Clinical Research: The Future of the Molecular Imaging Technologist—A White Paper Presented by Members of the Graduate Stakeholders Committee of the SNMMI Technologist Section

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dc.contributor.author Holbrook, Scott
dc.contributor.author Baldwin, John
dc.contributor.author Gilmore, C. David
dc.contributor.author Henkin, Robert
dc.contributor.author Hubble, William
dc.contributor.author Kiss, Christina
dc.contributor.author Bires, Angela M.
dc.contributor.author Mann, April
dc.contributor.author Nelson, Kasey
dc.contributor.author Owen, Mary A.
dc.contributor.author Sobey, Katie
dc.contributor.author Stucky, Alan
dc.contributor.author Wenzel-Lamb, Nikki
dc.contributor.author Wilkinson, Debbie
dc.contributor.author Wintering, Nancy
dc.date.accessioned 2019-02-19T16:51:38Z
dc.date.available 2019-02-19T16:51:38Z
dc.date.issued 2014-08
dc.identifier.citation Owen, MA, Gilmore, CD .Henkin, R, Baldwin, J., Bires, A., Nelson, K., Wilkinson, D., Holbrook, S., Hubble, W., Mann ,A., Sobey, K., Wintering, NA.(2014). "Clinical Research: The Future of the Molecular Imaging Technologist-A White Paper Presented by Members of the Graduate Stakeholders Committee of the SNMMI Technologist J Nucl Med Technol 2014; 42: 228-232 published ahead of print August 14, 2014 (10.2967/jnmt.114.146373 en_US
dc.identifier.uri http://hdl.handle.net/11347/278
dc.description.abstract The passage of the Food and Drug Administration Modernization Act of 1996 set into motion the eventual pathway for approval of biomarkers used in PET. This was the sentinel event in the history of molecular imaging as well as the lives and careers of countless patients and molecular imaging professionals. Subsequent federal regulations and guidance documents have established the environment for approval of future drugs. The translation of a concept or theory from the abstract to the clinical environment, or from the bench to the patient bedside, is a multidisciplinary effort often involving large teams of scientists and clinical professionals. The translation of novel biomarkers for use as companion diagnostic agents or research tools in nuclear medicine and molecular imaging is an evolving field. Because of the complexity of the imaging agents, the requirement for local drug manufacturing due to a short radioactive half-life of the agents, technical issues associated with accurate data collection, and patient management considerations, specifically certified nuclear medicine technologists are well suited to participate in research and development activities associated with these drugs. Opportunities for molecular imaging professionals to participate in research and development have been the focus of numerous professional societies including the Society of Nuclear Medicine and Molecular Imaging (SNMMI). In particular, SNMMI’s Center for Molecular Imaging Innovation and Translation convened a task force to focus on development of a curriculum for molecular imaging scientists who are involved with the translation of molecular imaging agents. This task force identified the domains of expertise necessary to successfully translate a drug or technology. These domains included the regulatory, preclinical trial phase during which a clinical dilemma is identified, identification of the target and selection of potential biomarkers for characterization of the target, preclinical imaging to validate the target biomarker and biodistribution, interfacing with medical devices, early-phase clinical development, preparation of the clinical package before initiation of human studies, clinical trial design and implementation, and clinical manufacturing postapproval activities. en_US
dc.language.iso en_US en_US
dc.publisher Journal of Nuclear Medicine Technology en_US
dc.subject Food and Drug Administration en_US
dc.subject nuclear medicine services en_US
dc.subject imaging clinical trial en_US
dc.subject molecular imaging en_US
dc.title Clinical Research: The Future of the Molecular Imaging Technologist—A White Paper Presented by Members of the Graduate Stakeholders Committee of the SNMMI Technologist Section en_US
dc.type Presentation en_US


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