The Future of Biobanking Relies on the Quality and Viability of Biospecimens

The theme of collaboration carried over into day three and four presentations at the ISBER Annual Meeting, from the role of industry in biobanking and the importance of collaboration between academia and the corporate sector to the importance of global biobank networking. Throughout the conference, in asides by presenters and conversations among attendees, another theme began to emerge: the lack of information about quality and viability of biospecimens.

• A roundtable led by Dr. Mark Cosentino of NCI Frederick was tasked with addressing the topic "Repository Science: Establishing a New Scientific Discipline." A packed table engaged in a discussion that covered degree types, funding, and oversight of educational programs to train repository scientists, but talk quickly turned to curriculum: how can biobanking scientists be trained without knowledge of appropriate biospecimen processing, handling, and storage for a variety of analyses? Participants were unanimous that much more information on biospecimen science is absolutely essential to train effective biobanking scientists.
• At poster sessions, there was a similar sentiment – not only is more information needed about biospecimen science, it is needed through a consolidated, open access resource. After walking me through her poster on varying RNA levels in breast tumor tissues collected by different protocols, Rebecca Barnes of the British Columbia Cancer Agency’s Tumor Tissue Repository noted that studies like hers were being performed by other researchers around the world, but it is difficult to know who is studying what and what the results mean without a clearinghouse or forum for information sharing.
• Carolyn Compton of OBBR at NCI and David Horsfall of the Australian Prostate Cancer Bioresource presided over a panel of speakers whose talks addressed the impacts of packaging, fixation, specimen type, and length of storage on biomarkers. One of the key panel presentations was given by Barbara O’Brien of Westat; she presented a study that focuses on stability testing of biospecimens in conjunction with the National Children’s Study (NCS). NCS will examine the effects of environmental influences on the health and development of 100,000 children in a 21-year longitudinal cohort, beginning pre-conception with sample collection and analysis from parents. The collection schedule and length of study mean that NCS will collect literally millions of samples in the first years of the study. To ensure the validity of data generated from these biospecimens, Westat will undertake long-term stability testing of samples collected from parents of study subjects. Sample specimens to be assessed include urine, saliva, vaginal secretions, hair, blood and blood derivatives, toenails, and breast milk, and Westat will evaluate the stability of dozens of analytes in each of these matrices over the course of the 21-year study. The results of this assessment will add a considerable body of evidence to the field of biobanking and biospecimen research.

The success of biobanking as a tool in fighting disease requires more insight into the properties of different types of biospecimens and how these should be collected, processed, and stored to preserve key biomarkers. Piece-meal studies alone would not address this need; instead, a coordinated effort, with data sharing and public access to findings, is necessary to ensure that this knowledge is appropriately applied. We look forward to ISBER’s leadership in paving the way to bridging this critical gap in scientific knowledge.

-- Kate Blenner, FasterCures, Program Analyst

Global Biobanking Collaborations: Challenges and Opportunities

Blogging from the ISBER 2008 Annual Meeting

The ISBER annual meeting theme of collaboration rang true at the opening plenary session and echoed throughout Monday’s program. Cooperation and harmonization among biorepository resources could bolster the scientific toolkit for understanding disease cause and treatment response.

Dr. Francis Collins, Director of the National Human Genome Research Institute (NHGRI), an esteemed scientist and luminary, provided the keynote address, outlining several pioneering projects that, with the use of biospecimens and collaboration, would inform our understanding of disease to unlock clues for developing cures. These projects include an international cancer genomics consortium that would collectively sequence 50 different tumor types, yielding molecular data to drive development of more targeted diagnostics, therapies, and prevention mechanisms. It also includes the 1000 Genome Project, an effort between the Wellcome Trust Sanger Institute, Beijing Genomics Institute, and the NHGRI that will sequence genomes from 1000 people. With this detailed information, researchers can better understand at a molecular level why some people contract certain diseases and others don’t, and why some treatments cure disease and others won’t.


Monday’s program highlighted global collaborative efforts, including:

• iBOL (International Barcode of Life) project involving 25 countries that aims to develop DNA barcodes that will allow for automated species identification and thus more active management of biodiversity;
• Asian Network of Biological Resource Centers that serves as a collection of microbial cultures across China, Japan, Thailand, and Korea; and
• Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) that intends to facilitate transnational collaboration, reduce fragmentation in the biobanking industry, and provide access of resources across academia and industry across the European continent.

Perhaps even more uplifting were discussions of not only collaboration, but also current and future activities to promote harmonization across biobanks. The lack of standards and practices across biorepositories is probably the most significant hindrance to realizing these resources' full contribution to the scientific process. An organization called P3G (Public Population Project in Genomics) is an international consortium whose members are public organizations undertaking large-scale genetic epidemiological studies and biobanks across North America, Europe, Asia, and Australia. P3G serves as a repository of information and tools and is developing tools such as their DataSHaPER (Data Schema and Harmonization Platform for Epidemiological Research). P3G notes that DataSHaPER is a comprehensive set of variables that should be collected by large epidemiological studies and biobanks for general-purpose biomedical research. The aim of the DataSHaPER is to provide a template to facilitate harmonization between biobanks and support the design of emerging ones. A future DataSHaPER will be developed for cancer as well.

The first two days of the meeting resonated with it's intended theme and demonstrated some impressive and ambitious collaborative efforts. The introduction of even early harmonization tools shows promise in unifying resources across institutions, countries, and continents. I look forward to tracking the progress of these efforts closely.

- Melissa Stevens, Director of Special Projects, FasterCures

Who is Ted Kennedy?

Two weeks ago, I testified before Sen. Ted Kennedy’s HELP Committee on the state of cancer research today. Lance Armstrong, Steve Case, and Elizabeth Edwards were some of the other witnesses. I brought my 16 year old daughter, Kalli, and my 18 year old son, Reid with me to observe the hearing. They were both excited to meet Lance and Steve in particular. When I told them they would meet Sen. Kennedy too, Kalli asked “Who is he?” I was dumbfounded. I had no idea where to start. He and his family have been at the center of American – and world – politics my entire lifetime. How was I to relate his career to my daughter’s generation?

I explained to Kalli who the Kennedy family was (she knew John Kennedy’s story) and then I realized the only answer I could give was that Ted Kennedy is simply the most successful and important legislator of the last 40 years. In lectures I give on how to advocate successfully in Washington, I always cite Kennedy as the most successful person in town in getting not what he wants every year, but what he needs – and after a while that meant that he has gotten a lot of what he wanted.

The news of Sen. Kennedy’s tumor so soon after he held a hearing to explore how to help others with this kind of tumor (Steve Case’s brother Dan died from a glioblastoma) and every other form of cancer is too poignant for comment. All of us at FasterCures hope and pray that Sen. Kennedy recovers as quickly as possible. All of us need him. We cannot afford to lose a warrior like Ted Kennedy in the fight against cancer.

Greg Simon, President, FasterCures

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Pre-ISBER Thoughts

In preparing for next week’s International Society for Biological and Environmental Repositories (ISBER) Annual Meeting, I recall some of the key takeaways from March’s Biospecimen Research Network Symposium "Advancing Cancer Research Through Biospecimen Science". The most startling came from Dr. Anna Barker’s opening remarks in which she noted that "of the 350 million specimens collected in the United States, only 30 percent of them were of a quality standard high enough for research purposes." And, we’ve actually heard other experts say that the number of viable samples could be even lower.

What if only 30 percent of the emails we sent everyday actually left our outboxes? What if our metro trains came only 30 percent of the time they were supposed to? That would make for a very unproductive world.

NCI’s Office of Biorepositories and Biospecimen Research (OBBR) brought together leaders in the field to discuss the challenges and recommend solutions. A number of the symposium speakers highlighted the variance in quality and study results across institutions and handling scenarios all underscoring the need for standard operating procedures. Carolyn Compton, Director, OBBR, outlined NCI’s role in elevating quality and Elizabeth Hammond, Professor of Pathology, University of Utah, presented a strong call to action for job aides, standard training, sharing of research, developing financial incentives, and implementing a biorepository “Goodhousekeeping Seal of Approval. ”

I hope the ISBER meeting could bring more focus to these calls to action in a global context. I am looking forward to discussing how international harmonization strategies can contribute in raising specimen quality. I am also very much looking forward to discussing communication strategies for engaging patients who are critical variables in the research equation. Most importantly I am looking forward to understanding how the global community can advance biorepository efforts to in turn accelerate medical solutions.

Check back next week as my colleague Kate Blenner and I bring you highlights from the ISBER meeting.

Melissa Stevens, FasterCures Director of Special Projects

Chronic Disease and Health Reform

With more than a hundred organizations from different industries, disciplines, and sectors committed and involved, The Partnership to Fight Chronic Disease in a year’s time, has effectively positioned itself to inform the nation’s health reform agenda and focus it on the role of chronic disease prevention. FasterCures is proud to be part of this partnership.

An April 2008 Kaiser Family Foundation poll found that healthcare costs rank among Americans’ top personal economic problems, and their struggles to deal with those costs have affected both their financial well-being and their family’s healthcare.

Healthcare issues top domestic policy concerns. Presidential candidates trumpet their respective healthcare reform proposals. And yet, while Americans are interested in hearing about how to make healthcare more affordable, improve delivery of care, and ensure access to the best treatments, many still do not understand the breadth or depth of the problems plaguing our healthcare system.

The Partnership makes the case that meaningful healthcare reform should center on addressing the problem of chronic disease, specifically on preventive interventions that focus on lifestyle choices. Its 2008 Almanac of Chronic Disease released today paints a grim picture of just how unhealthy we are as a nation. But, grim as it may be, the Almanac’s staggering statistics will help increase overall understanding of the burden of chronic disease and its effect on the way we live, the way we work, and the way we do business. Chronic diseases:

• Affect more than 130 million Americans directly;
• Account for 7 in 10 deaths;
• Account for more than 75 cents of every dollar spent on healthcare, and nearly two-thirds of the growth in healthcare spending over the past 20 years; and,
• Cost the U.S. economy $1 trillion a year in lost productivity.

What further exacerbates this problem is the reality that more than half of Americans have one or more chronic diseases. As our medical research enterprise continues its important work in studying these chronic diseases, we need to ensure efforts are in place to accelerate the research process to move it from the studying these diseases to curing these diseases.
The human and economic toll of chronic disease on patients' families and society is enormous. A Milken Institute report, An Unhealthy America: The Economic Burden of Chronic Disease -- Charting a New Course to Save Lives and Increase Productivity and Economic Growth, released in October 2007 and featured in the Almanac, quantified the economic and business costs of chronic disease: the potential impact on employers, the government and the nation's economy. The report estimated that:

• The total impact of these diseases on the economy is $1.3 trillion annually.
• Of this amount, lost productivity totals $1.1 trillion per year, while another $277 billion is spent annually on treatment.
• On our current path, in 2023 we project a 42 percent increase in cases of the seven chronic diseases.

Tackling the enormous burden of chronic disease is a daunting task. The silver lining is that now that we are armed with data, supported by collaborative efforts of all partner organizations, and have the attention of our nation’s policy and decision-makers, we have a chance to chart the course for meaningful health reform.
FasterCures looks forward to continuing to be a part of this important effort.

--Cecilia O. Arradaza, FasterCures, Communications Director