International standard for Biobanking

Transcription

1 International standard for Biobanking Georges Dagher Inserm, BBMRI Paris, France 20/10/2017 GBW meeting 1

2 Increase quality Decrease Cost Take home message 20/10/2017 GBW meeting 2

3 Most of our current knowledge on diseases as well as available diagnostic assays and drugs are based on systematic investigation of human biological samples and medical data

4 Alexandria 290 BC, Herophilus and Erasistratus 20/10/2017 GBW meeting 4

5 Human Biological Resources From Eigenschaften der Dinge Bartholomäus der Engländer 15th C. Zeiss 1879 HIV Bank Fraunhofer Saarland BGI 2009 Shenzhen, China 20/10/2017 GBW meeting 5

6 By making use of these resources, genomics, proteomics & imaging techniques has achieved major progress in the last decade 20/10/2017 GBW meeting 6

7 Infectious diseases Pathogenicity and the epidemiology of several diseases of world-wide importance has been achieved : Meningitis, Legionnaires disease, Diphtheria, Typhus fever, Influenza, Malaria, Dengue, AIDS. 20/10/2017 GBW meeting 7

8 Key to this progress has been the development of genomics that also revolutionized vaccine development and catalysed a shift from conventional culture-based approaches to genome-based vaccinology 20/10/2017 GBW meeting 8

9 Genetic association has been identified Type 1 diabetes, Type 2 diabetes, Coronary artery disease, Breast cancer, Colorectal cancer, Prostate cancer, Age-related macular degeneration, Crohn s disease, Autism, Neurodegenerative diseases 20/10/2017 GBW meeting 9

10 Neurodegenerative diseases Alzheimer Parkinson Dementia Spinocerebellar degeneration 20/10/2017 GBW meeting 10

11 Significant issues and limitations are restricting the impact of translational research And the broad implementation of these technologies in the health field

12 Bottlenecks Samples shortage Quality of samples and related data Fragmentation of research Redundancy Ethical and Legal issues Sustainability of infrastructures 20/10/2017 GBW meeting 12

13 Quality of samples can be bottlenecks for research and diagnosis 20/10/2017 GBW meeting 13

14 Cancer Genome Project struggles with sample shortage Nature Medicine ,000 Cancer deaths (North America; 2007) Fragmentation ELSI Funding Technical Follow-up 20/10/2017 GBW meeting 14

15 Many scientists reported difficulty obtaining biospecimens of adequate numbers and quality : 47% have trouble finding samples of sufficient quality 81% have limited the scope of their work 60% have questioned the findings of their studies Masset, H. A. et al. Assessing the Need for a Standardized Cancer HUman Biobank : Findings from a National Survey With Cancer Researchers, J. Natl Cancer Inst. Monogr. 2011, 8-15(2011) 20/10/2017 GBW meeting 15

16 Improvements also needed for Research In a 2009 NIH survey, researchers from 80% of more than 700 responding laboratories said they struggled to obtain standardized specimens for biomarker research. Post G.. Bring on the Biomarkers. Nature 469, , Jan the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US $28B)/year spent on preclinical research that is not reproducible - in the United States alone. Freedman LP, Cockburn IM, Simcoe TS (2015) PLoS Biol 13(6): e doi: /journal.pbio partly caused by pre-analytical errors and quality of samples 20/10/2017 GBW meeting 16

17 Lack of Reproducibility of Scientific Studies 20/10/2017 GBW meeting 17

18 More dreadful than wasted investment Loss of public trust

19 Reproducibility is a complex issue Quality of samples and solutions is one of the factors 30% 7-8 B$/year

20 An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible in the United States alone. Freedman et al, PLOS Biol, /10/2017 GBW meeting 20

21 Reproducibility is a complex issue Quality of samples is one of the factors 30%

22 Reproducibility in Science Improving the Standard for Basic and Preclinical Research C.G. Begley, J. P.A. Ioannidis Circ Res The Increasing Urgency for Standards in Basic Biologic Research L. P. Freedman and J Inglese, Cancer Res; Biomedical research: increasing value, reducing waste. Macleod MR et al. Lancet 2014 Six red flags for suspect work. Begley CG. Nature, 2013 Raise standards for preclinical cancer research. Begley CG, Ellis LM. Nature Believe it or not: how much can we rely on published data on potential drug targets? F. Prinz et al. Nature Review, 2011 April 2016 ISBER meeting, Berlin 22

23 An appropriate quality of samples 3 Pillars Control of pre-analytical variables Quality Management Quality Control 20/10/2017 GBW meeting 23

24 An appropriate quality of samples 3 Pillars Control of pre-analytical variables Quality Management Quality Control 20/10/2017 GBW meeting 24

25 Precision medicine requires reliable and robust diagnosis

26 Impact of Pre-analytical variables on quality of samples Biospecimen Research Network (NCI, USA). SPIDIA-project (FP7, EU) SPIDIA 4P Project (H2020): Comprehensive investigation of pre-analytical factors impacting on sample quality and biomolecules 20/10/2017 GBW meeting 26

27 SPIDIA and SPIDIA4P 20 Technical specificities to be developed: 20/10/2017 GBW meeting 27

28 Solid Tissues / Tumours FFPE* tissue Part 1: Isolated DNA (ISO/IS) FFPE tissue Part 2: Isolated RNA (ISO/IS) FFPE tissue Part 3: Isolated proteins (ISO/IS) FFPE Tissue in situ staining including Immunohistochemistry (IHC) (ISO/IS) frozen tissue Part 1: Isolated RNA (ISO/IS) frozen tissue Part 2: Isolated proteins (ISO/IS) frozen Tissue Isolated DNA (CEN/TS) 20/10/2017 GBW meeting 28

29 Whole Blood including Liquid Biopsies Venous whole blood Part 1: Isolated cellular RNA (ISO/IS) Venous whole blood Part 2: Isolated genomic DNA (ISO/IS) Fine Needle Aspirates Fine Needle Aspirates (FNAs) Isolated DNA (CEN/TS) Fine Needle Aspirates (FNAs) Isolated RNA (CEN/TS) Fine Needle Aspirates (FNAs) Isolated Proteins (CEN/TS) 20/10/2017 GBW meeting 29

30 Whole Blood including Liquid Biopsies Venous whole blood Part 1: Isolated cellular RNA (ISO/IS) Venous whole blood Part 2: Isolated genomic DNA (ISO/IS) Venous whole blood Part 3: Isolated circulating cell free DNA from plasma (ISO/IS) Venous whole blood Isolated circulating tumour cells, (CTCs) and circulating organ cells, (COCs), isolated DNA (CEN/TS) Venous whole blood Isolated circulating tumour cells, (CTCs) and Circulating organ cells,( COCs), isolated RNA (CEN/TS) Venous whole blood Isolated circulating tumour cells, (CTCs) and circulating organ cells, (COCs), isolated Proteins (CEN/TS) Venous whole blood Isolated circulating tumour cells, (CTCs) and circulating organ cells,( COCs), stains (CEN/TS) 20/10/2017 GBW meeting 30

31 Venous whole blood Isolated exosomes and isolated nucleic acids therefrom and ccfrna (CEN/TS) Non-invasive Body Fluids Urine and other body fluids Isolated cfdna (CEN/TS) Saliva Isolated human DNA (CEN/TS) Saliva and stool Isolated microbiome DNA (CEN/TS) Metabolomics Urine, Whole blood plasma and Serum : International ISO Standard (ISO/IS) 20/10/2017 GBW meeting 31

32 Session 10C: Quality Assessment A Key Factor for Successful Biobanks and Reproducible Science Friday 16:00 20/10/2017 GBW meeting 32

33 An appropriate quality of samples 3 Pillars Control of pre-analytical variables Quality Management Quality Control 20/10/2017 GBW meeting 33

34 State of the art 20/10/2017 GBW meeting 34

35 Hundreds of SOP More than 80 guidelines from international or national scientific entities (OECD, IARC,ISBER, NCI ) Quality Standards in France, UK, Ireland, Brazil EU Tissue/cells regulation Accreditation of several tissue biobanks, several micro-organisms biobanks ISO ; ISO 17020, ISO guide 34 Accreditation of several medical laboratories for precision medicine (ISO 15189) 20/10/2017 GBW meeting 35

36 80 guidelines and best practices for biobanks Which one is the most appropriate?

37 Chronicle for a fail foretold 20/10/2017 GBW meeting 37

38 The road towards international standard 20/10/2017 GBW meeting 38

39 METHODOLOGY Guidelines: OECD ISBER NCI Biobank Quality Standard (UK) NF S (France) MMI (Ireland) Brazilian Standard EU tissue/cells regulation ISO Standards: ISO ISO ISO Guide 34 ISO ISO ISO /10/2017 GBW meeting 39

40 85% Overlap of the requirements of 8 international guidelines items 20/10/2017 GBW meeting 40

41 ISO/TC 276 Biotechnology WG1- Terms and definitions WG2- Biobanking and bioresources WG3- Analytical methods WG4- Bioprocessing WG5 Data processing GBW 20/10/2017 meeting 41

42 23 Participating countries 10 Observing countries Austria Korea Arnetina Belgium Luxembourg Australia Brazil Netherlands Ecuador Canada Nigeria Estonia China Spain Hungary Czech Republic Sri Lanka Israel Denmark Sweden Lithuania Finland Tanzania Norway Germny UK Poland Iran USA Switzerland Ireland Italy Japan 20/10/2017 GBW meeting 42

43 SCOPE The ISO/TC 276/WG2 will elaborate a package of International Standards in the Biobanking field including human, animal, plant and microorganism resources for Research & Development, but excluding clinical diagnosis and therapeutics as well as food products 20/10/2017 GBW meeting 43

44 What are the requirements for a biobank to assure an appropriate quality of samples and Data? 20/10/2017 GBW meeting 44

45 3 pillars Competence of personnel Validation of methods Quality control Quality management Afnor, juillet 2017 Approved for public release. Distribution unlimited

46 Content 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 4.1 General 4.2 Impartiality 4.3 Confidentiality 5 Structural requirements 6 Resource requirements 6.1 General 6.2 Personnel General Personnel competence Personnel training Personnel competence assessment 6.3 Infrastructure 6.4 Environmental conditions 6.5 Control of externally provided processes, products and services General Type and extent of control 6.6 Financial sustainability 6.7 Equipment 6.8 Principles of access 20/10/2017 GBW meeting 46

47 7 Process requirements 7.1 Specimen and sample collection Information about the specimen origin Information about the specimen and sample Collection procedure 7.2 Transport Transport from and to the biobank (shipment) Internal transport 7.3 Reception and distribution of biological resources Reception of biological resources (accession/ logging procedure) Distribution of biological resources 7.4 Traceability of biological resources 7.5 Sample processing 7.6 Preservation of biological material General Freezing and thawing considerations 7.7 Characterization of biological material 7.8 Quality control of biological material and data General Process-related quality control Data specific quality control 7.9 Storage of biological material 7.10 Validation of methods General Pilot validation studies Validation of specimen and sample collection Validation of transport, reception and distribution of biological resources Validation of sample processing Validation of preservation of biological material Validation of quality control testing of biological material and data Validation of storage of biological material 7.11 Information technology and data management 7.12 Non-conforming materials and information General Legacy collections Non-conforming material and data 7.13 Complaints 7.14 Safeguard of biological material collections 8 Management requirements 20/10/2017 GBW meeting 47

48 Major chapters Personnel competence, training & assessment Access, collection, processing, storage, transport Validation of methods Characterisation of biological resources Quality control of biological resources, Process related quality control Data related quality control 20/10/2017 GBW meeting 48

49 ISO/AWI : General requirements for biobanking (V. 19) experts from 23 participating countries More than 12 face to face meetings 5 rounds for collecting comments More than 1100 comments discussed Liaison avec ISO TC 212 Draft International Standard (sept 2017) Guide to implement ISO Work in progress ( 7 chapters ) Afnor, juillet 2017 Approved for public release. Distribution unlimited

50 Comparative analysis ISO Vs NFS ISO Vs ISBER Best practices /10/2017 GBW meeting 50

51 85% Overlap of the requirements of 8 international guidelines items 20/10/2017 GBW meeting 51

52 Determination of the scope of the QMS Confidentiality Impartiality General requirements Documentation Documents control Management responsibility and authority Stakeholder needs and expectations Quality Policy Risks and opportunities assessment Planning of the QMS Planning of changes Communication Management review Monitoring and measurements Customer satisfaction Internal audits Data from the QMS analysis Improvement Corrective action Preventive action Management ISO vs NFS NFS and ISO Management requirements 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% NFS Specificities Shared requirements ISO Specificities 20/10/2017 GBW meeting

53 Support Staff Facilities Environmental conditions Equipment and consumables IT Procurement Process requirements Quality Controls Traceability Transportation Reception Collection Preparation Conservation Provision Non-conforming outputs Data management Validation of method support & technical requirements NFS and ISO Technical requirements 100% 90% 80% % 60% % 40% 30% % 10% 0% NFS Specificities Shared requirements ISO Specificities 20/10/2017 GBW meeting 53

54 Determination of the scope of the QMS Confidentiality Impartiality General requirements Documentation Documents control Management responsibility and authority Stakeholder needs and expectations Quality Policy Risks and opportunities assessment Planning of the QMS Planning of changes Communication Management review Monitoring and measurements Customer satisfaction Internal audits Data from the QMS analysis Improvement Corrective action Preventive action ISBER vs ISO Management requirements 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% ISBER Specific Shared requirements ISO Specific 20/10/2017 GBW meeting 54

55 ISBER vs ISO Technical requirements 100% 90% 80% % 60% % 40% 30% % 10% 0% ISBER Specific Shared requirements ISO Specific 20/10/2017 GBW meeting 55

56 ISBER best practices, in many aspects, provides guidance on how to implement ISO Examples 20/10/2017 GBW meeting 56

57 ISO Environmental conditions The biobank shall measure, monitor, control and record environmental conditions, as required or where they influence the quality of the biological resources, and/or the health and safety of personnel. 20/10/2017 GBW meeting 57

58 ISBER Best practices B2.000 HEATING, VENTILATION AND AIR CONDITIONING (2 pages) B2.100 Temperature and Humidity B2.200 Air Flow and Circulation B3.000 LIGHTING. B3.100 General Lighting B3.200 Task Lighting B3.300 Emergency Lighting B4.000 FLOORING 20/10/2017 GBW meeting 58

59 Collection ISO Biological material collection (ISO 20387) Collection information The biobank shall define and document information related to the collection of the biological material. This shall include taxonomic information, time and date (documented in a standard format according to ISO 8601), place and procedure of collection, and any other information relevant to accomplish the objectives of the biobank Pre-analytical steps The biobank shall document pre-analytical steps that can affect the properties of the biological material and provide elements to assess its fitness for purpose. For further details, refer to Annex A Collection procedure The collection of biological material shall be carefully planned by relevant and qualified personnel and users, if applicable. The collection procedure shall be selected according to the requirements of the biological material and the required quality and quantity for the subsequent purpose, when predefined. The collection of biological material shall be performed by qualified personnel. For human biological material requiring clinical assessment or clinical diagnosis, preparation/dissection of the biological material, evaluation of the pathology and sample collection shall be done under supervision of or by a medically qualified (e.g., board certified) person. 20/10/2017 GBW meeting 59

60 Collection ISBER best practices (12 pages) SECTION K: SPECIMEN COLLECTION, PROCESSING AND RETRIEVAL K1.000 GENERAL K2.000 PILOT STUDIES AND PROOF OF PERFORMANCE STUDIES K3.000 TIMING OF SPECIMEN COLLECTION K4.000 TEMPERATURE K6.000 COLLECTION AND STORAGE CONTAINERS K6.100 Sterility K7.000 COLLECTION PROCEDURES 20/10/2017 GBW meeting 60

61 K7.000 COLLECTION PROCEDURES K7.100 Solid Tissues K7.200 Blood Samples K7.300 Urine Samples K7.400 Nail and Hair Clippings K7.500 Saliva and Buccal Cell Samples K7.600 Breast Milk Samples K7.700 Stool Samples K7.800 Cervical Vaginal Lavage Samples 20/10/2017 GBW meeting 61

62 ISBER best practices, in many aspects, provides guidance on how to implement ISO /10/2017 GBW meeting 62

63 Challenges 20/10/2017 GBW meeting 63

64 Challenges How do we encourage and convince Biobanks to implement international standards? How do we fund the implementation of international standards? How do we train actors to implement Standards and audit Biobanks

65 Towards an international training in Biobanking 20/10/2017 GBW meeting 65

66 We are Glad to share and collaborate ISBER BBMRI-ERIC ESBB 20/10/2017 GBW meeting 66

67 Increase quality Decrease Cost Take home message 20/10/2017 GBW meeting 67

68 20/10/2017 GBW meeting 68