Should I Stay or Should I Go? National Bioterror Emergency Response Preparedness

By Zach Goble

The theme of this ASM Biothreats 2017 symposia was perhaps one of the more noteworthy callings for collaboration among groups. With more than 17 years of experience as the director of Hazardous Materials Emergency Response at the Massachusetts Department of Fire, David Ladd emphasized the need for a unified response when encountering any number of hazards. His slogan during his dialog, “what happens on the left coast, then happens on the right coast”, stressed the importance of initiating and maintaining communication with organizations near and far. No one stays unaffected in the world of today and without the exchange of ideas, experiences, and procedures disasters can have an overwhelming effect.

Rich Ozanich, from Pacific Northwest National Laboratory and Christina Egan, from the NY Dept. of Health, both echoed that close collaboration is a key factor in response. While Rich laid out the Department of Homeland Security’s framework for “The Onion”, which is a set of procedures to guide first responders in the event of a biothreat incident. The emphasis here was that to be successful the training for such events needs to be coordinated at a local, state, and national level.  Christina detailed the many training programs tailored to biological threat response within Emergency Management Departments specific to various states such as Minnesota and Wisconsin. The message here was that while many great programs exist at the state level, there is not a unified national response to confront CBRN threats with the United States.

David Ladd concluded the panel by presenting a proposed model for National Bioterrorism Response that was submitted by the Interagency Board in January, 2017. In the absence of a nationally recognized system for protecting the nation against bioterrorism, the need for such a system is certainly justified. This document provides a model for bringing together various organizations and departments to create a network of local bioterrorism response teams ready to deploy when the need arises. Models such as these represent steps in the right direction to achieving a unified response in ensuring the public remains safe from biological threats.

International Collaborations to Defend against Biological Weapons: The UK/US Experience

By Zach Goble

The second day of the ASM Biothreats 2017 conference focused on a range of topics from synthetic biology to host immune response. Perhaps one of the most interesting was the session on international collaborations to defend against biological weapons. Immediately the conversation began with talk of recognizing foreign organizations for their help in aiding research endeavors or providing resources to further science. Stuart Perkins, from the Defense Science and Technology Laboratory (DSTL) in the United Kingdom, highlighted the importance of shared resources and capabilities when responding to emerging infectious diseases. One organization doesn’t hold all the information, and nor should they, because while one strives for consistency in research methods, it is helpful to have differences to cast a wider net against the many research topics out there.

Lloyd Hough, from the United States Department of Homeland Security, talked about how DSTL helped provided support to their department during the most recent Ebola epidemic. Prior to the Ebola outbreak, DSTL in the United Kingdom had conducted research on how Ebola virus thrived on various surfaces and this inspired new ways forward for the U.S. to aid the countries affected in 2015. When worldly public health events occur it is often unified efforts that bring about successful outcomes.

Andrii Pavlenko, from the State of Service in Ukraine, showed how support from the United States Defense Threat Reduction Agency (DTRA) helped provide equipment and laboratory upgrades to several Ukrainian facilities working with biological pathogens. Not only did these upgrades prevent unauthorized access to potentially dangerous pathogens, but also helped to prevent the spread of emerging infectious diseases. African Swine Flu (ASF), a virus with high mortality rates in pigs and prevalent in Eastern Europe region, was on the rise in Ukraine, but the equipped laboratories helped bolster biosecurity detection and thus prevented the spread of the disease.

The message was very clear that alone, organizations could not effectively deal with biological threats that have no borders and target unremittingly. Thankfully, the gears are already in motion towards international collaboration with the organizations in attendance, among others that exist around the world. The panel left the audience with a strong message in which trust of fellow organizations is needed for it is not always action that is needed, sometimes it is the non-action in letting your partner do the work, so you can tackle another issue. While replication is important, redundancy should be left at the wayside to make room for more knowledge as there is no shortage of scientific questions out there.

Pandemic Preparedness: Learning from Experience

By Stephen B. Taylor

On February 7, 2017, Dr. Anthony Fauci, Director of National Institute of Allergy and Infectious Diseases, National Institutes of Health, gave the keynote speech at the ASM Biothreats 2017 conference. Dr. Fauci has spent over 35 years advocating infectious disease preparedness with United States policymakers. In his speech, Dr. Fauci discussed the substantial progress made in this arena since the 1980s when he first entered the field during the Reagan administration. At the time, there was a lack of appreciation in the U.S. about the potential of the newly emergent Human Immunodeficiency Virus (HIV).  Though Fauci tried to publish some disturbing initial findings about the nascent threat, the medical community rebuffed him for being an alarmist.  As the 1980s progressed, HIV/AIDS spread to epidemic proportions in the U.S.

During George H.W. Bush’s presidency, Dr. Fauci began making headway with national health and policy leaders to take seriously the threat of emerging infectious diseases. President Bush visited Dr. Fauci at NIH for a personal tutorial on HIV and took time to visit with HIV/AIDS patients. After President Bush received Dr. Fauci’s expert counsel and made a personal connection with the HIV/AIDS crisis, public health resources directed at the epidemic increased dramatically.

From the Clinton years onward, Dr. Fauci maintained his connection to lawmakers and executive leadership.  When infectious disease emergencies like West Nile Virus and antibiotic resistance came to a head during the Clinton years, politicians had a stronger relationship with the National Institutes of Health and funding came more quickly.

During George W. Bush’s term, the United States experienced the “double whammy” of 9/11 and Amerithrax.  This was a watershed moment for infectious diseases. For the first time since the early 20th century, it became widely apparent that infectious disease outbreaks posed a major threat to U.S. public health and security.  As the U.S government turned its attention and resources toward developing countermeasures against a bioterror attack, Dr. Fauci urged Washington leaders not to lose sight of the threat posed by natural outbreaks. When the H5N1 bird flu hit in the latter half of Bush’s presidency, the Bush administration worked closely with experts in health security to affect a paradigm shift: instead of reacting to outbreaks as they happen, the U.S. should expend more resources on preparing for future ones.

During Barack Obama’s presidency, emerging and re-emerging infectious disease outbreaks came in rapid succession: the H1N1 flu pandemic in 2009, MERS in 2012, Ebola in 2014, and Zika in 2015.  In close conjunction with experts like Dr. Fauci however, policy-makers have learned important lessons about preparedness, surveillance, capacity building, and coordination in preparation for the next major outbreak. Indeed, even before Inauguration Day this year, the Trump transition team invited Dr. Fauci to the White House for a disaster-response exercise.  As the world grows more interconnected and its climate changes, the threat of emerging infectious diseases looms larger.  U.S. leaders should continue to heed the advice of subject matter experts like Dr. Fauci and work closely with health and defense institutions to prepare for the future.

 

Pandora Report: 2.10.2017

Have you ever wondered what some of the most deadly diseases looked like in person? Check out this video depicting some of these germs and how they’d appear if you sat next to an infected person. Fortunately, this week was full of disease-filled media like this germ history video regarding the golden age of germs and how humans cause pandemics (spillover anyone?)

The Colosseum that is CRISPR Patent Wars
It seems like the ultimate display of gladiator games – researchers from major university (UC-Berkley, Harvard, and MIT) are in the midst of a battle for patent protection. You can check out the timeline here, but it seems that despite it being over two months since proceedings started, we’re not much closer to a conclusion. “A key feature of the U.S. debate is over which research group was the true first inventor of the CRISPR/Cas9 system, especially its use in eukaryotic cells. At the time the first patent applications were filed, the U.S. had a ‘first-to-invent’ system—which means the first person to develop an invention is entitled to have the patent, even if they were not the first to file a patent application (or the first to get a patent granted) for that invention. UCal has started “interference proceedings” against the Broad Institute to determine who was the first to invent the CRISPR/Cas9 system. UCal claims that they were the first to invent the use of the CRISPR/Cas9 system for gene editing, and that their earliest patent application enabled gene editing in eukaryotic cells. In contrast, The Broad Institute are arguing that UCal had not invented the use in eukaryotic cells at the time of filing its first patent application and are therefore claiming that The Broad Institute were the first to invent the use of CRISPR/Cas9 in eukaryotic cells.”

Public Health’s Greatest Threats 
We all have opinions regarding the greatest global threat- especially in terms of public health. Is it obesity? Cancer? Exposure to toxins or new emerging diseases? What about bioterrorism or bioerror? Dr. Larry Brilliant is an epidemiologist who focuses on the worst disease throughout history. He notes that the greatest threats to public health can be divided into biological and socio-political. “In the last 30 years, there have been at least 30 heretofore unknown viruses that have jumped from animals to humans, for worrying reasons Brilliant attributes to modernity and our increase in animal protein consumption. Still, the socio-political threats are the more immediately dangerous. There are centrifugal forces at play that are pushing society to two extreme camps. The domestic and global division caused President Trump’s ‘America First’ mentality and disregard for public health leaves us vulnerable to new viruses that, if they aren’t detected early enough, could be the next pandemic. ‘Right now because of the re-organization and nationalism… and dislike for the United Nations and its agencies, I think we’re in a period of grave vulnerability,’ says Brilliant.” Dr. Brilliant points to the reality that public health threats aren’t just biological, and as we saw with the 2014/2015 ebola outbreak (and Zika), the socio-political response can hinder or help public health efforts. While we’re always vulnerable to new diseases, are we becoming increasingly more susceptible from a socio-political standpoint?

ASM Biothreats 2017
From synthetic biology to national bioterror emergency response, the ASM conference was packed with biodefense goodies. We’ll be providing a detailed overview regarding certain sessions and the conference as a whole, so make sure to keep your eye out next week!

Find Out What New Viruses Are Brewing In your Backyard  screen-shot-2017-02-08-at-7-47-55-am
NPR is looking at what causes pandemics and where new diseases tend to spring up. By reviewing EcoHealth Alliance data, they note that within the past sixty years, the amount of new diseases appearing has quadrupled. Scarier yet, the number of outbreaks occurring each year has more than tripled since 1980. “We’re in a hyperinfectious disease world,” says epidemiologist Michael Osterholm, who directs the Center for Infectious Disease Research and Policy in Minneapolis. While the tools for surveillance and detection have gotten better, it also became apparent to researchers that old diseases are returning from the grave, while emerging diseases are transgressing into new regions. “So the big question is: Why? Why is this era of new diseases happening now? ‘Well, we’ve been boiling the frog for a long time. Eventually, it’s cooked,’ says Toph Allen, a data scientist with EcoHealth Alliance, a nonprofit that is trying to prevent pandemics by looking for diseases in wildlife. Wait. We’re boiling the frog? You mean, humans are responsible? Yes. Many scientists say we, humans, are to blame for this new disease era. That we’re responsible for turning harmless animal viruses into dangerous human viruses.” Unfortunately, it seems that humans have become especially skilled at causing spillover.

Center for Global Security Research Student Internship
Calling all GMU biodefense students! Lawerence Livermore National Laboratory’s Center for Global Security Research is looking for a student intern! The center has “openings for undergraduate and graduate students and recent bachelors or master’s level graduates within one year, to engage in practical research experience to further their educational goals.” The student may conduct “research in the fields of nuclear engineering, computational sciences, materials science and engineering, cyber security, interactive data mining, political science and international relations to support United States (US) policy and decision makers in developing strategies for national and international security. The Center for Global Security Research’s (CGSR) mission is to provide technology, analysis, and expertise to aid the US government in preventing the spread or use of weapons of mass destruction (WMD), and examining the policy implications of proliferation of WMD, as well as deterrence.”

Zika’s New Strategy – Spillback?
With over 5,000 cases in the U.S. alone, the Zika virus outbreak may be slowing, but it’s not gone. We’ve talked about spillover before, but what about spillback? We tend to worry about diseases spilling over from animals into humans, but what about the opposite direction? Researchers are now worried about Zika spillback into monkeys. “In areas where Zika infections are prevalent among humans and mosquitoes are abundant, the virus may be transmitted to wild primates, disease ecologist Barbara Han said February 6 at the American Society for Microbiology Biothreats meeting. If the disease gets established in monkeys or other wild primates, the animals may serve as reservoirs for future human outbreaks.” As scientists work to study this process and establish potential at-risk species, it’s a helpful reminder that infectious diseases like to keep us on our toes. Or should I say, paws?

Stories You May Have Missed:

  • Over 350 Organizations Write Trump About Vaccine Safety – More than 350 organizations have written to President Trump highlighting their “unequivocal support for the safety of vaccines”. Leading medical organizations and healthcare professionals have resorted to this measure since the January meeting Trump had with Robert F. Kennedy regarding a potential commission on autism and vaccines. “Vaccines protect the health of children and adults and save lives,” the letter opens. “Vaccines have been part of the fabric of our society for decades and are one of the most significant medical innovations of our time.” It continues: “Claims that vaccines are unsafe when administered according to expert recommendations have been disproven by a robust body of medical literature.”
  • Got C-diff? Grab Some Vancomycin!Clostridium difficile is an infection preventionist’s worst nightmare. This spore-forming bug is tough to kill, can cause mortality, and often wreaks havoc on hospitals. A recent study looked at the treatment efficacy of vancomycin versus metronidazole, with the goal of preventing recurrence of the disease. “Analysis of the data showed that there was no difference in risk of recurrence between those treated with vancomycin or metronidazole in any of the severity groups. And in patients with mild-to-moderate disease, there was no significant difference found in the risk of all-cause 30-day mortality. But among the patients with severe infection, patients treated with vancomycin were 4% less likely to die within 30 days of any cause than those treated with metronidazole. Stevens and her colleagues calculated that to prevent one death among patients with severe C difficile infection, 25 would need to be treated with vancomycin.”
  • Fighting Cholera– Cholera has been a scourge throughout history and sadly, we’re still battling it. Researchers have finally developed an effective vaccine and stockpiled it, however efforts are still in progress to get it to the most hard-hit countries, like Bangladesh. “Merely creating that stockpile — even of a few million doses — profoundly improved the way the world fought cholera, Dr. Margaret Chan, secretary general of the W.H.O., said last year. Ready access to the vaccine has made countries less tempted to cover up outbreaks to protect tourism, she said. That has sped up emergency responses and attracted more vaccine makers, lowering costs. ‘More cholera vaccines have been deployed over the last two years than in the previous 15 years combined,’ Dr. Chan said.”

 

 

Pandora Report 2.3.2017

Happy Friday! Do you remember the Jurassic Park character Dr. Ian Malcolm and his famous “life finds a way” quote? Well, in this case, nature is finding its own resistance against gene drive in the wild.

Bioterrorism Preparedness & Response Position Paper 
The InterAgency Board (IAB) has released their proposed model for bioterrorism response: initial operations and characterizations. “Under this model, responder organizations that meet eligibility requirements can apply to operate through contracts as approved bioterrorism response organizations within their own jurisdictions. These teams would be trained and equipped to meet a set of national standards and would work collaboratively with the Federal Bureau of Investigation (FBI) and the Centers for Disease Control and Prevention (CDC) Laboratory Response Network (LRN) in bioterrorism incident responses.” Within the report, you can find training standards and procedures for sampling and field biodetection devices. There is also a substantial section on funding that emphasizing the necessity of implementing and sustaining the bioterrorism response model via funding. The funding plan involves “three types of expenses: annual national program costs for WMD-CST and LRN participation of $22,237,824; participating response organizations start-up costs (per team) of $353,660—developed using a notional community;27 and annual participating response organizations costs of $66,332. This model does not address costs for validating field detection equipment performance, which could be significant.” This particular section breaks down costs that range from equipment maintenance to depreciation.

GMU Biodefense Master’s Open House
Looking to study about everything from anthrax to zika while advancing your education? Check out our biodefense master’s open houses – Thursday, February 16th and Wednesday, March 22nd at 6:15pm at our Arlington Campus. These open houses are a great opportunity to learn more about the GMU biodefense program, speak to a professor, and mingle with other biodefense gurus!

2017 ASM Biothreats Conference
The meeting on biothreat research, response, and policy is just around the corner and the Pandora Report is your source for this wonderful event! Registration is still open and we’ll be having four on-the-ground biodefense graduate student reporters giving us all the great updates from this three-day event. We’ll be live tweeting during the meeting and providing a substantial overview regarding certain sessions and more.

koblentz-moonGMU Biodefense Director Talks Growing Threats and Lack of Action
Take a venture down the biodefense rabbit hole with Dr. Gregory Koblentz! A member of the Scientist Working Group on Chemical and Biological Weapons at the Center for Arms Control and Non-Proliferation, you could say that Dr. Koblentz eats, sleeps, and breathes biodefense. His most recent work has looked at the role of responsible science in biodefense programs, dual-use research of concern, and the the growing concern of biosecurity/biosafety. In a recent report, “Koblentz indicates two factors that caused a concerning increase in the number of biodefense programs worldwide. The first was the global fear of the bioterrorist threat in the aftermath of 9/11, especially after the 2001 anthrax attacks. Also, since 2003, there have been several infectious disease outbreaks with global impact that caught people by surprise: SARS, H5N1, H1N1, Ebola and Zika. ‘There’s been a growth in the number of biosafety laboratories that are safe enough to do this work on these kinds of pathogens both because they’re caused by natural causes and also because of the fear of terrorists getting a hold of them.’ The growth in the number of programs poses additional risks themselves. Even though the biodefense programs are created as a means of stopping threats, the increased number of programs means that there are more chances for something bad to happen.” Dr. Koblentz points to the changing nature of biological threats – from state bioweapon programs to non-state actors and even naturally occurring outbreaks. The most recent BWC Review Conference is also a topic of concern for Dr. Koblentz, as he notes that it was “huge missed opportunity, and will setback efforts to reduce the risks posed by biological weapons and bioterrorism. At the outset of the conference [it] looked good. But in the final days of the conference, Iran sabotaged the proceedings and blocked the consensus needed to adopt any of these measures”

U.S. Biotech Rule – A Mixed Bag of Promises and Perils  screen-shot-2017-02-01-at-8-11-00-am
Regulations and policies have been struggling to keep up with the trajectory of genetic engineering. Reviewing these regulations falls on the FDA, EPA, and USDA, which means that they’re responsible for maintaining as modern and relevant practices as possible. Gene editing tools like CRISPR challenge these often slow efforts, however a new proposal was recently released, focusing on the path to market. This pathway, while built with good intentions, is often plagued with cracks. “Earlier this month, the White House released an update to the overarching system of biotech regulation, known as the Coordinated Framework for Regulation of Biotechnology. But it’s still up to individual agencies to clarify how they intend to classify and evaluate various GE products. In an apparent effort to get plans on the table before a change of administration, USDA and FDA put out draft proposals on 18 January addressing several categories of GE products”. As we reported a few weeks back, efforts to use genetically modified mosquitos to combat Zika, were met with residential resistance, which makes these regulations all the more sensitive. The FDA is responsible for overseeing “technologies for sterilizing and controlling animal populations, but giving it responsibility for gauging the environmental impact of a mosquito raised eyebrows on both sides of the debate”. Many have noted that the FDA truly doesn’t have the capacity to review such work in a timely manner. What about genetically engineered plants? Well, the USDA’s APHIS has specific definitions for what defines GE plants, however this definition previously focused on the production process and not the end product. “The proposed rule exempts certain products from the definition of GE, including plants containing inserted DNA from a sexually compatible species, and plants with DNA changes that could also be achieved through older chemical or radiation-based methods.” While many say that this change is good, others worry that the regulations tend to focus on projects that larger companies employ, while smaller companies lack the capacity for such controversial work, meaning that these regulations could inhibit their work.

The Cost of Cooperation in Global Health 
A recent publication in The Lancet looks to the financial backing for global health cooperation via the WHO, the World Bank, the Global Fund to Fight HIV/AIDS, TB, and Malaria, and Gavi, the Vaccine Alliance. Researchers found that the current financial flow allows donors to provide funds and assistance while maintaining closer control and monitoring throughout the entire project. “We highlight three major trends in global health governance more broadly that relate to this development: towards more discretionary funding and away from core or longer-term funding; towards defined multi-stakeholder governance and away from traditional government-centred representation and decision-making; and towards narrower mandates or problem-focused vertical initiatives and away from broader systemic goals.”

Stories You May Have Missed:

  • Federal Hiring Freeze Disrupts USDA’s Food Safety Testing – The transition of the new administration and federal hiring freeze seems to be having some concerning food safety implications. While the FDA has noted that the federal freeze won’t impact the Food Safety Modernization Act, the USDA has highlighted that it is causing issues with the Food Safety Inspection Service (FSIS). “In an internal message sent to FSIS employees on Jan. 18 and obtained by Food Safety News warned that delays in lab tests are expected through at least March 3. The FSIS is responsible for ensuring the safety of meat, poultry, processed egg products and catfish. ‘Effective Jan. 18, 2017, due to a temporary decrease in staffing, results on pathology samples submitted to the FSIS laboratory system will be delayed,’ according to the email sent to all FSIS employees. ‘AMR-01 and rush cases will be given priority status; however turnaround times are expected to be delayed by at least 24 hours on these samples. This is expected to be rectified by March 3, 2017, but is dependent on staffing key vacancies. The Pathology Branch apologies for the inconvenience these delays will cause’.”
  • Is Trump Causing a Brain Drain? – Last week’s immigration executive order  has many in the science community either unable to travel/return to the U.S. or considering relocation. “The Trump White House’s decision to clamp down on communication from various federal agencies, including the Environmental Protection Agency, has left researchers frightened over political influence seeping into their work. And his executive order has left students and scientists in limbo, removed from their classrooms and work. Advocates are warning that the inhospitable environment will lead, quite quickly, to a brain drain. A young generation of thinkers, academics and researchers might simply look to other countries to conduct their work.”
  • The Rise of MCR-1 and the Importance of Understanding the DURC Debate- This week, yours truly is talking to Contagion Live in regards to two very important topics- the rise of antimicrobial resistance and why everyone should understand the DURC debate. It’s easy to get tunnel vision when it comes to science and policy, however so many of these topics are becoming increasingly relevant and in the end, global health security impacts us all.

Week in DC: Events 1.30-23.2017

Monday, January 30th, 2017
America’s Place In The World – A Conversation With Former Secretary Of State Madeleine Albright- Center for Strategic and International Studies
Time: 5:30-6:30pm
Location: Center for Strategic and International Studies
1616 Rhode Island Ave NW, Washington, DC 20036 (map)
Please join the Center for Strategic and International Studies for a conversation with former U.S. Secretary of State Madeleine Albright on the importance of American leadership and engagement in world affairs, the refugee crisis, and the situation in the Middle East.  Dr. Albright was the first woman to serve as America’s top diplomat.  She served as the U.S. permanent representative to the United Nations from 1993 to 1997.  Currently, Dr. Albright is chair of the Albright Stonebridge Group and Chair of Albright Capital Management.  She is also a professor in the practice of diplomacy at the Georgetown University School of Foreign Service and is a member of the Defense Policy Board at the U.S. Department of Defense.  Dr. Albright received the Presidential Medal of Freedom, the nation’s highest civilian honor, in 2012. The Smart Women, Smart Power (SWSP) initiative is designed to amplify the voices of women in foreign policy, national security, and international business.

Tuesday, January 31st, 2017
Oversharing? How Much Should Government Be Telling Us About Cybersecurity Risks?– New America Foundation
Time: 9-10:30am
Location: New America
740 15th St NW #900, Washington, DC(map)
What intervention can and should the federal government make available to others to help empower defense against cyber intrusions? The Russian intrusions associated with the 2016 presidential elections have reinvigorated the debate on this issue—including among cybersecurity experts. In light of the government’s response to the intrusions, New America’s own Robert M. Lee and Dave Weinstein have both come out publicly with well-argued but contrasting visions of the wisdom and utility of that response. At this event, Dave and Rob will join with other experts from the cybersecurity community to consider what the incoming administration can and should be releasing to help make America more cyber-secure.

Wednesday, February 1st, 2017
Enemies Or Partners? Russia And Turkey In Syria– Bipartisan Policy Center
Time: 10-11:15am
Location: Bipartisan Policy Center
1225 I Street, NW Suite 1000, Washington, D.C. 20005 (map)
The roller coaster ride of Russian-Turkish relations, marked by violent incidents and rapid reversals, has absorbed the attention of anyone trying to make sense of Syria and the Middle East. In just over a year, Turkey has gone from shooting down a Russian jet to receiving Russian air support in its fight against ISIS in northern Syria. Now, with the new administration of President Trump, looking at this evolving relationship has become all the more important for understanding the prospects for U.S. foreign policy more broadly.
In the coming years Russian-Turkish relations will not only play a key role in shaping the future of Syria and the Islamic State, but also the fate of the Iran deal, NATO, and the Eurasian political order.

Thursday, February 2nd, 2017
The Spawn Of Frankenstein– New America Foundation
Time: 3-5:45pm
Location: New America
740 15th St NW #900, Washington, DC(map)
No work of literature has done more to shape the way people think about science and its moral consequences than Mary Wollstonecraft Shelley’s Frankenstein. Today, almost two centuries after the novel’s publication, advances in artificial intelligence, genetic engineering, robotics, and many other fields demonstrate the enduring salience of Frankenstein’s themes. Why are we still talking about Frankenstein? And what do we still have to learn from Victor Frankenstein and his creature, at a time when our scientific and technological capabilities make the novel’s premise of creating life in the lab more plausible than ever?  Join us on Thursday, February 2, in Washington, D.C., to discuss the legacy of Shelley’s Frankenstein and how the novel continues to influence the way that we confront emerging technologies, understand the complex relationships between creators and their creations, and weigh the benefits of innovation with its unforeseen pitfalls.

Friday, February 3rd, 2017
The State Of Security In Mexico: Why Are Homicides Increasing? How To Reduce The Violence?– Woodrow Wilson International Center for Scholars
Time: 8:45am-1pm
Location: The Wilson Center
1300 Pennsylvania Ave NW, Washington, DC (map)
Homicides appear to have increased significantly in parts of Mexico during 2016. By one calculation, organized crime related homicides increased roughly 49 percent between 2015 and 2016. October was the most violent month in nearly four years, and after two years of decline, 2016 roughly matched the homicide rate for 2013. Moreover, major cities like Tijuana and Ciudad Juarez that had experienced a decrease in homocides since 2012 saw a significant uptick. What is driving this troubling tren and what kinds of innovative programs are being implemented to reduce violence or prevent it altogether? Please join our panel of experts for a discussion about these and other questions.

Pandora Report 1.27.2017

The ghostbusters had proton packs and now researchers have DNA-analyzing smartphone attachments to help diagnose disease and fight antimicrobial resistance.

Doomsday Clock Moved 30 Seconds Closer to Midnight
The Bulletin of the Atomic Scientists announced that the clock setting was moved on Wednesday. This is the closest it has been to midnight since 1953 and now includes threats like climate change, cyberthreats, and biological weapons. The board has been critical of President Trump and noted that, “Over the course of 2016, the global security landscape darkened as the international community failed to come effectively to grips with humanity’s most pressing existential threats, nuclear weapons and climate change … This already-threatening world situation was the backdrop for a rise in strident nationalism worldwide in 2016, including in a U.S. presidential campaign during which the eventual victor, Donald Trump, made disturbing comments about the use and proliferation of nuclear weapons and expressed disbelief in the overwhelming scientific consensus on climate change.” You can get a better glimpse of the clock and its components here.

Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements- Final Rule
The CDC has released the final recommendations for select agent biosafety requirements in accordance with the 2002 Bioterrorism Response Act. The 2016 recommended changes included the removal of six biological agents, “add provisions to address the inactivation of select agents, add specific provisions to the section of the regulations addressing biosafety, and clarify regulatory language concerning security, training, incident response, and records.” However, as of January 19th, 2017,  HHS and USDA have published parallel amendments to the federal regulation for select agents and toxins. Following their review, HHS decided not to finalize the proposed changes to the list of select agents. They did however decide “to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records”. The amendments are set to take effect 30 days from the date of publication.

Biodefense World Summit
Don’t miss out on the Biodefense World Summit in Alexandria, VA from June 27-28th! This will be the third summit in order to “bring together leaders from government, academia, and industry for compelling discussions and comprehensive coverage on pathogen detection, sample prep technologies, point-of-care, and biosurveillance. Across the four-track event, attendees can expect exceptional networking opportunities in the exhibit hall, across panel discussions, and shared case studies with members of the biodefense community from technology providers to policy makers.” Make sure you don’t miss out on GMU Biodefense PhD student, Mary Sproull’s presentation, “Recent Advances in Radiation Biodosimetry for Partial and Total Body Exposures” during the tools and technologies at the point-of-care session!

Missing Russian Smallpox Researcher  
This may sound like the plot of a horror movie (or Sum of All Fears), but the reality may be just as worrisome. Professor and Russian microbiologist, Ilya Drozdov has been put on Interpol’s wanted list. Having knowledge of Russia’s historical bioweapons program means that Dr. Drozdov’s disappearance has authorities worrying he may have gone abroad. Dr. Drozdov was head of Vector for five years, which means he has considerable knowledge in both the offensive program and the recent work regarding plague vaccines and HIV cures. “After quitting the institute, he returned to his native Saratov, but has now vanished. It is now confirmed that last month the 63 year old scientist – who needed top vetting clearance to lead Vector – was put on the Interpol wanted list, indicating fears he has gone abroad. He is accused by state investigators of misappropriating some 2 million roubles – then worth around $55,000, while his tenure also led to an outflow of staff unhappy at his management style. A criminal case was filed against him in 2014, and a Novosibirsk court has now approved his arrest in absentia, said Elena Chernyayeva, a regional deputy prosecutor. The microbiologist allegedly used the cash to purchase an apartment. There is no suggestion he has taken secrets abroad, but the Interpol alert indicates the Russian authorities have lost track of his whereabouts. There was criticism of him at Vector for the poor pay of its expert researchers, and ‘conflicts’.”

Bill Gates Talks Bioterrorism 
Last week we looked into the Coalition for Epidemic Preparedness Innovation (CEPI), which aims to head off worldwide outbreaks through the development and stockpiling of vaccines. CEPI has received massive financial support and one sponsor in particular is the Bill and Melinda Gates Foundation. Bill Gates recently warned, at the recent World Economic Forum, that there is a true gap in bioterrorism preparedness. “What preparedness will look like for intentionally caused things, that needs to be discussed,” he said. “It’s very hard to rate the probability of bioterrorism, but the potential damage is very, very huge. I think an epidemic, either naturally caused or intentionally caused, is the most likely thing to cause, say, 10,000 excess deaths,” Gates said. “He voiced the same concern in March during a Reddit Ask Me Anything session: ‘The problem of how we prevent a small group of terrorists using nuclear or biological means to kill millions is something I worry about,’ he wrote.” Other biotech gurus like Sam Altman noted that the 2011 H5N1 gain-of-function controversies have opened their eyes to synthetic viruses as a form of terrorism or bioerror.

Health Security Memos to the New Administration and Congress 
Despite a recent move, researchers at the Center for Health Security aren’t taking a break when it comes to global health security. They’ve recently written a series of commentaries for the new administration regarding facts and assessments that are critical for the world of health security. The memos range from healthcare preparedness to improving biosurveillance, partnering with communities to foster trust, communication of new disease threats, and much more.

FDA’s New Farm Antibiotics Policy – Is It Enough?
The new FDA Guidance for Industry (GFI) #213 is what some would consider a victory, while others are calling it a mediocre milestone at best. The new policy looks to reduce the usage of antibiotics in agriculture by requiring veterinary oversight. That’s right, prior to GFI #231, farmers could go to their local feed stores and buy penicillin and tetracycline over the counter to add to feed and water to promote growth. “Under GFI #213, which was first announced in 2013 and has taken 3 years to fully implement, pharmaceutical companies have been asked to voluntarily remove production purposes (such as growth promotion) from the labels of all medically important antibiotics used in food production. All affected companies have done so as of Jan 3, the FDA says. In addition, the guidelines require veterinary oversight for the continued use of these drugs for disease prevention and control in herds and flocks. From now on, all antibiotics used in water will require a prescription from a licensed veterinarian, and those used in feed will need a veterinary feed directive (VFD).” Sure, this is a move in the right direction, but are we ensuring the quality of veterinary oversight and truly changing the culture within farming to support responsible antibiotic usage?

Outbreak Alert: Seoul Virus in Illinois and Wisconsin Rat-Breeding Facilities
While we’ve been busy with the inauguration and Zika virus, there’s been an emerging outbreak creeping up in Illinois and Wisconsin. Eight people have been infected with Seoul virus after working in several rat-breeding facilities across the two states. While not commonly found in the U.S., this is the first known outbreak associated with pet rats. “A home-based rodent breeder in Wisconsin was hospitalized in December 2016 with fever, headache, and other symptoms. CDC tested a blood specimen and confirmed that the infection was caused by Seoul virus, a member of the Hantavirus family of rodent-borne viruses. A close family member who also worked with rodents also tested positive for Seoul virus. Both people have recovered. A follow-up investigation at several rat breeders that supplied the initial patient’s rats revealed an additional six cases of Seoul virus at two Illinois rat breeding facilities.” While related to Hantavirus, Seoul virus presents with more mild symptoms.

Stories You May Have Missed:

  • Post-Ebola reforms: ample analysis and inadequate action–  Check out a new analysis on WHO response and global reaction to the Ebola outbreak. “Given the importance of improving our ability to battle current (Zika, yellow fever, etc) and future outbreaks of infectious disease, we examined seven major reports and identified areas of consensus on action. We then assessed what progress has been made and what can be done to address the gaps. The seven reports were selected on the following criteria: scope (tackling problems beyond a single organization, country, or sector); diverse authorship (defined by country of origin, organizational affiliation, area of expertise, and gender); and public availability (excluding internal reviews).”
  • Using the lessons of economics to stop global pandemics before they start -Larry Summers is looking to economics to calculate the likely future impact of pandemics on the global economy. By combining the mortality cost and losses in income, he and fellow researchers found that “it was on the same range as that of climate change-  although at the lower end of the possible scale. A moderately severe pandemic, of the kind that occurs every few decades, would knock 4-5% off global output. The “ultra scenario”—a pandemic similar in virulence to the flu of 1918—would raise that to 12%, reducing GNI in some developing countries by more than half.”
  • How Prepared is the U.S. for Avian Influenza?– Many are pointing to an impending avian influenza outbreak and questioning how well American response measures will work. “On Jan 9, the US Department of Agriculture (USDA) confirmed that a wild mallard duck in Montana had died from H5N2, a highly pathogenic avian flu strain that in 2015 affected farms in 15 states and led to the culling of more than 43 million poultry, with an estimated $3.3 billion in economic losses. ‘This confirmed H5N2 in a wild mallard duck in Montana keeps us on high alert,’ said Donna Karlsons, a public affairs specialist with the USDA’s Animal and Plant Health Inspection Service (APHIS). ‘We know the disease is out there and serves as a great reminder for constant biosecurity vigilance. There is never a good time to ease up on biosecurity, and it remains our greatest asset to protect against avian influenza’.”

 

Pandora Report 1.20.2017

We’ve got lots of biodefense goodies for you this week, so grab your PPE and let’s get rolling!

Billion-Dollar Vaccine and Epidemic Preparedness Project 
The Coalition for Epidemic Preparedness Innovations (CEPI) launched this week at the World Economic Forum with an initial $460 million backing from Norway, Germany, Japan, the Welcome Trust, and the Bill & Melinda Gates Foundation. CEPI expects to raise the rest of the needed $1 billion by the end of the year. Their focus is on pre-emptively developing and stockpiling vaccines to better prevent and respond to outbreaks. CEPI marks the largest vaccine development initiative and their plan is to start with vaccines against Nipah virus, MERS-CoV, and Lassa fever. While this is wonderful news, it may just be one step closer to marginalizing the WHO, which has been struggling to stay both relevant and effective. The WHO response to Ebola started drawing more recent attention to the organization’s struggles which were only fueled by slow vaccine procurement/development. These issues culminated with their recommendations to dilute the yellow fever vaccines during last year’s outbreak in Africa due to poor planning. Vaccine development and stockpiling is truly vital to outbreak response. “The CEPI intends to support research at every stage, from basic lab work to vaccine discovery and clinical trials. It also made its first call for research proposals on 18 January, and teams have until 8 March to submit preliminary proposals for grants. ‘For too long, we have separated out the academic work from the next step of taking it into all that is actually required to make a vaccine,’ says Farrar. There is also no market for vaccines against ‘potential’ epidemic threats, he notes, which explains why there is no commercial incentive to take research leads out of the lab and into clinical development’.”

ABSA DURC Roundtable
Don’t miss the Dual Use Research of Concern (DURC) Roundtable Discussion offered by ABSA International on March 15th! This distance learning opportunity will be offered from 12-2pm (CDT), and will aid the user in finding resources and guidance on the U.S. government DURC policies, developing a network of biosafety professionals, and more! “One size does not fit all when it comes to solutions to comply with research policy. The goal of this webinar is to provide best practices, provide insight on how several different institutions are meeting the DURC policy requirements, and help participants troubleshoot issues surrounding DURC that they may have at their institutions. Participants will have the opportunity to submit questions regarding DURC prior to the start of the webinar as well as during the live webinar.”

GMU Trains First Responders Against Infectious Disease  firstrespondertraining3_davefarris
GMU’s Office of Safety, Emergency, and Enterprise Rise Management is now providing local and national first responders with infectious disease training so that they’re better able to protect themselves during outbreaks. The program was made available through a three-year grant from the National Institute of Environmental Health Sciences. “This training is a natural extension of a program Mason’s Biomedical Research Lab biosafety manager Diann Stedman has offered to regional emergency response personnel since the 2010 opening of the lab on the Science and Technology Campus. Stedman is leading the training with Julie Zobel, assistant vice president of safety, emergency and enterprise risk management, and David Farris, executive director of safety and emergency management. Collectively, the three have more than 30 years of experience in the health and safety field, much of it focused on biological safety.”

Completing the Development of Ebola Vaccines 
CIDRAP and Welcome Trust have just released their report – Completing the Development of Ebola Vaccines: Current Status, Remaining Challenges, and Recommendations. “This is the third major report from the Wellcome Trust–CIDRAP Ebola Vaccine Team B. The first report, Recommendations for Accelerating the Development of Ebola Vaccines: Report and Analysis, was released in February 2015, and the second, Plotting the Course of Ebola Vaccines: Challenges and Unanswered Questions, was released in March 2016. In this report, similar to our previous efforts, we have three primary objectives. The first is to track progress toward ensuring that safe, effective, and durable multivalent Ebola vaccines are readily available and can be rapidly deployed when the next outbreak occurs. The second is to identify challenges and barriers where additional efforts are needed, although some of the remaining issues are complex and will require substantial resources to resolve. Our third objective is to provide a set of high-level recommendations that we believe, if implemented, will facilitate the goal of having a robust Ebola virus disease (EVD) prevention program in place that allows prophylactic vaccination of high-risk frontline workers and provides well- maintained vaccine stockpiles to facilitate rapid control of Ebola outbreaks.” The report highlights current clinical evaluations of Ebola vaccine candidates, funding, and regulatory activities. Some of the recommendations include reassessing the leadership structure for Ebola vaccine preparedness, developing strategies for mitigating the financial uncertainties and risks for manufacturers, etc. This report has left many experts pointing to the reality that we’re just not ready for another Ebola outbreak. 

Center for Health Security Joins Johns Hopkins Bloomberg School 
The Center for Health Security has a new home in Johns Hopkins Bloomberg School of Public Health! Previously affiliated with the University of Pittsburgh Medical Center, the CHS will now have significant new opportunities for research and work in national and international public health policy. Originally founded in 1998 by the late D.A. Henderson at Johns Hopkins, the center has been affiliated with UPMC since 2003. “The mission of our center is a perfect fit with the Johns Hopkins Bloomberg School of Public Health because we share a commitment to improving global health and to protecting lives through large-scale change,” says Tom Inglesby, director and CEO of the Center for Health Security. “Moving to the Bloomberg School will expand the reach of the center and help us collaborate with and tap into the universe of great talent at Johns Hopkins. We look forward to joining our expertise on health security and preparedness policy to Johns Hopkins’ internationally recognized community of scientists and public health scholars.” We’re looking forward to seeing all the great work that will be done as the center returns to Johns Hopkins!

Zika Outbreak Updates
As the dust settles, some are looking to the WHO and public health infrastructure failures regarding the Zika outbreak as many are pointing out how the response failed millions. “But the positives were counterbalanced by many negatives, experts said. They harshly criticized the partisan bickering that delayed a Zika-funding bill in Congress for months, and they decried the failure of every city in the hemisphere — other than Miami — to control mosquitoes.” You can also read an opinion piece here, from a pregnant woman living in Miami who tested positive for the Zika. As of January 18th, the CDC has reported 4,900 cases of Zika in the U.S.

Stories You May Have Missed:

  • screen-shot-2017-01-19-at-12-31-34-pmCDC Director’s Departing Words- As CDC director, Dr. Tom Frieden, prepares to leave office after 8 years, he’s offering some words of wisdom. Dr. Frieden has been tested by major health events like Ebola, Zika, MERS, 2009’s H1N1, and a growing domestic overdose issue. “Fundamentally, Americans are healthier and safer because of the work CDC has done over the last eight years. Americans are safer because we have better capacities in place, better infrastructure in place in this country and around the world to find threats early, stop them quickly and prevent them wherever possible. We’ve done that through laboratory work that looks at microbial genomics so we can stop outbreaks sooner. We’ve done that by training the next generation of public health specialists — more than 1,000 of them, fresh out of college and graduate school — deployed out to state and local governments. These people will be protecting Americans for decades to come.”
  • Proposed Presidential Autism-Vaccine Panel Could Help Spread Disease– The potential panel is drawing increasing attention as Robert F. Kennedy Jr. is poised to be the leader. The environmental lawyer has been vocal in his vaccine skepticism, which has led many to worry in terms of federal support for vaccine programs. “Although the autism–vaccine claim has been studied and debunked, the president-elect has also suggested a connection. His team later hedged about the panel, saying that nothing had been decided. (Kennedy’s office declined an interview request.) Nevertheless, public health experts and autism advocates are deeply worried that an effort with presidential backing could undermine public confidence in vaccines and trigger epidemics of all-but-eradicated diseases.”
  • Assad Linked to Syrian Chemical Attacks – The Syrian President has officially been linked to a series of chlorine bomb attacks in 2014/2015. “International investigators have said for the first time that they suspect President Bashar al-Assad and his brother are responsible for the use of chemical weapons in the Syrian conflict, according to a document seen by Reuters. A joint inquiry for the United Nations and global watchdog the Organisation for the Prohibition of Chemical Weapons (OPCW) had previously identified only military units and did not name any commanders or officials.”

Pandora Report 1.13.2017

Make sure to get the CRISPR a cappella song stuck in your head for not only a catchy tune, but one that educates you on the genome editing tool! In light of the recent sanctions, GMU Biodefense Director, Gregory Koblentz is discussing why holding the Assad regime accountable for its use of chemical weapons is likely a lost cause.

Recommended Policy Guidance for Potential Pandemic Pathogen Care & Oversight
On Monday, the White House Office of Science and Technology Policy (OSTP) released their report “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).” It would seem that P3CO is the new term for GoF research of concern (or GoFROC). Although, as Megan Palmer of Stanford noted, it’s going to be a challenge not calling it the C3PO policy. Adoption of these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and transmissibility to produce a potential pandemic pathogen (an enhanced PPP). This policy follows the 2016 NSABB Gain of Function (GoF) research oversight recommendations, which emphasizes the importance of domestic and international stakeholder input, tracking of lab incidents, etc. One of the suggestions was to refer to the GoF research (meeting the specific criteria) as GoFROC as to avoid lumping all GoF research within the same category of concern. Per the press release, “First, HHS will ask the NSABB to continue to provide advice on the oversight of the creation, transport, or use of enhanced PPP.  After HHS has reviewed its paused projects and made decisions about whether and how those projects will proceed, NSABB will review the process employed by HHS and provide advice, if necessary. Continued NSABB input will be essential to ensuring robust oversight of these projects. Further, discussing the department-level review process with NSABB will promote transparency and provide valuable forums for continued public dialogue. Second, given that studies involving enhanced PPP are often described as ‘dual use’ research, HHS is currently conducting a review of the implementation of policies for the oversight of dual use research of concern (DURC). HHS has asked NSABB to host a series of regional stakeholder meetings to gather information about the implementation of the DURC policies, and it will also solicit feedback more broadly related to their implementation.” Some of the proposed suggestions include risk mitigation and project oversight comments like “modifying the design or conduct of the project” or “if the risks posed by the project cannot be adequately mitigated with these measures, agencies should determine whether it is appropriate to: request voluntary redaction of publications or communications resulting from the project.” The plan will help U.S. agencies decide if they want to fund projects that will enhance the virulence and transmission capacity of dangerous organisms, which will hopefully end a two-year moratorium on GoF work regarding MERS, SARS, and H5N1.

Thinking About Bioterrorism with Schelling’s ‘Thinking About Nuclear Terrorism” 
GMU Biodefense MS student, Greg Mercer is looking at bioweapons through the lens of Thomas Schelling. Professor Schelling, who passed away in December, was an economist and Nobel laureate famous for his work on nuclear strategy and coercive diplomacy. Mercer uses Schelling’s 1982 article, Thinking About Nuclear Terrorism, to consider how he might have addressed the threat of biological weapons in the hands of terrorists. “As with nuclear weapons, it is immensely difficult to acquire and weaponize pathogens. Using them to coerce might be even harder. There are a very few distinct examples of bioterrorism. The Aum Shinrikyo cult, in addition to their sarin gas attacks on the Tokyo subway, pursued biological weapons. This was never viable, thanks to a number of mistakes, including using the wrong strain of anthrax.”

Whole Genome Sequencing in Developing Countries
The WHO/Pan-American Health Organization are working towards utilizing Whole Genome Sequencing (WGS) as a surveillance tool in developing countries. Experts will be meeting this week in DC to discuss the applications and practical advice needed by the recipient countries of such mechanisms. “WGS has the potential to change the way we detect, assess, investigate, manage, and monitor microbiological hazards and to improve the treatment of people suffering from infectious diseases. It allows for the identification and characterization of microorganisms with a level of specificity not previously possible. The technology provides significant cross-sector potential, enabling uniform typing systems across animal, food and human sectors.” This will be a new roadmap for WGS in developing countries, as its history has been primarily research based. While many agree that there are several roadblocks ahead, the potential for application is promising however, it needs the correct leadership to maintain efficacy.

Pandemics, Bioterrorism, and Global Health Security on LinkedIn
Looking for a LinkedIn group that is dedicated to analyzing the challenges facing the world at the nexus of health, science, and security? We’ve got just the one – Pandemics, Bioterrorism, and Global Health Security. The group’s purpose is to serve as a unique forum for discussions and debate on the critical issues on global health security. Nearing 3,000 members, you’ll find a diverse and engaged group of people who are looking to tackle the challenges that are posed by biological threats, regardless of source. This group is devoted to bridging the gaps between science and policy and between health and security to develop new strategies for reducing the risks posed by transnational threats to global health security. It is hoped that this group can serve as a means of keeping scientists informed about the latest policy developments in the global health security domain as well as to educate practitioners about the policy implications of emerging infectious diseases and advances in the life sciences and biotechnology.

America’s Growing AMR Problem  

Courtesy of Reuters
Courtesy of Reuters

Let’s start with a bit of a good news – for the first time, federal injury reports will include healthcare-associated antibiotic resistance bacteria infections in attempts to set penalties for healthcare facilities. The fourth installment in Reuter’s investigational series regarding antimicrobial resistance is out and it brings the issue full circle. Focusing on the costs of AMR, the lack of new antibiotics, and personal accounts, this series is everything we need to paint the full picture of the antibiotic abyss. The fourth installment, Deadly Silence, is particularly fascinating as it looks at the problem from a healthcare reporting perspective. Coming from this infection preventionist, it isn’t surprising to see the lack of required AMR reporting across the U.S. however, it is shocking to see the general indifference towards changing it. Focusing on long-term care facilities (like nursing homes or rehab centers), it becomes increasingly apparent that they’re uniquely vulnerable to outbreaks and have little incentive or responsibility to report cases or events. “As Reuters reported in September, the Centers for Disease Control and Prevention, the national public health monitor, lacks regulatory power to track superbug deaths. It also lacks the authority to enforce outbreak reporting. Instead, it sometimes assists states with their outbreak investigations, a spokesman said, but each state decides which diseases must be reported.” The reporting issues are especially important because it’s not just that we have a problem with lack of new antibiotics or a growing number of antimicrobial resistance, or even a growing usage of antibiotics among humans and animals, but also that we lack the oversight and enforcement to ensure healthcare facilities monitor the problem and do something about it. This gap means that we have little true understanding for not only the depth of the issue, but also the breadth of it. Simply put, we need a new game plan for combating the growing threat of antibiotic resistance.

PHEMCE Strategy & Implementation Plan
HHS recently released their 2016 Public Health Emergency Medical Countermeasures (PHEMCE) Strategy and Implementation Plan (SIP). The report provides updates and a blueprint regarding their plans to enhance national health security via medical countermeasures (MCM). Within the PHEMCE SIP, you can find a summary of their major accomplishments, activities currently being pursued, recap of the advanced research and development and procurement awards, and more. “In FY 2015, BARDA continued to work closely with NIH and DoD to monitor the progress of programs supported under research and development and transition promising candidates. In FY 2015, BARDA re-issued the three BAAs to support advanced development of CBRN and Influenza MCMs and the BAA for Innovations. They were modified to align with the 2015 PHEMCE SIP and to address remaining gaps in preparedness as well as address new initiatives such as CARB and EID.”

Zika Outbreak Updates
As Angola reports cases, a new Moderna Therapeutics mRNA vaccine enters clinical trials. “A $54.2 million grant in 2016 from BARDA has supported the development of the vaccine through the scale-up for larger phase 2/3 efficacy trials. Based on the vaccine’s performance and availability of more funding, BARDA may provide up to $125.5 million to further advance the development of Moderna’s vaccine.” On January 11th, the CDC reported a total of 4,866 cases of Zika within the U.S. Physicians have released a photo showing symptoms of the first person to experience local Zika transmission in the U.S.

Stories You May Have Missed:

  • FDA Drops Plan to Release GMO Mosquitoes – Initial FDA plans to drop millions of genetically engineered mosquitoes in Key Haven, Florida, were halted after local residents voted against it.  The plan “was designed to help fight the Zika virus with mosquitoes that had been genetically altered. It would have been the first such initiative executed in the United States. However, attorneys for Key Haven and concerned citizens noted that the FDA did not complete adequate testing on the potential impact the release would have on people, the local environment, nor area species concerned threatened and endangered. Local residents were presented with the issue via voting ballot in November 2016, in which voters unanimously shot down the release. The Florida Keys Mosquito Control Division met after the Nov. 8, 2016, public referendum and voted against the trial run in Monroe County in Florida, according to http://www.flkeysnews.com.”
  • The Woes of Camel Vaccination Plans – In efforts to test an experimental vaccine against MERS, researchers are trying to slow the spread via camel vaccination. We often forget the battles that make up public health and vaccine development, but camel vaccination is definitely a new one. “Camels are not a very, let’s say, cooperative kind of animal from this point of view,’’ Segalés told STAT. “To get them out from the truck was not that easy. To get them into the facility was not that easy. And to get them into the box (holding pen) was not that easy. Trying to push them in was quite difficult sometimes. And the worst-case scenario was trying to take them out.”
  • Trump Picks Vaccine-Skeptic to Lead Vaccine Safety Commission– “Robert F. Kennedy Jr., a proponent of a widely discredited theory that vaccines cause autism, said Tuesday that President-elect Donald Trump asked him to chair a new commission on vaccines. Hours later, however, a spokeswoman for Trump’s transition said that while Trump would like to create a commission on autism, no final decision had been made.”

Pandora Report 1.6.2017

Welcome to 2017 and a whole new year of biodefense news! While you’re heading back to work, make sure to wash your hands and stay safe – the CDC has reported increasing flu activity.

The Best of Bio and Chem Weapons Coverage in 2016
The Bulletin of the Atomic Scientists has put together their “five best articles” for bio-chem weapons in 2016 and we were happy to see two familiar faces – GMU PhD alum Daniel M. Gerstein and GMU Biodefense professor, Sonia Ben Ouagrham-Gormley. Daniel Gerstein’s article, How genetic editing became a national security threat, discusses the threatening components of gene drive, like low cost and growing availability. “Armed with the proper genetic sequences, states or bioterrorists could employ genome editing to create highly virulent pathogens for use in such attacks. They could, for example, change a less dangerous, non-pathogenic strain of anthrax into a highly virulent form by altering the genome, or recreate pathogens such as the deadly smallpox virus, which was eradicated in the wild in 1980.” Sonia Ben Ouagrham-Gormley teamed up with Kathleen Vogel to discuss the good, bad, and the hype of gene drive. They emphasize the importance of understanding gene drive to really discern the benefits and risks of the technological process. Looking at all angles, their article gives a wholistic approach to better appreciate the complexities of gene drive for biodefense. “Without a clear and detailed understanding of the range of social and technical factors that cause scientists to succeed or fail in their gene-drive endeavors, threat estimates can only rely on speculation and fantasy rather than fact.”

GMU Biodefense Students – Win Registration for 2017 ASM Biothreats Conference!
Calling all GMU Biodefense students – the program will be offering free registration to four lucky students to attend this premier biodefense event at the Marriott Wardman Park in Washington, DC on February 6-8th. This year, the meeting incorporates three major tracks, “Research, Response, and Policy” to cover relevant topics in basic and applied research; public health, emergency response and preparedness; and biosecurity, government, and policy responses. The exchange between these multidisciplinary communities will shape the future of this very important field. The keynote session on February 6 will be given by Thomas M. Countryman, Acting Under Secretary for Arms Control and International Security and Assistant Secretary to the Bureau of International Security and Nonproliferation at the Department of State.  Anthony S. Fauci, M.D., Director of NIAID Director at the National Institutes of Health, will be presenting at a special session on February 7. You can find the rest of the agenda here. As an attendant for the 2016 conference, I can tell you that it’s a great experience for not only learning, but also networking. Please check your GMU email for the information Dr. Koblentz sent out. To apply: students are required to submit a 250-word essay about how attending the conference will benefit your education/professional aspirations by 5pm today (Friday, January 6th) to Dr. Koblentz. Winners will be announced the following Monday and those selected will be asked to write up summaries of at least two panels for publication in the Pandora Report.

USGS Disease Maps
screen-shot-2017-01-03-at-6-04-01-amLove maps and diseases? Or do you simply like knowing what kinds of vectored diseases are transmitted around you? Check out the USGS disease maps that also allow you to interact with them. Utilizing data from CDC’s ArboNET, you can look at transmission among humans, mosquitoes, birds, sentinel animals, and veterinary transmission. The observable diseases include West Nile Virus, St. Louis Encephalitis, Eastern Equine Encephalitis, Western Equine Encephalitis,  La Crosse Encephalitis, Powassan Virus, Dengue fever (locally acquired and imported), and Chikungunya (locally acquired and imported). The USGS disease maps allow us to not only have a better understanding of vectored disease transmission, but also landscape epidemiology.

CRISPR Off-Switch
CRISPR is going to be a hot story in 2017 and here are the seven things to look for. The burgeoning concerns regarding CRISPR technology involve the rapid pace of development and lagging DURC policies, not to mention the inability to predict future outcomes. The interest and unease over this new form of genome editing has left many searching for an “off button”, but thankfully, researchers are believed to have found one.  While the new “off switch” isn’t capable of reversing changes that were already made, it can stop the system from making additional edits. “The switch is a series of ‘anti-CRISPR’ proteins that were discovered inside viruses that attack bacteria, where they’re used to disable the gene editing tool and sneak into the bacterial DNA. ‘Just as CRISPR technology was developed from the natural anti-viral defence systems in bacteria, we can also take advantage of the anti-CRISPR proteins that viruses have sculpted to get around those bacterial defences,’ said lead researcher Benjamin Rauch. The team isolated these anti-CRISPR proteins from Listeria bacteria that had been infected by viruses. The team isolated the proteins that appeared to be involved and tested whether any of them could stop CRISPR editing from taking place in human cells. They found that two of these proteins, AcrIIA2 and AcrIIA4, worked together to inhibit the CRISPR systems commonly used by scientists.”

CDC Concludes CDP Ricin Exposure Inspection
The CDC just finished their inspection of the lab that sold the ricin toxin that was used by the Centers for Domestic Preparedness (CDP) training facility. The ongoing debate between the CDP and lab regarding the mishandling or misunderstanding points to bigger, systemic issues in regards to select agents. CDP states that the lab is to blame, noting that they ordered a less toxic version of ricin, while the lab rebutted by pointing out that the ricin was always properly labeled as the toxic version and they, in fact, never offered the less toxic version. The site visit and inspection findings are under review as the CDC determines if the lab is responsible and violated federal regulations. The conclusion of the inspection also comes at a challenging time for the CDC as the agency is taking heat for blacking out many details in reports recently released via the Freedom of Information Act. The released laboratory reports were requested by USA TODAY and only fuel the attention to lab incidents and poor biosafety practices.

NAS DURC Committee Meeting 
This week the National Academies held the Committee on Dual Use Research of Concern (DURC): Option For Future Management. You can get not only the webcast recording (check out 2:42:00 in and you’ll see GMU Biodefense director and professor, Gregory Koblentz, talk about the zero sum game in terms of regulating DURC research – to regulate or not to regulate, that is the question!), but also the full presentations. Since the 2011 H5N1 controversies, “it remains unclear as to whether there are practical mechanisms or approaches for managing such dual use research of concern (DURC) and, specifically, how to deal with situations where there is a pressing need, for public health reasons, to publish research findings while limiting, due to national security concerns, the dissemination of certain details that ordinarily would be published. This is especially true in cases where an initial assessment of proposed research does not anticipate results that would warrant such consideration.”

Zika Outbreak Updates
Scientists are currently unveiling the key proteins in the virus that made it so deadly. The first comprehensive description of the Zika genome has identified seven key proteins that are helping researchers understand the devastation the virus does to the human body. “To test the virus, Dr. Zhao used fission yeast, a species that in recent years has become a relatively common way to test how pathogens affect cells. Fission yeast was originally used to make beer, particularly in Africa, where it originated. (Its species name is Schizosaccharomyces pombe; pombe means beer in Swahili.) Over decades, fission yeast has been used by many scientists to find out mechanisms and behavior of cells. For the experiment, Dr. Zhao and his colleagues separated each of the virus’s 14 proteins and small peptides from the overall virus. He then exposed yeast cells to each of the 14 proteins, to see how the cells responded. Seven of the 14 proteins harmed or damaged the yeast cells in some way, inhibiting their growth, damaging them or killing them.” The Entomological Society of America has noted that socioeconomic factors provide protection against a large scale Zika outbreak in the U.S., but that small outbreaks are an ongoing concern. As of January 4th, the CDC reported 4,618 cases of Zika in the U.S., of which 216 were locally-acquired.

Does the CDC’s New Quarantine Rule Violate Civil Liberties?
With a new vaccine and hopeful approach to emerging infectious diseases, have we buried Ebola? Back in August, the CDC proposed a new rule regarding its powers to respond to potential outbreaks via screening, testing, and quarantining people traveling into or within the U.S. You can read the new rule here, but it focuses on “non-invasive public health prevention measures” and reporting requirements for commercial passenger flights of death or illness to CDC, etc. While this may seem pretty reasonable given health emergencies like Ebola and SARS, many ” epidemiologists, lawyers, and health organizations say that the rule, in its current form poses a serious threat to civil liberties, allowing authorities to detain and examine people with little heed to due process and informed consent.” Attempted in 2005, this rule was initially met with criticism, however the recent Ebola outbreak has changed the way we approach travel during times of infectious disease outbreaks. Public health emergencies are defined as ‘communicable disease events’ that the director believes could be high risk for death or serious illness. “It is already authorized to detain people suspected of carrying diseases like plague, Ebola, and (somewhat improbably) smallpox. But the new rule does away with a formal list. It extends the same powers to any “quarantinable communicable disease,” and uses wider range of symptoms (from a list that federal agents can update as the need arises) for defining ‘ill’ people.” While the CDC can detain travelers prior to decision to quarantine, it notes that this shouldn’t last longer than 72 hours and fails to make provisions for a lawyer if the person can’t afford one. “The rule also gives the CDC ultimate authority to carry out medical tests and treatments, stating that ‘the individual’s consent shall not be considered as a prerequisite to the exercise of any authority’.” What are your thoughts? We’d love to hear from our readership – please email or tweet @PandoraReport to give us your thoughts!

USDA ARS 4th International Biosafety & Biocontainment Symposium Registration Deadline
Don’t miss the January 13th registration deadline for this event in Baltimore, Maryland! From February 6-9, the focus of the symposium will be Global Biorisk Challenges-Agriculture and Beyond. Seven presymposium courses will address topics including unique biocontainment challenges, decontamination and inactivation, and institutional governance. Topics include biorisk management challenges in a One Health World, arthropods, HPAI, risk assessments, and more!

Stories You May Have Missed:

  • 85 People Suspected to Have Contracted Rabies– Like something out of a zombie movie, 85 people are suspected of having contracted wild rabies after being bitten by bats in Peru. “Regional director of Health of Cusco, Julio César Espinosa La Torre said that among the group of victims with a bat bite are the 15 soldiers transferred to Lima, of this group, two cases were confirmed, of which one is deceased. Espinoza la Torre said that to date, more than 912 civilians and 680 soldiers have been vaccinated in Alto and Bajo Urubamba, in the district of Megantoni, who must receive up to four doses, every 7 and 14 days.”
  • Anticipating Epidemics Using Computational Models – the White House recently released a report to strengthen the capacity for outbreak prediction. Spearheaded by the National Science and Technology Council, Toward Epidemic Prediction: Federal Efforts and Opportunities in Outbreak Modeling, looks to predictive modeling and data utilization to better understand the “processes that drive disease emergence and transmission could help to predict and prevent large-scale outbreaks. These programs range from foundational research into disease emergence and spillover, to predictive modeling contests, to the development of decision-support technologies for public health responders.”
  • Pandemic Chats – Struggling to chat to a younger generation about diseases? Check out how the Bill & Melinda Gates Foundation is talking to the next generation about the next pandemic.