The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons. The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.

This volume is the product of the NATO Advanced Research Workshop on Radiation Inactivation of Bioterrorism Agents, held in March 2004 in Budapest, Hungary. Gazs (National Center for Public Health, National Research Institute for Radiobiology and Radiohygiene, Hungary) and Ponta ("Horia Hulubei" National Institute for Physics and Engineering, Roman.

Significant advances have been made in animal model development for biological research since the publication of the first edition of this volume, and the ramifications of the FDA’s Animal Efficacy Rule have become better understood in the scientific community. With each chapter completely updated with the latest research findings, Biodefense Research Methodology and Animal Models, Second Edition spans the spectrum of coverage from basic research to advanced development of medical countermeasures. Topics discussed in this volume include: A history of biological agents as weapons, from the use of corpses to contaminate water supplies to modern day anthrax attacks Concepts and strategies involved in biowarfare and bioterrorism The development, validation, and importance of animal models in biodefense research Infectious disease aerobiology Studies involving anthrax, glanders, plague, tularemia, Q fever, alphaviruses, orthopoxviruses, and a new chapter on brucellosis Animal models for viral hemorrhagic fevers Botulinum and Ricin toxins Staphylococcal and streptococcal superantigens As the scientific community works diligently to protect the world’s population from the misuse of infectious organisms and toxins, it is imperative that researchers stay abreast of the latest techniques for biodefense research. Exploring in vivo and in vitro assays, this volume brings researchers up to date on the latest information on bacterial and viral infectious agents and biological toxins considered to pose the greatest threats to public safety. In addition, the contributors take a step toward minimizing the use of animals in further experiments by presenting documented findings that can be built upon.

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