NTI Presentation- Biosecurity by Design: Getting Ahead of Risk in the World of Designer Operations

By GMU Biodefense graduate student Carlos Alvarado

On Wednesday June 13, 2018, the Nuclear Threat Initiative (NTI) hosted Dr. Reshma Shetty of Ginkgo Bioworks for a presentation on getting ahead of risk in the world of designer organisms. The presentation started off with remarks from NTI CEO Ernest J. Moniz announcing the new logo for NTI:Bio. He explained how NTI’s focus was on nuclear weapons and weapons of mass destruction however, with rapid advances in science technology NTI created a Global Biological Policy and Programs Unit. NTI:Bio’s focus is to continue to find ways to reduce threats from risks posed by advances in biotechnology. He then concluded with introducing Dr. Reshma Shetty and how her company Ginkgo Bioworks could provide insight of how these advances in biotechnology could support the future structure of biosecurity. Continue reading “NTI Presentation- Biosecurity by Design: Getting Ahead of Risk in the World of Designer Operations”

The Smithsonian’s “Outbreak: Epidemics in a Connected World”

By Zach Goble, Biodefense graduate student
On May 18, 2018, the Smithsonian’s National Museum of Natural History launched “Outbreak: Epidemics in a Connected World”, a new exhibit highlighting the impact infectious diseases have around the globe. The launching of this exhibit could not be more timely on the 100th anniversary of the 1918 influenza pandemic that shook the world.

To officially announce and celebrate the opening of this new exhibit, the American Society for Microbiology (ASM), National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention (CDC), the American Society of Virology (ASV), and Research America all partnered together to brief the public on infectious diseases and the vaccines that stop them in their tracks.

Research America shared survey results on the American public’s opinion on topics such as global health and vaccination. The main findings emphasize that the majority of Americans believe infectious diseases pose a threat to the U.S. and also that vaccines are important to the health of our society. In the 1970s, there were seven vaccines on the recommended immunization schedule and today there are 15 recommended vaccines, more than doubling the number of infectious disease we are now better protected from. Continue reading “The Smithsonian’s “Outbreak: Epidemics in a Connected World””

Pandemic Preparedness in the Wake of Ebola -CSIS Symposium

by Stephen Taylor, Biodefense MS student

On Thursday May 17, 2018, the Center for Strategic & International Studies (CSIS) brought together health security experts from around the globe for a symposium on pandemic preparedness in the 21stcentury.  The event opened with remarks from J. Stephen Morrison, Senior Vice President and Director of the CSIS Global Health Policy Center and Luciana Borio, Director of Medical & Biodefense Preparedness Policy for the National Security Council.  Dr. Morrison and Dr. Borio discussed the importance of lessons learned during the 2014-2016 West African Ebola pandemic to global health security.  In Nigeria, for instance, where Ebola containment efforts were successful, investments in detection and response capacities made for the Nigerian polio eradication program were instrumental in stopping Ebola. Surveillance systems and trained health care workers were embedded at the community level and field epidemiologists were ready to be deployed.  The Nigerian response was an excellent demonstration of how investments toward vaccination and eradication campaigns for one disease can have crosscutting benefits for pandemic preparedness as a whole.  Also important were the efforts that grew out of the bungled responses in Liberia, Guinea, and Sierra Leone.  In light of the massive casualties, slow and costly international response, and ruinous economic damage in these countries, the international conversation about pandemic preparedness and response was propelled forward.  The Global Health Security Agenda enjoyed an increased profile in the years following the pandemic.  National leaders committed to increasing prevention, detection, and response capacities and the international community re-evaluated its approach to emergency response efforts. Continue reading “Pandemic Preparedness in the Wake of Ebola -CSIS Symposium”

Elevating CRISPR-Cas9

By GMU Biodefense graduate student Janet Marroquin

The contentious debate regarding the precision of the commercially available gene-editing tool, CRISPR-Cas9, continues as Nature recently retracted a study published last year on the unintended effects of off-target mutagenesis.  The 2017 study used CRISPR-Cas9 to edit a genetic mutation causing blindness in mice but the researchers also observed CRISPR-induced mutations in other genes due to off-target editing at higher rates than previously documented.  In their report, the researchers expressed their concern over the alarming target imprecision of the widely-used gene-editing tool and its effect on unwanted mutations in gene therapy.  However, further evaluation of the study by other researchers raised questions about the validity of the study results given the possibility of natural genetic variation introducing mutations independent of CRISPR use.  After eight months of deliberation, Nature determined the cause of the unexpected mutations to be natural genetic variability, as the mice were not genetic clones, and not the pronounced off-target effects of the CRISPR-Cas9 system used, ultimately leading to the retraction of the study from the journal. Continue reading “Elevating CRISPR-Cas9”

An Afternoon with ASPR – Dr. Robert Korch and Dr. Dana Perkins

Anthony Falzarano, GMU Biodefense graduate student 

Last week, the National Academies of Sciences, Engineering and Medicine held another event in their monthly series on biological, chemical and health security issues. This luncheon – consisting of an open forum session with a two-member panel and a moderator – featured Dr. George W. Korch and Dr. Dana Perkins, both from the Department of Health and Human Services office of the Assistant Secretary for Preparedness and Response (ASPR). Drawing from their current roles with ASPR as well as their illustrious careers and vast experiences, two presenters made for a compelling afternoon discussing health security issues and the work being done by ASPR to prepare for and address them. Continue reading “An Afternoon with ASPR – Dr. Robert Korch and Dr. Dana Perkins”

Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention

Overview by: Morasa Shaker, GMU Biodefense graduate student

Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention
By Center for the Study of WMD
Spotlight Speaker: Michelle Rourke

It is more than likely that most people would not be opposed to efforts conserving the critically endangered Borneo elephant found on the island of Borneo in Sabah, or the Radiated Tortoise near extinction on the island of Madagascar. However, it would take a lot more convincing to reach a unanimous consensus that we should conserve a fatal virus. While the case can be made that endangered species pose an intrinsic value to the world’s genetic diversity, it is has proven less feasible to make the same case for a virus, specifically the variola virus—the causative agent of smallpox. Nevertheless, Michelle Rourke, a Fulbright scholar at Georgetown University’s O’Neill Institute for Domestic and Global Health Law, led an in-depth educational seminar organized by the Center for the Study of Weapons of Mass Destruction to support that very case—the smallpox virus is worthy of our conservation efforts.

This discussion, based on her article “Never Mind the Science, Here’s the Convention on Biological Diversity: Viral Sovereignty in the Smallpox Destruction Debate,” published in the Journal of Law and Medicine, addressed the smallpox virus retention controversy that has ensued since the disease was declared eradicated in in 1980. Rourke, a PhD candidate at Griffith Law School in Nathan, Australia, found it increasingly more difficult to access virus samples for research purposes while studying both dengue viruses and Ross River virus. These major hindrances in her studies served as the context for her research on the international law around ‘who owns virus samples’ and then using those principles of international law and extending them to a specific case: Who owns the smallpox stocks maintained in the Centers for Disease Control (CDC) in the United States in Atlanta, GA and in Koltsovo, Russia? Continue reading “Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention”

The Missile Technology Control Regime at 30

We’re please to provide an overview of this event from the James Martin Center for Nonproliferation Studies on February 14, 2018, by two GMU biodefense graduate students – Christopher Lien and Shauna Triplett.

PART I – Christopher Lien
I had the pleasure of attending an in-depth discussion on the work of the Missile Technology Control Regime (MTCR), now celebrating its 30th year of operation. Emphasizing the MTCR’s decades of efforts in slowing the spread of unmanned systems designed to carry and deliver weapons of mass destruction (WMD), the discussion highlighted various topics of concern and challenges that face the nonproliferation community in today’s ever-evolving technological and political environment. I detail a few of the key talking points herein.

A recurring theme in the discussion centered on the need for consensus within the nonproliferation community. Ambassador Piet de Klerk, former Chair of the MTCR, emphasized that one must maintain a realistic yet ambitious agenda when interfacing with both member states and non-member states. Learning where the “red lines” are in each individual state’s case and crafting an appropriate plan of action lends itself to fostering a culture of consensus.

Richard Speier of the RAND Corporation provided a summary of the MTCR’s history, from its launch in 1987 up to the present day, and left us with some thoughts for the regime’s future. He briefly detailed the evolution of the definition of an MTCR Category 1 item[1] – complete rocket and unmanned aerial vehicle (UAV) systems capable of carrying a payload of at least 500 kilograms a distance of at least 300 kilometers. These items and their major subsystems, related technology and software, and even their dedicated production facilities are all subject to ‘strong presumption of denial’ of export. This 300-kg/500-km threshold becomes important again later on.

Several challenges inevitably present themselves with rapid innovations in missile technology. For example, satellite launch vehicles (SLVs) are inherently dual-use in that their technology can be used to carry valuable satellites into orbit while also being interchangeable with large ballistic missiles. Speier highlights the case of Brazil’s space program that, between the 1980s-1990s, concerned United States policy makers – the same solid fuel propellants used to launch satellites into geosynchronous orbit could also have been diverted toward the world’s largest solid fuel intercontinental ballistic missile (ICBM).

Michael Elleman, a Senior Fellow at the International Institute for Strategic Studies, usefully pointed out that too often SLV programs are equated with ICBM programs – to date no state has ever successfully converted an SLV into an ICBM. He maintains that space programs are not a shortcut to ICBM development and instead directed attention toward the need for countermeasures against newer threats such as hypersonic cruise missiles (HCMs) and penetration aids. Hypersonic missiles confound the MTCR 300/500 threshold since they can be effective solely with their kinetic energy for destructive power and oftentimes do not carry any payload. I asked Elleman what existing policies might be or already have been adapted to address this modern threat or if there is a perceived need for the creation of new policies. The encouraging response from both Elleman and Speier was that hypersonic technologies have not been overlooked and research has been conducted studying the methods of hindering hypersonic missile proliferation. Since HCMs rely on advanced propulsion methods such as turbofan engines or scramjets, export controls may be imposed on these engines and their components, fuels for hypersonic use, sensors and navigation items, and other systems used in developing hypersonic vehicles.[2]

Amid the rapid pace of innovations in drone technology and maneuverable re-entry vehicles, political tensions precluding comprehensive nonproliferation cooperation, and questions about the MTCR’s adaptability to these issues, how is the MTCR moving forward?

Today 35 nations strong, the MTCR continues facilitating intelligence sharing on proliferant programs and upholding bilateral cooperation among member states while seeking to establish productive relations with would-be members. Vann Van Diepen, former Principal Deputy Assistant Secretary of State for International Security and Nonproliferation, delivered the event’s keynote address focusing on several key accomplishments of the MTCR in its 30 years of operation. The regime deals not only with tangible items subject to export control but also intangibles such as the sharing of technological information. Its control lists have served as models for those of other states, bolstering the environment of consensus among the nonproliferation community. Van Diepen states that the MTCR is now beyond just export control – it is now a full-fledged nonproliferation regime. The MTCR is not a panacea to the proliferation issue, but the regime and its mission continue to be needed.

[1] The Cat. 1 & Cat. 2 definitions are found at #13 in the FAQ section, I as unable to figure out how to anchor the hyperlink to go to that specific spot in the webpage.

[2] These recommended items for export control taken from the document that I hyperlinked in “hypersonic cruise missiles”;
Richard Speier, George Nacouzi, Carrie Lee, and Richard Moore, “Hypersonic Missile Proliferation: Hindering the Spread of a New Class of Weapons,” RAND Corporation (2017), p. 45.

PART II –Shauna Triplett
The Missile Technology Control Regime is wrapping up its 30th year anniversary. This time calls for reflection on the MTCR’s achievements and shortcomings. At this year’s MTCR 30th Year of Operations event at the James Martin Center for Nonproliferation Studies, MTCR experts reflected on the past three decades. Here are five takeaways:

            Since its founding in 1987, the MTCR has been expanded its regime to 35 nations. Vann Van Diepen, the U.S. Department of States’ Principal Deputy Assistant Secretary of the Bureau of International Security and Nonproliferation, outlined the MTCR’s key accomplishments.  He notes these accomplishments as the ability to place successful controls on pace, a strong focus on terrorism, and effective catch-all controls. He notes that the absence of the MTCR would have led to a stronger future for Iran and North Korea’s nuclear intentions. There is no doubt that the MTCR has been necessary over these past 30 years.

            The reflection of accomplishments also calls for the acknowledgement of shortcomings. The biggest concern for the regime is its inability to keep up with technology. Controls are harder to place on complicated weaponry and strategies have not become any simpler to achieve. The regime is faced with the task to update its objectives in order to meet these long-term challenges.

            Ambassador Piet de Klerk of the Netherlands highlighted the stigma that regimes are for the “haves and have-nots”. Looking at the MTCR’s membership would make one believe that it is an elite group for developed nations. Although 35 members are included in the MTCR, it should be noted that only three nations have been added this century. The need for expansion is important now more than ever. In this era of nuclear threat, the MTCR must have a stronger presence and focus on expansion. Although there is a concern of free riders, this is the also the time for the regime to consider whether it is promoting an environment of the “haves and have-nots’. Or is this even a concern to be addressed?

            Rachel Stohl, the Managing Director of the Henry L. Stimson Center, raised the concern of a drone’s place in the MTCR. UADs are expanding massively and Stohl acknowledged that the framework of the MTCR does not fit well with drones due to new technology capabilities. Although Stohl is skeptical of the future of drones in the MTCR, this anniversary is a time to reflect on how to adapt the regime to the expanding technologies of drone capabilities.

            The MTCR may be wrapping up its 30th year, but there’s more work to be done. Richard Speier of the RAND Corporation, notes that the MTCR’s focus should be directed towards DPRK and Iran while being cautious in regard to Turkey, Syria, the Arabian Peninsula, Taiwan, and Japan/Australia. Elleman acknowledges the need to overcome guidance challenges that counter-measures such as maneuverable re-entry vehicles face. He also advises the MTCR to find a strategy that would place controls on short range cruse missiles as well strategize the utilization of high altitude endurance UAVs.

There is no doubt that the MTCR is still necessary, but the regime must be prepared for an increase in challenges. There should be a re-focus on the regimes’ objectives, a better attempt to place controls on new technology, and an expansion of membership. With the increasing threat of nuclear warfare, the anniversary and need for reflection could not have come at a more appropriate time. Now, the MTCR must commit to action.

Peppermint, Ponies, and Unicorns: Unraveling the Post-Cold War Myth and Preparing for 21st Century Threats

by Stephen Taylor

“Things have changed in a very significant way.”  This was Dr. Robert Kadlec’s, Assistant Secretary for Preparedness and Response (ASPR), opening line at the February 12th, 2018 ASM Biothreats keynote address.  Coming out of the Cold War era, Dr. Kadlec elaborated, defense leaders asserted that the United States had “won history”.  For a brief time, U.S. global military dominance seemed immutable and the security of the American people against foreign threats enduring.  Today, however, the threat landscape includes sophisticated state actors, such as China and Russia, as well as less sophisticated, but still effective countries like Iraq and Syria, which have shown few scruples in developing and deploying chemical weapons like sarin and chlorine gas.  The Islamic State of Iraq and the Levant, though in retreat, still poses a multi-state threat in the Middle East.  Additionally, pandemics such as Ebola and Highly Pathogenic Avian Influenza have become increasingly common in our interconnected world.  Dr. Kadlec also acknowledged that global climate change will continue to contribute to unpredictable and intense weather events with potentially disastrous consequences.  The post-Cold War days of peppermint, ponies, and unicorns, Dr. Kadlec emphasized, were short-lived. Continue reading “Peppermint, Ponies, and Unicorns: Unraveling the Post-Cold War Myth and Preparing for 21st Century Threats”

ASM Biothreats 2018

We’re the source for all things biodefense and the annual ASM Biothreats conference is no different. GMU’s biodefense program was fortunate to send several students to attend and report back on some of the enlightening and captivating sessions during the biothreat event. Below you’ll find several commentaries from each student who attended – happy reading!

Mariam Awad – Biodefense MS Student
Mariam is a graduate student with a background in biochemistry and foreign affairs and is reporting on breakout sessions on the international landscape of biodefense and artificial intelligence for biosurveillance. “During this talk, speakers addressed both bilateral and multilateral research projects in various regions around the world led by various US agencies including State Department and defense threat reduction agency.” Next, Awad discusses “how we can utilize machine learning for creating situational awareness of both intentional and naturally occurring biological incidents. One of the current hurdles in conducting biosurvillance for Bacillus Anthracis and pandemic influenza include lack of tools that can rapidly structure, integrate and analyze large, disparate data with little human exposure and intervention.”

Jessica Smrekar – Biodefense MS Student
Jessica has a background in biology and biotechnology and is giving us insight into one of the keynote speakers, Dr. Ilaria Capua, and her frank talk about the relationship between the government and science. “This particular keynote described her story of shame, falsification, and the effects populism on the scientific community. She began by stating this was the hardest speech she has ever had to give and that we would understand why by the end of it.  She then set the scene by speaking of the turmoil of the modern age and how this age has brought along hard times for everyone.” Next, Smrekar evaluates one of the more controversial discussions – the future of P3C0, noting that “A large portion of the session was dedicated to analyzing the risk of gain of function studies with PPPs and how these risks compare to the benefits from such research.”

Anthony Falzarano – Biodefense MS Student
Anthony, having just attended the GHSA Kampala summit, delves into global approaches to threat reduction through OneHealth. “This new concept that we must consider all the health-related disciplines to truly understand and address the challenges faced in public health has grown to be the backbone of forward-thinking health initiatives like the Global Health Security Agenda.” Next, Falzarano is also giving his perspective on the panel on the international landscape of biodefense. “While these threats may be from natural or man-made infectious disease events, they all share a similar connection in that pathogenic diseases do not respect borders or political lines. This session featured speakers from the United States Department of State, Defense Threat Reduction Agency, and Edgewood Chemical and Biological Center. These entities are working both together and in parallel to address the biosecurity risks posed against our country and to the world.”

Justin Hurt – Biodefense PhD Student
Justin is providing us with a detailed account of the breakout session on planning for the future and the DoD programs to help inform biodefense policy. “One such player that has not only significant expertise, but also a robust research and development capability in countering biological threats is the Department of Defense (DoD). Joined by its partner agencies in the national security enterprise, the DoD leads a wide-ranging portfolio of projects geared toward preventing, preparing for, and mitigating the possibility of a future biological attack or public health crisis.”

Stephen Taylor – Biodefense MS Student
Stephen, also a GHSA Kampala Summit attendee, is delving into the talk from DARPA and BARDA researchers regarding prevention planning against the next pandemic. “Justin Yang, a project officer at BARDA, spoke about BARDA’s vision to shrink the gap between patients and treatment, both physically and temporally. For instance, U.S. healthcare providers have access to a myriad of influenza diagnostics. Using these tools in a timely manner, however, is problematic.” Stephen also provides an overview of Dr. Robert Kadlec’s keynote address. “The Islamic State of Iraq and the Levant, though in retreat, still poses a multi-state threat in the Middle East.  Additionally, pandemics such as Ebola and Highly Pathogenic Avian Influenza have become increasingly common in our interconnected world.  Dr. Kadlec also acknowledged that global climate change will continue to contribute to unpredictable and intense weather events with potentially disastrous consequences.  The post-Cold War days of peppermint, ponies, and unicorns, Dr. Kadlec emphasized, were short-lived.”


Breakout Session – Planning for the Future: Department of Defense Programs and Processes to Inform Biodefense Policy

By Justin Hurt

Any future approach to countering potential biological threats will require a multi-faceted, integrated effort by many players to ensure that all appropriate methodologies and scenarios are considered in developing policies and solutions. One such player that has not only significant expertise, but also a robust research and development capability in countering biological threats is the Department of Defense (DoD). Joined by its partner agencies in the national security enterprise, the DoD leads a wide-ranging portfolio of projects geared toward preventing, preparing for, and mitigating the possibility of a future biological attack or public health crisis.

In a discussion moderated by Dr. Jeffrey “Clem” Fortman of the Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense, several experts from the federal agencies associated with combating biological threats discussed emerging trends in the field of biodefense. Joined by Ms. Robin Wales of the Defense Threat Reduction Agency’s (DTRA) Global Futures Office, Dr. Brad Ringeisen of the Defense Advanced Research Projects Agency (DARPA) Biotechnologies Office, and Dr. David Shepard of the Department of Homeland Security’s Science and Technology Directorate, Dr. Fortman outlined the current DoD priorities and projects in the biodefense realm. The DoD’s multi-layered approach, informed by the June 2014 DoD Strategy for Countering Weapons of Mass Destruction (WMD), includes being the federal government’s technical lead for biothreat response, leveraging a range of internal and external experts, and interagency partners.

Collaboration between the internal service components of the DoD, including the Army, Air Force, and Navy provides the warfighter’s viewpoint on addressing biodefense needs in military environments. Through a series of ongoing studies and workshops, the services are providing perspectives to the myriad partners the DoD has in research and development, including bringing external experts and emerging leaders into the defense establishment through programs such as the American Association for the Advancement of Science’s Science and Technology Policy Fellows Program and the Vannevar Bush Faculty Fellowship. The DoD is currently working with such experts and interagency partners on a final report sponsored by the National Academy of Science on “Strategies for Identifying and Addressing Biodefense Vulnerabilities posed by Synthetic Biology.” This document, with a framework to identify and describe gaps in knowledge and technology as well as generate ideas for mitigation options, is expected in a final format in late Spring 2018. Continue reading “Breakout Session – Planning for the Future: Department of Defense Programs and Processes to Inform Biodefense Policy”