This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. ABSTRACT IMPACT: Chronic kidney

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... ase (CKD) affects ~15% of the US population and the majority of patients are diagnosed too late to benefit from early intervention. We are developing a new diagnostic imaging tool (RadioCF-PET) for the kidney to enable early detection of diseases and to monitor overall kidney health. OBJECTIVES/GOALS: Nephron mass, or the number of functioning nephrons, is a measure of the functional capacity of the kidney. RadioCF-PET may enable early detection of nephron loss in patients with or at risk of CKD before changes are clinically detectable, facilitating early interventions to improve outcomes in these patients. METHODS/STUDY POPULATION: RadioCF-PET, labeled with Cu-64, has the advantage of using sub pharmacological doses for imaging, carrying low risk and can be used with the FDA's exploratory IND (eIND) mechanism for early in human testing. We are developing the technology to be used in pre-eIND toxicology and pharmacology studies. We are also developing other aspects of translational science to propel this technology toward translation, including: market analysis, critical path to market, customer discovery, and