Abstract 5078: The NCI-NIST-FDA effort to develop fitness-for-purpose biospecimen assessment standards: Development of quality assessment metrics and standards for optimal biospecimen utilization

Abstract

Abstract The US Congress, through recent health care reform legislation, has directed the National Institutes of Health (NIH) to formulate a more aggressive strategy by which to translate scientific discoveries directly into the development of novel therapeutic and diagnostic capabilities. The National Cancer Institute (NCI) seeks to facilitate these efforts by targeting specific bottlenecks caused by the lack of standardization, quality metrics, and comparative benchmarks for research and clinical biospecimens used throughout the relevant discovery and validation pipelines. Many of the bottlenecks that currently impede routes to more effective biomarker discovery as well as drug, biologic and device development are impeded by a current lack of standards surrounding the research biospecimens used to advance this type of research. The National Institutes of Standards and Technology (NIST), the Food and Drug Administration (FDA) and the NCI have engaged in an interagency effort to develop fitness-for-purpose quality assessment tools and metrics for the research biospecimens used by the clinical research, diagnostics, and technology development communities. An interagency workshop was convened consisting of biomedical and biospecimen scientists, standards/metrology scientists, commercial assay developers, experimental design and research methods experts, statisticians, and regulatory scientists that are among the leaders in their field. Subsequent to that workshop, a number of specimen quality assessment metric development projects were initiated to target metrics and standards that would have a significant impact on the development pipelines for diagnostics and therapeutics development, including the incorporation of certain regulatory efficiencies that could potentially accelerate development. The NCI would like to present these ongoing projects and share ideas for future biospecimen quality assessment standards development projects for the cancer research, diagnostics, and technology development communities. Progress in designing such projects and preliminary results from experiments discussed in the October workshop will thus be described. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 5078. doi:10.1158/1538-7445.AM2011-5078