Sustainability of Canadian biorepositories:
Status, needs and national initiatives
Dr. Brent Schacter
Principal Investigator, CTRNet
Professor, Department of Medicine, University of Manitoba/CancerCare Manitoba
Dr. Peter Watson
Co-investigator, CTRNet
Director, BC Cancer Agency Tumour Tissue Repository and
Professor & Director University of BC Office of Biobank Education & Research
I. Biorepository landscape in Canada
www.ctrnet.ca
CTRNet’s mission: To enhance the capacity and quality of
biobanking through standardization and improvement of
biobanking processes and frameworks
Origins
• Established fall 2004
• Six founding programs
• Funded by ICR-CIHR
Focus
•Enhance access for research
•Promote national standards
•Provide education and training
www.ctrnet.ca
Organizational structure
Management Committee
Dr. Brent Schacter
Dr. Anne-Marie Mes-Masson
Dr. Peter Watson
Dr. John Bartlett
Dr. Kathryn Graham
Dr. Randy Johnston
Dr. Leigh Murphy
Dr. Lois Shepherd
Dr. Suzanne Vercauteren
Dr. Dominique Trudel
Two Node Province
External
Advisory
Committee
Single Node Province
CTRNet priorities in phase I
Standard Operating Procedures (SOPs)
• 46 SOPs and 10 policies for management and operation
of biobanks (available in English and French) .
• Over 15,000 file downloads from over 80 countries
worldwide.
Advanced Tissue Management (ATiM) software
• Development of a standardized tissue accessioning and
annotation tool to strengthen individual banks and to
enable creation of a virtual network.
Web Catalogue & Portal
• Virtual stock catalogue to enhance research access
• ~4000 unique visitors logged annually worldwide.
• Interfaces with the ATiM software and the SOP and
Policy archive, providing a single site for the entire
research community
www.ctrnet.ca
CTRNet node summary
Node
Biospecimen types (primary*, Projects supported
aliquots**, derived***)
annually
Cases released
annually
Biospecimens
released annually
1
All of the above
10
450
500
2
Derived products
15
2000
3000
3
All of the above
15
3500
6000
4
Derived products
30
400
550
5
Derived products
40
3,000
6500
6
All of the above
50
700
6500
*Primary samples (e.g., plasma, buffy coat, whole tissue blocks)
**Aliquots (e.g., tissue sections)
***Derived products (e.g., RNA, DNA, proteins)
www.ctrnet.ca
Major financial contributors to CTRNet biorepositories
Coverage by
Node
host institution
Coverage by
non-profit
Foundation
Coverage by
grants
Coverage by
user fees
1
70%
24%
-
6%
2
88%
-
10%
2%
3
80%
-
10%
10%
4
20%
78%
-
2%
5
15%
30%
50%
5%
6
75%
-
-
25%
www.ctrnet.ca
Canadian biorepositories are diverse in design and function
focus
participants
designs
Total
Biobanks
Total
Personnel
Mono-user
Collection related to single studies or research
laboratories and intended for a single primary
research question and sometimes stored for
secondary questions. Usually ‘small’ scale.
8,000
16,000
Oligo-user
Collection related to research groups and intended
for a series of primary research questions and also
planned for secondary questions within the
laboratory or group.
2,000
6,000
Poly-user
Collection related to a formal biobank to support
multiple research studies and intended for many
and diverse research questions. Usually ‘large’
scale.
80
400
~10,000
~22,400
Category
Characteristics
Total
www.ctrnet.ca
Assessing the role of user fees
• Survey of the biobank community in fall 2013:
– To gain an understanding of the processes that Canadian biobanks
were using when biospecimens and/or data are released to research
users.
– To assess whether the principles in the related CTRNet Policies/SOPs
are complete and to identify areas where there are needed
improvements/updates.
• Electronic survey – 15 questions
• Distributed to 45 individuals (PIs/Directors and Leaders/Managers)
www.ctrnet.ca
Baseline results
Length of operation
More than 5 yrs
1 to 5 yrs
Less than 1 yr
Have you released biospecimens and/or data?
Yes - more than 5 yrs
Yes - 1 to 5 yrs
Yes - less than 1 yr
Not yet
www.ctrnet.ca
The role of user fees in Canada
Does your biobank have a set fee schedule or
pricing guide for accessing materials?
Yes, set prices or ranges
are established
No, fees are determined
on a case by case basis
Just shipping costs
Not yet determined
Does your biobank have different fees for Canadian
vs. international applicants?
Yes
No
Not applicable (Not yet
determined; release is only
to internal projects)
www.ctrnet.ca
To what percentage do fees cover actual costs?
100%
50% to 75%
25% to 50%
less than 25%
www.ctrnet.ca
II. Needs and initiatives in Canada
www.ctrnet.ca
Dimensions of sustainability
Financial
• value
Social
Operational
• acceptability
• efficiency
www.ctrnet.ca
Dimensions of sustainability
Financial
• value
Social
Operational
• acceptability
• efficiency
Biobank types
Stakeholders
www.ctrnet.ca
Risks
Strategies for sustainability
www.ctrnet.ca
CTRNet strategies and tools to address sustainability
www.ctrnet.ca
Biobank certification processes
Mono
•
Founded on education program with a focus
on the ‘why best practices and SOPs’
•
Scaled & applicable to all entities conducting
biobanking
•
Targeted to address biospecimen quality
(standards) and governance (risk)
•
Launched spring 2013: >54 biobanks
enrolled
Poly
Oligo
CTRNet
www.ctrnet.ca
CAP
ISO
CTRNet Biobank Resource Center
•
Certification programs
▫ Other biobanks in Canada
▫ International biobanks
•
Education materials
▫ Online modules
▫ Online training demos
▫ Workshops
•
Services & Tools
▫ Consulting services: business & operational
plans
▫ Templates: governance, operations, facilities
etc.
▫ Tools: biospecimen reporting and User fee
calculator
▫ Strategies: Patient engagement/enrolment
program
www.ctrnet.ca
Patient Engagement Strategy
Patient engagement in clinical research strategy
Feasibility tested
• >10,000 patients enrolled
• Operating costs established ($1 - $20
per PTC)
Multiple benefits established
• Acceptability (broad opportunity
engages patients and health staff)
• Efficiency (reduces research costs
and accelerates projects)
• Enrolment (proven staff & training
value and expanded public support)
Broad value of PTC recognized
• Provincial business plan under
development
• National program under
consideration with clinical trials
initiative
Pre-procedure/
intervention
Diagnosis
Post-procedure/
intervention
Procedure and Therapies
Follow-up
Permission to Contact
Research Programs
Preliminary
interview
Preliminary
interview
Consent
interview
Consent
interview
Clinical studies
Biobank
Pathology
1.
Permission to Contact
2.
Collection of a minimal set of personal data to allow future
contact
3.
Access to health records for the limited purpose of prescreening for eligibility
www.ctrnet.ca
Biobank user fee calculator: the model
Goals
•
Establish ethically based user fees
•
Educate on total costs
•
Harmonize user fees
www.ctrnet.ca
Biobank user fee calculator: the model
Observations
•
Estimates show wide variation
•
Calculated user fees are always higher
•
Calculated user fees show convergence
www.ctrnet.ca
What does sustainability really look like?
people
BC Cancer Agency Tumor Tissue Repository
Clinic /
Diagnosis
Research
(‘large’, polyuser, institutional biobank)
Retrospective
questions
Hospital /
Surgery
Open access
BCCA
Clinic
Prospective
questions
Chart /
Follow-up
SOP driven processes
people
Expert team
Ideal/anticipated scenario……
$ (thousands)
Setup
1,000
900
800
700
600
500
400
300
200
100
0
Building
Program operating costs
Core biobank support
Services
Maintenance
…………………….. Real Life
$ (thousands)
Setup
1,000
900
800
700
600
500
400
300
200
100
0
Building
Program operating costs
Core biobank support
Services
Maintenance
Primary focus in years 1-2
$ (thousands)
&
# consents
Increase accrual
1,000
900
800
700
600
500
400
300
200
100
0
Program operating costs
Core biobank support
consents
Primary focus by years 3-5
$ (thousands)
&
# consents
Increase Internal
efficiency
1,000
900
800
700
600
500
400
300
200
100
0
Program operating costs
Core biobank support
consents
Primary focus by years 6-7
$ (thousands)
&
# consents
Increase enrollment
efficiency and
increase release
1,000
900
800
700
600
500
400
300
200
100
0
Program operating costs
Core biobank support
consents
Services
Primary focus by years 8-9
$ (thousands)
&
# consents
Establish targets,
protect accrual
capability, generate
new services
1,000
900
800
700
600
500
400
300
200
100
0
Program operating costs
Core biobank support
consents
Services
Primary focus by years 10-11
$ (thousands)
&
# consents
Develop and
Expand services
1,000
900
800
700
600
500
400
300
200
100
0
Program operating costs
Core biobank support
consents
Services
TTR Services
The BC Cancer Agency's Tumor Tissue Repository (TTR)
& UBC Office of Biobank Education and Research (OBER)
Dr. Peter Watson
Director
Simon Dee
IT Analyst
Sheila
O’Donoghue
Project Manager/
Biobank Leader
BCCA-TTR
Lise Matzke
Project Manager/
Biobank Design
Jodi LeBlanc
Consent Nurse
Sindy Babinszky
Biobank Lab
Supervisor
Stefanie Cheah
Project Manager/
Permission to
Contact
Candace Carter
Project Manager/
Advisor
Services
•
Case release (biospecimens & data)
•
Tissue analysis (IHC & TMA scoring)
•
Prospective study support (consenting & accrual)
•
Permission to contact release (PTC)
•
Biobank services (local training, IT and biobank support, etc.)
Accrual
Internal metrics
Stock
RNA quality
100%
80%
60%
Mod
40%
Exc
20%
0%
#1 #2 #3 #4 #5 #6 #7 #8 #9
External metrics
Metrics & Benchmarking
TTR
Total
Applications
>35
Biospecimens released
3720
Data records compiled
2514
TTR
2012
‘Other’
2012
Studies supported
35
11
9
Cases distributed
990
400
176
Publications supported
43
20
16
External metrics
Metrics & Benchmarking
TTR
Total
Applications
Response time
Biospecimens released
Patients engaged
TTR
2012
‘Other’
2012
>35
60 days
3720
>10,000
Data records compiled
2514
Services provided
>20
Studies supported
35
11
9
Cases distributed
990
400
176
% of Inventory used
22%
10%
8%
43
20
16
191
107
Publications supported
Cum 5 yr Impact Factor
Overall impact
Knowledge gained
Patient Engagement
Public Impact
clinical
scien fic
pa ent
societal
• Personnel trained
• Studies supported
• Publications generated
• Patients enrolled
• Research donor support
• Research opportunities enabled
• Impact on practice
• societal recognition
Contacts
CTRNet main site
CTRNet Biobank Resource Centre
Funders
www.ctrnet.ca
www.biobanking.org
Partners