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Βιολογικές επιστήμες, γονιδιωματική και βιοτεχνολογία στην υπηρεσία της υγείας

Βιολογικές επιστήμες, γονιδιωματική και βιοτεχνολογία στην υπηρεσία της υγείας. Γιάννης Οικονομίδης Ευρωπαϊκή Επιτροπή ΓΔ Έρευνας. THE SIXTH FRAMEWORK PROGRAMME The Sixth Framework Programme covers Community activities in the field of research, technological development

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Βιολογικές επιστήμες, γονιδιωματική και βιοτεχνολογία στην υπηρεσία της υγείας

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  1. Βιολογικές επιστήμες, γονιδιωματική και βιοτεχνολογία στην υπηρεσία της υγείας Γιάννης Οικονομίδης Ευρωπαϊκή Επιτροπή ΓΔ Έρευνας

  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. The European Research Area What makes a good proposal ? FP6-2004-LIFESCIHEALTH-5 FP6-2004-LIFESCIHEALTH-4 Overview of the presentation

  4. 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 Why European Research?

  5. Research is: Increasingly complex and interdisciplinary Increasingly costly Requires a constantly increasing “critical mass” Why European Research?

  6. 1950s - European Coal and Steel Community 1957 - European Atomic Energy Community 1984 - First Framework Programme 2000 - European Research Area 2002 - Sixth Framework Programme Historical Background

  7. First true European research policy Creating a “single market” for research at the European level Addresses fragmentation of Europe’s research efforts European Research Area

  8. Making a reality of ERA: Framework Programme 6 Member States’ research efforts Other European co-operative research activities European Research Area

  9. Key Principles of FP6Types of projects/modalities Integrated Projects (IP) aims at generating knowledge to increase Europe’s 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. Ethical aspects, science-society dialogue Training RTD 4 RTD 5 Management RTD 1 RTD 3 RTD 2 Demonstration Technology transfer, exploitation Integrated Projects Objectives • The objectives should aim at increasing Europe’s 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 Europe’s 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. Individual Evaluation/Review Consensus meeting(s) Ethical review Panel evaluation Commission decision Reserve List Negotiation Rejection 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 ofSMEs, big industry • Mobilization of resources value for money, justified if needed • Requested budget realistic, added value, overall budget • Solid management integration,project, dissemination

  17. 362/14078 participants (2.57%) 40/3451 funded (1.16%) Success rate: Total 24.5% Greece 11% The Greek Participation (1st and 2nd call)

  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 >> IP or NOE:€ 405-432 million >> STREP or CA or area specific SSA: EUR 108-135 million >> Strategic SSA across Thematic priority 1: EUR 8 million Identifier:FP6-2004-LIFESCIHEALTH-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 1st call 2nd call 3rd call Steps to ERA Structural Genomics: an example MATURE FIELD Membrane proteins Large complexes RNA virus BIOLOGICALLY-FOCUSED RESEARCH Synchrotron sites Protein production (STREP) TECHNOLOGICAL DEVELOPMENTS NMR (STREP/CA) 3D-EM 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 • Participation 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-CA:1 + CA-SSA: 2 • Participation of SMEs encouraged!

  38. Overarching topics 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) 3rd Call 1st Call 2nd Call N.A. Eicosanoids & nitric oxide (IP) Coordination of clinical trials (SSA)

  39. Cardiovascular disease 3rd Call 1st Call 2nd 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 Functional genomics of antibiotics producing organisms (IP) New molecular targets for anti-bacterial drugs (IP) Non-antimicrobial approachesto 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) 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

  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) Neuroimaging (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. Development of European networks to promote research into uncommon cancersin 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. Combating cancer

  48. 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. Combating cancer

  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!

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