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”

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

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”

Dual Perspectives on The International Landscape of Biodefense: New Terrain

Enjoy dual perspectives on this captivating talk by two biodefense MS students, Mariam Awad and Anthony Falzarano.

Part I – By Anthony Falzarano 
The increased attention to Biodefense by both the United States Government as well as other world governments has largely been spurred by advancements in knowledge and intelligence of various threats in the post-9/11 world. 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.

The US State Department addresses Biodefense largely through the Biosecurity Engagement Program (BEP). As Siddha Hover-Page, representative and presenter from the US State Department said, BEP works in three factors: Terror interest in bioweapons, dangerous pathogens, and bioscience capability and containment. She noted that naturally occurring diseases are typically the highest priority, but that it is also always a priority of the government to gather intel on and track terrorist groups or state actors who may be interested in deploying a biological weapon. In addition to the three pillars of the BEP, she spoke about the program’s extensive role in the Middle East and areas of Africa, in the roles of disease detection and response, and in scientist engagement.

While the US Department of State supports programs aimed at deterring and countering biological weapon use, the premier biological weapons nonproliferation agency for the US and her allies is the Defense Threat Reduction Agency (DTRA), according to the second speaker on this panel, Dr. Gavin Braustein. DTRA, Braustein says, heavily supports biosurveillance initiatives to help track diseases and provide epidemiological data, biosafety and security to promote worldwide safe and secure research, and engages in cooperative research efforts which largely support One Health initiatives. Braustein spoke extensively about how the first and foremost priority of DTRA is to focus on the select pathogens which are of interest and concern to the United States, and to address them by implementing programs which not only help detection and tracking of them worldwide, but also assist other governments in doing safe and responsible research for their own protection.

Finally, Dr. Calvin Chue spoke about the globally-collaborative programs supported by the Edgewood Chemical and Biological Center (ECBC), colloquially called “security through sharing.” According to Chue, ECBC regularly engages in science diplomacy – exchange programs including knowledge sharing, data sharing and analysis exchange, sharing of scientists and researchers, and the exchange of materials, protocols, equipment and organism strains. These collaborative efforts, Chue says, help countries to not only be transparent and supportive of the research with ultimately benefits the whole planet, but also provides a way for knowledge to be easily shared and governments to check and balance the research being done worldwide to promote responsible research initiatives.

This panel highlighted just a few of the myriad of ways that the United States Government works collaboratively and transparently with other governments and agencies around the world. Both One Health and science diplomacy have a very intimate, integral part in developing the entire world towards the capacity to prevent, detect and effectively respond to infectious disease threats, no matter the type, source, or location on the globe.

Part II – By Mariam Awad 
We are as strong as our weakest link. This phrase drives the purpose for the United States biodefense international efforts. During this talk, speakers addressed both bilateral and multilateral research projects in various regions around the world led by various US agencies including the State Department and DTRA. The objectives of these research projects are to increase global biosafety and biosecurity efforts. Some of the research projects aim to increase electronic surveillance reporting, early-detection of disease and collection of a world-wide select agent list. In Azerbaijan, researchers are working towards investigating mosquito and tick populations abundant in the south eastern region of the country. In Kazakhstan, the United States is working with a local team to conduct molecular characterization and genome sequencing of new castle disease virus strains native to that region. In addition, the US military is working on several projects in Jordan and Georgia to increase information and data sharing as well as strengthen material transfer and exchange programs for scientists to collaborate and learn about how to safely conduct bio/chem related research. An example of an on-going multilateral project is a collaboration between scientists in Turkey, Georgia and Armenia with US guidance focused on understanding the risk of bat-borne zoonotic disease emergence in western Asia. The discussion ended by addressing some of the difficulties with working on multi-lateral projects. “Personnel conflicts have historically provided the greatest setbacks”. In other words, it takes one person in a high position in a foreign country to stop multi-lateral agreements that may have taken place for a long time before his/her start date. 

We Are the World: Global Approaches to Threat Reduction Through OneHealth

By Anthony Falzarano

One Health – the booming initiative to encourage collaboration between all varieties of physicians, veterinarians, and virtually every remaining health-related field of practice – is a word that you’d be hard pressed to go ten minutes without hearing at any conference, meeting or coffee conversation involving global health and biodefense. 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.

Despite being a relatively new movement, One Health programs have been implemented around the world in many capacities, and have brought with them many successes while simultaneously uncovering new challenges. At ASM Biothreats this year, a session to showcase these new findings from various worldwide One Health approaches was organized. Titled We Are the World: Global Approaches to Threat Reduction Through One Health, this session featured a panel of experts from various organizations and agencies such as World Health Organization, World Organization for Animal Health, and the Nelson Mandela African Institution of Science and Technology. The speakers all highlighted projects within their various organizations which had flavors of One Health, demonstrating new and ambitious technologies to prevent, detect and respond to infectious disease threats. Continue reading “We Are the World: Global Approaches to Threat Reduction Through OneHealth”

The Background and Future Direction of P3CO

By Jessica Smrekar

Saving some of the most controversial discussions for the very last session, a conglomerate of private and government agencies came together to examine potentially pandemic pathogen care and oversight, nicknamed P3CO.  This collection of experts included Gerald Epstein of the White House Office of Science Technology and Policy, Ryan Ritterson from Gryphon Scientific LLC, and Mary Delarosa of HHS Office of the Assistant Secretary for Preparedness and Response. Each of these experts provided presentations that dissected the struggle between useful research of potentially pandemic pathogens (PPP) and the dual use this research may stimulate.

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. Gryphon is a specialized, small business consulting practice that has technical background in life sciences. Their analysis is dedicated to issues of global health and homeland security. This practice was contracted by the National Institutes of Health to run a risk and benefit analysis of gain of function research and provide an unbiased report of such research.  This proved to be a difficult task, as forecasting realized benefits of scientific research is challenging and risk analyses are hindered by data gaps.  Upon completion of this report, analysts found that though there are several concerning factors of gain of function research, such as lab accidents, accidental release and open sharing of research, the risk is relatively low when conducted in the proper manner.  There was found to be a low risk of lab accidents or potential for accidental release and the information released to the public did not increase the risk of potential threats.  With this information laid out, there was a plea to begin to fill in the data gaps that exist with missing biosafety information and to encourage timely and accurate incident reporting to keep the risks of this research from rising.

Funding for this research was also touched upon, which falls into the hands of the HHS.  This focused on the potential for pandemics and the creation of enhanced pathogens.  The rigorous system is set up to assess the research and review the risk and benefit analysis to establish the highest level of safety.  P3CO and enhanced pathogens are the main concern in this review, which covers pathogens that are highly transmissible and highly virulent and research to enhance virulence or transmissibility.  Such research runs through a multidisciplinary department evaluation and an advisory board to encourage transparency and public engagement.  This is considered the Pre-Funding Review and from this review HHS determines if funding will be provided, denied, or if modifications need to be made in order to receive funding.

The strong stigma against research of potentially pandemic pathogens is difficult to dislodge, but this panel of experts took up the challenge and discussed the topic through a full spectrum of risks, benefits, and how the scientific and policy community are working to protect the global community from harmful exposure.

Pills and Needles:  At the Forefront of Next Generation Pandemic Preparedness

by Stephen Taylor

How do you stop a pandemic?  Do you focus on rapid diagnosis and treatment of the infected?  Do you try to anticipate it and head it off at the start?  Do you vaccinate against the etiologic agent and stop it entirely?  The ‘Pills and Needles’ Panel on Monday, February 12th explored all of these options.  Distinguished speakers from the Defense Advanced Research Projects Agency (DARPA) and the Biomedical Advanced Research and Development Authority detailed prevention, planning, and response initiatives to better prepare the United States against pandemic threats.

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.  Influenza diagnostic capabilities are not networked, meaning that there is a two-week lag in the U.S. to collect and disseminate influenza incidence data.  With the population’s view of flu outbreaks constantly stuck two weeks in the past, patients are less likely to be proactive about reporting to a healthcare provider with flu-like symptoms.  By the time most patients receive a flu diagnosis, they are well outside the window of effectiveness for antivirals like oseltamivir.  BARDA’s solution to this diagnostic lag is to empower individuals as pandemic first responders, taking a personalized approach to a global problem.  BARDA modeling shows that if individuals were equipped with either in-home or wearable diagnostics in advance of an influenza pandemic, their time to report to a health care provider would be shortened, their spread of the virus to others limited, and overall incidence of flu cases greatly reduced.  BARDA is applying this paradigm to other pathogens of pandemic potential with the aim of building an early identification ecosystem around next generation wearable diagnostic technology.

Continue reading “Pills and Needles:  At the Forefront of Next Generation Pandemic Preparedness”

 Artificial Intelligence for Biosurveillance/ Real-time Situational Awareness/ US Department of Homeland Security

By Mariam Awad

The purpose of this series of talks was to discuss 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. The speakers focused on how to apply advancement in artificial intelligence and machine learning towards analysis of data for decision makers. Topic areas ranged from detection, tracking, and forecasting events, as well as analysis of genomic data as it relates to understanding and characterizing a biological event.

One speaker discussed how we can integrate data from multiple streams. One cheap stream is scanning social media accounts to track the spread of disease. This data, while unstructured, can be useful by incorporating a program that would give the raw data parameters such as location, population and duration. One limitation for this potential tool is its inability to predict unknown diseases. How can we conduct surveillance for a bug we don’t know? How do you know what data is significant?

A group from Carnegie Mellon University has designed a program that detects new novel symptoms through a “key-word” scan. The program assigns a significance value to new symptoms as well as old. If those new symptoms are occurring over and over in the data, then scientists are able to pay attention to them and assess whether or not they are significant. For example, if the program finds “tainted coffee” while scanning the data, it will assign it a significance value and will be added to the “memory” for future encounters. This tells us what to search from within the data. The potential impact of this tool in biosurvillance and early detection is huge.

 

 

Dr. Ilaria Capua’s Keynote Speech – Science and the Government

By Jessica Smrekar

As the third keynote speaker, Dr. Ilaria Capua broke the mold and gave the conference a personal, quick, intimate glance into a darker side of the relationship between science and government.  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. Politics, science, journalism, all lack the respect and compassion that keeps society grounded. Dr. Capua went on to describe the shift society has undergone towards a “populist” and “post-truth” movement. The combination of these two ideologies has begun to shift public opinion away from fact-based knowledge and aims to appeal to emotional based reactions. Dr. Capua defined populism as a set of ideas or activities geared to get support from ordinary people by giving them what they want. Post-truth was defined as an ideology that denotes circumstances in which objective facts are less influential in the public opinion than emotional response. In this “fake news” era occurring now, it seems that populism, post-truth, and science are oil and water. While populism instigates decision-making based on sentiment in searching for “good” and “bad,” science is not so black and white.  Through post-truth extravagant interpretation of scientific breakthroughs, including vaccines, animal use in laboratories, and genetically modified organisms, populism has begun to chip away at the credibility of scientists and their respective studies. This was the trap that Dr. Capua found herself caught in.

A veterinarian by training, Dr. Capua began her career as director of the Division of Biomedical Science of the Istituto Zooprofilattico Sperimentale delle Venezie in Padua, Italy. She found herself smack in the middle of the H7N1 avian influenza pandemic in 1999 and began to migrate toward avian influenza research. Fast-forward to the 2005 H5N1 pandemic, Dr. Capua was hard at work sequencing the pandemic virus to further research on a vaccination program. Her research caught the eye of the World Health Organization, who confronted her and demanded the sequence be kept from the public domain. Dr. Capua, believing in transparency and sharing of data, refused the orders and published her virus sequence on the website GenBank, which allows the sequence to be available to fellow scientists and sparked the beginning of a data sharing debate. Continue reading “Dr. Ilaria Capua’s Keynote Speech – Science and the Government”