Dr Kirstin Goldring
Title of Presentation
“Biobanking in Industry: Increasing utility of human biological samples (HBS) to improve the lives of patient’s and fulfill their wishes”
Date and Place
Dr Goldring graduated in Physiology and Pharmacology (BSc) and completed her PhD on asthma research at Southampton University. She carried out Post-Doctoral research in to Muscular Dystrophy at King’s College and Imperial College, before managing the UK Parkinson’s Disease Society Tissue Bank at Imperial College from 2002, until 2009. Dr Goldring then moved to UCL in 2009 as the Biobank facilitator and from 2012 this role included co-ordination of the UCL BioResource. In January 2015 moved to AstraZeneca to take on the role of Principal Scientist: Human Biological Sample Governance and Strategy.
Access to high quality HBS and data is key to drug discovery and diagnostic development, particularly in the era of personalized medicine. The true value of HBS in discovering medicines that impact patients’ lives can only be realized when they are utilized in scientific research to support target validation, biomarker identification, translational science and agile clinical trials. The responsibility of Industry to develop new treatments is matched by our desire to fulfill patients’ wishes around sample and data utility. Drug discovery and development needs rapid access to a wide range of sample types, formats, sample services and associated data. Various ways exist to access such samples and data, but it is essential that these samples are of high quality, fit for purpose, collected and curated within appropriately governed and managed frameworks, to ensure patient’s wishes are realized. At AstraZeneca we have been working to ensure the scientists need for samples satisfies the patient consent provisions, along with increased utilization and rationalization of our sample collections. This presentation will focus on:
- Development of governance and processes to support access and utility of HBS
- Consolidation of sourcing from HBS suppliers through a single automated hub
- Implementation of an IT infrastructure allowing visibility of our samples and data collections
Human Biological Sample (HBS) are essential in understanding human target validation and biomarker development in drug discovery. Consequently, increasing the speed of access to HBS is a primary focus for the AstraZeneca Biobank. In conjunction with the relocation of AstraZeneca’s UK R&D facility from Alderley Park, Cheshire to Cambridge, we took the decision to partner with Fisher BioServices for the long-term provision of HBS storage and processing, thereby leveraging strong core competencies and focused economies of scale. The transition of samples has been phased throughout 2015 and will be completed by the end 2016. By routing samples to Fisher Bioservices, total annual costs and the space needed for biobanking at the Cambridge facility has been reduced. We overcame several challenges during the sample and service transition, which are the focus of this poster: 1. Development of governance and business processes to support access and utility of HBS. The most significant challenge was maintaining traceability throughout the transition period, mitigated with up to date chain of custody records helped by collaborative communication of shared practice and clear understanding of all parties’ accountabilities 2. Implementation of automation and robust IT infrastructure to maximise value. The major challenge was to deliver the solution that met all businesses requirements, timelines, and budget expectations when the opportunity to deviate from one or all was ever present given the far reaching set of impacted stakeholders. Success was achieved through consistent communication, underpinned by strong change management principles within the wider project team.
AstraZeneca Biobank Application (ABBA): IT infrastructure enabling increased utilization of over 1 million samples through greater sample visibility and standardized data characterization. Steve Kelly, Kirstin Goldring and Clive Green. In 2015 AstraZeneca implemented the AstraZeneca Biobank Application (ABBA), a configured laboratory information management system to track and interrogate human biological samples. The tool gives greater visibility to the range of human biological samples that are stored in the AstraZeneca global biobank network. These biobanks predominantly hold samples from AstraZeneca-sponsored clinical studies, hence the system was implemented alongside a new internal clinical data standard for sample collection which is mandatory across all clinical studies. AstraZeneca now has over 1 million samples logged in ABBA, with characterization data starting to flow from the clinical data repositories. The implementation of ABBA has enabled: 1. Full traceability of samples in AZ biobanks. 2. AstraZeneca scientists to search for and request samples from the biobanks based on key clinical parameters. 3. Analysis of sample inventory and characterisation data to inform decisions on stock rationalisation. 4. Greater oversight of sample utilisation rates and trends, to support prediction of sample procurement needs. Current priorities for the system include the validation of an interactive search tool to simplify finding samples of interest, and ramping up the clinical data flow to maximize the characterization data available for searching.
Governance of human biological sample acquisition: Processes to ensure compliance with AstraZeneca policies and standards. Good governance around sourcing of human biological samples (HBS) is key to ensure that high ethical standards are maintained, alongside compliance with internal policies and standards and local legal and regulatory requirements. Whilst access to high quality HBS and data to support our drug discovery and diagnostic development can largely be met by our own internal sample collections and collaborators, where this is not possible, there is a need to source samples externally. At AstraZeneca over the past 18 months we have moved to a single centralized automated hub to support the compliance of our scientists when sourcing HBS. HBS sourcing in this dedicated compliance environment is supported through the AstraZeneca Innovation Marketplace (AIM) provided by Scientist.com. The HBS approval process includes both a commercial due diligence and an HBS due diligence process, allowing the relevant information to be requested, an approval decision to be made and relevant contracts to be put in place with sources meeting our internal standards, including requirements for consent and ethical approval. The AIM platform gives our scientists visibility to the approved sources and provides the workflow for them to request samples, communicate securely with providers, obtain quotes, seek approval and request samples in an auditable, controlled and compliant environment.