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 2004-05-06 with total page 161 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 Bioterrorism Countermeasure Development written by Wendy H. Schacht and published by DIANE Publishing. This book was released on 2010-10 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. During the 109th Congress, several bills were introduced (although not enacted) that would have generated additional incentives for the creation of new technologies to counteract potential biological threats. These bills proposed reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products. Contents of this report, updated Nov. 27, 2006: (1) Intro.; (2) Patents and Innovation; (3) Role of Patents in Pharmaceutical/Biomedical R&D; (4) Legislative Developments; (5) Proposals for Change.
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 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 The Molecularisation of Security written by Christopher Long and published by Routledge. This book was released on 2021-09-23 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book investigates the way that the molecular sciences are shaping contemporary security practices in relation to the governance of biological threats. In response to biological threats, such as pandemics and bioterrorism, governments around the world have developed a range of new security technologies, called medical countermeasures, to protect their populations. This book argues that the molecular sciences’ influence has been so great that security practices have been molecularised. Focusing on the actions of international organisations and governments in the past two decades, this book identifies two contrasting conceptions of the nature or inherent workings of molecular life as driving this turn. On the one hand, political notions of insecurity have been shaped by the contingent or random nature of molecular life. On the other, the identification of molecular life’s constant biological dynamics supports and makes possible the development and stockpiling of effective medical countermeasures. This study is one of the few to take seriously the conceptual implications that the detailed empirical workings of biotechnology have on security practices today. This book will be of much interest to students of security studies, bio-politics, life sciences, global governance, and International Relations in general.
Download or read book New Developments in Biological and Chemical Terrorism Countermeasures written by Ronald J. Kendall and published by CRC Press. This book was released on 2016-02-17 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: A science-based text, New Developments in Biological and Chemical Terrorism Countermeasures presents research that addresses the growing threat of chemical and biological terrorism as well as the need for improvements in the implementation of countermeasures. This new textbook building upon Advances in Biological and Chemical Terrorism Countermeasu
Download or read book Bioterrorism Countermeasure Development written by Wendy H. Schacht and published by . This book was released on 2007 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biodefense written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Bioterrorism and Public Health Preparedness and published by . This book was released on 2005 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Giving Full Measure to Countermeasures written by National Research Council and published by . 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 Bioterrorism written by United States. Congress. House. Committee on Homeland Security. Subcommittee on Emergency Preparedness, Response and Communications and published by . This book was released on 2014 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Crossing the Valley of Death written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Bioterrorism and Public Health Preparedness and published by . This book was released on 2005 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Biological Weapons Defense written by Luther E. Lindler and published by Springer Science & Business Media. This book was released on 2007-10-27 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2003, the President’s budget for bioterrorism defense totalled more than $5 billion. Today, the nation’s top academic scientists are scrambling to begin work to understand Bacillus anthracis and develop new vaccines and drugs. However, just five years ago, only the US Department of Defense (DOD) seemed concerned about these “exotic” agents. In 1997, the DOD spent approximately $137 million on biodefense to protect the deployed force, while academe, industry, local governments, and most of our federal leadership was oblivious to, and in some cases doubtful of, the seriousness of the threat. The National Institutes of Health (NIH) received the largest budget increase in the organization’s history. Fortunately, during this time of national urgency, a sound base exists on which to build our defenses against this new threat. A relatively small cadre of dedicated scientists within the US Army Medical Research and Materiel Command (USAMRMC) laid this foundation over the past 20 years.
Download or read book Bioterrorism Countermeasures Development written by Wendy H. Schacht and published by . This book was released on 2005 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt: Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. In the 109th Congress, several bills have been introduced, including S. 3, the Protecting American in the War on Terror Act, and S. 975, the Project BioShield II Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products. Patent ownership appears to be important in the promotion of innovation, particularly in the pharmaceutical sector. Patent title provides a limited-time monopoly over the use of a discovery in exchange for public dissemination of information contained in the patent application.
Download or read book Prepositioning Antibiotics for Anthrax written by Institute of Medicine and published by National Academies Press. This book was released on 2012-02-26 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur. Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.
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 BioShield written by United States. Congress. House. Select Committee on Homeland Security and published by . This book was released on 2004 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt:
