Post Conference DVD's
Scientific & Technical Considerations for Developing & Managing Biobanking Protocols DVD
The biospecimen research protocol is the cornerstone of any research utilizing precious biological samples and serves as a crucial tool to support both large and small biobanking programs. Determining the quality of biological specimens continues to be a significant challenge for all research programs as investigators struggle to delineate biological change from specimen artifact. Both financial and specimen management are interrelated components of any archival strategy which require careful management to ensure the quality and accessibility of renewable and more importantly, non-renewable biological resources. The management of biorepository protocols is one of the largest and most important considerations when calculating costs in biobanking programs today, putting sustainable quality operations of biospecimen resources at risk. While often overlooked, proactive management and design of biobanking protocols can dramatically improve & address critical issues helping most programs achieve the quality required for serving their community. Click here for more info
Highlights of Conference Presentations DVD
Advances in molecular high-throughput assays for gene expression (DNA/RNA) signatures have generated the parallel need for well annotated properly preserved biospecimens. Samples from both diseased and unaffected normal tissues are often required. Like traditional banks, biobanks are meant to be used and are most useful when the needs of end-users (researchers) are considered. Thus, a well managed biobank is a critical prerequisite for high-quality biological research. Cambridge Healthtech Institute’s Inaugural The Science of Biobanking is uniquely designed to explore the critical interactions between bioDEPOSITORS, bioBANKERS, and bioRECIPENTS who are all invested in the future of bioMOLECULAR research. Click here for more info
Post-Conference Wrap-up
Cambridge Healthtech Institute's Inaugural event, "The Science of BioBanking" was recently held in November of 2009 in Philadelphia, Pennsylvania.
The conference was a huge success with participation from more than 90 different companies. More than 60% of the attendees were decision makers. With coverage of Comprehensive BioBanking, Defining and Utilizing Biospecimens with an Eye for Fit-for-Purpose, as well as Profiling Gene Expression from Tissue, the conference was very informative, including unparalleled networking opportunities, and active attendee participation.
Please check back to this site in the near future for information and dates for next year's event.
Thank you to all the sponsors and participants for helping to make this one of the best BioBanking events available.
Related Article
Researchers Get 'Cold Hard Facts' at Cambridge Healthtech Institute's Inaugural Science of Biobanking Conference
By Joanna Radin, History and Sociology of Science, University of Pennsylvania.
On November 16 and 17, 2009 over 100 of the most important players in the world of biospecimens research gathered in Philadelphia for CHI's first annual conference on the "Science of Biobanking." This meeting represented one of the first efforts to bring together regulators, biomedical researchers, biorepository managers and practitioners to discuss new approaches for optimizing the use of biospecimens in cutting edge research.
In the words of keynote speaker Carolyn Compton, Director of the Office of Biorepositories and Biospecimen Research at NCI: "The biospecimen is the center of the molecular medicine universe," and is therefore deserving of increased attention. In her farsighted speech, Compton explained how the current genomic revolution in science and medicine is critically dependent on the availability of high-quality, easily accessed biospecimens. She expressed the concern, echoed by many others throughout the conference, that there is an urgent need to develop and implement standards to ensure quality and consistency in collection, processing, storage, and distribution of unique and valuable specimens.
In a series of informative presentations participants in Day 1 of the meeting discussed new approaches for identifying best practices necessary during the biospecimen life cycle for ensuring a continued supply of viable materials. Day 2 of the conference opened with a series of provocative breakout sessions dealing with topics ranging from new techniques for DNA extraction to the challenges facing those concerned with maintaining existing biospecimens as a renewable resource. Not only did these sessions enable participants to engage directly with leaders in the field, they facilitated networking and knowledge transfer opportunities between members of industry, academic medical research centers, and government.
Representatives from the Food and Drug Administration as well as the National Institutes of Health, spoke directly to regulatory issues that currently shape the terrain in which innovation in biospecimen use is occurring. Elizabeth Mansfield, Director of Personalized Medicine, Office of In Vitro Diagnostic Devices at FDA, discussed how her agency is adapting to the challenges genomics has posed to the conduct of biomedical research. She pointed out the importance of maintaining an ongoing dialogue as regulators continue to hone their approach to approving the best quality products in the most efficient ways. Stephen Hewitt, Chief of the Tissue Array Research Program and Applied Molecular Pathology Lab at NIH's NCI, emphasized the critical importance of devising ways to streamline specimen collection and use practices. The historical divide between clinicians and researchers must be bridged to ensure that specimen collection proceeds in ways that can best facilitate path-breaking cancer research. Hewitt offered suggestions for standardizing terminology as well as documentation and preservation procedures.
Throughout the conference, speakers from academia and industry emphasized the science that enables effective biospecimen preservation. Allison Hubel, from University of Minnesota, explained the scientific basis for current protocols in an effort to open the "cold black box" of storage. Recognizing and understanding these protocols is essential to ensuring the kind of innovation that facilitates automation, processing speed, and long-term quality of biospecimens. Participants also expressed concern with negotiating the appropriate ethical and legal issues associated with the preservation and use of such biospecimens. Biobanking involves the collection, storage, and use of human materials for the benefit of human health and wellbeing. Devising effective treatments means doing so in a way that respects matters of privacy, consent, patient integrity, and equitable access to resources.
The "Science of Biobanking," provided those engaged in high-profile biomedical research with inside access to the coming revolution in basic research, diagnosis, and treatment. As this field continues to attract attention and funding, keeping up with the cold chain is poised to become an essential dimension of life science.
Contact the author at jradin@sas.upenn.edu
Advances in molecular high-throughput assays for gene expression (DNA/RNA) signatures have generated the parallel need for well annotated properly preserved biospecimens. Samples from both diseased and unaffected normal tissues are often required. Like traditional banks, biobanks are meant to be used and are most useful when the needs of end-users (researchers) are considered. Thus, a well managed biobank is a critical prerequisite for high-quality biological research. Cambridge Healthtech Institute’s Inaugural The Science of Biobanking is uniquely designed to explore the critical interactions between bioDEPOSITORS, bioBANKERS, and bioRECIPENTS who are all invested in the future of bioMOLECULAR research.
Session Topics Include:
Comprehensive BioBanking: The Specimen Life Cycle
Defining and Utilizing Biospecimens with an Eye for Fit-for-Purpose
Profiling Gene Expression from Tissue
KEYNOTE SPEAKERS
Carolyn Compton, M.D., Ph.D.
Director, Biorepositories & Biospecimen Research
National Cancer Institute
Elizabeth Mansfield, Ph.D.
Director, Personalized Medicine Staff, Office of In Vitro Diagnostic Devices
CDRH/FDA
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Pre-Conference Short Course* – Sunday, November 15
2:00 - 5:00 pm Scientific & Technical Considerations for Development & Managing Biobanking Protocols
The biospecimen research protocol is the cornerstone of any research utilizing precious biological samples and serves as a crucial tool to support both large and small biobanking programs. Determining the quality of biological specimens continues to be a significant challenge for all research programs as investigators struggle to delineate biological change from specimen artifact. Both financial and specimen management are interrelated components of any archival strategy which require careful management to ensure the quality and accessibility of renewable and more importantly, non-renewable biological resources. The management of biorepository protocols is one of the largest and most important considerations when calculating costs in biobanking programs today, putting sustainable quality operations of biospecimen resources at risk. While often overlooked, proactive management and design of biobanking protocols can dramatically improve & address critical issues helping most programs achieve the quality required for serving their community. This workshop will present an in-depth overview and discussion of the following topics:
- Recommended Practice for Protocol Development
- Considerations for Evidence-based Protocol Design
- Factors related to Downstream Analysis
- Operational Strategies for Management of End User Protocols
- Guidelines to Optimize IRB Review
- Issues Related to Culling & Disaster Planning and Financial Considerations & Cost Use Cases
Who Should Attend?
Biospecimen Resource Directors, Lab Managers, Technicians, Scientists & Biobank End Users, Regulatory & Informatics Professionals and Policymakers & Grant Writers/Managers
Course Instructors:
Andrew Brooks, Ph.D., Director, Bionomics Research & Technology, Rutgers University Cell and DNA Repository, RUCDR
Lisa Miranda, President, Biobusiness Consulting Inc.; Former Technical Director, TTAB Core Facility, University of Pennsylvania
* Separate registration required
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