National Cancer Institute Programmatic Collaboration for Investigational Radiopharmaceuticals.

Radiopharmaceutical therapies have provided an attractive therapeutic approach since the introduction of 131I to treat thyroid cancer. New insights in cancer biology and radiochemistry have brought radiopharmaceuticals to the leading edge of oncology clinical research. National Cancer Institute (NCI) programs watch for new radiopharmaceutical breakthroughs that should be used to treat patients with unmet therapeutic needs. Such efforts occur through leveraged partnerships between NCI's Cancer Therapy Evaluation Program and its Radiation Research Program. If groundbreaking discoveries are made, NCI pulls together clinician scientists to design novel radiopharmaceutical phase I and II monotherapy or combination trials. The specific infrastructure needs, such as radiopharmaceutical dosimetry and treatment planning, demand new programmatic workflow and regulatory oversight. This article discusses a modern approach to the development of radiopharmaceutical therapies in the era of personalized medicine.