From Expressions of Interest to a Workprogramme for 2003

1. PRIORITY 1 Life sciences, genomics and biotechnology for health From Expressions of Interest to a Workprogramme for 2003

2. FP6 - Expressions of Interest - Response Priority theme 1: Life Sciences, Genomics & Biotechnology for Health IPs NoEs Unspecified Total Fundamental genomics 288 190 45 523 Applied genomics & biotech 240 125 36 401 Major diseases 459 219 24 702 Cancer 196 102 4 302 Poverty related diseases 41 28 - 69 Total 1224 664 109 1997 17% of EoIs for all 7 priority themes

3. FP6 - Expressions of Interest - Theme 1

4. FP6 - Expressions of Interest - Theme 1 Industry, including SME, involvement (% submitters) 4% overall 8% Fundamental knowledge and basic tools 10% Applications of knowledge and technologies... N.B 15% of budget for SMEs Gender balance (% submitters) 16% female 84% male

5. EoIs- countries of submitters - Theme 1 10 % from candidate countries

6. FP6 - Expressions of Interest - Theme 1 Outcome of the panel meeting Categories of scientific topics - all panels 1. Strategic importance for Europe & thematic priority; ready for implementation through an IP or NoE  2. Not-relevant to the thematic priority; less obvious strategic importance for Europe Some panels  3. Strategic importance for Europe & thematic priority; BUT not yet mature for an IP or NoE (based on the EoIs received)  4. Strategic importance but not covered by any EoIs or the EoIs were not well argued

7. FP6 - Expressions of Interest - Theme 1 Analysis Methodology At the panel meeting in Bussels “Citation list” of EoIs  to start the discussion - cited EoIs - non-cited EoIs - expert rapporteur for every EoI Some EoIs analysed by more than one panel (broad scope) Definition of topics for IP and NoE - no pre-selection of particular EoI or consortium

8. Fundamental knowledge and basic tools for functional genomics in all organisms • In total, 30 recommended topics • 15 topics will be published in first call; 15 in second call • The selected topics will be open only for the call indicated • It is envisaged that no more than 1 project utilising a new instrument will be funded for each topic • There will be competition between topics as well as within topic areas • This will result in some topic areas not being supported

9. Gene expression and Proteomics Examples • Advanced array technologies • High throughput proteomics for large data set of protein-protein interactions • In situ gene expression analysis in mouse and human tissues Structural genomics Examples • Viral replication • Large protein complexes • Membrane proteins • Supramolecular analysis (NoE) • Hardware and software for automated technologies at synchrotron sites (IP)

10. Comparative genomics & Population genetics • RNA interference screening in Arabidopsis for processes relevant to health • Phenotyping human populations • Bacterial diversity with relevance to human health (NoE) • High throughput genotyping in human populations (NoE) Examples • Non-mammalian vertebrate models (IP) • In-vivo imaging for phenotyping and functional analysis Bioinformatics Examples • Genomics grid for European research (NoE) • Software platform to tackle sequence-structure-function relationships • Annotation of human and other genomes (NoE)

11. Basic biological processes Examples: • Kidney disease • Peroxisomes • Inner ear or retina development • DNA damage and repair • Disease of the immune system or of the muscle • X-linked syndromes • Cell cycle • Non-human embryonic stem cell differentiation • Erythroid development (IP) • Lymphangiogenesis • Inflammation processes (NoE) • Ubiquitin-proteasome (NoE) • Epigenetics (NoE)

12. Traditional instruments Examples: • Transcription activation • Signal transduction • Intracellular communication • Non-coding genomic information • Integration of genes • In silico prediction of gene function • Simulation of complex regulatory networks • New tools and approaches, standard protocols producing knowledge in functional and structural genomics

13. Applications of knowledge and technologies in the field of genomics and biotechnology for health Strategic Objective: To foster the competitiveness of Europe’s biotechnology industry by exploiting the wealth of biological data produced by genomics and advances in biotechnology

14. - Health care progress - Increased quality of life - Cost reduction - Precise diagnostics - Individualised treatments - New drugs and therapies - Novel products from genomics and biotechnology • Industry • SME • Academics • Stakeholders Integrated Multidisciplinary Research Deliverables Civil society EU project Applications of knowledge and technologies in the field of genomics and biotechnology for health Development of Technological Platforms TECHNOLOGICAL PLATFORMS

15. Applications of knowledge and technologies in the field of genomics and biotechnology for health Technology Platforms will focus their research activities on: • New, safer and more effective drugs including pharmacogenomics approaches • New diagnostics • New in vitro tests to replace animal experimentation • New preventive and therapeutic tools such as somatic gene and cell therapies (in particular stem cell therapies) and immunotherapies • Innovative research in post-genomics (novel products from genomics and biotechnology)

16. STEM CELL Therapies • Detailed implementing provisions concerning research activities involving the use of human embryos and human embryonic stem cells which may be funded under the 6th Framework Programme shall be established by 31 December 2003. • During that period and pending establishment of the detailed implementing provision, the Commission will not propose to fund such research, with the exception of the study of banked or isolated human embryonic stem cells in culture.

17. New, safer and more effective drugs including pharmacogenomics approaches Examples • Drugs for aberrant molecular signalling in protein phosphorylation pathways (IP) • Genome-based individualised medicine • Drugs for psychiatric disorders (NoE) • Antiviral therapies (IP) • Medicines for paediatrics • Computer-assisted modelling for drugs • Therapeutics for neurodegenerative diseases Development of new diagnostics Examples • Genetic tests allowing for harmonisation, validation and standardisation • In-vivo molecular imaging • Non-invasive diagnostics: Development of markets for ante- and neonatal screening (NoE) Development of new in vitro tests Examples • Test batteries for human acute toxicity • Combined in vitro cell and sensor technologies for animal toxicology (IP)

18. New preventive and therapeutic tools Examples • Gene delivery systems against severe acquired diseases • Gene therapy of inherited diseases • Safety, quality, standardisation of stem cells (European registry) • Regeneration therapies for vital organs • Vaccine delivery systems (bacterial, synthetic, aimed at dendritic cells, etc…) • New chemokine modulators in autoimmune diseases • New cell lines for cell-based therapies (IP) • Allogenic stem cell transplantation for haematological and neoplastic diseases (IP) • Cell-based therapies for regeneration of connective tissue (IP) Innovative research in Post-Genomics Examples • RNA as human therapeutic tool • Post-genomic approaches to study human pathogens • Pre-clinical and clinical applications • Post-genomic approaches against asthma and autoimmune diseases (IP) • Plant platforms for immunotherapeutic biomolecule production (IP)

19. New, safer and more effective drugs including pharmacogenomics approaches Examples: Blood substitutes (e.g. oxygen carriers), G-Protein coupled receptors Development of new diagnostics Examples: Non-invasive diagnostics using bioinformatics tools, Diagnostics for prion diseases Development of new in vitro tests Examples: Competitive product screening & development process stages lead compounds by introduction of alternative testing New preventive and therapeutic tools Examples: Vaccine technologies targeted to dendritic cells Databank on immuno therapies, comprising advances from genomics, proteomics and cell biology Stem cell products for myocardial repair Innovative research in post-genomics Examples: Combinatorial biosynthesis, Optically-active therapeutic biomolecules by biocatalysis, Precision technology platforms from post-genomics

20. Combating major diseases Number of EoIs: Fields of research: 286 77 281 58 • Combating cardiovascular diseases, diabetes and rare diseases • Combating resistance to antibiotics and other drugs • Studying the brain and combating diseases of the nervous system • Studying human development and the ageing process • TOTAL • Cancer 702 58

21. Combating cardiovascular disease, diabetes and rare diseases Examples: • Molecular targets in obesity from diabetes • Coronary Artery Disease • Genomics of heart muscle development (NoE) • Genomics of vascular disease (NoE) • Pancreatic ion channels in type II diabetes (IP) • Rare disorders of mitochondria • Hypertension • Genomics of type II diabetes • Exercise and metabolic syndrome • Eicosanoids and nitric oxide as mediators of diseases • Rare disorders of plasma membrane transporters N° of EoIs: 286

22. Combating resistance to antibiotics and other drugs Examples: • Upper Respiratory Tract Infections (NoE) • Anti-viral drug resistance • Antibiotics producing organisms • New targets for drugs - the ribosome • Anti-fungal resistance • Microbial ecology - epidemiology • Control of hospital acquired infections • Broadening the knowledge base on molecular mechanisms behind resistance • Non antimicrobial therapies

23. Studying the brain and combating diseases of the nervous system Examples: • Protein aggregation • Eating disorders (IP) • Bipolar disorders (IP) • Rare neurological diseases: ataxias • Brain development, degeneration and regeneration (NoE) • Brain tissue research (NoE) • Addiction • Cortical processing: learning, memory, behavior • Cortical development • Stem cells and nervous system • Rare monogenic neurological disorders, Genetics and neurobiology of pain, Schizophrenia N° of EoIs: 281

24. Human Development and Ageing Examples: • Longevity • Mesodermal organ system (NoE) • Mitochondrial dysfunction • Embryo implantation • Congenital anomalies Markers • Aberrant Steroid signalling • Biochemistry of Reactive Oxygen Species • Molecular mechanisms of bone homeostasis N° of EoIs: 58

25. Cancer Selected 6 out of 14 topics for first call in order to ensure: • Potential co-ordination of complementary areas (e.g. molecular targets - molecular imaging) • Balanced coverage of the main WP areas: • A.Establishing facilities for exploitation of research • Registries and repositories • B.Clinical research • European networks for clinical trials • Molecular imaging for early detection • Radiation therapy • C.Translational research • Functional oncogenomics • Molecular targets

26. Overall Research Strategy of the 6th Framework Programme to confront HIV/AIDS, Malaria and Tuberculosis EUROPEAN DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP) Clinical Trials (Phase II/III) HIV/AIDS Malaria TB Phase I trials NEW INSTRUMENTS Pre-clinical • Vaccines • Microbicides • Therapy Trials in Europe • Vaccines • Biology and Pathology (NoE) • Drugs • Vaccines • Drugs Discovery CROSS-CUTTING TOPICS: Mucosal vaccines for PRD Neonatal vaccination strategies for PRD Genomics H I G H R I S K P R O J E C T S ( S T R E P)

27. Confronting the major communicable diseases linked to poverty High level of interest, excellent quality of the EoI: most EU leading researchers represented in one or more EoI

28. EoI’s Panel main recommendations • Encourage participation ofpartners from DC • Stimulate thetraining componentboth for the North and the South • Increase the professionalism ofmanagement • Include in the projects pre-clinical testing innon-human primates and GMP productionof candidate drugs or vaccines

29. PRIORITY 5 Food Quality & Safety From Expressions of Interest to a Workprogramme for 2003

30. 43% 33% 8% 41% 24% 51% 23% 77% Response to invitation to submit Expressions of Interest for priority 5 Type of instrument Type of submitter Gender of submitter

31. Expert comments on nonselected EoI • Very many EOIs on similar subjects • Many were technical skills looking for funds • Many were on a very large scale with little indication of management skills • Need for a “Development Bank” business plan approach • Lack of analysis on the importance of the problems to be addressed and of any potential benefits • No gender balance awareness • IP management was weak • No gender balance awareness and IP management was weak

32. From EoI to Workprogramme • Budget: 149 M€ in 2003 • Focussing: from 53 topics through EoIs down to ... • Consultation of AG and committee • Maturity of the topic • Readiness of the topics for new instruments or traditional instruments • Urgency of the issue: 2003 or 2004

33. Format of the Draft Workprogramme (1) • Common format for all Thematic Priorities • Follows the specific programme • Introduction to each area: clear signals • NI (NE/ IP) or TI (STREP/ CA)

34. Format of the Draft Workprogramme (2) • 2003: - selected topics - detailed description (objectives/disciplines/expected outcome) • 2004: - indicative areas - outline description • Objectives for Specific Support Measures

35. A likely (but non-binding) scenario

36. Total Food Chain Examples: • Food from low input and organic production systems: Ensuring the safety and improving quality along the whole chain • Quality seafood for improved consumer health and well-being • Improving the quality and safety of beef for the consumer • Pathogen free production systems

37. Epidemiology of food-related diseases and allergies Examples: • Validated food information database for Europe (NoE) • Epidemiology of food allergy • Influence of gene-nutrient interaction on the development of chronic diseases • Influence of nutrition and lifestyle on healthy ageing aimed at preventing adult degenerative disease • Nutritional and lifestyle habits of adolescents throughout Europe, including production of functional foods with sensory properties attractive to adolescents

38. Impact of food on health Examples: • Functional genomics in relation to food, nutrition and health (NoE) • Lipid metabolism and the metabolic syndrome • Food safety, risk assessment and communication • Programming effects of early nutrition on long-term health • Microbes, the immune system and gut health • Improving and enhancing the nutritional value and health benefits of cereals • Health risks from heat-treated foods and food products

39. “Traceability” processes along the production chain • Development of reliable traceability methods and systems to establish the origin/mode of productin of food products

40. Methods of analysis, detection and control Examples: • Zoonoses including food borne diseases (NoE) • Prion diseases (NoE) • Chemical contaminants in food products • Emerging and future food borne pathogenic microorganisms throughout the food chain • Quantitative risk assessment strategies based on probabilistic, genomic and profiling approaches including a risk-benefit analysis for novel foods • Cost-effective tools for risk management and traceability systems for zoonotic agents and phycotoxins in seafood

41. Safer and environmentally friendly production methods and healthier foodstuffs Examples: • Soil microbial community management for safe production under stress conditions • Plant biodiversity to reduce pesticide application • Immunological basis for protection against animal disease • High throughput analysis of plant composition and metabolism for optimising end-product quality • Animal welfare for improved food quality • Genomics of host-pathogen interactions in animals (NoE) • Antibiotic resistance • Crop protection systems based on biological control agents and semiochemicals • Modelling of improved crop establishment in low input systems • Plant flavonoids • Recycled organic wastes from the food chain • Sustainable aquaculture • GMO co-existence analysis • Use of genetic resistance to control plant viruses • Disease risk from alternative and enriched cage and free-range systems

42. Impact of animal feed on human health • New strategies to improve grain legumes for food and feed • Alternatives to antimicrobials in feeds

43. Environmental health risks Examples: • Allergy and asthma network • Exposure to chemical residues in the environment • Environmental factors and puberty onset • Cancer risk from environment, diet and genetic • Human pathogens in drinking water • Food and fertility • Neurotoxic effects of environmental contamineants • Exposure to complex chemical mixtures