Abstract
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The theme of the Bethesda meeting is Quality Biobanking for Precision Research and Medicine: Overcoming Scientific, Information Technology, and Policy Challenges. The location in Bethesda near the U.S. National Institutes of Health (NIH) has allowed the program committee to easily integrate discussions of policy and science issues important within the United States.
Several special lectures are planned on the first day, including the keynote address on the U.S. Precision Medicine Initiative, as well as presentations addressing the ethical, legal, and social issues (ELSI) related to biobanking in the United States and beyond.
Over the 2 days there will be several major symposia as well as a number of concurrent sessions. Symposium 1 will focus on ELSI and policy issues and laying out the evolving regulatory landscape. Successful precision medicine and research depend on the availability and sharing of high-quality specimens and associated data, especially genomics data. However, the uncertainty about how already-banked specimens may be used in the future, and the privacy and confidentiality issues raised by broad sharing of genotypic and phenotypic data raises numerous ELSI concerns. These issues include questions about the most appropriate models of informed consent and governance, and the need to engage and educate participants and the public about the use of specimens in research. In addition, these issues have raised questions about the adequacy of existing regulations and policies governing biobank research. This session will address these evolving issues and challenges in a series of short presentations followed by an interactive audience discussion period.
The second session, Symposium 2, will focus on practical implementation of Symposium 1 content. This session is tentatively entitled “Getting Real: Addressing Challenges and Obstacles to Achieving Next-Generation Biobanking.” Speakers will address real-world challenges to improving biospecimen processes in medical institutions, whether for personalized medicine, clinical trials, or research purposes—and how institutions can work to overcome these challenges. For example, what are some of the obstacles in trying to move to a more deliberative approach to collecting patient samples? How can you “get around” some of these obstacles? What obstacles seem to be non-negotiable? In addition, this session will cover real-world challenges to improving the availability of good clinical data accompanying research biospecimens—and how researchers and institutions are working to overcome these challenges. Is there hope for connecting electronic medical record systems to research data systems, to get beyond current paper forms and systems?
There will also be a “Best of Berlin” session, also on Monday November 7, which will highlight some of the major discussions from the ISBER Annual Meeting in April 2016.
On Tuesday, November 8, there will be two concurrent sessions planned for the morning, one focused on Biospecimen Science and the other focused on improving the sharing of biospecimens between institutions and researchers. Both sessions cover topics essential to furthering precision research and medicine. The Biospecimen Science session will cover biospecimen issues for molecular (“omic”) characterization for developing personalized precision medicine. The presentations will include discussion of microRNA expression, isolation of DNA/RNA biomarkers, and preanalytical variability surrounding detection of circulating tumor cells and circulating free-DNA, which are gaining clinical relevance for genomically informed precision healthcare. Such “liquid biopsies” can provide biological insight, informing drug and diagnostic development, and guiding therapeutic intervention.
The second concurrent session on Tuesday will be devoted to a discussion of sharing of biospecimens between institutions and researchers. The tentative title for this session is “Facilitating Sharing of Biospecimens and Associated Data for Translational Research.” The session is intended to focus on three aspects: (1) social aspects of biospecimen sharing, including attitudes of researchers on sharing specimens, (2) data challenges to sharing specimens, and (3) tools and mechanisms for sharing biospecimens.
The final afternoon session on November 8 will be devoted to reports on the results of an NCI research initiative examining the effects of major preanalytical factors on molecular analysis of formalin-fixed, paraffin-embedded (FFPE) tissues. As FFPE is increasingly utilized in molecular diagnostic assays as well as in medical research, it is increasingly important to better understand how preanalytical variation in FFPE may affect research results and patient care, and to take steps as possible to mitigate preanalytical effects.
In addition to the scientific plenary sessions, the Bethesda meeting will include other features consistent with ISBER's annual meetings: poster sessions, commercial exhibits, educational sessions, and social activities such as the welcome reception in the exhibit area. For more information and updates on the Bethesda Regional Meeting program, visit http://meetings.isber.org/regional2016/
November 8th is national election day in the United States. For those of us residing in the United States, do not forget to vote! For others, we hope that you will “elect” to attend ISBER's Regional Meeting!