ROUND TABLE ARISLA Milano 26 marzo 2014 Le BioBanche Nodo Italiano di Biobanking and Biomolecular Resources Research Infrastructure

Transcription

1 ROUND TABLE ARISLA Milano 26 marzo 2014 Le BioBanche Nodo Italiano di Biobanking and Biomolecular Resources Research Infrastructure Marialuisa Lavitrano Università Milano-Bicocca Coordinatore BBMRI-Italia

2 Time, March 13 th, 2009 Biobanks

3 Biological resources living organisms, cells, genes, and related information are the essential raw material for the advancement of biotechnology, human health, and research and development in life sciences OECD 2001

4 The European Strategy Forum for Research Infrastructures Roadmap One infrastructure for biobanks and biomolecular resources Scientific excellence Pan-European Access to resources and services Long-term sustainability (international integration)

5 BBMRI-ERIC Mission Increase efficacy and excellence of European bio-medical research: by facilitating access to quality-defined human health/diseaserelevant biological resources including associated data in an efficient and ethically and legally compliant manner, by reducing the fragmentation of the bio-medical research landscape through harmonization of procedures, implementation of common standards and fostering high-level collaboration, by capacity building in countries with less developed biobanking communities thereby contributing to Europe s cohesion policy and strengthening the ERA.

6 Scientific Excellence Quality of samples and data Coverage of European populations/patients Interoperability Ethical and legal compliance

7 BBMRI-ERIC: A pan-european Infrastructure 14 Founding Members: Austria, Bulgaria, Belgium, Czech Rep., Estonia, Finland, France, Germany, Greece, Italy, Latvia, Malta, Netherlands, Sweden 4 Observers: Norway, Poland, Switzerland and Turkey

8 BBMRI-ERIC: A Distributed Research Infrastructure Distributed hub and spoke structure Statutory seat (CEMO Austria, Graz) National nodes Associated partners Hospitals Universities Service providers

9 The ERIC Legal Framework Internationally recognized legal entity Establishement of operational sites in different Member States that operate under one legislation VAT exemption

10 The Italian Infrastructure for Biobanks

11 THE ITALIAN BIOBANK NETWORK IRCCS Ministry of Health Natl Institute of Health Hospitals Ministry of University and Research Universities Natl Research Council Patient associations GENETIC BBs ARCHIVE TISSUES BBs ONCOLOGY BBs ITALIAN NETWORK DISEASE-ORIENTED BBs MULTI SPECIALIST BBs VASCULAR BBs ISOLATES POPULATION BBs RANDOM COHORTS

12 BBMRI-IT Facts and figures BBMRI-IT is a distributed infrastructure including BBs & Biological Resources Centres allocated all over Italy They include, among others: 18 Universities 23 IRCCS (Institute of health care and research) 40 Hospitals 8 patient associations about 90 BBs, Biological Resources Centres and Collections 290 individuals (research groups) have formally declared their willingness to join BBMRI-IT

13 THE ITALIAN BIOBANK NETWORK Population biobanks, genetic or diseaseoriented biobanks are characterized by a collection of biological samples, such as blood, tissues and/or DNA, plus associated epidemiological, clinical, and research data, which may be important research tools for identification of new targets for therapy and may help in drug discovery and development cases collected new cases / year

14 THE ITALIAN BIOBANK NETWORK Biobank Specimen Archives have large collections of well-documented, up-to-date clinical and biological information samples, supplied with links to epidemiological and health care information and in most cases with the molecular genomic resources, which can support retrospective studies and accelerate research progress cases collected new cases / year All specimens are stored for at least 20 years

15 BBMRI-IT Aims BBMRI-IT main goals: to take Italian collections of biological resources, BBs and networks to a new level of coordination and efficiency to supply new common services for the community of the Italian biobanks to provide better access for users from public and private sector to contribute to the pan-european research infrastructure BBMRI-ERIC

16 BBMRI-IT Aims To achieve the aims Improve interoperability of research databases Provide tools to facilitate public/private partnership Develop conditions to ensure sustainability of BBs Harmonize SOPs and elaborate appropriate tools Implement quality management criteria Interface with BBMRI-ERIC by developing a national node

17 PATH OF BBMRI IT MEMBERSHIP First step: a survey has been designed to map and select well established Italian biobanks in terms of the level quality and richness in samples and data. Second step: an on-line self evaluation form have been administered, followed by the creation, in the new web site of the node, of a web page for each biobank / biological resource centre of the network. Third step: provide support, advice and documents to those willing to set new biobanks and / or improve the quality of their collections of biological samples.

18 16% were already operative before 1990, while 56% were set up after % have more than cases collected 66% collect at least 3 different types of samples per subject (frozen samples, FFPE, blood derivatives, nucleic acids, cell lines) 77% belong to regional, Natl and/or Intl networks Most are disease oriented, and about half are specialized in cancer and genetic diseases A vaste majority is ready to offer services oncology to the network (samples, 30% data, molecular analysis, expertise, support in handling, preservation, transfer) Results of the survey Neuro degenerative disorders 6% Focus of the biobanks Oncology 30% Products and services offered to the network Population studies 14% Sample handling, preservation and transfer 26%

19 Thematic and Multispecialty BB Networks BBMRI IT MATRIX ARCHITECTURE Italian Regional Biobank Networks Region 1 Region 2 Region 3 Region 4 Region 5 Region 6 Region n Multispecialty bb Oncology bb Archive Tissues Genetic bb Vascular bb Population and Isolates bb

20 NHS - Regional initiatives on biobanks Italy s health care system is a regionally organized Regional Authorities with regards to biobanks are responsible of: authorization funding monitoring & control Since 2011, National and Regional Institutions have set up a Task Force on biobank management and monitoring Some Regions have already put in place specific resolutions and laws

21 STRUCTURE OF THE ITALIAN NODE Ministry of Health Ministry of University and Research Regions National Institute of Health (ISS) National Research Council (CNR) Coordinator Member State Representative Governing Board Evaluation Board Network Board Secretariat (E Bravo) Scientific Board Stakeholder forum Service 1 Quality Management (B Parodi) Service 2 Harmonization (M Filocamo) Service 3 SOPs, Validation, training (MG Daidone) Service 4 Technology and Reagent (G Stanta) Service 5 Information Communication Technology (L Milanesi) Service 6 Ethical, Legal and Societal issues (M Lavitrano) Model for Regional biobank networks ( L Santi)

22 Common Service IT Services Sustain the matrix architecture of the network (links among BBs into Regional and thematic networks) Offer common services to the network Promote collaborative studies at the National and International levels Guarantee safe transfer of information Provide visibility to Italian BBs Adopt BBMRI standards and create the interface to National BBs Maintain the Lexicon BBMRI portal for multi-lingual BBs terminology definition Luciano Milanesi

23 Common Service Common Technology and Reagent Services Establish a National catalogue of facilities and services for the biobank network Identify Expert Centres Catalogue of services offered by BBs to the network DNA and RNA extraction supply of genetic material for method validation cell line production molecular characterization of biological samples cell line authentication validated mycoplasma QC cryopreservation biological samples preparation and storage pathogens Giorgio Stanta consultancy biological samples transport (IATA) statistical analysis counseling SOPs preparation counseling ethical issues data analysis data mining training of operators for cryobiology training of operators for biobanking

24 Sample Quality: Critical Issues Medication Surgical procedure Warm ischemia Fixation Fixative Time Transport Temperature Cold ischemia Sample processing Mech. alteration Selection+annotation Aliquotting Embedding Temperature Diagnosis Disease codes Storage Time temperature Freezing Freezing rate Temperature Cryostorage Temperature Temp. shifts Sample preparation Analysis

25 Common Service Quality Services Map and monitor BBs, repositories and biomolecular resources Harmonize and standardize SOPs Develop criteria for accreditation & certification Implement quality management criteria Improve interoperability Set up training in quality control Standardize and set up proficiency testing Promote a certification program Mirella Filocamo, Mariagrazia Daidone, Barbara Parodi

26 Common Service Ethical, Legal and Societal Issues Define the status of bioresources Define the status of BBs Promote public consultation Establish the informed consent form Define the access to bioresources Regulate patentability Set up and monitor good practices in biobanking Provide in-formation and permanent training Biobanking 2.0 Marialuisa Lavitrano

27 Access to Samples and Data

28 Outreach Public engagement Interdisciplinarity Public Private - Partnerships / Innovation Global integration

29 BBMRI and Publics Public perception (focus groups and Eurobarometer) Active participation of patient organizations Socio-economic impact study (impact on science, economy, health care) Political engagement process

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