Bruno Clément bruno.clement@inserm.fr http://crbfrance.fr/ Basic research Animal and plant resources Model systems Microorganisms Patients Annotated and validated biological resources Genomics, proteomics, metabolomics, HTS… Data bases bioinformatics systems biology Knowledge Health Agronomy Economical and societal output Centres de ressources biologiques 1999 Loi sur l’Innovation du 12 Juillet 1999 OCDE : définition des CRB 2001 Comité Consultatif des Ressources Biologiques Recommandations de l’OCDE pour les CRB, approuvées par 30 pays 2001 à 2003 - AAP de l’INSERM, CNRS, INRA, IFREMER, BRG… - Plan d’action du Ministère de la Santé pour les tumorothèques - Création du réseau national des biobanques (Inserm) 2003 Plan Cancer => action ciblée sur les tumorothèques par l’INCa Déclaration de l’Unesco 2004 Loi de bioéthique du 6 août 2004 Loi Santé Publique du 9 août 2004 OCDE Conseil des ministres => réseau global des CRB 2006 ANR : AO pour une norme française CRB Recommandations du Conseil de l’Europe Directives européennes 2006-17 2006-86 2007 Recommandations de l’INCa pour les tumorothèques - OCDE : Guide des bonnes pratiques pour les CRB d’origine humaine et microbienne - ESFRI : Biobanking and Biomolecular Research Infrastructure (20 pays, 50 institutions) 2008 - Très Grande Infrastructure de Recherche - Publication de la Norme française NF S 96-900 - Intégration du réseau des CRB au GIS Infrastructures en Biologie, Santé et Agronomie 2010-11 - Extension de la Norme NF S 96-900 - Investissements d’Avenir : Infrastructures en Biologie et Santé BBMRI MIRRI GBIFF Microorganismes Agronomie Réseau national des biobanques Tumorothèques Santé Comité Consultatif des Ressources Biologiques Infrastructures en Biologie, Santé et Agronomie http://www.ibisa.net Infrastructures en Biologie, Santé et Agronomie http://www.ibisa.net Eligibility criteria 63 Biological resources centers Animal and plant resources 9 Micro-organisms 7 Strategic importance Governance Quality assurance Human health 47 Information system Access Activity Typology of biobanks Non-transformed biological samples cells, tissues, blood, stools, urine….. Derived products: Cells Tissue slices DNA, RNA… Proteins….. Local biobanks, mono- ou multithematic Networked biobanks, monothematic Examples of biobanking networks Network infrastructures Transient biobanking networks • International Cancer Genome Consortium – • • • To describe >1000 epigenomes • To discover common SNPs in common disease To discover omic biomarkers in asthma Japan Biobank – To accrue rapidly 300,000 samples for genetics and pharmacogenetics in 50+ diseases To link all biological resource centres BBMRI.se (Sweden) – • To link all biological resource centres Spanish Biobanks infrastructure – • To link national centres of excellence French biobanques Infrastructure • • To add scientific value to MRC genetic collections German biobanking platform – IMI U-biopred – • To describe sequence variation To link national biobanking initiatives UK DNA Banking Network – Wellcome Trust Case Control Consortium – • • International Human Epigenome Consortium – • To specify a reference sequence (~10 libraries) BBMRI : Biobank and BioMolecular resources Research Infrastructure – 1000 Genomes Project – • To describe genomic, transcriptomic and epigenomic changes in 50 different tumor types and/or subtypes Human Genome Project – • national large-scale biobanking facility String of Pearls Initiative – To accrue samples in 9 diseases from 8 NL hospitals Objectives • Access to samples and associated data • Common services • Biobank supports – Regulatory affairs and ethics – Methodology, biostatistics – Technological development • Public/private partnerships • Links with European infrastructures: BBMRI and MIRRI • Coordination with other PIA and related projects Actors 75 biobanks and biological resources centers ~400 research teams Institutions : AVIESAN… Industry: ARIIS, equipments, IT… Bioclusters: Medicen, LyonBiopôle, EuroBiomed, Alsace Biovalley Coordination : Inserm Coordinator : Georges Dagher Scientific director: Bruno Clément Scientific counsellor: Chantal Bizet Preparatory phase 2012-2016 Scientific Advisory Board Governance Council Stakeholders forum Coordination committee BBMRI ERIC EMbaRC/ MIRRI Biobank Biobank BRC Preparatory phase 2012-2016 • 7 working groups – Data bases and interoperability – Quality assurance – Ethical, legal and societal issues – Technological developments – Methodology, Statistics – Public-Private partnerships – Training Budget : 11 M€ Operational phase 2016-2020 Common services • • • • • • • • On-step access to biological resources Platform « Quality-assurance, Biosecurity, Biosafety » Platform « Regulatory affairs and ethics » Platform « Methodology and biostatistics » Platform « Innovative technology » Biomarker validation unit Interoperability of data bases ; biocomputing Training Budget : 6 M€ Sustainability • Evaluation of biobanks • Links with other PIA F-CRIN, IHU, Labex RADICO, Constance, Canto, OFSep, CKD Rein, Perinat Metagenopolis IFB-core • European integration BBMRI-ERIC, MIRRI Collaboration UE-Chine ; UE-USA ; UE-Emirats Unis ; UE-Australie • Financing Biobank activities Regional funding European funding: Bioshare, IMI, Eucolex, Itfom Biobanks Are they REALLY useful for the R&D ? Strategic perspectives Sustainability Governance Shared and common platforms Top clinics Top biobanks Top science Evaluation Expertise Thematics Collections of biological samples from multicentre cohort of clinically welldefined patients with a high level of QA and annotations Partnerships and valorization of biological resources => Expert centers Expert Centers Hospital Patients Samples Med. data Expertise Samples Med. data Expertise Biobank Cost recov. Public (not-for-profit) Data Cost recov. Expert Centers Public-Private pre-competitive (not-for-profit) Research data Expertise Industry Expertise In-kind Cost recov. Private competitive (for-profit) Provides efficient access to samples, data and expertise Mutual benefit from expertise and in-kind contributions Joint generation of pre-competitive data and knowledge Reduces requirements for sample shipment Gateway for global collaborations Comte de Buffon 17071707-1788 Curiosity cabinet Muséum d’Histoire Naturelle