1. Biospecimen Repository & Processing Core Shared Resource Mission: To be the centralized solid tissue biobanking facility at Duke The Biospecimen Repository and Processing Core (BRPC) was designed to be the Shared Resource for solid tumor biobanking at the DCI, and was launched in 2012. The BRPC accomplishes its mission while protecting patient safety through tight integration with the Department of Pathology. The BRPC Director, Dr. Shannon McCall, also serves as the Director of Anatomic Pathology Quality Assurance for Duke. Her priority is maximizing tissue available for research while ensuring that sufficient, intact tissue is available for clinical pathologic assessment and reporting. The BRPC attained CAP Biorepository accreditation in 2013, only the 20 th biorepository to achieve such designation. The BRPC is a Clinical Research and Population Science Research Oriented Core Facility, with oversight by both the BRPC Executive Advisory and Duke Biobank Advisory Committees. Since the last CCSG renewal, the level of institutional support for centralized biobanking has increased significantly, with renewed emphasis on neoplastic and non-neoplastic solid tissue sample acquisition as an essential component of the institution-wide Duke Biobank. The overarching Duke Biobank addresses biobanking at an institution level, with the following objectives: 1.To develop and deploy a centralized surgical tissue procurement core to serve cancer and other disease researchers; 2.To select and deploy a comprehensive, enterprise-wide biobanking informatics software system; 3.To coordinate and harmonize the separate, independent biobanking activities on campus; and 4.To provide biobanking education and oversight. Overview Technologies & Equipment Management StructureFunding Sources & Cost Effectiveness CCSG Valued Added Examples of Scientific Impact Shannon J. McCall, MD Major Services Utilization Strategic Plan Publications: Characterization of an oxaliplatin sensitivity predictor in a preclinical murine model of colorectal cancer using patient-derived xenograft models derived from BRPC-obtained patient specimens. (Kim et al., Mol Cancer Ther (2012);11(7):1500-9) Comparison of histologic and molecular phenotypes of patient tumor samples and multiple generations of patient-derived colorectal cancer explants. (Uronis et al., PLoS One (2012);7(6):e38422) Identification of the role of the hedgehog signaling pathway in medullary thyroid cancer. (Bohinc et al., Thyroid (2013);23(9):1119-26) Investigation of a PK2/Bv8/PROK2 antagonist, found to suppress tumorigenic processes by inhibiting angiogenesis in glioma and blocking myeloid cell infiltration in pancreatic cancer. (Curtis et al., PLoS One (2013);8(1):e54916) Current Collaborations: Validation and Interrogation of Differentially Expressed and Alternatively Spliced Genes in African-American Prostate Cancer (PI: Steve Patierno, PhD) RNA Extraction and Amplification from Biopsy Specimens with Metastatic Renal Cell Carcinoma (PI: Michael Harrison, MD) Biologic Characterization of the Breast Cancer Tumor Microenvironment (PI: E Shelley Hwang, MD, MPH) The BRPC is a CAP-accredited biorepository housed within Duke South Clinics and occupies 1,199 ft 2 of floor space in the Department of Pathology. We have 161 ft 3 of cryogenic storage space under constant temperature surveillance. Equipment: Cryogenic storage: Liquid nitrogen storage tank, −80ºC freezers (5) Histology: Paraffin tissue processor, block printer, embedding station Quality assurance: NanoDrop® ND-1000, gel documentation system, barcode printers and readers Archiving: Digital photomicrograph station, paraffin and slide storage system Safety: Biosafety cabinet, flammables storage Technologies: OCT-embedding with frozen section creation Qiagen RNA and DNA extraction protocols optimized for OCT specimens NanoDrop® and gel-based quality assessment of DNA and RNA Paraffin processing and embedding Histologic verification of all samples by a board-certified anatomic pathologist Secure informatics system (MAW3®) with limited access to PHI, specifically developed for tissue banking and supported by the Dept. of Pathology Remote temperature monitoring of all freezers with automated alerts via pager and cell phone Barcoding for all specimens and slides Consent Specimen collection Processing (fresh, frozen, formalin) RNA and DNA extraction Release of banked specimens & data Customized ‘boutique’ services Histologic verification of every tissue specimen Storage of all specimens, derived products, clinical information, & electronic data Currently serves 61 DCI investigators, representing 9 DCI research programs, as well as Liver and Lung Transplant research programs Providing specific clinical trials support in addition to general biobanking services Human tumor samples obtained through the BRPC have been used by DCI members to study the molecular pathways of tumorigenesis and agent-associated treatment effect Novel work comparing the histologic and molecular phenotypes of patient-derived cancer explants is occurring Maintain CAP Biorepository accreditation, functioning as a “best practices” biobank with pathology leadership and a true “honest broker” model Implement centralized LabVantage Biobanking Information Management System Continue to respond to the needs of DCI Investigators Seek out opportunities for improving centralized biobanking at Duke The true cost of banking with the BRPC is roughly $1,000 per subject case. A significant discount from the true cost must be available to Duke Investigators in order to effect their acceptance of the BRPC. The discount is available because of a multi- year commitment from Duke, including significant budget support (~20%) from the CCSG. DCI Investigators currently benefit from a full subsidy for BRPC services, made possible by CCSG support. The BRPC is funded by the DCI (71%), including approximately 20% annual budget support from CCSG funding, and the Duke School of Medicine (29%). For Year 1, $600,000 of startup funding was designated to support a Director, personnel, and biobanking equipment and supplies. The yearly budget supports a capacity of 600 unique patient biobanking consenting and collection events. Years 1 and 2 have been completely subsidized for DCI investigators in an effort to increase investigator awareness of the shared resource. While significant institutional support remains to ensure accessibility, user chargebacks and integration of the BRPC into funding applications are being implemented to ensure sustainability.