1. Introduction to Biobanking @ UCL Dr Kirstin Goldring (Biobank and BioResource Coordinator)

2. Introduction Background to development of biobanking at UCL Physical Biobank Infrastructure –UCL Royal Free Hospital Biobank –UCL/UCLH Biobank for Studying Health and Disease Other Biobanks and Large Cohorts

3. 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

4. Concerns Ensure that samples stored legally once ethics approvals lapse Safety of storage of samples and data o Not backed up o Staff leaving and not knowing where samples are Missed opportunities with existing collections/available resources – open up to collaboration academic and industry Long term support for sample storage

5. Vision: Infrastructure for Biobanking at UCL UCL Physical Biobanks - Royal Free, Bloomsbury –UCL-RFH Biobank Frozen samples: -135 Liquid N vapour phase, -70 freezers –UCL/UCLH Biobank for Studying Health and Disease: Cancer Institute and Pathology Frozen and ambient (FFPE diagnostic archive): : -70 freezers (up to 10), fixed tissue and cells Facilitate the banking, storage and access to samples 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 by internal ethics committee

6. Models for Physical Biobanks 2 different models UCL – RFH facility Flexible service Large storage facility Cost recovery – individual costing for each sub-bank Research Tissue Bank (RTB) but only for future use of existing samples UCL/UCLH Biobank for Studying Health and Disease Primarily support the Cancer Institute and Pathology Access to diagnostic archive samples Approved Consent and PIS can be used – new collections, access to samples and to access patient records and imaging Resources and costs covered by PI with access to some central infrastructure, monitoring and alarms RTB for new collections and future use existing samples

7. UCL-RFH Biobank Service provider to UCL, RFH and external User groups. Multiple levels of service, from full management to training of staff belonging to user groups to use the biobank’s facilities. Cost recovery model for services provided Biorepository with a planned on-site capacity of 1 million aliquots. First sample banked in Dec 2009 30,000 aliquots banked so far (2013 03 08) 26 User groups (UCL, RFH, Other Academic, Commercial) Derivatives stored include Serum, Plasma, Cells, Tissue, Urine

9. UCL-RFH Biobank Flexible biobanking options for researchers across UCLP to bank samples to be stored at -80 or LN vapour phase -135 o C Vapour Phase LN Storage -70 o C Mechanical Freezer 2ml Cryovial Storage (100/box) 1ml Cryovial Storage (96/box) All samples labelled with 2-D barcode Standardised tubing and racking systems

10. 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

11. 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 Reduce the cost to RFH & UCL – individual licences and storage cost, each HTA licence cost ~£8,000 to maintain UCL-RFH Biobank

12. Advantages of using UCL-RFH Biobank  Central location, 20mins to central London UCL-RFH Biobank

13. Advantages of using UCL-RFH Biobank  Secure and emergency back up facilities UCL-RFH Biobank

14. Advantages of using UCL-RFH Biobank  Secure software for sample and data management and access, managed by WIBR central UCL IT. UCL-RFH Biobank

15. UCL-RFH Biobank – Information Systems BioChronicle PostgreSQL Database with Web browser – Sample Registration GUI PHI SSL encryption AES 256, in- transit & storage BioQuest Web browser – Sample Request / On- line ordering BioVault Freezer Management Syncing of aliquot availabilities Server 1Server 2Server 3

16. Subbanks

17. Annotations-- screenshot

18. PHI X Customised interface for Sample Registration

19. Biobank Services Fluid Separation Surgical Tissue Collection Viable Cell Cryopreservation DNA & RNA Extraction Flow Cytometry- 8 Colour Analysis/Cell Sorting Functional Assays – NK function

20. Biobank Services Fluid Separation Surgical Tissue Collection Viable Cell Cryopreservation DNA & RNA Extraction Flow Cytometry- 8 Colour Analysis/Cell Sorting Functional Assays – NK function

21. UCL/UCLH Biobank for Studying Health and Disease (based at Pathology-Rockefeller building and UCL Cancer Institute) Secure and emergency back up facilities Research Tissue Bank Ethical Approval – facilitates access to samples for research Applications to the Biobank Ethical Review Committee Access to samples in the diagnostic archive Approved Consent forms and Patient Information Sheets for recruiting patients Primarily supporting the research programme of the Pathology Department UCLH and the UCL Cancer Institute Users must prove compliance with the HTA and ethical requirements, regular audits carried out on training, SOPS, equipment etc UCL Physical Biobanks - Bloomsbury

22. Solid tissue From imaging & surgery Other premises: Satellites or non satellites (MTA) PI who funds banking: mainly to POGB/CI ALL BAR-CODED for pseudo- anonymisation (FreezerWoprks 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 for pseudo- anonymisation (FreezerWoprks Schematic of UCL/UCLH Biobank For Studying Health and Disease

23. Benefits to UCLH and UCL facilitate research broad in scope on which type of tissue can be collected/used (Normal/Tumour tissue, fresh/frozen or FFPE, body fluids including blood) improve research governance (internal ethics committee at UCL CI) Standardised consent, information sheets and Standard Operating Procedures Provide assistance with regulatory compliance Secure and emergency back up facilities Research Tissue Bank Ethical Approval:  No IRAS application needed  Pre-inspection of lab to ensure HTA compliance and meets biobank governance requirements  3 week approval process  Facilitates access to samples for research  Ability to add additional Tissue Collection Centres without additional ethics or R&D approval Enhance availability of UCL holdings to researchers within UCL and UCLH, Nationally and Internationally Ethics Application – Research Tissue Bank

24. Experiences and Challenges Challenges convincing researchers to hand over ‘control’ access willingness to share safety finding the right people – multi skills what model, complex landscape standardisation and harmonization Ethics and regulations Funding Experience overall positive need for multi talents/experience suiting changing landscapes similar ideas elsewhere, willingness to share experiences

25. Other Collections Biobanks: ICH – various (RTB), baby biobank, HDBR Eastman – Dental samples - (RTB) IoO – eye bank - (RTB) IoN – various (RTB) Infectious Diseases DNA bank – (RTB, stored at UCL-RFH biobank) Large collections including: Whitehall II UK CTOCS/FOCS etc Birth Cohorts UK CHIC Morbidly Obese

26. Information about Biobanks/Sample collections More information on the biobank website: http://www.ucl.ac.uk/biobank Aim to produce a more comprehensive list of the resources (biobanks, cohorts, sample collections etc) available across UCL on website, including contacts, sample types, accessibility criteria etc Please let me know details of any resources you want included Please let me know if you want access to particular samples: This afternoon you will here more about TAPb – accessing samples from across UCL and Partner Hospitals

27. Human Tissue Authority - Licensing Professor Adrienne Flanagan – UCL HTA Corporate Licence Holder Biobank website: list of UCL Licences and of Designated Individuals Arranged a meeting of UCL DIs and PDs for 13 th May 3pm Will be updating HTA details on the UCL SLMS website.

28. Thank You Kirstin Goldring k.goldring@ucl.ac.uk http://www.ucl.ac.uk/biobank UCL-RFH biobank Director/DI: Mark Lowdell Janet North Kwok Pang Sam Jide-Banwo uclrfhbiobank@ucl.ac.uk Acknowledgements UCL Biobank for studying health and Disease Director: Adrienne Flanagan DI: Manuel Rodriguez-Justo Person Designated: Nadege Presneau n.presneau@ucl.ac.uk TAPB Brian Davidson Barry Fuller Amir Gander a.gander@ucl.ac.uk UCL Platform Technologies Director: Jacky Pallas j.pallas@ucl.ac.uk