The Sixth RTD Framework Programme Thematic Priority 1 Life Sciences: Genomics & Biotechnology for Health

Focussing and integrating Community research: 7 Thematic priorities Budget (million € ) 1. Life sciences: genomics & biotechnology for health 2, Information society technologies3, Nanotechnologies & nanosciences….1, Aeronautics & space 1, Food quality & safety Sustainable development, global change and ecosystems 2, Citizens and governance…. 225

TP1. Life sciences: genomics & biotechnology for health Why focus on genomics ?  Sequencing of human genome (and other genomes)  Major opportunity to improve human health  Stimulus for business activity  Needs to transform mass of raw data into useful knowledge  To be competitive with US and Japan, we need to have a coordinated approach at the European level for many topics in genomics.  EU will invest by scientific interest and for avoiding to become a “client” Integration with other approaches  Multidisciplinarity

First call expected 17 December 2002 Deadline 25 March 2003 Thematic priority 1. First call & Work programme Illustrations only! focusing on Networks of Excellence and Integrated Projects TP1. Life sciences: genomics & biotechnology for health

Funding instruments New (inclusion of new partners during project life-time) - Networks of Excellence - Integrated Projects “Traditional” - Specific Targeted Research Projects (STREP) - Co-ordination actions (CA) - Specific Support Actions (SSA) Also don’t miss other opportunities (including fellowships) across the whole Sixth Framework Programme! TP1. Life sciences: genomics & biotechnology for health

Total budget for first call: € 513 million, broken down as follows: Instrument € (million) Integrated project or network of excellence385 – 410 Specific targeted research project or co-ordination action 92 – 121 Specific support actions 8 – 10 TP1. First call: indicative budget

15% of FP Thematic Priorities budget is for participation of small and medium sized enterprises (SMEs) Specific activities ‘Co-operative research’: carried out by research centres for SMEs or by high- tech SMEs in collaboration with research centres and universities ‘Collective research’: carried out by research centres for industrial associations or industry groupings in entire sectors of industry dominated by SMEs

i. Advanced genomics and its applications for health (€ 1,100 m) a. Fundamental knowledge and basic tools for functional genomics in all organisms (FP5: Generic Activities, Research into Genomes and diseases of genetic origin) b. Application of knowledge and technologies in the field of genomics and biotechnology for health (FP5: Key Action 3, The “Cell Factory” TP1. Life sciences: genomics & biotechnology for health

ii. Combating major diseases (€ 1,155 m) a. Applications- oriented genomic approaches to medical knowledge and technologies (FP5: GA 7-Chronic and degenerative diseases, diabetes, cardiovascular diseases and rare diseases, GA9-Neurosciences, KA6-Ageing population) b. Combating cancer (FP5: GA7) c. Confronting the major communicable diseases linked to poverty (AIDS, tuberculosis, malaria) (FP5: KA2 Control of Infectious Diseases)

Expressions of Interest Report on the analysis of expressions of interest 2002 Thematic priority 1 “Genomics and biotechnology for health” >Potential topics that could be used for first and subsequent calls of FP6 >To help potential participants become familiar with the new instruments TP1. Life sciences: genomics & biotechnology for health

i. Advanced genomics and its applications for health a. Fundamental knowledge and basic tools for functional genomics in all organisms to foster basic understanding of genomic information, by developing the knowledge base, tools and resources needed to decipher the function of genes and gene products relevant to human health TP1. Life sciences: genomics & biotechnology for health - Gene expression and proteomics - Structural genomics - Comparative genomics and population genetics - Bioinformatics - Multidisciplinary functional genomics approaches to basic biological processes

TP1. Indicative topics/ instruments for first call Gene expression and proteomics (2 topics in first call) (1 indicative topic for next call (s) ) Developing high throughput tools and approaches for monitoring gene expression and protein profiles and for determining protein function and protein interactions Development of advanced array technologies (IP/NoE) - for the analysis, with high precision and sensitivity, of large sets of proteins, DNA and RNA and for functional cell arrays Technology development

TP1. Indicative topics/ instruments for first call Structural genomics (3) (2) Developing high throughput approaches for determining high-resolution 3-D structures of macromolecules. Development of new hardware and software for the implementation of innovative automated technologies at synchrotron sites (IP) - developing, assembling, standardising and providing highly integrated and automated technological platforms at synchrotron research centres for high throughput structural genomics Specific and ambitious objectives Infrastructures can be part of IP and NoE

Comparative genomics and population genetics (2) (4) Developing model organisms and transgenic tools; developing epidemiology tools and standardised genotyping protocols. Integrated tools for functional genomics of non- mammalian vertebrate models for human development and disease mechanisms (IP) - develop and use high throughput tools, technologies and approaches …. for harvesting large data sets on gene functions... Model organisms: to complement the ‘integrated project’ on mouse functional genomics (funded by the QoL programme in FP5) TP1. Indicative topics/ instruments for first call

Bioinformatics (1) (2) Developing bioinformatics tools and resources for data storage, mining and processing; developing computational biology approaches for in silico prediction of gene function and for the simulation of complex regulatory networks. Developing methods and resources in bioinformatics to focus on the annotation of human and other genomes (NoE) - cooperation between life scientists and bioinformaticians to coordinate … the design and development of new integrated bioinformatics tools and approaches... Structuring the field - life scientists & bioinformaticians Spreading excellence TP1. Indicative topics/ instruments for first call

Multidisciplinary functional genomics approaches to basic biological processes (7) (8) Elucidation of the mechanisms underlying fundamental cellular processes, to identify the genes involved and to decipher their biological functions in living organisms. Integrated comparative and functional genomics approaches for studying the cell cycle (IP/ NoE) - multidisciplinary functional genomics approaches in different model organisms for elucidating.. Basic mechanisms controlling the cell cycle Basic knowledge - wide implications in health research TP1. Indicative topics/ instruments for first call

Multidisciplinary functional genomics approaches to basic biological processes (continued) Multidisciplinary approaches of functional genomics to study chronic inflammation processes in human disease (NoE) - co-ordination of research activities … Specific diseases can be addressed..but the emphasis should be on basic mechanisms Basic mechanisms - implications in many diseases TP1. Indicative topics/ instruments for first call

Research areas - 1st call - STREP/CA/SSA transcription activation, signal transduction, intra- cellular communication, the role of non-coding genomic information, mechanisms of integration of genes in silico prediction of gene function and simulation of complex regulatory networks development of new tools and approaches, including the standardisation of protocols, to facilitate generation of new knowledge in functional and structural genomics TP1. Indicative topics/ instruments for first call

1. Advanced genomics and its applications to health b. Applications of knowledge and technologies in the field of genomics and biotechnology for health to foster the competitiveness of Europe’s biotechnology industry the integration of small and medium sized enterprises (SMEs) in projects is essential TP1. Indicative topics/ instruments for first call

Technological platforms for developments in the fields of new diagnostic, prevention and therapeutic tools - New, safer, more effective drugs, pharmacogenomics approaches (4) (3) - New diagnostics (1) (2) - New in vitro tests to replace animals (1) (1) - New preventive and therapeutic tools (e.g. stem cells, immunotherapies) (3) (6) - Innovative post-genomic research with high potential for application (2) (4) TP1. Indicative topics/ instruments for first call

New, safer, more effective drugs, pharmacogenomics approaches (4)(3) translation of the knowledge and methods derived from genomics into concrete applications for drug design and development Genome-based individualised medicines (NoE) - structuring of efforts devoted to characterisation of drug targets.. to optimise individual drug selection, dosage and delivery.. to improve the benefit / risk ratio of drugs Cooperation of research and clinical centres, ethical bodies, regulatory authorities, healthcare providers, pharmaceutical industry TP1. Indicative topics/ instruments for first call

New diagnostics (1)(2) early diagnosis, monitoring of disease progression and interpretation of in-vivo data Non-invasive diagnostics and diagnostic procedures; development of markers for ante- and neo-natal screening (NoE) - structuring of efforts devoted to development of non- invasive tools for pre-natal diagnosis and the translation of genomics data into diagnostic applications…. Translational research; cooperation of academia, ethical bodies, regulatory authorities, pharmaceutical industry TP1. Indicative topics/ instruments for first call

New in vitro tests to replace animal experimentation (1)(1) Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes Combination and application of in vitro cell and sensor technologies in the field of animal in vivo toxicology (IP) - research should focus on in vitro cell-based toxicological and pharmacological tests for screening drug compounds Technology development TP1. Indicative topics/ instruments for first call

New preventative and therapeutic tools (3)(6) integration of different research activities in genetics, fundamental and clinical research and ethics to provide standardised research materials such as stem cell banks, clinical research protocols and novel preventive and therapeutic instruments at a European level. New advances in cell-based therapies for the regeneration of connective tissue (IP) - application of mesenchymal stem cell research, gene transfer and tissue engineering for the treatment of connective tissue diseases….. defining quality and safety standards for tissue regeneration... leading to new biological implants capable of functional load bearing Several disciplines involved Industry, regulatory authorities TP1. Indicative topics/ instruments for first call

Post-genomics with high application potential (2)(4) use cutting edge technologies in a multidisciplinary approach to address areas of research that will benefit from the developments resulting from genomics Plant platforms for immunotherapeutic biomolecule production (IP) - focus on pharmaceuticals (vaccines, other immunotherapeutics) for which a plant-based production system offers real advantage and potential Appropriate participation of developing countries Experimental design to minimise ecological impact TP1. Indicative topics/ instruments for first call

Research areas - 1st call - STREP/CA/SSA New drugs targeting G-protein coupled receptors through pharmacogenomics Educational schemes utilising interdisciplinary approaches for the integration of pre-clinical and clinical research (e.g. training events, workshops) Development of novel non-invasive and repeatable diagnostics using bioinformatic tools New diagnostic tools for prion associated diseases TP1. Indicative topics/ instruments for first call

Research areas - 1st call - STREP/CA/SSA Technology foresight meeting on test development, validation and implementation Workshop on business opportunities in pharmaceutical toxicology Partnership event on the development and manufacture of toxicology test methods for regulatory testing needs Forum on the achievements in raising awareness on the use of alternative methods in Candidate Countries TP1. Indicative topics/ instruments for first call

TP1. Life sciences: genomics & biotechnology for health ii. Combating major diseases a. Applications- oriented genomic approaches to medical knowledge and technologies - Cardiovascular disease, diabetes, rare diseases - Resistance to antibiotics and other drugs - Brain and combating diseases of the nervous system - Human development and the ageing process

TP1. Life sciences: genomics & biotechnology for health ii. Combating major diseases a. Applications- oriented genomic approaches to medical knowledge and technologies to develop improved strategies for the prevention and management – using also advanced technologies for health - of human disease and for living and ageing healthily integrate a genomic approach through all relevant organisms into more established medical approaches for investigating disease and health determinants translational research aimed at bringing basic knowledge through to clinical application

TP1. Indicative topics/ instruments for first call Cardiovascular, diabetes, rare diseases (6)(4) >Integrating clinical expertise and resources with relevant model systems and advanced tools in functional genomics ==>> breakthroughs in prevention and disease management > Pool Europe’s research resources to tackle rare diseases Genomics of heart muscle development and disease (NoE) - durable integration of researchers working on nor- mal/abnormal development of the heart… translation of new knowledge to the treatment of complications of heart disease (heart failure, arrhythmias) Child health: congenital cardiovascular malformation

TP1. Indicative topics/ instruments for first call Resistance to antibiotics and other drugs (2)(4) >Exploitation of knowledge of microbial genomes and host- pathogen interactions ==>> vaccines, alternative strategies; > Strategies for optimal use of antimicrobials > Support EC network on epidemiological surveillance and control of communicable diseases. Testing anti-viral drug resistance and understanding resistance development (IP or NoE) - setting up a broad approach towards testing and following up antiviral drug resistance in human virus infections…. integrate basic, clinical, pharmacological, immunological and virological research

Brain, combating diseases of the nervous system (6)(5) use genome information to understand better brain function, damage, plasticity and repair, learning, memory, cognition in order to gain new insight into mental processes, to combat neurological disorders and diseases, and to improve brain repair Human brain tissue research (NoE) - research and studies on genetic and environmental influences on brain diseases - standardisation of tissue sampling, shared use, diagnosis, ethical issues, clinical history, genotyping, accessibility and training Infrastructural aspects, structuring the field Spreading excellence TP1. Indicative topics/ instruments for first call

Human development and the ageing process (2)(4) Human genome sequence, genomic and postgenomic research applied to understand human development and healthy ageing in order to develop the evidence base for improving public strategies and to promote healthy living and healthy ageing Genetic factors of longevity and healthy ageing (IP/NoE) - to compare health status, family history, different age and gender groups, genetic background to identify genetic markers and expression profiles for the prediction of … longevity and healthy ageing Population studies, special expertise and facilities in Europe TP1. Indicative topics/ instruments for first call

Research areas - 1st call - STREP/CA/SSA Rare disorders of plasma membrane transporters for amino- acids, lipids and sugars Workshop on the structuring of European research activities to more effectively combat drug resistant hospital infections Specific brain research support actions Molecular mechanisms of bone homeostasis - prevention or treatment of osteoporosis TP1. Indicative topics/ instruments for first call

ii. Combating major diseases b. Combating cancer (6) (8) Establishing facilities for exploitation of research (evidence-based guidelines for good clinical practice and improved public health strategies), supporting clinical research/clinical trials, supporting translational reseach Translating basic knowledge of functional onco- genomics into cancer diagnosis and treatment (IP/NoE) - large-scale analysis to identify signalling pathways, oncogenes, tumour supressor genes - epigenetic mechanisms and genomic instability - new molecular targets for anticancer drug discovery Translational research TP1. Indicative topics/ instruments for first call

c. Confronting the major communicable diseases linked to poverty (5) (5) Developing candidate interventions, establishing a clinical trials programme, establishing an AIDS Therapy Trials Network - HIV/AIDS - malaria - tuberculosis Also: European and Developing Countries Clinical Trials Partnership (EDCTP) - action through Treaty Article 169 TP1. Indicative topics/ instruments for first call ii. Combating major diseases

Additional SSAs to be supported:  Promotion of SME participation  Stimulating international co-operation  Linking with Candidate Countries  Stimulating exploitation: of research results stemming from past and present EU programmes  Realising ERA objectives: activities such as pilot initiatives on benchmarking, cartography, networking, the debate on human values and technology options, or the collective management of the knowledge infrastructures of the future, etc  EU Strategy for Life Sciences and Biotechnology. Action Plan attached to COM(2002)27  Supporting future research policy development TP1. Indicative topics/ instruments for first call

EC contribution ? Integrated project Rough estimate: € million - but higher possible (compare QoL integrated projects in FP5) inal.pdf Network of excellence (examples) 100 researchers, 25 PhD students ca € 10.5 million 200 researchers, 50 PhD students ca € 18.5 million TP1. First call

How many integrated projects/ network of excellence will be funded for the first call in TP1? 53 topics to be published in the call Budget available for IP or NoE € 385 – 410 million Therefore, competition between proposals for the same topic, as well as between topics Some topics may not be funded TP1. First call

Indicative schedule First call published : 17 December 2002 First deadline : (25) March 2003 Other tentative deadlines : November 2003 November 2004 November 2005 TP1. First call

Other FP6 actions related to Life Sciences (health) “ERA-NET” Supporting the cooperation and coordination of research activities carried out at national or regional level Health of key groups (major diseases, rare diseases, poverty-related diseases, alternative/non-conventional medicine)

Other FP6 actions related to Life Sciences (health) Anticipating science and technology needs (“Priority 8” - FP5: GA10-11) >Research responding to health policy requirements: implementation of the European Social Agenda public health and consumer protection >Health determinants, provision of high quality and sustainable health care services (ageing, demographic change) >Public health issues, including epidemiology for disease prevention >Impact of environmental issues on health >Handicapped / disabled people

Other FP6 actions related to Life Sciences (health) TP2. Information society technologies bioinformatics; data handling; communication TP3. Nanotechnologies … nanobiotechnology; clean technologies; nanodevices for drug delivery; biosensors; tissue regeneration; biomaterials (FP5: Growth and QoL KA3) TP5. Food quality and safety nutrition; plant and animal biotech; food diseases and allergies; GMO traceability; functional food; pathogenic microorganisms; BSE (FP5: QoL KA1 & 4) TP6. Sustainable development and global change renewable energies; marine and terrestrial biodiversity and ecosystems (FP5: EESD)

Fundamental genomics: Applied genomics & biotech: Major diseases: Cancer: Poverty related diseases: Research related to structuring / strengthening ERA: Further Information TP1. Life sciences: genomics & biotechnology for health