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Pandora Report 10.27.2023

October 27, 2023 by dkellogg97, posted in Pandora Report

This week’s edition covers good news and upcoming open house events with the Schar School, the end of the EPA’s requirements for water utility facilities to undergo cybersecurity audits, and the arrest of the owner of the unauthorized, Chinese-owned lab in Fresno County, CA we previously covered. As always, new publications, upcoming events, and announcements round us out this week. Happy Halloween!

Biodefense PhD Student Lands Job with National Security Commission on Emerging Biotechnology

Kimberly Ma, a Biodefense PhD student, recently started a new job as a policy analyst on the National Security Commission on Emerging Biotechnology (NSCEB), which has been tasked with delivering a report on how advances in emerging biotechnology and related technologies will shape current and future DOD activities. Commissioners range from members of Congress to industry leaders and biotechnology subject matter experts, and the report will likely include components of both research analysis and policy recommendations. Kimberly’s primary work on the NSCEB will focus on the risks and threats associated with emerging biotechnology, along with international standards for managing these new tools within industry, government, and/or academia. These details and more about the NSCEB’s mission can be found here: https://www.biotech.senate.gov/section-1091-fy22-ndaa/

EPA Axes Certain Cyber Regulations for Water Utilities

Following growing concerns about the cybersecurity of the United States’ water infrastructure, the Environmental Protection Agency announced this week it will no longer require cybersecurity audits of water utility facilities through sanitary surveys. As explained in Cyberscoop, “In a letter to state drinking water administrators on Thursday, the EPA said litigation from Republican states and trade associations, which raised questions about the long-term legal viability of the initiative to regulate the cybersecurity of water utilities, drove the decision to rescind a March memorandum implementing the rule.”

“The announcement represents a major setback to the White House’s efforts to add more stringent cyber mandates to critical infrastructure sectors. The Biden administration’s National Cybersecurity Strategy described improving the digital defenses of critical infrastructure as a key priority.”

“Owners and operators of these systems are struggling to combat the deluge of ransomware and state-backed attacks and infiltration of the nation’s most sensitive networks. For critical infrastructure sectors, the consequences for a major cyberattack can be dire, and U.S. water utilities have been identified as particularly lacking in security.”

“EPA said it encourages “all states to voluntarily review public water system cybersecurity programs to ensure that any vulnerabilities are identified and corrected, and assistance is provided to systems that need help.”’

Owner of Unauthorized Lab in California Charged with Mislabeling and Lacking Permits for Work

Following reports of the uncovering of a Chinese-owned, unauthorized lab in Reedley, CA in August, the owner of the facility, Jia Bei Zhu, was arrested Thursday after an investigation conducted by the FDA. According to the AP, “The Chinese owner of an unauthorized central California lab that fueled conspiracy theories about China and biological weapons has been arrested on charges of not obtaining the proper permits to manufacture tests for COVID-19, pregnancy and HIV, and mislabeling some of the kits.”

In its press release, the US Attorney’s Office for the Eastern District of California said, ‘“As part of his scheme, the defendant changed his name, the names of his companies, and their locations,” U.S. Attorney Talbert said. “The disarray at the Reedley lab led to the glare of publicity he was trying to avoid, and the ensuing investigation unraveled his efforts to circumvent the requirements that are designed to ensure that medical devices are safe and effective.”’

‘“Providing materially false information to FDA inspectors regarding medical device manufacturing and distribution impedes the agency’s ability to protect public health, especially when those false statements relate to unauthorized and misbranded COVID-19 tests. Consumers who unknowingly use these misbranded COVID tests run the risk of incorrect results about their COVID status, which can lead to further spread of the virus,” said Special Agent in Charge Robert M. Iwanicki, FDA Office of Criminal Investigations Los Angeles Field Office. “We will continue to investigate and bring to justice those who jeopardize the health of U.S. consumers.”’

“According to court documents, between December 2020 and March 2023, Zhu and others manufactured, imported, sold, and distributed hundreds of thousands of COVID-19 test kits, in addition to test kits for HIV, pregnancy, clinical urinalysis, and other conditions in the United States and China. They did so through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), which were based in Fresno and Reedley. UMI and PBI did not obtain the required authorizations to manufacture and distribute the test kits and mislabeled some of the test kits. When questioned by FDA officials, Zhu made false statements about his identity, his ownership and control of UMI and PBI, and the activities of UMI and PBI.”

“According to the criminal complaint, Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using non-permitted plumbing that was visible from outside the warehouse. When code enforcement officials went to the warehouse the next day, they saw various types of in vitro diagnostic test kits, related manufacturing equipment, and shipping supplies.”

“Further investigation found that UMI first registered as a medical device manufacturer with the FDA in November 2015 in Tulare and moved to Fresno in 2018. FDA records show that its registration lapsed in 2022, and it is no longer permitted to manufacture or import any in vitro diagnostic test kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices.”

“To manufacture, import, and distribute COVID-19 test kits in the United States during the pandemic, a company must have applied for, and ultimately received, an Emergency Use Authorization (EUA) from the FDA. According to FDA records, UMI applied for an EUA for its COVID-19 test kits, but never received it due to major deficiencies in UMI’s test studies.”

“In November 2022, Fresno County officials notified UMI that they were going to inspect UMI’s Fresno facility to ensure everything was up to code following a fire that occurred at the facility. FDA officials then received an email from UMI’s attorney saying that the company had gone out of business and sold its assets to PBI, a company that was formed in Las Vegas, Nevada. PBI was never registered with the FDA to manufacture or import any in vitro diagnostic test kits in the United States, and never received an EUA to manufacture and distribute COVID-19 test kits. Therefore, any such test kits would be misbranded medical devices.”

“According to the criminal complaint, during the investigation, Zhu made several false statements to FDA officials, including that his name was Qiang “David” He; that he was hired by UMI as a COVID-19 consultant in 2021; that he was hired by PBI just a couple of weeks ago to communicate with government agencies and dispose of property at the warehouse as requested by those agencies; that he did not know anything about the manufacturing or distribution histories for UMI or PBI; and that he knew nothing about an Amazon webpage showing PBI‑branded pregnancy test kits for sale or a shipment of 47,500 pregnancy test kits from China to UMI at an address in Las Vegas.”

The press release concluded by explaining that “If convicted, Zhu faces a maximum statutory penalty of three years in prison for the misbranding of medical devices charge, and five more years in prison for the false statements charge. Any sentence, however, would be determined at the discretion of the court after consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables. The charges are only allegations; the defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.”

Schar School Open Houses

In-Person Graduate Open House

George Mason University’s School of Business, Schar School of Policy and Government, and the Carter School of Peace and Conflict Resolution invite prospective students to attend our IN-PERSON Graduate Open House.

Explore the different degree programs we offer at the master’s, doctoral, and professional levels, as well as our graduate-level certificates. Representatives will be in attendance to discuss our various graduate programs as well as how you can further your studies and continue to work while pursuing your degree. This event will take place on November 2 from 5 to 7 pm EST. Learn more and register here.

Virtual PhD Open House

Prospective students are invited to attend a virtual open house to learn more about the Schar School of Policy and Government PhD Programs and interact with the admissions staff and faculty program directors. This event will take place on November 8 from 7 to 8:30 pm EST. Learn more and register here.

Virtual Biodefense MS Open House

Prospective students are invited to attend a information session to hear more about the Biodefense M.S. program offered at the Schar School. The online session will provide an overview of the program, as well as the application process, student experience and graduate outcomes. This session admissions will be led by the Graduate Admissions team. This event will take place on November 13 from 12 to 1 pm EST. Learn more and register here.

“Safeguard the World’s Worst Pathogens”

Piers Millett recently published this editorial in Science, quoting the work of the Global Biolabs co-led by Biodefense Graduate Program Director Gregory Koblentz in the piece: “More people in more places are researching the world’s most dangerous pathogens. This work helps prepare against future pandemics, but it’s not without danger. Pathogens could escape from research facilities, so it is vital for countries to assess potential hazards and have procedures in place to manage the risks. This doesn’t happen enough…Earlier this year, the Global Biolabs initiative released a report tracking the growth of maximum containment labs. These facilities provide extremely high levels of protection when there are very high risks to lab personnel, the wider community, or the environment. The report reveals that in 2000, there were only 13 such labs in the world. The number of labs in operation, under construction, or planned has risen steadily: to 59 labs in 23 countries in 2021, and 69 labs in 27 countries in 2023. This boom in labs has not been sufficiently accompanied by strengthened safety and security.”

“The Code of Life and Death”

Braden R. Leach recently published this article in the Journal on Emerging Technologies, writing in part: “Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet.”

“The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences.”

“Unsurprisingly, voluntary guidance has not inspired full adherence. I argue that HHS should require providers to screen the sequences they provide and that it has the statutory authority to do so. This would improve security and level the playing field.”

“But it would not be enough. Private companies are not in the best position to perform background checks on their customers, and their economic incentives point the other way. I propose a novel license regime, where every buyer and seller of synthetic DNA and gene synthesis equipment would need to undergo a background check before transacting. In a world where biotechnology will only grow cheaper and easier to use, open access is untenable.”

“Informed by experts at the frontlines of science, industry, and security, this article advances novel regulatory solutions to counter the risks posed by dual-use biotechnology. If the US wishes to protect its people and remain the leader in the field, it must control who can access the code of life and death.”

“Verifying the BWC: A Primer”

James Revill recently authored this report for UNIDIR: “At the Ninth Review Conference of the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (BWC) in 2022, States Parties agreed to establish a new Working Group on the strengthening of the Convention, which will operate during the next intersessional period between 2023 and 2026. The agenda for the Working Group includes discussion on, among other things, compliance and verification. This is the first time in 20 years that verification will be formally discussed within the BWC framework, initiating a new process that opens a window of opportunity for States to advance work around monitoring and compliance.”

“This UNIDIR report, the first in a series, serves as a primer for the consideration of verification in the context of the BWC, with a particular focus on Article I and the core obligations contained in the title of the BWC. The paper begins with elements of a working definition of verification, before considering theoretically what contemporary biological weapons and biological weapons programmes might look like. The paper proceeds to discuss tools and approaches to verification of the BWC, and the importance of agreed procedures and resources, before concluding with some reflections on what the Working Group might be able to achieve.”

“The Biological and Toxin Weapons Convention Confronting False Allegations and Disinformation”

Jean Pascal Zanders recently authored this paper for the EU Non-Proliferation and Disarmament Consortium. He writes in part, “This paper reviews Russia’s information warfare campaign surrounding biological weapon research in Ukraine since the late 2000s and how Russia escalated the accusations after its invasion of Ukraine in 2022. It traces how Russia, having presented its allegations several times to the Security Council, manoeuvred to bring the USA-funded biological research in Ukraine within the ambit of the BWC, leading to the triggering of Articles V and VI. The paper then analyses why Russia failed in its objectives. It reflects on how the BWC has stood up against disinformation and sustained false allegations and concludes with some recommendations for the European Union (EU) given its long-standing commitments to strengthening the norm against biological weapons and major financial support for treaty implementation worldwide.”

“Annual Progress Report on the Implementation of the European Union Strategy against the Proliferation of Weapons of Mass Destruction (2022)”

EEAS recently released its annual WMD report, covering the EU’s participation and contribution in nonproliferation and related activities, including:

The EU supported efforts by the International Atomic Energy Agency (IAEA) to ensure nuclear safety and security worldwide, including by financing the IAEA’s staff presence in Ukrainian nuclear facilities in the face of Russia’s illegal war of aggression. This comes in addition to other bilateral EU assistance to Ukraine in this field.
The European Commission launched a new ambitious programme aimed at uplifting nuclear safeguards in Africa, in cooperation with the African Commission on Nuclear Energy (AFCONE) and Finland.
On the year of the 25^th anniversary of the entry into force of the Chemical Weapons Convention, the EU continued to fully support its implementing body, the Organisation of the Prohibition of Chemical Weapons (OPCW), both politically and financially. It also imposed further restrictive measures linked to the poisoning of Alexei Navalny and the production of chemical weapons delivery systems in Syria.
The EU participated actively in the Ninth Review Conference of the Biological Weapons Convention that decided to establish a Working Group to identify specific and effective measures to improve its implementation. The EU also played an active role in countering Russia’s disinformation campaign related to biological weapons in the context of its illegal war of aggression against Ukraine.”

“Testing Playbook for Biological Emergencies”

From Better Testing Now: “The purpose of this Diagnostic Testing Playbook is to provide executive leaders with a guide to easy-to-use information that will inform their planning on how equitable access to accurate testing can quickly be provided to all communities during an emerging biological event and how the data from testing can inform emergency decisions at each stage of a crisis.”

“Machine Learning and Gene Editing at the Helm of a Societal Evolution”

From the RAND Corporation: “The integration of artificial intelligence (AI) and biotechnology, while in its infancy, presents significant opportunities and risks, and proactive policy is needed to manage these emerging technologies. While AI continues to have significant and broad impact, its relevance and complexity magnify when integrated with other emerging technologies. The confluence of machine learning (ML), a subset of AI, with gene editing (GE) can foster substantial benefits as well as daunting risks that range from ethics to national security.”

“Both genome editing and AI technologies are being pursued at scale in various global markets. There is clearly an urgency to addressing policy issues surrounding these emerging technologies. Yet, this combined field has not been adequately studied from a policy perspective. The components need clear definitions and analyses with respect to their practical combined implications.”

“We investigated the policy implications of the application of AI/ML to gene editing in humans, in particular technology governance as a cross-cutting theme. This analysis developed a future scenario-focussed framework to protect human interest by considering the implications of these technologies being pursued at scale and globally.”

Pandora Report 10.20.2023

October 20, 2023 by dkellogg97, posted in Pandora Report

This week covers experts’ response to a White House OSTP RFI regarding potential changes to Policies for Federal and Institutional Oversight of Life Sciences Dual Use Research of Concern and Potential Pandemic Pathogen Care and Oversight Policy Framework, new publications focused on topics ranging from pandemic influenza and the BW taboo to global nuclear conflict, upcoming events, and professional development opportunities.

Hopkins Center for Health Security Publishes Response to White House Office of Science and Technology Policy RFI on Dual Use Research of Concern and Potential Pandemic Pathogen Care and Oversight Policy Framework

Experts in public health and security recently responded to an OSTP RFI regarding “potential changes to the Policies for Federal and Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) and Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework.” This included several faculty members at Johns Hopkins Center for Health Security, whose response “…follows the release of findings and proposed recommendations by the National Science Advisory Board on Biosecurity (NSABB) earlier this year. The NSABB report included recommendations for governance of research involving enhanced pathogens of pandemic potential (ePPP), an extremely small subset of gain-of-function research that has significant enough risks to warrant oversight.”

According to the authors, “The group’s RFI response supports the NSABB recommendations and emphasizes the importance of protecting humans, animals, plants, and the environment from especially dangerous DURC and ePPP research. “Research activities must be seen in the broader and more significant context of the United States Government’s responsibility to reduce risks of accidental or deliberate pandemics to which a narrow and limited segment of research—ePPP research—may contribute if un- or underregulated,” write the authors.”

Several other experts signed in support of the RFI, including Biodefense Graduate Program Director, Gregory Koblentz.

What We’re Listening To 🎧

GovCast: S6 E29, Protecting the Health Care Ecosystem from Cybersecurity Threats

“The Administration for Strategic Preparedness and Response (ASPR) at the Department of Health and Human Services leads the nation’s medical and public health preparedness for all disasters and public health emergencies.”

“After spending more than a decade at the Government Accountability Office, Brian Mazanec is taking on a new challenge as the Deputy Director of the Office of Preparedness at ASPR.”

“In his newly appointed position, Mazanec will use his expertise in cybersecurity and conflict to ensure the health care ecosystem has critical infrastructure protection to combat cyber threats.”

Listen here. Mazanec is an alumnus of the Biodefense PhD Program and a current Schar School adjunct professor.

“The Operational Risks of AI in Large-Scale Biological Attacks: A Red-Team Approach”

From the RAND Corporation: “The rapid advancement of artificial intelligence (AI) has far-reaching implications across multiple domains, including its potential to be applied in the development of advanced biological weapons. The speed at which AI technologies are evolving often surpasses the capacity of government regulatory oversight, leading to a potential gap in existing policies and regulations. Previous biological attacks that failed because of a lack of information might succeed in a world in which AI tools have access to all of the information needed to bridge that information gap.”

“The authors of this report look at the emerging issue of identifying and mitigating the risks posed by the misuse of AI—specifically, large language models (LLMs)—in the context of biological attacks. They present preliminary findings of their research and examine future paths for that research as AI and LLMs gain sophistication and speed.”

“The Biological Weapons Taboo”

Michelle Bentley recently authored this piece in War on the Rocks that is based on her recently released book of the same name. She writes in part, “COVID-19 has revitalized the debate on why biological weapons should not be used. International actors have expressed a new interest in the bioweapons threat — one that is focused on preventing and stigmatizing that threat as a priority concern. Biowarfare is on the global political agenda to a greater extent than it has ever been before.”

“This fresh interest has often centered on the biological weapons taboo. The taboo is the claim that bioweapons are so disgusting, immoral, and unacceptable that actors will not use them. The taboo has previously been dismissed as anemic and of little significance to both state and international security. The taboo was even criticized as a “potentially dangerous” way of doing arms control relating to biowarfare.”

“Yet the taboo is currently experiencing something of a second life in the wake of COVID-19. The pandemic has demonstrated the potential destruction of bioviolence in a whole new way. In doing so, the COVID-19 pandemic has strengthened the taboo and underpinned a renewed approach to biowarfare prevention that has the taboo at its core. This new shift in perception has significant implications not only for how we understand what actors think about bioweapons but also how we prohibit these armaments. The taboo is changing bioweapons policy in a major move further away from more traditional methods of arms control.”

“Many Potential Pathways to Future Pandemic Influenza”

Morens, Park, and Taubenberger recently published this piece in Science Translational Medicine: “Although influenza A viruses have caused pandemics for centuries, future pandemics cannot be predicted with our current understanding and resources. Concern about an H5N1 avian influenza pandemic has caused alarm since 1997, but there are many other possible routes to pandemic influenza.”

“Scientists Discuss Prototype Pathogens for Pandemic Preparedness”

From NIAID: “A special Oct. 19 supplement to the Journal of Infectious Diseases contains nine articles intended as a summary of a National Institute of Allergy and Infectious Diseases (NIAID)-hosted pandemic preparedness workshop that featured scientific experts on viral families of pandemic concern. Sponsored by NIAID, the supplement features articles on 10 viral families with high pandemic potential known to infect people. Concluding the supplement is a commentary from NIAID staff on the “road ahead.”’

“Many of the viruses in these 10 families have no vaccines or treatments licensed or in advanced development for use in people. Rather than facing the enormous task of developing medical countermeasures for individual viruses, one strategy is to use the “prototype pathogen” approach – which was shown to be successful with the rapid development of vaccines during the SARS-CoV-2 pandemic. This approach characterizes “representative” viruses within viral families so that knowledge gained, including medical countermeasures strategies, can be quickly adapted to other viruses in the same family.”

Pandora Report 10.13.2023

October 13, 2023 by dkellogg97, posted in Pandora Report

This week’s issue covers GMU Biodefense students’ recent trip to Mason’s own BSL-3 facility, Russia’s new Commission on Combating Biosecurity Threats, ARPA-H’s new vaccine discovery program, and the ticking clock for securing DHS’s CWMD Office’s future amid Congressional turbulence. Several new publications, upcoming events, and more are included.

Join Us on October 16 for a Virtual Schar School PhD Information Session

“Prospective international students are invited to attend a virtual information session to learn more about the admission requirements for our PhD programs that are unique to you. This session will be led by Katy Sombito, PhD Admissions Coordinator. Join us to learn more about the admission process for international students and get your questions answered.”

This includes the Schar School’s unique Biodefense PhD program!

Biodefense Students Get a Tour of George Mason’s BSL-3 Lab

Biodefense students got a chance to tour George Mason’s Biomedical Research Laboratory (BRL) this week while the lab was shut down for routine annual maintenance. The 52,000 square-foot laboratory was established in 2010 as one of 12 NIAID-funded regional biocontainment facilities to conduct research and development on novel diagnostics, therapeutics, and vaccines against viral and bacterial infectious agents. Rachel Pepin, director of research support operations for the BRL, led the tour and provided a behind-the-scenes look at the lab’s BSL-3 and ABSL-3 suites, aerosol test chamber, and sophisticated HVAC system. The tour provided the Biodefense students with insights into how infectious diseases research is conducted and the types of biosafety and biosecurity measures that are used by high containment labs.

*Biodefense Program Director Gregory Koblentz with Biodefense students outside George Mason’s Biomedical Research Laboratory.*

Russia Announces New Commission on Combating Biosecurity Threats

The Russian News Agency (TASS) announced this week that, “Russian President Vladimir Putin has signed a decree on the creation of an interdepartmental commission of the Russian Security Council that will be responsible for countering modern threats to biological security. It will be headed by Russian Security Council Deputy Chairman Dmitry Medvedev.”

“The same decree abolished another Security Council commission which was headed by Medvedev – responsible for creating a national system of defense against new infections. Its functions were transferred to the new entity.”

“The document also sets out the new commissions’ functions. These include assessing threats to biological security, facilitating scientific research in the field of biotechnology development, creating state policy in the field of biosecurity, developing measures to prevent and eliminate biological threats, international cooperation in the field of biotechnology development and biosecurity, as well as countering the policies of foreign countries that pose a threat to Russia’s national interests.”

The official President of Russia webpage posted a statement explaining the executive order, reading in part “In accordance with the Federal Law On Security of December 28, 2010, and the Regulations on the Security Council of the Russian Federation, approved by Presidential Executive Order On Certain Aspects of the Security Council of the Russian Federation of March 7, 2020, the President decided to establish an Interdepartmental Commission of the Security Council on Countering Modern Threats to Biological Security.”

“The Executive Order abolished the Security Council’s Interdepartmental Commission on the creation of a national system for protection against new infections. Its functions have been transferred to the new body.”

TASS further explained that “The commission will meet at least once every six months, and more often if necessary…According to the decree, the commission, which will be headed by Medvedev, will include the heads of the Interior, Health, Education and Science, Natural Resources, Economic Development Ministries, as well as the President of the Russian Academy of Sciences, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, the Federal Agency for Forestry and others.”

ARPA-H Launches APECx Program to Transform Vaccine Discovery

HHS announced this week that ARPA-H is launching the APECx to advance vaccine discovery. The Department said in its October 10 press release “The Advanced Research Projects Agency for Health (ARPA-H) launched today a research program to develop a computational toolkit that helps design vaccines that target many viruses at once. The program is called the Antigens Predicted for Broad Viral Efficacy through Computational Experimentation, or APECx.”

“Viruses remain a significant threat to global health and security, causing pandemics, cancers, and chronic illness — yet we lack vaccines for most of these viral diseases. The current methods for vaccine and drug development are often slow and expensive, due in part to an incomplete understanding of a virus protein’s structure and function, leading to years of research that is targeted narrowly to one virus.”

“To accomplish genus- and family-level vaccine development, APECx will leverage emerging computational innovations coupled with high-throughput biochemical and immunological data generation on a scale that has not been approached before. ARPA-H is emphasizing collaboration across academia and industry to accelerate these discoveries with unique tools that have yet to be tested for vaccine development.”

“Through a forthcoming Broad Agency Announcement (BAA), APECx will solicit proposals focused on three technical areas: high-throughput biochemical analysis and protein engineering, protein modeling toolkit development for antigen design, and translational candidate development and clinical evaluation. Antigens and targets identified through these technical areas will be transitioned to a development pipeline to produce vaccines and other treatments with the goal of targeting entire viral families with a single vaccine. The resulting vaccines would represent entirely new approaches to preventing the viral infections that are causing large acute and chronic health burdens across America.”

Congressional Turbulence Threatens CWMD Office

Amid yet another leadership shuffle in the House, the fate of the Department of Homeland Security’s Countering Weapons of Mass Destruction Office hands in the balance. Ellen Gilmer explains in her deep dive for Bloomberg Government, “Mary Ellen Callahan, assistant secretary for the Countering Weapons of Mass Destruction Office at the Department of Homeland Security, took the helm with just months to lock in support for the troubled office as lawmakers consider whether to renew it. Without a reauthorization, her office closes, and the US loses a division that trains first responders, researches and distributes technology, and helps detect threats nationwide.”

‘“The reauthorization is a sword of Damocles hanging over our head,” Callahan said in an interview at DHS headquarters last month.”

This comes after Federal News Network reported earlier this year that the office faced “…employee engagement scores near the bottom of the federal government.” That same piece explained some of the challenges this officefaces further, writing “DHS has consistently ranked near the bottom of the 17 “large” agencies in the “Best Places to Work in the Federal Government” rankings compiled by the Partnership for Public Service. Those low scores are largely driven by challenges at large DHS components like Customs and Border Protection, Immigration and Customs Enforcement and the Transportation Security Administration.”

“But the component with the lowest employee engagement score in all of DHS is the little known Countering Weapons of Mass Destruction office. Its employee engagement score of 39.4 in 2022 ranked 430th out of 432 subcomponents across the entire federal government…With approximately 230 employees, the CWMD office is responsible for working with state and local governments as well as international partners to guard against chemical, biological, radiological and nuclear threats to the United States.”

The product of a merger between the Domestic Nuclear Detection Office and the Office of Health Affairs, “One of the root causes of the low scores was a clash of different cultures between the two legacy offices, according to a GAO report from April 2022. While DNDO worked with physicists and law enforcement officials to detect and prevent threats, OHA was more focused on working with public health officials to coordinate preparedness and response, GAO reported.”

“Reimagining Incident Management Systems for Public Health Responses”

Hawkins et al. recently published this article in Health Security. They explain in their introduction: “In 2020, the COVID-19 pandemic brought a “perfect storm” to disaster response efforts in the United States: a large-scale emergency response, many uncertainties, a dearth of public health resources, uncoordinated state efforts inherent to our federalist form of government, and severe political tensions that led to unprecedented involvement by elected officials—many of whom were experiencing a public health response for the first time in their careers. Although some jurisdictions had previously responded to severe, large-scale natural disaster incidents (including widespread wildfires or devastating hurricanes), they did not have experience with response and recovery processes for infectious disease outbreaks, which are less routine. Response efforts for natural disasters are more routine because they occur more frequently, resources can be garnered from unaffected jurisdictions, lessons learned are incorporated from previous disasters, and mitigation actions are taken between each response. In contrast, SARS-CoV-2 brought a plethora of unknowns, with impacts on health, economies, educational systems, and most other foundational components of everyday life throughout most communities across the globe. No “pandemic response model” existed, and the public health system found itself stretched to a perpetual state of almost breaking.”

This article was co-authored by Kimberly Ma, a current Biodefense PhD Student.

“Strengthening Warfighter Resiliency Using Broad-Spectrum or Host-Directed Therapies within the Rapid Acquisition and Investigation of Drugs for Repurposing (RAIDR) Program”

From Quattrochi et al. in The Journal of Pharmacology and Experimental Therapeutics: “The ecosystem of CBRN threats is evolving and becoming more complex. To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. The Countering Emerging Threats – Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Responsible and relevant care must be more responsive to needs of expansive and novel threats, as showcased by lessons learned from the COVID-19 pandemic. Repurposing is one such method. The focus of the CET RAIDR effort is to bridge treatment gaps between threat identification and the implementation of licensed targeted MCMs, thereby strengthening warfighter resiliency. The CET RAIDR program conserves both time-to-market and funds by leveraging previous conventional development work as a launch point for repurposing efforts. The CET RAIDR program minimizes development and procurement costs by supplementing the military medical providers’ toolbox with post-Phase II therapies that demonstrate established safety and manufacturing processes, leading to a cost-sparing model for niche medicines (i.e., CBRN MCMs). The CET RAIDR program currently focuses on strengthening collaborations with industry, academia, and other government partners to survey and test and evaluate (T&E) U.S. Food and Drug Administration (FDA)-approved products, such as LEUKINE ®, PRECEDEX ®, Ketamine, Isoflurane, and XOFLUZA ®, as well as other promising developmental products against known or undocumented threats.”

Dr. Lauren Quattrochi is a classically trained electrophysiologist and neuro-pharmacologist currently serving as an Adjunct Professor in the Biodefense Graduate Program. Over the evolution of her career, she has worked within the biopharma industry, non-profits and for the past several years, in support of the government. Learn more about her here.

“Inside The Program To Dismantle Ukraine’s Nuclear Weapons”

Amos Cahpple recently published this article with Radio Free Europe discussing the work of the United States’ Defense Threat Reduction Agency, offering an easy-to-read review of the organization’s work in Ukraine accompanied by a number of pictures from DTRA’s work in the country in the 1990s. Chapple writes in the introduction, “In a “secret room” in Kyiv on April 13, 1993, Leonid Kravchuk, the first president of Ukraine, sat down with his Georgian counterpart Eduard Shevardnadze over borscht and puffy “pampushka” dumplings…Between bites, the Ukrainian reportedly confided that, even amid rampant corruption and economic turmoil, his “biggest headache” was pressure from Washington to hand over hundreds of Soviet-made nuclear weapons to Russia.”

“The Georgian president lowered his voice as he sympathized. Americans, he said, “do not understand the complicated, immensely difficult and brutal history of our relations with Russia and the Soviet Union, or other empires.”‘

“Shevardnadze then pitched an idea. Instead of allowing Ukraine to be entirely defanged, the country should keep just one functioning nuclear missile on its territory, to “ward off any madman.” After all, the Georgian president added, “today we have ‘democratic’ [Boris] Yeltsin” in the Kremlin, but “who knows who may come after him.”‘

“How Doing Justice to Ukraine Can Help Win the Battle for the Future of Nuclear Security”

Valeriia Hesse authored this issue brief for the Stimson Center explaining how “Russia occupation of Ukraine’s Zaporizhzhia Nuclear Power Plant has serious implications for nuclear security: urgent action is needed to mitigate risk.” She writes “The Russian occupation of the Zaporizhzhia nuclear power plant in Ukraine has created unprecedented risk in an era of increasing geopolitical tension. Deterring future attacks against nuclear facilities during armed conflict is an essential component of reducing nuclear risk and supporting nuclear industry – but how can this be achieved at a time when international cooperation has waned to new lows? This issue brief explores how the international nuclear security system must avoid nuclear disaster at ZNPP, end the Russian occupation of the plant, and prevent similar high-risk events from taking place in the future.”

Pandora Report 10.6.2023

October 6, 2023 by dkellogg97, posted in Pandora Report

This week’s Pandora Report brings several new publications covering a range of topics as well as new upcoming events, professional opportunities, and deets on an upcoming chance to learn more about the Schar School’s PhD programs, including the Biodefense PhD Program.

Join Us on October 16 for a Virtual Schar School PhD Information Session

This includes the Schar School’s unique Biodefense PhD program!

Katalin Karikó and Drew Weissman Awarded Nobel Prize for Work Enabling mRNA COVID-19 Vaccine Development

This year’s Nobel Prize in Physiology or Medicine was awarded jointly to Katalin Karikó, a biochemist, and Drew Weissman, an immunologist, for their discoveries that later enabled the development of mRNA vaccines for COVID-19.

A Nature News article about the announcement explained, “Karikó, who is at Szeged University in Hungary, and Weissman, at the University of Pennsylvania in Philadelphia (UPenn), paved the way for the vaccines’ development by finding a way to deliver genetic material called messenger RNA into cells without triggering an unwanted immune response.”

The same article explained that “Karikó is the 13th female scientist to win a Nobel Prize in medicine or physiology (see ‘Nobel imbalance’). She was born in Hungary, and moved to the United States in the 1980s. “Hopefully, this prize will inspire women and immigrants and all of the young ones to persevere and be resilient. That’s what I hope,” she tells Nature.”

October is Biosafety and Biosecurity Month!

October is the Association for Biosafety and Biosecurity’s Biosafety and Biosecurity Month!

In a post shared to the organization’s website, ABSA said “Rather than a theme for 2023, we like to bring Biosafety and Biosecurity Month back to the core components of ethical research, transparency, training, engagement, and stewardship of biosafety and biosecurity.”

“Use this month to shine the spotlight on training ideas, stewardship and engagement, how to foster positive relationships with the research community, or supporting responsible and ethical research through our profession.”

“2023 Was the Year the US Finally Destroyed All of Its Chemical Weapons”

Jen Kirby covers the destruction of the United States’ CW stockpile in this Vox piece that features quotes from the Schar School Biodefense Program’s Sonia Ben Ouagrham-Gormley. Kirby writes in part, “The US had some 30,000 tons of chemical warfare agents at the time of the CWC ratification. The US learned quickly that agreeing to eliminate chemical weapons was one thing. Actually doing so was far more complex. “These are weapons that were built to be used, not destroyed,” said Sonia Ben Ouagrham-Gormley, an expert in weapons programs and an associate professor at George Mason University.”

“Beyond Gain of Function: Strengthening Oversight of Research with Potential Pandemic Pathogens”

Biodefense Graduate Program Director, Gregory Koblentz, recently published this article-co-authored with Rocco Casagrande-in Pathogens and Global Health: “In 2017, the Department of Health and Human Services adopted a policy, known as the P3CO Framework, to govern proposed research that could enhance the lethality or transmissibility of a potential pandemic pathogen. The prospect of a human-made virus with artificially enhanced lethality and transmissibility has raised serious biosafety and biosecurity concerns. The COVID-19 pandemic has generated new concerns about the risks posed by such research. Even if the origins of the pandemic are presumed or proven to be the result of a natural zoonotic spillover event, the pandemic has placed greater scrutiny on research that could generate pandemic-capable viruses and dramatically illustrated the consequences if such a virus were released from a laboratory. This article assesses the strengths and weaknesses of the P3CO Framework and provides recommendations for strengthening oversight of research with potential pandemic pathogens. The P3CO Framework should be replaced by a national policy that would apply to all relevant research, regardless of the source of funding and be implemented by a new national agency for biorisk management. This new policy would need to be accompanied by a comprehensive analysis of potential pandemic pathogen risks, clear guidance on how to identify research that falls within the scope of the policy, a rigorous process for reviewing the risks and benefits of such research, and criteria for determining the appropriate measures needed to conduct such research safely, securely, and responsibly.”

“Identifying Outbreak Origins: How the Joint Assessment Mechanism Can Improve Pandemic Response”

From NTI: “NTI is working with international partners to develop a new Joint Assessment Mechanism (JAM) within the office of the UN Secretary-General to rapidly identify outbreak origins. Without the ability to quickly determine the origin of an outbreak, researchers are hampered in their ability to rapidly develop vaccines and other medical countermeasures that can slow the pace of the outbreak, ultimately saving countless lives. Drawing on a fictional scenario used in an NTI and Munich Security Conference tabletop exercise, NTI | bio’s Shayna Korol examines what the JAM would look like in action and describes the impact it could have on international security.”

“Negotiating Global Health Security: Priorities for U.S. and Global Governance of Disease”

From CFR’s Global Health Program: “Lessons from the COVID-19 pandemic could revolutionize global health security, but the window for change is closing—quickly. In the latest Council Special Report, Yanzhong Huang and Rebecca Katz outline the urgent reforms that could lead to a safer, healthier world.”

Access this report here.

“Mosquitoes Are a Growing Public Health Threat, Reversing Years of Progress”

Stephanie Nolan covers renewed and growing threats posed by mosquito-borne diseases in this piece for the New York Times, in which she explains “Climate change and the rapid evolution of the insect have helped drive up malaria deaths and brought dengue and other mosquito-borne viruses to places that never had to worry about them.”

“10 Years of the Syria Chemical Weapons Challenge”

Christine Parthemore covers ongoing issues in CWC compliance in Syria in this piece for the Council on Strategic Risks. She explains in her introduction, “In August 2013, the Syrian government used sarin to attack the Ghouta neighborhood of Damascus, killing more than 1,400 people, including women and children. The horrific impact of the attack was viewed all over the world and shortly thereafter Syria agreed in September 2013 to join the Chemical Weapons Convention (CWC). By the end of the following year, Syria’s declared chemical weapons program had been dismantled. Despite this, more than ten years later, Syria’s compliance with the CWC is marred by continued questions on compliance, as incident after incident have emerged of continued use of chemical weapons by the Syrian government.”

“AQ Khan Redux? The Ongoing Risk of Nuclear Proliferation Networks”

Daniel Salisbury offers at the start of this piece for RUSI “The 20th anniversary of the interdiction of nuclear technology that helped to bring down the AQ Khan nuclear proliferation network provides an opportunity to consider the enduring threat posed by nuclear proliferation networks.”

“Black Swans from Mars?”

Valerie Brown discusses the possibility of NASA and ESA’s studies on Mars inadvertently returning to Earth with something alive in this piece for the Bulletin of the Atomic Scientists. She explains “In the next decade, the US National Aeronautics and Space Administration (NASA) and the European Space Agency (ESA) plan to send robots to Mars to retrieve rocks and dust from the red planet for study on Earth. The multibillion-dollar question NASA’s Mars Sample Return (MSR) mission will attempt to answer is one that has intrigued scientists, writers, and the general public for centuries: Has there ever been life on Mars? If there are live organisms in the samples, NASA will be surprised. Several agency officials have suggested that it’s unlikely samples from Mars will contain anything that poses a risk to Earthlings. But one of the primary purposes of the mission is to see if life ever did exist on Mars, and so NASA must prepare for the possibility that something in the samples is … alive. Public interest in that possibility seems likely to become intense.”

“Red Cross Issues Rules of Engagement to War-Focused Hacker Groups, Who Say ‘Why Should I Listen to the Red Cross?'”

Rich Stanton discusses the growing challenges that have arisen as more civilian hackers choose to become involved with cyber attacks targeting states in this piece for PC Gamer. He explains “Russia’s invasion of Ukraine has turbo-charged another aspect to this: civilian hacker groups, sometimes called hacktivists, who are able to get involved in a conflict from anywhere. The International Committee of the Red Cross (ICRC) reckons that this particular conflict has seen unprecedented numbers of civilian hackers get involved and, for the first time, has published rules of engagement for cyber warfare…There are eight rules, including a ban on attacking hospitals, a ban on threatening civilians, and the production of computer viruses that spread uncontrollably…”

NEW: Digital Tools for Disarmament: An Overview of UNIDIR Portals and Databases (Side Event)

This hybrid event will take place on October 18 at 1:15 EDT. Learn more and register here.

NEW: AI for Scientific Discovery – A Workshop

“Join the U.S. National Academies of Sciences, Engineering, and Medicine for a workshop on AI for scientific discovery!”

“The goal for this meeting is to explore the future of AI in terms of its role as an autonomous researcher performing scientific discovery. This includes where AI stands, where it needs to go, and which disciplines should have increased investment for the utilization of AI scientists. Workshop sessions will discuss what it means to be an AI scientist, societal aspects of AI, enablers and hurdles to achieve AI independent scientific discovery, and steps in the direction of an AI grand challenge. The workshop will also explore the ethical aspects and potential pitfalls that loom for AI scientists.”

This event will take place October 12-13 in Washington, DC. Learn more and register here.

Advancing One Health in the United States through Interagency Collaboration

Lessons Learned from the Pediatric Tripledemic: Systems, Staff, Space, and Supplies

Medical Countermeasures-Expanding Delivery and Increasing Uptake Through Public-Private Partnerships Upcoming Workshop Series

“WORKSHOP SERIES: Medical Countermeasures- Expanding Delivery and Increasing Uptake Through Public-Private Partnerships: A Workshop Series
WHEN: October 3, 12, 17, 26, and November 2, 2023

The workshop will be accessible via webinar. Learn more on the project page.”

2nd International One Health Conference

“The One health conceptual framework and the possible contribution from the One Health approach in the urban resilience capacities enhancement will be the core of the congress dialogues.”

“The international One Health Conference 2022 will be in hybrid form from 19 to 20 of October at the Colegio de Medicos in Barcelona.”

Learn more and register here.

2023 EPA International Decontamination Research and Development Conference-“Advancing Preparedness through Science and Collaboration”

“This conference is free and open to the public. Content and presentations are geared towards the emergency response community, including local and state emergency mangers, homeland security officials, first responder coordinators, private sector industry, risk managers, educators in the field of emergency management, and others.”

This event will take place December 5-7 in Charleston, SC. Learn more and register here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

Call for Experts – One Health High-Level Expert Panel (“OHHLEP”)

“The Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Health Organization (WHO), and the World Organisation for Animal Health (WOAH), collectively, the Quadripartite collaboration on One Health, are seeking individuals to serve as experts on the One Health High-Level Expert Panel (OHHLEP).”

“Recognizing the complex and interdisciplinary challenges observed at the interface of human, animal and ecosystem health that require enhanced coordination and collaboration among sectors and agencies, nationally and internationally, in a One Health approach, the Quadripartite established the OHHLEP in 2021 to provide them with scientific advice in their support of Governments to implement and scale up the OH approach. The focus of the OHHLEP is set out in its Terms of Reference.”

“The OHHLEP has just completed its first term. Two annual reports detailing its work as well as several other products can be found here . The second term of OHHLEP will aim to provide advisory support to the Quadripartite in the roll out of the One Health Joint Plan of Action , a framework to integrate systems and capacity to collectively better prevent, predict, detect and respond to health threats. OHHLEP support to the Quadripartite will also include the provision of policy relevant scientific assessments on the emergence and spread of health threats arising at the human-animal-ecosystem interface, and defining OH research gaps.”

“The OHHLEP is interdisciplinary, with experts who have a range of technical knowledge, skills and experience relevant to One Health. The working language of OHHLEP is English.”

Learn more and submit expressions of interest here.

Request for Information: ARPA-H Seeks Ideas for ELSI Initiative

Learn more and submit here.

Pandora Report 9.29.2023

September 29, 2023 by dkellogg97, posted in Pandora Report

This week covers the recent UN political declaration on pandemic readiness, new efforts from the US Government to combat antibiotic resistance, the Sunak ministry’s increasing concerns about the potential misuse of AI to, among other things, aid in biological weapons development, and more. Several new publications and exciting upcoming events are also included. Finally, whether you’re celebrating Chuseok, Tsukimi, Tết Trung Thu, the Mid-Autumn Festival, or perhaps just enjoying tonight’s beautiful moon-have a great holiday weekend!

Join Us on October 5 for a Virtual Schar School Open House

“Prospective students are invited to attend a virtual open house to learn more about the Schar School of Policy and Government and our academic programs. During this online session, you will have the opportunity to hear from our Graduate Admissions Team about the Schar School and applying to graduate and certificate programs, as well as from program faculty about our graduate programs.”

This includes the Biodefense MS, which is available both online and in person.

UN Approves Political Declaration on Pandemic Readiness

This month, after the UNGA held the first of its kind head-of-state summit on pandemic preparedness, global leaders approved a declaration outlining steps to prepare for the next pandemic. According to CIDRAP, “Among several measures, the declaration recognizes the need for member states to finish work on a Pandemic Accord, a legal instrument that would be used to ensure that countries are better prepared to prevent and respond to future pandemics.

“Work on the Pandemic Accord, designed to ease response problems laid bare by the COVID-19 pandemic, has been under way since February 2022, and a final proposal is due in May 2024…Today’s pandemic declaration also covers population sustainable and equitable access to medical countermeasures, steps to address misinformation, protect health systems, strengthen the World Health Organization (WHO), and boost the healthcare workforce and surveillance efforts.”

WHO Director-General Tedros Adhanom Ghebreyesus said in a statement that the declaration was a “historic milestone,” and that “The lived experience of people who suffered through the COVID-19 pandemic must be at the forefront of our minds going forward in order to realize the clear direction provided by world leaders…The devastating impacts of COVID-19 demonstrated why the world needs a more collaborative, cohesive and equitable approach to preventing, preparing for, and responding to pandemics.”

India Battling Nipah Virus Outbreak

An outbreak of Nipah virus is currently on the move in parts of Asia, having spread across India and into other countries including Bangladesh, Malaysia, and Singapore. Nature News reports “In the southern Indian state of Kerala, the bat-borne Nipah virus has infected six people — two of whom have died — since it emerged in late August. More than 700 people, including health-care workers, have been tested for infection over the past week. State authorities have closed some schools, offices and public-transport networks.”

“The Nipah outbreak is the fourth to hit Kerala in five years — the most recent one was in 2021. Although such outbreaks usually affect a relatively small geographical area, they can be deadly, and some scientists worry that increased spread among people could lead to the virus becoming more contagious. Nipah virus has a fatality rate between 40% and 75% depending on the strain, says Rajib Ausraful Islam, a veterinary physician who specializes in bat-borne pathogens at the International Centre for Diarrhoeal Disease Research, Bangladesh, in Dhaka. “Each outbreak is a concern,” he says. “Every outbreak is giving the pathogen an opportunity to modify itself.”’

“The virus can cause fever, vomiting, respiratory issues and inflammation in the brain. It is carried mainly by fruit bats, but can also infect domestic animals such as pigs, along with humans. It spreads through contact with bodily fluids from infected animals or people. There are no approved vaccines or treatments, but researchers are investigating candidates.”

“These three transmission electron microscopic (TEM) images reveal some of the ultrastructural morphology exhibited by the Nipah virus (NiV). The figure at the top depicts a negative stain electron microscopic (EM) image of a single long stranded nucleocapsid. On the bottom left, you see a thin section EM image of a mature virus particle, and the bottom right image depicts a thin section EM image of nucleocapsids show adjacent to the plasma membrane of an infected cell.” | Credit: CDC PHIL

Paul Hunter, a professor of medicine at the University of East Anglia, discussed some of the implications of this outbreak in a piece for the Conversation, writing in part “Although the Nipah virus causes a deadly infection there is no evidence that it is likely to spread widely outside of areas where people or their livestock come into contact with infected bats. However, outbreaks of Nipah virus may be another indication that habitat loss as a result of human incursion forces greater contact between humans and animals increasing the risk of animal-to-human transmission.”

Nature News discussed some ways of addressing this problem, writing “A key step in preventing outbreaks of Nipah and other bat-borne viruses is developing better ways of managing wildlife that lives close to communities, says Andrew Breed, a veterinary epidemiologist at the University of Queensland near Brisbane, Australia. Studies on Hendra virus — another bat-borne pathogen that’s closely related to Nipah — suggest that infected bats shed more virus particles when they’re stressed³, increasing the chance that the disease will spill over into domestic animals, and then on to humans, says Breed. One approach that could go a long way towards heading off future outbreaks is to restore forest areas to improve bat habitats, which would provide them with more a reliable food source and reduce the risk of spillover, says Breed.”

“Another way to reduce the risk of bat-borne diseases spreading to humans is to plant more trees that produce fruit that is appetizing to bats but not to humans, says Islam. This could help to keep infected bats from contaminating food. “We need to learn how to live safely with bats,” he says.”

As of September 22, six people were infected, two of whom are now dead and the rest of which were reported to have recovered early this morning. Nipah virus has a fatality rate somewhere between 40 and 75%.

ARPA-H Announces the Defeating Antibiotic Resistance through Transformative Solutions Project

The US Department of Health and Human Services announced this week via the Advanced Research Projects Agency for Health (ARPA-H) that it will launch a new project aimed at fighting the growing threat of antibiotic-resistant bacteria. AMR infections are a leading cause of death globally, accounting for more than 2.8 million infections in the US annually and over 35,000 deaths, according to the CDC’s 2019 Antibiotic Resistance Threat Report.

ARPA-H said in a statement, “To combat this crisis, ARPA-H is funding through its Open Broad Agency Announcement (Open BAA) the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project. DARTS focuses on developing a set of diagnostic and experimental platforms that that can reveal insights into how antibiotic resistance starts, search for new antibiotics, and rapidly identify the right antibiotic to prescribe for a particular infection in real time.”

“This initiative complements activities funded by other federal research and development agencies by taking a unique approach to develop an ultra-high-speed screening system that analyzes billions of bacteria individually. The technology, if successful, could rapidly identify bacteria that can evade antibiotic treatments and quickly find the right compound to treat a specific infection. The goal is to create a platform that can be easily employed at any hospital or clinic and would advance U.S. government efforts on surveillance and stewardship.”

“DARTS will aid in the stewardship of current antibiotics helping to ensure that patients get the antibiotics they need and not ones that they do not need. This is a critical component of the strategy to preserve the effectiveness of antibiotics over time and slow resistance to these drugs. The DARTS project further aims to serve as a rapid platform for the discovery of new antibiotics from natural samples. Harvard Medical School in Cambridge, Massachusetts leads the multi-institution research team under an agreement of up to $104 million.”

“The ARPA-H Open BAA seeks transformative ideas for health research or technology breakthroughs. Continued support of each award is contingent on projects meeting aggressive milestones. The Open BAA began accepting abstracts in March 2023 and is open until March 2024. Projects will be funded on a rolling basis. To learn more about projects as they are awarded, visit https://arpa-h.gov/engage/baa/awardees/.”

DOD Releases Unclassified Version of 2023 Strategy for Countering Weapons of Mass Destruction

This week, DOD released the unclassified version of its 2023 Strategy for Countering Weapons of Mass Destruction (CWMD). According to the Department, “The 2023 DOD CWMD Strategy seeks to account for current and emerging WMD challenges and threats, and provide tailored methods to address them. The Department will account for WMD threats holistically to prevent, mitigate, withstand, operate through, and recover from WMD attacks in close consultation with Allies and partners.”

‘”This Strategy lays the foundation for the Department to confront the complex and demanding challenges presented by WMD,” wrote Secretary of Defense Lloyd Austin in the Secretary’s Foreword.”

“In line with the 2022 National Defense Strategy, the CWMD Strategy recognizes the People’s Republic of China as the pacing challenge, Russia as the acute threat, and the DPRK, Iran, and violent extremist organizations as persistent threats.”‘

“Recognizing that different actors and threat modalities pose distinct challenges, the CWMD Strategy outlines a strategic approach that requires tailored investments and actions to address each challenge. The CWMD Strategy explains how the Department will align authorities, operations, activities, and investments based on the DoD’s unique current and emerging CWMD needs.”

‘”This Strategy reinforces other guidance provided in the Nuclear Posture Review, the Missile Defense Review, and the Biodefense Posture Review by clarifying the role of the CWMD mission within the Department’s overall approach to integrated deterrence and conflict,” said Secretary Lloyd Austin, “I am confident that the Department possesses the ingenuity and determination necessary to outpace current and future threats.”‘

This strategy replaces the 2014 Strategy for CWMD. It is available here.

UK Government Concerned About AI’s Potential to Create Advanced Weapons, Seek to Build Global Consensus Ahead of November AI Safety Summit

Members of the British government are reportedly touring the world aiming to build consensus over a joint statement warning about rogue actors using AI to cause large-scale death and destruction. This comes ahead of the first AI Safety Summit the UK will host in November that will focus in part on misuse risks, “…for example where a bad actor is aided by new AI capabilities in biological or cyber-attacks, development of dangerous technologies, or critical system interference. Unchecked, this could create significant harm, including the loss of life.”

The Guardian reports that PM Sunak and many in Downing Street are increasingly concerned about these risks and are looking to determine how best to address them through regulation. The same piece explains that “Government sources worry that a criminal or terrorist could use AI to help them work out the ingredients for a bioweapon, before sending them to a robotic laboratory where they can be mixed and dispatched without any human oversight.”

“Several world leaders are due to attend the summit, including Canada’s prime minister, Justin Trudeau, and the French president, Emmanuel Macron. The UK has invited China to attend, but is considering allowing officials from Beijing to attend only part of the summit, amid concern about Chinese espionage in western democracies.”

“Gain-of-Function Pathogen Research is Controversial and Widespread. Can It Be Regulated?”

The Bulletin of the Atomic Scientists’ Matt Field tackles growing public concerns about Gain-of-Function research and challenges in regulating this hot-button topic in this piece. He explains that “Gain of function essentially means giving an organism a new property or enhancing an existing one. In the new study, Georgetown researchers looked at 7,000 English-language scientific papers published between 2000 and 2022 that involved manipulating pathogens. They then selected a representative sample of 488 of the articles to characterize gain-of-function research overall. More than half the publications involved US-affiliated researchers, followed by 21 percent that involved China-affiliated scientists. About a quarter of the studies were related to vaccine development. And less than 1 percent involved pathogens that the Centers for Disease Control and Prevention (CDC) recommends be studied under the highest level of biosafety.”

He further explains the increasingly political nature of this debate, writing “In Florida, Gov. Ron DeSantis, who has made opposition to the public health and scientific establishment his calling card during a bid for the Republican presidential nomination, announced a ban on enhanced potential pandemic pathogen research in May. Other states, including Texas and Wisconsin, are considering their own restrictions.”

“The Georgetown report echoes concerns that new regulations could stifle important research. Gain of function will be difficult to regulate, it argues, because of its use in public health research and because it involves experiments utilizing different technologies and techniques. The study also looked at so-called “loss-of-function” research, which could be affected by new regulations on gain-of-function experiments, even though it doesn’t involve enhancing a pathogen’s capabilities.”

“Congressional Staffers Create Antibiotic-Resistant Bacteria. And That’s a Good Thing”

Allison Berke and Jassi Pannu recently published this piece in the Bulletin of the Atomic Scientists covering programs run by Stanford University and the Institute for Progress that aimed to introduce congressional staffers to synthetic biology because of their involvement in regulating lab work and making biosecurity policy. They explain the rationale for the programs, writing “Despite the COVID-19 pandemic, biosecurity education and training remains a niche activity that has yet to reach the variety of programs or breadth of scholarship that nuclear security has attained in the United States. According to the Peace and Security Funding Map project, 17 US-based organizations received philanthropic funding specifically for nuclear security issues in 2021, while just seven received funding specifically for biosecurity. Funding for biosecurity education and policy-focused work is highly concentrated. It comes from a small handful of funders, and the academic programs receiving the most funding are all in the DC area, limiting the reach of biosecurity-specific programs and courses. Along with task-specific education, such as for health care workers exposed to disease or laboratory personnel working with hazardous pathogens, the COVID-19 response has demonstrated the need for policy makers to have a broader understanding of the technologies they are tasked with regulating and developing, which many have likely never touched.”

Read more about how staffers gained knowledge of a number of pressing topics in this piece available here.

CEPI’s “The Viral Most Wanted”

The Coalition for Epidemic Preparedness Innovations (CEPI) is currently releasing installments of its Viral Most Wanted series. The organization explained this week: “There are 25 or so viral families known to have viruses that can infect people and spark epidemics and pandemics. Follow CEPI’s investigators as we explore these viral threats to humankind; join us as we explore The Viral Most Wanted.”

“Throughout history, disease detectives have been on the hunt for The Viral Most Wanted – mapping out prime suspects in each family, deciphering how they spread, investigating who or what they infect, and, in some cases, using that knowledge to develop protective vaccines.”

“By gathering critical intelligence about these viral families, combining global resources, and harnessing the latest advances in vaccine science, the world can get ahead of the next Disease X threat before it becomes a deadly pandemic.”

“Written by Kate Kelland, CEPI’s Chief Scientific Writer and author of DISEASE X – The 100 Days Mission to End Pandemics, the series seeks to deepen our understanding of the families of viruses that pose the greatest risk to human life.”

“Starting with the Flavivirus and Paramyxovirus families, the hunt begins for The Viral Most Wanted.”

Two entries are now available, one focused on the Paramyxoviruses and one on the Flaviviruses.

“Assessing and Improving Strategies for Preventing, Countering, and Responding to Weapons of Mass Destruction Terrorism, Biological Threats: Proceedings of a Workshop-in-Brief”

From NASEM: “In December 2020, Congress passed the National Defense Authorization Act for Fiscal Year 2021, which includes a request for a National Academies of Sciences, Engineering, and Medicine effort to address the adequacy of strategies to prevent, counter, and respond to weapons of mass destruction (WMD) terrorism, and identify technical, policy, and resource gaps. The assessment encompasses both state-sponsored and non-state actor terrorism and acquisition or misuse of technologies, materials, and critical expertise involved in conducting WMD attacks. In response to this request, the National Academies held a virtual workshop on July 25, 26, and 27, 2022, focusing on attribution, threats of mis- and disinformation campaigns, and policy and programmatic gaps critical for countering biological terrorism. This Proceedings of a Workshop-in Brief provides a summary of the topics addressed at the workshop.”

“How COVID-19 is Reshaping U.S. National Security Policy”

GIT’s Margaret Kosal recently published this article in Politics and the Life Sciences; “In the wake of the COVID-19 pandemic, the United States is actively reshaping parts of its national security enterprise. This article explores the underlying politics, with a specific interest in the context of biosecurity, biodefense, and bioterrorism strategy, programs, and response, as the United States responds to the most significant outbreak of an emerging infectious disease in over a century. How the implicit or tacit failure to recognize the political will and political decision-making connected to warfare and conflict for biological weapons programs in these trends is explored. Securitization of public health has been a focus of the literature over the past half-century. This recent trend may represent something of an inverse: an attempt to treat national security interests as public health problems. A hypothesis is that the most significant underrecognized problem associated with COVID-19 is disinformation and the weakening of confidence in institutions, including governments, and how adversaries may exploit that blind spot.”

“Allied Joint Publication-3.23, Allied Joint Doctrine for Countering Weapons of Mass Destruction in Military Operations”

From the UK Ministry of Defence: “Allied Joint Publication (AJP)-3.23, Allied Joint Doctrine for Countering Weapons of Mass Destruction in Military Operations (Edition A Version 1) provides guidance to military authorities and informs North Atlantic Treaty Organization (NATO) political and civil authorities of their recommended roles in CWMD efforts within a joint and multinational framework…AJP-3.23 issues guidance to NATO commanders and staffs on their CWMD authorities at the strategic and operational level and also informs NATO political and civil authorities of their proposed roles.”

In the Room with Peter Bergen– “Episode 23: 1-on-1 with Robert F. Kennedy, Jr.”

“RFK, Jr.’s views on vaccines and penchant for questioning official narratives have kept him on the fringes of American politics for years. His blistering critiques of the Biden Administration on everything from the pandemic to the war in Ukraine have earned him praise from Republicans. Now, he’s running to beat President Biden in the Democratic primaries. In this lengthy sit-down, Peter probes Kennedy’s unrelenting skepticism about a wide range of issues.”

CNN national security analyst Peter Bergen “probes Kennedy’s unrelenting skepticism about a wide range of topics,” including his infamous opinions on vaccines in addition to those on the war in Ukraine, 9/11, and the moon landing in this episode of his podcast.

A fair warning, however, as this episode includes things like the use of the term “the Ukraine” and multiple statements that are false or offensive in nature, such as this one in which Kennedy compares pandemic restrictions to the Holocaust: “Even in Hitler’s Germany, you could, you could cross the Alps into Switzerland. You can hide in an attic like Anne Frank did. I visited, in 1962, East Germany with my father and met people who had climbed the wall and escaped. So it was possible. Many died doing it, but it was possible. Today, the mechanisms are being put in place that will make it so none of us can run.”

NEW: Advancements and Challenges in Biosafety and Biosecurity Oversight in the United States

From the Harvard Kennedy School’s Belfer Center: “The life sciences are fundamental to driving scientific progress, benefiting everything from public health to agriculture and environmental preservation. Yet, it is vital to recognize and mitigate potential risks, especially in the realms of biosafety and biosecurity. Join us for a discussion with moderator, Dr. Syra Madad with a panel of experts as we dive into the nuances of research oversight policies such as the policies for oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework.”

This online event will take place on October 5 at 10 am EST, and it will feature GMU’s Biodefense Graduate Program Director, Dr. Gregory Koblentz, as a panelist. RSVP here.

NEW: Advancing One Health in the United States through Interagency Collaboration

NEW: Lessons Learned from the Pediatric Tripledemic: Systems, Staff, Space, and Supplies

Medical Countermeasures-Expanding Delivery and Increasing Uptake Through Public-Private Partnerships Upcoming Workshop Series

“WORKSHOP SERIES: Medical Countermeasures- Expanding Delivery and Increasing Uptake Through Public-Private Partnerships: A Workshop Series
WHEN: October 3, 12, 17, 26, and November 2, 2023

The workshop will be accessible via webinar. Learn more on the project page.”

2nd International One Health Conference

“The One health conceptual framework and the possible contribution from the One Health approach in the urban resilience capacities enhancement will be the core of the congress dialogues.”

“The international One Health Conference 2022 will be in hybrid form from 19 to 20 of October at the Colegio de Medicos in Barcelona.”

Learn more and register here.

2023 EPA International Decontamination Research and Development Conference-“Advancing Preparedness through Science and Collaboration”

This event will take place December 5-7 in Charleston, SC. Learn more and register here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

Notice with Comment Period: National One Health Framework To Address Zoonotic Diseases and Advance Public Health Preparedness in the United States: A Framework for One Health Coordination and Collaboration Across Federal Agencies

“The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the draft National One Health Framework to Address Zoonotic Diseases and Advance Public Health Preparedness in the United States: A Framework for One Health Coordination and Collaboration across Federal Agencies (NOHF-Zoonoses). As directed by Congress through the House Appropriations Committee report accompanying the 2021 omnibus appropriations bill and the 2023 Consolidated Appropriations Act, CDC has partnered with the U.S. Department of the Interior (DOI), the U.S. Department of Agriculture (USDA), and other departments and agencies to develop this One Health framework to address zoonotic diseases and advance public health preparedness. This framework will facilitate One Health collaboration for zoonotic disease prevention and control across the United States Government for the next five years. It describes a common vision, mission, and goals for key federal partners involved in implementing a One Health approach to address zoonotic diseases and advance public health preparedness in the United States.”

“You may submit comments, identified by Docket No. CDC–2023–0075 by either of the methods listed below. Do not submit comments by email. CDC does not accept comments by email.”

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

• Mail: RE: NOHF-Zoonoses Public Comments, 1600 Clifton Road NE, Mailstop H16–5, Atlanta, Georgia 30329.

“Instructions: All submissions received must include the agency name (Centers for Disease Control and Prevention) and Docket Number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.”

One Health Day is Coming!

“Initiated in 2016 by the One Health Commission, the One Health Platform, and the One Health Initiative Team, International One Health Day is officially celebrated around the world every year on November 3. The One Health Platform closed its doors in 2021 so One Health Day was overseen in 2021 and 2022 by the One Health Commission and One Health Initiative Autonomous team.”

“The goal of One Health Day is to build the cultural will necessary for a sea change in how planetary health challenges are assessed and addressed and how professionals exchange information across disciplines. One Health Day brings global attention to the need for One Health collaborations and allows the world to ‘see them in action’. The One Health Day campaign is designed to engage as many individuals as possible from as many arenas as possible in One Health education and awareness events and to generate an inspiring array of projects worldwide.”

“Events do not have to fall right on November 3 but can occur anytime during the calendar year.”

Learn more and register events here.

Pandora Report 9.22.2023

September 22, 2023 by dkellogg97, posted in Pandora Report

We’re back! This week we have updates on a few happenings from our break as well as numerous new publications, upcoming events, and announcements. Happy (almost) First Day of Fall!

Kazakhstan Latest Kremlin Bioweapons Disinformation Target

Kazakhstan has joined the ever-growing list of countries targeted by Russia’s constant barrage of bioloigcal weapons-related disinformation. As Wilder Alejandro Sánchez explained in the Diplomat, “A recent fake news post about Kazakhstan in a Russian Telegram channel highlights how Astana must continue to walk a fine line regarding its interactions with Moscow and Washington…A July 21 post by the Telegram channel Baraeva, which has 2,300 followers, originally (and falsely) posted that Astana “has already given the US State Department consent to the relocation of almost 30(!) Pentagon biological laboratories from Ukraine.” The post covers its tracks fast, arguing that it is “waiting for official confirmation,” but still goes on to note that Kazakhstan would become a “biological weapons testing site if the news is true [reminder: it isn’t]. And this is right next to China.”’

“Alexander Kobrinsky, director of Russia’s Agency for Ethno-National Strategy, expanded on the Baraeva post in his own Telegram channel, Cobra, noting that Kazakhstan possesses Soviet-era labs which, “although in a semi-abandoned state, are suitable for the transfer of biological laboratories from Ukraine.” The transfer of these laboratories “is a threat not only to the host country and Russia but also to the whole of Southeast Asia,” including “China… India and Pakistan, [and] the entire Southeast Asia,” warned the Cobra channel. In so doing, it rephrased the Baraeva post, so it appears as if the fake agreement is a fact.”

The piece continues on, analyzing the absurdity of these claims targeting a country Moscow maintains a relatively warm relationship with. It seems nobody is safe from the Kremlin’s BW disinformation machine.

Wisconsin Legislature Considers Banning Gain of Function Research

Some state GOP lawmakers in Wisconsin have co-authored a bill that proposes a ban on gain of function research in response to incidents at the University of Wisconsin-Madison and amid growing similar sentiments in the Republican Party nationally. According to the Wisconsin Examiner, “Bill co-authors — Sen. Andre Jacque (R-DePere), Reps. Elijah Behnke (R-Oconto) and Ty Bodden (R-Hilbert) — stated in a memo that the “risks of these dangerous [gain of function] experiments are not only catastrophic, they are unnecessary.”’

“The University of Wisconsin-Madison has warned lawmakers against such a ban in a letter, saying it would stifle pathogen-related research and result in significant delays and uncertainty even for research that is not prohibited, including research being done to protect Wisconsin’s residents, crops and livestock.”

‘“Viruses mutate very rapidly all by themselves; they do not require humans conducting genetic engineering experiments to make them more lethally infectious,” the lawmakers said.”

Many worry that this will severely weaken the state’s contributions to scientific research and that this measure ignores the existing oversight GoF research has. Tom Still wrote in a piece for the Wisconsin Technology Council-“Wisconsin is Not Wuhan: Don’t Ban ‘Gain of Function Research'”-, “The Wisconsin legislation is a delayed reaction to accidents in 2013 and 2019 involving development of a potentially dangerous bird flu vaccine, and one in 2009 in which a lab broke federal rules by creating a drug-resistant strain of bacteria. The 2009 incident led to fines and the banning of a key scientist for five years. The 2013 and 2019 accidents were communicated properly and the UW-Madison complied with federal inspectors.”

Still continued, writing “These events happened, but what are the regulatory checks and balances today?”

“The UW-Madison has an Institutional Biosafety Committee and an Office of Biological Safety. Some “gain of function” experiments are run through the School of Veterinary Medicine and the Wisconsin Veterinary Diagnostic Lab, focusing on bacteria or viruses that can harm poultry, trigger bovine mastitis and cause blight in potatoes.”

“Federal oversight includes the Select Agent Program, which oversees the possession, use and transfer of many biological agents and toxins, and the National Institutes of Health Office of Science Policy. The Center for Disease Control also shares in the oversight, which was evident in a recent investigation of a mysterious biolab with Chinese ties near Fresno, Calif. In short, internal and national reporting requirements are stringent.”

“Compare that to the black hole of information about Wuhan Institute for Virology, where Chinese authorities blocked investigations by the World Health Organization and others.”

He finished with an important question and call for existing oversight to be strictly enforced: “Let’s suppose that concern is real. What’s worse? Waiting for a foreign pathogen release, either accidental or deliberate, or allowing U.S. scientists to continue precautionary work?”

“Many safeguards are in place for “gain of function” research, and they should be strictly enforced. An outright ban on experiments in one state out of 50 causes more problems than it purports to solve.”

US Scraps DEEP VZN

In related news, the US government also recently ended the Discovery & Exploration of Emerging Pathogens – Viral Zoonoses (DEEP VZN) program. Matt Field covered this in the Bulletin of the Atomic Scientists, writing “Back in 2009, the US government initiated a controversial $200 million program to identify new viruses in animals that might jump the species barrier and spark human pandemics. Although the Trump administration unceremoniously ended the PREDICT program in 2020, the US Agency for International Development (USAID), which managed the effort, subsequently proceeded to double down on the virus-hunting strategy. DEEP VZN, an initiative begun in 2021, was supposed to go beyond the roughly 1,000 viruses that its predecessor had found and identify up to 12,000 new viruses in wild and domestic animals, sequencing the genomes of those that “pose the most risk to animal and human health.” The idea was to find dangerous pathogens before they cause problems.”

“But the critics of this type of predictive virus hunting—who see it as wasteful or dangerous—seem to have finally nudged the government toward their view. The UK medical journal The BMJ reported Thursday that USAID quietly wound down the DEEP VZN virus-hunting juggernaut over the summer.”

“USAID confirmed to the Bulletin that it began shuttering DEEP VZN as it assessed its “priorities and approach to pandemic preparedness,” an agency spokesperson said in a statement. “As a result, USAID and Washington State University began working together in July 2023 to end the DEEP VZN cooperative agreement.”’

“The agency’s years-long approach of partnering with organizations and researchers in far-flung corners of the world to seek out new viruses in animals was predicated on a seemingly obvious idea: By finding and characterizing viruses, researchers could understand which pathogens were poised to “spill over” to humans before an outbreak or pandemic began. Researchers could then monitor for dangerous viruses broadly. But critics argued this concept of pandemic prediction was inefficient and risky. By uploading to the web—as PREDICT has done—the genetic makeup of new viruses, the government could inadvertently offer up the recipes for potential bioweapons to terrorists or other bad actors.”

University of Birmingham PhD Student Allegedly Worked to Create Chemical Weapons Drone for IS

Late last month, a PhD student at the University of Birmingham reportedly “…plotted to supply Islamic State terrorists with a drone capable of delivering a bomb or chemical weapon, a terror trial jury has heard,” according to the Coventry Telegraph.

The same article explained: “Opening the Crown’s case, prosecutor Michelle Heeley KC told the court: “His home was searched and police found a drone. They also found material suggesting this defendant supported Islamic State, a terrorist organisation.”‘

“The court heard Al-Bared, who lived with his parents, was arrested while driving at the same time as the raid took place, and had a mobile phone which police also seized. A 3D printer, which could be used to make parts for the drone, was also found at the home of Al-Bared, who was studying for a PhD at the University of Birmingham, the court heard.”

“Written material saying the idea for the drone was ‘somewhat inspired by the design of the Tomahawk missile’ was put before the jury, in what the Crown claims was Al-Bared describing his build process. Of the evidence found on an electronic device, which also included reference to fuses, mechanical detonators and an explosive head, Ms Heeley added: “He is literally reporting back to someone about what it is that he is doing.”

“Public Health Position Available: Low Pay. Promise of Burnout and Harassment. Master’s Preferred.”

Biodefense PhD student and current Bulletin Editorial Fellow with the Bulletin of the Atomic Scientists recently published this piece discussing challenges in growing the United States’ public health workforce. She writes in her introduction, “Will there be another pandemic after COVID? Considering that there have been at least four major international disease crises in the last 20 years alone—plus a number of smaller but still serious outbreaks—smart money would say, “yes.” But a look at trends in the US public health workforce, at first glance, suggests that government agencies have taken the opposite bet. The state and local health departments responsible for disease surveillance, vaccination campaigns, and assistance in natural disasters like wildfires or hurricanes are hemorrhaging workers, with an additional 130,000 at risk of leaving the profession by 2025. Unless something changes soon, there will be too few new employees to backfill empty positions—or to make up for the loss of invaluable institutional knowledge.”

Journal of Science Policy & Governance, Special Issue-Policy and Governance on Science, Technology and Global Security

The Journal of Science Policy & Governance recently published a special issue in partnership with the APS Forum on Physics and Society, titled “Policy and Governance on Science, Technology and Global Security.” Multiple Schar School students, alumni, and staff published their work in this issue. These include Lewis Grant (Biodefense MS ’23), “Revisiting Presidential Nuclear Autonomy”; Layla M Hashemi (Public Policy PhD ’20 and current researcher at the Schar School’s Terrorism, Transnational Crime and Corruption Center), “Advertising with Anonymity and Impunity: The Harmful Consequences of Counterfeit PPE Supply Chains”; and Aishwarya Sriraman (Biodefense PhD Student), “Optimizing Chemical Agent Medical Countermeasures in the Strategic National Stockpile”.

“China’s Quest for Human Genetic Data Spurs Fears of a DNA Arms Race”

The Washington Post‘s Joby Warrick and Cate Brown recently published this article discussing how one Chinese company amassed even more genomic information throughout the COVID-19 pandemic. They explain “That collection effort, underway for more than a decade, has included the acquisition of U.S. genetics companies as well as sophisticated hacking operations, U.S. and Western intelligence officials say. But more recently, it received an unexpected boost from the coronavirus pandemic, which created opportunities for Chinese companies and institutes to distribute gene-sequencing machines and build partnerships for genetic research in places where Beijing previously had little or no access, the officials said.”

This detailed article identifies several key facts and goes in-depth on the network BGI Group has built in recent years, providing important context to growing concerns about the PRC’s access to this kind of information.

“The Biodefense Posture Review Needs Focus to Succeed”

Al Mauroni’s recent piece for War on the Rocks tackles historical and current challenges in properly focusing government biodefense efforts. He writes in part, “As the first of its kind, the Biodefense Posture Review does not examine military biodefense capabilities and does not illuminate the department’s readiness posture. Instead, it obfuscates the department’s biopreparedness concepts, takes authorities away from military agencies that address biological threats, and calls for duplicating efforts of other government agencies that have significant national biopreparedness roles.”

“The Cyber-Biosecurity Nexus: Key Risks and Recommendations for the United States”

Abi Olvera recently published this briefer with the Council on Strategic Risks’ Nolan Center. It “…provides an overview of the trends and critical risks at the nexus of cybersecurity and biosecurity. It then offers high-level recommendations for addressing these risks.”

Olvera writes in part, “Whether to deny service, steal intellectual property, or propagate disinformation, countries such as Russia and North Korea have shown their willingness and ability to conduct malicious cyber activities through times of crisis and relative repose. Attacks on critical infrastructure, biotechnology enterprises, and medical research institutions highlight the need to prioritize prevention, improve detection, and scale national response mechanisms amidst the growing sophistication of malicious actors at this nexus. Such issues, which are increasingly referred to as “cyber-biosecurity” risks, have become a new toolset in the growing sub-threshold arsenals of those that oppose the rules-based international order.”

“A New Species of Trouble: Strengthening Capacity and Capability for the Identification, Attribution, and Consequence Management of Accidental and Deliberate Pathogen Releases in Africa”

New from Brown’s School of Public Health’s Pandemic Center, this policy brief provides a roadmap for preparing for the release of a deadly biolgoical agent. Its executive summary explains “Determining the origin of disease outbreaks and developing effective protocols based on the specific cause is critical to controlling the spread of disease and protecting human, animal, and environmental health and welfare as well as economies and national security. Many African countries have policies to address naturally occurring outbreaks. However, African countries are by no means alone in lacking the tools to identify and manage incidents caused by accidental or deliberate pathogen release. Recent growth in laboratory systems and widespread access to innovative but potentially dangerous technologies is creating a new species of trouble requiring a re-evaluation of the threat landscape. This policy brief, focused on Africa, discusses established protocols and measures aimed at preventing and containing outbreaks. It then takes a broad approach by recommending policies related to assessment and handling of accidental and deliberate pathogen releases as an integral part of existing outbreak protocols. The proposals provide specific strategies for surveillance, rapid response, containment, investigation, and mitigation of these human-made outbreaks, emphasizing strong biosafety and biosecurity measures. They further emphasize the importance of training, capacity building, collaboration (including collaboration in developing diagnostics and medical countermeasures), and early warning mechanisms. To further support the guidelines, the authors recommend establishing national multidisciplinary outbreak assessment units and consequence-management systems, capacity building of relevant security and law enforcement personnel, and sustainable domestic financing. The authors recommend piloting the guidelines outlined in this policy brief. Adopting the proposed strategies and instituting needed support structures will improve countries outbreak assessment and response capabilities and thus mitigate the health and economic consequences of accidental or deliberate infectious disease outbreaks.”

“Anthrax Revisited: How Assessing the Unpredictable Can Improve Biosecurity”

New from Sabra et al.: “B. anthracis is one of the most often weaponized pathogens. States had it in their bioweapons programs and criminals and terrorists have used or attempted to use it. This study is motivated by the narrative that emerging and developing technologies today contribute to the amplification of danger through greater easiness, accessibility and affordability of steps in the making of an anthrax weapon. As states would have way better preconditions if they would decide for an offensive bioweapons program, we focus on bioterrorism. This paper analyzes and assesses the possible bioterrorism threat arising from advances in synthetic biology, genome editing, information availability, and other emerging, and converging sciences and enabling technologies. Methodologically we apply foresight methods to encourage the analysis of contemporary technological advances. We have developed a conceptual six-step foresight science framework approach. It represents a synthesis of various foresight methodologies including literature review, elements of horizon scanning, trend impact analysis, red team exercise, and free flow open-ended discussions. Our results show a significant shift in the threat landscape. Increasing affordability, widespread distribution, efficiency, as well as ease of use of DNA synthesis, and rapid advances in genome-editing and synthetic genomic technologies lead to an ever-growing number and types of actors who could potentially weaponize B. anthracis. Understanding the current and future capabilities of these technologies and their potential for misuse critically shapes the current and future threat landscape and underlines the necessary adaptation of biosecurity measures in the spheres of multi-level political decision making and in the science community.”

“The Danger of ‘Invisible’ Biolabs Across the U.S.”

Dan Greene, Jassi Pannu, and Allison Berke recently published this piece discussing patchwork biosecurity regulations in the US and gaps in oversight, explaining in part “…bio labs in the U.S. fall through the cracks of government oversight if they are privately operated (i.e., not academic or government), do not receive funding from the government, and are not working with select agents. These “invisible” labs have much more leeway to work with pathogens that are not select agents but could still cause outbreaks, severe illness, and death—a category that includes some of the ones that the Reedley lab acquired. A forthcoming report by Gryphon Scientific, the biosafety and public health consultancy where one of us works, estimates that about ¼ of human pathogen research activities in the U.S. are performed by labs inside of private organizations, and about ¼ of those private organizations are “invisible.”’

“Impact Assessment of Research on Infectious Agents”

The American Society for Microbiology recently published this workshop summary. It explains in part “Infectious agents are a major source of death and disease worldwide. Research with infectious agents has provided many societal benefits but also has introduced concerns about the potential for negative impacts of modified pathogens on public health. There is an ongoing debate about what oversight, regulations and, potentially, legislative provisions are needed for a small subset of research with infectious agents commonly called gain of function research of concern (GOFROC) or enhanced potential pandemic pathogen (ePPP) research.”

“To develop a deeper scientific understanding, gathered from different perspectives of leading scientists who possess expertise on this issue, the American Society for Microbiology hosted a workshop. The goal of the event was to review the benefits and risks of GOFROC or ePPP research to science and society. The deliberation prompted 3 overarching recommendations from participants:

The need for standardized research terminology and practices.
Increased engagement and transparency with the public on infectious agents research.
Strengthened biorisk management systems for safe, secure and responsible research.”

“Homeland Threat Assessment 2024”

The Department of Homeland Security’s Office of Intelligence and Analysis recently released its annual homeland threat assessment that covers several broad areas of homeland security, including a section dedicated to foreign misinformation, disinformation, and malinformation. “The Department of Homeland Security (DHS) Intelligence Enterprise Homeland Threat Assessment reflects insights from across the Department, the Intelligence Community, and other critical homeland security stakeholders. It focuses on the most direct, pressing threats to our Homeland during the next year and is organized into four sections. This assessment is organized around the Department’s missions that most closely align or apply to these threats—public safety, border and immigration, critical infrastructure, and economic security. As such, many of the threat actors and their efforts cut across mission areas and interact in complex and, at times, reinforcing ways.”

“Chemical Weapons: Status of Forensic Technologies and Challenges to Source Attribution”

New from the US Government Accountability Office: “Despite the Chemical Weapons Convention’s ban on their use, chemical weapons have been used in the past decade in assassinations and on civilian populations. To identify the use of a chemical weapon and then attribute that weapon back to its source, researchers rely on several technologies for chemical analysis. Chemical analysis is one piece of an overall chemical weapon investigation.”

“This report discusses (1) the status of key technologies available to identify a chemical agent or its source, including their strengths and limitations; (2) challenges researchers and investigators face in trying to identify a chemical agent or its source; and (3) policy options that may help address the challenges of using key technologies to identify a chemical agent and its source.”

“To conduct this technology assessment, GAO reviewed key reports and scientific literature; interviewed government, intergovernmental, and academic representatives; conducted site visits; and convened two meetings of experts with the assistance of the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report.”

“Conducting Public Health Workshops in Ukraine–Under Threat of Missile Attack”

Filippa Lentzos recently published this piece with the Bulletin of the Atomic Scientists in which she discusses her experience running training workshops in Ukraine for public health officials and laboratory leads. She writes, “I was in Ukraine to run a series of training workshops for laboratory leads and public health officials. Designed with my King’s College London colleague Gemma Bowsher, the workshops focused on responding to bio-incidents—part of a US Agency for International Development (USAID)-funded project run through the Swiss Centre for Tropical and Public Health. The war has drawn increased political attention to ambiguous disease outbreaks in which it is unclear whether the incident is natural, accidental, or deliberate in origin; the workshops were in part a response to that attention.”

“The unfolding outbreak of Legionnaire’s Disease in Rzeszow, Poland, a small town turned logistical war hub for the West, is a good example. The outbreak—already infecting several dozens by the time I whizzed past on my way to Ukraine—is most likely of natural in origin. But with this bacterial pneumonia spreading through the water network (as it does all over Europe on occasion), there was concern that, in the context of continuous hybrid warfare attacks, the outbreak could be the result of sabotage meant to sow panic among Ukraine’s allies. Unfounded rumors of Russian responsibility were already circulating.”

“Avian H5N1 Flu Deaths are Marching Forward (The Beat Goes On)” and “Commentary: New Avian Flu Attacking More than Birds”

Lynn Klotz, a senior science fellow at the Center for Arms Control and Non-Proliferation, has provided updates and continuations of his June work discussing a highly transmissible H5N1 virus-“Avian H5N1 Flu Deaths are Marching Forward (The Beat Goes On)” and “Commentary: New Avian Flu Attacking More than Birds”. In them, he explains “Before the year 2015, the H5N1 bird flu virus killed over 52% of poultry workers and others who had close contact with infected poultry. Fortunately, the virus was rarely transmissible among humans. From 2015 to 2020, avian H5N1 fatalities in humans had almost disappeared, since the strains from nature that appeared in poultry markets were no longer deadly to humans. They were, so to speak, “defanged.” We thought we were finished with H5N1 bird flu. We thought we were in a good place.”

In the latter, he explains “Since 2021, we are facing a new threat to birds and mammals, a deadly and highly transmissible H5N1 bird flu virus. Worldwide, this new virus is responsible for the death of and purposeful culling of nearly a billion poultry birds; and according to one estimate, the deaths of 10 million wild birds. Recent deaths of large numbers of birds and a much smaller number of deaths of mammals who otherwise would be alive is alarming and sad.”

“What is the danger of the new H5NI bird flu virus to humans? So far, there have been almost no human fatalities. A protein called BTN3A3 protects humans from the virus. Analysis for the BTN3A3 genes of some primates that include humans, which separated in evolution around 40 million to 44 million years from other primates, show that humans have the gene that makes the BTN3A3 protein. The other primate group does not make the protein. So, an accident of genome evolution that occurred millions of years ago protects us from the new avian flu virus, an extraordinary bit of luck. It is possible but not yet probable that the virus could begin to infect humans too.”

“Perhaps a hundred species of mammals, which don’t usually reside on the seacoast, have been infected, and the number is growing. One recent example is noteworthy: an infected mountain lion in the state of Montana. But Montana is not on the seacoast, how did the mountain lion become infected? We don’t really know. For whatever reasons, infected mammals are found far inland. and the numbers of species and the number of animal deaths keep growing. The beat goes on.”

“A Virtual Dialogue Between Animal Health and Public Health Experts on Dual-Use Research”

“Life sciences research and associated technologies play a critical role in improving global public health supporting healthier populations worldwide and promoting health equity for all to achieve the health related United Nations Sustainable Development Goals (SDGs). Likewise, advances and innovation in the life sciences are essential for animal and plant health, for veterinary medicine and agriculture, and the environment. However, developments and advances in this field may also pose safety and security risks caused by accidents, as well as inadvertent and deliberate misuse to cause harm”

“A virtual dialogue between animal health and public health experts was co-organized by the World Health Organization (WHO) and the World Organisation for Animal Health (WOAH) on 14 March 2023 to discuss experiences in working with dual-use research, the different perspectives and challenges associated with the oversight of dual-use research and key considerations and priorities for governing dual-use research within the context of One Health.”

“The dialogue facilitated the exchanges of experiences and perspectives on dual-use research and challenges associated with its oversight and allowed participants to raise issues and suggestions for joint actions at the global level. Follow-up actions could include the organization of a second dialogue with additional stakeholders from the One Health approach to discuss and agree on joint actions for the governance of dual use research; the joint development of key common lines of communication at international level (e.g., for WOAH and WHO to raise awareness on the governance of dual-use research) and cross-referencing relevant guidance and activities; the joint development of tools to strengthen the governance of dual-use research such as educational tools, advocacy and awareness raising tools in the context of One Health; the joint mobilization of resources to achieve common goals; and to explore the establishment of a mechanism to report biorisks and dual-use issues to enhance public trust. This dialogue is intended to be the beginning of a continuing discussion bringing together different organizations, sectors and perspectives to reach a concerted One Health approach on the governance dual-use research.”

The Era of Global Risk: An Introduction to Existential Risk Studies

“This innovative and comprehensive collection of essays explores the biggest threats facing humanity in the 21st century; threats that cannot be contained or controlled and that have the potential to bring about human extinction and civilization collapse. Bringing together experts from many disciplines, it provides an accessible survey of what we know about these threats, how we can understand them better, and most importantly what can be done to manage them effectively.”

“These essays pair insights from decades of research and activism around global risk with the latest academic findings from the emerging field of Existential Risk Studies. Voicing the work of world leading experts and tackling a variety of vital issues, they weigh up the demands of natural systems with political pressures and technological advances to build an empowering vision of how we can safeguard humanity’s long-term future.”

“The book covers both a comprehensive survey of how to study and manage global risks with in-depth discussion of core risk drivers: including environmental breakdown, novel technologies, global scale natural disasters, and nuclear threats. The Era of Global Risk offers a thorough analysis of the most serious dangers to humanity.”

“Inspiring, accessible, and essential reading for both students of global risk and those committed to its mitigation, this book poses one critical question: how can we make sense of this era of global risk and move beyond it to an era of global safety?”

NEW: Medical Countermeasures-Expanding Delivery and Increasing Uptake Through Public-Private Partnerships Upcoming Workshop Series

“WORKSHOP SERIES: Medical Countermeasures- Expanding Delivery and Increasing Uptake Through Public-Private Partnerships: A Workshop Series
WHEN: October 3, 12, 17, 26, and November 2, 2023

The workshop will be accessible via webinar. Learn more on the project page.”

NEW: 2nd International One Health Conference

“The One health conceptual framework and the possible contribution from the One Health approach in the urban resilience capacities enhancement will be the core of the congress dialogues.”

“The international One Health Conference 2022 will be in hybrid form from 19 to 20 of October at the Colegio de Medicos in Barcelona.”

Learn more and register here.

No Checkered Flag: The Perpetual Race Against Biological Threats

From the Bipartisan Commission on Biodefense: “The Commission’s next meeting, No Checkered Flag: The Perpetual Race Against Biological Threats, will be held on September 27, 2023 in Indianapolis, Indiana. The meeting will take place at the historic Indianapolis Motor Speedway, the home of the Indianapolis 500.”

“The focus of this meeting will be to provide the Bipartisan Commission on Biodefense with a better understanding of: (1) state and local efforts to strengthen public health and biodefense; (2) special security management of biological threats to mass gatherings; and (3) efforts to understand and mitigate the agricultural impact of biological threats to plants and animals.”

This all-day event will take place in Washington, DC on September 27 at 9 am EST. Learn more and register here.

Women Building Bio: Building Better

“Virginia Bio’s Women Building Bio Conference celebrates the contribution of women to the life sciences in the Commonwealth and beyond. The 8th annual conference theme, Building Better, will prompt us to explore how life sciences contribute to building a better future and highlight the increasingly significant role of women in it.”

This event will take place from 8:30-4 pm in Manassas, VA on September 28. Register here.

2023 EPA International Decontamination Research and Development Conference-“Advancing Preparedness through Science and Collaboration”

This event will take place December 5-7 in Charleston, SC. Learn more and register here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

“You may submit comments, identified by Docket No. CDC–2023–0075 by either of the methods listed below. Do not submit comments by email. CDC does not accept comments by email.”

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

• Mail: RE: NOHF-Zoonoses Public Comments, 1600 Clifton Road NE, Mailstop H16–5, Atlanta, Georgia 30329.

One Health Day is Coming!

“Events do not have to fall right on November 3 but can occur anytime during the calendar year.”

Learn more and register events here.

The Pandora Report is Taking a Break!

August 25, 2023 by dkellogg97, posted in News

The Pandora Report is going on a brief hiatus. We’ll see you soon!

Pandora Report 8.18.2023

August 18, 2023 by dkellogg97, posted in Pandora Report

This week’s edition covers the recently released Biodefense Posture Review from the Department of Defense, CDC’s looming budget cuts, and an illegal lab uncovered in Reedley, CA. Several recent publications, exciting upcoming events, and announcements are also included.

DOD Releases Biodefense Posture Review

The Department of Defense released its much anticipated Biodefense Posture Review (BPR), crafted under the leadership of the Under Secretaries of Defense for Policy and Acquisition and Sustainment. DOD’s press release reads in part, “We’re increasing collaboration and synchronizing efforts across the DOD enterprise—everything from policies and authorities, to research, acquisition, and investments—to meet the department’s biodefense requirements,” said William LaPlante, Under Secretary of Defense for Acquisition and Sustainment. “One of the most important reforms in the Biodefense Posture Review that we have already institutionalized is the Biodefense Council.”

“The Biodefense Council will build on the intense collaboration of the DOD biodefense enterprise over the past several years and will synchronize and integrate authorities and responsibilities to provide a more empowered and collaborative approach to biodefense.”

‘”The Biodefense Posture Review and the Biodefense Council will further enable the Department to deter biological weapons threats and, if needed, to operate in contaminated environments,” said John Plumb, Assistant Secretary of Defense for Space Policy. He adds, “As biological threats become more common and more consequential, the BPR’s reforms will advance our efforts not only to support the Joint Force, but also to strengthen collaboration with allies and partners.”‘

Biodefense Graduate Program alumna and assistant professor Saskia Popescu offered her comments on the BPR to the Council on Strategic Risks, saying “Ensuring agile preparedness and response measures through pathogen-agnostic means is a critical strategy for rapidly addressing emerging and evolving biological threats. From strengthening the Biological Select Agents and Toxins Biorisk Program through training and bias-reduction, to ensuring the capacity to characterize a biothreat within one week of sample acquisition, the emphasis within the Biodefense Posture Review on modernizing capabilities underscores the multifaceted response needed to address the complex threat landscape and the investments necessary to mitigate risk.”

“Perhaps one of the most challenging aspects of responding to a biological incident is cohesive and engaged partnerships across agencies and stakeholders. The Biodefense Posture Review directly calls out the need to strengthen these relationships through not only collaborative engagement with allies, but also interagency exercises that ensure alignment and role clarity.”

DOD summarized the findings of the BPR, stating “The BPR emphasizes the need for the combatant commands and services to improve readiness through training and exercises to identify and report capability shortfalls, aiding in the prioritization of the department’s modernization efforts.”

CDC Facing $1.5 billion Budget Cut

The CDC is facing about $1.5 billion in budget cuts as a result of the July debt ceiling negotiations, totaling about 10% of the agency’s total budget. STAT News explains the challenges this will likely pose beyond staffing, writing “What few realize is that more than three-quarters of the CDC budget goes to the states and contract research organizations in the form of public health and prevention activities by state and local health organizations and agencies, national public health partners and academic institutions. Among the many tasks undertaken by the CDC are those for surveillance, detection and mitigation of diseases ranging from sexually transmitted infections such as syphilis, chlamydia, gonorrhea, and trichomoniasis to viral pathogens like those causing influenza, SARS, MERS, Ebola and Covid-19.”

“One glaring example of why there is a need for more, not less, CDC public health services is Mississippi’s 900% increase in cases of congenital syphilis over the past six years. Congenital syphilis is associated with the rapid rise in the number of stillbirths and infant deaths, both directly attributable to inadequate prenatal health care. If the CDC is unable to meet the current demands for controlling a well-studied disease like syphilis with current budget resources, it will be woefully unable to prepare for, much less deal with, the next vector or food-borne illness. It is not a question of whether such an illness will occur; it is simply a question of when.”

Illegal Laboratory Uncovered in California

Last week, the agricultural city of Reedley in Fresno County, CA reported that its lone full-time code enforcement officer discovered a particularly shocking violation: an illegal, Chinese-owned laboratory in a warehouse. According to the AP: “Jesalyn Harper, the only full-time code enforcement officer for the small, agricultural city of Reedley in California’s Central Valley, was responding to a complaint about vehicles parked in the loading dock of a cold-storage warehouse when she noticed a foul smell and saw a garden hose snaking into the old building.”

“A woman in a lab coat answered her knock, and behind her were two others in plastic gloves and blue surgical masks, packing pregnancy tests for shipping. Harper said they spoke broken English and told her they were from China. Walking through the lab, she found dozens of refrigerators and ultralow-temperature freezers hooked to illegal wiring; vials of blood and jars of urine in shelves and plastic containers; and about 1,000 white lab mice being kept in crowded, soiled containers.”

“The women said the owner lived in China, provided a phone number and email address and asked her to leave. Alarmed by what she saw, Harper, whose work mostly entails ensuring people have permits for yard sales and are keeping their lawns mowed, contacted Fresno County health officials and then the FBI.”

Fresno’s ABC30 wrote, ‘”I am mighty proud of our little city, this was a bad player company, a bad actor company that was kicked out of Canada, they went to Texas, they got kicked out of Texas, they came to California, they went to Fresno, kicked out of Fresno went to Tulare, kicked out of Tulare went back to Fresno, kicked out of Fresno, came to Reedley,” said Reedley City Manager, Nicole Zieba.”

“Scientific and Technological Developments: Benefits and Risks for the Biological Weapons Convention”

“This report encapsulates the outcomes of the two-day conference entitled ‘Scientific and Technological Developments: Benefits and Risks for the Biological Weapons Convention’ held in October 2022 in New Delhi, India. It was organised by the UNODA in partnership with the Manohar Parrikar Institute for Defence Studies and Analyses (MP-IDSA). The Conference’s primary objective was to review developments in science and technology relevant to the Biological Weapons Convention (BWC) and to prepare for the Ninth BWC Review Conference.”

“The Conference report provides expert insights on the evolving science and technology landscape in the context of the BWC, including in the fields of synthetic biology, public health responses, neurotechnology and digitalization.”

“ChatGPT Could Make Bioterrorism Horrifyingly Easy”

Jonas Sandbrink recently published this piece with Vox, explaining “Advances in artificial intelligence have tremendous potential to have positive impacts on science and health. Tools like ChatGPT are revolutionizing how society works and learns, and artificial intelligence applied to biology has led to solving the decade-old protein folding problem and is transforming drug discovery. However, as artificial intelligence raises the ceiling of biological engineering and helps distribute these powers to a tremendous number of individuals, there is a serious risk that it will enable ill-intentioned actors like Aum Shinrikyo, to potentially devastating effect. As I have discussed in a recent preprint paper, large language models (LLMs) like ChatGPT, as well as novel AI-powered biological design tools, may significantly increase the risks from biological weapons and bioterrorism.”

“Blood Simple. Several Russian Journalists and Activists Were Poisoned in Europe.”

Michael Weiss’ writes’ piece for The Insider opens with “Elena Kostyuchenko, Natalia Arno, and Irina Babloyan, have long worked to expose the Kremlin’s lies. While traveling through Europe in the last year, each was poisoned by unknown toxins. Their cases remain unsolved. Why?”

“JPEO-CBRND Embraces the Need for Speed in Biodefense: How JPEO is Shaping its Biological Defense and Medical Strategies”

The Army recently released this article discussing JPEO-CBRND’s efforts to improve national public health emergency responses. It explains “JPEO-CBRND’s Joint Project Lead for CBRN Defense Enabling Biotechnologies (JPL CBRND EB) has led a significant investment in platform technologies and programs to improve preparedness for future threats. Platform technology refers to the use of standardized processes and tools to rapidly develop and manufacture MCMs in response to a threat. This approach is like setting up an assembly line that can be turned on when needed, rather than building the line from scratch each time a product is required. The goal is to have the ability to quickly develop and manufacture MCMs in response to a threat.”

“In addition to the use of platform technologies, another practice to ensure rapid development of MCMs is to quickly pivot from a prototype to a product that can be distributed in compliance with U.S. Food and Drug Administration (FDA) regulations for emergency use. This puts safe and effective medicines and drugs into the hands of warfighters faster, leveraging processes such as emergency use authorization (EUA) on the path to full FDA licensure, since the licensure process can take nearly decades for countermeasures to be available.”

“GCBR Organization Updates – August 2023”

This quarterly newsletter “aims to provide…updates from organizations working to reduce global catastrophic biological risks (GCBRs).” It includes updates from 1Day Sooner, CLTR, Convergent Research, CSR, Effective Giving, Gryphon Scientific, IFP, CHS, NTI bio, Open Philanthropy, and SecureBio.

“In Conversation with David P. Fidler (CFR) on the Proposed Pandemic Treaty, Global Health, and India”

Animesh Roul interviews David P. Fidler in this piece for the Society for the Study of Peace and Conflict. It explains in part, ‘”I do not think a pandemic treaty is a good response to the COVID-19 pandemic. Nothing in the WHO-sponsored negotiation process so far has changed my perspective,” says global health expert David P. Fidler, Senior Fellow at Council on Foreign Relations (CFR) and the author of “A New U.S. Foreign Policy For Global Health: COVID-19 and Climate Change Demand a Different Approach” (June 2023). Animesh Roul asked Mr Fidler about the proposed global accord on pandemic prevention, preparedness and response; key challenges before the proposed treaty, including the much-emphasized accountability framework; geopolitics; and the possible role of India in the negotiation process and beyond.”‘

IDA Health Watch – Issue 5

“In this issue of IDA Health Watch, Rear Adm. Paul Reed, Deputy Assistant Secretary for Health and Director of the Office of Disease Prevention and Health Promotion, discusses resilience in the post-pandemic world, the Healthy People 2030 initiative and the trajectory of communications strategy in public health. Other articles comment on current recruiting challenges, interventions targeting the fitness of recruits, and the vital conditions framework and foreign influences.”

“ARPA-H Should Zero In on Pandemic Prevention”

In this recent piece for Issues in Science and Technology, Jassi Pannu, Janika Schmitt, and Jacob Swett write “With a smaller budget than hoped for, ARPA-H must focus. Here’s how the new agency can synergize existing government efforts and advance breakthrough technologies that protect us all.”

“Shaping Health Security: In Conversation with UKHSA’s Chief Scientist”

UK Health Security Agency Chief Scientists Isabel Oliver discusses the agency’s recently released science strategy in this interview for Civil Service World, writing in part “Our mission in the UK Health Security Agency is to protect people from infectious diseases and environmental hazards – that is radiation, chemical, extreme weather events. To do this, we need to generate and apply the best scientific evidence. We need to detect threats, we need to understand them and the risks they pose to our health. But also importantly, we need to understand how to best protect health from those. We can only do that through our scientific activities.”

“The other important aspect of this is that UKHSA was established from a pandemic and in the middle of a pandemic. So we’ve been doing a lot of reflection about what must be learned from the pandemic, and how to secure the legacy. There were a number of areas that we know had to be strengthened or developed very quickly during the pandemic – one example is genomic surveillance. We’re very keen to make sure that we learn from that experience, but also that we build on the capabilities that were strengthened during the pandemic. We’ve got a really tough job to do because unfortunately, we live in a context where the risk from pandemics and other threats to health is increasing because of factors such as climate and environmental change, for example.”

“The Monkeys Who Died to Fight COVID”

This Texas Monthly piece discusses the work done at the Texas Biomedical Research Institute in San Antonio and controversy surrounding its work with primates. It explains in part, “When weighing the risk of emerging global health crises against the accumulated suffering of research animals, judgments about the proper balance are inevitably subjective. Even before Pfizer reached out in early 2020 about testing its COVID-19 vaccine, Texas Biomed’s virologists, immunologists, and geneticists had already begun studying the novel coronavirus. Researchers infected dozens of primates—including baboons, macaques, and marmosets—with the pathogen to observe the course of the disease. These animals endured the little-understood effects of COVID to help determine which species would be best suited for testing the anticipated treatments to come. All the infected animals were eventually euthanized.”

“The Secret to Preventing the Next Pandemic Might Be in Our Poop”

Jackie Flynn Mogensen recently published this piece on wastewater surveillance in Mother Jones. She writes ‘“Wastewater surveillance”—the practice of monitoring sewage for pathogens, contaminants, or drugs—has since become a game-changer in the fight against Covid, particularly as at-home testing has eclipsed testing in clinics. As Palmer and his colleagues noted in a recent 151-page report for the National Academies of Sciences, Engineering, and Medicine, dozens of cities and states across the US have used sewer data to track Covid outbreaks, identify hotspots for vaccination outreach, decide where to allocate treatments like monoclonal antibodies, and serve as an early alarm for individual communities like schools or universities.”

“In other words, the data contained in our poop has likely saved lives. That lesson may come in handy the next time a pathogen threatens humanity.”

What We’re Listening To 🎧

Poisons and Pestilence 16 Bonus Episode: Before the Storm with Al Mauroni

“In this episode we examine preparations by the US in the advent of Operation Desert Storm (2003) for dealing with what was believed at the time to have been a large Iraqi CBW capability- with Al Mauroni.” Listen here.

NEW: The Department of Defense’s Newly Released Biodefense Posture Review

“Please join the CSIS Bipartisan Alliance for Global Health Security on Wednesday, August 23, from 10:30 am to 11:30 am ET for an event on the Department of Defense’s Biodefense Posture Review. Directed by Secretary Austin in November 2021, the review is charged with synchronizing, modernizing, and elevating the Department’s approach to biodefense across the full spectrum of natural, accidental, and deliberate biological threats. The review drew upon both the office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs and the Assistant Secretary of Defense for Space Policy. Following a keynote address by Hon. Deborah Rosenblum, Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs, CSIS Senior Associate RADM (ret.) Tom Cullison will moderate a roundtable conversation on the significance of the review, its priority elements, and how to move its recommendations forward. Participants will include Brandi Vann, Principal Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs; Richard Johnson, Deputy Assistant Secretary of Defense for Nuclear and Countering Weapons of Mass Destruction Policy; and Asha George, Executive Director of the Bipartisan Commission on Biodefense.”

NEW: Breaking Barriers 2023

CRDF’s Women in Science and Security Initiative is hosting the ninth annual Breaking Barriers event, which “will offer a variety of speakers, panels, and networking rooms to consider the ever-important topic of “Who Gets a Seat at the Table? Developing Diverse Spaces in Science and Security.” This event will take place on September 16 at 11:30 am EST on Zoom. Learn more and register here.

NEW: 2023 EPA International Decontamination Research and Development Conference-“Advancing Preparedness through Science and Collaboration”

This event will take place December 5-7 in Charleston, SC. Learn more and register here.

Bio and Beer

Join the Institute for Biohealth Innovation for this event on August 23 at 4:30 pm in Manassas, VA with “special guest, Dr. Eric Van Gieson, who will discuss the journey and quest of exploring the host response and harnessing the epigenome as a diagnostic and prognostic landscape. He will provide insight into his time at DARPA and talk about future possibilities for universities and industry to jointly pursue biotechnology innovation. Enjoy an evening of networking, drinks, and fun!” RSVP here.

Empirical Research in Biosafety: Filling Key Data Gaps

This September 14 event will be hosted by Rocco Casagrande in Columbia, MD and virtually beginning at 5 pm EST.

“In this session, we will present data from our empirical work in biosafety and our work exploiting existing data sets to inform biosafety. We will discuss our methodological framework for studying aerosols generated by laboratory accidents, and present information on the aerosols produced by dropping microtiter plates and tissue culture flasks. Also in the physical sciences, we will present data on the rate that conical centrifuge tubes leak and the frequency that splashes occur when opening microcentrifuge tubes via various opening methods. We will discuss the rate of spills and splashes when pipetting as drawn from experiments using volunteers and blinded samples in clinical laboratories. Interestingly, this experiment also sheds light on the ability of the researcher to know when they are making mistakes and take corrective action. We will present data on the rate at which needle sticks can be expected in the laboratory. We will examine how biosafety findings are distributed amongst laboratories in several institutions and what can be learned about the culture of biosafety. We will discuss how knowledge of the frequency and causes of accidents can lead to means to improve reproducibility in the life sciences.”

Learn more and register here.

No Checkered Flag: The Perpetual Race Against Biological Threats

This all-day event will take place in Washington, DC on September 27 at 9 am EST. Learn more and register here.

Women Building Bio: Building Better

This event will take place from 8:30-4 pm in Manassas, VA on September 28. Register here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

NEW: Thematic Consultation on Potential Amendments to the Human Pathogens and Toxins Regulations

“Canada’s biomanufacturing sector has rapidly expanded, drawing attention to growth and new challenges to the oversight of Canada’s biosafety and biosecurity program. In response to this expansion, we are seeking input from interested and affected parties, to inform potential regulatory amendments under the Human Pathogens and Toxins Regulations (the Regulations).”

Learn more and participate in this consultation here through September 5.

RUSI and NK News Launch New Nork Korea Reports Database

“A new RUSI and NK News initiative will provide access to high-quality, structured data from reports by the UN Panel of Experts on North Korea.”

“The database contains over 5,000 entities and their relationships, as described in successive reports by the UN Panel of Experts on North Korea from 2010 to 2023. The data allows countries and organisations to track sanctions compliance in a more easily accessible format. It is fully searchable and downloadable, and its fields are structured with ISO standards, making it easy to incorporate the data into existing databases.”

“This is a valuable tool for tracking sanctions compliance and promoting effective international sanctions implementation. It is particularly beneficial to smaller institutions, such as those in developing countries, who may often lack access to information and resources.”

Learn more and access the database here.

“Turning Listening into Action: A Proposal to Strengthen the NIH Guidelines”

A call from Acting NIH Associate Director for Science Policy, Lyric Jorgenson:

“As an unrepentant policy fanatic, I love talking about details, whether it be the implications of a strategically placed “shall” or where data should be in controlled access. However, most of the time, policymaking requires being a good listener. Listening is an underrated skill and is more than just waiting for your turn to speak. Typically, the scientific, ethical, legal, and social issues at the forefront of biomedical research are so complex that it is essential we turn to experts and members of the public to hear their perspectives before we can develop a policy responsive to their needs. Listening to this input and incorporating it into policymaking is vital to our work and to ensuring our policies hit the mark.”

“A recent case study in listening involves the Novel and Exceptional Technology and Research Advisory Committee, or as we like to call them, the NExTRAC. In 2020, we asked this committee to think through the different scenarios that may be used in gene drive research to advise on whether/how we should think about updating our existing biosafety policy framework. During its deliberations, the Committee also did a lot of listening, consulting with subject matter experts, and holding a public workshop. Ultimately, the NExTRAC produced some very thoughtful recommendations in its final report to the NIH.”

“Based on our internal deliberations and the NExTRAC’s recommendations, NIH is turning this listening into action by proposing some policy updates. The proposal is to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to strengthen our infrastructure for ensuring this research continues to proceed responsibly. Specifically, the proposed revisions would incorporate specific considerations and requirements for NIH-supported research involving gene drive modified organisms in contained research settings.”

“It is important to emphasize that all the proposed actions at this time focus on working with gene drive modified organisms in contained research settings. This research is already performed around the globe in labs with biosafety precautions in place. However, as technology evolves, we must make sure that our policies keep pace. Thanks to the work of the NExTRAC, we believe this proposal will allow researchers to safely proceed with contained gene drive research. I encourage all interested stakeholders to view the full proposal and provide us with your feedback. Comments on the full proposal will be accepted until October 10, 2023, and must be submitted electronically. I look forward to hearing your thoughts!”

Pandora Report 8.11.2023

August 11, 2023 by dkellogg97, posted in Pandora Report

This week’s Pandora Report covers recent cyberattacks targeting US hospitals in multiple states and other updates. New publications are listed, including a recent piece discussing the validity of Gabriel de Mussis’ account of the siege of Caffa. New events and announcements round out this week’s newsletter.

Hospitals in Three States Targeted by Cyberattacks

This week, Prospect Medical Holdings reported it was the target of a cyberattack, according to the AP, adding to a growing trend of violence and danger in the healthcare field. Prospect is an LA-based private equity company that runs 16 hospitals and 165 outpatient facilities in California, Connecticut, Pennsylvania, Rhode Island, and Texas. According to Axios, “The attack shuttered several emergency departments and required ambulances to be diverted from some hospitals, while health providers reverted to pen and paper in the immediate aftermath of the attack.”

“On Sunday, Eastern Connecticut Health Network’s website still reported closures of multiple services, including urgent care and elective surgeries, as it worked to restore systems. Pennsylvania-based Crozer Health and Rhode Island-based CharterCare still had posts on their websites alerting patients to the systemwide outage.”

“This is the latest in a surge of large-scale cyberattacks on health care facilities that have disrupted operations, with experts calling on better industry-wide efforts and federal regulations to harden defenses around America’s health care information infrastructure.”

Seiichi Morimura Dead at 90

Seiichi Morimura, author of the 1981 exposé, “The Devil’s Gluttony,” that detailed the horrors of Japan’s Unit 731, passed away on July 24 in Tokyo. The New York Times explained that “Mr. Morimura’s book sold more than 1.1 million copies within seven months of its publication. It was not the first account of Unit 731’s brutality — there were two others in the 1960s and ’70s — but Mr. Morimura’s was drawn from interviews with 60 Japanese participants in the program.”

‘“Mr. Morimura’s 246-page book is believed to be more accurate and more believable” than the others, The New York Times reported in 1982. The article quoted Mr. Morimura as saying: “This story should be told to all Japanese, to every generation. Japanese aggression should be written about to prevent another war.”’

Working Group on the Strengthening of the Biological Weapons Convention Convenes

The Working Group on the Strengthening of the Biological Weapons Convention is holding its second meeting currently in Geneva. CBW Events is posting daily updates about this and other working group meetings here.

20th CBRRNE Command Hosts Inaugural Joint Chemical, Biological, Radiological, Nuclear, Explosives Forum

Late last month, the Army’s 20th CBRNE Command hosted the first Joint Chemical, Biological, Radiological, Nuclear, Explosives Forum in Cockeysville, MD.

“Hosted by U.S. Army Brig. Gen. Daryl O. Hood, the commanding general of the 20th CBRNE Command, the event welcomed joint service Chemical, Biological, Radiological, Nuclear (CBRN) and Explosive Ordnance Disposal (EOD) personnel.”

“Headquartered on Aberdeen Proving Ground, Maryland, in Northeast Maryland’s science, technology and security corridor, the 20th CBRNE Command is home to 75 percent of the active-duty U.S. Army’s CBRN specialists and EOD technicians, as well as the 1st Area Medical Laboratory, CBRNE Analytical and Remediation Activity, five Weapons of Mass Destruction Coordination Teams and three Nuclear Disablement Teams.”

“This year’s forum highlighted the joint service personnel who confront and defeat CBRNE hazards in support of U.S. military operations around the world and civil authorities across the nation.”

“Catapulting Corpses? A Famous Case of Medieval Biological Warfare Probably Never Happened”

Matt Field discusses Jean Pascal Zanders‘ work critically assessing Gabriele de Mussi’s account of the siege of Caffa and the enduring belief that Mongol invaders engaged in medieval biological warfare by hurling the bodies of plague victims over the walls and into the city in this piece for The Bulletin of the Atomic Scientists. Field writes in part:

“Since de Mussi’s work was re-discovered in a university library in Poland in 1842, researchers of weaponry, the plague, and biological warfare have picked up parts of its narrative. Look up “The Black Death” in the Encyclopedia Britannica and it’s right there: “With his forces disintegrating, Janibeg used trebuchets to catapult plague-infested corpses into the town in an effort to infect his enemies. From [Caffa], Genoese ships carried the epidemic westward…” The medieval allegations are in YouTube and TikTok videos by the History Channel and others, some with millions of views. In the academic literature the anecdote can be found in reputable publications ranging from the Journal of the American Medical Association to the CDC’s Emerging Infectious Diseases.“

“The problem is, there’s strong reason to doubt de Mussi.”

This piece offers good discussion of the historiography surrounding this story and how it gained traction, insight into the logistics of this hypothetical attack, and compelling arguments about the dangers of perpetuating false claims about historical biological warfare.

“Bird Flu Has Never Done This Before”

Katherine J. Wu discusses concerns that H5N1 may now be endemic in North America in this piece for The Atlantic. She explains in her introduction “At bird breeding grounds this spring and summer, the skies have been clearer and quieter, the flocks drastically thinned. Last year, more than 60 percent of the Caspian terns at Lake Michigan vanished; the flock of great skuas at the Hermaness reserve, in Scotland, may have shrunk by 90 percent. Now more broken bodies are turning up: a massacre of 600 arctic-tern chicks in the United Kingdom; a rash of pelicans, cormorants, gulls, and terns washed up along West African coasts. In recent months, Peruvian officials have reported the loss of tens of thousands of pelicans—by some estimates, up to 40 percent of the country’s total population.”

“The deaths are the latest casualties of the outbreak of H5N1 avian flu that’s been tearing its way across the world. In the past couple of years, more than 100 million domestic poultry have died, many of them deliberately culled; out in the wild, the deaths may be in the millions too—the corpses have just been too inaccessible and too numerous for scientists to count. “It’s been carnage,” Michelle Wille, a virologist at the Peter Doherty Institute for Infection and Immunity, told me. “For many species, we are losing decades of conservation work.”’

“Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril”

From the National Academies: “The emergence of artificial intelligence (AI) in health care offers unprecedented opportunities to improve patient and clinical team outcomes, reduce costs, and impact population health. While there have been a number of promising examples of AI applications in health care, it is imperative to proceed with caution or risk the potential of user disillusionment, another AI winter, or further exacerbation of existing health- and technology-driven disparities.”

“This Special Publication synthesizes current knowledge to offer a reference document for relevant health care stakeholders. It outlines the current and near-term AI solutions; highlights the challenges, limitations, and best practices for AI development, adoption, and maintenance; offers an overview of the legal and regulatory landscape for AI tools designed for health care application; prioritizes the need for equity, inclusion, and a human rights lens for this work; and outlines key considerations for moving forward.”

“AI is poised to make transformative and disruptive advances in health care, but it is prudent to balance the need for thoughtful, inclusive health care AI that plans for and actively manages and reduces potential unintended consequences, while not yielding to marketing hype and profit motives.”

“Here’s the Intelligence Assessment of Donald Trump That the Government Can’t Write”

Schar School adjunct professor Donell Harvin recently published this Politico opinion piece. In it he explains that “Federal intelligence and national security agencies — from the FBI to DHS — are in universal agreement that domestic extremism and terrorism is the leading threat to the U.S. homeland. But homeland security officials are also trained to be apolitical, so here’s what they can’t tell you: Donald J. Trump poses a significant threat to homeland security.”

“While generally highly decentralized and fractured, violent extremist groups have begun to mesh over a unifying figure: Trump. The former president has become a focal point of domestic extremism, and by not denouncing them — and sometimes courting them — he has been adopted by these groups as a de facto spiritual leader. In some ways, Trump has also co-opted these groups to boost his own support. This, in my assessment, makes the former president a leading driver of domestic extremism, and an unprecedented danger to our security. The indictment of Trump for his push to overturn the 2020 election puts that in stark relief.”

Live Launch of the BWC National Implementation Measures Database

“At this side event to the BWC Working Group meeting, UNIDIR and VERTIC will launch the new BWC National Implementation Measures Database. The database is designed to strengthen the implementation of the BWC and enable States and Stakeholders to have a better understanding of different approaches to national implementation from around the world.”

“The event will consist of a demonstration of the Database website and will showcase the tool’s structure and functions. The demonstration will be followed by a Q&A session with the audience”

This event will take place on August 15 at 1:15 pm CEST. Register here.

Bio and Beer

Empirical Research in Biosafety: Filling Key Data Gaps

This September 14 event will be hosted by Rocco Casagrande in Columbia, MD and virtually beginning at 5 pm EST.

Learn more and register here.

No Checkered Flag: The Perpetual Race Against Biological Threats

This all-day event will take place in Washington, DC on September 27 at 9 am EST. Learn more and register here.

Women Building Bio: Building Better

This event will take place from 8:30-4 pm in Manassas, VA on September 28. Register here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

RUSI and NK News Launch New Nork Korea Reports Database

“A new RUSI and NK News initiative will provide access to high-quality, structured data from reports by the UN Panel of Experts on North Korea.”

Learn more and access the database here.

“Turning Listening into Action: A Proposal to Strengthen the NIH Guidelines”

A call from Acting NIH Associate Director for Science Policy, Lyric Jorgenson:

Pandora Report 8.4.2023

August 4, 2023 by dkellogg97, posted in Pandora Report

This week covers the National Institutes of Health’s appointment of a new National Institute of Allergies and Infectious Diseases director, the expiration of the Chemical Facility Anti-Terrorism Standards program, growing challenges for ProMED, and the appointment of the United States Public Health Service Commissioned Corps’ first official mascot. Several new publications and more are also included.

Pawsome News: USPHS Commissioned Corps Announces First Official Mascot, LCDR Abigail 🐾

The US Public Health Service Commissioned Corps recently announced its first official mascot-Lt. Cmdr. Abigail, a Labrador Retriever.

According to HHS, “Lt. Cmdr. Abigail was named after the former First Lady of the United States, Abigail Adams, who has a historical connection to the service. The origin and history of the USPHS Commissioned Corps trace back to July 16, 1798, when Congress passed an Act, signed by President John Adams, creating the US Marine Hospital Service to protect against the spread of disease from sailors returning from overseas ports and thus began the story of the Public Health Service.”

“The concept of the service mascot originated during the COVID-19 pandemic, when Public Health Service officers deployed to respond to the largest public health emergency in modern times. The mascot is intended to improve mental well-being, enhance camaraderie, and assist with public health messaging. When first appointed, the mascot receives an honorary rank in the USPHS Commissioned Corps equal to that of the primary handler.”

Unfortunately for this good girl, “This honorary rank will not include any salary or retirement benefits.”

NIH Taps Jeanne Marrazzo to Lead National Institute of Allergy and Infectious Diseases

The National Institutes of Health recently named Jeanne M. Marrazzo, MD as Director of the National Institute of Allergy and Infectious Diseases (NIAID). NIH explained in their press release, “Dr. Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham. She is expected to begin her role as NIAID Director in the fall. NIAID conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic and allergic diseases.”

“Dr. Marrazzo’s research in discovery and implementation science has focused on the human microbiome, specifically as it relates to female reproductive tract infections and hormonal contraception; prevention of HIV infection using biomedical interventions, including PrEP and microbicides; and the pathogenesis and management of bacterial vaginosis, sexually transmitted diseases in HIV-infected persons and management of antibiotic resistance in gonorrhea. She has been a principal investigator on NIH grants continuously since 1997 and has served frequently as a peer reviewer and advisory committee member. Dr. Marrazzo also has served as a mentor to trainees at all stages of professional development, including on NIH-funded training grants, and was the recipient of the American Sexually Transmitted Diseases Association’s Distinguished Career Award, the highest recognition of contributions to research and mentoring in the field.”

State Department Launches Bureau of Global Health, Security, and Diplomacy

This week, US Secretary of State Anthony Blinken announced that the “State Department is officially launching a new Bureau of Global Heath Security and Diplomacy. The Bureau’s overarching mission is to fortify the global health security architecture to effectively prevent, detect, control, and respond to infectious diseases, including HIV/AIDS. By leveraging and coordinating U.S. foreign assistance, the Bureau aims to foster robust international cooperation, enhancing protection for the United States and the global community against health threats through strengthened systems and policies.”

He explained further that “The COVID-19 pandemic underscored the vital role the United States must play in addressing global health and health security issues. To ensure U.S. leadership is sustained moving forward, the Bureau will provide a unified voice of leadership on global health security and diplomacy, combining strengths, functions, personnel, and resources from various offices.”

“Ambassador-at-Large Dr. John N. Nkengasong, will lead the bureau, serving as Ambassador-at-Large, U.S. Global AIDS Coordinator, and Senior Bureau Official for Global Health Security and Diplomacy, and reporting directly to me.”

“This new Bureau will seamlessly integrate global health security as a core component of U.S. national security and foreign policy, underscoring the Department of State’s commitment to advancing human health worldwide.”

Senate Fails to Reauthorize Chemical Facility Anti-Terrorism Security Program

The US Senate last week did not pass legislation to reauthorize the Chemical Facility Anti-Terrorism (CFATS) program before its July 27, 2023 expiration date. According to Industrial Cyber, “The bill was to extend the authorization of the program of the Department of Homeland Security (DHS) until July 27, 2025. The failure of the Senate to reauthorize the CFATS program has significant implications for chemical facility security measures, potentially putting these facilities at risk.”

“Senator Rand Paul, a Republican from Kentucky, blocked the H.R. 4470 bill in the Senate that would re-authorize the U.S. program to address terrorism and site security, allowing it to expire at the end of Thursday…Paul feared that the bill was being rushed through the Senate. He said there were no hearings about CFATS or whether it was effective. “We tend to re-authorise things without ever examining whether they work, what works and what doesn’t work.” He conditioned his support for the re-authorization bill on an amendment that would create what he called a duplicative scoring system for every future proposal brought before legislators. The system would determine how many programs in the bill are duplicated by ones that already exist in the government.”

CISA, which oversees CFATS, explains the program on its site, stating “Under CFATS, a chemical facility is any establishment or individual that possesses or plans to possess any of the more than 300 chemicals of interest (COI) in Appendix A at or above the listed screening threshold quantity (STQ) and concentration. These facilities must report their chemicals to CISA via an online survey, known as a Top-Screen. CISA uses the Top-Screen information a facility submits to determine if the facility is considered high-risk and must develop a security plan. Learn more on the CFATS process webpage.”

“The CFATS regulation applies to facilities across many industries – chemical manufacturing, storage and distribution, energy and utilities, agriculture and food, explosives, mining, electronics, plastics, colleges and universities, laboratories, paint and coatings, and healthcare and pharmaceuticals, among others.”

“Chemical security is not a temporary issue. As threats evolve, CISA is committed to working with stakeholders to protect the nation’s highest-risk chemical infrastructure.”

CISA said in a statement about the expiration, “As of July 28, 2023, Congress has allowed the statutory authority for the Chemical Facility Anti-Terrorism Standards (CFATS) program (6 CFR Part 27) to expire.”

“Therefore, CISA cannot enforce compliance with the CFATS regulations at this time. This means that CISA will not require facilities to report their chemicals of interest or submit any information in CSAT, perform inspections, or provide CFATS compliance assistance, amongst other activities. CISA can no longer require facilities to implement their CFATS Site Security Plan or CFATS Alternative Security Program.”

“CISA encourages facilities to maintain security measures. CISA’s voluntary ChemLock resources are available on the ChemLock webpages.”

ProMED On Its Way Out?

ProMED, “the largest publicly-available system conducting global reporting of infectious disease outbreaks,” looks to be in jeopardy as of yesterday. STAT News’ Helen Branswell explained in her reporting that “A number of the senior moderators of ProMED-mail, a program operated by the International Society for Infectious Diseases, posted a letter of protest early Thursday, challenging a recently revealed plan to charge for subscriptions to the service. The group of 21 moderators, who announced they were suspending work for ProMED, expressed a lack of confidence in the ISID’s administrative operations, suggesting ProMED needs to find a new home.”

She explained the importance of this platform further, writing “Prior to its inception in 1994, governments — which often have incentives not to be forthcoming — were the main sources of information about disease events. ProMED takes tips from scientists who can remain anonymous to the general readership — though not the moderators. It was also created at a time when access to the internet and email was just taking off, allowing people from around the world to supply information to its moderators, information those moderators assessed, curated, and sent out to the broader world.”

“In February 2003, it was ProMED that alerted the world to the fact that a new disease that caused pneumonia had started to spread in China’s Guangdong province. That disease became known as SARS — severe acute respiratory syndrome. In September 2012, an Egyptian doctor working in Saudi Arabia wrote to ProMED to reveal he had treated a patient who died from pneumonia triggered by a new coronavirus, a camel virus we now know as MERS — Middle East respiratory syndrome. Just before midnight on Dec. 30, 2019, a ProMED “RFI” post — request for information — was the first warning the outside world received of a fast-growing outbreak in Wuhan, China. That was the start of the Covid-19 pandemic.”

“Chinese Academics Are Becoming a Force for Good Governance”

The Biodefense Graduate Program’s Sonia Ben Ouagrham-Gormley recently co-authored this article alongside Joy Zhang and Kathleen Vogel for Issues in Science and Technology. In it they offer insight into the work of the Chinese scientific community to improve policies guiding responsible research, in contrast to the “Wild East” reputation many attribute to Chinese biosciences research. They write in part “It reflects important changes in the domestic dynamics of Chinese science—particularly the increasingly prominent role of academics. Chinese academics have become a proactive, effective force demanding science governance in China, but international counterparts too often fail to recognize their role and so undermine their efforts. China still has much work to do to develop a trusted and accountable regulatory system worthy of its scientific advancement and ambition, but meaningful, sustainable reforms must come from within the country.”

“Gain-of-Function Research Is About Much More Than Dangerous Pathogens”

Biodefense Graduate Program alumni Saskia Popescu and Yong-Bee Lim recently co-authored this STAT News piece with Angela Rasmussen. They write in part, “However, focusing exclusively on this one type of research has created deep rifts across key communities that balance innovation with safety and security in the life sciences. These rifts have made it almost impossible to have necessary, productive conversations to address global problems while ensuring such work is done safely and securely. Narrowing the definition of gain of function to only pathogen modification that prevents or addresses pandemic-level disease outbreaks is impeding progress in this space.”

They discuss differences in risk tolerance and perspectives on this issue, explaining in their conclusion that “Concepts such as gain of function are exceptionally nuanced, complex, and have even changed over time. This creates perennial, dynamic challenges for the scientific, safety, and security communities to make substantive advances on these issues, let alone the nontechnical policymakers and public. Ultimately, these communities seek the same goal: innovative, safe, and secure life sciences research to help solve critical global issues.”

“Existential Terrorism: Can Terrorists Destroy Humanity?”

The Schar School’s Zachary Kallenborn recently co-authored this article alongside Gary Ackerman for the European Journal of Risk Regulation.

Abstract: “Mass-casualty terrorism and terrorism involving unconventional weapons have received extensive academic and policy attention, yet few academics have considered the broader question of whether such behaviours could pose a plausible risk to humanity’s survival or continued flourishing. Despite several terrorist and other violent non-state actors having evinced an interest in causing existential harm to humanity, their ambition has historically vastly outweighed their capability. Nonetheless, three pathways to existential harm exist: existential attack, existential spoilers and systemic harm. Each pathway varies in its risk dynamics considerably. Although an existential attack is plausible, it would require extraordinary levels of terrorist capability. Conversely, modest terrorist capabilities might be sufficient to spoil risk mitigation measures or cause systemic harm, but such actions would only result in existential harm under highly contingent circumstances. Overall, we conclude that the likelihood of terrorism causing existential harm is extremely low, at least in the near to medium term, but it is theoretically possible for terrorists to intentionally destroy humanity.”

“Coordinating the U.S. Government Approach to the Bioeconomy”

From the Federation of American Scientists: “The bioeconomy touches nearly every function of the U.S. government. The products of the bioeconomy compete in an international marketplace and include medicines, foods, fuels, materials, and novel solutions to broad challenges including climate and sustainability. The infrastructure, tools, and capabilities that drive the bioeconomy must be safeguarded to maintain U.S. leadership and to protect against misuse. The vast scale of these issues requires a cross-governmental approach that draws on input and engagement with industry, academia, nongovernmental organizations, and other stakeholders across the bioeconomy.”

“To achieve a durable and strategic interagency approach to the bioeconomy, the Office of Science and Technology Policy (OSTP) should establish and Congress should fund a Bioeconomy Initiative Coordination Office (BICO) to coordinate strategic U.S. government investments in the bioeconomy; facilitate efficient oversight and commercialization of biotechnology products; safeguard biotechnology infrastructure, tools and capabilities; and serve as a focal point for government engagement with nongovernmental partners and experts.”

“Unraveling the Knot: The Complex and Multi-Pronged Negotiations of Global Pandemic Response Reform”

In this Speaking of Medicine piece, PLOS Global Public Health guest contribute Yassen Tcholakov explains “The COVID-19 pandemic has exposed the vulnerabilities and shortcomings of the global health system. From strained healthcare infrastructures to inequitable vaccine distribution through a burned out workforce, the crisis has underscored the urgent need for comprehensive pandemic response reforms. In response to these challenges, the world has embarked on one of the most complex processes in recent history: a multi-pronged approach to pandemic response reforms. This approach comprises three key processes: the Intergovernmental Negotiating Body (INB) negotiations for a new Pandemic Treaty, the Working Group on Amendments to the International Health Regulations (WGIHR) working on targeted amendments to the existing regulations, and the United Nations’ High-Level Meeting (HLM) on Pandemic Prevention, Preparedness, and Response (PPR) fostering high-level discussions on pandemic response. This article aims to dissect these intricate negotiations, shedding light on the various facets of this endeavor.”

“EMS Infectious Disease Playbook Version 2.0”

From ASPR TRACIE: “This document was created in 2017 using official or best practice information taken from multiple organizations that was vetted and assembled by subject matter experts working for the Technical Resources, Assistance Center, and Information Exchange (TRACIE) at the request of the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR). The aim was not to develop novel guidance for emergency medical services (EMS) agencies, but to unify multiple sources of information in a single, concise planning document addressing the full spectrum of infectious agents for EMS agencies developing their service policies. This document does not represent official policy of HHS ASPR or other federal or private agencies.”

“The information contained in this playbook is intended as a planning resource and should be incorporated into agency standard operating procedures and reviewed by the EMS medical director. EMS agencies should review the playbook and understand that while the core principle is preventing exposure to potentially infectious body fluids, there are multiple types of personal protective ensembles that may be appropriate based on the biological threat. Donning and doffing procedures are dependent on the personal protective equipment (PPE) ensemble selected. Appropriate education and training are critical to the success of infection prevention and control protocols. The authors, ASPR TRACIE, and HHS ASPR do not take responsibility or bear liability for any clinical care outcomes, provider injury/illness, or inaccuracies in or resulting from this document. The playbook was revised in 2023 and all recommendations were current at the time of publication and vetted to the best of our ability.”

Trust & Verify Issue Number 172

VERTIC’s latest issue of Trust &Verify is now available here. “The Summer 2023 edition of T&V opens with a lead article examining the effectiveness of the BTWC and CWC for preventing weaponization of toxins and bioregulators. The rest of the edition covers issues ranging from criminal proceedings against a fraudulent ship registry scheme in the Federated States of Micronesia to VERTIC and UNIDIR’s upcoming BWC National Implementation Database.”

“Health Security Intelligence Capabilities Post COVID-19: Resisting the Passive “New Normal” Within the Five Eyes”

This article from Patrick Walsh, James Ramsay, and Ausma Bernot recently appeared in Intelligence and National Security: “This paper spotlights lessons for health security intelligence across the ‘Five Eyes’ countries. The COVID-19 pandemic and recent worldwide patterns related to climate change have highlighted the crucial supporting role intelligence analysis may play in comprehending, planning for, and responding to such global health threats. In addition to the human lives lost, the COVID-19 pandemic has revealed serious national security concerns, notably for economic, societal, and in some cases, political stability. In response, a greater emphasis must be placed on intelligence. The paper has three goals. First, it outlines the major thematic areas where key ‘Five Eyes’ intelligence communities’ (ICs) skills were tested in supporting the management of COVID-19: 1) the origins of SARS-CoV-2, 2) disinformation campaigns, and 3) early warning systems. The article then explores how such factors have impacted ICs’ ability to provide decision-making support during COVID-19. Finally, the article discusses how ‘Five Eyes’ ICs may strengthen capacity in the three crucial areas. The ‘Five Eyes’ ICs must act swiftly but methodically to assess the security-based analytic lessons learned during the COVID-19 pandemic to maximize preparation for the next inevitable pandemic, whether caused by a natural disaster, climate change, or state or non-state threat actors.”

“Navigating Infodemics and Building Trust During Public Health Emergencies: Proceedings of a Workshop-in Brief”

From the National Academies: “An infodemic is the rapid spread of large amounts of sometimes conflicting or inaccurate information that can impede the ability of individuals, communities, and authorities to protect health and effectively respond in a crisis. The National Academies Board on Health Sciences Policy hosted a two-day, public workshop in April 2023 to explore the history of public health infodemics, the impact of infodemics on trust in the public health enterprise, and tools and practices used to address infodemics. Attendees learned action-oriented strategies and tactics for inspiring public trust and about the roles, responsibilities, and partnerships among relevant organizations and agencies in managing infodemics during a public health emergency. This Proceedings of a Workshop-in Brief summarizes the discussions held during the workshop.”

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

Registration for GHS 2024 Now Open

Call for Papers on the Interconnectvity of Norms

“The Justus-Liebig University Gieβen in collaboration with CBWNet are accepting paper proposals for a conference to take place on 23-24 October 2023 in Gieβen, Germany. The conference, titled Chemical and Biological Weapons: The Interconnectivity of Norms will examine selected issues pertaining to the normative regimes against biological and chemical weapons. Submissions in line with the thematic area are welcome.”
“Paper proposals should be no longer than 250 words in length. All submissions should be sent through by 30 July 2023 and may be submitted by email to: Barry.de-Vries@recht.uni-giessen.de”

“Find the full call here: call-for-papers.pdf“

Global Health Collaborators (GHC) – Volunteer Application

“Are you passionate about global health and eager to make a meaningful impact? Look no further! We are excited to announce an open call for volunteers to join Global Health Collaborators (GHC), a youth-led movement dedicated to driving impactful change in the field of global health.”

“At GHC, we believe that collective action and diverse perspectives can create a healthier, more equitable world. As a volunteer, you’ll have the opportunity to collaborate with like-minded individuals, organizations, and communities across continents. Together, we’ll advocate for health equity and address global health challenges through impactful projects, research, and advocacy initiatives.”

“We have various volunteer positions available in our hubs across Africa, Asia, Australia & Oceania, Europe, Middle East, North America, Latin America, and South Asia. Within each hub, you can contribute to Committees dedicated to Grants, Project Management, Communications and Social Media, Internal Management, and Research.”

“To become a part of this transformative journey, simply fill out our Volunteer Application Form here: https://docs.google.com/forms/d/e/1FAIpQLSfmEqFQT-t1baFT0kwfixw4L5MvaX7BylvBuINKw2xCQMirIQ/viewform“

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