1. Tissue Banking Operations and Infrastructure Mid-Atlantic Pathologists Assistants and Pathologists Assistants of New England June 5 th 2009 Beacon Hotel, Washington DC

2. Tissue Banking Initiatives Herceptin (blocks Her2neu receptor) Increasing need for high quality tissue samples for advancement medical research Translational research – “Bench to Bedside”

3. Tissue Banking Initiatives Outline of today’s presentation Outline of today’s presentation Evolution of the Maine Medical Center Tissue Bank Evolution of the Maine Medical Center Tissue Bank Overview of the tasks involved Overview of the tasks involved Operations Operations

4. MMC Tissue Bank 2001 - Spring 2004: Ardais Corp, Lexington, MA 2004 – 2007: Genomics Collaborative, Boston, MA. 2005 – Present: Established Maine Medical Center Tissue Bank Allowed us to work with multiple investigators (both internal and external) under the same IRB protocol All projects have used the same consent form MMC Investigators will get preference for tissue requests

5. MMC Tissue Bank Objectives To collect and archive high quality tissue samples for advancement of research To support tissue requirements for MMC-MMCRI researchers. To collaborate with external investigators to help defray operating costs.

6. MMC Tissue Bank: Current Collaborators Two large pharmaceutical companies Two “Tissue Broker” companies Internal research projects at MMC-Research Institute Currently in discussion with two New England Academic centers 2011: Future Participant in the National Children's Study (NCS)

7. Banking Data – ARDAIS 2001 to 2004: – 2600 Patients – 48000 samples – MMC TISSUE BANK Since 2005: 8000 samples from about 1200 patients Samples presently in inventory: ~ 5000 Samples distributed to investigators: ~3000

8. “Tasks” Determine what case types to bank Review surgical schedule to identify desirable cases Meeting and consenting patients Communication with the OR to identify targeted case and to arrange for timely specimen transport Handling the tissue/blood (Dividing and processing for various sample formats) Labeling samples and placing them into an inventory Maintaining the inventory (Update deposits and withdraws) Processing of histology blocks Pathology verification (tumor percent, ischemic time, sample weight) Develop / purchase a searchable database that can hold case information Data collection (Pathology report and clinical data retrieval) De-identification of all patient demographics Shipping or transporting samples to the researcher Office responsibilities Billing management for both external accounts. Equipment and supply needs

9. Tissue Banking Operations Specimen desirability / research need Approaching and consenting patients Targeting / Identifying potential cases Formats of tissue Specimen tracking Sample Data Inventory management Data Management

10. Tissue Banking Operations Specimen desirability / research need – Neoplastic disease (mostly malignant) – Inflammatory diseases (IBD, Arthritis) – Normal Tissue

11. Tissue Banking Operations Approaching and consenting patients – Structuring a consent process – “Generic vs. client specific” consenting – Pre vs. post surgical consenting – Consenting challenges for tissue banking – Linked (consented) vs. Unlinked (non-consented) tissue

12. Tissue Banking Operations Targeting potential cases (OR and PAU Schedules) Mailing List Schedule About two weeks prior to surgery a mailing is sent to all patients scheduled for surgery. A Tissue Banking Brochure is include in the mailing for select patients based on desirability Pre-admission Testing Schedule Many patients will come to the hospital within a week of surgery for initial work up and blood tests. This is a good place to approach the patient and introduce the project Daily Surgical Schedule Review the daily surgical schedule and cross reference for patients that have been approached Alternatives: Partner with physicians offices to identify patients and consent them.