The European Research InfrastructureThe European Research Infrastructure

for Biobanking and Biomolecular Resources for Biobanking and Biomolecular Resources

(BBMRI):(BBMRI):

Towards implementationTowards implementation

Kurt Zatloukal, Medical University of Graz, Austria

Stakeholder’s ForumBrussels, September 16th 2009

Preparatory Phase Grant Agreement Preparatory Phase Grant Agreement 212111212111

The Preparatory Phase of BBMRI The Preparatory Phase of BBMRI

• Assessment of existing resources and technologies

• Concept for integration• Prototype (voluntary effort)• Concept for operation• MoU for infrastructure members and funding

– Legal entity– Statutory seat– Governance structure

The ChallengesThe Challenges

• Harmonized processes • Incentives for contributors• Access rules• Heterogenous European ethical and legal

landscape• Data protection in biobanking• Sustainable funding

Starting PointsStarting Points

• OECD best practice guidelines for Biological Resource Centres

• OECD draft guidelines on Human Biobanks and Genetic Research Database

• P3G– International harmonization of biobanking

• FP5-FP7, national programs– Existing biobanks, resources and networks

Inventory on Existing BiobanksInventory on Existing Biobanks

• BBMRI questionnaires have been developed jointly by all WPs and P3G

• Detailed information on samples, data, access, governance, costs and funding

• Meanwhile questionnaires from <260 biobanks returned

• Stored in a relational database system

BBMRI PrototypeBBMRI Prototype

• Most advanced biobanks will start the construction of a prototype infrastructure already during preparatory phase on a voluntary basis

• Prototype should implement BBMRI policies and structure

• Requires support from national Funders and Ministries

• 9 proposals received

BBMRI Policies (in brief)BBMRI Policies (in brief)• Primacy

– Respect the primacy of national and European legislation and respect the jurisdiction of competent authorities

• Data protection policy: – No data on individuals will be made publicly accessible

• Access policy: – Fair access in context of specific research projects and after REC approval; biobanks do not

loose control• Informed consent:

– Implementation of the OECD guidelines for Human Biobanks and Genetic Research Databases

• Infrastructure and management:– Implementation of the OECD best practice guidelines for Global Biological Resource

Centres Networks. • Sample collection and processing:

– SOPs for processes considering the WHO/IARC guidelines for biological resource centres for cancer research

The Adaptor Approach of BBMRIThe Adaptor Approach of BBMRI

• Define criteria – Which samples and data

can be combined?– Evidence-based standards

• Develop tools– Data exchange– Sample intl. transfer

Possible Legal Structure Possible Legal Structure of BBMRI (ERIC) of BBMRI (ERIC)

Distributed hub and spoke structure

National members

Biobanks

Biomolecular res.

Technology centers

Associated partners

Hospitals

Universities

Service providers …

Secretariat

(statutory seat)

Expected Impact of BBMRIExpected Impact of BBMRI

• BBMRI should provide a pan-European framework to foster excellence in biomedical research– Better projects, faster, cheaper

• Access to high quality resources, technologies, services, education and training

• Partner for academia and industry– SMEs: Strategic partner, customer– Pharma: Biomarker and drug development

• Incubator for regional development– Start-up packages

BBMRI: The Wider ContextBBMRI: The Wider Context

• Global biobanking community• Life sciences community• Industry• Patients/donors• Publics• Political decision-makers

Involvement of the Involvement of the Biobanking CommunityBiobanking Community

• ESF workshop, Amsterdam Dec. 06• Establishment of FIBO, Paris, Dec. 06• Stakeholder meeting Vienna, Feb. 07• Presentation at EU Parliament , May 08• Joint workshop DG Research, BBMRI, PHOEBE;

Brussels, November 08• Joint conference, Brussels, March 09• Secretariat for OECD GBRCN pilot, September 09

Involvement of PatientsInvolvement of Patients

• 1st Stakeholder meeting: Brussels, March 20th 09 (Chair: M. Griffith)– European Cancer Coalition (H. Sundseth)– Heart EU (M. Livingston)– Europ. Fed. of Crohn‘s and Ulcerative Colitis Associations (R.

Mitchell)– EURORDIS (V. Bottarelli)– Internatl. Alliance of Patients‘ Organizations (S. McMahon)– Europ. Genetic Alliance Network (A. Kent)

• 2nd Stakeholder meeting: Brussels, September 16th 09

Involvement of IndustryInvolvement of Industry

• Specific issues– Quality management

• Projects: Proof-of-concept

• Strategic issues– Long-term strategy for PPP (EFIPA, EDMA)

• Joint analyses centers• Biomarker centers• Biobanking service

Expert centers

Expert Centers: A New Model for PPPExpert Centers: A New Model for PPP

HospitalPatients

BiobankExpert

CentersIndustry

Samples Med. data

Identified

Samples Med. data

Coded

Study data

Confidential

Public Private

Provides efficient access to samples, data and expertiseReduces requirements for sample shipment Avoids false impression of sample commercialization

BBMRI and PublicsBBMRI and Publics

• Socio-economic impact study(impact on science, economy, health care)

• Public perception (focus groups and Eurobarometer)

• Coordinated communication strategy of all BMS research infrastructures (joint task force)

• White paper for European Parliament

BBMRI and ESFRI Biological and Medical BBMRI and ESFRI Biological and Medical Sciences Research InfrastructuresSciences Research Infrastructures

EATRIS

ELIXIR

INFRAFRONTIER ECRIN

BBMRI

INSTRUCT

Target Id

Target Val Hit Lead

LeadOptim Preclininc Phase I Phase II

Research Discovery Development

Phase III

e-Infrastructure

EMBRC EISBIEU OpenScreen

Euro Bio-Imaging

BSL4Laboratories

B i o b a n k i n g

B i o i n f o r m a t i c s

PP projects

1st update of roadmap

Emerging infrastructures

White Paper: Key MessagesWhite Paper: Key Messages

• lay the foundation for improved health care for European citizens“generate value for society through collaboration”

• Provide unique opportunity to improve competitiveness of European science and industry – together generate a value generating chain without gaps– Generate an enormous momentum– for the first time generate a homogenous European research

space (ERIC)– Health-related economies are the potential next driver of

global economy

• Requires co-ordination and collaboration at national, European, and global levels– Redefine research strategies– New business models– Proper legal framework– Sustainable funding tools

ESFRI BMS infrastructures will

Next StepsNext Steps

• Joint web site www.infrastructures4health.eu• Media briefing London September 22nd

(FT, Bloomberg J Law, Nature, Biotech-Pharma)• High impact paper

I. Mattaj/F. Kafatos/ESFRI coordinators• White paper to be communicated to the

European Parliament in November 09, formal hearingEurope by Satellite (EBS)

• Events during Spanish, Belgium Presidency

www.bbmri.eu

M. Yuille et al. Briefing in Bioinformatics 9: 14-24 (2008)

Thank You