Pandora Report: 2.8.2019

Happy Friday and welcome to our weekly biodefense round-up! This is our favorite time of year as we get to provide some great summaries of ASM Biothreats 2019 from our student reporters.

ASM Biothreats 2019
We’re excited to present our student coverage from the ASM Biothreats conference. This was an engaging few days with lots of discussion surrounding high consequence pathogen research, biotechnology, and the threat of infectious disease. From converging technologies and biorisks to global perspectives on biodefense, we’ve got coverage of some great panels and sessions with the world’s top biodefense experts. Check out the landing page here, which provides insight into our student reporters and links to their individual summaries of the events.

Ebola in the DRC – Time to Sound the Alert?
Is it time to sound the global alarm for the DRC Ebola outbreak? As two more cases were reported and cases have reached nearly 800, many wonder if the outbreak should be declared a Public Health Emergency of International Concern (PHEIC). This outbreak has been particularly challenging – from an election to armed conflict and mass displacement, it has challenged response efforts in new ways. A new article in The Lancet discusses this very issue, noting that “The legal criteria for a PHEIC have been met. The International Health Regulations (2005) (IHR) empower the WHO Director-General to declare a PHEIC. A PHEIC is an extraordinary event with public health risk to other countries that requires a coordinated international response. IHR criteria include public health impact, novelty and scale, and movement of persons. The WHO Director-General must also consider health risks, potential international spread, and EC guidance, among other factors.The report of the EC in October, 2018, expressed concern about armed conflict and new cases without known links, but advised against a PHEIC ‘at this time’. Unlike past statements, the EC did not say ‘the conditions for a PHEIC have not been met’. The DRC epidemic meets PHEIC criteria and has for some time. The IHR empower a PHEIC for ‘potential’ cross-border transmission, without waiting until international spread has occurred. The Ebola epidemic in DRC is unfolding amid regional conflict, as attacks on medical staff coincide with subsequent spikes in cases. As the authors emphasize, the WHO and its partners must work together and with others to ensure success, as international solutions to these events are only becoming more challenging and complicated. “We must plan for a future in which political violence and instability become the new abnormal.” You can also see photos from the frontline of this outbreak here.

Removing Non-medical Obstacles in the Pursuit of Global Health Security 
Speaking of strengthening global health security…GMU biodefense alumni Dr. Jennifer Osetek discussed this very issue in her doctoral dissertation. Jen received her Bachelor of Arts from Drew University in 2003. She has been a commissioned officer in the Coast Guard Reserve since 2007, teaches with Penn State University, and works as a CBRNE analyst with the Coast Guard. She received her Master of Homeland Security in Public Health Preparedness from the Pennsylvania State University in 2008. Her dissertation focused on the very real issue of non-medical obstacles – While traditional public health responses are typically focused on pharmaceutical interventions, historically there have been outside obstacles that have a major influence on the success or failure of a response. Despite their importance, these impediments are typically studied retroactively instead of being a major component of pre-planning and execution considerations. This dissertation proposed a new framework introducing four major classes of Non-Medical Obstacles (NMOs): security, logistics, communications, and social/cultural issues. When the impact of these NMOs are better understood and incorporated into future public health responses, it will be possible to provide more effective and efficient care to populations in need.

 U.S. Experiment Aims to Created Gene-Edited Human Embryos
Despite the scrutiny over He announcing he had used CRISPR to edit the DNA of human babies, a scientist in New York is working to create gene-edited human embryos. “In contrast, Dieter Egli, a developmental biologist at Columbia University, says he is conducting his experiments ‘for research purposes.’ He wants to determine whether CRISPR can safely repair mutations in human embryos to prevent genetic diseases from being passed down for generations. So far, Egli has stopped any modified embryos from developing beyond one day so he can study them. Egli hopes doctors will someday be able edit embryonic human DNA to prevent many congenital illnesses, such as Tay-Sachs disease, cystic fibrosis and Huntington’s disease. In the lab, Egli is trying to fix one of the genetic defects that cause retinitis pigmentosa, an inherited form of blindness. If it works, the hope is that the approach could help blind people carrying the mutation have genetically related children whose vision is normal.”

Antimicrobial Resistance – A Neglected Biodefense Focus
It’s easy to think that biodefense is about defending against bioterrorism or the next pandemic…or even some laboratory accident..mostly because it is all these things but also so much more. Antimicrobial resistance isn’t a flashy topic and it certainly isn’t getting its own apocalyptic outbreak movie anytime soon (hint for Hollywood, this is the topic we’re missing) but it’s been a largely growing microbial threat since antibiotics were first discovered. Pew Charitable Trusts has been working hard to combat AMR and recently discussed the role it has in U.S. biodefense efforts. “Antibiotic-resistant bacteria are not only a threat to public health in the United States, but also to national security. The federal government has recognized that antibiotic-resistant pathogens complicate soldiers’ wounds, exacerbate casualties associated with both natural and manmade emergencies, and can be weaponized by our nation’s enemies. Consequently, the first U.S. National Biodefense Strategy, released last year, highlights the need to reduce the emergence and spread of such superbugs both domestically and internationally, and accelerate the development of new drugs, diagnostic tests, and vaccines. Rick Bright, director of the Biomedical Advanced Research and Development Authority(BARDA)—part of the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response—is among those leading the strategy’s implementation.”

One Health-Social Sciences Initiative (OHSS) Webinar in Spanish – El enfoque de “Una Salud”
The One Health Social Sciences (OH-SS) Initiative is hosting a free webinar series to feature inspirational speakers addressing the role of the social sciences in advancing animal, human, and environmental health systems. We are pleased to offer a webinar to our Spanish-speaking colleagues working to promote One Health and social science concepts in research, practice, and policy in Latin America. El Enfoque de “Una Salud” en Latinoamérica: Perú y México, A focus on “One Health” in Latin America: Peru and Mexico, will be held on Tuesday, Feb 26, 2019, from 10:00 AM – 11:00 AM EST (UTC-5). The Webinar is free to attend but you must RSVP.

Stories You May Have Missed:

  • Letter Pushes for Congressional Action to Stimulate Antibiotic Development – “A coalition of drug makers, infectious disease experts, and public health advocates yesterday called on US lawmakers to pass measures that could “jumpstart” the development of critically needed antibiotics. In a letter sent to lawmakers in the Senate and the House of Representatives, stakeholders from large and small pharmaceutical companies and organizations including the Infectious Diseases Society of America, the Pew Charitable Trusts, and Trust for America’s Health asked Congress to ‘swiftly enact a package of incentives that would sustainably reinvigorate the pipeline of antibiotics while ensuring patient access and appropriate stewardship’.”
  • Concerns for Resistant Flu Medications – “Microbial resistance is not reserved solely for bacteria and antibiotics; the truth is that viruses are wholly capable of mutating to become resistant against medications. Consider HIV—the virus has the ability to mutate and continue viral production in the presence of the antiretroviral drugs that are used to kill it. The same concerns exist for influenza viruses, which already mutate quite rapidly.  In late January, investigators published findings that a new influenza antiviral drug may not be as effective as originally anticipated. Marketed as a competitor for existing medications Tamiflu (oseltamivir) and Relenza (zanamivir), this new medication is called Xofluza (baloxavir marboxil) and is recommended for flu treatment. Although Xofluza doesn’t prevent the flu like the vaccine, if taken within 48 hours of becoming sick with symptoms, such antiviral drugs can help lessen the symptoms and shorten the duration of sickness. The driving point of Xofluza is that it is offered as a single dose while Tamiflu requires twice daily doses for 5 days.”

ASM Biothreats 2019

We’re the source for all things health security and the annual ASM Biothreats conference is no different. GMU’s biodefense program was fortunate to send several students to attend the 2019 ASM Biothreats conference in which topics ranged from diagnostics to technology as a source for biothreats. Held in Arlington, Virginia on January 29-31, this was an exciting event highlighting the importance of conversations surrounding high consequence pathogen research, biological threat reduction, and product development and policy. Our student attendees have reported back on some of the enlightening and captivating sessions during the biothreat event. Below you’ll find several commentaries from each student who attended:

Nicolas Bertini -Nicolas is currently pursuing an M.S. in Biodefense degree at George Mason University and hold an undergraduate degree in Government and International Politics with a double minor in Intelligence Analysis and Conflict Analysis and Resolution from George Mason University as well. He expects to graduate in the Fall of 2019 and plans to pursue a career in biodefense and biosecurity. He aims to identify new vulnerabilities in the national security apparatus while utilizing science and policy to propose creative and effective solutions that will strengthen the nation’s detection, mitigation, and response capabilities. At ASM, Nick attended a session on the different international perspectives on biodefense, noting that “One unique item that stood out is the recognition of the use of the internet to acquire materials that could be used to generate a biological threat. The United Kingdom is focused on modernizing their biodefense strategies to tackle future challenges by addressing the rising importance of new technologies and emphasizing fluid cooperation with international partners.” Nick also attended a session on WHO research and development roadmaps, which ” focused on the research and development roadmaps that the WHO has implemented and managed to initiate a targeted research campaign for the early delivery of vaccines, therapeutics, and diagnostics of Crimean Congo Hemorrhagic Fever (CCHF) and Nipah Virus.”

Georgia Ray – Georgia is a first-year master’s student in George Mason University’s Biodefense program. She studied microbiology and bacteriophage physiology at The Evergreen State College, and has done research with the Effective Altruism Foundation and the Future of Humanity Institute. She is interested in policy, synthetic biology, and averting global catastrophic biological risks. Georgia provides us with a recap of the keynote speakers and their talks on the biodefense landscape and historical lessons from Ebola. “Kadlec also talked about the 2018 National Biodefense Strategy. He likes that it’s deliberate and detailed, and includes risks from emerging technology. Often, bold strategies of its ilk are not tied to reality – for instance, to budgets or the skill levels.” Next, Georgia provides us with a recap of a panel on converging technologies and emerging risks, which also included GMU Biodefense graduate program director Dr. Gregory Koblentz. “Koblentz discussed his work on Editing Biosecurity, a multidisciplinary study on gene editing technology and biosecurity issues. He criticized reliance on “agent-specific” models – security measures that ban specific agents, like smallpox or Clostridium botulinum. In the age of genetic engineering, those boundaries fall apart – what does this system do with a disease that is a genetic combination of smallpox and an unlisted agent? Or a normally-harmless E. coli with an inserted plasmid that codes for botulinum toxin?”

Katelyn Smith – Katelyn Smith graduated from Virginia Tech in May 2018 with a Bachelors of Science in Biological Sciences and a Minor in Psychology. Now, Katelyn is a second semester Masters Student in the Biodefense program at George Mason, planning to graduate in May 2020.  Her academic and research interests include pathogenic bacteriology and epidemiology.  She hopes to one day to work in the field, studying biological agents and diseases and their potential roles in bioterrorism. Katelyn attended an informative session on R&D – from detection to diagnosis to vaccines, focusing on “research projects and product development from all over the United States pertaining to detection, diagnosis, and/or vaccines. Each of the six speakers, ranging from engineer to scientist, brought something unique and different to the table, from a dog’s nose, to immunoassays, to accelerated vaccines.” Next, Katelyn discusses the section of biological agents in the field, involving discussions on the latest bio-detection efforts, as well as historical practices. “Mediated by Dr. Kenneth B. Yeh, a senior science advisor at MRIGlobal, the panel of members were able to comment and answer questions, speaking about previous experiences of their own, as well as some of the research that they do.To start off the session, the panelists discussed a comparison of Real-Time qPCR and Sequencing, the roles they have played overtime in the biological field, as well as changes in the biodefense field in the last few decades.  More than 20 years ago, two major platforms were yielded in the Department of Defense: a real-time PCR system and a current generation diagnostic system.”

Justin Hurt – Justin Hurt is a student in GMU’s Biodefense PhD program, and is currently preparing for his comprehensive exams and dissertation proposal work. In addition to his part-time studies, he is an active duty officer in the United States Army, specializing in chemical, biological, radiological, and nuclear (CBRN) matters and is currently detailed to the Federal Bureau of Investigation as a Defense Liaison in the Weapons of Mass Destruction Directorate (WMDD), where he advises the Assistant Director and WMDD staff on interagency operations and capabilities and assists in policy development. Justin attended the Clade X panel at ASM – “A pandemic tabletop exercise hosted by JHU’s Center for Health Security on 15 May 2018, Clade X sought to identify important national policy issues and preparedness challenges that could be solved with sufficient political will and attention. Built on a fictional scenario based on epidemiological principles and challenges identified and unresolved in response to past outbreaks, key takeaways from Clade X were intended to inform senior leaders and decision makers at high levels in the government on how to deal with the potential for future pandemic events.”

 

 

ASM Biothreats – Keynote

By Georgia Ray

Two keynote speakers kicked off the 2019 ASM Biothreats meeting with some words about horrific diseases, and how health security learns from experience. Robert Kadlec and Anne Schuchat led this informative and engaging keynote event.

Robert Kadlec is a guru of the US Biodefense landscape. He was the main author on the Pandemic and All-Health Preparedness Act. He directed Biodefense efforts at the White House, first as the biodefense director of the Homeland Security Council, and then as the Special Assistant for Biodefense Policy to George W. Bush. Now, he’s the Assistant Secretary for Preparedness and Response at the US Department of HHS.

During the keynote speech of the 2019 ASM Biothreats conference, he talked about the 2014 Ebola pandemic, one of the worst outbreaks of one of the most lethal diseases seen in recent memory. As he saw it, this outbreak proved that two changes to the US disease response system were needed:

  • Training (since answered by the GHSA)
  • Medical countermeasures (still unsolved)

The response to Ebola and other high-consequence infectious diseases in the US is in a fragile state. While funding may run out, Ebola, obviously, will not. Kadlec also talked about the 2018 National Biodefense Strategy. He likes that it’s deliberate and detailed, and includes risks from emerging technology. Often, bold strategies of its ilk are not tied to reality – for instance, to budgets or the skill levels. That’s what Kadlec is working on. For U.S. biodefense efforts, HHS is most involved, but so is the DoD as well as others, including local governments and communities. Right now, ASPR (Kadlec’s office) is fleshing out the National Biodefense Strategy, starting with assessment and data-gathering methods. The B-PLAT, a policy exploration tool put together by PNNL, will explain this as it happens. Note that the plan is intended to be a living document, with refinements every year. As it develops, the office will seek feedback feedback from public groups, including from ASPR’s existing connections. Continue reading “ASM Biothreats – Keynote”

Policy Approaches to Synthetic Biology and Do-it-yourself Biology

By Georgia Ray

Synthetic biology, emerging technology, DIYbio, CRISPR-cas9, and other genetic modification tools – whatever you want to call this category, it’s coming in waves and it’s posing big problems to biodefense experts and regulators. An expert panel convened at the 2019 ASM Biothreats conference to discuss what it means.

Panelists:

Jessica Dymond, senior research scientist at Johns Hopkins University Applied Physics Laboratory

Matthew Walsh, associate staff at MIT’s Lincoln Laboratory

Aditya Kunjapur, principle investigator of the Kunjapur Labat the University of Delaware and biocontainment expert

Jessica Tucker, director of theNIH Office of Biosafety, Biosecurity, and Emerging Biotechnology

Mary Delarosa, at HHS ASPR

Peter Carr, senior scientist at MIT’s Synthetic Biology Center (moderating)

Dymond kicked off the panel by discussing distributed technology. These technologies pose special risks – they can be developed or owned by individuals or small groups, and do not come from a small number of controllable sources. We’ve seen national security grapple with this genre in the past: the proliferation of amateur radio, then cyber capacities, then drones. Biology is another step in this progression – it is, arguably, just worse than the others.

Recent red-teaming efforts have suggested that virus acquisition is doable through legal and black market sources. Constraints like tacit knowledge and funding are barriers, but not insurmountable ones.

So how do we govern this? Lessons from cybersecurity suggest the following:

  • Developing norms
  • No one-size-fits-all solution
  • Stakeholder engagement
  • Be willing to consider unusual approaches

Continue reading “Policy Approaches to Synthetic Biology and Do-it-yourself Biology”

International Perspectives on Biodefense Strategies

By Nick Bertini

Biodefense is an international undertaking. The successful implementation of biodefense strategies demands cooperation from global partners. This session, moderated by the National Defense University’s Dr. Gerald Epstein, analyzed different perspectives on biodefense issues ranging from policies to practices.

First to present was Sarah Telford from the British Embassy in Washington. Telford presented the United Kingdom’s newly published UK Biological Security Strategy. The document was designed to be a transparent and accessible plan for the public to obtain and understand. Telford highlighted that more than 13 government departments collaborated on the drafting of the document. The main focus of the document aims towards improving coordination and capabilities. One unique item that stood out is the recognition of the use of the internet to acquire materials that could be used to generate a biological threat. The United Kingdom is focused on modernizing their biodefense strategies to tackle future challenges by addressing the rising importance of new technologies and emphasizing fluid cooperation with international partners. Telford finished her presentation by illustrating the need for further cooperation on the global scale in order to keep the UK and its partner nations safe. Continue reading “International Perspectives on Biodefense Strategies”

The WHO Research and Development Roadmaps

By Nick Bertini

The World Health Organization (WHO) is constantly attempting to address public health threats before they become major local, regional, and global issues. This session focused on the research and development roadmaps that the WHO has implemented and managed to initiate a targeted research campaign for the early delivery of vaccines, therapeutics, and diagnostics of Crimean Congo Hemorrhagic Fever (CCHF) and Nipah Virus. Moderated by Tim Brooks of Public Health England, the session was geared toward educating the audience on the research and development frameworks that the WHO has in place in order to address the potential major public health threats of the near to midterm future.

Marie-Pierre Prezios, the head of the R&D roadmap program at WHO, started the session off with a general overview of what the WHO’s goals are for implementing these research blueprints. Prezios laid out the strategic priorities of her program by stating that the goals of the WHO are to “keep the world safe, improve health, and serve the vulnerable.” According to Prezios, the framework is designed to improve coordination, map the key stakeholders, and clearly identify products in the drug development pipeline. If these steps are completed, then the research and development process should be accelerated—specifically for priority pathogens and diseases. The roadmaps are generated using two key steps. First, a Baseline Situation Analysis (BSA) is conducted to identify gaps in knowledge and survey the current public health landscape. Second, a diverse technical taskforce is assembled and comes to a consensus regarding the results of the BSA. After a consensus is made, the technical taskforce drafts the research and development roadmaps. Finally, Prezios highlights the success of the roadmap by sharing that in May 2018 there was an outbreak of Nipah Virus in Kerala, India and a successful response was initiated within the first 24 hours. Furthermore, researchers and developers were able to provide the field with monoclonal antibodies within a week, stemming the number of cases and allowing the community to address the public health concerns and to recover from the outbreak. Continue reading “The WHO Research and Development Roadmaps”

From Detection to Diagnosis to Vaccines

By Katelyn Smith

During the “From Detection to Diagnosis to Vaccines” symposium, we were able to hear about research projects and product development from all over the United States pertaining to detection, diagnosis, and/or vaccines. Each of the six speakers, ranging from engineer to scientist, brought something unique and different to the table, from a dog’s nose, to immunoassays, to accelerated vaccines.

The first speaker was Matthew Staymates, a mechanical engineer from the National Institute of Standards and Technology, who spoke on a project titled “Non-Contact Aerodynamic Sampling Approaches for Aerosols and Airborne Particles: Lessons Learned from the Dog Nose”.  This project focused primarily on the olfaction background of canines, studying how a dog’s nose is a great detector system, and is “considered the gold standard in trace chemical sampling”.  Matthew spoke about how this research included looking into the fluid dynamics of the olfaction system of a canine, and how important biomimicry may be. He ended his session by asking this question: “Is there a smarter way to sample our environment (based on lessons learned from the dog’s nose)?”. Continue reading “From Detection to Diagnosis to Vaccines”

Detection of Biological Agents in the Field: Then and Now

By Katelyn Smith

Biology is an ever-changing, growing, and evolving field. To increase our defenses against biological agents in natural occurrences, accidental occurrences, and deliberate occurrences. At the ASM Biothreats Conference this year, there was a panel session organized to hear multiple experts’ commentary on biological agent detection in the field over the years.  Mediated by Dr. Kenneth B. Yeh, a senior science advisor at MRIGlobal, the panel of members were able to comment and answer questions, speaking about previous experiences of their own, as well as some of the research that they do.

To start off the session, the panelists discussed a comparison of Real-Time qPCR and Sequencing, the roles they have played overtime in the biological field, as well as changes in the biodefense field in the last few decades.  More than 20 years ago, two major platforms were yielded in the Department of Defense: a real-time PCR system and a current generation diagnostic system.   Continue reading “Detection of Biological Agents in the Field: Then and Now”

Converging Technologies & Emerging Risks

By Georgia Ray

This was a panel discussion involving four speakers discussing biotechnologies and the potential for mis-use, and the challenges of regulatory oversight.

Jesse Kirkpatrick– GMU’s assistant director of the Institute for Philosophy and Public Policy.

Chris Oehmen– PNNL cybersecurity expert

Gregory Koblentz– The GMU Biodefense program’s very own director.

Megan Palmer– A senior research scholar at Stanford’s Center for International Security and Cooperation.

Oehmen kicked off the panel by drawing parallels between the fields of cybersecurity and biosecurity. First he noted how we tend to misinterpret them – we draw on our classic metaphors for defense and security, and imagine building a castle or a fortress with physical walls, to guard that which we want to keep safe. But information is not a physical material. Its transfer is not cleanly constrained by energy, time, or physical space as physical matter is, and nor are the defenses we build. Oehmen suggests we replace this with a resilience-based model, taking other approaches to thinking of security in flawed systems. What assumptions are we relying on when we think of biosecurity? Are they true? Continue reading “Converging Technologies & Emerging Risks”

Clade X Discussion Panel

By Justin Hurt

Moderator: Gigi Gronvall, PhD

Julie Gerberding, PhD, former CDC Director

Jeffrey Smith, Partner, Arnold and Porter

Imagine a never-before-seen virus emerging simultaneous in multiple places on Earth with no warning, no current countermeasures, and no idea as to the origin. Think about the difficulties that leaders could encounter if one of the outbreaks was in a nation with which we had less than desirable relations, but was close enough that it was likely to spread to our shores quickly. What could that mean for effective response or humanitarian assistance and how would we broach that with our own leaders and diplomatically with our international partners? What if the virus was found to have been engineered and intentionally released? Finally, how do we determine the most effective distribution of any countermeasures we might develop? Continue reading “Clade X Discussion Panel”