Beating The World ~ International Recommendations for Best Practices in Biobanking A/Prof Dan Catchpoole Head, Tumour Bank, CCRU, KRI The Children’s Hospital at Westmead 12 th June 2018
Beating The World
~ International Recommendations for Best Practices in Biobanking
A/Prof Dan Catchpoole
Head, Tumour Bank, CCRU, KRI
The Children’s Hospital at Westmead
12th June 2018
Mission ISBER is a global biobanking organization which creates opportunities for networking, education, and innovations and harmonizes approaches to evolving challenges in biological and environmental repositories.
Vision ISBER will be the leading global biobanking forum for promoting harmonized high quality standards, education, ethical principles, and innovation in the science and management of biorepositories.
Goals 1. Disseminate information on repository management issues
2. Educate and share information and tools within the society
and with stakeholders
3. Act as the voice for repositories to influence regulations and
policy
4. Develop best practice guidelines
5. Provide centralized information about existing repositories
6. Bring members together to work on emerging issues
Standards, Best Practices, Guidelines, Recommendations….. What’s what?
• “Standards” - represent a rigid set of guidelines that define exactly how a task should be done.
• International Organisation for Standardization – Technical Committee 276
• “Best Practices” – recommended set of actions and principles that demonstrate an awareness of the standards.
• ISBER Best Practices (https://www.isber.org/bestpractices)
• NCI Best Practices (https://biospecimens.cancer.gov/bestpractices/)
• OECD Guidelines on Human Biobanks (www.oecd.org/sti/biotech/44054609.pdf)
• Rand Report 2003 (https://www.rand.org/pubs/monographs/MG120.html)
Standards: ISO TC276
General Requirements
Animal Genetics
Plant Genetics
Human Mesenchymal
Mammalian
Cell Lines
Data Microbial Data
Human
Biobank Validation
Furata et al, Biopreservation and Biobanking 16(1), 23-27, 2018
Standards: ISO TC276 – FDIS 20387 - Comments • Very high level comments…..
• “General requirements for the competence, impartiality and consistent operations of biobanks…”
• 4.1.3 – “The biobank’s mission should be defined and available.”
• 4.2.3 – “ The biobank shall be responsible for the impartiality of its biobanking and shall not allow internal and/or external pressure(s) to compromise impartiality.”
• 5.1 - “The biobank shall be a legal entity or a defined part of a legal entity…”
• 6.1.2 - “The biobank shall have a documented strategy to enable continued financial viability for its activities.”
• 8.8.1 – “The biobank shall (a) plan, implement and maintain an audit program….”
……in other words…..
….the biobank can no longer be considered as just the freezer down the end of the corridor!!
….but…. Vital and Worth Investing in Facilities and Departments
Accountable and Responsible Expert and Specialist
Taken seriously….
• ISBER BPs seek to harmonise scientific technical legal and ethics issues related to biobanking.
Campbell et al, Biopreservation and Biobanking, 16(1), 3-6, 2018.
Best Practices: ISBER 4th Edition – what’s new?
Notes from Dallas: General Comments • Big shift in focus from the practicalities of running biobanks to the
place biobanks have in the research environment.
• Increased presence of pathologists, business people, facility managers, industry (inc Pharma), stakeholders – not just researchers
• Standards, QC and biospecimen science prominent points of discussion
• Big data and analytics is an issue for biobanks too.
• Metrics…… how do we measure what we do???
• Certification happening…. Accreditation is round the corner!
• Biobanking as ‘business’…….!! How, what, why??
• IT’S ALL ABOUT ENGAGEMENT….
Notes from Dallas: ‘ENGAGEMENT’. • James O’Leary (Genetic Alliance) – attracting the general public.
Engagement is an ongoing activity - TIME
• Vicki Buenger (Texas A&M) – understanding parents/patients.
Engagement is two way - PARTNERSHIP
• Ngaire Brown (NGAOARA) – working within different cultures.
Engagement is sensitive to different ways of thinking - UNDERSTANDING
• Tanja Dowe (Venture Capitalist) – being attractive to business’/industry
Engagement into an ‘ecosystem’ - COLLABORATIVE
• Jane Rogan (Manchester UK) plus others – becoming routine.
Engagement into hospital clinical pathways - INTEGRAL
• Adrie Van Bokhoven (Orien Network, US) – hospitals sharing data (!).
Engagement for operational efficiency - ALLIANCES
Biobanking….. Its about the connections!!
Clinicians Health Care System
Researchers Knowledge Generation Biospecimens
Biobankers
Personalised
Medicine
Patients General Public
Advocates
Consent “Personalised
Research”
Can you standardized human behaviours?? • Biobanking is essentially a human activity.
• The value of a biobank is not measured by the biospecimens they collect
• The value of a biobank is not measured by the technology they use
• The value of a biobank is not determined by the money they attract
• The value of a biobank is determined by the connections they make to enable research.
• Successful biobankers build connections between…
The people who have the biospecimens,
the people who want to study the biospecimens
The people who need to know what the biospecimens have to tell us.
Can Standards, Best Practices, Certification, Accreditation and Business Models help us make the best connections?
Associate Professor Dan CATCHPOOLE
ISBER, Director-at-Large for Indo-Pacific Rim
Head, Tumour Bank, The Children’s Hospital at Westmead, NSW
12th June 2018