1. Jim Potter Malcolm Brock Biospecimen Collection and Processing

2. “To wrest from nature the secrets which have perplexed philosophers in all ages, to track to their sources the causes of disease, to correlate the vast stores of knowledge, that they are quickly available for the prevention and cure of disease – these are our ambitions.” - Sir William Osler, 1906 Biobanks: Collaborating for Cures

3. Basic Research Clinical ResearchTissue Repository Registry/Database CRMS DB Clinical Research Roles: Pt Identification Pt Recruitment Facilitate Clinical Trials, Translational and Basic Research Support of Patient Registry and Database Roles: Best Practices/SOP Tissue Processing Tissue Storage Management of Tissues Distribution of Tissues Repository CaTissue DB Translational Research

4. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

5. Purpose of the Biorepository: To formalize the collection of all specimens following Best Practices (BP) and Standard Operating Procedures (SOPs) The Informal collection of specimens stored in Investigator’s freezer should be avoided.

6. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

7. NCI / ISBER Guidelines for Biorepository Best Practices 1. Biospecimen collection 2. Biospecimen processing and annotation 3. Biospecimen storage and distribution 4. Quality assurance and standardization 5. Bioinformatics and data management 6. Ethical concerns 7. Intellectual property and legal issues 8. Outreach, patient education and post- research communication

8. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

9. Informed Consent: Restricted or tiered consent Specimen use limited to study design or disease state Specimen use may be limited to tenure of the investigator General consent Maximizes scientific utility of the repository Promotes valuable new science

10. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

11. Biorepository: Provide ethical oversight of all research involving repository specimens Assure the best possible biospecimen quality BP are followed SOP Manual reviewed, updated and followed Oversight Committee

12. Provide consistent documentation Establish guidelines for collection, processing, storage and retrieval of specimens Assessment of new technologies and the incorporation of new technologies into the repository Assure the fair and impartial utilization of specimen resources Oversight Committee

13. Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006. First-Generation Guidelines for NCI Supported Biorepositories Oversight Committee Investigator agreement covering confidentiality, use, disposition, and security of biospecimens and associated data. Timely, equitable, and appropriate access to specimens Fair and clearly communicated access procedures Scientific merit with institutional research qualifications, and a research plan appropriate to answer the study questions An appeals process for addressing disputes over allocation decisions Access decisions guided by a set of general principles defined in the NCI Best Practices including:

14. GI-TxB Oversight Committee Division Director Core Center PI - Mark Donowitz Directors - Jim Potter, Steve Brant One PI from each of “8 study sections” At least two rotating independent non-GI, JHU investigators (Geneticist, Bioethicist) Anthony Kalloo Oversight Committee Example:

15. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

16. Funding Grants Divisional Support Charge Back Scheme by Biorepository Core Donation of Specimens to Biorepository Core

17. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

18. Hardware: Cryofreezer (N 2 vapor ) -80˚C freezer -20˚C freezer 4˚C Refrigerator Freezer Monitoring System alarmed to FTE Cell phone internet accessible N 2 vapor transport system Barcoding Centrifuges Cryostat

19. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

20. Tissue Bank Database Software CaTissue DB Software – NCI Open Source software established through caBig (Cancer Biomedical Informatics Grid) Pilot Projects: James Cassella – Sickle Cell Disease Multi-Institutional – 3 sites Richard Roden – Cervical Cancer SPORE Jim Potter, Steve Brant - IBD

21. caTissue Suite: Core Functions / Modules – –Administration: Create and edit users, protocols, and storage systems associated with a biospecimen inventory. – –Biospecimen: Create and edit data concerning participants and their corresponding biospecimens. – –Query: Identify biospecimens and their data based upon one or more selection criteria.

22. Key Functions and Benefits of caTissue Suite Search Allows biospecimen resource staff and scientists alike to search for biospecimens based on a combination of properties Biospecimen Tracking Allows biospecimen resource staff to record events related to biospecimen processing and quality assurance and to annotate biospecimens with pathological, clinical, and custom data Biospecimen Inventory Management Allows biospecimen resource staff to record data about biospecimen collection, storage, requests, and distribution.

23. For University centralized application centralized application no licensing fees (Open Source) no licensing fees (Open Source) HIPAA compliance easy to monitor HIPAA compliance easy to monitor Data Security and Integrity Data Security and Integrity For PIs: No need for custom databases No need for custom databases Easier data sharing Easier data sharing Improved data organization Improved data organization HL7 importing of data HL7 importing of data caTissue - Benefits

24. Pilot approach – –Install caTissue and provide training – –Migrate pilot tissue banking data to caTissue – –Integrate with JHM systems (ADT, eIRB, CRMS – –Customize for non-cancer tissue banks – –Extend to handle data elements not in caTissue – –Bug fixes/ maintenance during pilot period – –Funding in place to hire group to extend and support caTissue caTissue Pilots:

25. Specimen Collection: Factors to be considered: Purpose of the Biorepository Best Practices / SOPs Consent Governance / Oversight Funding Support Hardware Software/Audit/Security Personnel (FTE)

26. FTE role Cataloging, storing, removal and processing of tissues Cataloging, storing, removal and processing of tissues Supervision and training of FTEs directly receiving tissues from patients to assure Best Practices. Supervision and training of FTEs directly receiving tissues from patients to assure Best Practices. Personnel Best Practice: All FTEs responsible for tissue procurement should be directed by the tissue repository administration

27. Specimen Collection FTE Procure via Best Practices & SOP Specimen ID (barcode) Preserve specimen Transportation to the Tissue Bank Register specimen ID (barcode) in database Process the specimen, if required (blood, RNA, DNA, etc.) Storage Archive

28. Systematic BioSpecimen Collection for Personalized Cancer Medicine at Johns Hopkins Medical Institutes (Robotic Biospecimen Storage Facility)

29. Blood specimen processing and cryopreservation

30. Tumor and control tissue cryopreservation

31. Would you use a Specimen Processing Service? Research Phlebotomist Services and possibly processing capability can be purchased. Specimen Processing:

32. References: Best Practices for Repositories I: collection, storage and retrieval of human biological materials for research, ISBER. Cell Preservation Technology; Volume3, Number1, 2005, Update 2008. Best Practices for Repositories I: collection, storage and retrieval of human biological materials for research, ISBER. Cell Preservation Technology; Volume3, Number1, 2005, Update 2008. National Cancer Institute, Best Practices for Biospecimen Resources 2007 National Cancer Institute, Best Practices for Biospecimen Resources 2007 Case Studies of Human Tissue Repositories; Best Practices for a Biospecimen Resource for the Genomic and Proteomic Era. RAND Scientific Corporation, prepared for the National Cancer Institute. http://biospecimens.cancer.gov/nbn/rand.asp Case Studies of Human Tissue Repositories; Best Practices for a Biospecimen Resource for the Genomic and Proteomic Era. RAND Scientific Corporation, prepared for the National Cancer Institute. http://biospecimens.cancer.gov/nbn/rand.aspttp://biospecimens.cancer.gov/nbn/rand.asp

33. References: Cancer Bioinformatics Grid, caBIG: https://cabig.nci.nih.gov/. Cancer Bioinformatics Grid, caBIG: https://cabig.nci.nih.gov/. https://cabig.nci.nih.gov/ First Generation Guidelines for NCI Supported Biorepositories:http://biospecimens.cancer.gov/bioreposito ries/NCI-Supported_Biorepositories.pdf First Generation Guidelines for NCI Supported Biorepositories:http://biospecimens.cancer.gov/bioreposito ries/NCI-Supported_Biorepositories.pdfhttp://biospecimens.cancer.gov/bioreposito ries/NCI-Supported_Biorepositories.pdfhttp://biospecimens.cancer.gov/bioreposito ries/NCI-Supported_Biorepositories.pdf Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006. First-Generation Guidelines for NCI Supported Biorepositories Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006. First-Generation Guidelines for NCI Supported Biorepositories