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| Biospecimens and Biorepositories A Bit of History and Perspective on Progress in Biobanking in the United States from Paula: I was pleasantly surprised to see Biobanks as # 8 in the "10 Ideas Changing the World Right Now" list in the March 23, 2009 edition of TIME magazine. It wasn't all that long ago that biospecimens and their use were not very high on the radar screen of many people including myself and surprisingly public agencies like those within the United States Department of Health and Human Services-National Institutes of Health. What I mean by that is human biospecimens have been collected for use in research for a long time (i.e. 100 plus years) however, I do not think it is a gross overstatement to say that only in the past ten or so years has the importance of high quality well annotated biospecimens and their management and use received a high enough level of attention and interest here in the United States by public agencies, funders and users of said biospecimen banks to realize and acknowledge that in some cases the Emperor is not wearing any clothes. This is not meant to diminish the important and critical work accomplished by many people dedicated to creating and maintaining human biospecimen repository systems, but rather to highlight the need for unparalleled attention and teamwork from the public and private sectors now to build a system that is sustainable and simultaneously serves the needs of many, none of which is more important than those of the patient. My education about biospecimens started around 1999 when the pancreatic cancer researchers I was working with and advocating on behalf of shared with me the importance of human biospecimens in research and how they were critical to making progress for pancreatic cancer. For me, it did not matter whether or not I understood the scientific explanations (which I really didn't)...I trusted them and they trusted me... so all I needed to know was that high quality biospecimens were important to research which meant they were vital and potentially the key to helping prevent, cure, manage and treat diseases...especially tough and rare ones like brain tumors and pancreatic cancer... They also told me biospecimen banking and its related components were kind of like an orphan area of research in terms of organized support and infrastructure. pancreatic cancer and many other disease areas sorely needed help with better means of collaborating, sharing, organizing, collecting, and using biospecimens. Well for me, that sealed the deal... the deal in terms of what catches my attention and where to direct my energy...any obstacle that stands in the way of progress for patients is fair game for obliterating the obstacle so we can all move on to other challenges. For the next three years or so, I tried to gather and learn as much as I could from a patient advocacy standpoint. I convened a meeting with NCI funded investigators in pancreatic and GI cancers through the Specialized Programs of Research Excellence program to get everyone into the same room so we could share ideas and explore ways to address the key issues. I learned there is great diversity in opinions, approaches, methodology, and willingness or not to collaborate. Since then, I have come to appreciate this convergence of diversity is not unique to the pancreatic cancer community, in fact, it is common in just about every research related effort I have been involved in since. It is the research version of "variety is the spice of life." My research colleagues told me about innovative approaches used in other diseases like alzheimers disease and juvenile diabetes for addressing biospecimen needs for research and suggested similar efforts were needed for pancreatic cancer and other underserved diseases...made sense to me. In March 2002, as a member of the Research Team of the then National Dialogue on Cancer, now C-Change, co-chaired by former President and Mrs. George H.W. Bush and Senator Dianne Feinstein of California, I was part of the National Dialogue on Cancer Research Team Forum I held in Bethesda, MD to identify barriers and obstacles to research progress. Much of the vision and leadership for this Forum and subsequent biospecimen related efforts came from Dr. Anna Barker, NDC Research Team Chair and Deputy Director of the National Cancer Institute, and supported by then NCI Director Dr. Andy von Eschenbach. Dr. Barker's team also included strong leadership from Dr.'s Julie Schneider and Gregory Downing. Nearing the end of this groundbreaking Research Forum I, it was decided that each of us could self-select our "obstacle" topic of choice to work on and it should come as no surprise that armed with my aforementioned and newly obtained awareness about the importance of biospecimens in research, that I self-selected myself on the team that would tackle that issue. The NDC Tissue Access Working Group (TAWG) was born and our job was to investigate the barriers involved in tissue access and explore possible avenues for improvement. No sooner did we get our group organized and I found myself on the receiving end of an invitation to serve as a co-director of the TAWG with Dr. Jeff Trent (of TGen). I had to ask myself, was I up for the challenge? Being a non-scientific layperson representing the patient advocacy community was a fair amount of responsibility and I really didn't want to screw it up. There is a certain burden of responsibility that any active advocate will tell you is always with us in research settings amongst researchers, and that is to assimilate and contribute to their "research world", (which is really the world for all of us...) while objectively representing the "patient advocacy world", and helping everyone not lose sight of the real goal and real "world" which for me, is all about the patient. Add to this, the fact that by then, I had begun to get a sense of the academic debates and posturing that was taking place around biospecimens and you can imagine my sense of trepidation about taking on a leadership role in the TAWG. I am always drawn to opportunities of contributing to the creation of something from nothing to meet a need, so on that level, I accepted the invitation and know that I was driven in some ways by my instincts which told me this felt like the right thing to do, Dr. Barker provided some very convincing rationales, and I was excited about the potential upsides for research and patients if we could really pull it off. We convened several times over the next twelve months and the NDC Forum II was held March 5, 2003 for all groups to report their progress and strategize next steps. At Forum II we had an opportunity to really look outside the United States borders for some additional clues in how to proceed...or in simple terms, how to help dress the emperor. Countries like the UK, Wales, and Singapore were much further along in their process of developing and adopting national strategies around biospecimen banking including financial and regulatory support from their respective governments. Their elected officials understood and were paving the way for the good of not only the researchers and science, but for the good of the public health and welfare that they are elected to serve. Keep in mind, the United States did not then and still does not yet have a fully developed and fully funded national plan for biospecimens...but the NCI is working on it... and not a day too soon. It became quite evident that the development of a national tissue resource was more than just something to debate academically ad nauseam...it was really something that needed to be done...yesterday. The NDC TAWG then worked to get a clear goal in its' sights and came up with .. “establish a national, pre-competitive, regulatory compliant and genetic privacy protected, standardized, inclusive, highest quality network of biological sample(s) banks; supported by and developed via novel financial and other partnerships with cancer survivors and advocates, the private sector and nonprofit organizations as appropriate; that is shared, readily accessible, and searchable using state-of-the-art informatics systems (e.g., amenable to molecular profiling capability).”(Source: NBN Blueprint; 1. Why The National Biospecimen Network; Page 2 ) Now with a goal in hand, the task was to move vision into reality. The NBN Design team was assembled and engaged in a flurry of activity between May and July 2003 to shape and engineer the National Biospecimen Network blueprint, as a biospecimen resource to optimize and accelerate the development of interventions for cancer. There was a fair amount of discussion in the scientific and academic community about the audacity and far reaching nature of this goal. Wearing my advocacy hat, the goal made total sense to me and my only question was, when do we get started. I was not concerned with whether or not it could or should be done, and I was puzzled and sometimes downright disappointed and angry with the schisms, angst and lack of participation from quite a number of folks (mostly from outside the patient advocacy community) who spent more time questioning and criticizing our efforts, but not caring enough about the issue and potential for patients, to show up and step up to the plate to work with us as part of the solution. Nothing and I mean nothing is ever perfect and ready for prime time in research and this ongoing effort to develop a national system for biospecimens is no exception. Not having all the answers at hand for how to solve a problem is a sorry excuse for not getting started at all. Our being ambitious was not to be confused with being cavalier or naive about our odds for success. It simply meant we had the wisdom to know we could do better than what existed at the time and the will to try and change it... Coming soon, we will continue with a bit of history and perspective with where the rubber hit the road...and the NBN journey towards a plan.
About Biospecimens All Information from the National Cancer Institute's Office of Biorepositories and Biospecimen Research (OBBR) Website Biospecimens are biologically-derived materials — such as tissue, blood, urine — used for diagnosis and analysis. When cancer patients undergo procedures such as biopsies or surgery in which malignant tissue is removed for diagnostic or therapeutic purposes, it is often possible for a small amount of the excised specimen to be stored and later used for research. Many patients have given consent for their biospecimens to be applied to research, in the hope that the resulting knowledge might help other patients in future years. Biospecimens are stored in “libraries” known as biobanks or biorepositories. There are thousands of biorepositories in the United States, which vary widely in their size, nature of biospecimen collections, and purpose. RAND: Handbook of Human Tissue Sources Human biospecimens can provide a bridge between emerging molecular information and clinical information, by enabling researchers to study the molecular characteristics of actual disease, and then correlating those patterns with what is known about the clinical progression of the disease. Specifically, human biospecimens can be used to: - Identify and validate drug targets
- Identify disease mechanisms
- Develop screening tests for “biomarkers” associated with certain sub-types of a disease
- Group patients based on their genetic characteristics and likelihood of positive response, for testing of new drugs
- Group patients based on the “biomarkers” of their disease to determine which treatment is appropriate
Consider Donating a BiospecimenIf you are scheduled to have a biopsy or surgery, you may be asked prior to the procedure if you would consider donating a biospecimen for research. You will receive a brochure describing how the process works, as well as a consent form for your review. Such donation is entirely voluntary, and regardless of your decision to donate or not, there will be no impact on the surgical procedure itself. | |
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