IBBL: Introduction to Biobanks and their services

Transcription

1 IBBL: Introduction to Biobanks and their services HighTech meets Health, Oss (NL), 15 th June 2017 Monica Marchese, PhD Biomarker Validation Scientist

2 AN ACCREDITED & CERTIFIED BIOBANK INFRASTRUCTURE FOR APPLIED MEDICAL RESEARCH IBBL (Integrated BioBank of Luxembourg) is an autonomous institute dedicated to supporting biomedical research for the benefit of patients. We provide biospecimen-related services and biobanking infrastructure for applied medical research.

3 INTEGRATED CONCEPT BIOBANKING FACILITY BIOSERVICE PROVIDER BIOSPECIMEN RESEARCH INSTITUTE BIOMEDICAL RESEARCH SUPPORTER

4 OUR STRATEGIC GOALS To support European and worldwide biomedical research on cancer, diabetes, Parkinson s disease and microbiome To increase Luxembourg s visibility on the world stage and attract economic activity in the biomedical research sector

5 OUR QUALITY MANAGEMENT An integrated QMS structure ISO 9001:2008 Certification General requirements for quality management systems in client-based organisations (since 2014) NF S Certification Requirements for the management system of a Biological Resource Centre (BRC) and the quality of biological resources (since 2014) French Norm ISO 17025:2005 Accreditation General requirements for the competence of testing and calibration laboratories (since 2016) ISO 17043:2010 Conformity assessment -- General requirements for proficiency testing Luxembourg Quality & Excellence Award (2015)

6 OUR BUILDING LUXEMBOURG DUDELANGE

7 OUR PARTNERS & CLIENTS

8 IBBL AS A PREFERRED PARTNER FOR EU CONSORTIA EXISTING COLLABORATIONS WITH EU CONSORTIA & PROJECTS European Union-supported MINDACT study (Microarray In Node negative Disease may Avoid ChemoTherapy) BIOMARKAPD project of the European Union Joint Programme for Neurodegenerative Disease (JPND) Research European Commission FP7 Framework Programme: STORE (for Sustaining access to Tissue and data from Radiobiological Experiments) IMI Cancer ID, blood based biomarkers in cancer H2020 SPIDIA4P

9 THE CONCEPT OF PERSONALIZED MEDICINE

10 BIOBANKS AND PERSONALIZED MEDICINE (The EPMA Journal, 2016) ( from The EPMA Journal, 2016)

11 BIOBANKS AND SUPPORT TO PM Biospecimen collection Preanalytical processing, storage & banking Biospecimen for biomolecular analysis Translational Research outcomes: Identification and validation of diagnostic and predictive biomarkers Personalized clinical decision making: Diagnosis and Therapy (Adapted from Source: Time Magazine: March 23 rd 2009, 10 ideas changing to world right now : Biobanks)

12 BIOMEDICAL RESEARCH AND REPRODUCIBILITY (Sci Transl Med., 2016) (Nature, 2013) (Sci Transl Med., 2016)

13 SOME KNOWN CAUSES OF IRREPRODUCIBILITY (Nature 28 January 2016;529:456)

14 SOURCES OF ERROR 15% 23% Post-analytical Pre-analytical Analytical 62%

15 SOLUTIONS /1 Binding regulation: - IVD regulation Binding corporate policies and procedures: Editors - SPREC - Reporting guidelines SPREC: Standard PREanalytical Coding for Biospecimens Document biospecimen preanalytical variations Facilitate and consolidate biomarker identification research

16 SOLUTIONS /2 Market regulation Development and implementation of new ISO accreditation standards applying to the preclinical research areas -Biobanks - Bioprocessing method validation - Pre-analytical control - Sample qualification - EQA programs (=proficiency testing) -Research laboratories - Change control - Reference materials - EQA programs

17 SPREC Biospecimen preanalytical code: TIS BPS N B RNL A A TIS Solid tissue BPS biopsy N warm ischemia N/A B < 10 min cold ischemia RNL RNA Later A < 15min fixation time A PP 2ml -80 C (Biobanking and Biopreservation, 2012) COMPARE WHAT IS COMPARABLE!!!!!

18 WHAT IS A BIOMARKER? A biomarker (BM) is a characteristic that is objectively, precisely and reproducibly measured and evaluated as an indicator of normal and pathogenic processes, or a pharmacologic response to a therapeutic intervention (Biomarkers Definitions Working Group, Clin Pharmacol. Ther, 2001) WHY VALIDATION IS IMPORTANT? NEEDED? To Regulators develop call CDxfor in a terminology PM contextand methodology To standardization increase public and private partnership To cull help that with90% data of reproducibility BM candidates that have no future in clinical applications, Healthcare payers by bridging demand Academia, evidencesmes that BMs and Industry deliver benefit to To patients move to from justify scientific their use validity in clinical to a reliable practice and robust BM

19 ONE BIG HIGH Biomarkers have long been hailed as the key to better patient care and lower medical costs

20 Thousands of PubMed citations related with BMs discovery -> only few have been validated for use in clinical routine BUT MANY LOWS Drucker, E., EPMA J Feb 25;4(1):7 Poste, G., Nature. 2011;469:

21 BIOMARKER DEVELOPMENTAL STAGES (From Fondation Fournier-Majoie)

22 WHAT IS BIOMARKER VALIDATION BIOMARKER VALIDATION o Assessing the BM o Establishing its performance characteristics o Determining the range of conditions under which it will give reproducible and accurate data o Pre-analytical validation o Analytical validation o Clinical verification o Method comparison o Quality control material VALIDATION LINKS THE BM TO ITS BIOLOGICAL PROCESS AND THE CLINICAL ENDPOINT

23 ASSESSING FIT-FOR-PURPOSENESS EXPLORATORY PROBABLE VALID FIT- FOR- PURPOSE (Cummings et al. British Journal of Cancer 2010;103: )

24 OF SAMPLES AND BIOBANKS Biomarker discovery: - Samples - fitness for purpose - analyzed one SOP, at a time - Data (clinical, biological, preanalytical) - Certified biobanks (consistency) Biomarker validation: - Samples - fitness for purpose - many SOPs - validated methods - QC - Data (clinical, biological, preanalytical) - data QA - Accredited biobanks (consistency, competency) Reference Materials: Annotated samples Qualified samples Certified samples Analytical validation Clinical validition

25 IBBL PROCESSING IBBL PROCESSING SERVICES PROFICIENCY SERVICES (1) (2) TESTING SERVICES o o o o o o BENEFITS o o o o 11 processing schemes: CSF Aliquoting DNA, RNA and protein Molecular Viable Biology PBMC Assays Isolation Genomic and circulating DNA o RIN (RNA Integrity Assay) DNA Extraction from Whole Blood extraction o Total protein quantification DNA Extraction from FFPE Cells mirna / mrna extraction o qpcr o gene Cell culture expression analysis DNA Extraction from Frozen Tissue Protein extraction o Long-range o Lymphoblastoid PCR cell Microbial line DNA Extraction from Saliva Freeze drying o DNA fingerprinting establishment Microbial DNA Extraction from Stool Peripheral blood mononuclear cell o Frozen biospecimen Cell-Free DNA (cfdna) Extraction from Whole Blood (PBMC) extraction aliquoting Imunological RNA Extraction QC Assays from Whole Blood Cell sorting o Slide and image o processing SIB RNA (Serum Extraction Integrity from BM) FFPE measurement cells o Tissue microarrays o IHC Total RNA Extraction from Frozen Tissue construction o Serum fingerprinting 8 testing schemes: DNA Quantification and Purity Cellular QC Assays RNA Quantification and Purity Uniform high quality of samples o Cell availability apoptosis RNA Integrity High throughput processing o Cell subpopulation purity Cell Viability Experienced and highly trained staff o Histological QC (tumor, stroma, Haemoglobin necrosis) Quantification in Plasma Combined processing, analysis and storage in a CSF Haemoglobin Quantification WaferGen single location CD40 Ligand Quantification in Serum miseq NGS Tissue Histology BioPlex Protein Analysis

26 TRAINING PROGRAM

27 HOW BIOBANKS CAN HELP MEDICAL RESEARCH AND COMPANIES Interoperability between biobanks: bottom up Trusted biobank networks Harmonisation of data and processes between biobanks High quality biospecimens and data sets Acceleration of biomarker research by access to established cohorts and biobanks Application of more flexible consenting procedures Development of European Reference Networks

28 CONCLUSIONS Biobanks are a strategic tool for Personalized Medicine High standards Certification Accreditation Validation of processing methods Biospecimens fit-for-purpose Well characterized biospecimen Accurate annotation Precise validation tools Advanced technology Security and Ethics

29 Thank you for your attention Monica Marchese