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Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development: Workshop Summary (2011)
Board on Health Sciences Policy (HSP)

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. "1 Introduction." Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development: Workshop Summary. Washington, DC: The National Academies Press, 2011.

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Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development: Workshop Summary

States (Eiseman and Haga, 1999) (Table 1-1) and an informal survey Ginsburg conducted among colleagues before the workshop found that one major pharmaceutical company enrolls about 32,000 patients per year in clinical trials and an academic health center reported 45,000 patients in trials and registries in 2010, although each collects specimens from only a fraction of those patients. Additionally, a recent survey by Willett and colleagues (2007) revealed that roughly a million specimens are associated with large U.S. cohort studies for which clinical data exist. Based on these surveys, Ginsburg estimates that millions of biospecimens in the United States are linked to at least some phenotypic information, but access to these samples is limited, and the biobanks tend to be fragmented and isolated. “Samples are widely distributed and nobody actually knows where they are [and], for a lot of them, what they are,” said Ginsburg, “with limited access even among investigators in the academic health center enterprise.” Thus, immense benefit could be realized if a framework were developed that would allow these samples to be pooled together and shared precompetitively in a collaborative venture.

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