jim potter malcolm brock

Jim PotterJim PotterMalcolm BrockMalcolm Brock

Biospecimen Collection and Biospecimen Collection and ProcessingProcessing

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

- Sir William Osler, 1906- Sir William Osler, 1906

Biobanks: Collaborating for Cures

BasicResearch

Clinical Research Tissue Repository

Registry/DatabaseRegistry/DatabaseCRMS DBCRMS DB

ClinicalResearch

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

RepositoryRepositoryCaTissue DBCaTissue DB

TranslationalResearch

Specimen Collection: Factors to be considered:

• Purpose of the Biorepository• Best Practices / SOPs

• Consent• Governance / Oversight• Funding Support• Hardware

• Software/Audit/Security• Personnel (FTE)

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.

NCI / ISBER Guidelines for Biorepository Best Practices

1. Biospecimen collection2. Biospecimen processing and annotation3. Biospecimen storage and distribution4. Quality assurance and standardization5. Bioinformatics and data management6. Ethical concerns7. Intellectual property and legal issues8. Outreach, patient education and post-

research communication

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

Biorepository:

•Provide ethical oversight of all research involving repository specimens•Assure the best possible biospecimen quality

BP are followedSOP Manual reviewed, updated and followed

Oversight Committee

•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

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 principlesdefined in the NCI Best Practices including:

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:

Funding

•Grants•Divisional Support•Charge Back Scheme by Biorepository Core•Donation of Specimens to Biorepository Core

Hardware:

•Cryofreezer (N2 vapor )•-80˚C freezer•-20˚C freezer •4˚C Refrigerator •Freezer Monitoring System

alarmed to FTE Cell phoneinternet accessible

•N2 vapor transport system•Barcoding •Centrifuges •Cryostat

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

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.

Key Functions and Benefits of Key Functions and Benefits of caTissue Suite 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.

For UniversityFor University• centralized applicationcentralized application• no licensing fees (Open Source)no licensing fees (Open Source)• HIPAA compliance easy to monitorHIPAA compliance easy to monitor• Data Security and IntegrityData Security and Integrity

For PIs:For PIs:• No need for custom databasesNo need for custom databases• Easier data sharingEasier data sharing• Improved data organizationImproved data organization• HL7 importing of dataHL7 importing of data

caTissue - Benefits

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:

FTE roleFTE role Cataloging, storing, removal and processing of Cataloging, storing, removal and processing of

tissuestissues Supervision and training of FTEs directly receiving Supervision and training of FTEs directly receiving

tissues from patients tissues from patients to assureto assure Best Practices. Best Practices.

Personnel

Best Practice: All FTEs responsible for tissue procurement should be directed by the tissue repository administration

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

Systematic BioSpecimen Collectionfor

Personalized Cancer Medicineat

Johns Hopkins Medical Institutes

(Robotic Biospecimen Storage Facility)

Blood specimen processing and cryopreservation

Tumor and control tissue cryopreservation

•Would you use a Specimen Processing Service?

•Research Phlebotomist Services and possibly processing capability can be purchased.

Specimen Processing:

References:

Best Practices for Repositories I: collection, storage and Best Practices for Repositories I: collection, storage and retrieval of human biological materials for researchretrieval of human biological materials for research, ISBER. , ISBER. Cell Preservation Technology; Volume3, Number1, 2005, Cell Preservation Technology; Volume3, Number1, 2005, Update 2008. Update 2008.

National Cancer Institute, National Cancer Institute, Best Practices for Biospecimen Best Practices for Biospecimen Resources 2007Resources 2007

Case Studies of Human Tissue Repositories; Best Practices for Case Studies of Human Tissue Repositories; Best Practices for a Biospecimen Resource for the Genomic and Proteomic Era. a Biospecimen Resource for the Genomic and Proteomic Era. RAND Scientific Corporation, prepared for the National RAND Scientific Corporation, prepared for the National Cancer Institute. hCancer Institute. http://biospecimens.cancer.gov/nbn/rand.aspttp://biospecimens.cancer.gov/nbn/rand.asp

References:

Cancer Bioinformatics Grid, caBIG: Cancer Bioinformatics Grid, caBIG: https://cabig.nci.nih.gov/https://cabig.nci.nih.gov/.. First Generation Guidelines for NCI Supported First Generation Guidelines for NCI Supported

Biorepositories:Biorepositories:http://biospecimens.cancer.gov/biorepositories/NCI-http://biospecimens.cancer.gov/biorepositories/NCI-Supported_Biorepositories.pdfSupported_Biorepositories.pdf

Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006. Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006. First-Generation First-Generation Guidelines for NCI Supported BiorepositoriesGuidelines for NCI Supported Biorepositories

jim potter malcolm brock

Documents

best practices bp

ethical oversight

disease statespecimen

firstgeneration guidelines

institutional research

cure of disease

causes of disease

tiered consentspecimen