An NCI Perspective on Creating Sustainable Biospecimen Resources

With the rapid growth in knowledge of the molecular basis of both disease and health status, biomedical research and health-care delivery are shifting toward a vision of "personalized medicine." The vision of "personalized medicine" is to improve the standard of medical care by including an individual's genetic and molecular information in the clinical decision-making process. This molecular information holds the potential to highlight individual differences among patients with the same disease and enable health-care pro- viders to predict a patient's response to therapy, thereby prospec- tively guiding the plan for treatment and eliminating trial-and-error approaches. High-quality biospecimens with appropriate clinical annotation are critical in the era of personalized medicine. It is now widely recognized that biospecimen resources need to be developed and operated under established scientific, technical, business, and ethical/legal standards. To date, such standards have not been widely practiced, resulting in variable biospecimen quality that may compromise research efforts. The National Cancer Institute (NCI) Office of Biorepositories and Biospecimen Research (OBBR) was established in 2005 to coordinate NCI's biospecimen resource activities and address those issues that affect access to the high-quality specimens and data necessary for its research enterprises as well as the broader translational research field. OBBR and the NCI Biorepository Coordinating Committee developed NCI's "Best Practices for Biospecimen Resources" after consultation with a broad array of experts. A Biospecimen Research Network was established to fund research to develop addi- tional evidence-based practices. Although these initiatives will improve the overall availability of high-quality specimens and data for cancer research, OBBR has been authorized to implement a national biobanking effort, cancer HUman Biobank (caHUB). caHUB will address systematically the gaps in knowledge needed to improve the state-of-the-science and strengthen the standards for human biobanking. This commentary outlines the progressive efforts by NCI in technical, governance, and economic considerations that will be important as the new caHUB enterprise is undertaken.