1. Tissue Biorepositories: Do You Really Want to Know How the Sausage is Made? David A. August Professor of Surgery The Cancer Institute of New Jersey UMDNJ / Robert Wood Johnson Medical School The Cancer Institute of New Jersey

2. CINJ “SNP” Protocol Goal: to identify genetic variants as markers for risk of developing breast cancer earlier age of diagnosis outcomes 1168 patients consented 980 genomic DNAs isolated Demographics to date from chart review Collaborative studies with: Dr. Arnold J. Levine Dr. Vassiliki Karantza-Wadsworth Dr. Shridar Ganesan Dr. Bruce Haffty Dr. Mark Brenneman

3. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

6. NCI_Best_Practices_060507biospecimens.cancer.gov

8. Types of Tissue Support Tissue banking (de- identified:discarded, annotated) Protocol specific support Translational research Bench support Clinical Basic

9. Front End / Back End Clinical Processes (collectors) Protocol development Regulatory approval Subject consent Tissue acquisition Clinical analyses Initial processing Clinical annotation Linkage/de-identification Tissue storage Acquisition QA Longitudinal annotation Technical Processes (repository, recipients) Tissue storage Quality assurance Sample preparation Sample distribution Database management End user support

10. Clinical Uses Prognosis Risk assessment Pharmacodynamics (Phase O trials) “Fingerprinting” Inheritance analysis Etiology Response assessment Response prediction

11. The Worker Bees Director Pathologist Database development/management/support Manager Technicians (histo, retrieval, IHC, TMA) Data managers, research nurses, chart abstracters Regulatory manager Protocol support (writer, “shepherd”, consultant) Consent docents