Pandora Report 2.17.2017

screen-shot-2017-02-15-at-10-06-56-amHappy Friday! Since Tuesday was Valentine’s day, it was fitting to have a super romantic story about Ebola super-spreaders and their role in causing most of the cases. Have you ever wondered why killer viruses are on the rise or what some of these infectious disease terms mean?

ASM Biothreats 2017 Highlights 
If you missed this event or weren’t able to make some of the sessions, check out our overview! GMU sent four graduate biodefense students to ASM’s biothreats conference to not only aid in their education, but also to report back for our readers. With their unique backgrounds, we’ve got articles on the FDA’s Animal Rule, international biosecurity efforts, and more. Check out the link above and you’ll find a special edition post with all of our highlights.

A Step Closer Towards Human Embryo Editing
A new report from an international committee put together by the U.S. National Academy of Science and the National Academy of Medicine found that a clinical trial regarding DNA editing of a human embryo “might be permitted, but only following much more research” on risks and benefits, and “only for compelling reasons and under strict oversight.” Consideration would be given to couples who are both afflicted with serious genetic disease and editing is “really the last reasonable option” for them to have a healthy child. While some applaud this as a first step towards a very specific and narrow subset of DNA altering, “others see the report as lowering the bar for such experiments because it does not explicitly say they should be prohibited for now. ‘It changes the tone to an affirmative position in the absence of the broad public debate this report calls for,’ says Edward Lanphier, chairman of the DNA editing company Sangamo Therapeutics in Richmond, California.” You can read the full report here.

The Biotechnological Wild West: the Good, the Bad, and the Underknown of Synthetic Biology
GMU Biodefense PhD student and Predoc at Lawrence Livermore National Laboratory, Yong-Bee Lim, is taking on the 2017 ASM Biothreats conference and the pipette-slinging world of synthetic biology. Lim first focuses on the panel at ASM’s conference, which looked at the current state of synbio and where the future might take us. Like most things in life, there’s also a flip side to that coin – the negative aspects of this new technology. “While the benefits derived from synthetic biology are great, presenters noted that it suffers from the dual-use dilemma: the same information applied to beneficial uses could also be repurposed for nefarious purposes. Dr. Hassell noted that synthetic biology increases biologically-derived risks through three mechanisms. First, synthetic biology can be used to enhance existing microbial threats; synthetic biology allows actors to more easily manipulate the characteristics of microbes, including increasing environmental stability and introducing hypervirulence. Secondly, traditional methods of restricting access to biological select agents and toxins (BSATs) may be less effective in an age where synthetic biology can be used to construct microbes de novo. Finally, synthetic biology can be used to construct novel threats that are meant to subvert countermeasures.” Lastly, one of the most interesting components to this presentation and Lim’s article is the underknown components to synethic biology. The erosion of the knowledge and technical barriers and the rise of the do-it-yourself (DIY) practitioners all give way to a new frontier in terms of benefits and dangers.

Broad Institute Wins CRISPR Patent 
This week, the U.S. Patent Office appeal board ruled that the dispute regarding the discoveries between the University of California, Berkeley and the Broad Institute do not overlap. “The ruling is a win for the Broad Institute, which had asked for the finding of no interference. It will be able to retain its valuable patents, which cover the use of CRISPR in human and animal cells. In a statement, Berkeley said it “respects” the decision but still maintains that Berkeley biochemist Jennifer Doudna and European collaborator Emmanuel Charpentier were the first to invent the CRISPR system.” The CRISPR patent dispute has brought to light the most foundational question of who truly owns the patent rights to CRISPR work in animals and plants. This new development doesn’t mark the end of the CRISPR dispute, as many expect Berkeley to appeal the decision and the Broad Institute’s patent is facing dispute from other researchers, including the Rockefeller University. While the CRISPR patent road may have been smoothed for a bit, it will continue to remain rocky and cause ripples for business developments and the biotech industry.

Defense Civil Support: DoD, HHS, and DHS Should Use Existing Coordination Mechanisms to Improve Their Pandemic Preparedness screen-shot-2017-02-14-at-10-41-11-am
In this Government Accountability Office (GAO) report, they found that the DoD should utilize guidance developed to aid in support of civil authorities (specifically HHS and DHS). “HHS and DHS have plans to guide their response to a pandemic, but their plans do not explain how they would respond in a resource-constrained environment in which capabilities like those provided by DOD are limited. DOD coordinates with the agencies, but existing coordination mechanisms among HHS, DHS, and DOD could be used to improve preparedness. HHS’s Pandemic Influenza Plan is the departmental blueprint for its preparedness and response to an influenza pandemic.” The GAO’s goal was to assess the DoD’s plans and processes to support civil authorities during a pandemic, of which they found that the existing coordination mechanisms should be used to explore opportunities to improve preparedness if their capabilities are limited.

Global Health Security Transparency 
Global health security is a finicky creature as it requires cooperation and transparency from all countries. One weak link in the chain can cause an international public health crisis. No More Epidemics is imploring countries to publish their Joint External Evaluations (JEE) performed by the GHSA (Global Health Security Agenda). As of now, only Ethiopia, Liberia, Peru, Uganda, UK, and the U.S. have openly shared their JEE’s. “Knowledge of baseline data provided by the JEE will result in more effective programming, prevention and detection of infectious disease outbreaks and early response. The JEE and roadmap processes are critical tools for civil society to use in developing appropriate and adequate programming to help countries close health systems gaps and become IHR-compliant. Transparency and accountability are vital in addressing global health threats. No More Epidemics urges all countries carrying out their Joint External Evaluations to make the results publicly available and for these to be made available on the World Health Organization’s Strategic Partnership Portal, the online repository for tracking funding, donor profiles and country level data.” Information sharing is also a mechanism for strengthening partnerships among countries.

Webinar on Ebola’s Aftermath 
Doctors Without Borders (MSF) will be hosting this live webinar on Thursday, February 23rd at 8pm EST. Following the publication of the book, The Politics of Fear: Médecins Sans Frontières and the West African Ebola Epidemic, the MSF webinar will do a deep-dive into the 2014/2015 outbreak and the lessons learned. This event will include a panel of MSF experts, who were directly involved in the MSF response in West Africa.

Fighting Antimicrobial Resistance with Physics
The battle against antimicrobial resistance (AMR) isn’t slowing and the proposed strategies emphasize the need for increased research and development of new antimicrobial agents, which means we’re running out of options. Swinburne University is trying a new tactic though – physics. “Elena Ivanova was studying physical surfaces that could repel bacteria before they even had time to settle. In clinical settings, such as hospitals and dental practices, 80% of infections are caused by bacteria that cling to surfaces in such densities that no antibiotic can remove them. First, she tried making surfaces so smooth that bacteria would, theoretically, simply slide off. Although that was the case for some bacteria, many others—such as the common Staphococcus aureus, or staphstill managed to cling on and multiply.” This is where Greg and Jolanta Watson come in – they have amassed a huge collection of biological samples in their laboratory. Ivanova and the Watsons communicated back and forth regarding natural properties that might make bacteria incapable of sticking to and growing on surfaces. Starting with cicada wings, Ivanova found that it was able to kill one of the two main types of bacteria, which was a partial success. Next, a gecko’s skin was tested, which revealed a wealth of knowledge. “Green had added a sample of the small, rod-shaped bacterium that causes gingivitis, Porphyromonas gingivalis, to the surface. In total, he added around 10 million microbes every day for a week. What’s more, this mass of microbes was given everything that they needed for a good life: a constant temperature of 98.6˚ F, an atmosphere without oxygen, and a daily ration of food. Regardless, after the week, nearly all were punctured and torn, their cellular carcasses strewn over the gecko skin. ‘Bacteria are trying to move and settle on the surface,’ Green says. ‘And they’re just getting spiked and skewered by these long hairs’.” Looking to nature, these researchers have focused on the physics of repelling bacterial growth, which may help broaden the arsenal against resistant germs.

Stories You May Have Missed: 

  • Talking About Bioethics & Policy in the U.S. Under the Trump Administration – Dual-use research of concern, CDC’s new quarantine rule, and the Animal Rule are all topics involving bioethics and Johns Hopkins University is hoping to provide the resources needed to address these complex issues. The new administration brings with it concerns over vaccine skepticism and how they will handle these bioethical dilemmas. How will Trump address the work of biotechnology and public health crises?
  • Breaking Barriers: Women in Science Event: Don’t miss this March 8th event at 6pm at Top of the Town in Arlington, VA. The 3rd annual reception will “bring together scientific, political, and cultural leaders to celebrate the achievements of women in STEM and take a stand for the critical role women play in science and technology communities”.
  • The Cost of Biosecurity – For $1 million a year, you can buy yourself global biosecurity! A recently published list of the unit staff costs from the 2017 BWC Meeting of State Parties, gives an eye-opening revelation into the cost of biodefense. For $1.1 million a year, you can financially support the implementation unit staff of the BWC – quite a bargain, no?
  • Surprise Us, Mr. Trump – A Letter From the Global Health Community – In this editorial article from The Lancet Global Health, the authors point to the role of the U.S. in the WHO Executive Board and the future of WHO leadership. “Two legislative bills introduced in early January in the US House of Representatives and Senate are seeking to withhold funds from the UN and open a way for the USA to leave the global body, and therefore withdraw membership of WHO.” The current political and global health atmosphere is unsettled, which has many concerned about the future of U.S. involvement in global health programs.
  • CRISPR Creates TB-Resistant Cattle – Chinese researchers have created tuberculosis resistance in cattle using CRISPR/Cas9. “As the researchers reported today in Genome Biology, they used somatic nuclear transfer to get the edit into an egg cell, creating 11 cows in vitro with NRAMP1 (nine using Cas9 nickase) and demonstrating that the gene provided increased resistance to tuberculosis.Moreover, they said that while the Cas9 nickase did not completely eliminate off-target edits, it did reduce them, especially when compared to standard Cas9 which creates double-strand breaks and is much more likely to create indel mutations via the non-homologous end-joining DNA repair pathway.”

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.”