BIOBANK QUALITY. Office:

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1 BIOBANK QUALITY David F Carpentieri, M.D. Pediatric Pathologist and Biorepository Director, Phoenix Children s Hospital Assistant Professor of Pediatrics and Clinical Pathology, University of Arizona Assistant Professor of Laboratory Medicine and Pathology, Mayo Medical School [email protected] Office:

2 PERSONALIZED MEDICINE ADOLESCENT FEMALE WITH POSTERIOR MEDIASTINAL MASS

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4 PRE-ANALYTICAL

5 TISSUE PROCESSING Chung JY et al. J Histochem Cytochem 56: , 2008

6 RNA AND HISTOLOGIC PRESERVATION Florell SR et al. Mod Pathol 2001;14(2);

7 Khoury T et al. Mod Pathol 2009; 22(11): FIXATION AND IMMUNOHISTOCHEMISTRY ER PR DELAY 0 HOURS 4 HOURS 8 HOURS OVERNIGHT

8 HANDLING AND STORAGE Tim C Peakman and Paul Elliott. International Journal of Epidemiology 2008;37:i2-i64

9 MASS SPECTROMETRY Ahmad S et al. Anal Biochem

10 STORAGE

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12 BIOBANK QA STANDARD?

13 STABILITY Betsou F et al. Long-term stability of coagulation variables: Protein S as a biomarker for preanalytical storage-related variations in human plasma Thromb Haemost 2009; 101:

14 BIOBANK QA STANDARD?

15 DATA

16 DATA

17 PRE-ANALYTICAL CODING SPREC BRISQ First tier: Necessary to report Second tier: Advisable to report Third tier: Additional items to report 1. Betsou F et al. (ISBER working group on biospecimen science).cancer Epidemiol Biomarkers Prev Apr 19 (4): Moore HM et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol Apr 25;119(2):

18 BIOBANK QA STANDARD?

19 BIOBANK QUALITY STANDARD? 1. DNA INDEX 2. RIN 3. % TISSUE NECROSIS 4. PROTEIN QUANT or COAG FUNCTION? 5. SPREC x BRISQ

20 BIOBANK QUALITY David F Carpentieri, M.D. [email protected] Office:

21 Building a Biorepository Resource, One Step at a Time Svetlana Mihaylova-Todorova, PhD, MS CRM, CCRC Maricopa Integrated Health System

22 Building a Biorepository Resource, One Step at a Time Funding Agency Grants and Research Advisory Committee Biorepository Operations IRB FACILITIES BIOMED / PURCHASSING LIMS Clinical RESEARCH Space Allocation & Adaptation Equipment -85 o C ULT Freezer/EPS Temp Monitoring Device LN2 storage system Oxygen Deficiency Monitor Biosafety Cabinet FFPE Blocks & Slides Storage Computers, Printer Barcode reader/printer Data Management System FreezerWorks Program FreezerWorks Support FreezerWorks Training Server IT Support Protocols Development Collection Protocols PROSPECTIVE UNLINKED LINKED SOPs Regulatory CLINICS, DR s OFFICE LAB PATHOLOGY LIMS SUPPORT, BIOMED FINANCE Patient Recruitment & IC Administration / Data Collection Biospecimen Procurement, Processing & QC Biospecimen Storage Data Storage Biospecimen Disbursement Through ABL

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24 GRANTS Funds multi-disciplinary, multi-institutional collaborations that will make Arizona a leader in biomedical research. ABRC is committed to enhancing and furthering bioscience and clinical research in Arizona and has provided over $100 million in research funding to help understand diseases better and work towards finding treatments and cures.

25 Arizona Public Cord Blood Banking Program The State of Arizona has had a long-standing interest in advancing public cord blood banking to target the collection for minority groups and increase the availability of cord blood units for transplantation and for preclinical research to Arizona scientists. ABRC partnered with the University of Colorado Public Cord Blood Bank (UCCBB). The cord blood units are collected at hospitals throughout Arizona and shipped to UCCBB and made available through the National Marrow Donor Programs for transplantation..

26 Educational Symposiums and Workshops ABRC has been providing in-depth education and policy guidance for clinical researchers across Arizona. Previous events include topics on use of biospecimens in research, patient registries, grant writing and clinical research compliance. ABRC continues to plan for future educational opportunities with topics based on feedback from the clinical research community. SAVE THE DATE May 7, 2014 IRB EDUCATIONAL AND NETWORKING EVENT May 8-9, 2014 FROM RESEARCH TO PRACTICE: FUNDING FOR A HEALTHIER ARIZONA For more information, please visit:

27 Arizona Biospecimen Consortium and Locator To meet the needs of researchers seeking high quality specimens for their research, ABRC has developed the Arizona Biospecimen Locator (ABL), a centralized, web-based biospecimen database. This on-line tool allows researchers worldwide to browse query and request biospecimens stored in physical repositories at member Arizona hospitals and research facilities. The ABL system displays information for researchers to locate biospecimens suitable for their research, including disease, type of specimen, preservation type, anatomic source, and demographics of participants.

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30 ABRC from its active involvement in the Arizona Biosciences Roadmap and Arizona Translational Research Pathway efforts recognized the importance of providing both the capacity and the quality of biospecimens for researchers to accelerate the pace of translational research From outreach to hospitals and the research community, ABRC learned that a comprehensive and coordinated effort was needed to raise the capacity of existing and emerging biospecimen banks across the state and manage the interface with the community To achieve this goal, ABRC funded the development of the Arizona Biospecimen Consortium to guide the development of a centralized, web-based database of biospecimens collected and stored at participating Arizona hospitals and medical centers and govern its processes

31 Advancing the Consortium Effort Advancing a State-of-the- Art Biospecimen IT System

32 Advancing the Consortium Effort ABRC decided it was important to work first with a geographically focused group given the time and effort needed to facilitate information system specifications, standards development and governance approaches. The Pilot consortium members represent legal, scientific and research personnel from each of the participating sites:

33 Governance Committee Addresses policy and governance issues Standards Committee Addresses standardization and quality assurance issues Standardize policies, forms and procedures to ensure smooth participation in a statewide biospecimen effort Create a standardized Material Transfer Agreement template to be used by all sites providing and receiving biospecimens through the ABL Develop a standardized approach for researchers seeking access to biospecimens through the ABL Set policies for new participants to join the consortium Review and finalize data elements for the data fields within the ABL Develop a quality assurance process for the consortium and the ABL Standardize standard operating procedures for collection, processing and storage of biospecimens based on best practices Identify and develop education and training efforts

34 Advancing a State-of-the-Art Biospecimen IT System Public can browse information on biospecimens available for research Research staff can request biospecimens Institution where biospecimen is stored reviews request Institution approves request and ships biospecimen Researcher receives biospecimens & if requested, returns unused biospecimen

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36 Registration required in order to view data for specific samples Register for an Account

37 Biospecimen Catalog

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39 Required Information for the Request Process: Protocol and IRB approval/exemption Information PI Information Shipment information Upload the signed ABL Material Transfer Agreement

40 Researchers Accessing the ABL Worldwide Daily Activity Visitors: 1955 Registered Users: 68 Registered Institutions: 51

41 Going forward, the consortium will continue to: Invite additional biobanks to join the ABL Inform the research community about this resource ABL Collaborate with 5AM on refinements of the ABL system Continue to develop and monitor a centralized quality assurance process Determine best practices for biospecimen collection, process and storage

42 If your biorepository is interested in providing samples through the ABL website, please contact ABRC at: To learn more about the ABL, please visit: