Pandora Report: 5.24.2019

Happy Friday fellow fans of biodefense! We hope you had a lovely week and are ready to get your dose of all things health security…starting with the role of investors in pushing restaurant chains to cut antibiotics in the meat supply.

 Summer Workshop – Get the Early Registration Discount!
Just a couple more weeks to get this early registration discount – are you registered? This 3.5 day workshop will be a great place to hear from experts in the biodefense field, but also network and learn about the current biological threats we face. “The spectrum of biological threats is diverse, including naturally occurring disease outbreaks such as SARS, Zika, and Ebola, lapses in biosafety, dual-use research of concern, and the threat of bioterrorism. A severe disease outbreak, whether natural or man-made, can affect not just public health, but also public safety and national security. Pandemics and bioterrorist attacks will confront government agencies and the private sector with the need to make high-impact decisions with limited information during a rapidly evolving situation. Further complicating this domain is the dual-use nature of biology: the knowledge, skills, and technology developed for legitimate scientific and commercial purposes can be misused by those with hostile intent. Research with dangerous pathogens and the development of advanced biotechnologies such as synthetic biology and genome editing poses a dilemma for policy-makers and researchers who seek to maximize the benefits of such research while minimizing the risks. Thus, public health, law enforcement and national security agencies, the pharmaceutical and biotech industries, and the academic life sciences community need to develop new types of expertise, adopt new types of risk assessment and risk management strategies, and learn to collaborate with each other.” Make sure to register before June 1st for your discount! You can also get an additional discount if you’re a returning participant, part of a large group, or GMU alum/current student or faculty.

 Portable Isolation Unit: Coast Guard-Developed System for Evacuating Infectious or Contaminated Patients 
GMU Biodefense alum Dr. Jen Osetek is giving us a special look into how the Coast Guard developed systems for safer transport of highly infectious patients. “The Ebola outbreak of 2014-2015 was notable for a number of important reasons: it was the largest outbreak in history, there were affected Americans (both overseas and domestically), and it was the catalyst for the development of new capabilities that could help transport infected or potentially infected people. One such capability is the Department of Defense’s Transportation Isolation System (TIS) that was featured in the March 15, 2019 issue of Global Biodefense. Another critical solution was the U.S. Coast Guard-developed Portable Isolation Unit (PIU), manufactured by ISOVAC Products and formerly known as the Operational Rescue Containment Apparatus (ORCA®). This was specifically designed to be used in situations involving a rotary-wing maritime evacuation and will allow infected (or potentially infected) patients to be transported without risk of contaminating the aircrew or aircraft.  Due to this mission, it was designed to be used with stokes litter and NATO litter, among others.  he PIU is an FDA-approved positive-pressure device that utilizes a powered air-purifying respirator to supply air to the patient while filtering the exhaust air through a CBRNE cartridge. As a positive pressure apparatus that can filter inlet and exhaust air the PIU can withstand the mechanical force or rotor wash at hover during the hoist phase or rotary wing casevac/medevac evolutions. This is an important aspect of the design that enables its safe use in a variety or challenging operations and environments. The unit is battery operated and capable of running continuously for 4 hours. The PIU is constructed from Gore’s ChemPak® membrane barrier that is utilized in other CBRNE individual protective items. A window is installed for patient visibility and is supported by two flexible rods to prevent contact with the patient’s head and face. Glove ports present on both sides of the PIU are manufactured with Gore’s UltraBarrier® material and allow for limited patient interaction with rescue personnel. As a single-use item, the PIU contains the infectious agent or hazardous chemical contaminant during transport, which after use, is decontaminated for final disposal.”

Blue Ribbon Study Panel – A Manhattan Project for Biodefense: Taking Biological Threats off the Table
The Blue Ribbon Study Panel on Biodefense is hosting this event on July 11th – “Eighty years ago, the United States began leading a research and development effort to produce the world’s first nuclear weapons. Military and federal agencies, academia, industry, government contractors, and predecessors of today’s national laboratories worked together – with a great deal of support from Manhattan, NY and other localities – to establish overwhelming military superiority for the Allies during World War II. Their efforts effectively ended the war. Today, the challenge is defense against the biological threat, for which we are at a decided disadvantage. No matter what the source – intentional, accidental, or natural – the Nation and the world are at catastrophic biological risk. We need to tale this threat off the table for good. Please join the Panel on July 11, 2019, when we hold a meeting to discuss a Manhattan Project for Biodefense – a national, public-private research and development undertaking to defend the Nation against biological threats. Representatives from the same sorts of organizations that contributed to the original Manhattan Project will gather to talk with the Panel about the biological threat, cutting edge biodefense research, needed resources, and business risk. We will also talk about universal flu vaccine as an example of public-private interagency activity.” Make sure to RSVP by July 3rd – the event is available in person and online.

Immune to Drugs: AMR Could Kill 10 Million Per Year and Building New Models to Support the Ailing Antibiotic Market 
Remember that time we kept having increasing antimicrobial resistance but not a lot of people were paying attention? Well, “the United Nations created the Interagency Coordinating Group on Antimicrobial Resistance, and published a report with international agencies and experts noting that without immediate global action, the crisis of drug resistance bacteria and viruses could lead to an economic catastrophe as bad as the 2008-2009 global financial crisis, and by 2030 could force as many as 24 million people into poverty. And it hits home more often than we know. In the U.S., antimicrobial resistance causes more than 2 million infections and 23,000 deaths per year – the equivalent of a Boeing 747 crashing each week.  Financially, it is projected that due to lost wages, hospital stays and premature death, the U.S. lost about $35 billion in 2008 to antibiotic-resistant infections, and this number continues to rise.” Guess what is the root cause of breeding resistance? Hospitals. “Just days ago Senator Chuck Schumer of New York called for the CDC to declare a state of emergency over a fast-spreading outbreak of Candida Auris, a drug-resistant fungus that has infected more than 600 New Yorkers in health centers. But in New York, the state is trying to fight back not with hospital changes or environmental changes, but with technology. ;Given the amount of money it takes to battle these superbugs, and that the states are paying for all the Medicare and Medicaid patients, it makes sense as a money-saving initiative for states to be investing in genomic DNA and informatics,’ says Evan Jones, CEO of OpGen, a genomics and informatics company working with the New York Department of Health.” In the face of the dying antibiotic market, BARDA director Rick Bright recently discussed new approaches to bring some life back into the R&D we desperately need. “Now is the time to build new business models and novel partnerships that foster a robust end-to-end enterprise, making critically needed antimicrobials available to patients. At BARDA, we recognize the complexity of this challenge and are optimistic about what can be achieved. In the near term, these new models must not rely on exits to large pharma, but will benefit from decreases in market fragmentation and leveraging economies of scale. The industry needs to move toward market strengthening by leveraging capital in new ways across a broad portfolio of products with a long-term view and realistic revenue projections. BARDA simply cannot continue to provide non-dilutive investment, only to have companies collapse and their newly minted antibiotics shelved or lost completely. We will focus on bold ideas and new partnerships, utilizing its unique authorities to stimulate innovation, streamline R&D and successfully commercialize critically needed antibiotics. Thereby, ensuring greater health security for our nation. In addition, the biotech and pharmaceutical industry must join in pursuing better, sustainable business models for antimicrobials.”

Biosecurity Workshop – Engaging Young Scientists from the Global South in Biosecurity Diplomacy
Young scientists from the Global South working on topics related to the Biological Weapons Convention are invited to participate in the workshop Engaging Young Scientists from the Global South in Biosecurity Diplomacy. “The workshop will be financed under the auspices of European Union Council Decision 2019/97/CFSP in support of the BWC, managed and implemented by UNODA. The workshop aims to bring together up to 20 young and talented scientists from the Global South working on topics related to the BWC. Participants will be selected on the basis of their professional backgrounds and accomplishments. Young female scientists from the Global South are particularly encouraged to apply. The workshop recognizes that scientific and technological innovation, and youth and women’s empowerment and inclusion in multilateral BWC discussions, are essential to the realization of a world free from biological weapons. The workshop will provide an informal and interactive space for young scientists from the Global South to share their knowledge, insights and concerns, and to provide their vision for the future of responsible bioscience in their own countries. It will also encourage the development of networks of young professionals and provide an opportunity for capacity development in biosafety and biosecurity.”

 Ebola Outbreak Updates and the Role of Nosocomial Transmission
The UN Health Chief recently warned of the very high risk that Ebola will spread – especially in the face of community mistrust for health workers and government officials. “Efforts to combat the epidemic have been hobbled by attacks on treatment centers and health workers; deep suspicion of the national government, which is managing the eradication efforts; and growing mistrust of the international medical experts who have struggled to steer patients into the treatment centers, according to interviews with dozens of family members, politicians, doctors and health workers in recent weeks. When a doctor was killed, and treatment centers attacked by gunmen or set on fire, front-line health workers suspended their work, giving the virus time to spread. Some medical and aid groups have decided to pull some of their personnel from the very areas where Ebola has hit hardest. So far nearly 1,150 people have died in the outbreak, according to the World Health Organization. But that is a significant undercount, aid groups said in interviews. Health workers have been turned away regularly from homes where someone has died, leaving them unable to test for Ebola.” Healthcare workers are increasingly on edge with the attacks and threats, as 19 more cases were reported on May 22nd.  GMU Biodefense doctoral student and infection preventionist Saskia Popescu also discusses the trend of healthcare worker cases in this outbreak. “During the 2013-2016 outbreak, health care workers in West Africa were 32 times more likely to be infected with Ebola. Earlier this week, a nurse was reported as the latest case in this trend, bringing the total of health care worker infections to 99. On Friday, the World Health Organization situation report noted that this number had increased to 101 and now accounted for 6% of the cases. Of these health care worker cases, there have been 34 deaths. The continued need for more health care workers, especially in the wake of frequent threats and violence, makes the possibility of nosocomial transmission that much more real. The enhanced personal protective equipment (PPE) alone is difficult for a novice and can be a considerable source of exposure. Bringing in local health care workers and staff is critical to maintaining local engagement and earning trust in this rapidly evolving environment, however, the tacit knowledge of caring for an Ebola patient is complicated on the best of days.”

ASPR FY2020 Budget-In-Brief 
Check out the latest on the Office of the Assistant Secretary for Preparedness and Response (ASPR) and its FY2020 budget. “ASPR is funded through appropriations to the Public Health and Social Services Emergency Fund. The Fiscal Year (FY) 2020 budget request is $2.6 billion, which is $26 million above the FY 2019 enacted budget. This funding level supports the launch of a new pediatric disaster care initiative to enhance care to infants and children during emergencies; coordination of the National Biodefense Strategy (NBS); support for emergency operations planning and response; and, advanced development of MCMs through procurement, storage, and deployment. These investments ensure that ASPR can fulfill its unique role in protecting Americans from the impact of natural disasters, terrorist threats, and emerging infectious diseases. The request provides: $1.6 billion for the Biomedical Advanced Research and Development Authority (BARDA), including $322 million for Advanced Research and Development (ARD); $180 million for Combating Antibiotic Resistant Bacteria (CARB); $735 million for Project BioShield (PBS); and, $256 million for pandemic influenza (PI). $620 million for the Strategic National Stockpile (SNS) to manage and deliver life-saving MCMs during a public health emergency. $258 million for the Hospital Preparedness Program (HPP) to support cooperative agreements and other programs and initiatives that improve surge capacity and enhance health care readiness. $106 million for Preparedness and Emergency Operations (PEO), the National Disaster Medical System (NDMS), and the Civilian Volunteer Medical Reserve Corps (MRC) to support federal staff and local volunteers in preparing for and responding to public health emergencies and disasters, including training, modernization of equipment, and creation of a pediatric disaster care pilot initiative. $51 million for ASPR’s policy, planning, acquisitions, grants, financial management, business operations, and executive leadership.”

 PHEMCE Multiyear Budget
Have you read the 2017-2021 fiscal budget for the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)? “For the five-year period Fiscal Years (FYs) 2017–2021, this report provides estimates for HHS total spending which would be $24.8 billion, a $4.4 billion, or 22 percent, increase compared with the projection for FYs 2016–2020, which was $20.4 billion. The five-year funding total aggregates MCM-related spending estimates for NIH, BARDA, SNS, and FDA includes estimates of these replenishment costs, would be incurred by the SNS beginning in FY 2020. This change accounts for approximately $900 million of the estimated total $4.4 billion increase described below. This report developed the spending estimates as follows. For FY 2017 and FY 2018 the enacted annual appropriation levels were used and for FY 2019 the President’s Budget was used. The out-year funding levels (FY 2020 and FY 2021) for NIH, BARDA, SNS, and FDA were developed without regard to the competing priorities considered in the budget development process and that must be considered as Congressional budget submissions are developed. These estimates are subject to change in the future.”

Managing an Exposure- Why the EMR is Lacking
Since measles is on the rise, the concern for exposure in an emergency department or healthcare setting is very real. Unfortunately, managing such an event can be problematic with existing electronic medical records systems. “One of the most problematic aspects of an exposure is determining who is involved—both patients and staff alike. If the source case was a patient, the staff involved in their care must be identified, and if the source case is a health care worker, then the exposure list is usually longer as it involves both the individual’s patients and colleagues. For a disease like measles, which is highly contagious and infectious, we must also account for any patients exposed in waiting areas and other public areas where the patient went without the proper isolation (this includes considering patients on the same air-handling unit) Since the incubation period is usually 10-12 days, this often leaves little time for response efforts. One of the tools we often use to identify those involved in an exposure (for both notification and even prophylaxis purposes) is the electronic medical record (EMR) system. The EMR allows us to rapidly pull a list of staff who were involved in the care of a patient (assuming the patient was the index case)…or at least it should. ”

Stories You May Have Missed:

  • CRISPR Used to Tackle Superbugs -“‘We are getting to the point where there are organisms that are resistant to every known antibiotic,’ says Michael Priebe, a doctor who heads the spinal cord injury service at the VA medical center. ‘My fear is that as we are in this arms race, there gets to the point where we are not able to keep up with the enemy — the resistant bacteria. The superbugs take over, and we have nothing to defend against it,’ Priebe says. So Priebe enlisted Evans to help develop a different way to fight superbugs. It’s a new kind of antibiotic made out of viruses that have been genetically modified using the gene-editing tool CRISPR. ‘What CRISPR is able to do is something that we’ve not been able to do before. And that is, very selectively modify genes in the viruses to target the bacteria,’ Priebe says.”
  • Alleged Use of CW By the Assad Regime in Northwestern Syria – “The United States continues to closely watch the military operations by the Assad regime in northwest Syria, including indications of any new use of chemical weapons by the regime. Unfortunately, we continue to see signs that the Assad regime may be renewing its use of chemical weapons, including an alleged chlorine attack in northwest Syria on the morning of May 19, 2019. We are still gathering information on this incident, but we repeat our warning that if the Assad regime uses chemical weapons, the United States and our allies will respond quickly and appropriately. The May 19 alleged attack in northwest Syria is part of a violent campaign by the Assad regime that violates a ceasefire that has protected several million civilians in the greater Idlib area. This renewed Syrian regime offensive has targeted the communities of that area, which include a large number of Syrians who were already displaced from violence in others parts of Syria, and has destroyed known health facilities, schools, residences, and internally displaced person camps. The regime’s attacks against the communities of northwest Syria must end.”

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