?????????? ep?st?

1
?????????? ep?st?µe?, ????d??µat??? ?a?
ß??te???????a st?? ?p??es?a t?? ??e?a?

• G?????? ??????µ?d??
• ????pa??? ?p?t??p?
• G? ??e??a?

2
THE SIXTH FRAMEWORK PROGRAMME The Sixth
Framework Programme covers Community activities
in the field of research, technological
development and demonstration (RTD) for the
period 2002 to 2006
Work Programme for the specific programme for
research, technological development and
demonstration "Integrating and strengthening the
European Research Area" PRIORITY 1 Life
Sciences, Genomics and Biotechnology for
Health 10 June 2004 Commission Decision
C(2004)2002
3
Overview of the presentation

• The European Research Area
• What makes a good proposal ?
• FP6-2004-LIFESCIHEALTH-5
• FP6-2004-LIFESCIHEALTH-4

4
Why European Research?

• A legal and political obligation resulting from
  the Treaty of Amsterdam
• Competitiveness of companies and the employment
  they create depends on RTD
• Support of other policies such as consumer
  protection or protection of the environment

5
Why European Research?

• Research is
• Increasingly complex and interdisciplinary
• Increasingly costly
• Requires a constantly increasing critical mass

6
Historical Background

• 1950s - European Coal and Steel Community
• 1957 - European Atomic Energy Community
• 1984 - First Framework Programme
• 2000 - European Research Area
• 2002 - Sixth Framework Programme

7
European Research Area

• First true European research policy
• Creating a single market for research at the
  European level
• Addresses fragmentation of Europes research
  efforts

8
European Research Area

• Making a reality of ERA
• Framework Programme 6
• Member States research efforts
• Other European co-operative research activities

9
Key Principles of FP6Types of projects/modalities
Integrated Projects (IP) aims at generating
knowledge to increase Europes competitiveness or
solving major societal needs (average 3-5 years,
5-20 million ) Network of Excellence (NoE)
durable integration of research capacities /
restructuring and reshaping the way research is
carried out in Europe (average 3-7 years, 5-20
million ) Specific Targeted Research Projects
(STREP) research, demo, or innovation projects,
same objectives as for IP, (average 2-4 years,
1-4 million ) Co-ordination Action (CA)
co-ordination of research and innovation
(average 2-4 years, 1-3 million ) Specific
Support Actions (SSA) activities complementing
the funded research such as workshops,
conferences, studies, etc. (average 6 months-3
years, 0.1-2 million ) In addition fellowships,
infrastructures, co-operative research, ERA-net,
... funded by other parts of FP6
10
Integrated Projects Objectives

• The objectives should aim at increasing Europes
  competitiveness or at addressing major societal
  needs. Must bring together a critical mass of
  resources and competencies
• project scale 3-5 year, 5-20 M
• What does integration mean??? Stakeholders
  involved, multidisciplinary teams, activities
  (from basic research to exploitation), public and
  private actors (especially academy- SMEs) and
  public and private funding

11
Integrated Projects activities

• Project Management (100 funding but max 7 of EC
  contribution to the project)
• RTD - Research and Technological Development
  activities innovation related activities (50
  funding) creation of new knowledge, IPR
  management, dissemination and exploitation
• Demonstration activities (35 funding) proving
  the technical and economic viability under
  realistic conditions, e.g. testing of product
  like prototypes
• Training activities (100 funding) training of
  researchers and other key staff, research
  managers, industrial executives (in particular
  for SMEs), and potential users, the training
  should contribute to the professional development
  of the persons concerned

12
NoE - Networks of Excellence objectives and
activities

• The main deliverable is a durable structuring and
  shaping of how research is carried out in Europe
• project scale 3-7 years, 5-20 M
• Joint programme of activities sharing of
  research platforms/tools/facilities, joint
  management of the knowledge portfolio,staff
  mobility and exchange, development of new
  research tools and platforms for common use,
  training researchers and other key staff,
  dissemination and communication activities,
  networking activities to help transfer knowledge
  to teams external to the network, where
  appropriate innovation-related activities such as
  exploitation of the results generated within the
  network
• Grant for integration based on number of
  researchers,

13
STREP - Specific Targeted Research Projects
objectives and activities

• The objectives should aim at increasing Europes
  competitiveness or at addressing major societal
  needs. The STREPS should be sharply focussed on
  RTD and/or demonstration activities.
• project scale 3-5 years, 5-20 M
• Project Management (100 funding but max 7 of
  EC contribution to the project)
• RTD - Research and Technological Development
  activities (50 funding) creation of new
  knowledge and/or
• Demonstration activities (35 funding) proving
  the technical and economic viability under
  realistic conditions, e.g. testing of product
  like prototypes
• Innovation related activities (50 funding) in
  particular IPR management and dissemination

14
SSA - Specific Support Actions objectives and
activities

• Aims at supporting activities complementing the
  funded research
• project scale 6 months-3 years, 0.1-2 M
• eligible with ONE single legal entity
• Project Management (100 funding but max 7 of EC
  contribution to the project)
• Activities (up to 100 funding) conferences,
  studies, training courses, partnering events,
  etc. etc.

15
Different steps of the evaluation process
Submission of proposals
Eligibility check
eligible
not eligible/Exclusion
CR
above thresholds
below a threshold
ESR
ESR
Priority List
Commission decision
report
16
What makes a good proposal ?

• Excellent science state-of-the-art and beyond
• Focused clear objectives, targets,
  deliverables
• Relevant to the call topic not just one aspect
• Quality of the consortium keyplayers in Europe,
  young investigators
• Potential impact European Research, durable
  integration
• Integration of WPs collaboration,
  interdependencies
• Commercial exploitation inclusion of SMEs, big
  industry
• Mobilization of resources value for money,
  justified if needed
• Requested budget realistic, added value,
  overall budget
• Solid management integration, project,
  dissemination

17
The Greek Participation (1st and 2nd call)

• 362/14078 participants (2.57)
• 40/3451 funded (1.16)
• Success rate Total 24.5
• Greece 11

18

Thematic call in the area of Life sciences,
genomics and biotechnology for health
Official journal of the European Union 2004/C
158/04 Annex II Publication date 15 June
2004 Closing Date 16 November 2004 at 17.00
(Brussels local time). Specific programme
Integrating and Strengthening the European
Research Area Total indicative budget
EUR 540 million gtgt IP or NOE 405-432 million gtgt
STREP or CA or area specific SSA EUR 108-135
million gtgt Strategic SSA across Thematic priority
1 EUR 8 million IdentifierFP6-2004-LIFESCIHEALT
H-5
19

i) Advanced genomics and its applications for
health
a) Fundamental knowledge and basic tools for
functional genomics in all organisms
20

Overview IP/NoE 11 topics (7 IP, 2 NoE, 2
NoE/IP) STREP/CA/SSA 25 areas
(14/5/6) Indicative budget 122 million (98
million for IP/NOE 24 million for
STREP/CA/SSA) Participation of SMEs encouraged!
21

• Selection of topics
• Based on
• Assessments of EoI (mature non mature)
• Recommendations of scientific advisory group
• Suggestions from programme committee (PC)
• Workshops organised by EC
• Budget available (number of topics)
• Complementarity with results of 1st 2nd calls
  

70 of topics suggested by PC will have been
covered in 1st/2nd calls and the proposed 3rd call
22

3rd call IP/NoE

• Gene expression/proteomics
• technologies for
• - Temporal spatial proteomics in the cell (IP)
• - Role of nuclear organisation and chromatin
  structure in regulation of gene expression (IP)
• Structural genomics
• Structural genomics interdisciplinary initiative
  (IP)

23

3rd call IP/NoE

• Comparative genomics/population genetics
• - Functional genomics of the rat model (IP)
• - Genome-wide mutagenesis in mouse (IP)
• Bioinformatics
• - Databases and tools for systems biology (NoE)
  

24

3rd call IP/NoE

• Basic biological processes
• functional genomics in
• -Mechanisms functions of post-translational
  modification of proteins (NoE/IP)
• -Intracellular routes of growth factor
  signalling (IP)
• -Alternative RNA splicing (NoE)
• -Circadian clock in different models (NoE/IP)
• -Human embryonic stem cell differentiation (IP)

25

3rd call STREP
areas must not be covered by IP/NoE! Role of
non-coding genomic information Systems biology -
complex cellular networks or transcriptional
networks Metabolomics Clinical epigenetics
Adult stem cells Genetic variation in different
human populations Innovative technologies /
methodologies
-Metabolomics -Chemical genomics -Cellular
arrays -Protein arrays
- Model organisms - Structural genomics - Mass
spectrometry
26

3rd call CA
CA Strategy for sustainable databases for model
organisms Structuring systems biology Increase
production of proteins for Structural Genomics
(public-private) Improved co-ordination in
developing NMR methods Improved collaboration
between human tissue banks
27

3rd call SSA
SSA -EU third country regions functional
genomics areas of mutual benefit -Chemical
genomics current status and future developments
(study) -Human population genetics EU, national,
international synergies -Comparative genomics of
primates (workshop) -Future opportunities in RNA
biology (workshop) -Structural genomics
infrastructures and a strategic agenda (policy
forum)
28
Interdisciplinary Initiative in Structural
Genomics
Steps to ERA Structural Genomics an example
MATURE FIELD
Membrane proteins
Large complexes
RNA virus
BIOLOGICALLY-FOCUSED RESEARCH
Synchrotron sites
Protein production (STREP)
3D-EM
TECHNOLOGICAL DEVELOPMENTS
NMR (STREP/CA)
FP5 foundations for European Structural Genomics
SPINE (pilot IP 2002-2005)
FP5 FOUNDATIONS
29

i) Advanced genomics and its applications for
health
b) Application of knowledge and technologies in
the field of genomics and biotechology for health
30

Overview IP/NoE 11 topics (10 IP, 1
NoE) STREP/SSA 19 (12/7) Indicative budget
132 million (80 New Instruments 20
Traditional) Technological Platforms Participatio
n of SMEs encouraged!
31
New drugs

• Accelerated development of new medicines (IP)
• Pharmacogenomics for individualised medicines
  (IP)
• Stem cells/primary cells for rare diseases (IP)
• Determination of immunogenicity of
  biopharmaceuticals (STREP)
• Enhanced parameters for biopharmaceuticals
  (STREP)
• Targeted delivery of protein-based drugs (STREP)
• Educational approaches to new biopharmaceuticals
  (SSA)

32
Diagnostics

• New Screening techniques for solid tumors (IP)
• Tests for haematological malignancies (STREP)
• Genetic and molecular diagnostic markers of
  alcoholic liver diseases (STREP)
• Diagnostic tools for human and animal prion
  associated diseases (STREP)
• Safety of human blood origin products (SSA)
• Ethical issues raised by new diagnostic methods
  (SSA)
• Trends and perspective in new diagnostics (SSA)

33
In Vitro alternatives

• Cell systems to enhance toxicity testing (IP)

• Optimization and pre-validation of in-vitro
  models for drug absorption, modification and
  detoxification (STREP)

• Socio-economic impact of FP5 in-vitro contracts
  (SSA)

• Assessing the risk of chemical compounds in
  vitro, in silico et in numero (SSA)

• Mini-pigs as models for toxicity testing (SSA)

34
New Therapies

• Stem cell therapy for solid tumours (IP)
• Chemokines for chronic inflammation and
  autoimmune diseases (IP)
• Quality and safety for clinical gene transfer
  (NoE)
• Gene delivery technologies (STREP)
• Human stem cells for spinal cord injury repair
  (STREP)
• The potential of human umbilical cord blood stem
  cells for application other than haematopoietic
  transplantations (STREP)
• Oncolytic virus vectors for cancer (STREP)
• Workshop on stem cells as a tool for gene
  therapy (SSA)

35
Post-Genomics

• The molecular basis of asthma (IP)
• Indicators for the control of inflammatory
  rheumatic disease (IP)
• Human pandemic influenza vaccine (IP)
• Complex multifactorial diseases (except Cancer)
  (STREP)

36

ii) Combating major diseases
a) Application-orientated genomic approaches to
medical knowledge and technologies
37

Overview IP/NoE 11 topics (10 IP, 1
NoE) STREP/CA/SSA 18 (10/1/7) STREP-CA1
CA-SSA 2 Participation of SMEs encouraged!
38
Overarching topics
3rd Call
1st Call
2nd Call

• Collaboration between the EU and certain
  third country regions (e.g. within Latin America,
  Indian peninsula, South-east Asia), to be held in
  the corresponding regions to identify research
  activities of mutual benefit in the fields of
  Major Diseases, including Cancer (SSA)

N.A.
Eicosanoids nitric oxide (IP) Coordination of
clinical trials (SSA)
39
Cardiovascular disease
3rd Call
2nd Call
1st Call
Impaired salt and water homeostasis in
hypertension heart failure (IP)
reserve Molecular basis of thrombotic stroke
(STREP) Spectroscopy and imaging in CVD and
diabetes (SSA) not covered
Pathogenesis of coronary artery disease (IP or
NoE) Genomics of heart muscle development and
disease (NoE) not covered Vascular disease
network (NoE) Translational Res. in CVD (SSA)
not covered
Cardiomyocyte signalling in heart failure
(IP) Heart repair cardiac plasticity
(IP) Functional genomics of vascular remodelling
(IP) Arrhythmias ion channels (STREP)
40
Diabetes
3rd Call
1st Call
2nd Call
Molecular basis of exercise effects on the
metabolic syndrome insulin resistance (IP or
NoE) Functional genomics of type 2 diabetes
network (NoE) Prevention of autoimmune
destruction replacement of beta cells in type 1
diabetes (SSA) not covered
Targets for treatment of obesity in context of
diabetes (IP or NoE) Ion channels in pancreatic
beta cells (IP) not covered CA on type 1
diabetes (CA) Obesity and type 2 diabetes (SSA)
Functional genomics markers of type 1 diabetes
(IP) Functional genomics of beta cells in type 2
diabetes (IP) Adipose tissue liver dysfunction
in metabolic syndrome (IP) Genomics of diabetes
complications (STREP)
41
Rare diseases
3rd Call
1st Call
2nd Call
Prader-Willi syndrome (STREP) Rare autoimmune
disorders (STREP) Rare genetic skin disorders
(CA) Disorders of inborn errors of metabolism
(CA)
Rare disorders of nuclear organisation
(STREP) Pharmacogenomics - orphan medicinal
products (STREP) Cystic fibrosis
(CA) Methodological challenges of early clinical
trials (CA or SSA)
Rare disorders of mitochondria (IP or NoE) Rare
disorders of plasma membrane transporters for
amino-acids (STREP) Network for early clinical
trials in Wilson disease (CA) Coordination of
rare diseases Research (SSA)
42
Resistance to antibiotics and other drugs
3rd Call
1st Call
2nd Call
Antiviral drug resistance (Influenza, HBV, HCV)
(NoE) Lower respiratory tract infection (NoE)
not covered Basic mechanisms of resistance
(STREP or CA) Exploitation of microbial genomics
(SSA) Hospital-infection (SSA) - not covered
Functional genomics of antibiotics producing
organisms (IP) New molecular targets for
anti-bacterial drugs (IP) Non-antimicrobial
approaches to address resistance (STREP or CA)
Lower respiratory tract infection (NoE) Mobile
genetic elements and resistance genes
(STREP) Ecological factors impacting on fitness/
virulence/ resistance (STREP) From ba sic
research to clinical practice (SSA) Microbial
genome annotation (SSA)
43
Brain nervous system
3rd Call
1st Call
2nd Call
Affective disorders (IP/NoE) Protein aggregation
(IP) Ataxias (IP) Brain tissue research
(NoE) Eating disorders (IP or NoE) Brain
development (NoE) not covered Rare neurological
disorders (STREP/CA) Pain (STREP/CA) Schizophrenia
(STREP/CA)- not covered Brain research (SSA)
Addiction ( IP/NoE) Learning memory
(IP) Neurodegeneration (NoE) Stem cells (NoE)
- not covered Cortical development
(STREP/CA) Excitotoxicity (STREP/CA) Autism
(STREP/CA) Neuroscience funding (SSA) - not
covered Brain research (SSA)
Synaptic processing (IP) Neuroimmune disorders
(IP) Dyslexia (STREP/CA) Sleep
(STREP) Neuroscience networks (CA/SSA) Neuroimag
ing (SSA) Brain Databasing (SSA) Future brain
research (SSA)
44
Human development ageing
3rd Call
1st Call
2nd Call
Functional and proteomic analysis of ageing
(IP) Nuclear receptors in development and ageing
(IP) Ageing of elastic tissue (STREP) Hormone
replacement therapy (STREP) European research
on ageing (SSA)
Regulation of mitochondrial activity (IP or
NoE) Embryo implantation (NoE) Coordinating
European research on ageing and longevity
(CA) European research on ageing (SSA)
Genetics of healthy ageing (IP/NoE) Mesodermal
organ systems (NoE) Bone homeostasis (STREP)
45

ii) Combating major diseases
a) Combating cancer
46

Overview IP/NoE 5 topics (3 IP, 2
NoE) STREP 3 Participation of SMEs
encouraged! Patient-oriented strategies Develop
guidelines for GCP Support clinical research
47
Combating cancer

• Development of European networks to promote
  research into uncommon cancers in adults and
  children NETWORK OF EXCELLENCE.
• Relevant models for pre-clinical tests and
  evaluation of new therapies INTEGRATED PROJECT.
   
• Research on tumours associated with infectious
  agents INTEGRATED PROJECT.
•  
• Prevention of cancer in high risk populations
  NETWORK OF EXCELLENCE.  

48
Combating cancer

• Research into immune control of tumours for
  prevention and therapy INTEGRATED PROJECT.
• Prevention, detection and treatment of familial
  cancers, such as cancer of the prostate, ovary,
  breast, colon and skin STREP.
•  
• Molecular-oriented detection and treatment of
  minimal disease STREP.
• Tumour-host interactions STREP.

49

ii) Combating major diseases
c) Confronting the major communicable diseases
linked to poverty
50

Overview IP/NoE 4 topics (2 IP, 2
IP-NOE) STREP 3 CA 2 Indicative budget 54
M Participation of SMEs encouraged!
51
Confronting the major communicable diseases
linked to poverty

• HIV/AIDS
• New HIV/AIDS vaccine approaches (IP NoE)
• (Discovery, antigene engineering delivery,
  GMP, preclinical, early human testing)
• European network of HIV/AIDS cohort studies
  (CA)

52

• Malaria
• New drugs or drugs combination for (IP)
• the treatment of malaria
• Malaria vaccine development (IP NoE)
• Tuberculosis
• New drugs for the treatment of tuberculosis (IP)

53

• Cross-cutting Immunology
• Neonatal immunity (STREP)
• Immunology of concurrent infections (STREP)
• SME-directed topics
• research in poverty-related diseases by SMEs
  (STREP)
• Coordination of SME activities in PRD (CA)

54
Overall Research Strategy of the 6th Framework
Programme to confront HIV/AIDS, Malaria and
Tuberculosis

EUROPEAN DEVELOPING COUNTRIES CLINICAL TRIALS
PARTNERSHIP (EDCTP) activities supported not in
call!
Clinical Trials (Phase II/III)
HIV/AIDS
Malaria
TB
Phase I trials
SOME STRUCTURING CAs, SSAs ?
NEW INSTRUMENTS

• Vaccines (IP/NoE)
• Microbicides (IP/NoE)
• Therapy Trials in Europe (NoE)

Pre-clinical

• Drugs (IP)
• Vaccines (IP/NoE)
• Biology and Pathology (NoE)

• Vaccines (IP/NoE)
• Drugs (IP/NoE)

Discovery
Genomics
CROSS-CUTTING TOPICS Mucosal vaccines for PRD
(IP/NoE) Neonatal vaccination strategies for
Poverty Related Diseases
HIGH RISK PROJECTS (STREPS) DEFINED SUPPORTING
ACTIVITIES (SSA)
55

SSAs across Thematic Priority 1
Minimum n of participants 1 legal entity from
MS or AS!
56

• LSH-2004-3-1 Promoting Collaboration between
  SMEs and Academia
• Accelerating technology transfer
• LSH-2004-3-2 Stimulating international
  co-operation
• -Networking events with countries having S T
  cooperation agreements with EU, to explore common
  research priorities
• LSH-2004-3-3 Promotion of cooperation with
  Associated Candidate Countries (ACC)
• Stimulation, encouragement and facilitation of
  the participation of organisations from the
  Associated Candidate Countries (Romania, Turkey
  and Bulgaria)
• LSH-2004-3-4 Realising ERA objectives

57

• LSH-2004-3-5 Life sciences and biotechnology
  A strategy for Europe
• - science communication, promote public
  perception
• Pilot study on the feasibility of a Europe wide,
  publicly available, database on new therapies
• LSH-2004-3-6 Supporting policy development
• - Conferences linked to Presidency activities.
• Impact assessment of past programme activities
• LSH-2004-3-7 1-day Conference on the state of
  the art of stem cell research, focusing on the
  potential and limitations for curing severe
  diseases, aimed at patients
• LSH-2004-3-8 European human embryonic stem cell
  registry

58

Thematic call in the area of Life sciences,
genomics and biotechnology for health
Official journal of the European Union 2004/C
158/04, Annex I Publication date 15 June
2004 Closing Date 9 September 2004 at 17.00
(Brussels local time). Specific programme
Integrating and Strengthening the European
Research Area Total indicative budget
EUR 4 million gtgt CA or SSA Feasibility study for
the co-ordination of national cancer researcg
activities IdentifierFP6-2004-LIFESCIHEALTH-4
(2nd Cancer call, Art.169)
59
2nd Cancer call
SSA/ CA
Feasibility study for the coordination of
national cancer research activities
The 6th Framework Programme offers the
possibility to participate in research programs
undertaken jointly by several Member States,
including participation in the structures created
for the execution of national programs. In this
context, the objective of the proposed CA/SSA
would be, in the field of cancer research,  to
define the existing needs,  to identify the
potential benefits and added value of such a
coordination initiative and to address its
feasibility. The CA/SSA should address potential
areas in which the structuring of EU research
capacity in cancer may have a significant impact
such as platforms for (molecular) epidemiology,
bio-informatics, networking of research on cancer
registration and surveillance strategies.
60
Reasons for failure
Relevance

• Not covering properly the published topic(s).
• Only marginally relevant to the objectives of the
  topic.
• A project side-tracking the topic.
• Does not address the topic in its entire
  complexity. Focus on only one aspect of the
  topic.
• How can you reject my proposal? It matched
  perfectly the second sentence of the topic
  description.

61
ST excellence

• The scientific approaches taken have not been
  state-of-the-art.
• Description of work is not sufficiently
  convincing.
• Lack of innovation and duplication of already
  existing work.
• Missing important aspects, such as control
  experiments, or unclear scientific plan
  description.
• Proposals that try to tackle every scientific
  question rather than being focused.

62

• Extensive introduction and state-of-the-art, but
  then vague descriptions of Workpackages.
• State-of-the-art lacking one or more key
  references/findings of the past 3-6 months.
• Working hypotheses are not sound.
• The quality of the approaches proposed is not
  convincing or has previously failed.
• Workpackages do not show any complementarity.
• JPA no demonstration of any integration plans
  for integration too poorly described.

63
Other

• Lack of plans for dissemination of results.
• Insufficient involvement of SME.
• Unbalanced consortium.
• Doubts about quality of some participants.
  (heterogeneous consortium)
• Absence of key partners.

64

• Lack of involvement of industrial partners (when
  needed).
• Despite high quality of individual partners,
  their integration may be poor.
• Poor description management.
• Poor mobilization of financial resources.
• One of the partners asking for much more money
  than the others, without it being the
  coordinating partner or without explanation.

65
What makes a good proposal ?

• Excellent science state-of-the-art and beyond
• Focused clear objectives, targets,
  deliverables
• Relevant to the call topic not just one aspect
• Quality of the consortium keyplayers in Europe,
  young investigators
• Potential impact European Research, durable
  integration
• Integration of WPs collaboration,
  interdependencies
• Commercial exploitation inclusion of SMEs, big
  industry
• Mobilization of resources value for money,
  justified if needed
• Requested budget realistic, added value,
  overall budget
• Solid management integration, project,
  dissemination