Pandora Report 2.15.2019

Summer Workshop on Pandemics, Bioterrorism, and Health Security
We’re excited to announce that the Summer Workshop is now open for registration! From July 15-18, you can participate in 3.5 days filled with topics ranging from vaccine development to bioterrorism response, cyber biosecurity, global health security, biosecurity implications of CRISPR and GoF research, and so much more! Even better, if you register before May 1st, you can get the early-bird discount. We also have discounts available for returning attendees, large groups, and GMU affiliates. This is a great opportunity to learn from the top minds in the field – we hope to see you there!

Talking Biodefense with Senator Daschle
Next week GMU Schar School of Policy and Government at George Mason University will be hosting an informal discussion about key issues in biodefense with former Senator Thomas Daschle, founder of the Daschle Group and a Panel Member on the Blue Ribbon Study Panel on Biodefense. The event will be held on February 19 but is open only to Schar/GMU faculty, students, and alum. If you haven’t registered, feel free to email biodefense@gmu.edu with your GMU account for a registration link.

GMU Biodefense Student Named ELBI Fellow
For a fourth year, Schar Biodefense has a graduate student selected for the Johns Hopkins Health Security Emerging Leaders in Biosecurity (ELBI) program. Congrats to biodefense doctoral student Justin Hurt on being selected for this prestigious fellowship! 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. His recent experience includes positions as a section leader for the Defense Threat Reduction Agency’s CBRN/WMD Military Advsory Team program, the Army’s WMD programs manager and capabilities development coordinator with the Manuever Support Center of Excellence at Fort Leonard Wood, and as a CBRN Technical Escort Response Detachment Commander, as well as command of both chemical and infantry organizations. Justin also originated and leads the Intergancy Counter-WMD Training and Education Working Group, a collaborative inter-departmental organization dedicated to sharing WMD-related training programs and opportunities throughout the government service. His primary research interests lie in improving public-private sector education and cooperation in mitigating international spread of pandemic disease and improving biosafety procedures and training in the expanding number of pathogenic organism research facilities around the world. On being selected, Justin noted that “ELBI represents an annual cohort of future thinkers, advisors, and policy makers in biodefense that come from a wide variety of unique backgrounds and skills that bring together new viewpoints and knowledge applied to tackling some of the nation’s biggest emerging challenges, such as the illicit use of new biotechnologies or the threats to a growing bioeconomy. To be able to participate with such a highly qualified group of developing leaders in this nascent field is really humbling and I will endeavor to contribute and learn as much as I can along the way. I believe the education and perspectives I have gained from studying in George Mason University’s Biodefense Program and the interactions I have beeen fortunate enough to have had during the past two years with the Schar School have prepared me well for contributing in a significant way to the EBLI Fellowship. GMU’s Biodefense students are likewise an incredibly diverse, motivated, and highly intelligent group of future scholars and I’m proud to be able to represent them as a group and the outstanding faculty and staff of the Schar School in this opportunity, and I want to thank my professors, fellow students, and the school’s staff in supporting not only my educational development but also my desire to broaden – and I know that participating in the ELBI program will be a fantastic adjunct to my challenging and rewarding studies at GMU.” Dr. Gregory Koblentz, GMU biodefense graduate program director stated that “Justin is an outstanding student who combines a wealth of practical experience with a passion for biodefense policy. I know Justin will make an important contribution to the Center for Health Security’s objective of building a network of professionals working at the nexus of health, science, and security. This is the fourth year in a row that a student from the Schar School’s Biodefense Program has been selected to participate in the ELBI program. I am gratified to see that the excellence of our students and their unique ability to bridge the gap between science and policy is recognized and valued by the biosecurity community.”

Gain of Function H5N1 Research Resumes 
GoF research involving H5N1 is set to resume…without review comments as the review panel has kept mum. “HHS cannot make the panel’s reviews public because they contain proprietary and grant competition information” – regarding the two labs approved to run such experiments. “The outcome may not satisfy scientists who believe certain studies that aim to make pathogens more potent or more likely to spread in mammals are so risky they should be limited or even banned. Some are upset because the government’s review will not be made public. ‘After a deliberative process that cost $1 million for [a consultant’s] external study and consumed countless weeks and months of time for many scientists, we are now being asked to trust a completely opaque process where the outcome is to permit the continuation of dangerous experiments,’ says Harvard University epidemiologist Marc Lipsitch.” One of the experiments- “Kawaoka’s grant is the same one on H5N1 that was paused in 2014. It includes identifying mutations in H5N1 that allow it to be transmitted by respiratory droplets in ferrets. He shared a list of reporting requirements that appear to reflect the new HHS review criteria. For example, he must immediately notify NIAID if he identifies an H5N1 strain that is both able to spread via respiratory droplets in ferrets and is highly pathogenic, or if he develops an EPPP that is resistant to antiviral drugs. Under the HHS framework, his grant now specifies reporting timelines and who he must notify at the NIAID and his university.” Overall, many are concerned regarding the lack of transparency surrounding the decision to approve such research, especially with the amount of work that has gone into collaborative and informative discussions to help guide policy.

Ebola Outbreak Updates & Hot Zone Drama
On Wednesday, four more cases of Ebola were identified in the DRC and close-calls have prompted testing in Uganda. “A family’s transport of a Ugandan man who died on Feb 8 in the DRC’s outbreak region across the border and back into Uganda sparked intensive contact tracing, location of the body, and sample testing, according to a statement yesterday from the World Health Organization (WHO) African regional office. The 46-year-old man was a construction worker who had been living and working the DRC for the past 8 years. He was first admitted to the hospital in Bunia, one of the towns in Ituri province that has reported Ebola cases, in November 2018 with symptoms that included chest pain and a sometimes-bloody cough. After learning of the incident, Uganda’s health ministry—with support from the WHO—intercepted the man’s relatives and the vehicle with the dead body in it before they reached their village in Tororo district. A ministry burial team and surveillance officer took oral swabs, conducted a verbal autopsy, and made plans to conduct a safe and dignified burial.” If you’re still not getting enough Ebola conversations in your life, watch out for the latest National Geographic series – The Hot Zone. Adapted from the book by Richard Preston, this prime-time drama will likely provide the eagle-eyed biodefense nerd some good scientifically inaccurate depictions of the disease and response measures.

Safeguarding the Bioeconomy Event 
The NextGen Global Health Security Network & GMU Biodefense Discussion Group are hosting an event with guest speaker FBI Supervisory Special Agent Edward You. This event will be held on February 21st at 7:30pm in Arlington, and is exclusive to current Schar students and faculty. Seating is limited and to reserve your spot (RSVP is required), please contact jmarroq2@gmu.edu or staylo30@gmu.edu

Fighting Tuberculosis in the Wake of Hurricane Maria
GMU Biodefense doctoral student Saskia Popescu discusses the challenges of continuing TB control in the wake of a natural disaster. “Responders from the US Centers for Disease Control and Prevention (CDC)’s Division of Global Migration and Quarantine, Puerto Rico Department of Health, and the CDC’s Division of Tuberculosis Elimination have provided insight into their experiences following Hurricane Maria via notes from the field published in a January CDC Morbidity and Mortality Weekly Report. The authors emphasized several unique facts that challenged public health efforts in Puerto Rico. For example, less than a week after the hurricane, 84% of hospitals there had no electrical power or fuel for generators, and within the span of 2 weeks there had been 2 declarations of major disasters due to Hurricane Maria and Hurricane Irma, which passed 57 miles north.
Prior to the storms, the Puerto Rico Department of Health Tuberculosis Control Program (PRTB) worked to prepare at its six regional clinics. The department “provided all patients receiving treatment for active TB with a 1-month supply of anti-TB medications before the hurricane and encouraged patients to tell health officers at shelters about their diagnosis if they had to be relocated from their homes.” Furthermore, the Puerto Rico Health Department worked to educate and inform shelters of the potential risk for tuberculosis transmission. They also provided guidance for screening procedures that extended beyond tuberculosis. ”

The True Burden of Resistant Infections
We’ve been basing the burden of resistant infections in the U.S. on data that might not be accurate anymore. “For several years now, the most frequently cited number has been 23,000 deaths a year, a figure put forward by the US Centers for Disease Control and Prevention (CDC) in a 2013 report on the most dangerous antibiotic-resistant pathogens. The CDC calculated that number—and the estimate of more than 2 million illnesses a year caused by antibiotic-resistant bacteria—using data from the National Healthcare Safety Network, the Emerging Infections Program, the National Antimicrobial Resistance Monitoring System, the National Center for Health Statistics, and hospital surveys.” For many of us in infection prevention, this number has always seemed smaller than what we really saw on the hospital units. The CDC is working though, to update this as it’s likely these are quite conservative numbers. “Michael Bell, MD, deputy director of the Division of Healthcare Quality Promotion at the CDC, agrees. He contrasts death data with birth data, which is based on an event that generally happens in a controlled setting, with people present to record it. ‘Death data is very different,’ he said. ‘We don’t have that degree of control about understanding when someone dies, how they die, where they die, and with whom they die.’ There are other challenges in estimating US deaths from drug-resistant infections, including a lack of universal reporting of antibiotic-resistant pathogens and the absence of ICD-10 codes—the alpha-numeric codes used by physicians, health insurers, and public health agencies—that specifically denote diagnoses of multidrug-resistant infections, which are the most severe and life-threatening forms of bacterial infection.”

Zika As An Occupational Hazard for Laboratory Biomedical Research Workers
GMU Biodefense doctoral alum Chris Brown is addressing the risk that Zika poses for laboratory workers. In a letter to the editor, he and Jill Shugart describe “several reports of laboratory and biomedical research workers having been potentially exposed to Zika virus, including as a result of sharps injuries. Also emphasizes the importance of implementing appropriate controls, including proper PPE and worker training, to prevent future Zika exposures.”

Stories You May Have Missed:

  • FDA Takes New Steps to Secure Drug Supply Chain– “A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in our nation’s drug supply chain. As part of these efforts, today, the agency is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain. Eligible entities may apply to participate in the program. The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act. This new program will pilot technologies that may become part of our enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.”

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”