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Development of Biomarkers for Radiation Biodosimetry and Medical Countermeasures Research: Current Status, Utility, and Regulatory Pathways

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Biomarkers are important indicators of biological processes in health or disease. Consequently, they play an important role in advancing development of radiation biodosimetry tools and in the development of medical… Click to show full abstract

Biomarkers are important indicators of biological processes in health or disease. Consequently, they play an important role in advancing development of radiation biodosimetry tools and in the development of medical countermeasures (MCMs) (1). They can aid in the assessment of radiation exposure level, as well as help determine the extent of radiation-induced injury, and/or MCM efficacy. In response to the threat of a radiological or nuclear incident, in 2004, the U.S. Department of Health and Human Services tasked the National Institute of Allergy and Infectious Diseases (NIAID) with identifying and funding early-to-late-stage MCM development to treat radiation-induced injuries. Although there are products approved to treat radiation-induced hematopoietic damage (Neupogen, Neulasta, Leukine, Nplate), there are still no qualified biomarkers of radiation injury, or approved biodosimetry tools, to assess the extent or severity of radiation exposure for triage or treatment purposes in the event of a radiation mass casualty incident. Biomarkers are integral to research and development pathways for both biodosimetry and MCM advancement. For this reason, the NIAID Radiation and Nuclear Countermeasures Program (RNCP) sponsored a workshop in Bethesda, MD on June 1, 2020, titled ‘‘Biomarkers in Radiation Biodosimetry and Medical Countermeasures.’’ Speakers included academicians, representatives of industry, as well as members of U.S. Government (USG) agencies [NIAID, U.S. Food and Drug Administration (FDA), and the Biomedical Advanced Research Development Authority (BARDA)]. This commentary provides a brief overview of the information presented at the workshop and key points considered during discussions. A more comprehensive summary of the workshop presentations and discussions are presented in the full meeting report [(2) available at https://doi.org/10.1667/RADE-21-00157.1].

Keywords: development; radiation biodosimetry; medical countermeasures; radiation; research

Journal Title: Radiation Research
Year Published: 2022

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