Opportunities for industry/smes in EU-funded health research Stéphane Hogan, M.Sc, MBA Head of Unit Applied Genomics and Biotechnology for Health DG Research - European Commission 1 Paris, 31 May 2005
Outline 1. EU research programmes 2. Opportunities in Framework programme 6 3. Perspectives: the 7 th Framework programme 2
The rationale for EU programmes Promoting the competitiveness of EU industries Improving quality of life for citizens Support to policy Health and consumers (DG SANCO) also environment, agriculture,... 3
Why participate in the 6 th Framework programme? Financial support for R&D ( 533 million in 2005) Access to transnational networks of expertise Prestige arising from the European label Benefit from the various support mechanisms measures for SMEs, IPR help desk, communication activities) 4
FP6: schedule for Health research (annual calls for proposals) The story so far Year ( call ) published evaluated negotiated/funded 2002-1 st call b b b 2003-2 nd call b b b 2004-3 rd call b b from April 2005 2005-4 th call June 2005 Jan. 2006 March 2006 (est.) + SME call (to Nov. 05) 5
Next funding opportunity New Publication of call for proposals scheduled in June 05 Thematic call (fourth and final annual call) SME call (special call) Closing date expected: 9 th November 05 (tbc) Work programme being finalised, draft available online: www.cordis.lu/lifescihealth Check official documents on publication 6
Main conditions for participation and criteria for selection EU dimension: minimum of 3 participants from different member states or associated states (BU, RO, CH, NO, Iceland, Israel, Turkey). Relevance: proposals must match the published topics. Scientific quality: foremost criteria for peer evaluation. Potential impact: is also a criteria for evaluation. Managerial quality: appropriate partners/expertise, well organised and robust management structure and plans, including consortium agreement (esp. for IPR). 7
Funding mechanisms ( instruments ) Integrated projects (IP) Networks of excellence (NoE) Specific targeted research projects (STREP) Coordination action (CA) Specific support action (SSA) Funding basis: up to 50% from EU Actions to promote human resources and mobility 8
Characteristics of SME call (1) A new funding approach: STREPS dedicated to SMEs specifically to support SME efforts towards research and innovation research-intensive SMEs expected to play leading roles and results should be of interest to SMEs. 9
Characteristics of SME call (2) A new funding approach: STREPS dedicated to SMEs Topics: broad in advanced genomics and applications for health more focused in specific disease areas possible participation of universities, research centres, (big) industry and industrial associations 30-50% of the EU contribution should go to the SME partners subcontracting discouraged (not counted as SME participation) 10
Life sciences, genomics and biotechnology for health Priority 1 in the 6th Framework programme (2003-06) 1. Advanced genomics and its applications for health ( 1100m) 1.1 Fundamental knowledge and basic tools for functional genomics in all organisms 1.2 Applications of knowledge and technologies in the field of genomics and biotechnology for health 2. Combating major diseases ( 1155m) 2.1 Application oriented genomic approaches to medical knowledge and technologies 2.2 Combating cancer 2.3 Confronting the major communicable diseases linked to poverty 11
533 million for health research in 2005 Areas 4 th call SME call Total Fundamental knowledge and basic tools for functional genomics in all organisms 73 35 108 Application of knowledge and technologies in the field of genomics and biotechnology for health 87 46 133 Application-orientated genomics approaches to medical knowledge and technologies 100 45 145 Cancer 49 25 74 Communicable diseases linked to poverty 47 20 67 Strategic Specific Support Actions 6 0 6 Total 362 171 533 12
Fundamental genomics Main areas for research 2005 budget: 73m (+ 35m for SMEs) Gene expression and proteomics Structural genomics Comparative genomics and population genetics Bioinformatics Multidisciplinary functional genomics approaches to basic biological processes 13
2005 topics in Fundamental genomics (1) Gene expression and proteomics A systems approach to understanding the regulation of gene transcription (IP) Structural genomics Structural genomics interdisciplinary tool for predictive toxicology (IP) Comparative genomics and population genetics Functional genomics of Arabidopsis thaliana (IP) High throughput phenotyping tools and approaches for large scale functional genomics studies (IP) Population cohorts for molecular epidemiological studies in European and other populations (IP) 14
2005 topics in Fundamental genomics (2) Bioinformatics (no topics in 2005) Multidisciplinary functional genomics approaches to basic biological processes Functional genomics of autosomal aneuploid syndromes (IP) The biological role of small regulatory RNAs (STREP) STREP dedicated to SMEs Development of tools and technologies for functional genomics 15
Genomics and biotechnology 2005 budget: 87m (+ 46m) Main areas for research Rational and accelerated development of new, safer and more effective drugs including pharmacogenomics approaches Development of new diagnostics Development of new in-vitro tests to replace animal experimentation Development and testing of new preventative and therapeutic tools, such as somatic gene and cell therapies (in particular stem cell therapies) and immunotherapies Research in post-genomics, with high potential for application 16
2005 topics in Genomics and biotechnology (1) development of new, safer and more effective drugs... Marker profiling as a new tool for predictive toxicology (IP) New tools to investigate ADME properties of drugs involving a carrier system (STREP) STREP dedicated to SMEs Rational and accelerated development of new, safer and more effective drugs including pharmacogenomics approaches 17
2005 topics in Genomics and biotechnology (2) Development of new diagnostics High throughput molecular diagnostics for hereditary diseases (IP) Development of innovative methods for diagnosis of nervous system disorders (STREP) Nanoparticles-based diagnostics (STREP) STREP dedicated to SMEs Development of new diagnostics 18
2005 topics in Genomics and biotechnology (3) New in-vitro tests to replace animal experimentation Predictive in vitro testing strategies for human exposure to chemicals (IP) Workshop on business opportunities for in vitro pharmaceutical toxicology (SSA) Forum for researchers and regulators to meet manufacturers of toxicology test methods (SSA) STREP dedicated to SMEs New in-vitro tests to replace animal experimentation 19
2005 topics in Genomics and biotechnology (4) new preventative and therapeutic tools, such as somatic gene and cell therapies and immunotherapies Tissue engineering approaches to treating children with birth defects (IP) Hepatitis C vaccine (IP) Stem Cell Therapy for Stroke Patients (STREP) Methodological research to underpin stem cell banking (STREP) Understanding monogenic rare diseases using insight from stem cell lines (STRP) Use of baculovirus as a vector in gene therapy (esp. for SMEs) (STREP) STREP dedicated to SMEs Development and testing of new preventative and therapeutic tools, such as somatic gene and cell therapies and immunotherapies 20
2005 topics in Genomics and biotechnology (5) Research in post-genomics with high potential for application Application of post-genomics to xenotransplantation research (IP) Post-genomic approaches exploiting aquatic molecular biodiversity for biomedical applications (IP) Use of cell lines to define new bioassays for the identification of therapeutic biomolecules (STREP) STREP dedicated to SMEs research in post-genomics with potential for application 21
Major diseases 2005 budget: 100m (+ 45m) Main areas for research Application-oriented genomics approaches Cardiovascular disease, diabetes and rare diseases Resistance to antibiotics and other drugs The brain and diseases of the nervous system Human development and ageing 22
2005 topics in Major Diseases (1) Application-oriented genomics approaches genetic control of pathogenesis based on iron metabolism (STREP) Cardiovascular disease, diabetes and rare diseases Genome-wide mapping and functional genomics of susceptibility to coronary artery disease (IP) Hypertension and cardiovascular disease (NoE) Molecular genomics & applied genomic studies for the prevention of accelerated cardiovascular death in uremia and end-stage renal disease (STREP) Functional genomics and regulatory networks in lipid metabolism (STREP) Gene-environment interaction on the incidence of type 2 diabetes (IP) Molecular pathways underlying decreased beta cell mass in diabetes (STREP) 23
2005 topics in Major Diseases (2) Cardiovascular disease, diabetes and rare diseases (cont d) Rare inherited neuromuscular disorders (NoE) Rare disorders of protein folding (STREP) Rare diseases of connective tissues affecting bone and/or cartilage (STREP) STREP dedicated to SMEs Research on cardiovascular disease (devices and cerebrovascular disease excluded) Development of preventive and therapeutic strategies for Type 1 diabetes (devices for insulin delivery excluded) Development of in vitro and/or animal models for rare diseases 24
2005 topics in Major Diseases (3) Combating resistance to antibiotics and other drugs Control of anti-microbial resistance in hospital acquired infections (IP) Molecular ecology of antibiotic drug resistance (STREP) Workshop: vaccines to control antibacterial resistance (SSA) STREP dedicated to SMEs Development of new diagnostics for anti-microbial resistance Development of novel principles for anti-microbial treatment 25
2005 topics in Major Diseases (4) The brain and diseases of the nervous system Neuroimaging: bridging genetics and neural function (IP) Functional genomics and neurobiology of epilepsy (IP) Cortical information processing (STREP) Schizophrenia: from genotype to phenotype (STREP) Initiative in coordinating neuroinformatics activities (SSA) STREP dedicated to SMEs Neuroscience-oriented new technologies Characterisation and use of animal models for neurological and psychiatric diseases Early markers and new targets for neurodegenerative diseases Perinatal brain damage: early markers and neuroprotection 26
2005 topics in Major Diseases (5) Human development and ageing Integration of research in development and ageing (NoE) Attracting researchers to ageing research (SSA) STREP dedicated to SMEs Understanding the responsiveness of elderly people towards vaccination and infectious diseases 27
Major diseases 2005 budget: 49m (+ 25m) Main areas for research Combating cancer 28
2005 topics in Major Diseases (6) Combating cancer...molecular mechanisms underlying chemotherapy resistance, therapeutic escape, efficacy and toxicity (IP) Modulation of apoptosis in cancer prevention and therapy (STREP) Diagnostic approaches and novel therapies of childhood cancers (STREP) Research on palliative care in patients with advanced stages of cancer (STREP) Exploring the patient s cancer stem cell as a novel therapeutic target (STREP) Conference on cell differentiation, plasticity and cancer (SSA) STREP dedicated to SMEs Innovative technological approaches for cancer therapy Small ligand libraries: improved tools for prospective therapy Improving resolution of imaging devices for cancer diagnosis and therapy 29
Communicable diseases linked to poverty (i.e. HIV/AIDS, malaria & tuberculosis) 2005 budget: 47m (+ 20m) Main areas for research Developing promising candidate vaccines and therapies Establishing a programme for advanced clinical trials through EDCTP: www.edctp.org 30
Communicable diseases linked to poverty (i.e. HIV/AIDS, malaria & tuberculosis) Developing promising candidate vaccines and therapies HIV/AIDS therapeutic clinical trials network (NoE) HIV/AIDS vaccines/microbiocides network (NoE) rational design of malaria vaccine (IP) new approaches for research into host/vector-pathogen interactions for HIV/AIDS, malaria and tuberculosis (STREP) STREP undesirable consequences of drugs and vaccines for poverty-related diseases 4 SSA/CA topics STREP dedicated to SMEs Using highly innovative concepts to identify new drugs or vaccine candidates Fast tests for diagnosis suitable for use in resource-poor settings Innovative delivery mechanism for treatment and depot therapy ^ 31
Profile of earlier applications in Genomics and biotechnology Profile of submitted proposals: Average number of proposals received per topic: 3.8 Ratio of funds requested : funds available: ~ 5 Success rate (% of proposals funded): 27% Profile of funded projects (average): Type of project participants EU funding Integrated projects (IP) 24 10.5 m Specific targeted projects (STREP) 9 2.3 m 32 Industrial participation (% of participants): 16% SME involvement (% of budget): 19.5%
Information sources - basic documentation www.cordis.lu/fp6/lifescihealth - Call for proposal - official text - Work programme - description of each topics and background - Guide for proposers (for each type of instrument ) - Guidelines on proposal evaluation and selection procedures - Guidance notes for evaluators - Financial guidelines 33
More information & assistance FP6 web sites europa.eu.int/comm/research/fp6/index_en.html www.cordis.lu/fp6 National Contact Points for each themes and country: www.cordis.lu/fp6/lifescihealth SMEs GO LIFESCIENCES (SSA): 28 partners in 26 countries www.smesgolifesciences.org European Commission, DG Research Become an Evaluator or Reviewer: www.cordis.lu/experts/fp6_candidature.htm 34
EBE workshop Brussels, 28 June 2005 SME Call Workshop organised by Emerging Biopharmaceutical Enterprise (EBE) in cooperation with the European Commission Date/time: 28 June, 10h-16h Location: Maison des Associations Internationales 40 rue Washington, B-1050 Brussels Programme www.ebe-biopharma.org/conferences/6fpworkshop_2005.htm 35
Perspectives: FP7 The Seventh Framework programme Time frame: 2007-2013 Status: Commission proposal (6 April 2005) Main features: budget, new approaches, continuity & simplification 36