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Advancing Nuclear Medicine through Innovation
initially mainly for assessment of neuroendocrine tumors, is now showing promise in early diagnosis of heart failure, a major health and economic issue in the United States. It is important to keep in mind that any new developments in targeted radionuclide therapy require access to research radionuclides (see Chapters 4 and 5).
6.4 CURRENT NEEDS AND IMPEDIMENTS
Although the scientific opportunities and medical challenges have never been more exciting and the demand for new radiopharmaceuticals has never been greater, the nuclear medicine infrastructure on which future innovation and discovery depend hangs in the balance. Four major impediments—some of which are elaborated further in other chapters of the report—stand in the way of scientific and medical progress and the competitive edge that the United States has held for more than 50 years:
Lack of Support for Radiopharmaceutical R&D. The committee finds that as a result of the reduction in funding from the U.S. Department of Energy-Office of Biological and Environmental Research (DOE-OBER) has seen a substantial loss of support for basic radiopharmaceutical chemistry research. This includes methodological research in synthetic chemistry, yield optimization, purification strategies, structure-activity relationships, radionuclide and targetry research, and preclinical and clinical evaluation. In addition, there is no support for infrastructures (accelerators, imaging instruments) that are the underpinning of radiopharmaceutical development.
Shortage of Trained Chemists and Physician Scientists (see Chapter 8). One of the most enriching aspects of radiopharmaceutical research is that it is generally carried out in an interdisciplinary environment where chemists, physicists, engineers, biologists, and physicians work together sharing the excitement of solving important problems in medicine. However, there is a critical shortage of trained chemists (typically, synthetic chemists with expertise in nuclear chemistry and radiochemistry are needed) for radiotracer and radiopharmaceutical R&D. This is a major impediment that has been documented in multiple reports over the past 20 years (e.g., DOE 2002, NRC 2007). There is also a lack of trained physician-scientists who are able to provide the expertise to collaborate in the basic clinical feasibility studies required to translate promising radiopharmaceuticals to the clinic.
Inappropriate Regulatory Requirements (see Chapter 4). Because the ultimate goal in radiopharmaceutical R&D is to use radiopharmaceuticals as scientific and clinical tools to investigate the systems biology of disease in healthy human subjects and patients, obtaining approval to