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 Linda.Hendy@nsai.ie 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

e.snapes@ucc.ie