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Developing Global Quality Controls and Standards

Realistic and Cost-Effective Strategies to Extend ‘Next-Tech Assays’ to Tissue Samples 

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Clinical Focus Technical Guide
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Transitioning a Biobanking Effort with Scientific and Fiscal Responsibility

2009 Presentation Highlights 

Scientific & Technical Considerations for Developing & Managing Biobanking Protocols Short Course

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As biobank repositories grow, the pressure increases for standardization, documentation, protocols, and preservation procedures to efficiently produce the best quality product. In addition, “omics” has complicated the direction of biomedical research, and those managers involved must now negotiate the regulatory, ethical, and legal issues involved in the preservation and use of biospecimens.

Monday, December 6, 2010

1:30 pm Main Conference Registration

 

Opening Session
Investing in the Future - Managing Change

2:00 Chairperson’s Opening Remarks

2:10 Changing the Paradigm for Biobanking in the U.S.

Helen M. Moore, Ph.D., Director, Biospecimen Research Network, Office of Biorepositories and Biospecimen Research, Office of the Director, National Cancer Institute

Human biospecimens provide the basis for research and development efforts in cancer and all human diseases, and will provide the analytes for patient care in the age of personalized medicine. To produce the high-quality biospecimens needed to achieve advances in R&D and patient care, we must make changes throughout the infrastructure that supports the collection, processing and storage of human biospecimens. The National Cancer Institute leads efforts designed to raise the quality of biospecimens, including producing the NCI best practices for biospecimen resource, sponsoring research through the NCI Biospecimen Research Network, and building a national biobank (“caHUB”).

2:50 A New Concept for Networking Tissue Banks to Overcome Barriers of Language, Standardization and the “My Syndrome”

Peter Riegman, Ph.D., Tissue Resource Manager, Erasmus MC Tissue Bank; Coordinator, European Human Frozen Tumor Tissue Bank (Tubafrost); President, ISBER

Combining the knowledge gained in three European Biobanking projects brought together a format of networking without the need to upload all sample data of all samples in a collection. The biobank manager fills in a questionnaire and the data can be searched for finding the right biobank to request samples. In addition, the database can support separate projects in parallel to aid in sample exchange having their own coordinator. New parameters have been introduced to choose the biobanks for requests and it fits into the competitive research environment and avoids classical bottlenecks.

3:30 Refreshment Break

4:00 Preparing for Next-Generation DNA Sequencing: Sample Quality and Quantity -- When is Enough Enough?

William Farmerie, Ph.D., Associate Director, Interdisciplinary Center for Biotechnology Research, University of Florida

The rapid evolution of next-generation sequencing (NGS) technology makes genome-scale genetic profiling both an invaluable and a cost-effective tool for clinical and epidemiological investigation. The many varied applications for NGS, and the input needs of the NGS instruments themselves, determine the journey each sample makes from biobank specimen to successful NGS template. What are the major applications for NGS, and how does the specific application guide the upstream preparation of biological samples for downstream analysis? Second-generation DNA sequencing platforms are well-established tools for gene-based research, however emerging third-generation platforms may once again reshape the landscape.

4:40 Planning and Integration of Biospecimen Collection in Clinical and Epidemiology Trials

Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, Laboratory of Pathology, NCI

Clinical and epidemiology trials are carefully designed and planned to address specific questions. Only within the last decade has collection of biospecimens for molecular analysis evolved and become an element of nearly all trials. As these specimens have been collected and analyzed, the limitations of this approach have been uncovered. Not all biospecimens are equal. The goal is to minimize the impact of pre-analytic variables. Critical decisions are required to address choices such as the use of residual clinical specimens or collection of dedicated research specimens. Means of processing, shipping and storage of specimens generate a decision tree that must be explored before the first specimen is collected. Application of a fit-for-purpose model allows all variables to be addressed with the goal of a feasible biospecimen collection and utilization strategy.

5:20-6:30 Networking Reception in Exhibit Hall