Next Generation Bioweapons
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Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2018 Clinical/Antimicrobial Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2018 Clinical/Antimicrobial TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 A. Historical Background................................................................................................................... 2 B. Indication for Prophylaxis of Inhalational Anthrax ................................................................... 2 III. DEVELOPMENT PROGRAM ....................................................................................... 3 A. General -
Patentability of Human-Animal Chimeras Ryan Hagglund
Santa Clara High Technology Law Journal Volume 25 | Issue 1 Article 4 2008 Patentability of Human-Animal Chimeras Ryan Hagglund Follow this and additional works at: http://digitalcommons.law.scu.edu/chtlj Part of the Law Commons Recommended Citation Ryan Hagglund, Patentability of Human-Animal Chimeras, 25 Santa Clara High Tech. L.J. 51 (2012). Available at: http://digitalcommons.law.scu.edu/chtlj/vol25/iss1/4 This Article is brought to you for free and open access by the Journals at Santa Clara Law Digital Commons. It has been accepted for inclusion in Santa Clara High Technology Law Journal by an authorized administrator of Santa Clara Law Digital Commons. For more information, please contact [email protected]. PATENTABILITY OF HUMAN-ANIMAL CHIMERAS Ryan Hagglundt Abstract The chimera was a mythological creature with a lion 's head, goat's body, and serpent's tail. Because of recent advances in biotechnology, such permutations on species are no longer the stuff of myth and legend The term "chimera " has come to describe a class of genetically engineered creatures composed of some cells from one species, which thus contain genetic material derived entirely from that species, and some cells from another species, containing only genetic material from that species. Scientists have created a goat- sheep chimera or "geep" which exhibits physical characteristicsof both animals. Likewise, scientists have also used the tools of modern molecular biology to create human-animal chimeras containing both human and animal cells. While none of the human-animal chimeras hitherto created have exhibited significant human characteristics,the synthesis of human-animal chimeras raises significant ethical concerns. -
Hidden Cargo: a Cautionary Tale About Agroterrorism and the Safety of Imported Produce
HIDDEN CARGO: A CAUTIONARY TALE ABOUT AGROTERRORISM AND THE SAFETY OF IMPORTED PRODUCE 1. INTRODUCTION The attacks on the World Trade Center and the Pentagon on Septem ber 11, 2001 ("9/11") demonstrated to the United States ("U.S.") Gov ernment the U.S. is vulnerable to a wide range of potential terrorist at tacks. l The anthrax attacks that occurred immediately following the 9/11 attacks further demonstrated the vulnerability of the U.S. to biological attacks. 2 The U.S. Government was forced to accept its citizens were vulnerable to attacks within its own borders and the concern of almost every branch of government turned its focus toward reducing this vulner ability.3 Of the potential attacks that could occur, we should be the most concerned with biological attacks on our food supply. These attacks are relatively easy to initiate and can cause serious political and economic devastation within the victim nation. 4 Generally, acts of deliberate contamination of food with biological agents in a terrorist act are defined as "bioterrorism."5 The World Health Organization ("WHO") uses the term "food terrorism" which it defines as "an act or threat of deliberate contamination of food for human con- I Rona Hirschberg, John La Montagne & Anthony Fauci, Biomedical Research - An Integral Component of National Security, NEW ENGLAND JOURNAL OF MEDICINE (May 20,2004), at 2119, available at http://contenLnejrn.org/cgi/reprint/350/2112ll9.pdf (dis cussing the vulnerability of the U.S. to biological, chemical, nuclear, and radiological terrorist attacks). 2 Id.; Anthony Fauci, Biodefence on the Research Agenda, NATURE, Feb. -
Amerithrax Investigative Summary
The United States Department of Justice AMERITHRAX INVESTIGATIVE SUMMARY Released Pursuant to the Freedom of Information Act Friday, February 19, 2010 TABLE OF CONTENTS I. THE ANTHRAX LETTER ATTACKS . .1 II. EXECUTIVE SUMMARY . 4 A. Overview of the Amerithrax Investigation . .4 B. The Elimination of Dr. Steven J. Hatfill as a Suspect . .6 C. Summary of the Investigation of Dr. Bruce E. Ivins . 6 D. Summary of Evidence from the Investigation Implicating Dr. Ivins . .8 III. THE AMERITHRAX INVESTIGATION . 11 A. Introduction . .11 B. The Investigation Prior to the Scientific Conclusions in 2007 . 12 1. Early investigation of the letters and envelopes . .12 2. Preliminary scientific testing of the Bacillus anthracis spore powder . .13 3. Early scientific findings and conclusions . .14 4. Continuing investigative efforts . 16 5. Assessing individual suspects . .17 6. Dr. Steven J. Hatfill . .19 7. Simultaneous investigative initiatives . .21 C. The Genetic Analysis . .23 IV. THE EVIDENCE AGAINST DR. BRUCE E. IVINS . 25 A. Introduction . .25 B. Background of Dr. Ivins . .25 C. Opportunity, Access and Ability . 26 1. The creation of RMR-1029 – Dr. Ivins’s flask . .26 2. RMR-1029 is the source of the murder weapon . 28 3. Dr. Ivins’s suspicious lab hours just before each mailing . .29 4. Others with access to RMR-1029 have been ruled out . .33 5. Dr. Ivins’s considerable skill and familiarity with the necessary equipment . 36 D. Motive . .38 1. Dr. Ivins’s life’s work appeared destined for failure, absent an unexpected event . .39 2. Dr. Ivins was being subjected to increasing public criticism for his work . -
Pandemic Disease, Biological Weapons, and War
Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2014 Pandemic Disease, Biological Weapons, and War Laura K. Donohue Georgetown University Law Center, [email protected] This paper can be downloaded free of charge from: https://scholarship.law.georgetown.edu/facpub/1296 http://ssrn.com/abstract=2350304 Laura K. Donohue, Pandemic Disease, Biological Weapons, and War in LAW AND WAR: (Sarat, Austin, Douglas, Lawrence, and Umphrey, Martha Merrill, eds., Stanford University Press, 2014) This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: https://scholarship.law.georgetown.edu/facpub Part of the Defense and Security Studies Commons, Military and Veterans Studies Commons, Military, War, and Peace Commons, and the National Security Law Commons PANDEMIC DISEASE , BIOLOGICAL WEAPONS , AND WAR Laura K. Donohue * Over the past two decades, concern about the threat posed by biological weapons has grown. Biowarfare is not new. 1 But prior to the recent trend, the threat largely centered on state use of such weapons. 2 What changed with the end of the Cold War was the growing apprehension that materials and knowledge would proliferate beyond industrialized states’ control, and that “rogue states” or nonstate actors would acquire and use biological weapons. 3 Accordingly, in 1993 senators Samuel Nunn, Richard Lugar, and Pete Dominici expanded the Cooperative Threat Reduction Program to assist the former Soviet republics in securing biological agents and weapons knowledge. The Defense Against Weapons of Mass Destruction Act gave the Pentagon lead agency responsibility. 4 Senator Lugar explained, “[B]iological weapons, materials, and know-how are now more available to terrorists and rogue nations than at any other time in our history.”5 The United States was not equipped to manage the crisis. -
In Defense of Cyberterrorism: an Argument for Anticipating Cyber-Attacks
IN DEFENSE OF CYBERTERRORISM: AN ARGUMENT FOR ANTICIPATING CYBER-ATTACKS Susan W. Brenner Marc D. Goodman The September 11, 2001, terrorist attacks on the United States brought the notion of terrorism as a clear and present danger into the consciousness of the American people. In order to predict what might follow these shocking attacks, it is necessary to examine the ideologies and motives of their perpetrators, and the methodologies that terrorists utilize. The focus of this article is on how Al-Qa'ida and other Islamic fundamentalist groups can use cyberspace and technology to continue to wage war againstthe United States, its allies and its foreign interests. Contending that cyberspace will become an increasingly essential terrorist tool, the author examines four key issues surrounding cyberterrorism. The first is a survey of conventional methods of "physical" terrorism, and their inherent shortcomings. Next, a discussion of cyberspace reveals its potential advantages as a secure, borderless, anonymous, and structured delivery method for terrorism. Third, the author offers several cyberterrorism scenarios. Relating several examples of both actual and potential syntactic and semantic attacks, instigated individually or in combination, the author conveys their damagingpolitical and economic impact. Finally, the author addresses the inevitable inquiry into why cyberspace has not been used to its full potential by would-be terrorists. Separately considering foreign and domestic terrorists, it becomes evident that the aims of terrorists must shift from the gross infliction of panic, death and destruction to the crippling of key information systems before cyberattacks will take precedence over physical attacks. However, given that terrorist groups such as Al Qa'ida are highly intelligent, well-funded, and globally coordinated, the possibility of attacks via cyberspace should make America increasingly vigilant. -
Maximum Containment: the Most Controversial Labs in the World
Maximum Containment: The Most Controversial Labs in the World By Alison K. Bruzek B.A. Biological Sciences Northwestern University, 2010 SUBMITTED TO THE PROGRAM IN COMPARATIVE MEDIA STUDIES/WRITING IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE IN SCIENCE WRITING AT THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY MASSACHUSETTS IN'T-QUTE OF 7ECHNOLOqi September 2013 JUL 0 22013 @2013 Alison K. Bruzek. All rights reserved. Li__RARI ES The author hereby grants to MIT permission to reproduce and to distribute publicly paper and electronic copies of this thesis document in whole or in part in any medium now known or hereafter created. Signature of Author: -----.. Program in Con rativeMedia Studies/Writing June 10, 2013 Certified by: Philip Hilts Director, Knight Science Journalism Fellowships Thesis Supervisor Accepted by: Seth Mnookin Assistant Professor of Science Writing Director, Graduate Program in Science Writing 1 2 Maximum Containment: The Most Controversial Labs in the World By Alison K. Bruzek Submitted to the Program in Comparative Media Studies/Writing on June 10, 2013 in Partial Fulfillment of the Requirements for the Degree of Master of Science in Science Writing ABSTRACT In 2002, following the September 1 1 th attacks and the anthrax letters, the United States allocated money to build two maximum containment biology labs. Called Biosafety Level 4 (BSL-4) facilities, these labs were built to research new vaccines, diagnostics, and treatments for emerging infectious diseases, potential biological weapons, and to contribute to the nation's biodefense. These labs were not the first dramatic reaction to the threat of biowarfare and are in fact, one product of a long history of the country's contentious relationship with biological weapons. -
Conversions of Former Biological Weapons Facilities in Kazakhstan
SWEDISH DEFENCE RESEARCH AGENCY FOI-R--0082--SE NBC Defence May 2001 SE-901 82 Umeå ISSN 1650-1942 User report Conversion of former biological weapons facilities in Kazakhstan A visit to Stepnogorsk July 2000 Roger Roffey, Kristina S. Westerdahl 2 Issuing organization Report number, ISRN Report type FOI – Swedish Defence Research Agency FOI-R--0082--SE User report NBC Defence Research area code SE-901 82 Umeå 3. Weapons of Mass Destruction Month year Project no. May 2001 A472 Customers code 2. NBC-Defence Research Sub area code 34 Biological and Chemical Defence Research Author/s (editor/s) Project manager Roger Roffey Lars Rejnus Kristina S. Westerdahl Approved by Scientifically and technically responsible Report title Conversion of former biological weapons facilities in Kazakhstan, A visit to Stepnogorsk July 2000 Abstract (not more than 200 words) Report from the conference “Biotechnological development in Kazakhstan: Non-proliferation, conversion and investment” held in Stepnogorsk, Kazakhstan July 24-26 2000. The conference was sponsored by US DOD and organised by the Biotechnology Centre at Stepnogorsk in co-operation with the NIS Representative office in Astana, Kazakhstan of the Centre for Non-proliferation Studies, Monterey Institute of International Studies. The conference concentrated on the dismantlement and conversion of former BW producers. The intent was to present to a larger public the results of the US DOD CTR (Cooperative Threat Reduction) program at the Biotechnology Centre of Stepnogorsk and attract some potential partners to encourage conversion projects. The conference gave a good overview of the conversion projects in progress in Kazakhstan and scientific results were presented of research being funded by the US. -
Pathogens As Weapons Gregory Koblentz the International Security Implications of Biological Warfare
Pathogens as Weapons Pathogens as Weapons Gregory Koblentz The International Security Implications of Biological Warfare Biological weapons have become one of the key security issues of the twenty-ªrst century.1 Three factors that ªrst emerged in the 1990s have contributed to this phenomenon. First, revelations regarding the size, scope, and sophistication of the Soviet and Iraqi biological warfare programs focused renewed attention on the prolifera- tion of these weapons.2 Second, the catastrophic terrorist attacks on September 11, 2001, and the anthrax letters sent to media outlets and Senate ofªces in the United States during the following month, demonstrated the desire of terror- ists to cause massive casualties and heightened concern over their ability to employ biological weapons.3 Third, signiªcant advances in the life sciences have increased concerns about how the biotechnology revolution could be ex- ploited to develop new or improved biological weapons.4 These trends suggest that there is a greater need than ever to answer several fundamental questions about biological warfare: What is the nature of the threat? What are the poten- tial strategic consequences of the proliferation of biological weapons? How ef- Gregory Koblentz is a doctoral candidate in Political Science at the Massachusetts Institute of Technology. I would like to thank Robert Art, Thomas Christensen, Linda Fu, Jeanne Guillemin, Kendall Hoyt, Milton Leitenberg, John Ellis van Courtland Moon, Julian Perry Robinson, Harvey Sapolsky, Mar- garet Sloane, Jonathan Tucker, and Stephen Van Evera for their support and discussion of previous drafts. I am also grateful for comments from the participants in seminars at the Massachusetts In- stitute of Technology’s Security Studies Program, Harvard University’s John M. -
Molecular Subtyping of Bacillus Anthracis and the 2001 Bioterrorism-Associated Anthrax Outbreak, United States Alex R
BIOTERRORISM-RELATED ANTHRAX Molecular Subtyping of Bacillus anthracis and the 2001 Bioterrorism-Associated Anthrax Outbreak, United States Alex R. Hoffmaster,* Collette C. Fitzgerald,* Efrain Ribot,* Leonard W. Mayer,* and Tanja Popovic* Molecular subtyping of Bacillus anthracis played an important role in differentiating and identifying strains during the 2001 bioterrorism-associated outbreak. Because B. anthracis has a low level of genetic variabil- ity, only a few subtyping methods, with varying reliability, exist. We initially used multiple-locus variable- number tandem repeat analysis (MLVA) to subtype 135 B. anthracis isolates associated with the outbreak. All isolates were determined to be of genotype 62, the same as the Ames strain used in laboratories. We sequenced the protective antigen gene (pagA) from 42 representative outbreak isolates and determined they all had a pagA sequence indistinguishable from the Ames strain (PA genotype I). MLVA and pagA sequencing were also used on DNA from clinical specimens, making subtyping B. anthracis possible with- out an isolate. Use of high-resolution molecular subtyping determined that all outbreak isolates were indis- tinguishable by the methods used and probably originated from a single source. In addition, subtyping rapidly identified laboratory contaminants and nonoutbreak–related isolates. he recent bioterrorism-associated anthrax outbreak dem- subtype 26 diverse B. anthracis isolates into six PA genotypes T onstrated the need for rapid molecular subtyping of Bacil- (8). Although sequencing of pagA results in limited numbers lus anthracis isolates. Numerous methods, including multiple- of subtypes, it does have the added benefit of determining if locus enzyme electrophoresis (MEE) and multiple-locus the pagA gene has been altered or engineered. -
(MBR) Technology for Wastewater Treatment and Reclamation: Membrane Fouling
membranes Review Membrane Bioreactor (MBR) Technology for Wastewater Treatment and Reclamation: Membrane Fouling Oliver Terna Iorhemen *, Rania Ahmed Hamza and Joo Hwa Tay Department of Civil Engineering, University of Calgary, Calgary, AB T2N 1N4, Canada; [email protected] (R.A.H.); [email protected] (J.H.T.) * Correspondence: [email protected]; Tel.: +1-403-714-7451 Academic Editor: Marco Stoller Received: 14 April 2016; Accepted: 12 June 2016; Published: 15 June 2016 Abstract: The membrane bioreactor (MBR) has emerged as an efficient compact technology for municipal and industrial wastewater treatment. The major drawback impeding wider application of MBRs is membrane fouling, which significantly reduces membrane performance and lifespan, resulting in a significant increase in maintenance and operating costs. Finding sustainable membrane fouling mitigation strategies in MBRs has been one of the main concerns over the last two decades. This paper provides an overview of membrane fouling and studies conducted to identify mitigating strategies for fouling in MBRs. Classes of foulants, including biofoulants, organic foulants and inorganic foulants, as well as factors influencing membrane fouling are outlined. Recent research attempts on fouling control, including addition of coagulants and adsorbents, combination of aerobic granulation with MBRs, introduction of granular materials with air scouring in the MBR tank, and quorum quenching are presented. The addition of coagulants and adsorbents shows a significant membrane fouling reduction, but further research is needed to establish optimum dosages of the various coagulants/adsorbents. Similarly, the integration of aerobic granulation with MBRs, which targets biofoulants and organic foulants, shows outstanding filtration performance and a significant reduction in fouling rate, as well as excellent nutrients removal. -
Mitchell & Kilner
THE NEWSLETTER VOLUME 9 OF THE CENTER NUMBER 3 FOR BIOETHICS AND SUMMER 2003 HUMAN DIGNITY Inside: Remaking Humans: The New Utopians Versus a Truly Human Future1 Remaking Humans: The New Utopians Versus a Truly Human C. Ben Mitchell, Ph.D., Senior FeIIow,The Center for Bioethics and Human Dignity 1 John F. Kilner, Ph.D., President,The Center for Bioethics and Human Dignity Future If the nineteenth century was the age of the mentally by making use of reason, science, The Genetics of Mice and Men: machine and the twentieth century the infor and technology. In addition, respect for the Can—and Should—We mation age, this century is, by most accounts, rights of the individual and a belief in the 2 the age of biotechnology. In this biotech cen power of human ingenuity are important ele Intervene? tury we may witness the invention of cures for ments of transhumanism. Transhumanists genetically linked diseases, including also repudiate belief in the existence of super Movie Review natural powers that guide us. These things 4 Alzheimer’s, cancer, and a host of maladies News from the Field that cause tremendous human suffering. We together represent the core of our philosophy. may see amazing developments in food pro The critical and rational approach which duction with genetically modified foods that transhumanists support is at the service of the 6 Book Review actually carry therapeutic drugs inside them. desire to improve humankind and humanity in all their facets.” Bioterrorism and high-tech weaponry may 7 Center Resources also be in our future. Some researchers are even suggesting that our future might include Again, the idea of improving society through the remaking of the human species.