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Research Policy developments and instruments towards Personalised Medicine in Spain

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EuroBioForum 2012 | 18 April 2012 …

EuroBioForum 2012 | 18 April 2012
Presentation by Rafael De Andrés Medina, Chief of the Technical Studies Department, Fund for Health Research (FIS), National Institute of Health Carlos III (ISCIII)

Published in: Health & Medicine, Technology

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  • 1. Is Europe ready for Personalised Medicine? Perspectives from funders and regions2012 Policy developments and funding towards Personalised Medicine. Spain Dr. Rafael De Andrés Medina rdam@isciii.es Fund for Health Research Spain Brussels, April 18 th, 2012
  • 2. ISCIII. MISSION [i]is a Public Body of Spain with legal personnalitywhose main mission on Reearch is:• the generation of scientific knowledge in Biomedical and Health Sciences and to promote innovation in health care and disease preventionreports to the Ministry of Economy and Competitivenessand the Ministry of Health, Social Services and Equality.• It manages the Strategic Action for Health Research (AES) within the National Plan for R+D+I. Budget = 333 M € (2010))
  • 3. Spain. Legal background The National Institute of Health Carlos III (ISCIII)• has is own legal personality (General Act 14/1986 of Health).• reports to the Ministry of Economy and Competitiveness and the Ministry of Health, Social Services and Equality.• is entitled to plan, promote and coordinate Biomedical and Health Research and Innovation in Spain (Act 14/2007 for Biomedical Research, that provides the framework for regenerative and Personalised Medicine research too)• funds Biomedical and Health Scientific and Technical research (Act14/2011 of Science, Technology and Innovation).• acts as intramural Research Performing Organisation (RPO), extramural funding agency and regulatory in some areas too. e.g. in biobanking.• redefines R+D+I capacities and capabilities of the Spanish National Health System (SNS) R+D+I within S&T System of Spain for a robust structural engagement within the European ones.• promotes the Sectorial Initiative for Health Research -ISIS- (Act 16/2003, of cohesion and quality of SNS) and manages the Strategic Action for Health Research (AES) upon scientific plus strategic and opportunity assessments
  • 4. SPAIN. PLANING AND FUNDING FOR R+D+I Ministry of Economy • NATIONAL PLAN (NP) R+D+I & Competitiveness (MINECO) • STRATEGIC ACTION FOR National Institute ofPLANING HEALTH RESEARCH (AES) Health “Carlos III” • NATIONAL STRATEGY Ministry of Economy FOR INNOVATION (NSI) & Competitiveness (MINECO) • GENERAL DIRECTORATE NP R+D+I OF SCIENTIFIC & (no prioritised TECHNICAL RESEARCH, Research)FUNDING MINECO • NATIONAL INSTITUTE OF AES HEALTH “CARLOS III” (ISCIII)
  • 5. ISCIII. MISSION [ii] EU: RESEARCH -ERANets -Art. 185/ex 169 TCE, JPIs, ESFRI-ERICs, … Intramural Extramural •250 M € (2010)ISCIII’s Reference Centers (7) Competitive Structural Strategic Action for Health -Participated Centers Research (AES) -Foundations (3) •Projects & infrastructure grants -Consortia (10) Research &Technical Manpower -Omics Platforms (4) •Fellowships -Health Research Institutes (16) •Contracts -Alliances •Mobility & Sabattical - Joint Centers • Loans - National-Regions-EU/international.
  • 6. Spanish approach: National Infrastructure for Personalised MedicineAcademia Laboratory driven Candidate biomarker Basic research Candidate Bioinformatics driven identification biomarker(s) Preliminary assay POC validated Clinical research Clinical samples biomarker(s) POC validation Validation of Drug Targets OMICs platform BBH6 BBH2 ISSs EATRIS • INB ELIXIR H6 H2 • Proteored BBa BBd • CeGen BBH5 BBH1 BBf BBb H1 H5 H3 BBc BBe BBH3Spanish Network of H4 BBH4BioBanks BBMRI Clinical trials platform Spanish Technology Platform IMI CAIBER ECRIN Innovative Medicines National or International Patent Offices Industry? modified from Comella J. EATRIS[ES], 2010
  • 7. Structuring Spanish Capacities for Pan-European Biomedical Research Infrastructures. . Spain. ISCIII as funder and NIB as Scientific partner ELIXIR PM PM PM PM Spain. ISCIII as funder with up to 10 M € per year and CAIBER as ECRIN Scientific partner (40 CRO) Spain. ISCIII as funder and Health Research Institutes´ network as pan-European EATRIS Scientific partner infrastructures MRI Spain. ISCIII as funder with up to 6 M € per year and 63 biobanks´ providing generic BBMRI network as Scientific partner tools and services modified from Demotes J, ECRIN 2009 pan-European investigation networks developping specific tools and scientific content7
  • 8. 1.- What is the state of affairs in Personalised Medicine in Spain [1] I ISCIII EXTRAMURAL • National Institute of BioinformaticsRESEARCH FUNDING (2011) (INB, 9 nodes) 1.5 M € • National Institute of Proteomics (PROTEORED, 19 nodes) 1.3 M € OMICs • National Center for GenotypingTechnological Platforms: (CeGen, 3 nodes) 1 M € • Spanish Biobanking Network (RETBIOH 63 biobanks + 11 affiliated) 6 M € Other Platforms: • 16 certified Health Research Institutes (ISS) for translational research ***. • CLINICAL TRIALS PLATFORM Total = 20.4 M € (2011) (CAIBER, 40 CRO) 8 M € • Cell Therapy Research Network (TERCEL, 28 groups) 2.6 €
  • 9. 1.- What is the state of affairs in Personalised Medicine in Spain [1A]ISCIII strutured and fundsTechnological Platforms:The National Institute of Bioinformatics (INB): 9 nodes• works in computational biology and gives service support to RPO and enterprises for genomic and proteomic projects• INB is the Spanish scientific partner in ELIXIR.The National Institute of Proteomics (Proteored): 19 nodes• supports to the research community and develops new technological applications.The National Center for Genotyping (CeGen): 3 nodes• big scale SNPs (Single Nucleotide Polymorphisms) for RPO, hospitals and enterprises.• These services on the Spanish population genotyping are focused in the molecular basis of prevalent diseases and the inter-individual genetic variation response to pharma drugs.The cell therapy research network (TERCEL):• 27 groups based in Madrid, Andalusia, Catalonia, Valentian Community, Castille and Leon, Navarre, Galicia, Extremadura and Murcia.
  • 10. 1.- What is the state of affairs in Personalised Medicine in Spain [1B]ISCIII also strutured and fundsThe Spanish 63 biobanks (+ 11 affiliated ones) Network (RETBIOH)• Most are disease based biobanks. It also includes the population based National Bank of DNA (BancoADN) managing representative DNAsample collections of the Spanish population to serve for a rational, efficient, ethic and legal use in research, providing warranty of meeting donor´s right.• RETBIOH is the Spanish scientific partner of BBMRI.The 16 certified Health Research Institutes (ISS) for translational research• Each core is based on a hospital plus other PROs´ S&T capabilities.• IISs is the Spanish scientific partner in EATRIS.CAIBER (40 CRO in leading University hospitals)• The Spanish platform for clinical trials and• CAIBER is the Spanish scientific partner in ECRIN.
  • 11. 1.- What is the state of affairs in Personalised Medicine in Spain [2]The Council of Ministers of Spain approved (11 th October 2007)the Plan for Advanced Therapies within a Regenerative Medicinescope: Therapeutic alternatives (including clinical trials) for 12pathologies with no therapeutic protocol..• transplant of pancreatic isolates; cell therapy for diabetic complications, diabetic foot, diabetic cardiopathy, • cardiopathy, • ELA, multiple sclerosis, • skin regeneration, • Khron disease, • muscular dystrophies; • bone and cartilagous regeneration; • cell therapy in medular lesions; • hepatic regeneration
  • 12. 1.- What is the state of affairs in Personalised Medicine in Spain [2B] ISCIII extramuralResearch co-funding (2011) The Andalusian Centre of Molecular Biology & Regenerative Medicine(Seville) Andalusia: The Andalusian Bank of Stem Cells 2.0 M € (Granada) Valentian Community The Research Centre Principe Felipe *** (Valencia) Catalonia: 2.0 M € The Centre of Regenerative Medicine (Barcelona) Aragon 0.45 M € Organization, coordination and fostering of basic, pre- clinical and clinical research in Castille & Leon regenerative medicine 0.45 M € Organization, coordination and fostering of basic, pre- clinical and clinical research in Total = 4.9 M € (2011) regenerative medicine
  • 13. 1.- What is the state of affairs in Personalised Medicine in Spain [2C]The Plan for Advanced Therapies within a RegenerativeMedicine scope(Council of Ministers of Spain,11 th October 2007) ISCIII co-funds: • The Andalusian Centre of Molecular Biology and Regenerative Medicine (Seville) cell therapy applied to diabetes and neurodegeneration • The Andalusian Bank of Stem Cells (Granada) Biology of reprogramming and retrotransposition; embryonic, hematopoietic and mesenchymal stem cells; cell and gene therapy. • The Research Centre Principe Felipe (Valencia) cell therapy; reprogramming and biohybrids; Molecular Neuroendocrinology, Biomaterials; Biology of the stem cells. • The Centre of Regenerative Medicine (Barcelona) adult, embryonic and induced stem cells and its use for the treatment of neurodegenerative diseases (ELA, spinal cord muscular atrophy, Alzheirmer, ...); bone, cartilage, and hepatic regeneration; and right – left vertebrate heart patterning. • The organization, coordination and fostering of basic, pre- clinical and clinical research in regenerative medicine in Aragon and Castille & Leon Regions. The Fundation Inbiomed (San Sebastian) • works in Cell Therapy for cardiovascular and neurodegenerative diseases; tumor stem cell, engineerized skin production for the treatment of epidermoydes bullosa.
  • 14. 2) What are the challenges for Spain ]Translation“from the bench to the bedside • to the clinical / public health practices • and the enterprises (economic growth)
  • 15. 3) What is your expectation of the Horizon 2020 and where do you see opportunities for collaboration.Personalised Medicine can be a good candidate forjoint programing like schemes upon agreed common national,European and international scientific priorities via joint calls andprogramme funding alignments.• It should include Horizon 2020 and global positioning, as well as e.g. International scientific evaluation applied both to national, multi-country and European funding schemes. FET FlagshipsThe Virtual Patient System • Molecular modelling in health and medicine• offering a revolution in healthcare: aiming at the ultimate goal of developing personalised preventive medicine based on individual data processed against globally integrated medical knowledge Pay attention to undesired redundancies
  • 16. Dr. Rafael De Andres-Medina rdam@isciii.eswww.isciii.esMany thanks for your attention!!