Expert Centres for Improved Access to Research Infrastructures

Transcription

1 HOBB Helsinki September 25th, 2014 Expert Centres for Improved Access to Research Infrastructures Kurt Zatloukal M.D. Institute of Pathology Medical University of Graz Austria

2 Disease-oriented biobanks for investigation of molecular mechanisms of diseases, establishment of human disease relevance Population-based cohorts for identification of genetic risk factors Tissues, sera, plasma collected in clinical trials for biomarker validation (companion diagnostics) Tissue banks for investigation of target expression in diseased and non-affected organs Tissue banks to investigate target expression in large patient cohorts to support the design of clinical trials Tissue banks for validation of human disease relevance of animal models Archived tissues, sera, plasma for biomarker discovery Target Id Target Val Hit Lead Lead Optim Preclininc Phase I Phase II Phase III Research Discovery Development Zatloukal & Hainaut, Biomarkers Med 2010

3 Nature September 2009

4 Common good (donations) Industry Medical data Biological samples Knowledge? Diagnostics Drugs Public (not-for-profit) Private (for-profit)

5 Health care system Patients Donors Doctors Doctors Biobanks Researchers Academia Researchers Industry Researchers Academia Researchers Industry Industry

6 Common good (donations) Expertise Expertise Industry Funds Medical data Biological samples Knowledge Primary data generation Diagnostics Drugs Public (not-for-profit) Data Public Private pre-competitive (not-for-profit) Products IPR Private (for-profit) Standardisation of data generation Basis for data sharing Better usage of finite resources Collaborative research to improve innovation

7 Highest level of standardization but flexibility For a specific medical problem or analytic technology (e.g., genomic analyses, metabolomics, molecular pathology, infectious diseases) Public-Private or Public-Public Partnerships Collaboration agreement (e.g., consortium agreement) or legal entity Not part of BBMRI-ERIC but collaboration agreement with and validation by BBMRI-ERIC

8 Partnership agreement Implementation of common quality management system Sharing SOPs Using common reference samples Participation in proficiency testing International & interdisciplinary harmonization No exclusivity or closed shops Validation by BBMRI-ERIC

9 Lack of incentives for collaboration Career models only refer to performance of individuals Unclear transition from pre-competitive to competitive research Role of intellectual property/know how Differences between SMEs and big Pharma New business models required New financing models required

10 Common good (donations) Expertise Medical data Biological samples Knowledge Standardized primary data generation Knowledge for research & innovation Public (not-for-profit) Data pre-competitive (not-for-profit) Finite resource Value generation Unlimited resource

11 (public) Expert Centres as Highways for International Research Collaborations Biological Resource Centre Samples Medical Data Expert Centre Research Data Expert Centre Samples Medical Data Biological Resource Centre Country 1 Country 2 Biological Resource Centre Samples Medical Data Expert Centre OECD GBRCN Country 3

12 Gert-Jan v Ommen, NL George Dagher, FR Eero Vuorio, FI David Cox, Pfizer Christian Brechot, Merieux Institute Klaus Lindpaintner, Roche/Thermo Fisher Michael Griffith, IPPOSI Gert-Jan B van Ommen 1, Outi Törnwall 2, Christian Bréchot 3, Georges Dagher 4, Joakim Galli 5, Kristian Hveem 6, Ulf Landegren 5, Claudio Luchinat 7, Andres Metspalu 8, Cecilia Nilsson 9, Ove V Solesvik 10, Markus Perola 2,11, Jan-Eric Litton 12 and Kurt Zatloukal 13. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. EJHGR (accepted)

13 Thank you