Biobanks ensuring the governance and management of biological resources have become essential entities. The development of biotechnologies, the increased prevalence of biological drugs and the identification of biomarkers associated with molecular classifications of tissue lesions make it essential to have organized access to human biological samples, which have become precious and rare. The digital era and the production of massive data that comes with it have rendered biobanks the guarantors of the reproducibility of experiments and of the overall quality of medical research.
Biobanks in Healthcare explores the upheaval linked to the massive deployment of digital health and precision medicine. The future of health biology lies in the deployment of biobanks in fields that have yet to be explored, putting them at the forefront of this extraordinary 21st-century research adventure.
Table of Contents
Foreword ix
Acknowledgments xiii
Introduction xvii
Chapter 1 Biobanks, a Source of Human Samples and Health Data 1
1.1 From the collection of biological samples to the concept of a biobank 3
1.1.1 The biobank concept 6
1.1.2 The first biobank described in the Framingham study 7
1.1.3 Classification of human sample biobanks 8
1.2 Mapping of biobanks 13
1.2.1 The large catalog of European biobanks 15
1.2.2 International biobanks 17
1.2.3 The first results from the megacohorts 26
1.3 Process management in biobanks 34
1.3.1 Sample quality, the priority of biobanks 35
1.3.2 Protection of the human person and personal information 41
Chapter 2 Biobanks in the Digital Age and Precision Medicine 51
2.1 Medical imaging biobanks 52
2.1.1 The UK Biobank prospective medical imaging study 53
2.1.2 The Rotterdam prospective imaging study 56
2.1.3 The German National Cohort 59
2.1.4 The European medical imaging biobank project 63
2.2 Radiomics data powered by digital technology 65
2.2.1 A multitude of application areas for biomarkers 67
2.2.2 Biomarkers in quantitative imaging 69
2.2.3. Artificial intelligence for automatic reading of medical images .. 74
2.3 The infallible traceability of biobank data 83
2.3.1 Automated sample flow, essential for population biobanks 83
2.3.2 Computerized management of clinicobiological annotations 85
2.3.3 International Biobanks of Excellence or Expert Centers 90
2.3.4 The FAIR principles of health data management 98
Chapter 3 The Biobanking Lexicon 101
3.1 Accreditation 101
3.2 Anonymization (or de-identification) 104
3.3 ANSM, the French National Agency for the Safety of Medicines and Health Products 104
3.4 Artificial intelligence 104
3.5 BBMRI, the coordinating center for European biobanks 104
3.6 BBMRI-ERIC, the research infrastructure for biobanking 105
3.7 BBMRI-ERIC Biobank of Excellence or Expert Center 105
3.8 Biobank information management system (BIMS) 105
3.9 Biobank or biological resource center (BRC) 106
3.10 Biomarker 106
3.11 Biospecimen 106
3.12 Buffy coat 108
3.13 Certification 108
3.14 Clinical biobank 109
3.15 Clinical research or clinical trials 109
3.16 Clinical trial sponsor 109
3.17 CNIL, the French National Commission for Information Technology and Civil Liberties 110
3.18 Cohort and megacohort 110
3.19 Collection of biological samples 110
3.20 Companion test 111
3.21 Computed tomography (CT) 111
3.22 CPP, the French Committee for the Protection of Individuals 111
3.23 Data protection officer (DPO) 111
3.24 Diagnostic biomarker 112
3.25 Digital health or e-health 112
3.26 Electronic case report form (eCRF) 112
3.27 ESBB, the European, Middle Eastern and African Society for Biopreservation and Biobanking 113
3.28 FDA, the US Food and Drug Administration 113
3.29 Formalin-fixed, paraffin-embedded (FFPE) tissue 113
3.30 Free and informed consent 114
3.31 General Data Protection Regulation (GDPR) 114
3.32 Imaging biobank 115
3.33 Imaging biomarker 115
3.34 ISBER, the International Society for Biological and Environmental Repositories 115
3.35 ISO 20387:2018 Biotechnology - biobanking - general requirements for biobanking 115
3.36 Laboratory information management system (LIMS) 116
3.37 Liquid biopsy (in oncology) 116
3.38 Machine learning and deep learning 118
3.39 Medical imaging 118
3.40 Microbiota 118
3.41 Monitoring biomarker 122
3.42 MTA or biological material transfer contract 122
3.43 Nf S96-900 124
3.44 Omics 124
3.45 Peripheral blood mononuclear cells (PBMCs) 124
3.46 Personalized or individualized medicine 125
3.47 Pharmacodynamic/response biomarker 125
3.48 Population biobanking 125
3.49 Positron emission tomography (PET) 125
3.50 Pre-analytical phase 126
3.51 Precision medicine 126
3.52 Predictive biomarker 127
3.53 Prognostic biomarker 127
3.54 Prospective study/survey 127
3.55 Quality management system (QMS) 127
3.56 QR code 128
3.57 Radiomics 128
3.58 Region of interest or volume of interest (ROI/VOI) 128
3.59 Retrospective study/survey 128
3.60 Standard operating procedures (SOPs) 128
3.61 Stratified medicine 129
3.62 The process of fixation and paraffin embedding 129
3.63 Translational research 130
3.64 Tumor biobank 131
Conclusion 133
Glossary 137
References 145
Index 159
