Issue Date: February 11, 2008
NCI Leads Push To Standardize Management Of Biological Specimens
Personalized medicine starts with biological specimens. They are the raw materials, and the raw materials are a mess.
The collection, storage, and use of biological material in clinical research reflect the nature of that research. Nearly all of the activity is done for a specific project at one clinic according to protocols established by researchers working only on that project. The quality of materials in most biobanks—long-term storage facilities for biological materials—is inconsistent.
"The biomarkers essential to personalized medicine will come about through the study of tumor tissues and DNA in biobanks," notes Greg Simon, president of the advocacy group Faster Cures. "But the biobanking world is very fragmented." Researchers routinely invent their own methodologies for collection, storage, and freezing of materials, as well as for making specimens available to other researchers in the kind of collaborative efforts needed to advance personalized medicine. "We have nothing near the standards we need for a national system of biobanks," Simon says.
Roy S. Herbst, chief of thoracic medical oncology at the University of Texas M. D. Anderson Cancer Center, agrees. "We need to standardize the way we collect tissue, and we need to educate first responders—the clinicians who take the biopsies," says Herbst, who is codirecting a personalized medicine research effort on lung cancer called Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination, or BATTLE.
Led by the National Cancer Institute, the health care industry is starting to discuss standardization.
"Without high-quality biobanking, there will be no personalized medicine," says Carolyn Compton, head of the office of biorepositories and biospecimen research at NCI. "Personalized medicine means designing therapies and diagnostics based on the particular molecular makeup of a disease. The molecules are in the cells, and the cells are in the biological specimens. Getting high-quality data from biobanks is the basis for the personalized approach and the sine qua non of translational research."
And biobanks need to catch up with research, Compton maintains. "Biobanking to date has only been as labor intensive as needed to produce the quality of specimen for a given purpose," she says. But as technologies have become more sensitive, they have raised the quality bar for the specimens being analyzed.
NCI has published a set of best practices, starting with basic policy documentation. "The standard will not be one-size-fits-all," she says. "But the first step to establishing harmonization across the country is to get people to state what their current policy is—to write it down and make it transparent."
Collaborative research, however, will not wait. NCI has launched a $100 million program in partnership with the National Human Genome Research Institute to dig into the genetic material on three cancers???brain, lung, and ovarian. Called the Cancer Genome Atlas, the project is bringing together a league of academic researchers from across the U.S., armed with the latest high-throughput screening technology, to look at the genome of these cancers, broadly and deeply. Researchers will pool and integrate data from all platforms and make them publicly available.
"Much like the Human Genome Project, we are trying to give researchers a new lexicon," Compton says.
The research world is bracing itself. Gordon B. Mills, chairman of the department of molecular therapeutics at M. D. Anderson, says Atlas is the next big thing. "It's cutting-edge stuff." He adds that while the research community is anxiously awaiting the results of the project, it is also bracing for a "tsunami" of data.
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