Sunday, September 14
1:30 pm Short Course Registration
2:00-5:00 pm
Biobanking operations must comport with a complicated regulatory environment, including provisions of the Clinical Laboratory Improvement Amendments (CLIA), patient privacy protections under the Health Insurance Portability and Accountability Act (HIPAA) and Institutional Review Board regulations. Well-organized biobanks are critical to advancing translational science and the promise of personalized medicine. This short course will focus on regulatory compliance, business planning, quality control and operations of academic and governmental biobanks.
2:00 pm Welcome
2:15 Med Center Biobanking
Angen Liu, M.D., Ph.D., Director, Specimen Accessioning Core, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
The infrastructure and accessibility of biobanks have a direct impact on drug discovery and biomarker validation. The principle of biospecimen collection and storage is relatively straightforward, but the practicalities and development of high-quality biobanks are complicated and remain challenging. Expertise in standardization, quality control, information technology and awareness of cutting-edge research development are generally required for biobank development and management. With new genetic and proteomic techniques being developed continuously, biobanks will greatly advance translational research and personalized medicine.
2:55 Development and Implementation of a National Biospecimen Collection Network in a Community Hospital System
Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives
Catholic Health Initiatives (CHI) is the fifth-largest health system in the United States, with 87 hospitals in 18 states. The CHI Center for Translational Research has built a national network for biospecimen collection. This program involves close partnering with the local hospitals, placement of staff and infrastructure within the hospital, maintenance of chain-of-custody and implementation of industry best practices. This program permits the collection of biospecimens that are of the highest quality, thus enabling reproducible and meaningful downstream research.
3:35 Refreshment Break
3:55 Ensuring Regulatory Compliance in Business Planning for an Academic Biobank
Stephen Schmechel, M.D., Ph.D., Associate Professor, UW Medicine Pathology and Director, NWBioTrust, University of Washington
Procurement of biobank specimens and associated annotation data, and release of materials for research, are subject to a complex regulatory environment including federal law, Institutional Review Boards and policy guidelines provided by national organizations, hospitals and pathology and laboratory medicine departments. This presentation presents the approach of one pathologist and biobank director in navigating this regulatory environment.
4:35 PANEL DISCUSSION: Running a Financially Sustainable Biobank
Angen Liu, M.D., Ph.D., Johns Hopkins University
Jeffrey Otto, MBA, Ph.D., Catholic Health Initiatives
Stephen Schmechel, M.D., Ph.D., University of Washington
5:00 Close of Short Course
*Separate registration required
(Limited to 50 participants)
6:00-8:00 pm
Join your colleagues for an evening of networking at the University of Washington’s Center for Cancer Innovation (CCI) at UW Medicine’s South Lake Union Research Campus.
- Hear about a novel approach to advancing clinical cancer research and personalized medicine
- Visit the Quellos High Throughput Screening Core facility
A networking reception precedes and follows the tour.
The tour and reception are hosted by NWBioTrust (NWBT), a collaborative project between Fred Hutchinson Cancer Research Center, Institute of Translational Health Sciences, Seattle Cancer Care Alliance, Seattle Children’s Hospital and University of Washington Medicine. This innovative hub-and-spokes resource system connects donated biospecimens from consenting individuals with innovative research projects aimed at advancing biomarker discovery and improving prevention, diagnosis and treatment of human disease.
Detailed Agenda:5:30 pm Check-in for Laboratory Tour
5:45 Shuttle Service to Laboratory Tour
*Complimentary roundtrip shuttle service to and from the Sheraton Seattle Hotel
6:00 Reception Begins and Continues until 8:00
*Includes light food and beverage
6:05 Welcome from NWBioTrust Director, Stephen Schmechel, M.D., Ph.D.
6:10 University of Washington’s Center for Cancer Innovation
6:30 Tours of Quellos HTS Core Begin
*Anticipate 3 Groups Starting at 6:30, 6:50 and 7:10
7:30 Tours of Quellos HTS Core Conclude
8:00 Reception Concludes; Board Shuttle and Return to Hotel
8:15 Close of Day