Standortfaktor Positionierung der klinischen Forschung in der Schweiz

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1 Forum Gesundheitswirtschaft 2012 Basel Standortfaktor Positionierung der klinischen Forschung in der Schweiz Die Sicht der Schweizerischen Akademie der medizinischen Wissenschaften Prof. Dr. Peter J. Meier-Abt

2 Biopatente 2

3 Clinical research is personoriented integrative research!

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5 GCP: Flow Chart Registration Authorities Authorization Inspection Sponsor Reporting of starting/stopping a trial Serious adverse events Study report Clinical Laboratory Study protocol Investigator s brochure Monitoring On-site visit (Audit) Investigator Investigator s CV (curriculum vitae) Serious adverse events Case report forms, signed Signature of protocols and study report Amendments to protocol Written approval Ethics Committee Study medication Information Patient management Consent Compliance with protocoll Patients, Healthy Volunteers

6 2009 Positionspapier der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW) Medizin als Wissenschaft Die Medizin basiert auf wissenschaftlichen Grundlagen und braucht einen kompetenten akademischen Nachwuchs sowie professionelle Strukturen für die klinische Forschung.

7 Medicine as a Science (Position paper of the Swiss Academy of Medical Sciences (SAMS) 2009) Visions and Perspectives: 1) Scientifically-based university training for all medical students - Physician Track and Dr. med. the direct route to clinical practice - Medical Sciences Track a route for those interested in research - MD-PhD training a recommendable route to academic medicine

8 Physician-scientists in the US Although numbers of researchengaged physicians decline: MD-PhDs are on the rise 1.6 fold more graduates in 2009 compared to MD-PhD Matriculants and Grauates of U.S. Medical Schools Matriculants Graduates The number of MD-PhDs enrolled in US medical schools increased by one third since Total Enrollement of MD-PhDs by U.S. Medical Schools Men Women Source: Biopatente AAMC DW: Student File as of 7/1/2010; APP Mat File as of 11/5/2010 8

9 MD-PhDs: Comparison US - CH Population Doctors pro 10 3 population new med. students p.a. new MD-PhDs p.a Mio (2.7%) 308 Mio (3.3%) Data Biopatente from 2009 and Sources: BfS, BAG, AAMC and US Census Bureau 9

10 Swiss MD-PhD fellowship program % of MD-PhD graduates currently do Clinical work only Clinical work only and research in their spare time Clinical work and research >75% Clinical Work 25-75% Clinical Work <25% Clinical Work Full time basic research Something else n=46 Kuehnle, Biopatente Winkler, Meier-Abt. Swiss national MD-PhD program: an outcome analysis. SMW

11 Universitaeten und Industrieforschung sind komplementaer, nicht austauschbar Grundl. Forschung angewandte Forschung Wissenszuwachs kommerzielle Anwendung Ausbildung * * * * * * * * * * * University Industry Industry * * * * * * * * * * * P. Herrling 2005 Biopatente 11

12 Medicine as a Science (Position paper of the Swiss Academy of Medical Sciences (SAMS) 2009) Visions and Perspectives: 1) Scientifically-based university training for all medical students - Physician Track and Dr. med. the direct route to clinical practice - Medical Sciences Track a route for those interested in research - MD-PhD training a recommendable route to academic medicine 2) Contact with science during specialist medical training - Specific promotional scholarships for research, on a competitive basis, during clinical specialisation - Compatibility between a career in academic medicine and family (Optimisation of work/life balance)

13 Medicine as a Science (Position paper of the Swiss Academy of Medical Sciences (SAMS) 2009) Visions and Perspectives: 1) Scientifically-based university training for all medical students - Physician Track and Dr. med. the direct route to clinical practice - Medical Sciences Track a route for those interested in research - MD-PhD training a recommendable route to academic medicine 2) Contact with science during specialist medical training - Specific promotional scholarships for research, on a competitive basis, during clinical specialisation - Compatibility between a career in academic medicine and family (Optimisation of work/life balance) 3) More efficient research platforms and clear management structures in the university hospitals - Creation of stronger research structures (e.g. Clin. Research Centers) - Establishing of Dual Leadership - Strengthening of coordination and responsibility in management

14 SCTO June 22, 11 Portrait of the Swiss Clinical Trial Organisation Annette Magnin, Managing Director SCTO Biopatente 14

15 SCTO CTU Network SCTO Clinical Trial Units: support and and conduct conduct of of clinical clinical studies studies in university in university hospital hospital Biopatente 15

16 Structure and Organisation

17 SCTO Tasks (as of agreement SAMS& SNSF) Coordination of CTU-Network Quality Management Harmonized Quality Policy Common QMguidelines and SOPs External audits Data Management Common Data Management & Reporting Guidelines Common tools (DMS system) Continued Education E-tool Approved courses for I/SI Workshops Harmonized Education Programs

18 SCTO Tasks (as of agreement SAMS& SNSF) Cooperation Platform Internal Processes Steering Executive Office Steering CTU Board Steering SCTO Boards Internal Processes Network and Lobbying Exchange with national & international organizations Cooperation in task forces & specific expert groups Links to industry, administration, and academia Network specific indications & network of experts Study intermediation Public Relations Webpage Internet/Intranet Centralised documentation Regular news Cooperate Design Representation of SCTO/CTU Network Forum klin. Forschung/Symposium

19 SCTO Tasks (as of agreement SAMS& SNSF) (Inter)national coordination tasks of the SCTO ECRIN (European Clinical Research Infrastructure Network) The SCTO represents ECRIN in Switzerland Swiss European Correspondent ECRIN has the aim to forster multinational (academic) clinical research by harmonizing processes and acting as a powerful stakeholder within Europe Swiss PedNet The five Swiss University Children s Hospitals (Basel, Bern, Geneva, Lausanne and Zurich) and the three paediatric hospitals (Aarau, Lucerne and St. Gallen) join efforts and forces for a Swiss network of paediatric clinical research the Swiss PedNet. SCTO will employ a Swiss coordinator for pediatric clinical research Swiss PedNet Coordinator.

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21 Was ist Personalisierte Medizin? - Für den individuellen Patienten massgeschneiderte präventive, palliative und kurative Untersuchungs- und Behandlungsmethoden. - Berücksichtigung des komplexen Zusammenspiels von genetischen und erworbenen Ursachen für die Entstehung, Ausbildung und Verlauf von Krankheiten - Screening und Stratifizierung von Patientenpopulationen mittels Biomarkern - Individuelle Spezifizierung von Krankheitsdisposition, Diagnose, Prognose und Auswahl von massgeschneiderten Therapieoptionen

22 Genetische und Erworbene Krankheitsfaktoren Alter Geschlecht Genetische Faktoren Drogen Krankheit (Risiko, Art, Prognose Therapieverlauf) Ernährung Lebensstil Sozialer Status Epigenetics vererbte Faktoren erworbene Faktoren Biopatente 22

23 Individualisierte Arzneimitteltherapie Genetische Faktoren Biopatente 23

24 Molekulargenetische Varianten des Metastasierenden Dickdarmkarzinoms benötigen eine an die molekulare Tumorindividualität angepasste Therapie A: Bardelli A and S Siena: J Clin Oncol 28: , 2010 Biopatente 24

25 Translational Research translation Basic Molecular BioSciences Systemsbiology Applied/Clinical Research reverse translation Biopatente 25

26 Translational Medicine Basic Scientist (PhD) Physician-Scientist (MD-PhD) Clinical Scientist (MD) Biopatente 26

27 The Industry-Academia Collaboration Education Academia Industry Research The borders between Academia and Industry must be dismantled Biopatente 27

28 Academia-Industry Collaboration Project: Basel Translational Medicine Hub Mark Jurgens

29 Basel Network of Excellence in Life Sciences Pharma- Industry University of Applied Sciences (FHNW) Startup Companies Systems Biology (D-BSSE ETHZ) University of Basel (Biozentrum, DBM, CRC) Friedrich Miescher Institute University Hospitals Swiss TPH Institute

30 Zusammenarbeit Aerzteschaft Industrie Richtlinien der SAMW Neufassung 2012, In Vernehmlassung

31 2009 Positionspapier der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW) Medizin als Wissenschaft Die Medizin basiert auf wissenschaftlichen Grundlagen und braucht einen kompetenten akademischen Nachwuchs sowie professionelle Strukturen für die klinische Forschung.

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33 Vision Clinical research in Switzerland is innovative, of high quality, and at the cutting edge internationally Mission - To advance patient oriented clinical and translational research and to foster knowledge transfer between basic research and therapeutic applications - To improve quality and scientific profile of clinical research - To support nationally efficient and well linked infrastructures and promote involvement of Swiss clinical research in international networks - Building bridges between academia, industry and the authorities, as well as trade organisations and professional associations - To advocate for favourable legal, political, and financial conditions in the field of clinical research