evaluate promising new labeled compounds in humans is essential. Currently, this is a bottleneck, stifling innovation and driving many research groups to carry out their initial evaluations of new radiopharmaceuticals with collaborators in other countries. A regulatory framework specific for radiopharmaceuticals that will facilitate the rapid and safe translation of radiopharmaceuticals from animals to humans for clinical feasibility studies is clearly needed.
Limited Radionuclide Availability (see Chapter 5). There is no dedicated domestic high energy accelerator for R&D and training for the development of the radionuclides of the future and for year-round production of medical radionuclides. These are needed not only for developing and evaluating the targeted radiotherapeutic agents, but also for production of some largely unexplored PET tracers. Radionuclides that are available intermittently from DOE labs are expensive due to full cost recovery requirements preventing their development for nuclear medicine.
The committee formulated two recommendations to meet the future needs for radiopharmaceutical development for the diagnosis and treatment of human disease and to overcome national impediments to their entry into the practice of health care.
RECOMMENDATION 1: Enhance the federal commitment to nuclear medicine research. Given the somewhat different orientations of the DOE and the National Institutes of Health (NIH) toward nuclear medicine research, the two agencies should find some cooperative mechanism to support radionuclide production and distribution; basic research in radionuclide production, nuclear imaging, radiopharmaceutical/radiotracer and therapy development; and the transfer of these technologies into routine clinical use.
Implementation Action 1A1: A national nuclear medicine research program should be coordinated by the DOE and NIH, with the former emphasizing the general development of technology and the latter disease-specific applications.
Implementation Action 1A2: In developing their strategic plan, the agencies should avail themselves of advice from a broad range of authorities in academia, national laboratories and industry; these authorities should include experts in physics, engineering, chemistry, radiopharmaceutical science, commercial development, regulatory affairs, clinical trials, and radiation biology.