1. Szeged, Sept. 28th 2007 1 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

2. Szeged, Sept. 28th 2007 2 Inserm : key figures 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) 335 Inserm laboratories 25 research centers 374 French and foreign firms are partners of Inserm An active patent portfolio of 572 families 41 Clinical Investigation Centers (CIC) 56 start-up companies based on Inserm technology

3. Szeged, Sept. 28th 2007 3 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.

4. Szeged, Sept. 28th 2007 4 The Inserm performance about:blank

5. Szeged, Sept. 28th 2007 5 Organization  Bottom-up initiatives: selection based on quality and innovation  Networks focused on major public health issues: “National Research Programs”: -Diabetes, Cardiovascular, Hepato-Gastro- Enterology -Bone and joint diseases, endocrinology and reproduction etc….

6. Szeged, Sept. 28th 2007 6 Bone and Joint Diseases 2.2% Diabetes 2.6% Hepatitis 3.1% Genetic diseases 10.5% 16.8% Cancer Cardiovascular diseases 9.1% 17.1% Immunology of which 9.3% for neurologic disorders 20.6% Neurosciences Infectious diseases and microbiology (without Aids and Hepatitis) 8.3% Public health 7.5% Handicap 5.1% Nutrition 4.8% AIDS 3.7% Research laboratories being often involved in more than one domain, the overall distribution is over 100 %

7. Szeged, Sept. 28th 2007 7 Research organizations CNRS, CEA, Inra, Inria, IRD, Pasteur Institute, Curie Institute Scientific & medical societies, Patients associations, Foundation, Charities UniversitiesIndustry Hospitals National research & Public health agencies International scientific community

8. Szeged, Sept. 28th 2007 8 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 (turn- over of scientific teams : mobility, hosting new scientists or teams,…)

9. Szeged, Sept. 28th 2007 9 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

10. Szeged, Sept. 28th 2007 10 Inserm Unit 596 7 departments 550 staffs Strasbourg 3 Avenir programs Facilities - Cellular imaging - DNA microarray platform - Monoclonal Antibody - Structural biology - Bio-informatic - Protéomics Thematics - Molecular pathology - Developmental and physiological gentics - Fonctional genomics - Cellular biologie and signal transduction - Molecular neurobiology Partners - Inserm - Louis Pasteur University - CNRS Technology transfer - > 20 contrats with industries - Public-private Partnerships Director : D.Moras www-igbmc.u-strasbg.fr

11. Szeged, Sept. 28th 2007 11 Facilities - Proteomics - Biotherapy - Cytometry - Cellular imaging - Animal imaging Centre de recherche Jean-Pierre Aubert JPARC Director : Pierre Formstecher Thematics - Neurosciences - Cellular différenciation and cancer Partners - Lille 2 University - Lille University Hospital - Inserm Inserm Unit 837 5 teams 150 staffs Lille Technology transfer - Public-private Partnerships www.crjpa.lille.inserm.fr

12. Szeged, Sept. 28th 2007 12 Institut du Fer à Moulin IFM Director : Jean-Antoine Girault Facilities - Animals - Cellular imaging - Quantitative PCR - Cytometry - Peptide synthesis - Proteomics Technology transfer - Public-private Partnerships Thematics Signalling mechanisms involved in the nervous system developpement Partners - Université Paris 6 - Paris University hospital - Inserm Inserm Unit 839 19 teams 99 staffs Paris 1 Avenir program

13. Szeged, Sept. 28th 2007 13 Evolution of Research Units and Research centers at Inserm (from 2001 to 2007)

14. Szeged, Sept. 28th 2007 14 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

15. Szeged, Sept. 28th 2007 15 Functional exploratory platform/animals National Biological resources : 11 13 Animal experimentations Transcriptomics Proteomics Bioinformatic in vivo imaging Structural biology Cellular imaging Sequencing Human biological resources Electronic microscopy Lipidomics Vegetal experimentations Chemistry Bacterial 2 9 6 4 5 4 8 2 1 1 1 1 6 Lille Rouen Caen Paris Reims Nancy Strasbourg Rennes Tours Orléans Dijon Nantes Lyon Bordeaux Grenoble Clermont- Ferrand Poitiers Nice Toulouse Marseille Montpellier 11 211 11 1 2 11 11 11 11 11 111 1 11 1 1 1 1 1 64 141 11 1 1 1 1 1 Rousset 1 11 11 1 1 1 1 1 11 1 1 1 1 1 1 1 Research platforms

16. Szeged, Sept. 28th 2007 16 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

17. Szeged, Sept. 28th 2007 17 Researchers : Career, Training and Mobility

18. Szeged, Sept. 28th 2007 18 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

19. Szeged, Sept. 28th 2007 19 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)

20. Szeged, Sept. 28th 2007 20 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 ?)

21. Szeged, Sept. 28th 2007 21 Interface contracts for Inserm scientists : Tenure position + 3-5 year contracts: " 2/3 – 1/3 " Tenured scientists Hospital International institutions Sanitary Agencies « Internal » Inserm UniversityIndustry

22. Szeged, Sept. 28th 2007 22 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

23. Szeged, Sept. 28th 2007 23 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

24. Szeged, Sept. 28th 2007 24 Clinical research and Translational research strategy

25. Szeged, Sept. 28th 2007 25 Basic Research Preclinical studies : Proof of concept Inserm [CRC] Inserm Phases IIb-III Phase IV Cohorts Clinical trials Clinical trials Proof of concept Phases I-IIa Biotherapy

26. Szeged, Sept. 28th 2007 26 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

27. Szeged, Sept. 28th 2007 27 Clinical research infrastructures 2006 20012002200320042005 Clinical research centers 41 1721283141 Tissues Banks 47 163047 Cohorts 118 131135142147 Registries 35 1729 3135 Networks 22 9

28. Szeged, Sept. 28th 2007 28 41 Clinical Investigation Centres CIC Epidemiology studies Biotherapy Access to patients Support to investigators

29. Szeged, Sept. 28th 2007 29 France Inserm Spain SCReN Sweden SweCRIN Germany KKS Denmark DCRIN Italy IRFMN & CIRM Hungary HECRIN UK UKCRN Ireland ICRIN EFGCP National networks of Clinical Research Centres / Clinical Trial Units Austria ATCRIN Switzerland SCRN EORTC Finland FinnCRIN European Clinical Research Infrastructures Network, co- ordinated by INSERM: Pan-European infrastructure providing services to the preparation and the conduct of multinational clinical studies, with GMP facilities for biotherapy

30. Szeged, Sept. 28th 2007 30 Biological Resources Centres a networking action at both National and European Levels

31. Szeged, Sept. 28th 2007 31 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 Network of Biological Resources Facilities Cohorts of Patients

32. Szeged, Sept. 28th 2007 32 The necessity of a European network :  To co-ordinate European scientific programs and policies : 7 th 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. European Biological Resources network (BBMRI)

33. Szeged, Sept. 28th 2007 33 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

34. Szeged, Sept. 28th 2007 34 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)

35. Szeged, Sept. 28th 2007 35 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

36. Szeged, Sept. 28th 2007 36 Competitivity Clusters Atlantic Biothérapies Cancer Bio Santé Prod’Innov Lyonbiopôle Virology Innovations thérapeutiques Nutrition Santé Longévité Medicen Orpheme Nutrition International National Emergent Imaging, Cancer, Biotehrapy, Neurosciences Cancer Bio Santé Réunion Qualitropic 67 created clusters 7 involving Inserm units

37. Szeged, Sept. 28th 2007 37 The European policy of Inserm

38. Szeged, Sept. 28th 2007 38 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

39. Szeged, Sept. 28th 2007 39 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)

40. Szeged, Sept. 28th 2007 40 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

41. Szeged, Sept. 28th 2007 41 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

42. Szeged, Sept. 28th 2007 42 Brussels Heidelberg Glasgow Rome Milan Prague Dundee Barcelona Porto  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) London Freiburg Joint Research Unit in Europe : Université de Glasgow / C. Doerig U609 DKFZ / J. Rommelaere U701

43. Szeged, Sept. 28th 2007 43 Montreal Pittsburgh Rio de Janeiro INSERM Unit Associated Laboratory In preparation Irvine Montreal Shanghai Tokyo Kyoto Seoul New York Nanjing Dallas Beijing Haïfa Doha Los Angeles Buenos Aires Laval WuhanRabat Guangzhou Singapour

44. Szeged, Sept. 28th 2007 44  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 European Mobility of Researchers « Towards a European Career Track »

45. Szeged, Sept. 28th 2007 45 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..

46. Szeged, Sept. 28th 2007 46 Cooperations between Inserm and Hungarian Partners 46 148 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…)

47. Szeged, Sept. 28th 2007 47 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

48. Szeged, Sept. 28th 2007 48 Development of services covering the whole technology transfer process : Detection of inventions / “coaching” 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 Integrated Technology Transfer Skills “From the bench to the partnering and the license” Inserm Research Intellectual Property License Biotec h start- up Detectio n of Invention s Transfert

49. Szeged, Sept. 28th 2007 49 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