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 Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Download or read book Medical Countermeasures Dispensing written by Institute of Medicine and published by National Academies Press. This book was released on 2010-12-16 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.
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 Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise written by National Academies of Sciences, Engineering, and Medicine and published by . This book was released on 2022-08-03 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.
Download or read book Pandemics Pills and Politics written by Stefan Elbe and published by JHU Press. This book was released on 2018-06 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encapsulating security : pharmaceutical defenses against biological danger -- Discovering a virus's achilles heel : flu fighting at molecular scale -- The pill always wins: Gilead Sciences, Roche and the birth of Tamiflu -- What a difference a day makes : the margin call for regulatory agencies -- Virtual blockbuster : bird flu and the pandemic of preparedness planning -- In the eye of the storm : global access, generics and intellectual property -- 'Ode to Tamiflu' : side effects, teenage 'suicides' and corporate liabilities -- Data backlash : Roche and Cochrane square up over clinical trial data -- 'To boldly go ... ' : pharmaceutical enterprises and global health security -- Epilogue : pharmaceuticals, security and molecular life
Download or read book Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2012 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2011 with total page 860 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Science the Endless Frontier written by Vannevar Bush and published by Princeton University Press. This book was released on 2021-02-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.
Download or read book Bioterrorism Controlled Substances and Public Health Issues written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Determining Core Capabilities in Chemical and Biological Defense Science and Technology written by National Research Council and published by National Academies Press. This book was released on 2013-01-13 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of the U.S. Department of Defense's (DoD's) Chemical and Biological Defense Program (CBDP) is to provide support and world-class capabilities enabling he U.S. Armed Forces to fight and win decisively in chemical, biological, radiological, and nuclear (CBRN) environments. To accomplish this objective, the CBDP must maintain robust science and technology capabilities to support the research, development, testing, and evaluation required for the creation and validation of the products the program supplies. The threat from chemical and biological attack evolves due to the changing nature of conflict and rapid advances in science and technology (S&T), so the core S&T capabilities that must be maintained by the CBDP must also continue to evolve. In order to address the challenges facing the DoD, the Deputy Assistant Secretary of Defense (DASD) for Chemical and Biological Defense (CBD) asked the National Research Council (NRC) to conduct a study to identify the core capabilities in S&T that must be supported by the program. The NRC Committee on Determining Core Capabilities in Chemical and Biological Defense Research and Development examined the capabilities necessary for the chemical and biological defense S&T program in the context of the threat and of the program's stated mission and priorities. Determining Core Capabilities in Chemical and Biological Defense Science and Technology contains the committee's findings and recommendations. It is intended to assist the DASD CBD in determining the best strategy for acquiring, developing, and/or maintaining the needed capabilities.
Download or read book Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2016 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and published by . This book was released on 2015 with total page 1292 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Informing the Future written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-12 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.
Download or read book Global Health Risk Framework written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-05-06 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.
Download or read book Global Health and the Future Role of the United States written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-05 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency â€" both within the U.S. government and across the global health field.
Download or read book The Causes and Impacts of Neglected Tropical and Zoonotic Diseases written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-01 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neglected tropical diseases (NTDs) afflict more than 1.4 billion people, many of whom live on less than $1.25 a day. While there are effective ways to manage NTDs, policy-makers and funders have only recently begun to recognize the economic and public health importance of controlling NTDs. The IOM's Forum on Microbial Threats held a workshop September 21-22, 2010, to discuss the science of and policy surrounding NTDs.
Download or read book Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2015 Oversight hearing Public Health Emergency Medical Countermeasure Enterprise U S Department of Health and Human Services Budget hearing future of biomedical research written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and published by . This book was released on 2014 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt:
