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Recent studies have demonstrated that early transfusion of plasma or RBCs improves survival in patients with severe trauma and hemorrhagic shock. Time to initiate transfusion is the critical factor. It is essential that transfusion begin in the prehospital environment when transport times are longer than approximately 15 to 20 minutes. Unfortunately, logistic constraints severely limit the use of blood products in the prehospital setting, especially in military, remote civilian, and mass disaster circumstances, where the need can be most acute. US military requirements for logistically supportable blood products are projected to increase dramatically in future conflicts. Although dried plasma products have been available and safely used in a number of countries for over 20 years, there is no dried plasma product commercially available in the United States. A US Food and Drug Administration-approved dried plasma is urgently needed. Considering the US military, disaster preparedness, and remote civilian trauma perspectives, this is an urgent national health care issue. [ABSTRACT FROM AUTHOR]

Transfusion of plasma early after severe injury has been associated with improved survival. There are significant logistic factors that limit the ability to deliver plasma where needed in austere environments, such as the battlefield or during a significant civilian emergency. While some countries have access to more logistically supportable dried plasma, there is no such product approved for use in the United States. There is a clear need for a Food and Drug Administration (FDA)-approved dried plasma for military and emergency-preparedness uses, as well as for civilian use in remote or austere settings. The Department of Defense (DoD) and Biomedical Advanced Research and Development Authority are sponsoring development of three dried plasma products, incorporating different technologic approaches and business models. At the same time, the DoD is sponsoring prospective, randomized clinical studies on the prehospital use of plasma. These efforts are part of a coordinated program to provide a dried plasma for military and civilian applications and to produce additional information on plasma use so that, by the time we have an FDA-approved dried plasma, we will better understand how to use it. [ABSTRACT FROM AUTHOR]

Although chemical and radiological agents cause toxicity through different mechanisms, the multiorgan injuries caused by these threats share similarities that convene on the level of basic biological responses. This publication will discuss these areas of convergence and explore "multi-utility" approaches that could be leveraged to address common injury mechanisms underlying actions of chemical and radiological agents in a threat-agnostic manner. In addition, we will provide an overview of the current state of radiological and chemical threat research, discuss the US Government's efforts toward medical preparedness, and identify potential areas for collaboration geared toward enhancing preparedness and response against radiological and chemical threats. We also will discuss previous regulatory experience to provide insight on how to navigate regulatory paths for US Food and Drug Administration (FDA) approval/licensure/clearance for products addressing chemical or radiological/nuclear threats. This publication follows a 2022 trans-agency meeting titled, "Overlapping Science in Radiation and Sulfur Mustard Exposures of Skin and Lung: Consideration of Models, Mechanisms, Organ Systems, and Medical Countermeasures," sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). Discussions from this meeting explored the overlapping nature of radiation and chemical injury and spurred increased interest in how preparedness for one threat leads to preparedness for the other. Herein, subject matter experts from the NIAID and the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR), summarize the knowledge gained from recently funded biomedical research, as well as insights from the 2022 meeting. These topics include identification of common areas for collaboration, potential use of biomarkers of injury to identify injuries caused by both hazards, and common and widely available treatments that could treat damage caused by radiological or chemical threats.

With the end of the Cold War in 1991, U.S. Government (USG) investments in radiation science and medical preparedness were phased out; however, the events of 11 September, which involved a terroristic attack on American soil, led to the re-establishment of funding for both radiation preparedness and development of approaches to address injuries. Similar activities have also been instituted worldwide, as the global threat of a radiological or nuclear incident continues to be a concern. Much of the USG's efforts to plan for the unthinkable have centred on establishing clear lines of communication between agencies with responsibility for triage and medical response, and external stakeholders. There have also been strong connections made between those parts of the government that establish policies, fund research, oversee regulatory approval, and purchase and stockpile necessary medical supplies. Progress made in advancing preparedness has involved a number of subject matter meetings and tabletop exercises, publication of guidance documents, assessment of available resources, clear establishment of anticipated concepts of operation for multiple radiation and nuclear scenarios, and identification/mobilization of resources. From a scientific perspective, there were clear research gaps that needed to be addressed, which included the need to identify accurate biomarkers and design biodosimetry devices to triage large numbers of civilians, develop decorporation agents that are more amenable for mass casualty use, and advance candidate products to address injuries caused by radiation exposure and thereby improve survival. Central to all these activities was the development of several different animal constructs, since efficacy testing of these approaches requires extensive work in research models that accurately simulate what would be expected in humans. Recent experiences with COVID-19 have provided an opportunity to revisit aspects of radiation preparedness, and leverage those lessons learned to enhance readiness for a possible future radiation public health emergency., (Creative Commons Attribution license.)

An Interagency Panel Session organized by the NASA Human Research Program (HRP) Space Radiation Program Element (SRPE) was held during the NASA HRP Investigator's Workshop (IWS) in Galveston, Texas on 26 January 2017 to identify complementary research areas that will advance the testing and development of medical countermeasures (MCMs) in support of radioprotection and radiation mitigation on the ground and in space. There were several areas of common interest identified among the various participating agencies. This report provides a summary of the topics discussed by each agency along with potential areas of intersection for mutual collaboration opportunities. Common goals included repurposing of pharmaceuticals, nutraceuticals for use as radioprotectors and/or mitigators, low-dose/chronic exposure paradigms, late effects post-radiation exposure, mixed-field exposures of gamma-neutron, performance decrements, and methods to determine individual exposure levels.

Ionizing radiation can cause devastating injuries including hemorrhage, immune suppression, increased susceptibility to infection, and death. Medical countermeasures (MCMs) that address and mitigate radiation-induced injuries are the most important tools for countering the consequences of radiation exposure. Likewise, in matters of public health security, the development and advancement of radiological MCMs are fundamental for establishing an effective response to radiological and nuclear threats. United States Government agencies such as the Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Aeronautics and Space Administration (NASA) have dedicated significant efforts to advance the development of MCMs to treat radiation injury and facilitate their introduction into the public sphere. Due to the severe nature of radiation injuries, clinical trials are unethical. Therefore, nonclinical models that accurately replicate clinical manifestations of ionizing radiation injury observed in humans are essential to MCM advancement. The most frequently used nonclinical models of radiation injury are rodents and non-human primates (NHPs). These species reproduce many aspects of human disease caused by ionizing radiation and have been pivotal for the development and licensure of radiological MCMs. Despite these successes, model drawbacks have prompted the exploration and development of additional nonclinical models. Minipigs and rabbits show promise as acceptable models of radiation injury and demonstrate the potential to contribute significantly to MCM advancement. This collection of research showcases the capabilities of minipigs and rabbits in mirroring clinically relevant aspects of radiation-induced disease and documents the potential value these models may hold for radiological and nuclear MCM research. Together, these government-funded studies represent advances in radiological MCM development that can facilitate the emergence of cutting-edge technologies.