Inserm French National Institute of Health and Medical Research • Created in 1964 from the National Institute of Hygiene and Hospital Research • Working through the Ministries for Research and Health Szeged, Sept. 28th 2007 1 Inserm : key figures 335 Inserm laboratories 25 research centers 41 Clinical Investigation Centers (CIC) Budget 2007 : 700 M€ Total staff: 13 000 (2 500 physicians) of which 4900 Inserm employees: 2100 scientists and 2800 technical staff (62% of total budget dedicated to salaries) An active patent portfolio of 572 families 374 French and foreign firms are partners of Inserm 56 start-up companies based on Inserm technology Szeged, Sept. 28th 2007 2 What is Inserm ? The French performing research organisation entirely dedicated to Biomedical & Clinical research and Public Health All fields of research are covered in these domains 90% of the 335 research units are located in University hospitals Research units with 8 years mandate with mid-term (4 year) evaluation. Stringent evaluation Investigator- driven projects - AVENIR programme Close collaboration with French Funding agencies (ANR, INCa ANRS), Sanitary agencies (InVS, AFSSAPS), Charities (AFM, …) and industrial partners. Szeged, Sept. 28th 2007 3 The Inserm performance about:blank Szeged, Sept. 28th 2007 4 Organization Bottom-up initiatives: selection based on quality and innovation Networks focused on major public health issues: “National Research Programs”: - Diabetes, Cardiovascular, Hepato-GastroEnterology - Bone and joint diseases, endocrinology and reproduction etc…. Szeged, Sept. 28th 2007 5 Infectious diseases and microbiology (without Aids and Hepatitis) Public health 7.5% Handicap 5.1% Nutrition 4.8% 8.3% AIDS 3.7% Hepatitis 3.1% Diabetes 2.6% Cardiovascular diseases Bone and Joint Diseases 2.2% 9.1% Genetic diseases 10.5% Neurosciences 20.6% of which 9.3% for neurologic disorders 16.8% Cancer 17.1% Immunology Research laboratories being often involved in more than one domain, the overall distribution is over 100 % Szeged, Sept. 28th 2007 6 Hospitals Universities National research & Public health agencies Research organizations CNRS, CEA, Inra, Inria, IRD, Pasteur Institute, Curie Institute Szeged, Sept. 28th 2007 Industry International scientific community Scientific & medical societies, Patients associations, Foundation, Charities 7 Inserm : creation of research centers Objectives and main characteristics: • Critical mass (100 to 300 staffs), • Mutualisation and Integration • International visibility, Attractiveness Assessment criteria: • Scientific excellence • Quality of the management : Governing structure, mutualised administration & management Technology transfert and research outcomes Sharing of technical facitilies Coordination of scientific events and programmes Implementation of research training programmes International scientific council for evaluation of scientific strategy (turnover of scientific teams : mobility, hosting new scientists or teams,…) Szeged, Sept. 28th 2007 8 25 Research Centers in 2007 Some exemples: 1- Paris 6, Pluri-thematic 2- Paris 6, Neurophysiology 4- Paris 5, Pluri-thematic 5- Créteil, Pluri-thematic 6- Lilles, Pluri-thematic 7- Dijon, Cancer/Nutrition 8- Bordeaux, Neurophysiology 9- Grenoble, Neurophysiology 10- Grenoble, Cancer 11- Toulouse, Pluri-thematic Szeged, Sept. 28th 2007 9 Director : D.Moras Inserm Unit 596 7 departments 550 staffs Strasbourg 3 Avenir programs Facilities Partners Thematics - Inserm - Louis Pasteur University - CNRS - Molecular pathology - Developmental and physiological gentics - Fonctional genomics - Cellular biologie and signal transduction - Molecular neurobiology - Cellular imaging - DNA microarray platform - Monoclonal Antibody - Structural biology - Bio-informatic - Protéomics Technology transfer - > 20 contrats with industries - Public-private Partnerships www-igbmc.u-strasbg.fr Szeged, Sept. 28th 2007 10 Centre de recherche Jean-Pierre Aubert JPARC Director : Pierre Formstecher Inserm Unit 837 5 teams 150 staffs Lille Facilities - Proteomics - Biotherapy - Cytometry - Cellular imaging - Animal imaging Thematics - Neurosciences - Cellular différenciation and cancer Partners - Lille 2 University - Lille University Hospital - Inserm Technology transfer - Public-private Partnerships www.crjpa.lille.inserm.fr Szeged, Sept. 28th 2007 11 Institut du Fer à Moulin IFM Director : Jean-Antoine Girault Partners Inserm Unit 839 19 teams 99 staffs Paris 1 Avenir program - Université Paris 6 - Paris University hospital - Inserm Thematics Signalling mechanisms involved in the nervous system developpement Facilities - Animals - Cellular imaging - Quantitative PCR - Cytometry - Peptide synthesis - Proteomics Szeged, Sept. 28th 2007 Technology transfer - Public-private Partnerships 12 Evolution of Research Units and Research centers at Inserm (from 2001 to 2007) Szeged, Sept. 28th 2007 13 Research infrastructures • National Genomic Research Consortium: CNRG National Sequencing Center National Genotyping Center Regional Genopoles Core Facilities • Biosafety-level 4 laboratory • Local and regional technological plateforms • Clinical Research Infrastructures Szeged, Sept. 28th 2007 14 Research platforms 1 Lille 1 1 1 2 Sequencing 9 Transcriptomics 6 11 13 Rouen Caen 1 1 4 1 1 6 4 1 1 Paris 1 1 1 1 Proteomics 1 1 1 Rennes Cellular imaging 4 Electronic microscopy 5 Functional exploratory platform/animals 1 1 in vivo imaging Tours 1 Reims Nancy Strasbourg Orléans 1 1 1 1 1 2 1 1 1 1 Dijon Nantes Poitiers 1 6 2 Animal experimentations Vegetal experimentations 4 Structural biology 8 Bioinformatic 1 1 ClermontFerrand 1 Toulouse 1 Human biological resources 1 Bacterial 1 Chemistry Szeged, Sept. 28th 2007 1 1 1 1 Lipidomics National Biological resources : 1 Lyon Grenoble 1 Bordeaux 1 1 1 1 1 1 1 1 1 1 Montpellier 1 1 1 Rousset Marseille 1 1 1 1 2 1 Nice 15 Main Inserm’s priorities 1. « Researchers » : Careers, Training & Mobility 2. To focus Inserm on its main mission: support both basic and clinical research; develop translational research with a multidisciplinary approach 3. To establish Inserm in a European and International context 4. To develop public/private partnerships Szeged, Sept. 28th 2007 16 Researchers : Career, Training and Mobility Szeged, Sept. 28th 2007 17 Career tracks at Inserm • Junior, temporary contract (5 years with a 3-year intermediate evaluation), high level (research director) contracts Avenir program European programs: EURYI, ERC • Permanent positions for senior scientists Szeged, Sept. 28th 2007 18 AVENIR Programme • Eligibility: Young scientists with permanent or temporary position, clinicians • Aim: To strengthen the status of young scientists; to recognize, evaluate and continuously promote scientific qualities • A yearly budget of 200K euros for 5 years • Minimum lab space of 50 m2 • Running costs • Salaries, human resources (Post-doc, engineers, technicians) Szeged, Sept. 28th 2007 19 Interface contracts : General principles • Based on : a permanent position + temporary, 3-5 year contracts • To reinforce interactions with partners and mobility - Hospitals: clinical research, medical issues - Health agencies: health policy issues - Universities: teaching, making scientific information available to the society • Industry: technological transfer and valorisation • European partners / European mobility (a new scheme of the Marie Curie actions - PEOPLE programme ?) Szeged, Sept. 28th 2007 20 Interface contracts for Inserm scientists : Tenure position + 3-5 year contracts: " 2/3 – 1/3 " Hospital Industry International institutions University Tenured scientists Sanitary Agencies « Internal » Inserm Szeged, Sept. 28th 2007 21 Interface Contract grants for MDs • Reinforce research activities of clinicians and university research assistants and professors • 3-5 year contracts for clinicians : assistant professors and professors, university employees • Grant paid by Inserm to hospitals and universities to be used for : - clinical and teaching activities: temporary positions - financing research activities Szeged, Sept. 28th 2007 22 The School of Inserm A 3-year Theoretical and Practical Education which leads to a Master’s • First year of Inserm School - Second year of Medical School : Special School Intensive Training Session in February June: Competitive Exam • Second year of Inserm School - Third year of Medical School 6 month full time Research Clerkship in an Inserm Research Laboratory • Third year of Inserm School - Interruption of Medical School : Clerkship in a Research Laboratory and educational program for the Master Degree Szeged, Sept. 28th 2007 23 Clinical research and Translational research strategy Szeged, Sept. 28th 2007 24 Clinical trials Inserm Basic Research Preclinical studies : Proof of concept Szeged, Sept. 28th 2007 Inserm Proof of concept Phases I-IIa Biotherapy [CRC] Inserm Phases IIb-III Phase IV Cohorts 25 Inserm, as a major actor of the Clinical Research in France and in Europe • To set-up an efficient Translational research towards the benefits of patients • To develop dedicated performing Research Infrastructures : ECRIN, GMP facilities platforms (innovative biomedicines), BRCs, (Roadmap ESFRI) • To sponsor clinical studies and innovative therapeutic clinical trials • To ensure appropriate training of Physicians to Research skills and vice-versa : School of Inserm • To built a continuum from Basic research to Clinical Research Szeged, Sept. 28th 2007 26 Clinical research infrastructures 2006 2001 2002 2003 2004 2005 Clinical research centers 41 17 21 28 31 41 Tissues Banks 47 16 30 47 47 47 118 131 135 142 147 147 Registries 35 17 29 29 31 35 Networks 22 9 22 22 22 22 Cohorts Szeged, Sept. 28th 2007 27 41 Clinical Investigation Centres • • • CIC Epidemiology studies Biotherapy Access to patients Support to investigators Szeged, Sept. 28th 2007 28 Finland FinnCRIN Sweden SweCRIN Ireland ICRIN UK UKCRN Denmark DCRIN EORTC Germany KKS France Inserm Spain SCReN EFGCP Austria ATCRIN Switzerland SCRN Hungary HECRIN Italy IRFMN & CIRM European Clinical Research Infrastructures Network, coordinated by INSERM: Pan-European infrastructure providing services to the preparation and the conduct of multinational clinical studies, with GMP facilities for biotherapy National networks of Clinical Research Centres / Clinical Trial Units Szeged, Sept. 28th 2007 29 Biological Resources Centres a networking action at both National and European Levels Szeged, Sept. 28th 2007 30 Network of Biological Resources Facilities Cohorts of Patients • Science Case: A European network to coordinate European Scientific programs and policies Clinical data and follow-up of patients and Healthy volunteers Innovative targets, biomarkers, clinical studies Technology transfer, dissemination of knowledge, valorisation • Technical case: Repositories for qualified biological samples (DNA, RNA, proteins,…), coupled to clinical data. Providers/distributors of samples within scientific project objectives Development of QA standards for European BRCs To store samples for the future (heritage) Distributed facilities / centralised database Szeged, Sept. 28th 2007 31 European Biological Resources network (BBMRI) The necessity of a European network : To co-ordinate European scientific programs and policies : 7th PCRD To develop and harmonize assurance-quality standards for European BRCs : exchanges of authenticated biological materials. Valorisation of knowledge Attractiveness of public research and development of innovative SMEs. Szeged, Sept. 28th 2007 32 Platforms for GMP production State of the art : Platforms for production of therapeutic vectors : Nantes (Atlantic biothérapies), Généthon, etc. Platforms for production of bio-medicines : LFB, Genopole Ile-de-France, Vivalis, Lipidomix, etc. Platforms for production of therapeutic virus : Heidelberg Perspectives : availability of GMP products Partnership with Inserm-Transfert Costs sharing European dimension : ESFRI / IMI Szeged, Sept. 28th 2007 33 EU approach for of GMP Facilities • Needs : to develop innovative “non-commercial” clinical trials - Lack of specific financial support • Science Case: Reinforcing clinical research and translation of basic research to therapy Production and evaluation of innovative therapeutic and diagnostic agents : biomarkers and biotherapy / regenerative medicine : cell therapy, gene therapy, tissue engineering • Technical case: Production of new therapeutic/diagnostic agents from biotechnologies Products for Cell and Gene therapy Good Manufacturing Practices (GMO dissemination regulation), in line with national legislation, able to cooperate across the borders Direct links with Clinical Research Centres (CRC - ECRIN) Szeged, Sept. 28th 2007 34 IMI : Innovative Medicines for Europe European Joint Technology Initiative (JTI) to develop new therapeutic drugs in a faster and safer way. Inserm is the French representative in the Member states contact Group of IMI Szeged, Sept. 28th 2007 35 Competitivity Clusters Nutrition Santé Longévité Innovations thérapeutiques Medicen Imaging, Cancer, Biotehrapy, Neurosciences Atlantic Biothérapies Qualitropic Lyonbiopôle Virology Prod’Innov International National Emergent Réunion 67 created clusters 7 involving Inserm units Szeged, Sept. 28th 2007 Cancer Bio Santé Orpheme Nutrition 36 The European policy of Inserm Szeged, Sept. 28th 2007 37 Inserm’s priorities in Europe 1. « Researchers » : attractive careers, training, mobility 2. “European” Research Laboratories: European Associated Laboratories, Joint Unit abroad 3. Research Infrastructures for biomedical research (ECRIN, Biobanks, EATRIS) and Translational research based on Public-Private Partnership (IMI - European Joint Technology Initiative) 4. FP7 and other European programmes of interest 5. EU Prospectives (ESF-EMRC, EUROHORCS,etc.) => Green paper on new perspectives of ERA Szeged, Sept. 28th 2007 38 Multilateral cooperations’ actions Inserm in FP6 • around 150 EU research projects • 224 participating research teams • 26 in coordination Inserm in FP7 First call of the Health priority : Total of 152 selected projects, out of which 7 coordinated by Inserm (preliminary data) Szeged, Sept. 28th 2007 39 Bilateral cooperations’ actions Researchers' mobility (short-medium term, Interface Contract grants) European research networks at the bilateral level and within the EU programmes European Associated laboratories Joint Research unit abroad Szeged, Sept. 28th 2007 40 Bilateral cooperations’ tools: Associated Laboratories and Inserm’s Units abroad Scientifically driven 8 years mandate with mid-term evaluation Synergies: competencies and facility access Co-funded by Inserm and Associated partner Temporary/permanent positions (Mobility of Post-Doc, researchers - Interface contracts) Institutional “label” Leverage effect for additional funding Szeged, Sept. 28th 2007 41 European Associated Laboratories (LEA) Toulouse : D. Langin U586 / Prague : V. Stich (Univ. Charles) Lille : M. Capron U547 / Brussels : M. Goldman (IMI) Toulouse : AC Prats U589 / Dundee : JC Bourdon (Univ. Dundee) Bordeaux: A. Bikfalvi E 113 / Milan: L. Bello (Univ. Degli Stuli) Nice: G. Meneguzzi U 634 / Rome: G. Zambruno (IDI-IRCCS) Villejuif: D. Samuel U 785 / Rome: M. Levrero (Univ. La Sapienza) Montpellier: K. Ritchie U 888 / London: G. Thornicroft (King’s College of London) Strasbourg: T. Baumert U 748 / Freiburg: H. Blum (Univ. of Freiburg) Villejuif: T. Moreau U 780/ Barcelona: J. Antό (PRBB, IMIM-CREAL) Bordeaux: L. Bordenave U 577 / Porto: M. Barbosa (IBMC, INEB) Glasgow Dundee Joint Research Unit in Europe: London Université de Glasgow / C. Doerig U609 Brussels DKFZ / J. Rommelaere U701 Prague Freiburg Barcelona Porto Szeged, Sept. 28th 2007 Heidelberg Milan Rome 42 Laval Montreal Montreal Los Angeles Irvine New York Rabat Pittsburgh Beijing Haïfa Seoul Wuhan Nanjing Dallas Doha Tokyo Kyoto Shanghai Guangzhou Singapour Rio de Janeiro Buenos Aires Szeged, Sept. 28th 2007 INSERM Unit Associated Laboratory In preparation 43 European Mobility of Researchers « Towards a European Career Track » International Cooperation Contracts (up to 4 years) Salary paid by “home” institution + additional salary paid by “host” institution Reciprocal, bi-directional (Imperial College London, CNR,…) => Marie Curie « Co-fund » Programme (FP7) Joint Post-doctoral training contracts 2 phases, commitment for a contractual recruitment when they return, bidirectional call for applications Prospectives towards Internationalisation of School of Inserm Szeged, Sept. 28th 2007 44 Joint post-doctoral career track • 3-year post-doctoral positions in host institutions: Joint selection with Inserm Joint calls under preparation with European institutions (ICL, Univ. Dundee, Porto…) • Evaluation at the end of post-doctoral fellowship • Junior, 5-year Inserm contract • Tenure: Inserm, CNRS, University, industry etc .. Szeged, Sept. 28th 2007 45 Cooperations between Inserm and Hungarian Partners 148 joint publications Inserm – Hungarian partners since 2000 Main Partner Institutions : Institutes of the Hungarian Academy of Sciences (BRC Szeged), Semmelweis University Budapest, University of Debrecen Main thematic areas : Neurosciences, Cardiovascular diseases, Molecular and Cell Biology, Biochemistry etc. 6 Hungarian Researchers and Fellows within Inserm's research units in 2006 18 FP6 projects involving Inserm and Hungarian partners (6 NoEs - 10 IPs - 2 STREP) Further FP7 collaborations (IMI, ECRIN, BRCs…) Szeged, Sept. 28th 2007 46 Transfert • Inserm’s private subsidiary • Created in 2001, funded up to € 4,5 million • 60 people with scientific/industrial background Missions: • Drive value creation from Inserm research • Allow an efficient partnering with the Industry • Ensure a fair economic return towards Inserm • Contribute to economic development Szeged, Sept. 28th 2007 47 Transfert Integrated Technology Transfer Skills “From the bench to the partnering and the license” Inserm Research Detectio n of Intellectual Property License Biotec h Invention s Development of services covering the whole technology transfer process : start• Detection of inventions / “coaching” up • • • • • • • • Protection of inventions & follow up / intellectual property management Pre-technology transfer / Applied and Translational Research Technology Transfer, collaborative and R&D agreements Preclinical Development / Proof of Concept development Industrial Partnerships / Clinical trials development International and European projects management Biotech start up coaching and funding (pre seed fund Inserm Transfert Initiative) Legal and financial expertise Proximity between both scientific and industrial communities for a best partnership development Szeged, Sept. 28th 2007 48 Contacts : Inserm’s web site : www.inserm.fr/en/inserm Department of French Regional and European Strategic Policies • Anne Bisagni, Director : anne.bisagni@tolbiac.inserm.fr • Philippe Arhets, Deputy Director : philippe.arhets@tolbiac.inserm.fr • Cécile Bergouignan, Bilateral cooperation : cecile.bergouignan@tolbiac.inserm.fr Human Resources : Researchers task force • Anne-Marie Laffaye, School of Inserm, Avenir : anne-marie.laffaye@tolbiac.inserm.fr • Richard Salives, Marie Curie Programme : richard.salives@tolbiac.inserm.fr Szeged, Sept. 28th 2007 49