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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
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Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

Jul 27, 2020

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Page 1: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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

Page 2: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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.

Page 3: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry
Page 4: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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

Page 5: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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)

Page 6: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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

Page 7: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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….”

Page 8: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

……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….

Page 9: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry
Page 10: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

• 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?

Page 11: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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….

Page 12: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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

Page 13: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

Biobanking….. Its about the connections!!

Clinicians Health Care System

Researchers Knowledge Generation Biospecimens

Biobankers

Personalised

Medicine

Patients General Public

Advocates

Consent “Personalised

Research”

Page 14: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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?

Page 15: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry
Page 16: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry
Page 17: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry
Page 18: Beating The World International Recommendations …...place biobanks have in the research environment. •Increased presence of pathologists, business people, facility managers, industry

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