I-Corps: Radiotracer Synthesis Commercialization

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The proposed I-Corps project involves bringing advantageous new methodologies for synthesis of [18F]-labeled molecular imaging agents into the clinic. The proposed activity builds upon fundamental discoveries in synthetic chemistry that were made possible by prior NSF funding. In the current project the team assesses the suitability of newly developed and demonstrated technology as the basis for forming a startup enterprise. Activities to be performed during the 6 month funding period will include market assessment, evaluation of the intellectual property surrounding these inventions, and extensive direct contacts with potential customers, licensees, and competitors. These activities will be guided and informed by the curriculum of the I-Corps program. Positron Emission Tomography (PET) is a powerful, noninvasive diagnostic molecular imaging technique. For most PET applications, [18F]fluorinated radiotracers are preferred. The short half-life of this isotope of fluorine (~110 min) requires relatively complex compounds to be prepared and distributed under significant time constraints, while still providing the excellent image quality, compliance with FDA good manufacturing practices, and acceptable radiodosimetry typical of short half-life radionuclides. One such compound, [18F]- 2-fluoro-2-deoxyglucose (FDG), now accounts for the almost all of the [18F]-PET imaging market, estimated to be approximately $500MM/yr in the United States and provides significant support for the clinical management of cancer patients. Unique technology developed in the laboratory will permit rapid and efficient production of additional very high specific activity fluorinated PET compounds for which clinical use has been constrained by the limitations of current radiochemical synthesis methods. The new technology to be advanced in this project provides commercially compatible synthetic pathways and new chemical intermediates for the synthesis of [18F]-labeled imaging agents that can be used to evaluate the pathophysiology of specific cellular receptors in the brain and in the heart, to localize and stage tumors, and to assist in cancer management by monitoring patients' responses to therapy.