Irish Participation in Standard Creation for Biotechnology
Emma Snapes
INFANT Biobanks • 2007- Present
• Multicentre cohorts & Clinical Trails
• Unique sample codes, no F-T
• Monitored ULT -80 deg C
• Customised databases
• Randomised sample retrieval
• Defragmentation
• Continuous dev & optimisation informed by • experience, • user feedback • improvements in the industry
• SFI Infrastructures Award – BSF offsite • Further protection (split location holding) • Increased capacity (>4M reduced vol tubes)
Evolution of Biobank Infrastructures
Biobanking 3.0 • Recognition of the need to
focus on activities, products and services provided by sustainable biobanks that relate to URS.
• Long term sustainability -social (acceptability), -operational (efficiency) -financial(accomplishment) for sample & data use, suitability for research.
Adapted from Simeon-Dubach, D. & Watson, P. Clinical Biochemistry, 47, 2014
Development, publication and updating of guidelines and quality metrics has established biobanking as an independent scientific and professional entity.
The Nuremberg
Code
ISO Biobanking Standard
Health Products Regulatory Authority-
Submissions
Integration of biobank resource infrastructures in
scientific road map
Clear sign of Irish commitment to
creation of a strong networked RI base in
Ireland
Statement of Compliance -
lends authority
Promote perceptions of
value
Build Confidence in Biobanking
Participants/Donors
/Families
Institutions/
Owners
Biobanking
Community
Registration
Agencies
Ethics
Committees
Data
Inspectorate
Assurance of Sample Quality
Enable comparative analysis &
interoperability
Reference materials -Educational Tools
End users/ Biobank Clients
Standards – a major asset for Stakeholders
Innovators/Researchers
Why not Just Use Existing Guidelines?
• Some biobanks in existence since before the current guidelines produced
• Lack of interoperability between biobanks • When comparing between biobanks, differences are not always obvious until after analysis is
performed and sometimes not even then • Confused end users • Can devalue a biobank by association
• To ensure that emerging biobanks do not repeat hard learned mistakes made by biobanking pioneers
• 50-80 guidelines existing, vary in topics covered, relevance & the extent of detail
• Serve as a reference when no applicable standard is in place.
• Also GxPs, existing ISO standards ISO9001, ISO17025, ISO13485 etc.-relevance?
International Organization for Standardisation
• A network of national standards bodies from all regions of the world e.g. National Standards Authority of Ireland, working in partnership with international organizations such as the United Nations, its agencies and the World Trade Organization.
• Standards development is carried out by technical committees which receive inputs from associated committees at the national level, and from liaison organizations.
• Technical committees are established by the Technical Management Board to serve specific industries or generic subjects, to develop International Standards or other ISO publications appropriate to the needs of that sector.
ISO TC276 & Irish Initial Timeline
Standards for Biology Workshop
ISO Technical
Committee Biotech
DIN
Foundation Meeting
Working Group & plenary
NSAI Biotech Standards
Consultative Committee
Working Group
Meeting
Active Irish participation
……to date
Irish observers
• ISO Biology Task Force identified Biotechnology as an area of potential for international standardisation – 2011
Nov 2011 May 2014 Jan 2014 Feb 2013 Nov 2014 Dec 2014
Ireland became participatory member 2014: http://www.nsai.ie/Standards-Committee-for-Biotechnology.aspx
24th-28th October 2016: ISO TC 276 Working Group Meeting Dublin Castle, Ireland
http://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspxhttp://www.nsai.ie/Standards-Committee-for-Biotechnology.aspx
Mirror Committees at Country Level • NSAI Standards Consultative Committee for Biotechnology: Hosted by NSAI (Linda Hendy), Chaired
by MMI (Dr. Suzanne Bracken)
• Technical experts participate in standards development in at least one of the five Working Groups
• Call for experts: • Reach out to organisations & personal contacts for increased active participation at the national and
international level in all WGs and to ensure all stakeholders are represented
• Participation in the NSAI SCC Biotech –open to all interested parties
• Contact [email protected] for Committee Member Application & further information.
NSAI SCC Biotech SCOPE
To monitor and participate in the work of ISO TC 276 and to advise NSAI on the development and approvals of standards in the field of Biotechnology, ensuring Irish interests are represented in the development of any such standards
Participants 22 Observing 13 Secretariat: DIN Chair Dr Richardo Gent http://www.iso.org
ISO Technical Committee 276 Biotechnology • WG1: Terminology
• WG2: Biobanks & Bioresources: • Biobanks, Biological resources centres and specimen repositories
• WG3: Analytical methods: • Cell counting approaches
• Nucleic acid quantification methods/concentration of total nucleic acids
• Evaluate the quality of the massive sequencing data
• WG4: Bioprocessing • Control bioreactor processes for cell culturing
• Raw materials control for bioprocessing
• Best practice in raw materials selection in the design of human cell therapy manufacturing
• WG5: DS Data processing & integration: traceable, searchable, and interoperable data together with integrated data processing • definition of data and model formats and their interfaces; of metadata and relations of data and models;
• quality management of processed data and models
-.
WG2
• Harmonise procedures for biobanks, Biological Resources Centres and specimen repositories
• Ensure samples of known quality
• Improve access to samples and related data
• Stimulate access of partners from the public and private sector
• Improve trust between stakeholders ultimately optimising the outcome of collaboration
• Foster research & innovation
• Academic national expert: ES Supported by HRB Travel Grant; Other experts: Peadar McGowan, Diarmuid Cahalane
WG2 SCOPE
ISO/TC 276/WG2 will elaborate a package of International Standards in the field including human, animal, plant and microorganism resources for Research & Development, but excluding therapeutic products.
WG5
• The main foci are: • definition of data and model formats and their interfaces; • definition of metadata and relations of data and models; • quality management of processed data and models.
• Expert: Jason Carr
• WGs build on existing community standards and develop standards where needs and gaps are identified.
• WGs coordinate work with relevant technical committees and standardization initiatives. This includes coordination with all working groups of ISO/TC 276.
WG5 SCOPE
ISO/TC 276/WG 5 aims to develop standards for traceable, searchable, and interoperable data together with integrated data processing for biotechnology/life sciences.
For Excellence in Irish Biobanking
• Biobanking undertaking in Ireland needs to focus on the essential elements of • deliverance of research excellence and • Interoperability • Within a ethical, legally compliant and consenting framework
• There is enormous potential benefit for the Irish biobankers to be part of a wider (European) knowledge- and resource-rich community
• For biobanking to successfully continue to underpin progressive translational research in Ireland, efforts must be diverted to the quality of the research rather than the duplication of essential capacities by individual biobanks
• Need for national coordination of Irish biobanking efforts capable of establishing strong active links to the pan-European capacities (ELSI, IT, education, clinical biobanking, H2020, Quality….and many more) that have been and are being developed by BBMRI-ERIC.
Thank you for listening
Questions/ Comments please