Infectious Disease Research Biocontainment in Gain-Of-Function
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A Paradox of Zoonotic Disease
Tropical Medicine and Infectious Disease Communication The Convergence of High-Consequence Livestock and Human Pathogen Research and Development: A Paradox of Zoonotic Disease Julia M. Michelotti 1,* ID , Kenneth B. Yeh 1 ID , Tammy R. Beckham 2, Michelle M. Colby 3 ID , Debanjana Dasgupta 1, Kurt A. Zuelke 4 and Gene G. Olinger 1 1 MRI Global, Gaithersburg, MD 20878, USA; [email protected] (K.B.Y.); [email protected] (D.D.); [email protected] (G.G.O.) 2 College of Veterinary Medicine, Kansas State University, Manhattan, KS 66503, USA; [email protected] 3 Institute of Food Production and Sustainability, National Institute of Food and Agriculture, United States Department of Agriculture, Washington, DC 20250, USA; [email protected] 4 Strategic Biosecurity and Biocontainment Facility Management Consultant, Kurt Zuelke Consulting, Lenexa, KS 66220, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-240-361-4062 Received: 23 April 2018; Accepted: 23 May 2018; Published: 30 May 2018 Abstract: The World Health Organization (WHO) estimates that zoonotic diseases transmitted from animals to humans account for 75 percent of new and emerging infectious diseases. Globally, high-consequence pathogens that impact livestock and have the potential for human transmission create research paradoxes and operational challenges for the high-containment laboratories that conduct work with them. These specialized facilities are required for conducting all phases of research on high-consequence pathogens (basic, applied, and translational) with an emphasis on both the generation of fundamental knowledge and product development. To achieve this research mission, a highly-trained workforce is required and flexible operational methods are needed. -
Placing Global Biosecurity Engagement Programs Under the Umbrella of Global Health Security
FAS Issue Brief May 2014 Placing Global Biosecurity Engagement Programs under the Umbrella of Global Health Security Michelle Rozo Federation of American Scientists FAS ISSUE BRIEF Author Michelle Rozo, Ph.D. Candidate, Cell, Molecular, Developmental Biology and Biophysics, Johns Hopkins University. About FAS Issue Briefs FAS Issue Briefs provide nonpartisan research and analysis for policymakers, government officials, academics, and the general public. All statements of fact and expressions of opinion contained in this and other FAS Issue Briefs are the sole responsibility of the author or authors. This report does not necessarily represent the views of the Federation of American Scientists. About FAS Founded in 1945 by many of the scientists who built the first atomic bombs, the Federation of American Scientists (FAS) is devoted to the belief that scientists, engineers, and other technically trained people have the ethical obligation to ensure that the technological fruits of their intellect and labor are applied to the benefit of humankind. The founding mission was to prevent nuclear war. While nuclear security remains a major objective of FAS today, the organization has expanded its critical work to address urgent issues at the intersection of science and security. FAS publications are produced to increase the understanding of policymakers, the public, and the press about urgent issues in science and security policy. Individual authors who may be FAS staff or acknowledged experts from outside the institution write these reports. Thus, these reports do not represent an FAS institutional position on policy issues. All statements of fact and expressions of opinion contained in this and other FAS Issue Briefs are the sole responsibility of the author or authors. -
Biosurveillance Signatures for Biosecurity and Public Health
Biosurveillance Signatures for biosecurity and public health A Los Alamos National Laboratory Implementation Plan for the Science of Signatures Biological Signatures for National Security Los Alamos National Laboratory Biosurveillance at Los Alamos Table of Contents Los Alamos National Laboratory’s charge is to develop science and technology that will make the nation safer and enhance our global standing. This breadth of mission scope requires careful Biosurveillance at Los Alamos ....................................2 internal planning and effective cooperation with external partners and other governmental agencies. The document you A National Imperative .................................................4 are holding is one of the products of ongoing planning efforts that are designed to bring to bear the Laboratories unique Laboratory Planning .....................................................5 capabilities on problems of the greatest significance. To those unfamiliar with the extent of our science, it may seem odd that Who should read this ....................................................5 our planning includes such a strong biology focus, yet our work in this area extends all the way back to the Manhattan Project and the birth of large scale LANL Strategic Context ...............................................6 government-sponsored research. Following World War II, the Laboratory began programs in health and radiation physics that expanded to become the robust Biosurveillance Overview.............................................8 -
Biosecurity: a Comprehensive Action Plan Center for American Progress
Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto Jonathan B. Tucker Progressive Ideas for a Strong, Just, and Free America Biosecurity: A Comprehensive Action Plan Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto and Jonathan B. Tucker June 2006 After Guantanamo: A Special Tribunal for International Terrorist Suspects 1 Biosecurity: A Comprehensive Action Plan Center for American Progress Table of Contents EXECUTIVE SUMMARY i BIOLOGICAL THREATS FACING THE UNITED STATES 1 PREVENTING BIO-CATASTROPHES: THE NEED FOR A GLOBAL APPROACH 9 PREVENTING THE MISUSE OF THE LIFE SCIENCES 9 RECOMMENDATIONS STRENGTHENING BIOLOGICAL DISARMAMENT MEASURES 14 RECOMMENDATIONS 8 CONTAINING DISEASE OUTBREAKS: AN INTEGRATED PUBLIC HEALTH STRATEGY 21 TIMELY DETECTION OF OUTBREAKS 22 RECOMMENDATIONS 0 RAPID CONTAINMENT OF OUTBREAKS 32 RECOMMENDATIONS 5 DEFENDING AGAINST BIOLOGICAL THREATS: AN INTEGRATED RESEARCH STRATEGY 37 REFORMING THE DRUG DEVELOPMENT PROCESS 38 RECOMMENDATIONS 41 RATIONALIZING BIODEFENSE SPENDING 42 RECOMMENDATIONS 44 GLOSSARY 47 Biosecurity: A Comprehensive Action Plan ACKNOWLEDGMENTS The authors are deeply grateful to the following individuals for their valuable comments and criticisms on earlier drafts of this report: Bob Boorstin, Joseph Cirincione, P. J. Crowley, Richard Ebright, Gerald L. Epstein, Trevor Findlay, Brian Finlay, Elisa D. Harris, David Heyman, Ajey Lele, Dan Matro, Caitriona McLeish, Jonathan Moreno, Peter Ogden, Alan Pearson, Michael Schiffer, Laura Segal, and Bradley Smith. 4 Center for American Progress Executive Summary iological weapons and infectious diseases share several fundamental characteristics that the United States can leverage to counter both Bof these threats more effectively. Both a bioweapons attack and a natural pandemic, such as avian flu, can be detected in similar ways, and the effectiveness of any response to an outbreak of infectious disease, whether natural or caused deliberately by terrorists, hinges on the strength of the U.S. -
Challenges and Options for the National Biosurveillance Integration Center
United States Government Accountability Office Report to Congressional Requesters September 2015 BIOSURVEILLANCE Challenges and Options for the National Biosurveillance Integration Center GAO-15-793 September 2015 BIOSURVEILLANCE Challenges and Options for the National Biosurveillance Integration Center Highlights of GAO-15-793, a report to congressional requesters Why GAO Did This Study What GAO Found A biological event, such as a naturally The National Biosurveillance Integration Center (NBIC) has activities that support occurring pandemic or a terrorist attack its integration mission, but faces challenges that limit its ability to enhance the with a weapon of mass destruction, national biosurveillance capability. In the Implementing Recommendations of the could have catastrophic consequences 9/11 Commission Act of 2007 (9/11 Commission Act) and NBIC Strategic Plan, for the nation. This potential threat GAO identified three roles that NBIC must fulfill to meet its biosurveillance underscores the importance of a integration mission. The following describes actions and challenges in each role: national biosurveillance capability— that is, the ability to detect biological • Analyzer: NBIC is to use technology and subject matter expertise, including events of national significance to using analytical tools, to meaningfully connect disparate datasets and provide early warning and information information for earlier warning and better situational awareness of biological to guide public health and emergency events. GAO found that NBIC produces -
Biosurveillance and Outbreak Detection
Chapter 3 Biosurveillance and Outbreak Detection Paola Sebastiani, PhD∗, Kenneth D. Mandl, MD, MPH × ∗ Department of Biostatistics, Boston University, 715 Albany Street, Boston, MA 02118 ×Informatics Program and Division of Emergency Medicine, Children’s Hospital Boston, 300 Longwood Avenue, Boston, MA 02115 Abstract: Faced with the very real threat of bioterrorism, the critical need for early detection of an outbreak has shortened the time frame for major enhancements to our public health infrastructure. The early detection of covert biological attacks requires real time data streams revealing of the health of the population, as well as novel methods to detect abnormalities. Keywords: bioterrorism, spatial clustering, syndromic surveillance, temporal model- ing. 3.1 Biological warfare agents Our national security, threatened by asymmetrical warfare against military and civilian targets, has become increasingly dependent on quick acquisition, processing, integra- tion and interpretation of massive amounts of data. In the mid 1990s, the White House 191 AUTHOR 192 and DOD identified bioterrorism directed against civilian populations as a substantial risk [Centers for Disease Control, 2000], and then stepped up efforts to prevent mass civilian casualties after the anthrax attacks in fall 2001 [Jernigan et al., 2001]. Early de- tection of bioterrorism requires both real time data and real time interpretation. Toward this goal, the biomedical, public health, defense, law enforcement, and and intelligence communities all endeavor to develop new means of communication and novel sources of data. Public health surveillance is defined as “the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health” [Centers for Disease Control and Prevention, 2001]. -
Testimony of Aaron Firoved Senior Biodefense Advisor Office of Health
Testimony of Aaron Firoved Senior Biodefense Advisor Office of Health Affairs U.S. Department of Homeland Security Before the U.S. Senate Committee on Homeland Security and Governmental Affairs April 14, 2016 Chairman Johnson, Ranking Member Carper, and distinguished members of the Committee, thank you for inviting me to speak with you today. I appreciate the opportunity to testify on the Department of Homeland Security’s role in biodefense. The Changing Biological Threat In the fifteen years since the U.S. anthrax attacks, we have continued to face not only the threat of biological attacks, but also naturally occurring disease outbreaks (e.g., avian influenza, Ebola virus, Zika virus), global pandemics (e.g., H1N1 influenza), and criminal acts using biological agents (e.g., ricin). The threats and risks posed by emerging and re-emerging infectious diseases and the potential research, development, acquisition, and use of biological agents by international terrorist organizations, homegrown violent extremists, and rogue states will continue to challenge our ability to warn, prepare, and protect the Homeland. The Blue Ribbon Study Panel on Biodefense’s recent National Blueprint for Biodefense made it abundantly clear that the threat of both manmade and natural biological disasters has not waned and, in fact, continues to grow and evolve. The effects of climate change, global connectivity, advances in biotechnology, and increased instability in the Middle East, Africa, and parts of Asia increase the likelihood of a biological event in the Homeland. Synthetic biology and gene editing offer the promise of great medical breakthroughs; however, they also offer international terrorist organizations, homegrown violent extremists, and rogue states similar potential to modify organisms for malicious purposes. -
Playbook for Early Response to High-Consequence Emerging Infectious Disease Threats and Biological Incidents
Not for Public Distribution PLAYBOOK FOR EARLY RESPONSE TO HIGH-CONSEQUENCE EMERGING INFECTIOUS DISEASE THREATS AND BIOLOGICAL INCIDENTS TABLE OF CONTENTS 1 Not for Public Distribution C HAPTER I - EXECUTIVE SUMMARY I. PLAYBOOK PURPOSE ............................................................................................. PAGE 04 II. POLICY COORDINATION AND EXERCISING THE PLAYBOOK ....................... ................. PAGE 04 Ill. RISK ASSESSMENT DASHBOARD ....... .................................... ................................................. PAGE 05 A . INTERNATIONAL ..................................... ......... .. ......................................................... .. ..... PAGE 06 B. DOMESTIC ................ ....................... .... ............................................. .......... ........... ............ PAGE 07 IV. SAMPLE PATHOGENS INVOLVED ......................................................................................... PAGE 08 V. OTHER KEY CONSIDERATIONS ..............................................................................................PAGE 11 CHAPTER II- PLAYBOOK: DECISION-MAKING RUBRICS I. INTERNATIONAL...... ................................................................................................................. PAGE 14 II. DOMESTIC .... .......................................................................... ................................................. PAGE 31 CHAPTER Ill - APPENDIX MATERIAL I. DECLARATION AND MlnGATION OPTIONS .................. ............. -
Environmental Biodetection and Human Biosurveillance Research
Environmental Biodetection and Human Biosurveillance Research and Development for National Security Priorities for the Department of Homeland Security Science and Technology Directorate MELINDA MOORE, ERIC LANDREE, ALISON K. HOTTES, SHOSHANA R. SHELTON HS AC HOMELAND SECURITY OPERATIONAL ANALYSIS CENTER An FFRDC operated by the RAND Corporation under contract with DHS Published in 2018 Preface Biological threats are among the priorities addressed by the biodefense community and, more broadly, the U.S. homeland security enterprise. Early detection of such threats is a foundation for preparedness and timely, effective response to a biological attack. As potential adversar- ies become more decentralized and capable in the development and deployment of biological weapons, U.S. research and development (R&D) must strive to stay ahead to effectively detect biological threats and minimize their effects. The U.S. Department of Homeland Security (DHS) Science and Technology Directorate (S&T) asked the Homeland Security Operational Analysis Center (HSOAC) to assess priori- ties for its investments in R&D, specifically addressing biological threats. The project entailed three tasks: (1) assess the relevant policy and practice landscape for national biosurveillance and biodetection efforts; (2) conceptualize how R&D can be brought to bear to improve bio- surveillance and biodetection; and (3) review and assess DHS S&T R&D in support of bio- surveillance and biodetection programs. This report aims to describe the results of analyses addressing these tasks. HSOAC exam- ined in detail the current and projected S&T R&D portfolio related to biological threats and also sought to understand relevant R&D supported by non-DHS sponsors. -
DHS Exploring New Methods to Replace Biowatch and Could Benefit from Additional Guidance
United States Government Accountability Office Report to Congressional Requesters May 2021 BIODEFENSE DHS Exploring New Methods to Replace BioWatch and Could Benefit from Additional Guidance GAO-21-292 May 2021 BIODEFENSE DHS Exploring New Methods to Replace BioWatch and Could Benefit from Additional Guidance Highlights of GAO-21-292, a report to congressional requesters Why GAO Did This Study What GAO Found Early detection of a biological attack The Department of Homeland Security (DHS) is following the agency’s acquisition can help reduce illness and loss of life, policy and guidance to acquire Biological Detection for the 21st Century (BD21). but DHS has faced challenges in This system-of-systems concept—an assembly of technologies to gain higher acquiring biodetection capabilities to functionality—is intended to combine various technologies, such as biological replace BioWatch, the current system sensors, data analytics, anomaly detection tools, collectors, and field screening used to detect aerosolized biological devices to enable timelier and more efficient detection of an aerosolized attack attacks. According to DHS, it is involving a biological agent than the current biodetection system. The BD21 exploring the use of a new anomaly program is early in the acquisition lifecycle and DHS has not yet selected the detection capability that, if developed technologies to be used. Potential technologies are still being analyzed to successfully, could reduce the time to demonstrate that certain components of the overall concept are feasible, such as detection. an anomaly detection algorithm. GAO was asked to examine the BD21 acquisition and assess technical However, BD21 faces technical challenges due to inherent limitations in the maturity. -
Southeast Asia Strategic Multilateral Biosecurity Dialogue with Participation from Indonesia, Malaysia, the Philippines, Singapore, Thailand, and the United States
Center for Health Security Southeast Asia Strategic Multilateral Biosecurity Dialogue with participation from Indonesia, Malaysia, the Philippines, Singapore, Thailand, and the United States Meeting Report from the 2019 Dialogue Session April 29-May 1, 2019 Phuket, Thailand Johns Hopkins Center for Health Security Project Team Tom Inglesby, MD Director Anita Cicero, JD Deputy Director Matthew P. Shearer, MPH Senior Analyst Divya Hosangadi, MSPH Analyst Project Sponsori Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction (PASCC) United States Air Force Academy Defense Threat Reduction Agency, US Department of Defense i This publication results from research supported by the United States Air Force Academy’s Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction (PASCC). The views expressed in written materials of publications, and/or made by speakers, moderators, and presenters, do not necessarily reflect the official policies of the United States Air Force Academy nor does mention of trade names, commercial practices, or organizations imply endorsement by the US Government. Johns Hopkins Center for Health Security 1 Executive Summary The Johns Hopkins Center for Health Security and Thailand Ministry of Public Health co-hosted the 2019 Southeast Asia Multilateral Dialogue on Biosecurity from April 29- May 1 in Phuket, Thailand. This year’s dialogue meeting was attended by participants from Indonesia, Malaysia, the Philippines, Singapore, Thailand, and the United States. Participants represented a broad scope of sectors relevant to biosecurity, including public health and healthcare; defense, national security, and law enforcement; homeland security and home affairs; plant and animal health; WMD nonproliferation; academia; and the media. -
Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans
Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans 3 Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans Final – January 2017 Final-January 2017 0 Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans Handling Instructions Information contained in this draft annex is subject to the restrictions outlined in the Response and Recovery Federal Interagency Operational Plans. Distribution of this document is limited and not releasable to the public or to any public web site (public availability to be determined under 5 U.S. Code §552). Although this is an interagency annex, dissemination must be approved by the Department of Homeland Security (DHS). Use of this Document This annex provides guidance and serves as a reference for federal agency planning efforts involving biological incidents. Other stakeholders (e.g., local, state, tribal, territorial, and insular area governments; nongovernmental organizations; voluntary agencies; and the private sector) engaged in their own planning will find this document useful in enhancing their understanding of how the Biological Incident Annex will be implemented and how their planning efforts can be complementary. Distribution, transmission, and destruction of this annex will be in accordance with DHS Management Directive 11042.1, which is publicly available. Questions pertaining to the distribution, transmission, or destruction of this annex or to obtain a copy of DHS Management Directive 11042.1 should be submitted to the Federal Emergency Management Agency Response Directorate, Planning and Exercise Division, National Planning Branch at response- [email protected]. Thank you for your continued support of DHS and assistance throughout this process.