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

The Alzheimer's Fight

"I'm not going down without a fight," said Jackson, who often pleads for more money for research and treatment. "It's time to find, if not a cure, at least better medicine so people will live through this better." - Washington Post, Man With Alzheimer's Fights 'Family Disease': 5th-Generation Patient Copes With Early Onset, May 14, 2008.

Yesterday’s Washington Post highlighted the strife of Chuck Jackson, a man diagnosed with Alzheimer’s disease at age 50 and dedicating his life to advocating for research and treatment for the disease. The article notes that 5 million Americans live with this disease, but through our own research of this disease for the FasterCures’ Philanthropy Advisory Service program, we know that the Alzheimer’s Association projects this number to alarmingly double (and even triple) by 2050. This disease was the 7th leading cause of death in 2004 and results in $100 - $180 billion of economic costs for our nation each year.

Because there are so many unanswered questions about Alzheimer’s disease, there are even more areas of research to explore for answers and solutions, including:

• Etiology or cause of the disease, specifically with respect to the protein plaques and tangles in the brains of Alzheimer’s patients;
• Risk factors associated with patient populations, such as the genetic predisposition that Chuck and his family have towards this disease; and
• Biomarkers to better diagnose and monitor the progression of the disease.

Right now the only accurate diagnosis method is via brain autopsy.

Going beyond the current drugs available, there is research ongoing about treatement that target the protein plaques and tangles that are believed to be the fundamental cause of the disease, as well as how to best deliver care to patients suffering from this disease. Through the Philanthropy Advisory Service FasterCures hopes to help philanthropists identify high impact areas for Alzheimer’s disease research and channel nonprofit research funding to those areas. We also know that research and treatment of this disease could be tremendously helped through the development of a centralized map of research activities across sectors in order to identify priority areas for development. Other strategies include educating patients to build awareness of the importance of participating in clinical trials and engaging regulators about how to accelerate the approval of Alzheimer’s disease therapies.


We're glad that U.S. Senate Special Committee on Aging convened yesterday's hearing on Alzheimer's disease. We join the rest of the nation in anxiously awaiting the report of the Alzheimer's Study Group. We need a national strategy to accelerate research into new Alzheimer's treatments. We owe it to Mr. Jackson and to the more than 5 million people with Alzheimer's disease and their caregivers.
Melissa Stevens, FasterCures Director of Special Projects

The “War on Cancer” 37 years later

The U.S. Senate HELP Committee heard a resounding cry to reinvigorate the war on cancer. The Committee convened a hearing on “Cancer Challenges and Opportunities in the 21st Century,” as part of Sens. Kennedy and Hutchison’s legislative efforts to look into a comprehensive approach to cancer research, prevention, and treatment.

Bipartisan efforts in 1971 led to President Nixon’s announcement of the “War on Cancer.” Now our society faces what Senator Kennedy called "a perfect storm of conditions that increased the number of people living with cancer today – aging population, environmental issues, increased life expectance, and unhealthy individual behavior." And still, 37 years since we waged the war on cancer, it continues to be the second leading cause of death in America.

• Cancer will claim over 565,000 Americans in 2008, more than 1,500 people each day
• There will be 1.4 million new cancer cases in 2008

Arguing that the nation can no longer afford the human and financial toll from cancer, FasterCures President Greg Simon told the Committee that “we cannot fight this war on cancer with the strategy we’ve got. We’ve got to fight it with the strategy we need.”

Some of the strongest advocates in cancer care, prevention and treatment presented the Committee with some key points to consider as they pursue this effort:

• Lance Armstrong, Chairman and Founder, Lance Armstrong Foundation: “This opponent is probably tougher than anything we'll ever face… Cancer doesn't care if you're Republican or Democrat, young or old, black, white or Native American, rich or poor. It comes and it comes hard, and it is ruthless and relentless.”
• Elizabeth Edwards, Senior Fellow, Center for American Progress and wife of former Senator John Edwards “We have chosen as a nation to turn our backs on some of us who have cancer. We need to acknowledge that health insurance matters and lack of insurance changes health outcomes.” She urged the Committee to “reform healthcare responsibly, morally and aggressively and save millions of us.” Steve Case, Chairman and CEO, Revolution Health: “Policies now in place limit collaboration and slow innovation…we should not prevent NCI from pursuing the most effective model to find a cure for cancer.”
• Ed Benz M.D., President, Dana Farber Cancer Institute: “The American public has made an investment in cancer research unequalled by that of any other nation…We have the opportunity, now, to honor that investment by ensuring a level of funding that will bring the promise of current cancer science to fruition.”
• Greg Simon, President, FasterCures: pointed out that all cancer research organizations face the same problems regardless of the diseases they focus on. “We need to devise a system to cure diseases. We need to bring the appropriate tools to this problem, whether it is human or financial capital.”
• Hala Moddelmog, President and CEO, Susan G. Komen for the Cure: In talking about where we stand on cancer research and policy, said “this balkanization of body parts is not necessary…We are facing a cancer crisis in our investment in prevention and early detection of cancers; a crisis in our dedication to innovative cancer research; and a crisis in patient access to the highest quality cancer care and treatment.”

Here’s hoping this hearing will spur the development of the right strategy to wage a war against cancer that we could and should win. The troops are at the ready.

It’s All About Collaboration

From a distance, the scene could’ve been another day at middle school, with students scurrying in the hallway to get to one classroom from another. Except, we’re in the Beverly Hilton Hotel and the 3,000 or so people scurrying from one ballroom to another are no middle schoolers – they’re some of the most extraordinary people in the world: executives, academic experts, government officials and Nobel laureates. Almost all sectors of the global economy are represented here. What struck me most is the common thread that seemed to permeate each of the more than 130 sessions and discussions: the strong desire and need to collaborate.

Amidst the diversity of expertise and opinions, these influential thinkers and doers of our time recognize the need for and recommend more collaborative efforts – whether it’s across industries, beyond borders, or between public and private sectors. They all share the drive to find and implement workable solutions to some of our most serious challenges. And they’re all committed to sharing the enormous task of being the change agents themselves.

Here’s a glimpse of how collaboration echoed throughout a broad spectrum of sessions:

* Nobel laureate Muhammed Yunus presented the “social business” model to revolutionize healthcare in the developing world. He underscored the need to consider community-based strategic financing mechanisms to motivate the development of new therapies for global disease.
* In a discussion on eliminating malaria as a global threat, the panel that included Peter Chernin, President of News Corporation said that sustained political will, and building of health systems and infrastructure in developing countries were critical to efforts to control malaria. And, this could only be realized through collaborative efforts between governments, as well as between governmental agencies and NGOs.
* A panel which included FDA Commissioner Andy von Eschenbach examined the pharmaceutical pipeline and identified some of the reasons for why the pipeline is drying out. The barriers to innovation are many and include standards for tissue collection, better designed clinical trials, and increased human capital to tackle these problems. Breaking down these barriers to improve the chances of more advancement requires substantial, sustained commitment from both private and public sectors.
* And, in a luncheon discussion between Mike Milken and the “governor of the planet,” Gov. Arnold Schwarzenegger about California’s current infrastructure, the governor stressed the need to rebuild the state in the next 20 years. He emphasized the importance of expanding public-private partnerships; working with other governors; and learning from the best practices the world has to offer.

Throughout the Global Conference, participants had numerous opportunities to get to know, get reacquainted and become engaged with FasterCures and our programs. A few minutes before Mike Milken and Gov. Schwarzenegger’s discussion, Greg Simon presented a powerful overview of FasterCures and its programs. The strength of FasterCures is in its innate ability to spur and drive collaboration among otherwise siloed entities involved in medical discovery.

Visit the FasterCures Web site for session summaries and conference highlights.