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Biodefense Research Methodology and Animal Models, Second Edition

Author: James R. Swearengen

Publisher: CRC Press

Published: 2012-02-16

Total Pages: 427

ISBN-13: 1439836329

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.

Biodefense Research Methodology and Animal Models

Author: James R. Swearengen

Publisher: CRC Press

Published: 2012-02-16

Total Pages: 415

ISBN-13: 1439836337

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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 Resea

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents

Author: National Research Council

Publisher: National Academies Press

Published: 2006-09-07

Total Pages: 87

ISBN-13: 0309102111

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The National Institute of Allergy and Infectious Diseases (NIAID) gives the highest priority to developing countermeasures against bioterrorism agents that are highly infective when dispersed in aerosol form. Developing drugs to prevent or treat illnesses caused by bioterrorism agents requires testing their effectiveness in animals since human clinical trials would be unethical. At the request of NIAID, the National Academies conducted a study to examine how such testing could be improved. Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents provides recommendations to researchers on selecting the kinds of animal models, aerosol generators, and bioterrorism agent doses that would produce conditions that most closely mimic the disease process in humans. It also urges researchers to fully document experimental parameters in the literature so that studies can be reproduced and compared. The book recommends that all unclassified data on bioterrorism agent studies-including unclassified, unpublished data from U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)-be published in the open literature. The book also calls on the U.S. Food and Drug Administration to improve the process by which bioterrorism countermeasures are approved based on the results of animal studies.

Critical Needs for Research in Veterinary Science

Author: National Research Council

Publisher: National Academies Press

Published: 2005-10-18

Total Pages: 238

ISBN-13: 0309164982

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Research in veterinary science is critical for the health and well-being of animals, including humans. Food safety, emerging infectious diseases, the development of new therapies, and the possibility of bioterrorism are examples of issues addressed by veterinary science that have an impact on both human and animal health. However, there is a lack of scientists engaged in veterinary research. Too few veterinarians pursue research careers, and there is a shortage of facilities and funding for conducting research. This report identifies questions and issues that veterinary research can help to address, and discusses the scientific expertise and infrastructure needed to meet the most critical research needs. The report finds that there is an urgent need to provide adequate resources for investigators, training programs, and facilities involved in veterinary research.

Biodefense in the Age of Synthetic Biology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-01-05

Total Pages: 189

ISBN-13: 0309465184

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Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Biodefense

Author: James R. Swearengen

Publisher: CRC Press

Published: 2005-11-21

Total Pages: 352

ISBN-13: 9780849328367

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The importance attached to rapidly developing our biodefensive capabilities has recently resulted in a significantly increased funding for biodefense research. Accordingly, researchers will respond with an effort equal to the challenge, producing an impressive body of findings. To ensure that this effort continues in the most efficient manner, Biodefense: Research Methodology and Animal Models presents a thorough historical and current review of biodefense research, encouraging researchers to leverage relevant results, rather than duplicate them. By building on the work of others, scientists will be able to proceed in a way that makes the best use of available resources, while avoiding unnecessary duplication of animal research. Including contributions from recognized leaders in the field who have developed and refined the animal models presented, this book examines those bacterial, viral, and toxic agents considered to pose the greatest threats to public safety. Each section on a specific agent provides pertinent background information, followed by a description of those animal models employed in research and testing and a discussion of how the findings translate to human impact.

Responsible Research with Biological Select Agents and Toxins

Author: National Research Council

Publisher: National Academies Press

Published: 2010-02-12

Total Pages: 188

ISBN-13: 030914535X

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The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.

Animal Models for Assessing Countermeasures to Bioterrorism Agents

Author: National Research Council

Publisher: National Academies Press

Published: 2012-01-09

Total Pages: 152

ISBN-13: 0309219094

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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.