Pandora Report 3.2.2018

Happy Friday! We’ve got a full plate of biodefense news this week, so we hope you’re hungry for everything from ASM Biothreats 2018 coverage to Gain of Function research, and a side of pandemic budgeting.

ASM Biothreats 2018 – GMU Biodefense Coverage
We’re excited to present our annual coverage of the ASM Biothreats conference from some of GMU’s very own biodefense graduate students. Our overview is a great way to catch up on some of the hot topics and captivating breakout sessions from the conference. You can find a landing page for all the reviews here, which will have links and a brief synopsis for each section the students wrote. GMU biodefense graduate students covered a variety of sessions – from artificial intelligence in biosecurity to the GHSA, future DoD programs in biodefense policy, and BARDA/DARPA projects- we’re reporting it all!

New Pathogen Research Rules: Gain of Function, Loss of Clarity
GMU Biodefense professor and graduate program director Gregory Koblentz is teaming up with Lynn Klotz (co-managing director of Bridging BioScience and BioBusiness LLC), to evaluate the December 2017 release of the latest Gain of Function (GoF) research rules. The DHHS release finally lifted the funding moratorium on GoF research following the controversial projects involving H5N1 in 2011. While the DHHS policy (or “Framework for guiding funding decisions about proposed research involving enhanced potential pandemic pathogens”) is similar to the Office of Science and Technology Policy guidance that was released in January 2017 (the “P3C0 Framework”), it came with the bonus of restoring funding for such research. Unfortunately, there are still considerable concerns with how GoF research is evaluated and if these frameworks have really addressed the gaps. “We, the authors, harbor concerns about adequate oversight of potentially dangerous research, and the framework incorporates several elements that address those concerns. The framework is thorough. It does a good job of laying out the principles and processes through which the Health and Human Services Department will make funding decisions regarding research that involves enhanced potential pandemic pathogens. The framework’s approach to dual-use research of concern is not based on lists of experiments or on specific pathogens, but instead takes a risk-based approach that focuses on the attributes of modified organisms. While the identity of starting organisms is central to existing oversight policy for dual-use research of concern, the framework emphasizes the importance of organisms’ properties once the experiment is over. This more comprehensive approach to dual-use research is a welcome change. Some elements of the new framework, however, remain worrisome.” Koblentz and Klotz point to several limitations of the new framework – it’s too narrow and not broad enough in that it only applies to research funded by DHHS, the terminology and definitions are lacking (especially in the definition of a potential pandemic pathogen), and the review process that was created is a limited. The framework also has new criteria for risks and benefits, which is “inherently problematic” and agreement is often never achieved. “The criteria used to judge which experiments involving enhanced potential pandemic pathogens warrant review by the Health and Human Services Department—and how the risks, benefits, and ethical aspects of such experiments are measured and weighed—are ambiguous enough to provide departmental reviewers wide latitude in their funding decisions. The process and outcomes must be transparent in order to demonstrate that the process is conducted in good faith and that policy is implemented appropriately. The framework, though it recognizes the importance of transparency for maintaining public trust in science, does not go far enough in actually providing the requisite level of transparency.” Lastly, Koblentz and Klotz point to the international considerations as a considerable weakness within the new framework. Sadly, it only applies to research done within the United States and the truth is that this is an international issue and needs global consideration and collaboration.

 2018 NASPAA Student Simulation – Global Health Security
How did you spend your Saturday? Battling a virtual pandemic? We were fortunate to participate as judges at an international collaboration and simulation to test students on their response during a pandemic. The NASPAA-Batten simulation (Network of Schools of Public Policy, Affairs, and Administration) involved a total of 563 students in 117 teams, from 159 universities across 27 countries. Teams represented approximately 336 million fictitious people in 4 fictitious countries per 1 fictitious world and were battling 1 seriously tough outbreak. GMU’s Schar School and the biodefense program were represented in both participants and judges. Professor and graduate program director Gregory Koblentz and PhD student Saskia Popescu were judges while six Schar students participated (four of which were biodefense students!) at the Carnegie Mellon University site in DC – Alexandra Williams (Biodefense MS), Annette Prietto (Biodefense MS), Stephen Taylor (Biodefense MS), Justin Hurt (Biodefense PhD), Fleciah Mburu (MPA), and Ryan Kennedy (MPP). The two finalist teams from the CMU site included biodefense MS students Alexandra and Justin, which means they’ll now move on to the global round where they are competing for the $10,000 prize. GMU biodefense students know how to battle a pandemic – whether it’s simulated or real! From a judge’s perspective, this was a great experience to not only observe how people respond to the complexities of a global outbreak, but also pose questions that help them see all the moving pieces in response.

Blue Panel Study Panel on Biodefense Calls For Strategic Budgeting Tied to New National Biodefense Strategy
The Blue Ribbon Study Panel has released a statement on the desperate need for decision-makers to commit to biodefense funding and recognize it as an imperative component to national security.  “We would do well to remind ourselves that we are really just as vulnerable now as we were then. In addition to the enormous potential toll on human health that intentional or natural outbreaks can inflict, the cost of the relentless rise of outbreaks is also entirely unsustainable based on current funding approaches. Emergency appropriations reach into the billions in direct outlays to the U.S. government. Economic impacts of a catastrophic outbreak could reach into the trillions.” You can also read the OpEd by Sen. Joe Lieberman and Former Gov. Tom Ridge, stating that American lives are worth budgeting for biodefense. “We call upon the president to release the National Biodefense Strategy soon and ensure that his next budget request to Congress conforms to the priorities in this strategy, showing how money requested for biodefense programs support the National Strategy’s goals and objectives.”

CDC Plans for New High Containment Lab
The CDC is asking congress for $350 million to start building the high containment continuity laboratory on their main campus to replace the existing one that has been used since 2005, but requires replacement by 2023. “The existing facility contains a number of BSL4 labs and labs that are one step down the biosafety and biosecurity ladder, BSL 3 enhanced. That’s where research on dangerous avian influenza viruses like H5N1 and H7N9 is conducted. Buildings that house these types of labs simply require a lot of maintenance, explained Dr. Dan Jernigan, head of the CDC’s influenza branch. ‘We’re just faced with the realities of what it takes to maintain something as complex as the high containment lab,’ he said.” The complex design of high containment labs makes them both expensive to build and maintain.

Battelle Takes On Biological Threats With New Software
Between naturally occurring outbreaks, bio-error, and bio-terror, there are a lot of ways infectious diseases can pose a threat to human life and safety. Battelle is seeking to change this through a new software for the U.S. government that “would screen small bits of DNA and assess whether they belong to potentially dangerous genetic sequences.The local research institution is one of six groups awarded an $8.7 million, two-and-a-half-year grant by the Intelligence Advanced Research Projects Activity (IARPA), an organization within the Office of the Director of National Intelligence.” The growing application of CRISPR and other genome editing technologies has underlined the gaps in DNA sequence screening for biosecurity concerns, especially when one considers the recent horsepox synthesis. “In the absence of national or international policy that would monitor bioengineering activity — and the technological gap for keeping an eye on never-before-encountered organisms — Battelle and the other groups awarded the federal contract are trying to figure out how to stay a step ahead. ‘At first I thought it would be too big of a lift for us,’ Dickens said. At the end of January, Battelle researchers completed a first version of the software, which they are now testing and optimizing. It can, for example, analyze a small fraction of an influenza virus’ genetic code and identify or predict whether it has the potential to make people, animals or the environment sick. The tool then assigns the genetic scrap a threat level: dangerous, potentially hazardous or safe. The tool is artificially intelligent enough to detect whether the sample is related to any known specimens, such as botulism or anthrax, and predict the function of never-seen-before DNA sequences.”

Workshop on Women’s Health In Global Perspective
GMU Schar School is hosting this free workshop on March 7-8th in Arlington,VA – don’t miss out! “The Workshop on Women’s Health in Global Perspective seeks to contribute to understanding and improve policy on women’s health and wellbeing around the world. The program includes panels on Communicable and Non-Communicable Disease; Health and Wellbeing; Maternal Health; and Reproductive Technology and Family Planning. It will cover topics such as HPV Vaccine Awareness, Maternal Mortality, and Cross-border Reproductive Care.”

GMU Biodefense Alum Leads NEIC Laboratory 
We love getting to brag about the amazing things that GMU Biodefense students and alum do with their passion for health security. Biodefense MS alum Francisco Cruz was recently named the Chief of the EPA’s National Enforcement Investigations Center (NEIC) Laboratory Branch! “The branch’s primary responsibility is conducting forensics analysis on environmental samples related to criminal and civil cases. The lab is a fully accredited forensics laboratory staffed by 21 chemists who can not only conduct the lab analysis, but also testify in court regarding the science behind the analysis. Additionally, the lab is capable of developing novel analytical methods for rare and difficult matrices that most labs cannot analyze. The lab supports EPA and other federal law enforcement partners with either lab analysis or technical consultation on how to process a sample.” Biodefense alums – don’t forget to stay connected so we can recognize you for all the amazing biodefense work you do!

DARPA Names Pandemic Prevention Platform Researchers
Launched in 2017, the P3 program from DARPA hopes to stop the spread of an outbreak before it becomes a pandemic. “In contrast with state-of-the-art medical countermeasures, which typically take many months or even years to develop, produce, distribute, and administer, the envisioned P3 platform would cut response time to weeks and stay within the window of relevance for containing an outbreak.” DARPA recently announced the institutions that are contracted for the program and will hopefully make progress in the fight against pandemics – MedImmune, Abcellera Biologics Inc., Duke University, and Vanderbilt University.

 The WHO – What Went Wrong from Swine Flu to Ebola?
The WHO has struggled to find its strong foot since 2009’s H1N1 influenza pandemic and then the 2014/2015 Ebola outbreak. With new leadership, many are hoping the WHO’s abilities can be strengthened and some faith restored in their capacity to prevent and respond to international health events. One particular evaluation of this can be found in a chapter of Political Mistakes and Policy Failures in International Relations. “This chapter examines a series of mistakes and the structural, cultural, political and epidemiological factors that contributed to the WHO’s mishandling of the first pandemic of the twenty-first century and the world’s largest ever outbreak of Ebola. The chapter then concludes by examining the reforms currently being implemented to strengthen the WHO’s global health security capabilities and what these signify for the future.”

Stories You May Have Missed:

• CDC Epidemiologist Missing – “Police investigators are bewildered as they work through the “extremely unusual” circumstances surrounding the missing-person case of Timothy Cunningham, a researcher who vanished Feb. 12, shortly after hearing why he had been passed over for a promotion at the Centers for Disease Control and Prevention (CDC). Cunningham, 35, told colleagues he was not feeling well and left work at CDC headquarters in Atlanta, not long after speaking with his supervisor about why he had not been promoted, Atlanta Police Maj. Michael O’Connor told reporters. Cunningham works in the chronic disease unit at the CDC, not in the part of the CDC that deals with infectious disease, according to authorities.”
• Iraqi, Dutch, Vietnamese Officials Report Avian Flu Outbreaks – “Several countries reported new avian flu outbreaks, including two more H5N8 events at commercial poultry farms in Iraq, an H5 outbreak at a poultry farm in the Netherlands, and the first known H5N6 detection of the year in Vietnam. In Iraq, which has reported ongoing H5N8 activity since early January, authorities reported new outbreaks in Diyala and Baghdad province that began on Feb 13 and Feb 14, respectively, according to a report yesterday from the World Organization for Animal Health (OIE). The investigation said the source of the virus was contact with wild species.”
• 11 Fall Ill After Suspicious Letter Arrives At Military Base– “Eleven people fell ill after a suspicious letter was opened in an administrative building at Joint Base Fort Myer-Henderson Hall in Arlington, Virginia, on Tuesday, according to the Arlington County Fire Department. A law enforcement official said field tests for the letter all came back negative for any harmful substance, but the FBI is transporting it tonight to its lab in Quantico for further analysis. The law enforcement official said the text of the letter contained derogatory, at time unintelligible and ranting language, and was addressed to a commanding officer at the base. Investigators are still determining what relationship, if any, the sender had with the base. A corporal, gunnery sergeant and a colonel all exhibited symptoms of a burning sensation on their hands and face, according to Specialist Nicholas Hodges who spoke to CNN from the base.”

Thank you for reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport