The NBDA concept has been nearly two years in development and was officially launched at the National Press Club January 13, 2014 in Washington, DC.
To identify and understand the specific barriers in biomarker development from discovery through translation into clinical trials and ultimately clinical practice, the NBDA sought expert advice and council from trans-sector groups of national and local experts through workshops, think tanks, and local meetings and other local scientifica organizations*. During the past year, the NBDA brought together experts in think tanks and workshops to both define a rational NBDA biomarker development pipeline and to identify the major barriers that negatively impact progress in each of the individual phases (modules). In collaboration with these groups of experts, the NBDA has undertaken analysis of each of the biomarker development “modules” and organized its initial work around four classes of biomarkers: genomic, proteomic, imaging, and complex or multi-component bio-signatures. In addition, the NBDA will assemble and/or develop “standards” based on six major components of biomarker discovery and development: the clinical question; sample quality; technology platform standards; experimental/clinical trials design; data quality and analysis. Several demonstration projects, representing the targeted biomarker classes, are entering late stage planning and will be launched in early 2015.