UCL recognises the challenge of developing personalised medicine, which requires access to large clinical cohorts. We have over 80 biospecimen collections ranging in size from a few tens to over 200,000 samples. These cover all disease themes where UCL has excellence in research – neurological disorders, cancer, cardiovascular, rare genetic diseases of childhood as well as large prospective cohorts. The grand challenge is to maximise the value of these unique resources and support development of new projects.

Infrastructure being put in place covers a lot of the complex requirements of biobanking using different models, but still some gaps that need to be addressed, discuss as go through diagram. Need to know what the requirements will be strategically going forward: next slide

The grand challenge is to maximise the value of these unique resources and support development of new projects. We are doing this in 2 ways – putting in place a physical storage facilities at the Royal Free and Bloomsbury. These biobanks are Human Tissue Authority Licenced Facilities with flexible banking options. They provide a secure environment for samples and systems in place and staff on call to deal with any emergencies. The Banks will be ethically approved as Research Tissue Banks allowing less onerous ways of accessing samples for research. The Royal Free Biobank will have capacity to hold up to 1 million samples, it will initially hold samples from the North London Cancer Network, the Neuroendocrine tumour collection and other haemato-oncological studies, but will also hold other studies. The Bloomsbury bank will support the Cancer Institute and Pathology. We are also developing a software system to house the sample and phenotype data for UCL’s studies, with a powerful search facility to view information across all collections. This then links to the study ‘owner’ with details for accessing samples from the collections. Access to data and samples always under control of study leaders – this is a supporting activity not a take-over! Allows increased visibility of samples available at UCL promoting development of research collaborations.

Mention more detail some users:

Biobanking @ UCL – researcher-focused central resources Kirstin Goldring Biobank Facilitator

Introduction Background to development of biobanking @UCL Physical Biobank Infrastructure UCL RFH Biobank UCL Biobank for Studying Health and Disease Virtual Biobank

The Grand Challenge: Maximising value of UCL’s biospecimen repositories At least 80 specimen collections Tissue, blood, plasma, DNA Cancer, cardiovascular, child health, neurological, etc 20 to 200,000 samples More funding sought for new collections No consistency Data formats and types No record of location of collections No way of searching across collections Risk of data being lost or stored insecurely

Complex Biobank Requirements: Source Fresh Frozen Fixed Fixed embedded Fixed Frozen Processing Required Extraction Separation Culturing Aliquoting Samples Type Collection site Data Collector Transport to biobank Storage

Different Requirements: Need to understand: what want to measure from what samples time critical – to bank, in processing, to store temp critical – to bank, in processing, to store training of staff – collecting samples etc, clear SOP SOPs and QC – QA of all steps – needs to be practical associated data (IT) access policies To ensure samples are fit for purpose For Example: Interested in finding out best way to acquire and process samples to measure certain analytes, bloods to be sent in from different centres

Vision: Infrastructure for Biobanking at UCL UCL Physical Biobanks - Royal Free, Bloomsbury Bloomsbury Cancer Institute and Pathology Frozen and ambient: -70 freezers, fixed tissue and cells Royal Free Frozen samples: -135 Liquid N vapour phase, -70 freezers UCL Virtual Biobank – data repository for many biospecimen collections Secure data storage Search facility within and/or across collections Data and samples ‘owned’ by researchers Owner sets access controls on what data can be viewed Access to data and samples only after Ethics approval

UCL RFH Biobank HTA-approved for tissue and cells Flexible sample collection, processing and access options Secure and emergency back up facilities Research Tissue Bank Ethical Approval – facilitates access to samples for research (pending) Initially serving NeuroEndocrine Tumor bank and North Central London and West Essex Cancer Network, but has extra capability, up to 1 Million samples to add extra studies in vapour phase liquid N. Current studies include those from immunology, hepatology, neurology, nephrology, oncology and also Clinical Trial samples. UCL Physical Biobanks - UCL-RFH biobank

UCL-RFH Biobank Flexible biobanking options for researchers across UCLP to bank samples to be stored at -80 or LN vapour phase -135oC Vapour Phase Storage -70oC Mechanical Freezer All samples labelled with 2-D barcode

Requirements Service and costs based on requirements of the user (sub-bank) including: - kit preparation - sample collection/receipt (theatre/clinic) - sample processing (fluid sep, cryo-preservation, RNA/DNA extract, etc) - quality control of samples - sample logging - sample storage - sample dispatch Service level agreements reflect requirements and define responsibilities of depositor and biobank with respect to regulatory and governance requirements UCL-RFH Biobank

Advantages of using UCL-RFH Biobank Samples and data owned by depositor HTA Licence Samples remain in biobank after ethics approval expires Regulatory requirements for storage and tracking of samples undertaken by biobank Research Tissue Bank Ethics approval Can apply to biobank for approval for future studies using samples Flexible Options End to End Tracking and Traceability of specimens Secure and emergency back up facilities Software for sample and data management and access Reduce the cost to RFH & UCL – individual licences and storage cost Standardisation of Collection and Storage procedures and data entry: Ensuring the quality of research material collected through SOP Improve access to research material between research groups within UCL and externally, encourage collaborations between groups UCL-RFH Biobank

Timeline Developing costing structures and service level agreements for users New purpose built facility at Royal Free Hospital now taking in samples, launched February 2011 Working with GLS – Canadian software company to develop the software for the physical Biobank, used knowledge from in- house sample and data tracking system – NEW SYSTEM NOW LIVE UCL-RFH Biobank

Specimen Booking in (entering generic data & sub-bank specific data) Generation of paper worksheet Generation of ISBT labels (10 for processing and >30 for aliquot storage) PROCESSING (results are recorded on the paper worksheet) Input processing results into database Assign Aliquot Storage Location Re-print paper worksheet (now containing all booking in data, processing results and storage locations Store Aliquots in physical vault The aliquot ISBT and storage box barcodes are scanned at the time of storage to ensure correct physical placement File worksheet 2-D barcode label Receiving Specimens in to Biobank Flow chart: Kwok Pang – Royal Free Biobank

Search database ( Enter list of request aliquots) Releasing Specimens from the Biobank Database Find paper worksheets Locate physical location of the aliquots from the worksheet Aliquot Request ( ~5 to ~100 aliquots maybe request in one event) Retrieve Aliquots from physical vault The aliquot ISBT barcodes are scanned at the time of removal from the temperature dependent physical vault. System will compare against requested list. Update Database Record removal of aliquots on paper worksheet Produce a paper “packing form” (showing the aliquots remove from system) File paper worksheet Aliquots pick up by third party or courier (signing release form) Produce a paper release form (Receiving centre will sign on receipt of aliquots Aliquots arrive with requester (aliquots checked against packing list .Release form signed and faxed to Biobank Flow chart: Kwok Pang – Royal Free Biobank

Solid tissue From imaging & surgery Other premises: Satellites or non satellites (MTA) PI who funds banking: mainly to POGB/CI ALL BAR-CODED RF: Rockefeller, Department of Histopathology POGB/CI: Paul O’Gorman Building Cancer Institute Other premises including satellites (same HTA licence) and non satellites (under other HTA licence) MTA: Material transfer agreement LN: Liquid Nitrogen End of clinical trials Blood / body fluids UCLH and other hospitals Collaborators and other institutions UK and worldwide (MTA) Storage facilities in RF & POGB/CI: LN, freezers & xenografts Private clinics Histopathology Rockefeller/tissue surplus to dx requirements BAR CODED Schematic of Biobank For Studying Health and Disease

Virtual Biobanking at UCLP  UCLP Virtual Biobank will be a data repository for many biospecimen collections with: – Secure data storage – Search facility within and/or across collections Holders of samples and data in locations across UCLP will be invited to add information on their holdings to the BioBank Research database hosted by UCL. We are  developing a software system to house the sample and phenotype data for UCL’s studies, with a powerful search facility to view information across all collections. This then links to the study ‘owner’ with details for accessing samples from the collections. This Research Database, which is currently being developed.

Virtual Biobanking at UCLP Current status Holders of samples and data in locations across UCL should inform the biobank facilitator of their holdings. This information is currently being posted on the UCL Biobank website (www.ucl.ac.uk/biobank/)

Thank You Kirstin Goldring k.goldring@ucl.ac.uk http://www.ucl.ac.uk/biobank