundamental knowledge and basic tools for
  functional genomics in all organisms (Total
  of 10 topics)
• Gene expression and proteomics (1 topic)
• Structural genomics (1 topic)
• Comparative genomics and population genetics (3
  topics)
• Multidisciplinary functional genomics approaches
  to basic biological processes (2 topics)
• Across the area (2 topics)
• Topics for SME-specific call (1 topic)

10
INSTRUMENTS

• Specific Targeted Research Project (STREP)
• Integrated Projects (IP)
• Network of Excellence (NOE)
• Specific Support Actions (SSA)
• Co-ordinated Action (CA)

11
Instruments

• Specific Targeted Research Project (STREP)
• knowledge-focused, aimed at
• Research and technology development activity
• Demonstrate activity viable new technologies
• Countries 3 legal minimum, but larger number of
  partners required in reality. Optimum size 6-15
  participants.
• Average EC Funding 0.8 to 3 million
• Duration Typically 2 - 3 years

12
Example of STREP

• Development of new diagnostics
  LSH-2005-1.2.2-2
• Development of innovative methods for diagnosis
  of nervous system disorders.
• The project should conform to the genomic and
  molecular approaches of this thematic priority.
  The project should have a clear and direct focus
  on medical applications in diagnosis and
  therapeutic follow-up. It should involves SMEs.

13
Instruments

• Integrated Projects (IP) more ambitious
• generate knowledge to implement the priority
  thematic areas
• objective-driven research
• Address major society need boost EU
  competitiveness
• Technological development, demonstration and
  training
• Emphasis on effective knowledge and project
  management
• Partners 3 legal minimum. Optimal Size 10-20
  participants
• Funding varied between 4 - 25 million.
• Average EC Funding 10 million
• Duration 3 5 years

14
Example of Integrated Projects (IP)

• Development of new diagnostics LSH-2005-1.2.2-1
• High throughput molecular diagnostics for
  hereditary diseases - The project should lead to
  the development of advanced tools by
  incorporation of genomics, proteomics and
  metabolomics in combination with advanced
  read-out technology. Deliverables must be the
  development of high throughput, sensitive,
  reliable and especially cost effective diagnostic
  and pre-symptomatic methods, which display clear
  advantages over currently available genetic
  tests. The project must address quality assurance
  issues and should offer opportunities for
  industrial exploitation and involve SMEs.
  Consideration may be given to ethical issues
  related to the diagnosis of hereditary diseases.

15
Instruments

• Network of Excellence.
• Strengthen scientific and technology Excellence.
• Aimed at tackling the fragmentation of existing
  research.
• Proposed for the Integration of activities, joint
  research programmes, and joint training
  programmes.
• Participants as many as possible. Optimal size
  6- 12 participants.
• Funding between 4 to 15 million.
• Average 7 Million
• Duration 4-5 years.

16
Example of a Network of Excellence (NOE)

• Combating, cardiovascular disease, diabetes and
  rare diseases LSH-2005-2.1.1-2
• Hypertension and cardiovascular disease. The
  project should lead to the integration of
  research teams working on genetics, functional
  genomics and molecular mechanisms of hypertension
  and hypertension-related cardiac and vascular
  damage.

17
Instruments

• Specific Support Actions (SSA)
• To complement other FP 6 grants, to aid in
  preparations for future EU RTD policy
  initiatives,
• 2 types
• Support activities conference seminar
  organization, performance of studies,
  fact-finding missions, high level scientific
  awards competitions
• Project management activities
• Partners Single or a group of partners (1-15
  participants).
• Funding between 0.03 to 1 million.
• Average 0.5 million
• Duration Typically one-off event 9 to 30
  months

18
Example of Specific Support Actions (SSA)

• Other actions across thematic priority 1
  LSH-2005-3-1
• Promoting Collaboration between SMEs and
  Academia Innovative activities aiming at
  stimulating and strengthening collaboration
  between SMEs and researchers in specific areas
  supported by the Theme will also be considered
  for support.

19
Instruments

• Coordinated Action (CA)
• Purpose Coordinated Networking
• Intended to improve and effect the coordination
  of research.
• Meetings, Seminars,
• Workshops, Working groups,
• Study analysis, Exchanges of personnel,
• Exchanges dissemination of good Practices,
• Partners Optimum 13-26 participants
• Funding between 0.5 to 1.2 million.
• Average 1 million
• Duration 1.5 -3 years

20
Example of a Coordinated Action (CA)

• Fundamental knowledge and basic tools for
  functional genomics in all organisms
  LSH-2005-1.1.0-1
• Proposals for Co-ordination Actions (CA) in
  functional genomics research (proteomics, gene
  expression, structural genomics, comparative
  genomics, population genetics, bioinformatics,
  multidisciplinary functional genomics approaches
  to basic biological processes) will also be
  considered.

21

• STREPs
• Dedicated to SMEs

22
SME-STREPs

• Designed to encourage SME efforts towards
  research and innovation.
• SME is expected to play a leading role in the
  project.
• Expected project results should clearly be of
  benefit to SMEs
• SME-STREPs must include at least 3 independent
  legal entities from 3 different member states or
  associated states.
• All consortia should aim at having 30-50 of the
  requested EC contribution budget going to SMEs.
• Results will be available 4 months after the
  closure date of the call.

23
SMEs in FP6 4th call

• In addition to the specific call for
  SME-STREPs, SMEs have additional opportunities
  to participate in other topics in the Thematic
  Call.
• Proposals submitted to the Thematic Call are
  recommended to have at least 15 of the budget
  reserves for SMEs

24
Example - STREPs dedicated to SMEs

• Development of new diagnostics LSH-2005-1.2.2-4
• Development of new diagnostics. This topic
  covers new diagnostic tests and development of
  new tools and non-invasive methods for
  prevention, early diagnosis, monitoring of
  disease progression and interpretation of in-vivo
  data so as to increase the possibilities and
  effectiveness of the existing therapies.

25
Definition of SME as defined by the EC

• Fewer than 250 employees
• Annual turnover 50 million / an annual balance
  43 million
• Conforms to the criteria of independence (an
  SME that is not owned for 25 or more of the
  capital or the voting rights by one enterprise or
  jointly by several enterprises falling outside
  the dominion of an SME).
• Is normally not a research centre, research
  institute, contract research organization or
  consultant
• Is registered and operating in one of the Member
  States or in a State which is associated with the
  FP.

26
Attention should be paid to the following

• Childhood diseases and related treatments
• Gender aspects in the research will be taken into
  account.
• Clincal Research and Clinical trials (Phase I and
  II)- development of application towards human
  health.
• Ethical Issues such as research with human being
  or use of human stem cells or animals.

27
SUPPPORT GRANTS

• http//www.fp6-ireland.com
• Feasibility Grant Scheme
• Eligible to Companies
• Contact Dr Ronan Breslin  Tel  [phone]
  2707,  
• Email ronan.breslin_at_enterprise-ireland.com
• Travel Support
• Eligible to Researchers in Irish Universities or
  Institutes of Technology
• Contact Rita Ward, Enterprise Ireland Tel
  353 1 8082767Email rita.ward_at_enterprise-ireland
  .com
• Support for the preparation of proposals to
  co-ordinate FP6 Projects
• Eligible full-time academic staff and associated
  hospitals.
• Contact Brian Sheridan, Enterprise Ireland
  Tel [phone].
• Email brian.sheridan_at_enterprise-ireland.com

28
Partner Search

• Service available at http//partners-service.cor
  dis.lu/
• The Service allows you to
• Publish your profile on CORDIS by entering your
  project idea or specific expertise.
• Search the Partners profiles submitted by other
  organizations
• Update or delete your existing profile on-line at
  any time using your CORDIS user name and
  password.

29
Preparing Submit a Proposal

• Login Password Procedures
• Electronic Proposal and Submission System (EPSS)
  or by downloading electronic forms.
• To use the EPSS online submission, co-ordinators
  have to register on the system.
• http//fp6.cordis.lu/fp6/subprop.cfm click on
  the EPSS user guide and down load document

30
Intellectual Property Rights

• IPR-related links and reports http//europa.eu.in
  t/comm/research/area/ipr_en.html
• IPR-Helpdesk http//www.ipr-helpdesk.org

31
Register as an Evaluator

• To register as an Expert re peer review of FP 6
  proposals
• www.cordis.lu/experts/fp6_candidature.htm
• notify NCP

32
Evaluation of a Proposal

• Relevance Threshold 3/5
• Potential impact Threshold 3/5
• ST excellence Threshold 4/5
• Quality of the consortium Threshold 3/5
• Quality of the management Threshold 3/5
• Mobilisation of the resources Threshold 3/5

33
Evaluation of a Proposal

• 1. Relevance
• Address the objective (topic description)
• 2. Potential Impact
• Suitable ambitious
• Optimal use of project results
  commercialisation
• Added value

34
Evaluation of a Proposal

• 3. ST excellence
• Clearly defined objective
• Progress beyond the current state-of-the-art
• Proposed ST approach to achieve objectives
• 4. Quality of the Consortium
• Collective participant constitute a high quality
  consortium.
• Well-suited and committed to the task
• Complementary participants.

35
Evaluation of a Proposal

• 5. Quality of Management
• Organisation structure matches complexity of
  the project
• Project Management previous experience
• Management of knowledge (IP)
• 6. Mobilisation of Resources
• Critical mass of resources personnel,
  equipment, finance
• Integration of resources for a coherent project.
• Adequate Financing plan

36
Cost Models

• Eligible cost direct cost indirect costs.
• Direct costs easily measured eg. Receipts
• Example
• Personnel Travel and subsistence
• Durable Equipment Consumables
• Subcontracting
• Indirect costs Overheads not directly related
  to the Framework but are incurred by the
  organisation.
• Example - Rent, heating and lighting etc.,

37
Cost Models

• Additional Cost (AC) Universities, Public
  bodies
• Full cost Flat Rate (FCF) Company, research
  organisations
• Full cost (FC) large organisations
  multinationals
• Additional Cost Full cost Flat Rate
  Full cost

38
Guides to Proposals Essential Reading

• http//fp6.cordis.lu/lifescihealth/call_details.cf
  m?CALL_ID213
• This includes
• Work Programme for Thematic Priority 1 (July
  2005),
• FP6 in Brief,
• Guide for Proposers of Integrated Projects,
  Networks of Excellence, Specific Targeted
  Research Projects, Coordination Actions, Specific
  Support Actions,
• Guidelines on Proposal Evaluation and Selection
  Procedures,
• Model Contract, Financial Guidelines, Negotiation
  Guidelines
• Guide to Proposers of STREPs dedicated to SMEs
• http//fp6.cordis.lu/lifescihealth/call_details.cf
  m?CALL_ID214

39
Proposal Documentation Form Filling

• Part A
• A1 prepared by the co-ordinator
• A2 prepared by each partner
• A3 Financial information, cost models used.
  Etc,
• Part B
• The various aspect of the Project
• Acronym

40

• 7th Framework

41
7th Framework Planning is underway

• FP7 will run for a seven period 2007 to 2013.
• It will be fully operational as of 1 January
  2007.
• The Proposed Budget
• Total EC 73 billion
• Health 8 billion

42
7th Framework -9 themes proposed.

• Health
• Food, agriculture and biotechnology
• Information and communication technologies
• Nanosciences, Nanotechnologies, Materials and new
  Production Technologies
• Energy
• Environment and Climate Change
• Transport and Aeronautics
• Socio-economic sciences and the humanities
• Space and Security Research

43
Activities in FP7

• Biotechnology, generic Tools and technologies for
  human health.
• High throughput research
• Detection, diagnosis and monitoring
• Predicting, suitability, safety and efficacy of
  therapies
• Innovative therapeutic approaches and
  intervention

44
2. Translating research for human health
Activities in FP7

• Integrating Biology data and processes
  large-scale data gathering, systems biology.
• Research on the brain and related diseases, human
  development and aging.
• Translational research in infectious Diseases.
• Translational research in major Diseases
• cancer, cardiovascular disease,
  diabetes/obesity rare disease and other
  chronic disease (e.g. osteoarthritis)

45
3. Optimising the delivery of health care to
European Citizens
Activities in FP7

• Translating clinical outcome into clinical
  practice.
• Quality, efficiency and solidarity of health
  systems including transitional health systems.
• Enhanced disease prevention and better use of
  medicines.
• Appropriate use of new health therapies and
  technologies.

46
http//www.fp6-ireland.com

• Courses Run by Enterprise Ireland
• Whats your strategy for Framework?-Sean
  McCarty
• Financial Management of Projects -Richard Tomlin
• Fit for Audit? Preparing the first round of Cost
  Statements and obtaining Audit Certificates -
  Richard Tomlin
• Contract and Consortium- Sean McCarty

47
Technology Platform for Innovative Medicines

• Innovative Medicines Initiative Strategic
  Research Agenda
• 4 cornerstones
• Prediction of Safety,
• Early indication of Efficacy,
• Knowledge Management and
• Education Training.
• "living" document and will be regularly updated.
• A draft of the document is found by clicking on
  Innovative Medicines Initiative Strategic
  Research Agenda at http//europa.eu.int/comm/resea
  rch/fp6/p1/innovative-medicines/index_en.html

48
Previously funded Projects

• Success stories Lifesciences, Genomics and
  Biotechnology for Health.
• Successful Integrated Projects and Networks of
  Excellence. 
• http//europa.eu.int/comm/research/fp6/projects.c
  fm?p1 
• Search using key words
• For more Success Stories go to http//europa.eu.in
  t/comm/research/success/en/med/succ-med.html

49
Useful links

• Communications
• http//www.biotechnologyireland.com/fp6
• http//www.fp6-ireland.com
• Cordis- Lifescience, Genomic and biotechnology
  for Health
• http//www.cordis.lu/lifescihealth/
• Definition of an SME according to the New
  Commission Recommendations 2003/361/EC
• http//europa.eu.int/comm/enterprise/enterprise_po
  licy/sme_definition/index_en.htm
• http//europa.eu.int/comm/enterprise/enterprise_po
  licy/sme_definition/sme_user_guide.pdf
• Partner Search
• The service is available at http//partners-servic
  e.cordis.lu/ and you can down load brochure on
  partner service at
• http//partners-service.cordis.lu/index.cfm?pgname
  Help
• Hyperion Sean McCartys website
• http//www.hyperion.ie/ go to useful websites

50
Useful links

• Technology Platforms
• http//www.cordis.lu/lifescihealth/innovativemedic
  ines.htm
• Cordis www.cordis.lu/fp6
• Europa http//europa.eu.int/comm/research/nfp
• FAQs http//europa.eu.int/comm/research/fp6/pdf/f
  aq_en.pdf
• To keep up-to-date with latest news
  www.cordis.lu/fp6/eoi-instruments
• To locate a Call http//fp6.cordis.lu/fp6/calls.c
  fm
• To register as an Expert re peer review of FP 6
  proposals
• http//www.cordis.lu/experts/fp6_candidature.htm
  (notify NCP)
• Model contract http//europa.eu.int/comm/research
  /fp6/working-groups/model-contract/index_en.html

51
Contact Details

• Dr. Martha Cahill
• FP6 National Contact Point For Life Science,
• Genomics Biotechnology For Health,
• Biotechnology Directorate,
• Enterprise Ireland,
• Glasnevin,
• Dublin 9,
• Tel [phone]
• Mobile -00353-87-2868920
• Fax[phone]
• martha.cahill_at_enterprise-ireland.com