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
Dinner Short Course*
Tuesday, September 16
5:15-5:45 Dinner Short Course Registration
Dinner Short Course Description
This course provides the comprehensive background information, requirements and guidelines necessary to successfully run biobanks while also serving clients. To translate research needs to a high-functioning lab program that produces high-quality biomaterial and data deliverables, detailed upfront planning, efficient processes, cutting-edge science and technology plus an understanding of program management are critical. Such elements affecting strategic and day-to-day responsibilities, as well as fundamentals like staying within time, cost, scope and quality constraints while meeting customer needs; maintaining proper documentation, from Standard Operating Procedures to training records, in a controlled environment; and contingency operations for freezer malfunction will be presented. The course will benefit not only biorepository operations managers, but also nurses, administrators of sample collection and storage entities and even research scientists who will better understand how biobanker practices align with and support their own goals.
Learning Objectives
- Share effective program and project launches
- program governance
- Explain the establishment of a strong
- Discuss quality assurance and control
- Describe the process of controlling and mitigating risk
- Provide tips for managing stakeholder expectations
- Explain the importance of properly closing a project
- Provide guidelines for formatting and streamlining an SOP
- Discuss the contents to include in different SOP sections
- Describe training records and how to best maintain them
- Share the factors and circumstances a site auditor will want to see
- Describe the process of version controlling both training records and SOPs
- Explain disaster management and the need for backup SOPs
Who Should Attend
- Biobank and Biorepository Operations Managers
- Sample Collection and Storage Administrators
- Nurses
- Research Scientists
Instructors and Detailed Agenda
5:45 pm Welcome
6:10 Fundamentals of Building Effective Lab Service Programs
Stephanie Frahm, Senior Project Manager and Technology Developer, RUCDR Infinite Biologics, Rutgers University
Translating client requirements into a lab program producing high-quality biomaterial and data deliverables requires detailed upfront planning and an efficiently run lab. Assembling these moving parts into a high-functioning, successful program requires cutting-edge science and technology, plus an understanding of program management – how to stay within time, cost, scope and quality constraints to meet customer needs and ensure the program’s future growth and success. Based on my BioProcessing Solutions Alliance experience, I will address fundamentals of our successful strategic partnership.
7:00 Dinner Break
7:30 Controlled Documents: SOPs and Training Records
Colleen M. Mitchell, Joint Biorepository Operations Manager, Indiana University Genetics Biobank and Indiana Biobank
Maintaining proper documentation in a controlled environment is elusive and sometimes overwhelming. We present Indiana University Genetics Biobank’s approach to streamlining SOPs and maintaining training records. Topics include how to format an SOP and the contents to include in different sections, what a site auditor will want to see in training records and how to version control both training records and SOPs.
8:30 Interactive Q&A with Instructors and Participants
9:00 Close of Short Course
Course Length and Time
3.25 hours 5:45 – 9:00 p.m.
Course Date
September 16, 2014
FEE: $699 Commercial/ $399 Academic, Government, Hospital-Affiliated
ACCREDITATION
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3.25 hours (0.325 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will email ACPE statements within three weeks of program completion.
ACPE#: 0778-0000-14-091-L01-P.
Released: 9/14.
*Separate registration required