{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T22:04:46Z","timestamp":1791497086544,"version":"4.3.4"},"reference-count":33,"publisher":"Radiation Research Society","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Radiation Research"],"published-print":{"date-parts":[[2024,5,8]]},"abstract":"<jats:p>The Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies are unethical or unfeasible. The NIAID portfolio includes grants, contracts, and inter-agency agreements designed to span all aspects of drug development and encompasses basic research through FDA approval. In addition, NIAID manages an active portfolio of biodosimetry approaches to assess injuries and absorbed radiation levels to guide triage and treatment decisions. NIAID, together with grantees, contractors, and other stakeholders with promising products, works to advance candidate MCMs and biodosimetry tools through an established product development pipeline. In addition to managing grants and contracts, NIAID tests promising candidates in our established preclinical animal models, and the NIAID Program Officers work closely with sponsors as product managers to guide them through the process. In addition, a valuable benefit for stakeholders is working with the NIAID Office of Regulatory Affairs, where NIAID coordinates with the FDA to facilitate interactions between sponsors and the agency. Activities funded by NIAID include basic research (e.g., library screens to discover new products, determine early efficacy, and delineate mechanism of action) and the development of small and large animal models of radiation-induced hematopoietic, gastrointestinal, lung, kidney, and skin injury, radiation combined injury, and radionuclide decorporation. NIAID also sponsors Good Laboratory Practice product safety, pharmacokinetic, pharmacodynamic, and toxicology studies, as well as efficacy and dose-ranging studies to optimize product regimens. For later-stage candidates, NIAID funds large-scale manufacturing and formulation development of products. The program also supports Phase 1 human clinical studies to ensure human safety and to bridge pharmacokinetic, pharmacodynamic, and efficacy data from animals to humans. To date, NIAID has supported &gt;900 animal studies and one clinical study, evaluating &gt;500 new\/repurposed radiation MCMs and biodosimetric approaches. NIAID sponsorship led to the approval of three of the six drugs for acute radiation syndrome under the FDA Animal Rule, five Investigational New Drug applications, and 18 additional submissions for Investigational Device Exemptions, while advancing 38 projects to the Biomedical Advanced Research and Development Authority for follow-on research and development.<\/jats:p>","DOI":"10.1667\/rade-23-00144.1","type":"journal-article","created":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T08:34:45Z","timestamp":1708936485000},"page":"471-478","source":"Crossref","is-referenced-by-count":7,"title":["Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program"],"prefix":"10.1667","volume":"201","author":[{"given":"David R.","family":"Cassatt","sequence":"first","affiliation":[{"name":"Radiation and Nuclear Countermeasures Program (RNCP), Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L.","family":"DiCarlo","sequence":"additional","affiliation":[{"name":"Radiation and Nuclear Countermeasures Program (RNCP), Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Molinar-Inglis","sequence":"additional","affiliation":[{"name":"Radiation and Nuclear Countermeasures Program (RNCP), Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1243","reference":[{"key":"2","doi-asserted-by":"crossref","unstructured":"MJ Homer, R Raulli, AL 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(2012)","DOI":"10.1097\/HP.0b013e31825f75a7"},{"key":"18","doi-asserted-by":"crossref","unstructured":"AM Farese, MV Cohen, BP Katz, et al.  \"Radiat Res.\"  179, \"Filgrastim improves survival in lethally irradiated nonhuman primates.\" 89 (2013)","DOI":"10.1667\/RR3049.1"},{"key":"11","doi-asserted-by":"crossref","unstructured":"TJ MacVittie, AW Bennett, AM Farese, et al.  \"Health Phys.\"  109, \"The effect of radiation dose and variation in Neupogen\u00ae initiation schedule on the mitigation of myelosuppression during the concomitant GI-ARS and H-ARS in a nonhuman primate model of high-dose exposure with marrow sparing.\" 427 (2015)","DOI":"10.1097\/HP.0000000000000350"},{"key":"26","doi-asserted-by":"crossref","unstructured":"AL DiCarlo, JM Kaminski, RJ Hatchett, et al.  \"J Radiat Oncol.\"  5, \"Role of thrombocytopenia in radiation-induced mortality and review of therapeutic approaches targeting platelet regeneration after radiation exposure.\" 19 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Report from the Centers for Medical Countermeasures Against Radiation network.\" 504 (2015)","DOI":"10.1016\/j.ijrobp.2015.02.042"},{"key":"7","doi-asserted-by":"crossref","unstructured":"TJ MacVittie,  \"Health Phys.\"  109, \"The MCART consortium animal model series: MCART animal model refinement and MCM development: Defining organ dose, organ-specific tissue imaging, model validation and the natural history between the acute radiation syndrome (ARS) and the delayed effects of acute radiation exposure (DEARE).\" 335 (2015)","DOI":"10.1097\/HP.0000000000000318"},{"key":"12","doi-asserted-by":"publisher","unstructured":"A Gibbs, P Gupta, B Mali, et al.  \"Radiat Res.\"  199, \"A C57L\/J mouse model of the delayed effects of acute radiation exposure in the context of evolving multi-organ dysfunction and failure after total-body irradiation with 2.5% bone marrow sparing.\" 319 (2023)","DOI":"10.1667\/RADE-22-00178.1"},{"key":"14","doi-asserted-by":"crossref","unstructured":"M Doyle-Eisele, W Weber, DR Melo, et al.  \"Int J Radiat Biol.\"  90, \"Whole-body distribution of americium in rats for different pathways of intake.\" 1068 (2014)","DOI":"10.3109\/09553002.2014.925606"},{"key":"15","doi-asserted-by":"crossref","unstructured":"W Weber, M Doyle-Eisele, SK Seilkop, et al.  \"Health Phys.\"  103, \"Biokinetics of systemically distributed 60Co in the rat: An experimental model useful in evaluating medical countermeasures for internal contamination.\" 474 (2012)","DOI":"10.1097\/HP.0b013e31826248d1"},{"key":"16","doi-asserted-by":"crossref","unstructured":"TJ MacVittie, AM Farese, MA Kane, et al.  \"Health Phys.\"  116, \"DEARE, and multiple-organ injury: A strategic and tactical approach to link radiation effects, animal models, medical countermeasures, and biomarker development to predict clinical outcome.\" 453 (2019)","DOI":"10.1097\/HP.0000000000001050"},{"key":"20","unstructured":"\"Neupogen\u00ae (filgrastim) [package insert].\"  (2015)"},{"key":"23","unstructured":"\"Neulasta\u00ae (pegfilgrastim) [package insert].\"  (2015)"},{"key":"24","unstructured":"\"Leukine\u00ae (sargramostim) [package insert].\"  (2018)"},{"key":"25","unstructured":"\"Udenyca\u00ae (pegfilgrastim-cbqv) [package insert].\"  (2022)"},{"key":"30","doi-asserted-by":"crossref","unstructured":"DI Bunin, HS Javitz, J Gahagen, et al.  \"Int J Radiat Oncol Biol Phys.\"  \"Survival and hematologic benefits of romiplostim after acute radiation exposure supported FDA approval under the Animal Rule.\" (2023)","DOI":"10.1016\/j.ijrobp.2023.05.008"},{"key":"31","unstructured":"\"Nplate\u00ae (romiplostim) [package insert].\"  (2021)"},{"key":"32","doi-asserted-by":"crossref","unstructured":"RJ Abergel, PW Durbin, B Kullgren, et al.  \"Health Phys.\"  99, \"Biomimetic actinide chelators: An update on the preclinical development of the orally active hydroxypyridonate decorporation agents 3,4,3-LI(1,2-HOPO) and 5-LIO(Me-3,2-HOPO).\" 401 (2010)","DOI":"10.1097\/HP.0b013e3181c21273"},{"key":"33","doi-asserted-by":"publisher","unstructured":"GW Schaaf, JN Justice, EE Quillen, et al.  \"Geroscience.\"  \"Resilience, aging, and response to radiation exposure (RARRE) in nonhuman primates: A resource review.\" (2023)","DOI":"10.1007\/s11357-023-00812-7"}],"container-title":["Radiation Research"],"original-title":[],"link":[{"URL":"https:\/\/meridian.allenpress.com\/radiation-research\/article-pdf\/doi\/10.1667\/RADE-23-00144.1\/3334059\/10.1667_rade-23-00144.1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/meridian.allenpress.com\/radiation-research\/article-pdf\/doi\/10.1667\/RADE-23-00144.1\/3334059\/10.1667_rade-23-00144.1.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:42:13Z","timestamp":1791247333000},"score":1,"resource":{"primary":{"URL":"https:\/\/bioone.org\/journals\/radiation-research\/volume-201\/issue-5\/RADE-23-00144.1\/Product-Development-within-the-National-Institutes-of-Health-Radiation-and\/10.1667\/RADE-23-00144.1.full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,8]]},"references-count":33,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2024,5,1]]}},"URL":"https:\/\/doi.org\/10.1667\/rade-23-00144.1","relation":{},"ISSN":["0033-7587","1938-5404"],"issn-type":[{"value":"0033-7587","type":"print"},{"value":"1938-5404","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,8]]}}}