Download or read book Animal Models for Assessing Countermeasures to Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2012-01-09 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2006-09-07 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biodefense Research Methodology and Animal Models Second Edition written by James R. Swearengen and published by CRC Press. This book was released on 2012-02-16 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biodefense Research Methodology and Animal Models written by James R. Swearengen and published by CRC Press. This book was released on 2012-02-16 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Giving Full Measure to Countermeasures written by National Research Council and published by National Academies Press. This book was released on 2004-04-06 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

Download or read book Critical Needs for Research in Veterinary Science written by National Research Council and published by National Academies Press. This book was released on 2005-10-18 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biological Threats and Terrorism written by Institute of Medicine and published by National Academies Press. This book was released on 2002-03-07 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.

Download or read book Advancing Disease Modeling in Animal Based Research in Support of Precision Medicine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-05-29 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: Precision medicine is focused on the individual and will require the rapid and accurate identification and prioritization of causative factors of disease. To move forward and accelerate the delivery of the anticipated benefits of precision medicine, developing predictable, reproducible, and reliable animal models will be essential. In order to explore the topic of animal-based research and its relevance to precision medicine, the National Academies of Sciences, Engineering, and Medicine convened a 2-day workshop on October 5 and 6, 2017. The workshop was designed to focus on the development, implementation, and interpretation of model organisms to advance and accelerate the field of precision medicine. Participants examined the extent to which next-generation animal models, designed using patient data and phenotyping platforms targeted to reveal and inform disease mechanisms, will be essential to the successful implementation of precision medicine. This publication summarizes the presentations and discussions from the workshop.

Download or read book Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2006-08-07 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Advancing Regulatory Science for Medical Countermeasure Development written by Institute of Medicine and published by National Academies Press. This book was released on 2011-08-27 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

Download or read book Defense Against Biological Attacks written by Sunit K. Singh and published by Springer. This book was released on 2019-03-30 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first volume of a two-volume set describes general aspects, such as the historical view on the topic, the role of information distribution and preparedness of health-care systems and preparedness in emergency cases. Part two describes and discusseses in detail the pathogens and toxins that are potentially used for biological attacks. As such, the book is a valuable resource for faculties engaged in molecular biology, genetic engineering, neurology, biodefense, biosafety & biosecurity, virology, and infectious disease programs, as well as professional medical research organizations.

Download or read book Department of Homeland Security Bioterrorism Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2009-01-03 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: The mission of Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change, the book published in December 2008, is to independently and scientifically review the methodology that led to the 2006 Department of Homeland Security report, Bioterrorism Risk Assessment (BTRA) and provide a foundation for future updates. This book identifies a number of fundamental concerns with the BTRA of 2006, ranging from mathematical and statistical mistakes that have corrupted results, to unnecessarily complicated probability models and models with fidelity far exceeding existing data, to more basic questions about how terrorist behavior should be modeled. Rather than merely criticizing what was done in the BTRA of 2006, this new NRC book consults outside experts and collects a number of proposed alternatives that could improve DHS's ability to assess potential terrorist behavior as a key element of risk-informed decision making, and it explains these alternatives in the specific context of the BTRA and the bioterrorism threat.

Download or read book Chemical and Biological Terrorism written by Institute of Medicine and published by National Academies Press. This book was released on 1999-03-12 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: The threat of domestic terrorism today looms larger than ever. Bombings at the World Trade Center and Oklahoma City's Federal Building, as well as nerve gas attacks in Japan, have made it tragically obvious that American civilians must be ready for terrorist attacks. What do we need to know to help emergency and medical personnel prepare for these attacks? Chemical and Biological Terrorism identifies the R&D efforts needed to implement recommendations in key areas: pre-incident intelligence, detection and identification of chemical and biological agents, protective clothing and equipment, early recognition that a population has been covertly exposed to a pathogen, mass casualty decontamination and triage, use of vaccines and pharmaceuticals, and the psychological effects of terror. Specific objectives for computer software development are also identified. The book addresses the differences between a biological and chemical attack, the distinct challenges to the military and civilian medical communities, and other broader issues. This book will be of critical interest to anyone involved in civilian preparedness for terrorist attack: planners, administrators, responders, medical professionals, public health and emergency personnel, and technology designers and engineers.

Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Principles of Animal Research for Graduate and Undergraduate Students written by Mark A. Suckow and published by Academic Press. This book was released on 2016-11-16 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Animal Research is the first publication to offer a broad look at animal research science for a student, early researcher, or technician. Offering guidance for all aspects of the research experience, including the research and development of a thesis, model selection, experimental design, IACUC protocol preparation, and animal husbandry and technical procedural needs, the book is a necessary addition to every student, technician, and researcher's education. - Provides background material for students to understand the broader backdrop against which animal research is undertaken - Includes ethical and regulatory information - Covers commonly used animal models and the process to choose a model for biomedical research

Download or read book BioWatch and Public Health Surveillance written by National Research Council and published by National Academies Press. This book was released on 2011-01-25 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the attacks of September 11, 2001 and the anthrax letters, the ability to detect biological threats as quickly as possible became a top priority. In 2003 the Department of Homeland Security (DHS) introduced the BioWatch program-a federal monitoring system intended to speed detection of specific biological agents that could be released in aerosolized form during a biological attack. The present volume evaluates the costs and merits of both the current BioWatch program and the plans for a new generation of BioWatch devices. BioWatch and Public Health Surveillance also examines infectious disease surveillance through hospitals and public health agencies in the United States, and considers whether BioWatch and traditional infectious disease surveillance are redundant or complementary.

Download or read book Sequence Based Classification of Select Agents written by National Research Council and published by National Academies Press. This book was released on 2010-11-08 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent. A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up. Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.'