Enabling Biobank Data Exchange The Challenges of Data

Enabling Biobank Data Exchange The Challenges of Data Integration and Advantages of Virtualizing a Centralized Technology Solutions Platform Dr Balwir Matharoo-Ball – Deputy Director Nottingham Health Science Biobank Colin Thurston - Director of Informatics

Agenda • Problem Statement: Supply and demand of biological samples • Nottingham Health Science Biobank (NHSB) Case Study • Technology Solutions to enable a sample market place • Brooks ISIDOR Platform for Biobanks • Conclusions / Q&A

Nottingham Health Science Biobank (NHSB) Start Ethical approval • Established in 2011 • Hub and Spoke model of biobanking that includes and synergises existing facilities in NUH and other key research environments • Trust wide ethical approval for generic and enduring donor consent • Allows the collection of any biomaterial taken in the course of routine care which is excess to routine care Collection • The NHSB collects a wide range of biomaterials including: fresh tissue, snap-frozen tissues, Formalin-fixed, paraffin-embedded tissues (FFPEs), blood (serum and plasma) • Has access to over 1 million archived FFPE samples from all disease types including rare diseases Storage • The NHSB uses state of the art systems for biomaterial storage and tracking, temperature monitoring and sample processing, and has worked closely with Achiever Medical to develop a sophisticated centralised computer-based system of biosample linked-data procurement and management • Rapid approval for distributing material to approved research projects Distribu- • Material distributed to internal research groups, national charities such as the Breast Cancer Campaign, and commercial organisations tion

Statement of the Problem • The trend in personalised medicine is increasing demand for samples, especially the right kind of sample. • Biobanks should be thriving in their pivotal role to provide researchers access to samples from a large population of subjects • Question: Why do so many biobanks struggle with sustainability?

The Changing Market A number of factors are increasing the demand for human tissue… Drug Discovery and Development Stratified Medicine BIOBANKS Biomarker Discovery Human tissue rather than animal testing Noncommercial academic research

The Changing Market Developments in personalised medicine and translational research require high quality and clinically annotated human tissue… Advances in molecular technology linked to clinical phenotype enable personalised medicine Stratified Medicine Translational Biomarker Discovery High Throughput technologies for biomarker discovery require rigorously designed and well structured collections of biospecimens Research to translate basic research more quickly and efficiently into medical practice

Biobanks are key resource • Biobanking infrastructure has a critical impact on the discovery, impact and implementation of new drugs, diagnostic tests, and personalized therapy • Can be directed at specific medical conditions OR as general collections • Biospecimens must be linked to high quality clinical data informative of phenotype • It is essential to harmonise biobanking procedures and to develop innovative solutions supporting biobanking interoperability and specimen sharing • Major goal is to contribute toward efficiencies in research.

The Changing Market The market is relatively undeveloped… ü Prices vary considerably – for example there is a fivefold difference in the price of breast cancer samples ü Many biobanks appear to collect tissue for the sake of collecting and distribution is not a key part of their strategies ü Many biobanks do not want to deal with commercial companies ü Commercial organisations recognise the quality of NHS sources of bio- medical material ü Well annotated data sets, including follow-up data, is in demand Based on research from PA Consulting

Nottingham University Hospital Case Study • Nottingham University Hospital NHS Trust (NUH) is one of the largest acute teaching NHS Trusts in the UK. • NUH set up the Nottingham Health Science Biobank (NHSB) as a large scale biobank holding high quality tissues to support pioneering research. • Key goals for the program were: • • An IT solution linking clinical data to phenotypes Implementation of biobanking best practices Ensuring HTA compliance Increased research efficiency

NHSB Competitive Position NHSB has developed a number of unique selling points… Embedded in the NHS Access to histopathology services and equipment Major operational advantage Service Orientated Operations team have research, pathology and clinical expertise Quality of samples and data Public Patient Involvement (PPI) Embeds the patient perspective and experience at the core of biobanking Access to plentiful & rare biomaterials NUH is a Regional referral centre Rapid approval via NHSB Access Committee Innovative Informatics Innovation in informatics captures resources of the NHS e-Health record as a Biobanking resource Biobank management system with external research access

Current progress NHSB has now centralised the collection of biomedical material… Existing collections have been transferred to the NHSB, which include 14, 901 samples from legacy collections during 2004 to 20012 NUH is one of the top 10 largest trusts in England provides services to over 2. 5 million residents of Nottingham and its surrounding communities An extensive breast tissue collection of over 5, 500 fresh frozen samples The brain bank containing material from 7308 patients collected over 20 years including dementia and motor neurone cases. The NHSB has access to the Histopathology archives of surplus diagnostic blocks of over 85, 000 cases per year. It also provides specialist services to a further 3 -4 million people from neighbouring counties each year.

Current progress NHSB is rapidly accumulating a diverse and high-value sample set… Since 2011 Total patient consents = 23600 Total sample aliquots = 133800

Current progress NHSB has already released over 120, 000 samples, making it a leading UK biobank… NHSB has distributed over 60, 000 samples in the last four years Customers include internal and external research groups , Breast Cancer Now and leading pharmaceutical companies NHSB is already one of the largest biobanks in the United Kingdom.

Innovative Informatics -Our Solution to Partnership Data Management – Moving Beyond the Firewall

Brooks Life Sciences Systems The global leader of comprehensive sample lifecycle management solutions which unlock the sample intelligence that advances scientific discovery and development. Storage Consumables and Instruments Sample Management Solutions Sample Prep, Genomics & Lab Analytics Automated Storage Systems Cryopreservation Storage Solutions Cold Chain Logistics & Relocation Informatics Solutions

Technology Solutions for Sustainability • The trend in personalized medicine is increasing demand for samples, especially the right kind of sample. • Biobanks should be thriving in their pivotal role to provide researchers access to samples from a large population of subjects • Question: Why do so many biobanks struggle with sustainability? • Hypothesis: Biobanks need technology platforms to facilitate access to samples and cost recovery

Connecting Samples to Data unlocks their Potential Value Trea tmen t ics et Gen $10 -20 • • • Cost of tube = ~$1 Cost of collection = $8 Cost of storage = $3 Material Cost of a sample • • ++Value s nosi Diag Stored and processed correctly? Patient consented for research? Specific tissue and disease? Profiled phenotype and genotype? Research Value of a sample © 2017 Brooks Automation, Inc. • Proprietary Information

Example Biobanking Technology Platform Find and request research materials Protect and manage anonymised samples Collect clinical subject samples © 2017 Brooks Automation, Inc. • Proprietary Information Consents to provide samples for research

Biobanking Technology Platform Requirements • A biobanking platform must: • Simplify data access for researchers • Unify data terminology across different sources • Allow access to multiple collections within a single framework • Enable data mining using donor, study, phenotypical attributes • Facilitate research applications and cost recovery • Work in close to real time Connect Inventory and Data and Facilitate Access to Samples “Virtual Biobank e. Catalogue” © 2017 Brooks Automation, Inc. • Proprietary Information ‘

Brooks ISIDOR Platform for Biobanks • NHSB has successfully implemented an informatics solution using the core technology from Brooks ISIDOR, specifically Bio. Studies which provides: • • • Support for project, study management and inventory management Sample collection, through manifesting, receipt, storage and disposal workflow Integration of a variety of data types – clinical, phenotypical and laboratory data Management of patient consent records Research sample request portal with end-to-end fulfilment Comprehensive support for automation of storage, bioprocessing and bio-analysis • Integration of Bio. Insight technology enables further value and delivers a full featured “virtual biobanking” platform © 2017 Brooks Automation, Inc. • Proprietary Information

Brooks Bio. Studies – Technology Overview • Software to support tissue tracking in clinical and academic environments • Clinical projects and studies • Donor information including demographic and clinical information • Sophisticated consent management features • Tissue collection and storage • Robust security and compliance features • Virtual Biobank / e. Catalog & Storefront • Aggregation of sample data numerous sources • Central warehouse • Storefront for search , request, sharing • Web based with on-premise and hosted deployment options • Solution deployed in multiple hospitals and universities • Fast Track Implementations • Data migration • Comprehensive Training • Validation Support © 2017 Brooks Automation, Inc. • Proprietary Information

Comprehensive Sample Lifecycle Management Support © 2017 Brooks Automation, Inc. • Proprietary Information

Bio. Studies – Home Page Home page Summary View Sample View Donor View Collaborator Institute view Planned Activities Project View Storage / Inventory View © 2017 Brooks Automation, Inc. • Proprietary Information

Brooks Bio. Insight – Technology Overview • Dashboarding, searching and data visualisation to extract true value from research data. • Visualize your data and make it interactive and actionable Powered by © 2017 Brooks Automation, Inc. • Proprietary Information

Bio. Insight: Visualizing Tissue Availability for Research © 2017 Brooks Automation, Inc. • Proprietary Information

Creating an integrated Virtual Biobank e. Catalogue © 2017 Brooks Automation, Inc. • Proprietary Information

Enable researchers to find apply for needed samples • I am looking for tissue from…. • Female subject • Hispanic ethnicity • 25 – 45 years old (at time of sample collection) • Has diabetes • Does not have cardiovascular disease • Informed consent allows sharing of samples © 2017 Brooks Automation, Inc. • Proprietary Information

The Business Case for Technology Investments • Simplifying access to samples ensure biobanks can demonstrate a return on investment: • • Facilitate connection of samples to data Facilitate access to samples by researchers Facilitates applications and fulfilment Facilitates cost recover and monetization = more samples provided to researchers = increased number of cited publications = monetization of biological assets = sustainability © 2017 Brooks Automation, Inc. • Proprietary Information

Conclusions

Strategic Approach NHSB is aiming to meet Trust Research priorities… Trust Research Priorities: Ensure an excellent environment for commercial and non-commercial research Ensure strategic alignment of sample collections with areas of strength to maximise value To meet these priorities NHSB will: Created a biobank business unit dedicated to commercial partnership Build close relationships with partner Universities and other key stakeholders Link biosamples to anonymised and accurate patient data (via e-Health record) Extend the Nottingham informatics platforms between research partners Develop dynamic ICT systems to add value and facilitate networking Generate income from commercial operations for reinvestment

SUSTAINABILITY Rapid request response time Quality in sample processing Cost efficient processes

Financial Planning For 2014/15 NHSB already has enough firm contracts to cover direct costs and overheads, with potential for further income during the year… £ 1, 200, 000 £ 1, 000 Potential contracts Annual Income/Costs £ 800, 000 Overheads NHSB and BCC Non Pay £ 600, 000 £ 400, 000 Commercial contracts NHSB Pay £ 200, 000 BCC Income BCC Pay 2014/5 Income 2014/5 Costs £ 0

Conclusions • Data standards are an important step in supporting the interconnectivity of sample data; however, they must be distinct and evolve over time. • Technology solutions are required that go beyond simple sample management: • Connect diverse sample collections and data sets • Enable samples to be connected to clinical, phenotypic and laboratory data • Provide research access portals, data visualisation and application fulfilment • Virtual biobanking catalogues allow researchers to more easily locate biobank samples which drive biobanking sustainability