a large number of often disease-specific, large-cohort studies that collect biosamples. A preliminary estimate of the number of such studies involving more than 5,000 subjects was 139 altogether—90 domestic and 49 international, with some 5 million people involved. These studies are not integrated or standardized, yet the government investment in them could be of great public interest and use.

The collection, storage, and use of biological specimens in biobanks offers the opportunity to look at risk and exposures prospectively as well as retrospectively in a representative sampling of a large population. Biobanks also can be mined in new ways as technology and concepts develop. However, several barriers exist with regard to biobank development, maintenance, and use, including confidentiality concerns when obtaining consents for broad-based studies or sharing of samples, a lack of standardization for collection, handling, and storage, limitations based on the sampled population, and the overall expense.

By examining the NIH’s efforts in the area of biobanks and large cohort studies, a number of possible opportunities to improve or leverage the investments that have been made present themselves, said Insel. The samples that are collected could be improved by thinking about how to sample a population that is actually representative of the United States. Standardized approaches in terms of consent, the kinds of information collected, and the handling and distribution of samples, according to Insel, all could lower some of the barriers to the greater use of biobanks. Additionally, the experiences of other countries in establishing and using biobanks offer lessons for the United States as it moves forward.

In the area of biomarkers, four years ago the Foundation for NIH launched the Biomarkers Consortium as a joint effort with the Food and Drug Administration (FDA) and pharmaceutical and biotechnology companies. The consortium, which now has a large number of for-profit and not-for-profit partners, is organized around four steering committees in the areas of neuroscience, cancer, metabolic disorders, and other disease or scientific areas. The goals of the consortium are to develop biomarkers for diagnosis and treatment, and there already have been a number of examples of success. Funding has come largely from industry, with NIH providing samples or other support.

The consortium provides a valuable opportunity to share resources, said Insel, and the involvement of FDA has great advantages, but there have been barriers to progress. One has been a clash of cultures. “The academics are looking for papers, the industry reps are looking for products, and the NIH folks are often arguing about whether there’s public health impact,” said Insel. There also have been issues about discovery versus the development of biomarkers and about whether industry representatives can speak for their companies. Garry Neil added that “there’s been a lot of



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