The Pandora Report

Pandora Report 11.8.2024

November 8, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report discusses one Biodefense MS student’s research on malaria, the UK’s recently-announced sanctions against 56 people and entities linked to Russia, the CDC’s call for more avian influenza testing, and what a second Trump administration likely means for US public health and global health security.

Biodefense MS Student Presents at Malaria Research Symposium

Zachary Berliner, a Biodefense MS student, is presenting a poster at the 10^th Annual Future of Malaria Research Symposium in Baltimore, MD, on November 8. This conference, jointly run by the Johns Hopkins Malaria Research Institute and the University of Maryland School of Medicine, provides “a platform for early-career scientists to share their research with peers, emerging leaders, and established investigators.” In 2023, nine cases of locally acquired malaria occurred in the United States, the first such cases in twenty years. Zak’s project, Public Opinions Toward Malaria Control Interventions in the National Capital Region, featured a survey of adults in the National Capital Region about their opinions toward various malaria control interventions. His study serves as an indicator of preliminary opinions among a small group of Americans to better inform politicians. His poster can be found here, and the full paper can be found here. The poster is based on the capstone paper that Zak wrote as a culmination of his experience in the Biodefense program. Zak is graduating with his MS in Biodefense in December and is looking for policy and analysis opportunities focused on biodefense and health security.

United Kingdom Announces Sanctions on 56 People and Entities Linked to Russia

The UK announced its largest sanctions package against Russia since May of last year this week, in a series of actions the government hopes “disrupts the supply of vital equipment for Putin’s war machine and bears down on Russian malign activity globally, exposing the corrupt activities of Russian proxy military groups in Africa.” Those sanctioned include Denis Sergeev (who was charged by the Met Police in the attempted murder of Sergei Skripal), entities in China, Turkey, and Central Asia, Africa Corps and other private mercenary groups linked to the Kremlin, and others. The UK is the first G7 country to directly sanction Africa Corps, which has directly threatened peace and security in Libya, Mali, and the Central African Republic.

CDC Calls for Expanded Bird Flu Testing as California and Washington Report More Cases

Officials at the CDC called for more testing on farms with avian influenza cases after a recent study found some dairy workers have shown signs of infection even though they did not report feeling sick. The study that 7% of the 115 farmworkers whose blood was tested (eight) had antibodies consistent with previous H5N1 infection, pointing to more infections than the 46 identified so far. More cases in farmworkers have also been reported in recent days, including at least four in California and three in Washington. The California Department of Public Health also recently reported one other probable case in a dairy worker who met the case definition, though CDC’s confirmation test was negative.

What Lies Ahead in Trump’s Second Term

President-Elect Trump’s recent victory likely will have severe implications for both domestic health policy and global health security. The first Trump administration largely failed in its response to the COVID-19 pandemic, despite the US ranking very well in pre-pandemic preparedness assessments like the Global Health Security Index and the Trump administration being handed a pandemic playbook by the preceding Obama administration that specifically flagged novel coronaviruses as a potential pandemic threat. The upcoming second Trump administration looks ready to fair just as poorly in terms of not just pandemic preparedness, but in general public health and global health engagement as well.

The president-elect, who has repeatedly and falsely claimed that climate change is a hoax, has promised to rollback federal regulations on the oil and gas industry that are aimed at slowing climate change. Trump pulled the United States out of the 2015 Paris Climate Accord in 2017, and his campaign has indicated it intends to do the same again once he is back in office. Trump is also expected to target the EPA during his second term. Changes like this are especially concerning as the effects of climate change, such as increased extreme weather and easier spread of infectious diseases, pose a growing threat globally.

Trump does plan to involve at least one environmental lawyer in his administration-Robert F. Kennedy Jr., an environmental lawyer who Trump has suggested may play a large role in public health in his administration. Unfortunately, Kennedy has no training in public health or medicine, and he has repeatedly peddled anti-vaccine conspiracy theories over the years. Kennedy also faced backlash for comments suggesting COVID-19 was “ethnically targeted,” saying “COVID-19 is targeted to attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese…We don’t know whether it was deliberately targeted or not but there are papers out there that show the racial or ethnic differential and impact.” Kennedy has also voiced criticism of the childhood vaccine schedule and public water fluoridation, claiming the latter is “lowering IQ in our children,” in contrast to what numerous studies over multiple decades show about its safety and efficacy.

Trump has promised to allow Kennedy to “go wild on” health, medicines, and food policy, with Kennedy saying he believes entire departments at the FDA “have to go.” Kennedy has also said he wants an eight-year-long “break” in NIH funding for infectious disease research, and that he would move that money to chronic disease research. Congressional Republicans have targeted the NIH in recent years, including efforts to strip its authority over gain of function research and repeatedly attacking former NIAID Director, Anthony Fauci.

Trump’s second term also may pose threats to global health security more directly. For example, in 2020, the Trump administration formally notified the United Nations that it intended to withdraw the country from the World Health Organization. This move would have cut off one of the largest funding sources to the WHO in the middle of the COVID-19 pandemic. Furthermore, some experts argue the attempt was unlawful, in addition to the threat it posed to domestic and global health and security. While the Trump campaign mentioned few specifics about foreign policy for a second term, the United Nations is bracing itself for this incoming administration.

This week’s election results have many experts deeply concerned about what this administration will bring. Saskia Popescu, an alumna of the Schar School’s Biodefense PhD Program and current adjunct professor at the school made this statement to The Bulletin of the Atomic Scientists about the election result’s implications for public health: Right now, I think you’d be hard-pressed to find many in public health, healthcare, and pandemic preparedness/response, who are not deeply concerned. The recent notion that Robert F. Kennedy Jr. could be in charge of public health for the United States poses a real danger. From his claims that vaccines are harmful or unnecessary to his proposed efforts to remove fluoride from public water systems, Kennedy continuously pushes anti-science rhetoric and dis/misinformation.

History has shown us what might happen under another Trump administration during times of crises, from extreme weather events to a pandemic. We have seen how an administration that pits itself against science and dedicated public service officials reacts. As we face an ongoing H5N1 outbreak, persistent outbreaks of emerging infectious diseases, an erosion of trust in public health, a rise in dis/misinformation, and widening social disparities, we need leadership that will unite rather than divide.

We are at a critical time in forming effective and pragmatic policies to address complex issues such as the ways in which developments in artificial intelligence (AI) will affect biosecurity, the safety and security around critical research of dangerous pathogens, the effects of climate change on infectious diseases, and the need to strengthen global health through equity and partnership.

Developing policies in these areas will require strategies based on collaboration and evidence-based measures–not inflammatory, inaccurate, and harmful rhetoric that furthers partisan divides and enflames social discourse. It’s our responsibility to find a path that ensures the protection of public health and global health security. We’ve got a lot of work to do, and I fear a hard road ahead of us.

Others have voiced concerns about a return to US isolationism in global health, Trump not seeking out quality scientific advice, policies regarding vaccines, and more that can be read in this piece from The Bulletin of the Atomic Scientists.

“HHS’ ASPR Playing ‘Quarterback’ for Cyber Response, Resilience”

Jason Miller discusses ASPR’s cyber efforts with Biodefense PhD Program alumnus, Schar School adjunct professor, and current Deputy Director of ASPR’s Office of Preparedness in this piece for Federal News Network: “Just a little over a year ago, that coordination was occurring, but not as smooth as it needed to be. We took some steps, and actually now have a Public Health Service, captain, or an 06 officer, permanently embedded within the National Cyber Investigative Joint Task Force, that the FBI leads. We have a HHS ASPR person embedded full time with the FBI agents and other law enforcement folks who work in that task force and really are dealing with very sensitive information and responding to cyber incidents in the healthcare sector every day,” said Mazanec on Ask the CIO. “That’s just another example where we’ve really tightened up and continue to mature our partnership with the FBI. We do work with the other health focused entities like the Veterans Affairs Department, the Defense Health Agency, certainly within HHS, with the Indian Health Service and with the Centers for Medicaid and Medicare Services.”

Read more here.

“GHSD Five-year Strategy 2024-2028 (October 2024)”

The State Department’s Bureau of Global Health Security and Diplomacy recently released its strategic plan for 2024-2028: “The COVID-19 pandemic underscored the importance of preventing, detecting, and responding to health crises to safeguard American lives and the global economy. Building on the successes of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), which has saved more than 25 million lives from HIV/AIDS, and to address the growing challenges posed by health threats, the State Department established the Bureau of Global Health Security and Diplomacy in August 2023.”

“Building on decades of leadership on global health within the State Department, the Bureau of Global Health Security and Diplomacy’s mission is to lead U.S. diplomatic engagement, help coordinate foreign assistance, and promote international cooperation against health threats, integrating global health security as a core component of national security and foreign policy. The bureau’s first ever five-year Strategy for 2024-2028 outlines the State Department’s role in ending HIV/AIDS as a public health threat and advancing global health security and pandemic prevention, preparedness, and response efforts for the U.S. government.”

“The goals of the Strategy are to:

End HIV/AIDS as a public health threat by 2030
Catalyze the political will, financing, and leadership necessary to achieve heath security and address public health threats, including HIV/AIDS
Improve global multisectoral preparedness and response through diplomacy to protect against health security threats
Empower the diplomatic workforce to prioritize and integrate global health security as a key pillar of U.S. foreign policy.”

Read the strategy here.

“Chemical Weapons Policymakers Must Act to Balance the Prospects and Perils of AI”

Patrick Norén recently published this CBNW article covering a conference organized by the OPCW and Kingdom of Morocco focused on the role of AI in advancing implementation of the CWC. Norén covers general trends in speakers’ comments, the dual use nature of AI, challenges in legislation, regulation, and cooperation, and issues with misinformation and disinformation.

“MATCH 2.0 Enters Demonstration and Live Testing Phase”

From Stimson: “Behind every chemical transfer is a story, and too often, that story includes discrepancies in reported data. The Stimson Center’s MATCH project team has completed development of an updated DLT prototype and is demonstrating to CWC National Authorities and other stakeholders how it traces these narratives and creates a clear, immutable record of each transaction, aligning records of national authorities and industry while maintaining data confidentiality, reducing risks of misreporting, and enhancing nonproliferation by enabling faster reconciliation of discrepancies in the annual reporting of chemicals covered by the Chemical Weapons Convention (CWC).”

Read more here.

“THE NEXUS BETWEEN SCIENCE AND NATIONAL SECURITY IN CANADA: THE CASE OF THE NATIONAL MICROBIOLOGY LABORATORY IN WINNIPEG”

The Canadian House of Commons’ Special Committee on the Canada-People’s Republic of China Relationship recently released this interim report. Among other things, the report reveals that CSIS “issued a direct and unheeded warning to senior health officials in August 2018, raising concerns about “insider threat activities” linked to Dr. Xiangguo Qiu and her husband, Keding Cheng.” The report explains in its conclusion “The events at the Winnipeg NML facility revealed, as outlined in this report, the fundamentally open and collaborative nature of Canadian scientific research as a means of contributing to the common good, on the one hand, and, on the other, the need for a cultural shift within the scientific field in terms of its vigilance over national security risks and the need to reconsider how we collaborate with entities or states that may not share the same interests as Canada. For example, with regard to the PRC, Mr. Vigneault said that “[i]t is sometimes in our own national interest to collaborate with Chinese entities, but we need to do it with our eyes wide open and make sure that we protect our own base.”’

Read Sam Cooper’s coverage of this report in The Bureau here.

NEW: Developing Guardrails for AI Biodesign Tools

From NTI: “Join us for a virtual webinar releasing the findings of NTI | bio’s new report, Developing Guardrails for AI Biodesign Tools, followed by a moderated discussion and Q+A with distinguished guest Claire Quereshi.”

“Artificial intelligence (AI) promises to revolutionize not only aspects of daily life but cutting-edge scientific research and development. Within the life sciences, AI biodesign tools (BDTs) have improved significantly in their ability to design biological molecules and make predictions about living systems, displaying potential for beneficial applications and posing significant potential risks if misused.”

“Authors Sarah R. Carter, Ph.D., Nicole E. Wheeler, Ph.D., Christopher R. Isaac, M.Sc., and Jaime M. Yassif, Ph.D. conducted interviews with experts with deep experience creating bioinformatic tools, developing BDTs, and crafting biosecurity policies. The report outlines several proposed measures that could be deployed to design governance approaches to reduce biological risks without unduly hindering scientific advances.”

This event will take place virtually on November 14 at 11 am ET. Learn more and register here.

NEW: A Year-End Review, Recapping Global AI Governance Efforts

From CSET: “This time last year seemed to herald a landmark period in establishing AI governance regimes around the world. After ChatGPT and other AI tools burst onto the scene, U.S. policymakers issued new executive orders, hosted hearings and high-profile learning sessions, and developed new frameworks and standards to support the safe and secure development of AI. Elsewhere, the European Union worked to finalize its AI Act, and China announced its Global AI Governance Initiative. One year later, where do the promises and commitments to govern AI stand?”

“Join us on November 14, as we look back on the last year of global AI governance efforts and evaluate what progress has been made, what work remains to be done, and what the actions of global partners and competitors alike mean for U.S. strategy going forward. CSET Associate Director of Analysis Owen J. Daniels will moderate a conversation with CSET researchers Mia Hoffmann, Mina Narayanan, and Cole McFaul as we survey governance developments around the world over the past year. The moderated discussion will be followed by audience Q&A.”

This event will take place at 1 pm ET on November 14. Learn more and RSVP here.

NEW: Enhancing the Resilience of Healthcare and Public Health Critical Infrastructure

From NASEM: “Healthcare and public health infrastructure, technology, and operations are rapidly changing and are increasingly interdependent and interconnected. Threats to the nation’s critical social and physical infrastructure systems are also rapidly evolving and highly complex—posing potentially new or growing risks of disruption and challenging the assumptions used to design and protect these systems.”

“The National Academies Forum on Medical and Public Health Preparedness for Disasters and Emergencies will host a hybrid public workshop to explore strategies, policies, and innovative actions to improve the resilience of healthcare and public health (HPH) critical infrastructure to impacts from disasters and other emergencies.”

This event will take place in DC on December 9 and 10. Register here.

NEW: Resilience in the Face of Global Risks

From CSR: “The Council on Strategic Risks (CSR) cordially invites you to our first annual CSR symposium, Resilience in the Face of Global Risks, scheduled for Tuesday, December 10, 2024. This is the first event bringing together all three of CSR’s institutions—the Center for Climate & Security, the Converging Risks Lab, and the Janne E. Nolan Center on Strategic Weapons—to engage with leaders across our mission sets.”

“The United States and its allies face a complex global security landscape where systemic risks like climate and ecological crisis, nuclear proliferation, and biological threats are blending with war, geopolitical competition, and human insecurity in new and profound ways. While there has been tremendous leadership—and meaningful progress—across these overlapping risk areas, they require persistent innovation in community building to meet the modern risk landscape.”

“The symposium will dive into the progress our communities have made—and how our passionate communities can better work together to help shape the future.”

“In addition to a keynote address, guests will hear from panels, take part in breakout sessions showcasing important issues and new ideas, plus engage with thought leaders between sessions. It will be a widely attended gathering, free to attendees.”

“As we enter a new year with an exceptionally dynamic security environment, we hope CSR’s December event will inspire and build a stronger community across professionals dedicated to anticipating and addressing the world’s greatest risks. We appreciate your consideration and hope you will be able to join us on the 10th of December.”

RSVP here.

Preparing for the Next Outbreak: Designing Closer Collaboration between Healthcare and Public Health to Deploy Pathogen-Agnostic Testing as an Early Warning System

From PNNL: “Please join us in welcoming Dr. Adi V. Gundlapalli, Senior Advisor for Data Readiness and Response in the Office of Public Health Data, Surveillance, and Technology at the CDC for his talk titled “Preparing for the Next Outbreak: Designing Closer Collaboration between Healthcare and Public Health to Deploy Pathogen-Agnostic Testing as an Early Warning System”. This webinar will take place Wednesday, November 13th, at noon PT.”

Learn more and register here.

Developing Guardrails for AI Biodesign Tools

This virtual event will take place on November 14 at 11 am EST. Learn more and register here.

13th Annual Jonathan Tucker Symposium

“The James Martin Center for Nonproliferation Studies cordially invites you to the 13th annual Jonathan Tucker Symposium on chemical and biological weapons issues on November 13th and 14th, 2024.”

Among this year’s speakers are Dr. Yong-Bee Lim, an alumnus of the Biodefense PhD Program and Deputy Director of the Converging Risks Lab and Biosecurity Projects Manager at the Council on Strategic Risks, who will give a talk titled “Technology Democratization and its Implications for CBW Safety and Security: Lessons Learned from Engagement with Non-Traditional Communities.”

Learn more and register here.

One Health and the Politics of COVID-19 Book Launch

The Writer’s Center is hosting a book launch for Dr. Laura Kahn’s new book, One Health and the Politics of COVID-19 (blurb below) on November 23 at 2 pm EST in Bethesda, MD. Learn more and RSVP here.

“One Health and the Politics of COVID-19 unpacks the mysteries of COVID-19’s origins to impart important lessons for future outbreaks. The One Health concept recognizes the interconnected links among the health of humans, animals, plants, and the environment. By comparing the history, science, and clinical presentations of three different coronaviruses—SARS-CoV-1, MERS, and SARS-CoV-2 (COVID-19)—Kahn uncovers insights with important repercussions for how to prepare and avoid future pandemics. The One Health approach provides a useful framework for examining the COVID-19 pandemic. Understanding the origins of this zoonotic disease requires investigating the environmental and molecular biological factors that allowed the virus to spread to humans. The book explores the many ways in which the wild animal trade, wet markets, and the camel industry contributed to the spread of the earlier SARS-CoV-1 and MERS coronaviruses. For SARS-CoV-2 (COVID-19), Kahn examines the biosafety, biosecurity, and bioethics implications of gain-of-function research on pandemic potential pathogens. This book is a must read to understand the geopolitics of the COVID-19 pandemic.”

2024 CBD S&T Conference

From DTRA: “The CBD S&T Conference brings together the most innovative and influential chemical and biological defense community members from around the globe to share insights and collaborate on the emerging chem-bio threats of tomorrow.”

“Join the Defense Threat Reduction Agency’s (DTRA) Chemical and Biological Technologies Department in its role as the Joint Science and Technology Office (JSTO) for Chemical and Biological Defense, an integral component of the Chemical and Biological Defense Program, as we Focus Forward to uncover novel concepts and examine groundbreaking discoveries within the chem-bio defense landscape.”

“The 2024 CBD S&T Conference will be held at the Broward County Convention Center, December 2–5, 2024.”

Learn more and register here.

Health Security Intelligence: Managing Threats Risks and Hazards Post-Covid 19
“As the acute impact of the COVID-19 pandemic recedes, many unaddressed questions remain for Australia about how to better prepare for the next likely health threat, risk or hazard.”

“In addition to how we enhance national public health capacity, what are the important lessons we can learn from the pandemic from national security and biosecurity perspectives?”

“Given the likelihood of another pandemic at some point, an increasingly uncertain geo-political order and the potential exploitation of biotechnology by bad actors how does Australia and its allies better prepare for a future of increasingly complex health security and biological security threats, risks and hazards?”

“This event is for all health security intelligence stakeholders (policy-makers, national security staff, scientists, researchers and clinicians) who work across the one health continuum and national security agencies.”

“It will introduce participants to Charles Sturt’s extensive research agenda across the one health biosecurity, health and biological security and discuss both their national security and scientific implications. You will hear briefings from key researchers across both STEM and social sciences disciplines working on assessing key health security threats, risks and hazards relevant to your work.”

This event will take place in-person and over livestream on December 4 from 2-4 pm AEDT. Learn more and register here.

US AI Safety Institute Issues RFI on Responsible Development of Chem-Bio Models

From AISI: “The U.S. Artificial Intelligence Safety Institute (U.S. AISI), housed within the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST), released a Request for Information seeking insight from stakeholders regarding the responsible development and use of chemical and biological (chem-bio) AI models.”

“Input from a broad range of experts in this field will help the U.S. AISI to develop well-informed approaches to assess and mitigate the potential risks of chem-bio AI models, while enabling safe and responsible innovation.”

“Respondents are encouraged to provide concrete examples, best practices, case studies, and actionable recommendations where possible. The full RFI can be found here.”

“The comment period is now open and will close on December 3, 2024, at 11:59PM Eastern Time. Comments can be submitted online at www.regulations.gov, under docket no. 240920-0247.”

Roadmap for Biosecurity and Biodefense Policy in the United States (2018)

November 5, 2024November 22, 2024 by dkellogg97, posted in Gryphon

The U.S. policy landscape for countering biological threats is split into two main groups: 1) biosecurity, which specifically focuses on preventing theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies to cause harm; and 2) biodefense, which involves the development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats. This project involved the first ever systems-based analysis of the entire U.S. biosecurity and biodefense policy landscape, which enabled greater understanding of the functional relationships between policies as of 2017. These analyses, along with reviews of methodologies for measuring policy implementation and historical case studies to better understand factors that lead to opportunity costs, informed the development of a roadmap for implementing biosecurity and biodefense policies that leverages science and technology advances and minimizes security risks. In addition to the roadmap, this study presents two analytic frameworks for evaluating policy implementation and analyzing opportunity costs.

Roadmap-of-US-Biosecurity-and-Biodefense-Policy_2018 Download

Supplements:

Executive Summary

Opportunity Cost Analysis Framework

Historical Case Studies for Opportunity Cost Analysis

Policy Case Study: Synthesis of the Horsepox Virus

Policy Evaluation Metrics Framework

Roadmap

Roadmap for Biosecurity and Biodefense Policy in the United States: Executive Summary

November 5, 2024November 22, 2024 by dkellogg97, posted in Gryphon

Executive-Summary_Roadmap-of-US-Biosecurity-and-Biodefense-Policy_2018 Download

Pandora Report 11.1.2024

November 1, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report discusses the WHO’s activation of the Global Health Emergency Corps, updates on H5N1 in the United States, a reported Lassa fever death in Iowa, and USAID’s recently-launched Strengthening Infectious Disease Detection Systems project.

WHO, Partners Activate Global Health Emergency Corps in Response to Mpox Outbreaks

The WHO and partners, in collaboration with Member States, announced this week the activation of the Global Health Emergency Corps (GHEC) for the first time in response to mpox outbreaks in several countries. The GHEC is a group of professionals whose goal is to strengthen response to health emergencies. It also functions as a collaboration platform for countries and emergency health networks. The WHO explained in a press release that, “In collaboration with the International Association of National Public Health Institutes, GHEC is assessing the emergency workforce capacities in 8 countries affected by the mpox outbreak, including the Democratic Republic of the Congo and Burundi, the two most affected countries. The assessment has so far identified 22 areas that need strengthening, including epidemiology and surveillance, laboratory capacities, infection prevention and control, risk communication and community engagement. In the Democratic Republic of the Congo, the Health Cluster partners have joined in strengthening the coordination set up by the Ministry of Health under the leadership of the public health emergency operations centre.”

H5N1 Updates

US Detects H5N1 in Backyard Swine

H5N1 infection in a pig on an Oregon backyard farm was confirmed this week, the US Department of Agriculture announced on Wednesday. The farm does have a mix of poultry and livestock, so the infected pig did share an environment with poultry, including water sources, housing, and equipment. Because the detection was found on a small farm, the USDA says risk to the nation’s pork supply and to the general public is low.

In addition to concerns about impact on farming and the food supply, this is concerning because pigs can be a mixing vessel for zoonotic and human influenza viruses as they are susceptible to avian, swine, and human influenza A viruses (IAV). Notably, the novel IAV that caused the 2009 H1N1 pandemic included two separate segments from the H1N1 swine virus lineage. However, it is unknown whether the animal had a systemic infection or if contamination caused positive nasal swab results.

NIAID: “Bovine H5N1 Influenza from Infected Worker Transmissible and Lethal in Animal Models”

“A highly pathogenic avian influenza (HPAI) H5N1 virus, isolated from the eye of a farm worker who became infected through contact with dairy cows, was lethal in mice and ferrets infected in a high-containment laboratory environment, according to a new study in Nature. The study investigators also found that the virus isolated from the worker, who experienced mild inflammation of the cornea (conjunctivitis), could be transmitted through the air between separated ferrets and might be capable of binding to and replicating in human respiratory tract cells.”

Read more here.

“Was Stone Age Scandinavia Struck by Plague?”

In this New York Times article, Franz Lidz discusses recent genetics research that points to a plague outbreak in Scandinavia more than 5,000 years ago, driving the Neolithic decline. Lidz explains in part, “A new genomic study published in July in the journal Nature makes the case for another candidate, which had been found in people living at the time but was never thought to have been widespread: the plague…Until now, it was unclear how virulent the Neolithic plague was within a human population. “There is a hypothesis that the oldest plague bacterium lacked epidemic potential,” said Dr. Seersholm, the lead author of the paper. “That hypothesis no longer holds.”’

ICYMI-“Lessons from History: A Conversation with Author John M. Barry”

“On Monday, October 28, a public seminar at the Brown University School of Public Health explored the history of pandemics and the lessons that apply to us today. The event featured a discussion with Brown alumnus John M. Barry ’68, author of The Great Influenza: The Story of the Deadliest Pandemic in History, which received the Outstanding Book on Science and Medicine for 2004 by the National Academies of Sciences.”

Pandora Report 10.25.2024

October 25, 2024 by dkellogg97, posted in Pandora Report

Happy almost Halloween! This week’s Pandora Report includes news from the Biodefense Graduate Program and discussion of the Biden administration’s latest National Security Memorandum, a new multilateral effort from the US, Canada, and Mexico to improve regional health security, the WHO’s praise for Rwanda’s swift and effective Marburg response, and more.

Upcoming Virtual Information Sessions on the Biodefense Graduate Program

The Schar School PhD programs will be holding a virtual open house on Wednesday, October 30 from 6-7:30 PM. Please join Dr. Gregory Koblentz, director of the Biodefense Graduate Program, to learn more about the Biodefense PhD program and ask any questions you may have. Register here.

GMU Biodefense Students Tour Mason’s Biomedical Research Laboratory

Last week twelve Biodefense students had the opportunity to visit George Mason’s 52,000 square-foot Biomedical Research Laboratory (BRL) located on the SciTech campus in Manassas, Virginia. The BRL was inactive after being decontaminated for annual maintenance . The tour, led by the BRL’s Director of Research Operations, Rachel Pepin, provided students with a firsthand look at Mason’s Biosafety Level 3 (BSL-3) and supporting Biosafety Level 2 (BSL-2) labs. Among the many highlights was the BRL’s autoclaves and gloveboxes, which left students impressed.

The BRL is one of 12 Regional Biocontainment Labs in the United States funded by the National Institute of Allergy and Infectious Diseases NIAID. Constructed in 2010, it became an active “hot” lab in 2012. Fifteen Mason faculty members and thirty students at any time work within the facility on research pertaining to a variety of infectious diseases, new vaccines, diagnostics, and therapeutics. The stated mission of Mason’s BRL is to 1) advance pathogen biology, 2) train the future workforce to safely handle infectious agents and conduct innovative research in BSL-3 environments, 3) evaluate diagnostics, therapeutics and vaccines, and 4) serve as a resource in the event of a bioterrorism or infectious disease emergency. Overall, students gained an appreciation for the critical work and numerous safety controls in George Mason’s BSL-3 laboratory.

This write up was written by Biodefense MS Student Will MacDonald.

OPCW Workshop on Legislative and Regulatory Frameworks for Chemical Security
On October 21-22, 2024, Dr. Gregory Koblentz, director of the Biodefense Graduate Program, attended a meeting of chemical security experts sponsored by the Organization for the Prohibition of Chemical Weapons (OPCW) to discuss best practices for establishing legislative frameworks for chemical security. According to INTERPOL, from the records of 4,100 captured ISIS members, 109 of them have a background related to chemistry, science, technology, engineering, and mathematics. Meanwhile, across the word, the chemical industry and trade are rapidly growing, increasing the risk of toxic chemicals being misused, especially by non-state actors. Many countries are therefore seeking to strengthen their legal and regulatory regimes to address risks such as attacks on chemical facilities, the theft of toxic chemicals, or their release with malicious intent. Initial take-aways from the meeting included a recognition that there is an urgent need for robust national legislative frameworks for chemical security in many countries, that national threat assessments and risk analyses should be the basis for identifying legislative needs, and best practices are most useful if they can be adapted to country-specific contexts and resource setting. This meeting of an international group of chemical security experts kicks off a longer-term discussion on best practices for establishing legislative frameworks for chemical security sponsored by the Implementation Support Branch of the International Cooperation and Assistance Division at OPCW.
A Risky Review of Research
On September 25, 2024, Senator Rand Paul introduced a revised version of the Risky Research Review Act (S. 4667) which was voted out of the Senate Homeland Security and Government Affairs Committee by a vote of 8-1. In a recent OpEd in StatNews, Gregory Koblentz, director of the Biodefense Graduate Program, and David Gillum and Rebecca Moritz, past presidents of the American Biosafety Association (ABSA) wrote of the original bill: “this legislation threatens to cast a shadow over the future of life sciences research and slow it down.” While this revised bill contains some positive changes, it remains deeply flawed and does not represent a viable solution to the challenges posed by dual-use research. You can read their analysis of the good, the bad, and the ugly of the revised Risky Research Review Act here.
Russia Expanding Secret BSL-4 Lab at Sergiev Posad
The Washington Post has identified new construction activity at Sergiev Posad-6, part of the former Soviet and current Russian biological weapons program, consistent with the building of additional high containment laboratories, including BSL-4 lab suites. The construction started in 2022, shortly after Russia’s invasion of Ukraine which was accompanied by unfounded allegations that Ukraine was developing biological weapons with the help of the United States and other NATO countries. Dr. Gregory Koblentz, director of the Biodefense Graduate Program, is quoted in the article as saying, “I would not be surprised if some influential segment of the Russian national security community has drunk the Kool-Aid and really believes that the United States really is developing biological weapons.” Satellite imagery obtained and analyzed by the Washington Post has identified the construction of “10 new buildings, totaling more than 250,000 square feet, with several of them bearing hallmarks of biological labs designed to handle extremely dangerous pathogens.” The Global BioLabs Initiative identified Sergiev Posad-6 as having a BSL-4 lab in 2021. The existence of a BSL-4 lab at this site was confirmed by a 2017 scientific article co-authored by a researcher at the 48^th Central Research Institute of the Ministry of Defense at Sergiev Posad. Russia has not declared the existence of a BSL-4 lab at this site on Form A of the confidence building measures that it submits to the Biological Weapons Convention.

White House Releases New National Security Memorandum on Advancing AI Leadership

The Biden administration issued this week the first-ever National Security Memorandum (MSM) on AI. The NSM direct the federal government to take steps to 1) “ensure that the United States leads the world’s development of safe, secure, and trustworthy AI,” 2) “harness cutting-edge AI technologies to advance the U.S. Government’s national security mission,” and 3) “advance international consensus and governance around AI.”

The NSM directives are focused on actions to improve chip supply chain security and diversity, making collection on competitors’ operations against the US AI sector a top-tier intelligence priority, formally designating the AI Safety Institute, doubling down on the National AI Research Resource, directing “the National Economic Council to coordinate an economic assessment of the relative competitive advantage of the United States private sector AI ecosystem,” and more.

Among its other measures, the NSM also directs the creation of a Framework to Advance AI Governance and Risk Management in National Security, which was published alongside the NSM. This framework and any successor document will specify that each covered agency has a chief AI officer and guidance boards, offer guidance on AI activities that pose “unacceptable levels of risk and that shall be prohibited,” and more.

A fact sheet for the new NSM is available here.

US, Canada, and Mexico Announce Efforts to Improve Regional Health Security

This week, the US Departments of Health and Human Services, State, Agriculture, and Homeland Security, along with their counterparts in Canada and Mexico made good on commitments made at the 2021 and 2023 North American Leaders’ Summits in releasing the North American Preparedness for Animal and Human Pandemics Initiative (NAPAHPI). NAPAHPI is “…a flexible, scalable, and cross-sectoral platform to strengthen regional capacities for prevention, preparedness, and response to a broad range of health security threats that builds on lessons learned from COVID-19 and other health security events in the last decade. It is based on a long-standing trilateral collaboration under the 2007 North American Plan for Avian and Pandemic Influenza and the 2012 North American Plan for Animal and Pandemic Influenza. This initiative recognizes that the high degree of interconnectedness among our three countries of our critical infrastructure, supply chains, and societies means that disruptions affecting one country often impact the others. Only by working together can we protect the health security of our region.”

Learn more here.
Egypt Declared Malaria Free

Egypt was officially certified malaria-free by the World Health Organization this week. Following Morocco and the UAE, Egypt is just the third country in the WHO’s Eastern Mediterranean region to receive this certification. Globally, 44 countries and one territory currently have this designation.

“This certification of Egypt as malaria-free is truly historic, and a testament to the commitment of the people and government of Egypt to rid themselves of this ancient scourge,” said WHO Director-General Tedros Adhanom Ghebreyesus in a statement. “I congratulate Egypt on this achievement, which is an inspiration to other countries in the region, and shows what’s possible with the right resources and the right tools.”

WHO Praises Rwanda’s Marburg Response

WHO Director-General Tedros Adhanom Ghebreyesus praised Rwanda’s response to its Marburg virus outbreak, noting their success in treating patients infected with this especially deadly disease. As of earlier this week, Rwanda has made it a full week with no new cases, and its total number of patients still in treatment is down to just one. “Leadership from the highest levels of government is essential in any outbreak response, and that’s what we see here in Rwanda,” Tedros said during the press briefing. The Director-General also noted that multiple patients experiencing multiple organ failure were put on life support, intubated, and eventually extubated. “We believe this is the first time patients with Marburg virus have been extubated in Africa. These patients would have died in previous outbreaks,” Tedros explained.

Burgers, Deli Meat, and Waffles-Oh My! US Responding to E. Coli and Listeria Outbreaks

It has been a rough couple of weeks for many major food suppliers in the United States amid headlines about recalls and reports of multiple cases of E. coli and listeria across the country. McDonald’s, KFC, Burger King, and other restaurant chains have pulled onions from their menus following an outbreak of E. coli traced back to McDonald’s Quarter Pounders. The CDC announced this week it is investigating 49 cases linked to “slivered onions used in the Quarter Pounder and sourced by a single supplier than serves three distribution centers.” One person is dead and ten more have been hospitalized. The supplier, Taylor Farms, has issued a recall on all of its peeled, diced, and whole peeled yellow onion packs due to potential contamination.

This comes amid multiple listeria outbreaks affecting several kinds of products, including deli meat, frozen waffles and pancakes, and even salmon. While these recalls are certainly nothing to ignore, they might not necessarily be happening more frequently than before as some have suggested. Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told CBS this week that “Every step of food processing, there’s the opportunity for contamination. That’s number one. Consumers want ready-to-eat food, so of course, they’re more processed as a result.” She continued, saying “We have better tests. So it used to be we might not have been aware or known what made you sick. Now we can actually test, detect and tell you what made you sick.”

“Assessing the Burden of and Potential Strategies to Address Antimicrobial Resistance”

From NASEM: “Antimicrobial resistance (AMR) is linked to millions of deaths globally each year. As an evolving public health threat, there is a need to further develop methods to quantify AMR’s burden within medical practice and other sectors like food production. The National Academies Forum on Microbial Threats hosted a public workshop in March 2024 to explore the burden of AMR and discuss clinical, scientific, and policy strategies for addressing the growing AMR health threat across sectors.”

“This proceedings highlights the presentations and discussions that occurred at the workshop.”

“The Changing Face of Pandemic Risk: 2024 Report”

From GPMB: “The 21st century has seen a significant rise in global health threats. Epidemics and pandemics are now a constant danger rather than rare events. The 2024 GPMB report, The changing face of pandemic risk, is a call to action for global leaders, policy-makers, health professionals, and communities to build a safer, more resilient future. It outlines the key drivers of pandemic risk and provides a roadmap for strengthening our defences.”

“Mpox: Neglect Has Led to a More Dangerous Virus Now Spreading Across Borders, Harming and Killing People. Leaders Must Take Action to Stop Mpox Now”

McNab et al. recently published this opinion article in PLOS Global Public Health, writing in part “In other words, mpox is an ever-growing regional health crisis in Africa, and without urgent action to stop the epidemics when and where they occur, it will continue to spread across borders and continents. The few tools we have that could help to stop the outbreaks have yet to become adequately available in the most affected low-income countries where they are urgently required, as is financing to support the public health response. Mpox cannot be allowed to continue spreading widely across the African continent or anywhere. The world cannot continue to simply ‘learn’, but not apply the costly lessons of neglecting disease outbreaks.”

“Are We Ready For A Bird Flu Vaccination Campaign?”

Ram Koppaka and Richard Hughes IV discuss the possibility of H5N1 human transmission and a hypothetical mass vaccination program against this virus in this piece for Health Affairs. They write in their conclusion, “The most recent pandemic clearly demonstrated the inadequacy of our existing level of vaccine preparedness. So far, we have failed to seize this moment and put in place the infrastructure to support immunization of both children and adults. Worse still, it indicates a failure to learn some of the pandemic’s hardest lessons. As a result, we are destined to once again endure the consequences, knowing that they had been largely avoidable…Or we can do it differently this time. We can act now to be truly ready and prepared to mount a mass vaccination campaign against the next pandemic threat—whenever it comes. We have risen to the occasion before, and we can do it again.”

“COVID, Mpox, Cholera: Is the World Prepared for Another Pandemic?”

Faras Ghani discusses recent outbreaks and infectious disease developments, alongside analysis of global lack of adequate access to essential healthcare services and an interview with Dr. Ahmed Ogwell, Vice President of Global Health Strategy at the UN Foundation, in this piece for Al Jazeera.

“Inside the Bungled Bird Flu Response, Where Profits Collide With Public Health”

Katherine Eban discusses the USDA’s action or lack thereof in responding to H5N1 cases in Texas dairy cattle in this Vanity Fair article, writing in her summary “When dairy cows in Texas began falling ill with H5N1, alarmed veterinarians expected a fierce response to contain an outbreak with pandemic-sparking potential. Then politics—and, critics say, a key agency’s mandate to protect dairy-industry revenues—intervened.”

“Combining AI Breakthroughs and Better Policy to Defeat Superbugs”

Akhila Kosaraju discusses the transformative opportunity AI poses in addressing AMR in this piece for the Stanford Social Innovation Review: “Superbugs may have met their match in generative AI, but to fully tackle the crisis of antimicrobial resistance, policy makers need to find new ways to help scientists and researchers overcome long-standing obstacles and revitalize a broken antibiotic market.”

“NTI | Bio Champions Effort to Enhance Transparency to Strengthen the Biological Weapons Convention”

From NTI: “From September 30 to October 2, 2024, NTI | bio convened more than 30 experts for a workshop on enhancing transparency for bioscience research and development and bolstering confidence in compliance with the Biological Weapons Convention (BWC). Held in Amsterdam, The Netherlands, the workshop gathered an international group of participants from 15 countries spread across five continents with expertise in biosecurity and biotechnology governance and international security, as well as previous experience working to establish a verification mechanism for the BWC and involvement in ongoing discussions to strengthen the Convention.”

“The meeting updated existing concepts and generated new ideas about options to enhance transparency in regard to BWC compliance. NTI helped frame these discussions by tabling a concept paper on this topic, and the group discussed approaches to advance these goals, including through scientific and technical measures for data collection and analysis, procedural approaches, and institutional structures to house such efforts. Dozens of approaches were discussed during the meeting which will inform NTI’s continued efforts to highlight and explore promising opportunities to further advance this work.”

Read more here.

“Preparing for Ecological Disruption: A Strategic Foresight Approach to Ecological Security”

Lily Boland recently authored this report for the Council on Strategic Risks: “This report leverages insights gained from the use of strategic foresight as an approach for better anticipating how risks to global security are heightened by ecological disruption. It offers a range of use-cases for applying the foresight toolkit to the field of ecological security and to establish a knowledge base to assist practitioners, governments, and institutions in enhancing their anticipatory decision-making and planning processes for addressing the security ramifications of large-scale destabilization and decline of the biosphere and ecosystems.”

“How Zombies and Vampires Help Me Grapple with Disaster”

Neil Vora, a physician who has served in the Epidemic Intelligence Service and now treats TB patients and works with Conservation International, discusses what many in this field know all too well-an obsession with works of horror, especially those about contagions and disasters. Vora explains in part, “To help manage my anxieties about the fate of the world, I often turn to scary stories about contagions and other doomsday scenarios. This may seem counterintuitive, but I find the horror genre to be a perfect sandbox to explore pressing societal problems without real-world repercussions. Horror allows me to navigate my fears to their extremes from the comforts of my living room.”

However, the author also cautions, “But while fictionalized catastrophes help me grapple with my worst fears, I’ve also come to realize that consuming them without a critical eye can lead to a paralyzing level of despair—a luxury we can’t afford at this pivotal moment in history.”

While you’re at it, check out this episode of the Poisons and Pestilence podcast guest starring Biodefense PhD Program alumna and faculty member Saskia Popescu reviewing the films, Contagion and Outbreak, and read about her intro to the field at just 9-years-old via Richard Preston’s book, The Hot Zone.

NEW: Vision for Health Forum

Panel Discussion
Moderator:
M. Shafeeq Ahmed, M.D., MBA, F.A.C.O.G
President, Johns Hopkins Howard County Medical Center

Topic: Partnership between JHHCMC and APL
Jeanette Nazarian, M.D., Vice President, Medical Affairs and Chief Medical Officer- Johns Hopkins Howard County Medical Center

This event will take place at the Johns Hopkins Applied Physics Laboratory on November 4 at 4:30 pm EST. Learn more here.

The Advancing Threat Agnostic Biodefense Webinar Series

From PNNL: “Please join us in welcoming Drs. Matthew Kasper and Lindsay Morton from the Department of Defense (DoD) Global Emerging Infections Surveillance (GEIS) program for their talk titled “Challenges and Opportunities in Pathogen Agnostic Sequencing for Public Health Surveillance: Lessons Learned From the Global Emerging Infections Surveillance Program.” This webinar will take place Tuesday, October 29th, at noon PT.”

Learn more and register here.

13th Annual Jonathan Tucker Symposium

Learn more and register here.

One Health and the Politics of COVID-19 Book Launch

2024 CBD S&T Conference

“The 2024 CBD S&T Conference will be held at the Broward County Convention Center, December 2–5, 2024.”

Learn more and register here.

BID2025 Stakeholder Input Request
“From BARDA: We are excited to host our next BARDA Industry Day (BID) conference on June 30 – July 1, 2025, in Washington, D.C.! BID2025 will delve into the critical intersection of health security and sustainability with experts from various sectors to discuss cutting-edge medical countermeasure (MCM) innovations and strategies.”

“We want to make sure that the event reflects the interests of our attendees. Your feedback will help us curate sessions, speakers, and topics that are relevant and engaging for you. This short questionnaire should take no more than three minutes to complete. Please share your thoughts on what you would like to see at the conference by October 30, 2024.“

Share thoughts here.

US AI Safety Institute Issues RFI on Responsible Development of Chem-Bio Models

“Respondents are encouraged to provide concrete examples, best practices, case studies, and actionable recommendations where possible. The full RFI can be found here.”

“The comment period is now open and will close on December 3, 2024, at 11:59PM Eastern Time. Comments can be submitted online at www.regulations.gov, under docket no. 240920-0247.”

A Risky Review of Research

October 21, 2024November 5, 2024 by dkellogg97, posted in Commentary

Gregory D. Koblentz, David Gillum, and Rebecca Moritz

October 15, 2024

On September 25, 2024, Senator Rand Paul introduced a revised version of the Risky Research Review Act (S. 4667) which was voted out of the Senate Homeland Security and Government Affairs Committee by a vote of 8-1. In a recent OpEd in STATNews, we wrote of the original bill: “this legislation threatens to cast a shadow over the future of life sciences research and slow it down.” While this revised bill contains some positive changes, it remains deeply flawed and does not represent a viable solution to the challenges posed by dual-use research. This article analyzes the good, the bad, and the ugly of the revised Risky Research Review Act and finds that the negative features outweigh the positive ones.

The Good

The revised bill contains three positive additions compared to the original: the inclusion of a biosafety expert on the Life Sciences Research Security Board, the provision for expedited review of high-risk life sciences during an emergency, and a clearer definition of high-risk research that is more closely aligned with current U.S. government policy.

The composition of the Life Sciences Research Security Board has improved slightly. In our OpEd, we wrote, “The composition of the proposed board also raises serious concerns about its ability to effectively oversee high-risk research. The board would consist of political appointees, including life scientists and national security experts, but lacks a requirement for members to have expertise in biosafety and biosecurity. This omission is critical, as effective oversight of high-risk research requires nuanced understanding and practical, hands-on experience in these areas.” The revised bill now includes one biosafety expert on the Board, in addition to the executive director, five non-governmental life scientists, and two non-governmental experts in national security. Ideally, this expert should have practical hands-on biosafety experience both implementing research policy on a daily basis as well as reviewing life science research for potential misuse and developing risk mitigation measures. The new composition of the Board is one step closer to the long-recognized and widely supported need for a multidisciplinary approach to oversight of dual-use research. For example, current guidance from Office of Science and Technology Policy is that committees at Federal funding agencies conducting reviews of dual-use research should include representatives with experience in scientific research, biosafety, biosecurity, national security, and ethics, and other relevant areas.

The revised bill, however, does not address a problem we raised regarding how the bill’s conflict of interest provisions could affect the composition of the board: “The bill’s provisions regarding conflicts of interest defined too broadly could also disqualify many well-qualified individuals from serving on the board. It would exclude scientists with experience conducting high-risk research, which could result in a board lacking the necessary knowledge, expertise, and skills to make informed decisions about the risks and benefits of life sciences research, thereby undermining its effectiveness and credibility.”

Another good addition to the bill is a provision, in section 7906(d), for expedited review of high-risk life sciences research during a public health emergency or to address a specific national security concern. This was a necessary addition given the legislation’s 120-day timeline for reviewing and approving research proposals involving high risk life sciences research.

The revised bill also more clearly defines the scope of what it considers “high risk life sciences research” and this definition is in closer alignment with the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (also known as the 2024 DURC/PEPP Policy), but the scope of high-risk research still has important ambiguities. The definition of high-risk life science research includes “gain of function” research and dual-use research of concern (DURC) involving a high-consequence pathogen (HCP), a new term of art introduced by this bill. However, the overall scope of the Risky Research Review Act is actually narrower than the 2024 DURC/PEPP Policy.

The definition of dual-use research of concern in section 7901(4) is mostly aligned with the definition of Category 1 Research in the 2024 DURC/PEPP Policy, with a few minor exceptions. The bill adds two additional experiments of concern to what constitutes DURC under the 2024 Policy: enhancing the transmissibility of a pathogen in humans (7901(4)(B)(i)(X)) and enhancing the virulence of a pathogen in humans (7901(4)(B)(i)(XI)). Since enhancing the transmissibility and virulence of pathogens are already covered under 7901(4)(B)(i)(I) and (7901(4)(B)(i)(II), respectively, it is not clear what the purpose of including these additional experiments are.

In addition, the bill includes “generate, use, reconstitute, or transfer an eradicated or extinct high-consequence pathogen” which is broader than the 2024 DURC/PEPP Policy which specifies such research with a pathogen with pandemic potential (PPP) or a previously identified pathogen with enhanced pandemic potential (PEPP). There are only three eradicated or extinct pathogens of concern—variola major, variola minor, and rinderpest. Since the generation, use, reconstitution, or transfer of variola major and variola minor are already covered by 18 US Code 175c, the 2024 DURC/PEPP Policy, and the Select Agent Regulations, the only impact of this provision is to apply the same restrictions to rinderpest, which is not considered a PPP since it does not affect humans.

The bill defines gain of function under section 7901(7) as “a research experiment that may enhance the transmissibility or virulence of a high-consequence pathogen.” The inclusion of gain of function as a separate category is redundant since the revised bill’s definition of dual-use research of concern also includes research involving the enhancement of transmissibility under 7901(4)(B)(i)(I) and 7901(4)(B)(i)(X) and enhancement of virulence in 7901(4)(B)(i)(II) and 7901(4)(B)(i)(XI).

This bill, like the 2024 DURC/PEPP Policy, covers these specified research activities when conducted in conjunction with certain pathogens. Like the 2024 DURC/PEPP Policy, the bill uses list-based and risk-based approaches to define what it considers to be a high consequence pathogen. The risk-based approach is identical to that used by the 2024 DURC/PEPP Policy to identify a PPP, namely a “pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.” The list-based approach used by the bill (which is shorter than the original bill) yields a narrower list of agents subject to oversight compared to the 2024 DURC/PEPP Policy.

The list used by the revised bill includes wild-type or synthetic versions of influenza A viruses (excluding seasonal strains); sarbecoviruses, a subgenus comprised of 1 species; merbecoviruses, a subgenus comprised of four species; 11 other specific viruses; Yersinia pestis; and “a select agent or toxin, work with which poses a significant risk of deliberate misuse.” There are currently 68 agents and toxins under the Federal Select Agent Program. It is unclear what the bill means by “work with which poses a significant risk of deliberate misuse,” under what conditions research with a select agent and toxin would be trigger this provision and be considered a high-consequence pathogen, and how this definition relates to how the bill defines dual-use research of concern. If this provision is intended to subject all research with select agents, even with unmodified wild-type strains, to approval by the Board, then it belongs in the category of bad features of the bill.

Overall, the revised bill is an improvement over the original. However, the improvement is marginal and the bill is still plagued with definitional ambiguities. Overall, these positive changes are outweighed by the continued negative aspects that are retained from the original bill and are detailed in the next section.

The Bad

At its heart, this bill contains the same flawed process for reviewing high-risk life sciences research and the same excessive overreach we criticized in the original bill. As we wrote in STAT News,

“The proposed Life Sciences Research Security Board would have the unprecedented authority to veto funding for life sciences research, regardless of whether it is deemed high risk. This authority would effectively place the entire federally funded life sciences research enterprise under the board’s jurisdiction. This provision is particularly worrisome because it would allow the board to overrule agency decisions on a wide range of life sciences research, potentially including projects with minimal, or even no significant risk. Such extensive veto power could disrupt the research funding process, causing extensive delays that hamper scientific progress. This broad oversight could lead to a significant increase in the volume of research proposals subject to review by the board, further slowing down the funding process and creating bottlenecks that impede timely scientific advancements.”

Under the original and revised bills, entities that apply for Federal life sciences research funding must attest to whether their research falls into the category of “high-risk life sciences research” or not (section 7905(b)). The Federal funding agency receiving the proposal must then review these attestations and forward positive attestations to the Board for review. However, the funding agencies must also review negative attestations and “certify” that these attestations are valid. While the enforcement provisions in section 7905(g) of the revised bill are less draconian than those in the original bill, they are stiff enough that they will create a strong incentive for agencies to scrutinize every life sciences research proposal submitted to ensure that the offered attestation, positive or negative, is correct. In addition, the need to review and certify life science research proposals that are not deemed to be high risk will absorb additional resources within funding agencies. This will inevitably slow down the review and approval of all proposed life sciences research, even if it is declared not to pose a high risk.

The Board can take up to 150 days (an agency submits notification 30 days before award and the Board has 120 days to review) to render their determination on proposed high-risk research. Therefore, proposed high-risk life sciences research could be delayed for up to five months beyond the current process, assuming this new review process runs smoothly. If proposers or funding agencies categorize a broad range of life sciences research as high-risk to avoid being accused of not following the legislation, then this lengthy review process could affect a much larger volume of research beyond that which is genuinely high-risk, and it will be more difficult for the Board to review proposals based on this timeline.

The bill also gives the Board the ability to expand its jurisdiction unilaterally by changing the definition of dual-use research of concern (under section 7901(4)(B)(ii)) and expand the list of HCPs (under section 7901(8)(A)(ii)(XVII). Coupled with the lack of provisions requiring the Board to solicit public comment on proposed procedures for the high-risk life sciences proposal review process (under section 7904(c)), there is a significant risk that the Board could engage in regulatory overkill that fails to balance the risks and benefits of the dual-use research it is charged with overseeing.

A highly problematic provision of the original bill retained in the revised bill extends the jurisdiction of the Board to all life sciences research, even if it is not considered high-risk. Under section 7906(a)(2), the Board will have the authority to review all proposed research in the field of the life sciences, even if it is not designated as high-risk and determine if it should be funded or not. In section 7901(10), the revised bill defines life sciences research as the study or use of a living organism, virus, or product of a living organism, and “each discipline, methodology, and application of biology, including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques.” While this is a narrower definition than found the original version, it is still broad enough to provide the Board with unfettered control over the entire Federally funded life sciences research enterprise. Federal agencies spent $42.5 billion on life sciences research in 2020. In 2022, Federal agencies awarded approximately $30 billion to academic institutions for life sciences research.

The Ugly

Several features of the bill make the Board vulnerable to abuse which could have a chilling effect on a wide swathe of life sciences research that includes work on infectious diseases and the development of medical countermeasures.

Under section 7906(a)(3), the Board will have the authority to audit previously funded life sciences research that was determined not to be high-risk. The bill, under section 7905(e), also gives the Board the power to demand “any information relating to Federal funding awards for life sciences research determined necessary by the Board to provide oversight of the agency.” In addition, under 7905(h)(3), the Board may request additional information directly from an entity that has proposed or is receiving Federal funding and uses subawards or subcontractors to conduct its research. These provisions appear designed specifically to empower the Board to investigate the National Institutes of Health’s (NIH) previous decision to fund research on chimeric coronaviruses by EcoHealth Alliance at the Wuhan Institute of Virology, which was deemed by NIH not to fall within the scope of the Office of Science and Technology Policy’s Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (or P3CO Policy). Senator Paul has been one of the leading voices linking this research to the origin of SARS-CoV-2 and the COVID-19 pandemic.

The partisan nature of the bill is reinforced by several provisions that grant Congressional members and committees’ extensive access to the inner workings of the Board, Federal funding agencies, and research institutions that conduct life sciences research. Under section 7902(g), the Senate Homeland Security and Government Affairs Committee and the House Committee on Oversight and Accountability shall “have access to any records provided to or created by the Board.” The Board must respond to requests for information from a member of Congress within 30 days and the Board must brief the appropriate Congressional committees at least quarterly. While congressional oversight of executive agencies is both proper and necessary, the degree of congressional access and influence hardwired into the Board makes it more vulnerable to political pressure. The perception that the Board is being used as a stalking horse by political actors will undermine its legitimacy, credibility, and effectiveness.

Conclusion

Although this legislation is touted as focusing on the review of high-risk life sciences research, the Board’s authority to review all life sciences research, regardless of risk level, and veto funding agency decisions, will result in the close scrutiny of a much wider swathe of life sciences research which will likely lead to significant delays in the funding of this research. In addition, the ambiguities in its definition of high-risk life sciences research, the additional scrutiny of life sciences research that is not deemed high-risk, and the broad authority to investigate how funding agencies and institutions conduct research has the potential to have a chilling effect on the willingness of U.S. scientists to seek Federal funding for research with dangerous pathogens and for Federal agencies to fund such research. This could, paradoxically, incentivize researchers to seek funding from the private sector or foreign sources, which will exercise little to no oversight for biosafety or biosecurity. The end result could be a less dynamic, innovative, and competitive life sciences research enterprise in the United States and riskier research being conducted with less oversight.

Gregory D. Koblentz is director of the Biodefense Graduate Program at George Mason’s Schar School of Policy and Government and co-director of the Global BioLabs Initiative. David Gillum is associate vice president of compliance and research administration at the University of Nevada, Reno, an associate editor of Applied Biosafety, and co-founder of Tutela Strategies. Rebecca Moritz is co-founder of Tutela Strategies and is the immediate past president of ABSA International.

Pandora Report 10.19.2024

October 19, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report covers updates from the Biodefense Graduate Program, a new biosecurity and biosafety declaration from ASEAN leadership, the United States’ IV fluid shortage, new publications and upcoming events, and more.

Upcoming Virtual Information Sessions on the Biodefense Graduate Program

Biodefense MS Grads Starts at National Security Commission on Emerging Biotechnology as Policy Advisor

Olivia Parker, a recent graduate of the Biodefense MS program, recently joined the National Security Commission on Emerging Biotechnology (NSCEB) as a policy advisor. NSCEB is a legislative branch advisory entity charged with conducting a thorough review of how advancements in emerging biotechnology and related technologies will shape current and future activities of the Department of Defense. To learn more about NSCEB, visit their website here: https://www.biotech.senate.gov.

Establishing a National Biosafety and Biosecurity Agency for the United States
Professor Gregory Koblentz, director of the Biodefense Graduate Program, along with co-authors David Gillum and Rebecca Moritz, past presidents of the American Biosafety Association (ABSA), have published an article proposing the establishment of an independent Federal agency to oversee a unified national biorisk management system in the United States called the National Biosafety and Biosecurity Agency (NBBA). The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological research, including risks associated with accidental, inadvertent, and deliberate biological incidents. The NBBA would consolidate various regulatory functions, streamline processes, and enhance oversight. This oversight would encompass life sciences research in the United States, regardless of the source of funding or level of classification. The agency could also contribute to the bioeconomy by streamlining requirements to safeguard public health and the environment while fostering scientific and commercial progress. The proposed agency would govern high-risk biological pathogens, manage the Federal Select Agent Program, enforce policies related to dual use research of concern, pathogens with enhanced pandemic potential, and nucleic acid synthesis screening, administer regulations on the use and care of laboratory animals, as well as regulate other relevant biosafety and biosecurity activities. The goal would be to provide one-stop shopping for the biomedical research and biotechnology sectors subject to oversight by the Federal government. To ensure leadership in global biosafety and biosecurity, the agency’s mission would include international collaboration, applied research, education, workforce development, and coordination with national security initiatives. Creating an agency like the NBBA will be politically challenging but presenting a comprehensive vision and engaging stakeholders early and frequently, and being transparent in the process, will be essential for garnering support. Creating a unified biosafety and biosecurity governance system in the United States will ensure the safe and secure advancement of biological research while sustaining innovation and maintaining international competitiveness. The article is open access and can be downloaded here.

George Mason Scientist Secures $1.4 Million from DTRA to Study Viruses’ Impacts on Organ Health

George Mason University researcher Aarthi Narayanan recently secured a $1.4M grant from the Defense Threat Reduction Agency (DTRA) to investigate how an infection spreads between organs, and how a therapeutic will impact connected organs. The work will initially focus on mosquito-transmitted viruses while Narayanan hopes to expand the implications from these studies to other human disease states. Read more here.

ASEAN Leaders Make Declaration on Strengthening Regional Biosafety and Biosecurity

Leaders of the nations comprising the Association of Southeast Asian Nations (ASEAN) made a declaration on biosafety and security earlier this month during the 44th and 45th ASEAN Summits in Vientiane, Lao PDR. Their declaration includes an agreement to strengthen biosafety and biosecurity in the region by committing to strengthening multi-sectoral and multi-stakeholder coordination at the national level on these issues, establishing the ASEAN Biosafety and Biosecurity Network, establishing or strengthening relevant national legal frameworks, upholding commitments around responsible and ethical research using high-risk pathogens and toxins and related data to prevent DURC issues, enhancing protocols and procedures for the safe storage and transport of high-risk pathogens and toxins, ensuring the provision of necessary relevant human resources, supporting efforts to develop sustainable lab infrastructure, and tasking ASEAN Health Ministers to cooperate with relevant ministries to begin consultation, coordinate, and monitor efforts to meet the declaration’s deliverables.

Amid IV Fluid Shortage, Biden Administration Invokes Defense Production Action

The Biden administration told news outlets this week that it has invoked the Defense Production Act (DPA) in order to quicken the reconstruction of a Baxter facility in North Cove, North Carolina that was heavily damaged by Hurricane Helene. The plant was responsible for about 60% of the nation’s IV solutions, so the damage done to it by the storm has left many hospitals postponing surgeries and other procedures. Several products are affected, including multiple concentrations of dextrose IV solution, lactated ringers IV solution, peritoneal dialysis solution, sodium chloride 0.9% IV solution and for irrigation, and sterile water for injection and irrigation.

The DPA was passed in response to the Korean War and is historically based on the War Powers Acts of World War II. Over the years, Congress has expanded the term “national defense” as defined in the DPA so its scope includes things like enhancing and supporting “domestic preparedness, response, and recovery from natural hazards, terrorist attacks, and other national emergencies.” The DPA can be used to compel companies to prioritize government contracts and to help the federal government incentivize expansion of productive capacity and supply. The DPA was similarly invoked by both the Trump and Biden administrations in response to the COVID-19 pandemic.

Baxter said this week that 450 truckloads of undamaged products were removed from the site and that it is working with seven of its plants around the world to help address the shortage. The company is working with the FDA to import nearly 18,000 tons of product from Europe and Asia through the end of the year. Shipments from Baxter plants in Mexico and Spain began arriving last week, and the FDA has already authorized temporary importation from five sites in Canada, China, Ireland, and the United Kingdom. The company is also looking into other strategies, such as expiration date extension requests.

While this recent escalation of IV solution shortage is concerning, it is part of a broader problem that has existed in the US for years. Many of the products listed above were already in shortage prior to Hurricane Helene damaging the North Cove facility. For example, sterile water for injection was placed on the FDA shortage list in November of 2021, and multiple types of dextrose IV solution were added in early 2022. Perhaps most shockingly, saline solution has been on the list since June of 2018.

The reason the US has been grappling with this shortage for years, unsurprisingly, comes down to their lack of profitability. There is a high barrier to entry in that companies must invest substantial time and money in meeting regulatory requirements and setting up a manufacturing facility. At the same time, they are pressured to keep the prices of these products low. There are also issues with managing storage and transportation of these products, as a single bag of saline is about a foot long and weighs more than two pounds. Maintaining the sterility needed to safely make these products further complicates matters as well. Erin Fox, Senior Pharmacy Director at the University of Utah Health, told NBC that “These are life-saving products, but at the same times these are absolutely treated as kind of commodities.”

This situation is mirrored in an even more threatening issue-the dearth of antibiotic research amid rising antimicrobial resistance. While the WHO firmly warned last year that “We have arrived in the post-antibiotic era,” research and development of new antibiotics are still falling flat. Similarly, much of the issue comes down to reliance on private companies for innovations when those companies no longer have enough incentive to try and bring new antibiotics to market. By the 1980s, pharmaceutical companies knew they were unlikely to develop broad-spectrum antibiotics, and it is not very profitable to treat specific types of infections. This hurt private sector research greatly and, by 2021, just four major US pharmaceutical companies had dedicated antibiotic divisions. The FDA and its EU equivalent, the European Medicines Agency, have approved just 12 new antibiotics since 2017, 10 of which were similar to existing drugs.

There are some measures in work to help address this issue, including ARPA-H’s recently announced Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project. Another example is the proposed Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act, or PASTEUR Act. The bipartisan bill failed to pass the Senate in 2021, but a revamped version (albeit with less funding) was introduced last year. The bill calls for the creation of a Committee on Critical Need Antimicrobials, requirements for HHS to award grants that support appropriate stewardship of antimicrobial drugs, and authorization of HHS to enter into subscription contracts for critical-need antimicrobial drugs.

No one potential law will address the lack of antibiotic research in the US, let alone the broader challenge of AMR and superbugs. Similarly, using the DPA once to help hasten the rebuilding of the North Cove Baxter facility will not get the country completely out of trouble in maintaining adequate IV solution supply. These kinds of challenges are long games that are only going to get worse amid economic and supply chain challenges, in addition to problems like climate change. Addressing these kinds of problems requires long-term thinking and sustained funding, rather than relying on reacting to issues as they worsen.

“Public Health Departments Face a Post-COVID Funding Crash”

Jazmin Orozco Rodriguez tackles the newest iteration of the public health boom-and-bust funding cycle in this article for KFF Health News: “But public health leaders quickly identified a familiar boom-and-bust funding cycle as they warned about an incoming fiscal cliff once the federal grants sunset. Now, more than a year since the federal Department of Health and Human Services declared the end of the coronavirus emergency, states — such as Montana, California and Washington — face tough decisions about laying off workers and limiting public health services…Public health experts warn that losing staff who perform functions like disease investigation, immunization, family planning, restaurant inspection and more could send communities into crisis.”

“Mitigating Risks from Gene Editing and Synthetic Biology: Global Governance Priorities”

Stewart Patrick and Josie Barton authored this report for the Carnegie Endowment for International Peace: “Rapid advances in bioscience and bioengineering hold immense promise for human betterment. But as these disruptive technologies become more widely distributed, their inherently dual-use nature and susceptibility to unintended consequences could create unprecedented dangers.”

“AI Scans RNA ‘Dark Matter’ and Uncovers 70,000 New Viruses”

Smriti Mallapaty breaks down recent AI-powered research in this article for Nature News, explaining in part “Researchers have used artificial intelligence (AI) to uncover 70,500 viruses previously unknown to science, many of them weird and nothing like known species. The RNA viruses were identified using metagenomics, in which scientists sample all the genomes present in the environment without having to culture individual viruses. The method shows the potential of AI to explore the ‘dark matter’ of the RNA virus universe.”

“Tackling AMR: A Call for Global Action to Preserve Medical Progress”

Paul Murray, CEO of Life and Health Reinsurance at Swiss Re, discusses AMR and compounding factors like climate change in this piece for the World Economic Forum, writing in part “More such efforts are needed. Ultimately, stewardship programmes that promote the appropriate use of antimicrobials will be critical to preserving the effectiveness of existing medications. In addition, renewed drug development efforts to invent novel antibiotics are necessary, with resistant species emerging more quickly after a new drug’s introduction.”

“The Changing Face of Pandemic Risk: 2024 Report”

From GPMB, this report is a “…call to action for global leaders, policy-makers, health professionals, and communities to build a safer, more resilient future. It outlines the key drivers of pandemic risk and provides a roadmap for strengthening our defences.”

“Emerging Trends in Chemical Weapons Usage in the Middle East”

Natasha Hall discusses multiple issues regarding CW in the Middle East in this CSIS Brief, including the international community’s failure to address the Assad regime’s use of these weapons, challenges in multipolarity, and how actors are most likely to challenge existing norms by escalating from using RCAs to TICs and PBAs while spreading disinformation and slowing evidence collection.

“Putin Ordered Novichok Attack, Double Agent Skripal Tells UK Inquiry”

This reporting from Reuters details Sergei Skripal’s statement to the public inquiry into the death of Dawn Sturgess, and the poisoning of Yulia and Sergei Skripal in addition to a police officer who responded to the incident. In it, Skripal says “I believe Putin makes all important decisions himself. I therefore think he must have at least given permission for the attack on Yulia and me.”

Read more here.

“Russia’s Chemical Weapons Lies”

John V. Parachini and Svitlana Slipchenko discuss Russia’s CW-focused disinformation in this piece for the National Interest, writing in part “State parties should demand that Russia stop weakening the global ban on chemical weapons use with its torrent of falsehoods about others, disclose its own secret chemical weapons activities, and lay out a plan for coming into compliance with an accord it helped negotiate.”

“Russia’s Latest Target in Africa: U.S.-Funded Anti-Malaria Programs”

The New York Times‘ Elian Peltier discusses Russia’s use of African influencers to discredit US-funded anti-malaria programs on the continent amid to help stoke distrust and fear of the West in this article: “Western-backed health initiatives in Africa are one of Russia’s latest targets, a scenario reminiscent of the Cold War, when the Soviet Union accused the United States of spreading AIDS on the continent. The State Department says that African Initiative, a news outlet backed by Russia’s intelligence services, has spun similar accounts, including “disinformation regarding an outbreak of a mosquito-borne viral disease.”’

“Fueling China’s Innovation: The Chinese Academy of Sciences and Its Role in the PRC’s S&T Ecosystem”

Cole McFaul, Hanna Dohmen, Sam Bresnick, and Emily S. Weinstein recently published this CSET Issue Brief: “The Chinese Academy of Sciences is among the most important S&T organizations in the world and plays a key role in advancing Beijing’s S&T objectives. This report provides an in-depth look into the organization and its various functions within China’s S&T ecosystem, including advancing S&T research, fostering the commercialization of critical and emerging technologies, and contributing to S&T policymaking.”

What We’re Listening To 🎧

The BWC Global Forum: Biotech, Biosecurity & Beyond, Episode 15-Open-Source Intelligence

This episode features Yong-Bee Lim, an alumnus of the Biodefense PhD Program and the current Deputy Director of the Converging Risks Lab and Biosecurity Projects Manager at the Council on Strategic Risks.

“In this episode, we discuss the availability and use of open-source data to monitor BWC-related activities. Dr. Lim is leading a study to identify tools, techniques, and sources to support the ability to identify, track, and evaluate biological activities using publicly available information. Open-source analysis of biological activities, facilities, programs, and capabilities has been revolutionized through the convergence of radically expanded public access to data previosuly only available to state-level intelligence agencies and the emergence of advanced analytic tools, such as machine learning and artificial intelligence (AI). These new capabilities potentially offer civil society experts—or state governments without advanced intelligence programs—the opportunity to identify trends and patterns in data that can provide insight into the nature of biological activities.”

New: 13th Annual Jonathan Tucker Symposium

Learn more and register here.

NEW: 2024 CBD S&T Conference

“The 2024 CBD S&T Conference will be held at the Broward County Convention Center, December 2–5, 2024.”

Learn more and register here.

Potential Research Priorities to Inform Readiness and Response to Highly Pathogenic Avian Influenza A (H5N1)

“The National Academies will host a 2-day virtual public workshop, October 22-23, to explore research priorities for the ongoing H5N1 outbreak in the U.S. Recognizing the interconnection between people, animals, and their shared environment, this workshop will take a One Health approach to bring together federal government agencies, the academic community, and the private sector, as well as other relevant stakeholders across the health, agriculture, and food safety sectors.”

“Workshop discussions will focus on basic science and research areas of concern and may help inform future research that could provide local, national, and global communities with information about virus transmission, mitigation of risks, and appropriate measures to prevent the spread of disease.”

Learn more and register here.

The Advancing Threat Agnostic Biodefense Webinar Series

Learn more and register here.

One Health and the Politics of COVID-19 Book Launch

NEW: BID2025 Stakeholder Input Request
“From BARDA: We are excited to host our next BARDA Industry Day (BID) conference on June 30 – July 1, 2025, in Washington, D.C.! BID2025 will delve into the critical intersection of health security and sustainability with experts from various sectors to discuss cutting-edge medical countermeasure (MCM) innovations and strategies.”

“We want to make sure that the event reflects the interests of our attendees. Your feedback will help us curate sessions, speakers, and topics that are relevant and engaging for you. This short questionnaire should take no more than three minutes to complete. Please share your thoughts on what you would like to see at the conference by October 30, 2024.“

Share thoughts here.

US AI Safety Institute Issues RFI on Responsible Development of Chem-Bio Models

“Respondents are encouraged to provide concrete examples, best practices, case studies, and actionable recommendations where possible. The full RFI can be found here.”

“The comment period is now open and will close on December 3, 2024, at 11:59PM Eastern Time. Comments can be submitted online at www.regulations.gov, under docket no. 240920-0247.”

ACHS Fellowship Program 2025

From the Asia Centre for Health Security: “The ACHS Fellowship Program aims to inspire and connect the next generation of biosecurity leaders and innovators.”

“Newly launched in 2025, ACHS Fellowship is a highly competitive, part-time program that provides an opportunity for talented graduate students and professionals to deepen their expertise, expand their network, and build their leadership skills through a series of training and project work coordinated by the Asia Centre for Health Security based at the Saw Swee Hock School of Public Health, National University of Singapore (NUS).”

“This 12-month fellowship does not require relocation to Singapore and can be completed alongside full-time employment or an academic schedule.”

Learn more and apply here.

Pandora Report 10.11.2024

October 11, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report covers updates from ARPA-H, new UK guidance for use of nucleic acid synthesis technologies, the UK’s recently-announced sanctions on Russian troops and organizations for use of CW in Ukraine, and more.

Upcoming Virtual Information Sessions on the Biodefense Graduate Program

A virtual open house for the MS in Biodefense will be held online on Thursday, October 17, 7 to 8 p.m. ET . The Biodefense Program offers flexible part-time or full-time options that teach applicable, real-world skills for bridging the gap between science and policy. The online session will provide an overview of the program, as well as the application process, student experience and graduate outcomes. Register here.

ARPA-H Launches Predictive Drug Safety and Efficacy Model Program

The Advanced Research Projects Agency for Health (ARPA-H), part of the Department of Health and Human Services, recently announced a new funding opportunity through its Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. The program aims to create human physiology-based computer models to accurately predict safety and efficacy profiles for Investigational New Drug (IND) candidates.

The announcement explains “Through a forthcoming Innovative Solutions Opening (ISO) solicitation, CATALYST invites proposals across three technical areas: data discovery and deep learning methods for drug safety models, living systems tools for model development, and in silico models of human physiology. If successful, CATALYST will significantly improve drug safety testing in preclinical and clinical studies and create a drug development tools pipeline for use in regulatory science applications.”

Read more here.

UK Announces Sanctions on Russian Troops Using CW in Ukraine

The UK government announced this week that it has sanctioned Radiological, Chemical and Biological Defence Troops of the Russian Armed Forces and their leader, Igor Kirillov, following their use of chemical weapons in Ukraine. The announcement also described Kirillov as “a significant mouthpiece for Kremlin disinformation, spreading lies to mask Russia’s shameful and dangerous behaviour.” The UK also sanctioned two Russian MOD laboratories (the 27th Scientific Centre and the 33rd Central Scientific Research and Testing Institute) for the support they provided in developing and deploying the weapons.

UK Publishes Voluntary Guidance for Providers and Users of Synthetic Nucleic Acid

“The UK National Vision for Engineering Biology, published in December 2023, set out an ambition for the UK to be a world leader in responsible innovation in engineering biology. This Guidance delivers on that ambition by championing and enabling the legitimate use of nucleic acid synthesis technologies, whilst reducing the risks which could result from accidental or purposeful misuse.”

“The Guidance makes recommendations to UK providers and users of synthetic nucleic acid to promote screening practices. It supports the safe study or engineering of existing or novel biological systems to help unlock the exciting benefits of this technology in applications across healthcare, chemical and materials, low carbon fuels, and agriculture. Uptake of the Guidance will be reviewed to ensure that it is providing proportionate guardrails.”

Read Christopher East’s discussion of this guidance in this piece from the Council on Strategic Risks-“New “Gene Synthesis Screening Guidance” in the UK: A Positive Step Towards Responsible Innovation”

UK Department for Science, Innovation and Technology Launches Regulation Innovation Office

The UK government also recently announced the creation of the Regulation Innovation Office, which aims to “reduce the burden of red tape and speed up access to new technologies that improve our daily lives – from AI in healthcare to emergency delivery drones”. The announcement explains that “The new Regulatory Innovation Office (RIO) will reduce the burden for businesses hoping to bring new products and services to the market in some of the UK’s fastest-growing sectors through innovations like –AI training software for surgeons to deliver more accurate surgical treatments for patients and drones which can improve business efficiency and quickly send critical deliveries to remote parts of the country.”

“To do so, it will support regulators to update regulation, speeding up approvals, and ensuring different regulatory bodies work together smoothly. It will work to continuously inform the government of regulatory barriers to innovation, set priorities for regulators which align with the government’s broader ambitions and support regulators to develop the capability they need to meet them and grow the economy.”

“National Security Debate on Global Health Enters a New Phase”

David P. Fidler discusses the debate about the expansion of the concept of national security and how global health fits into this in this piece for Think Global Health: “To date, the securitization of pandemics and climate change in U.S. policy has become orthodoxy but has failed, which raises questions about the value of national security arguments concerning global health problems. Geopolitical competition and polarized domestic politics are shrinking what national security means in U.S. policy, making national security claims about global health threats even more difficult to sustain.”

“Pathway to a Healthier America: A Blueprint for Strengthening Public Health for the Next Administration and Congress”

This report from Trust for America’s Health “…provides the Administration and Congress taking office in 2025 a policy roadmap for improving the nation’s health, economy, and national security.” It outlines several priorities, such as investing in public health infrastructure and workforce, improving health security threat readiness, and promoting health across the lifespan.

“Optimizing Federal, State, and Local Responses to Public Health Emergencies: Lessons from COVID Proceedings of a Workshop—in Brief”

From NASEM: The National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law is pleased to announce the release of the proceedings of its May 30-31, 2024 workshop, Optimizing Federal, State, and Local Response to Public Health Emergencies. The workshop, which was organized by a planning committee co-chaired by Georges Benjamin (American Public Health Association) and Erwin Chemerinsky (University of California, Berkeley School of Law), featured the following sessions: Optimizing Federal, State, and Local Public Health Preparedness, The COVID-19 Pandemic: What happened? What went right? What went wrong? –, Public Health Emergency Authorities: What we know about them and how did we experience them before, during, and after the COVID-19 pandemic?, Exploring Routes and Barriers to Effective Public Health Response Efforts During the COVID-19 Pandemic, Looking to the Future: Where do we go from here?, and Concluding Thoughts from Workshop Planning Committee.

“AI in Public Health: Gaps, Disparities, and Remarkable Potential”

Shi En Kim covers a panel-“Making AI a Lifesaver”-hosted by the Johns Hopkins University Bloomberg Center in Washington DC in this article for Global Health Now, writing in part “The panelists broadly agreed that there needs to be more transparency in how AI is being used. For starters, noted Ehrenfeld, better visibility into AI will help flag flaws that lead to inequity as well as make AI a more effective tool for public health workers. Stuart noted the clear need for training on AI’s ethical issues and applications presents a big opportunity for schools of public health and medical schools.”

“Framework for Nucleic Acid Synthesis Screening”

The NSTC’s Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening recently released this framework: “This framework outlines a unified process for screening purchases of synthetic nucleic acids and benchtop nucleic acid synthesis equipment. While the framework will be incorporated into requirements for recipients of federal research funding, including through domestic and international funding documents, broader use of the framework is encouraged. This approach guides providers of synthetic nucleic acids (“Providers”) and manufacturers of benchtop nucleic acid synthesis equipment (“Manufacturers”) to screen purchase orders to identify sequences of concern (SOCs) and assess customer legitimacy.”

“A New Biosecurity Strategy for the World to Follow”

CSR’s Jackson du Pont discusses CEPI’s recently launched Biosecurity Strategy in this blog post, writing in part “On Wednesday, September 25th, the Coalition for Epidemic Preparedness Innovations (CEPI) launched its inaugural Biosecurity Strategy—an incredibly important contribution towards galvanizing efforts to advance global biosecurity prioritization and governance. It represents a significant step in strengthening biosecurity norms and should serve as a model for future efforts to increase investments in addressing biological risks in the safest, most responsible ways possible.”

DHS Releases 2025 Homeland Threat Assessment

The Department of Homeland Security (DHS) recently released its Homeland Threat Assessment (HTA) for 2025. The HTA aims to “…inform both the public and the Department’s partners of the threats to public safety and security, in order to assist federal, state, and local partners in preparing, preventing, and responding to an ever-evolving threat environment.” This year’s HTA explains that the threat environment is expected to “remain high” in the coming year. Among other topics, the HTA also discusses the potential for CBRN attacks and nefarious use of emerging technologies:

“We expect predominantly aspirational and rudimentary interest in CBRN attacks will continue in 2025. Among foreign and domestic threat actors, we assess that DVEs and criminals will remain the most likely perpetrators of deliberate CBRN-related attacks. Over the last year, there were 18 known deliberate chemical- or biological-related incidents in the Homeland, four of which were linked to political or ideological motives while the rest were criminal in nature. All of the incidents employed simple methods, and one incident caused at least one death. Two of the 18 incidents involved the alleged use of ricin, while 14 of the incidents employed easily obtainable chemicals—including a range of pesticides, chlorine, bear spray, and other chemical irritants. Fentanyl was weaponized in two instances. Foreign and domestic threat actors maintain aspirational interest in radiological and nuclear attacks, but these attacks remain unlikely.”

“We expect threat actors will continue to explore emerging and advanced technologies to aid their efforts in developing and carrying out chemical and biological attacks. Over the last year, foreign and domestic extremists online expressed interest in using DNA modification to develop biological weapons to target specific groups. We remain concerned about the potential exploitation of advances in artificial intelligence (AI) and machine learning to proliferate knowledge that supports the development of novel chemical or biological agents. (For more information on AI and threat actors, see pages 26–27.) Such advances could be exploited by state and state-sponsored adversaries, but the necessary expertise for such exploitation most likely exceeds that of most nonstate actors. We also remain concerned about the potential for threat actors to use unmanned aircraft systems (UAS) in chemical or biological attacks due to the continued advancement of UAS technology and the growing availability of UAS.”

“Tehran’s Tactical Knockout: Weaponized Pharmaceutical-Based Agents”

Matthew Levitt discusses Iran’s use of PBAs in this article from the CTC Sentinel: “As early as the 1980s, the U.S. intelligence community documented the ways in which Iran deployed chemical weapons for tactical delivery on the battlefield. Nearly 40 years later, U.S. officials formally assessed that Iran was in non-compliance with its Chemical Weapons Convention (CWC) obligations, pointing specifically to Tehran’s development of pharmaceutical-based agents (PBAs) that attack a person’s central nervous system as part of a chemical weapons program. Over time, concern about this program has increased, with reports to the Organisation for the Prevention of Chemical Weapons (OPCW), statements by multilateral groups such as the G7, and a variety of U.S. government reports and sanctions. Today, with Iran’s proxies wreaking havoc throughout the region, officials worry Tehran may have already provided weaponized PBAs to several of its partners and proxies. Such a capability, tactically deployed on the battlefield, could enable further October 7-style cross-border raids or kidnapping operations. With the region on edge following the targeted killing of Hezbollah leader Hassan Nasrallah, followed by an Israeli ground campaign targeting Hezbollah infrastructure along the border, and the Iranian ballistic missile attack on Israel, concern about the use of such tactical chemical weapons is high.”

What We’re Listening to 🎧

Poisons and Pestilence: ‘Back to Source’ with Seth Carus

“In this bonus episode I am joined by Seth Carus, as we explore some of the earliest allegations of biological warfare- as well as the more recent modern developments, which transformed ancient fears, into Cold War era weapon systems.”

Listen here.

NEW: The Advancing Threat Agnostic Biodefense Webinar Series

Learn more and register here.

Potential Research Priorities to Inform Readiness and Response to Highly Pathogenic Avian Influenza A (H5N1)

Learn more and register here.

One Health and the Politics of COVID-19 Book Launch

NEW-US AI Safety Institute Issues RFI on Responsible Development of Chem-Bio Models

“Respondents are encouraged to provide concrete examples, best practices, case studies, and actionable recommendations where possible. The full RFI can be found here.”

“The comment period is now open and will close on December 3, 2024, at 11:59PM Eastern Time. Comments can be submitted online at www.regulations.gov, under docket no. 240920-0247.”

NEW-Infodemic Management Course from Open WHO

“In the recent years, the circulation of health misinformation and disinformation has exploded with the digitalized information ecosystem. They cause confusion and risk-taking behaviours that can harm health. They also lead to mistrust in health authorities and undermines the public health response. Misinformation and disinformation can intensify or lengthen outbreaks when people are unsure about what they need to do to protect their health and the health of people around them especially during health emergencies. Public health workers need knowledge and skills to manage harm from health misinformation and disinformation. This course will help them to better understand the infodemic mechanisms that underlie the emergence and spread of misinformation, the complex and harmful nature of disinformation and how to intervene to better prevent and respond to both of these types of information-based harms.”

Access this self-paced course here.

NEW-ACHS Fellowship Program 2025

From the Asia Centre for Health Security: “The ACHS Fellowship Program aims to inspire and connect the next generation of biosecurity leaders and innovators.”

“This 12-month fellowship does not require relocation to Singapore and can be completed alongside full-time employment or an academic schedule.”

Learn more and apply here.

External Review of Ethical, Legal, Environmental, Safety, Security, and Societal Issues of Engineering Biology Research and Development

From NASEM: “Engineering biology holds significant potential to transform the U.S. and global economy, with promise to deliver innovative solutions in health, climate, energy, food and agriculture, and more. As research and development in engineering biology and other areas of the bioeconomy advance, addressing the societal issues related to these technologies is imperative. As requested by the CHIPS and Science Act, this study will conduct an evaluation of the ethical, legal, environmental, safety, security, and other societal issues related to engineering biology, and make recommendations on research needs related to these issues and means to effectively incorporate their consideration into research practice.”

“The National Academies of Sciences, Engineering, and Medicine (NASEM) will appoint an ad hoc committee to review and make recommendations on the ethical, legal, environmental, safety, security, and other appropriate societal issues related to engineering biology research and development. The committee will address the scholarship and practice of addressing these issues, focusing specifically on:

(1) An assessment of the current knowledge and practice on assessing and mitigating various societal issues including ethical, legal, environmental, safety, and security issues.
(2) A description of the gaps and needs relating to such issues, focusing on approaches for co-generation of assessment approaches and design of products, technologies, and services with users of engineering biology research and development
(3) Actionable recommendations on how the National Engineering Biology Research and Development Initiative, established by the CHIPS and Science Act, can address the identified gaps and needs.
(4) Actionable recommendations on how researchers across the range of disciplines engaged in engineering biology can best incorporate considerations of such societal issues into the development of research proposals and the conduct of research.”

“NASEM will produce a consensus report presenting the results of its work and offering its findings, conclusions, and recommendations.”

“We invite you to submit suggestions for experts to participate in this activity. The call for experts closes on October 16, 2024 at 11:59 (ET).”

Recommend an expert here.

Pandora Report 10.4.2024

October 4, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report covers the recently-reported outbreak of Marburg virus disease in Rwanda, the recent discovery of four more Missouri healthcare workers who experienced respiratory symptoms after caring for a patient infected with H5 avian influenza, new human cases of bird flu in California, and more.

Upcoming Virtual Information Sessions on the Biodefense Graduate Program

Marburg Outbreak Confirmed in Rwanda

Last week, the Rwanda Ministry of Health announced that it had confirmed cases of Marburg virus disease (MVD) in the country. Blood samples taken from symptomatic people were tested using RT-PCR, and were found to be positive for Marburg virus. So far, there have been 36 confirmed cases and eleven deaths across at least seven of the country’s 30 districts. As of last week, over 70% of cases were in healthcare workers from two locations in Kigali, the nation’s capital. More than 300 contacts have been traced so far.

This is the first time MVD has been reported in the country, and the WHO has emphasized that it is likely the disease will spread to neighboring countries, many of which are currently struggling amid the mpox outbreak. There is currently no available treatment or vaccine for MVD. WHO has assessed the risk of this outbreak to be very high nationally, high regionally, and low globally.

MVD, formerly known as Marburg hemorrhagic fever, is severe, often fatal in humans, and is caused by a virus in the Filoviridae family, which also includes Ebola virus. Egyptian fruit bats are natural hosts of the virus; it is spread from them to people, and it then spreads further via human-to-human transmission. While the average MVD case fatality rate is about 50%, this has varied from 24% to 88% during past outbreaks. Early supportive care improves survival odds.

Experts are concerned as there were already more than two dozen confirmed cases by the time the Rwandan government announced the outbreak. It can take as long as 21 days between exposure and symptom onset with MVD. Furthermore, because Rwanda has never had an outbreak before, healthcare professionals may have not been suspicious of MVD and did not think to test for it. All of these are worrying signs that the disease may have been circulating in the country for a few weeks before the announcement.

The Centers for Disease Control and Prevention issued a Health Alert Network Health Advisory on Thursday to inform clinicians and health departments in the US about the outbreak and advise them to be aware of the potential for imported cases.

Read more:

“Deadly Marburg Virus: Scientists Race to Test Vaccines in Outbreak,” Ewen Callaway, Nature News
“Marburg Virus Outbreak in Rwanda Draws Concern Over Possibility of International Spread,” Helen Branswell, STAT News
“Marburg is an Especially Scary Virus. How Scared Should We Be of Rwanda’s Outbreak?” Gabrielle Emanuel, Goats and Soda

World Leaders Announce Target of 10% Fewer Superbug Deaths by 2030

World leaders gathered during a meeting at the UN General Assembly announced a new political declaration on antimicrobial resistance (AMR) that was signed by 193 member states. Each year, AMR is linked to 4.7 million deaths, and that number is projected to reach 8.2 million by 2050. The declaration calls for increased action across sectors like farming, pharmaceutical manufacturing, environmental protection, and healthcare to combat AMR. Furthermore, it calls for financial support for poorer countries, who are most affected by this issue, and to commit to scaling up efforts in order to reduce AMR-related deaths by 10% by the end of the decade. The declaration also invites the Quadripartite organizations (WHO, UN Environment Programme, World Organisation for Animal Health, and the Food and Agriculture Organization of the UN) to create an independent panel to provide scientific evidence to support strategies to combat AMR. They will also update a global AMR action plan by 2026.

Avian Influenza Updates

Four More Missouri Healthcare Workers Develop Respiratory Symptoms After Contact with Bird Flu Patient

Four more healthcare workers who came into contact with a hospitalized bird flu patient in August are now confirmed to have later developed mild respiratory symptoms, bring the total to six. The Missouri patient had no contact with infected animals. One worker tested negative on a flu test, while the others’ symptoms were discovered too late to do testing. Missouri is continuing to investigate this situation with CDC’s assistance.

New Human Cases in California

CDC has confirmed two additional human cases of H5 bird flu from specimens submitted by California. Both cases are in people with occupational exposure to infected cattle. While California’s investigation is ongoing, there is no known link or contact between the two cases, which suggests these are two separate instances of animal-to-human spread of the virus. As the identification of H5 in people with exposure to infected animals is expected, CDC has not changed its risk assessment for the general public.

Read more:

“Pathogen Detection, Testing & Monitoring the H5N1 Outbreak,” Ava Desouza, Council on Strategic Risks

ISC Announces Expert Group for the Biological Weapons Convention

The International Science Council (ISC) recently announced the formation of its Expert Group dedicated to enhancing the Biological Weapons Convention (BWC). In May, ISC and the UN Office for Disarmament Affairs were jointly awarded a grant by the Geneva Science Policy Interface to strengthen the BWC. In a statement, ISC said this “…initiative is a significant step toward integrating scientific advancements into the operations of the BWC, addressing the critical need for a structured mechanism to review relevant science and technology developments.”

It further explained that “The ISC project “Science-policy synergies for the Biological Weapons Convention” fosters collaboration between BWC delegates and scientific experts, developing methodologies that build mutual understanding and trust. By facilitating targeted discussions and creating tailored knowledge products, the initiative aims to equip delegates with tools to tackle current and future biological threats, enhancing the BWC’s effectiveness in global biosecurity.”

Learn more here.

“Inside HHS’ ‘One-Stop Shop’ for Health sector Cybersecurity”

Federal News Network’s Justin Doubleday interviews Biodefense PhD Program alumnus and Schar School adjunct professor Brian Mazanec in this article and accompanying Federal Drive episode. Mazanec is currently the deputy director of the Administration for Strategic Preparedness and Response’s Center for Preparedness. He discusses how his organization is responding to recent attacks like the Change Healthcare ransomware attacks and what HHS can offer health organizations recovering from major cyber incidents.

“Anonymous Answers: How Can We Manage Infohazards in Biosecurity?”

Anemone Franz and Tessa Alexanian discuss input from eleven experts on how to best manage infohazards in biosecurity in the third part of this series from 80,000 Hours. Answers focus on helping researchers use information responsibly, limiting secrecy to improve problem solving, considering the effects of withholding information, and more.

“Vanishing Workforce: An Antimicrobial Resistance Threat”

James Anderson, Chair of the AMR Industry Alliance, discusses the decline of the antimicrobial research and development field, its importance to the fight against AMR, and how this decline can be reversed, writing in his conclusion, “Ultimately, to meet the need for new antimicrobials that can stay ahead of the resistant bacteria, both the public and private sectors should invest in the people who are responsible for the discovery of antimicrobials to attract and retain the best scientists into the future.”

“Proceedings of Workshop: Mitigating Arboviral Threat and Strengthening Public Health Preparedness”

From NASEM: “Arboviruses, or viruses carried by arthropods like mosquitoes or ticks, are responsible for hundreds of thousands of deaths worldwide each year. As the climate changes globally, the geographic distribution of these diseases, including Zika, dengue, chikungunya, West Nile, and yellow fever, are steadily expanding. The National Academies Forum on Microbial Threats hosted a public workshop in December 2023 to explore avenues of threat reduction from known and emerging arboviral diseases in the context of public health preparedness and capacity building. The workshop featured talks from experts in entomology, public health, ecology, virology, immunology, disease modeling, and urban planning.”

“This proceedings highlights the presentations and discussions that occurred at the workshop.”

“WHO Technical Advisory Group on the Responsible Use of the Life Sciences and Dual-Use Research: Report of the Meeting, Geneva, Switzerland, 16-18 April 2024”

“The WHO Technical Advisory Group on the Responsible Use of the Life Sciences and Dual-Use Research (TAG-RULS DUR) was established to provide independent advice to WHO on the monitoring and mitigation of biorisks, the advances in the life sciences and related technologies, the governance of dual-use research and the responsible use of the life sciences. The first hybrid meeting of the group took place at WHO headquarters in Geneva, from 16 to 18 April 2024, in order to provide the opportunity for TAG-RULS DUR members to exchange on WHO and related advisory groups activities relevant to their areas of work; to discuss current and upcoming activities related to the implementation of the WHO Global Guidance Framework for the responsible Use of the Life Sciences and to provide technical guidance to WHO.”

Read the meeting report here.

“Exclusive: Sen. Todd Young on biosecurity, National Security Commission on Emerging Biotechnology (NSCEB)”

“Sen. Todd Young (R-IN) was recently named Chair of the National Security Commission on Emerging Biotechnology (NSCEB), established by Congress to recommend policy on biotech and national security. Bio.News spoke to him in an exclusive interview about the work of the commission, the BIOSECURE Act and PASTEUR Act, and more.”

1540 Compass Second Issue

“The second issue of the 1540 Compass explores the critical components of United Nations Security Council resolution 1540 (2004), with a focus on border and export control systems crucial for its full and effective implementation. This edition particularly underscores the significance of clauses in operative paragraph 3, highlighting the global commitment to securing a world where proliferation risks are minimized through robust domestic controls.”

“This issue offers a comprehensive look at the implementation, especially across Africa, examining the varied approaches to managing exports of biological weapons-related materials. It presents a range of contributions and in-depth interviews that delve into national efforts to develop voluntary action plans and regional collaborations.”

“Discussions also extend to the impact of emerging technologies, including artificial intelligence, on the resolution, especially concerning the need for end-user controls in exports. The edition further explores strategic trade controls with best practices from selected countries that have effectively implemented such measures.”

“A significant portion of this issue is dedicated to addressing the challenges of proliferation finance, providing insights into the complexities of this area without an official definition and offering practical recommendations for future approaches.”

“In recognizing the role of civil society in preventing weapons of mass destruction proliferation, the journal includes discussions on how various stakeholders can collaborate with governments and international organizations to ensure compliance with the resolution.”

“This issue also introduces a new Letters-to-the-Editor section, encouraging a thoughtful and nuanced discussion within the dedicated community towards enhancing global security through stringent border and export controls.”

“Reforming the Australia Group to Better Combat Biological Threats”

Kyle Wilgus discusses recent moves by the Department of Commerce’s Bureau of Industry and Security to remove export controls on biological materials and technologies for companies and individuals residing in nations participating in the Australia Group. He argues that this is an important step in strengthening biotechnology and broader technological innovation because it “…incentivized free, unburdened trade in biological materials and technologies among its members and showcased the potential impact of the Australia Group.” He argues that, in the future, the group should build on this progress by “reformulating and expanding to better mitigate the ever-evolving spectrum of biological threats.”

“Healthy Ecosystems, Healthy Humans”

Tomas Weber discusses how biodiversity acts as a barrier against disease as “Flourishing ecosystems safeguard humans from a panoply of zoonotic illnesses,” in this piece from Hopkins Bloomberg Public Health. He covers multiple drivers of biodiversity loss and research work that is being done to help combat these effects.

“‘He Began to Complain of Sharp Pain in the Stomach”: Official Documents Obtained by The Insider Confirm Navalny Was Poisoned in Prison”

Roman Dobrokhotov re-visits Navalny’s death in this piece, writing in part “The Insider has obtained access to hundreds of official documents related to Russian opposition leader Alexei Navalny’s death in the Polar Wolf penal colony in the Russian Far North on Feb. 16, 2024. Officially, Navalny’s death was attributed to natural causes, and Russia’s Investigative Committee stated in July that the case “does not have a criminal nature.” However, the contents of the documents in The Insider’s possession demonstrate that Russian authorities consistently removed references to symptoms Navalny was noted by prison doctors to have been suffering — symptoms that did not fit with the Russian state’s official cause of death. As medical experts confirm, these symptoms clearly indicate that Navalny was poisoned.”

“Chemical Terrorism Threat Perceptions”

In his latest working paper, Alexander Kelle of the Arms Control and Emerging Technologies program at IFSH Hamburg examines the evolving salience of chemical terrorism within the CWC framework and the contribution of the OPCW. He finds that responses have been linked most often to the international cooperation and assistance norms, and regularly noted the work of the Open-Ended Working Group on Terrorism. Read the working paper here.

ICYMI: NTI|Bio Briefs Capitol Hill on Innovative Solutions to Biotechnology Risks

From NTI: “Against a backdrop of growing risks associated with advances in bioscience and biotechnology, NTI | bio and the Center for Arms Control and Non-Proliferation (CACNP) hosted a September 17 Congressional staff briefing on “Preventing Biological Catastrophe and Protecting the U.S. Bioeconomy.”’

“The event, which explored opportunities for Congress and the White House to mitigate the risks, featured a panel discussion on safeguarding evolving capabilities that arise from the combination of artificial intelligence with biotechnology and providing oversight of dual-use life science research of concern. Participants included:

Dr. Ryan Ritterson, specialist lead, Deloitte.

Mr. Daniel Gastfriend, director for Biodefense and Pandemic Preparedness, National Security Council

Dr. Gregory Koblentz, associate professor and director of the Biodefense Graduate Program, George Mason University”

Read more here.

NEW: Synthesis Screening Workshop 2-Securing Bioproduction Against an Evolving Threat Landscape

From AI for SynBio: “Advances in AI are changing the threat landscape in many fields, including in the field of biology. With AI assisted design tools, the complexity and obfuscation potential of the synthetic biological materials is expected to increase. Conversely, the same AI advances can be deployed to help screen DNA/RNA synthesis requests before they can be used for malicious purposes. This workshop seeks insight on current and future advances that will shape both the threat and countermeasure landscapes and prepare the community for the changing threat landscape. The workshop seeks perspectives from academia, industry, and government….The Fall Workshop will focus on the evolving landscape in the years beyond 2026 with an eye towards 2030.”

This hybrid event will take place on October 9. Learn more and register here.

NEW: Airfinity Avian Influenza Webinar

“Join Airfinity and its expert panelists in a discussion of the current avian influenza outbreak. Key topics will include the evolution of the virus, the potential of a recombination event and the current state of pandemic preparedness.”

This event will take place on October 10 at 10 am ET. Learn more and join here.

NEW: Potential Research Priorities to Inform Readiness and Response to Highly Pathogenic Avian Influenza A (H5N1)

Learn more and register here.

NEW: One Health and the Politics of COVID-19 Book Launch

Responsible AI: Design, Development, and Use

Join the Mason Autonomy and Robotics Center (MARC) for this 3-day in-person course on Responsible AI: Design, Development, and Use!  As AI becomes increasingly pervasive across various domains, it is essential that we prioritize responsible principles, policies, and practices. Learn from top AI scholars and industry experts about ethical and safe AI deployment. You’ll also gain the critical skills to navigate the complexities of AI in business, healthcare, transportation and more.
Course Dates: October 15-17, 2024
Registration Deadline: October 8, 2024

FLUency: True Expertise and Effectiveness in the Battle Against Influenza

“This Commission meeting, FLUency: True Expertise and Effectiveness in the Battle Against Influenza, will be held on Tuesday, October 8th, in Washington, DC. The focus of this meeting will be to provide the Bipartisan Commission on Biodefense with a better understanding of: (1) national leadership to defend food and agriculture against influenza; (2) federal operational requirements for preparedness, coordination, and response; (3) biosurveillance, forecasting, and the need for diagnostic tests; and (4) front-line needs and partnerships in the fight against influenza.”

This event will take place in-person on October 8 from 9:20 am to 2 pm EST. Learn more and register here.

Bio and Beer (October 10)

From the Northern Virginia BioHub: Join us for a panel discussion with local investors as they share their funding priorities, insights on what’s ahead, and tips for meaningful engagement. Also, connect with our dynamic community of professionals from industry, academia, healthcare, investment, and government for a fun evening of networking!

Our panelists include:

Deborah Hemingway, Managing Partner, Ecphora Capital
Bibhash Mukhopadhyay, Managing Partner, Sound Bioventures
Kevin O’Connell, Senior Vice President, In-Q-Tel

Location: JLL Tysons Office, 1800 Tysons Boulevard, McLean, Virginia 22102

Hosted by: The Northern Virginia BioHub

Signature Sponsor: JLL

Additional Sponsors: Virginia Bio, the Prince William County Department of Economic Development, and George Mason University’s Institute for Biohealth Innovation

External Review of Ethical, Legal, Environmental, Safety, Security, and Societal Issues of Engineering Biology Research and Development

“NASEM will produce a consensus report presenting the results of its work and offering its findings, conclusions, and recommendations.”

“We invite you to submit suggestions for experts to participate in this activity. The call for experts closes on October 16, 2024 at 11:59 (ET).”

Recommend an expert here.

DARPA Invites Proposals for AI Biotechnology Pitch Days Dec. 5-6

“DARPA funds the research and development of technologies with the potential for transformational impact, central to delivering on the agency’s mission to create and prevent strategic surprise for national security. The agency’s Biological Technologies Office focuses on the natural world to derive revolutionary capabilities centered on:

Foundational technologies that promote simulation and prediction of biological systems and outcomes, like simulation, foundational models, and data generation,
Warfighter readiness, health, and recovery, such as medical countermeasures, diagnostics, health IT and medical devices, and
Operational support of U.S. forces to enable their execution of missions across the spectrum, ranging from fibers for garments to distributed, point-of-need manufacturing.”

“To capitalize on these new opportunities and further accelerate the pace of scientific and technological discovery and development, DARPA looks to include targeted and limited-scope investments via an AI BTO solicitation seeking proposals on technologies focused at the intersection of artificial intelligence and biotechnology.”

‘“AI BTO seeks to fund proposals that catalyze the formation of future research projects by clarifying the opportunity space and de-risking technical barriers to achieving high impact,” said BTO Director Dr. Michael Koeris. “To this end, the office is providing $4.5 million to support up to 45 revolutionary catalyst projects and will be finalizing research agreements day of. We look forward to reviewing the novel biotechnology approaches to further our national security mission.”’

“BTO leadership is interested in engaging first-time or non-traditional proposers and seeks revolutionary approaches to emerging or anticipated Department of Defense challenges. During these events, BTO will introduce five new overarching topics that align with AI/ML applications:

Prediction and Health
Autonomous Science
Biomanufacturing/Synthetic Biology
Challenges with Scale
Exciting Frontiers”

Pitch Days

“DARPA will host AI BTO Pitch Days on December 5-6, 2024, in the Washington, DC, region to select and award AI BTO catalyst projects. To be considered for AI BTO Pitch Day participation, offerors must submit a short white paper consisting of a technical description of the proposer’s idea in response to one of the focus areas listed above.”

“DARPA will notify offerors if they are selected for further evaluation via an in-person Pitch Day presentation to a panel of BTO program managers at the AI BTO Pitch Day event.”

“If selected for award at Pitch Day, DARPA may issue a Research Other Transactions award for one of three award scenarios – $100,000, $200,000, or $300,000. The maximum amount of government funding given to any single proposer will be $300,000.”

“To submit a white paper, register at https://usg.valideval.com/teams/aibto_2024/signup. The deadline is Friday, October 9, 2024 by 4:00PM EDT. Late applications will not be accepted.”

“Additional information is available on SAM.gov.”

Call for Experts: Health-Security Interface Technical Advisory Group (HSI-TAG)

“The World Health Organization (WHO) is seeking two experts to serve as new members of the Health-Security Interface Technical Advisory Group (HSI-TAG). This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection.”

“The concept of Health-Security Interface (HSI) applies to those public health activities whose performance involves to some extent the security sector broadly understood (e.g. international and non-governmental organizations, civil defense, military health personnel, law enforcement and armed forces, defense-related research programmes), certain international organizations and other entities with a security relevant mandate. These activities may include protection of health from traditional and emerging infectious disease threats; deliberate events and investigation of alleged use of chemical and biological agents including non-permissive environments and conflict zones; and any health activities performed in collaboration with security actors.”

“The HSI-TAG is multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to the Health-Security Interface.”

“Considering the recent developments and global trends, the Secretariat realized that there was a need to strengthen the following areas of expertise/experience, hence welcomes expressions of interest from:

Bioterrorism experts (knowledge on pathogens of security concern, their microbiological characterization and application/modification for weaponization, diagnostics, countermeasures and containment measures),
Decision/policy makers with hands-on experience dealing with significant deliberate event(s) (biological/chemical) response at the local, regional, or national level.”

“For the improved geographical and gender representation of the HSI-TAG members, the WHO Secretariat encourages applications from the WHO African, Western Pacific, European, Eastern Mediterranean and Pan American Health Organization/Americas regions and female or non-male gender identities.”

Learn more about the HSI and express interest by October 7 here.

Pandora Report 9.27.2024

September 27, 2024 by dkellogg97, posted in Pandora Report

This week’s Pandora Report covers updates from the Biodefense Graduate Program, the Risky Research Review Act, H5N1 updates, the UNGA’s adoption of the Pact for the Future, and more.

Schar School Virtual Information Sessions

If you are interested in a career in biodefense or global health security or want to develop the knowledge and skills necessary to work at the nexus of health, science, and security, find out what the Schar School of Policy and Government has to offer. A virtual open house for all of the Schar School’s master’s and certificate programs will be held online on Monday, September 30, 7-8 PM ET. The Schar School offers flexible part-time or full-time options for graduate certificate and master’s degree programs that teach applicable, real-world skills for in-demand careers. Register here.

Talking Global BioLabs in Galveston

Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, was in Galveston, Texas this week to give a talk as part of the Biosafety and Bioethics Seminar series sponsored by the Institute for Human Infections and Immunity, the Institute for Translational Sciences, and the Department of Bioethics and Health Humanities at the University of Texas Medical Branch (UTMB). Dr. Koblentz’s talk, “The Global BioLabs Initiative and Biorisk Management,” provided an overview of the results of the Global BioLabs 2023 report and its recommendations for strengthening global biorisk management. While in Galveston, Dr. Koblentz was given a guided tour of the Galveston National Laboratory, one of two BSL-4 labs at UTMB. For biosafety and biosecurity reasons, he was not allowed into the lab space, but he enjoyed visiting the HVAC floors which are marvels of mechanical engineering. In addition, Dr. Koblentz visited the positive pressure suit storage area where he learned that Dover, the sole US-based manufacturer of positive pressure suits, is no longer producing these suits. Dr. Koblentz also had the opportunity to visit the Biocontainment Care Unit (BCU) operated by the Special Pathogens Excellence in Clinical Treatment, Readiness, and Education (SPECTRE) Program at UTMB. The BCU is a 6-room critical care unit that can manage patients infected with highly infectious diseases such as Ebola. Luckily, the BCU has not had to treat such a patient, but it stays busy by providing training, education and research to benefit other healthcare facilities in HHS/FEMA Region VI.

Risky Research Review Act 2.0

On September 25, the Senate Homeland Security and Government Affairs Committee voted 8-1 to approve an amended version of the Risky Research Review Act introduced by Senator Rand Paul (R-KY), ranking member of the committee. According to Senator Paul, the “bipartisan Risky Research Review Act, a first-of-its-kind proposal to establish a Life Sciences Research Security Board within the Executive Branch…The Life Sciences Research Security Board will serve as an independent body responsible for thoroughly evaluating gain-of-function research and other potentially harmful studies involving high-consequence pathogens.” The text of the bill can be found here. In July, Biodefense program director Gregory Koblentz co-authored an opinion piece with David Gillum and Rebecca Moritz that identified significant problems with original version of the bill, “While the Risky Research Review Act aims to address legitimate concerns about the potential hazards associated with life sciences research, its current form is deeply flawed, posing significant threats to scientific progress and public safety. The broad and ambiguous definition of high-risk research, the overreach in funding decisions, and the inadequacies in the board’s composition all point to a need for a more thoughtful and effective approach.” It remains to be seen whether the amended version satisfactorily addresses the deficiencies in the original bill.

UN Adopts Pact for the Future

World leaders gathered in New York for the United Nations General Assembly adopted the Pact for the Future last week. In a press release, the UN described the pact as “… the culmination of an inclusive, years-long process to adapt international cooperation to the realities of today and the challenges of tomorrow. The most wide-ranging international agreement in many years, covering entirely new areas as well as issues on which agreement has not been possible in decades, the Pact aims above all to ensure that international institutions can deliver in the face of a world that has changed dramatically since they were created.”

The pact promises to refocus on existing obligations and commitments to nuclear and biological disarmament, aiming to make relevant global institutions more representative and responsive in the process. Action 26 in the document specifically focuses on disarmament obligations and commitments. It reads:

47. We express our serious concern at the increasing number of actions that are contrary to existing international norms and non-compliance with obligations in the field of disarmament, arms control and non-proliferation. We will respect international law that applies to weapons, means and methods of warfare, and support progressive efforts to effectively eradicate the illicit trade in arms. We recognize the importance of maintaining and strengthening the role of the United Nations disarmament machinery. Any use of chemical and biological weapons by anyone, anywhere and under any circumstances is unacceptable. We call for full compliance with and implementation of relevant treaties. We reaffirm our shared determination to exclude completely the possibility of biological agents and toxins being used as weapons and to strengthen the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. We decide to:

(a) Revitalize the role of the United Nations in the field of disarmament, including by recommending that the General Assembly pursue work that could support preparation of a fourth special session devoted to disarmament (SSOD-IV);

(b) Pursue a world free from chemical and biological weapons and ensure that those responsible for any use of these weapons are identified and held accountable;

(c) Address emerging and evolving biological risks through improving processes to anticipate, prevent, coordinate and prepare for such risks, whether caused by natural, accidental or deliberate release of biological agents;

(d) Identify, examine and develop effective measures, including possible legally binding measures, to strengthen and institutionalize international norms and instruments against the development, production, acquisition, transfer, stockpiling, retention and use of biological agents and toxins as weapons;

(e) Strengthen measures to prevent the acquisition of weapons of mass destruction by non-State actors;

(f) Redouble our efforts to implement our respective obligations under relevant international instruments to prohibit or restrict conventional weapons due to their humanitarian impact and take steps to promote all relevant aspects of mine action;

(g) Strengthen our national and international efforts to combat, prevent and eradicate the illicit trade in small arms and light weapons in all its aspects;

(h) Address existing gaps in through-life conventional ammunition management to reduce the dual risks of unplanned conventional ammunition explosions and the diversion and illicit trafficking of conventional ammunition to unauthorized recipients, including to criminals, organized criminal groups and terrorists.

H5N1 Updates

Missouri Healthcare Workers Who Cared for H5N1 Patient Not Tested After Developing Respiratory Symptoms

Last Friday, the CDC reported that a second healthcare worker who cared for a patient hospitalized in Missouri with H5N1 avian influenza developed respiratory symptoms. The patient and a household contact who also became ill have both recovered. Through contact investigation, the state discovered that healthcare workers who cared for the patient developed mild respiratory symptoms. The first worker’s symptoms resolved before the investigation began. State health officials told the CDC they did not learn of the second worker’s symptoms until after they had recovered, making it too late for diagnostic testing. CDC says that serologic testing will be offered to this worker.

Concerns About Lack of Testing Grow as California Reports More Outbreaks

Questions and concerns about the true extent of the H5N1 outbreak in the US are growing, with California reporting eighteen more outbreaks concentrated in herds in its Central Valley this week. Experts worry a lack of testing in both humans and animals is helping conceal the true extent of the outbreak across the nation. In addition to the Missouri healthcare workers, 663 poultry workers in Colorado are known to have been exposed. Of those, 109 reported symptoms and consented to testing, with nine testing positive in July.

Farms near the affected herds in California will begin bulk milk testing. Colorado mandated bulk milk testing, which promptly led to the discovery of outbreaks in an additional eleven herds. Eric Deeble, Deputy Undersecretary for Marketing and regulatory Programs at the USDA, said in a call in August that officials have considered requiring such testing through mandates, but had opted not to. He also said that the success in Colorado is “probably unique to Colorado, and extrapolating out to the rest of the country is not entirely appropriate.”

Currently, the USDA requires H5N1 testing only for dairy cows who are lactating and will be moved across state lines. Deeble expressed a high degree of confidence that the current level of testing is accurately capturing cases in animals being moved between states. He did also say “I do feel like the response is adequate,” in regards to spread and movement within states, even though it is not being monitored as closely.

Efforts to Control Mammal-to-Mammal Transmission Aren’t Working

Researchers led by the UK’s Pirbright Institute recently published an article in Nature that offers an overview of the current H5N1 avian influenza panzootic in mammals. The article-“The Global H5N1 Influenza Panzootic in Mammals”-includes analysis of H5N1 outbreaks European fur farm animals, South American marine mammals, and US dairy cattle. It notes the diversity of these outbreaks and that the virus is at increased risk for spillover to different mammals because of changes to its ecology and molecular evolution in birds.

Read CIDRAP’s Lisa Schnirring’s discussion of the article and its implications here.

US Announces More Mpox Vaccine Donations

This week, the US Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), announced it is undertaking actions to help increase the United States’ supply of mpox vaccine and support the nation’s commitment to make more than a million doses available to the global mpox response. These actions include:

“The United States is donating 1,000,000 doses to the international mpox response. The United States has also committed to provide at least $500 million to support the mpox response, aligned with the WHO and Africa CDC Joint Response Plan.”
“ASPR is also loaning JYNNEOS manufacturer Bavarian Nordic 200,000 doses of ASPR-procured vaccine to ensure continued supply within the domestic commercial market. This action allows uninterrupted access to Americans without diminishing the manufacturer’s availability to fulfill international orders and donations.”
“ASPR is collaborating with the Health Resources and Services Administration (HRSA) to make JYNNEOS that may otherwise expire available to HRSA funded health centers and Ryan White HIV/AIDS Program Part C and D clinics. These doses are available from the Strategic National Stockpile (SNS) for the purposes of expanding vaccine access for at-risk uninsured and underinsured individuals who otherwise cannot afford them.”
“These latest vaccine donation announcements follow a USG donation of 50,000 doses of mpox vaccine that was delivered to the DRC on September 10.”
“Another 10,000 doses of USG donated mpox vaccine were delivered to Nigeria in August 2024 to support the government’s clade I mpox response.”
“These vaccine efforts build off the $1.94 billion ASPR has invested in funds and technical expertise to develop and sustain JYNNEOS. The product would not exist without the investment and technical expertise provided by the USG.”
“Other HHS actions include case surveillance, risk communication and community engagement, laboratory supplies and diagnostics, infection prevention and control, increasing capacity for local field epidemiologists, and vaccine planning.”

HHS Secretary Xavier Becerra said in a statement, “A public health threat to one is a public health threat to all. HHS is committed to fighting the current mpox outbreak, including through this vaccine donation. Disease doesn’t respect borders and it is our duty to work together to make our world healthier. Our partnerships across the globe in fighting infectious disease will help keep us safe.”

ARPA-H Announces Awards for Developing Multi-Virus Vaccine Design Computational Platform

HHS’ Advanced Research Projects Agency for Health (ARPA-H) announced this week the teams that will receive awards from the agency’s Antigens Predicted for Broad Viral Efficacy through Computational Experimentation (APECx) program. The announcement explains that “APECx will pursue 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 then be evaluated for their ability to target entire viral families with a single vaccine.”

The teams are led by:

La Jolla Institute for Immunology focusing on beta and gamma-herpesvirus antigen and vaccine candidate development, including cytomegalovirus infections.
University of Washington focusing on alpha and gamma-herpesvirus antigen and vaccine candidate development, including herpes simplex virus infections.
Vaccine Company, Inc. focusing on vaccine development for flaviviruses, which include threats such as West Nile virus, dengue virus, and Zika virus.
Vanderbilt University focusing on antigen design and vaccine candidate development against alphaviruses, such as Chikungunya virus and Eastern equine encephalitis virus.

Furthermore, ARPA-H has chosen a team led by the Texas A&M Engineering Experiment Station that will focus on data and tool integration across the program.

“HHS Needs to Match Speed of Cyber Threats to Better Protect Health Care”

Brian Mazanec-an alumnus of the Biodefense PhD Program, Schar School adjunct professor, and Deputy Director of ASPR’s Office of Preparedness-recently discussed his office’s tools to help address cyber threats in healthcare at the GovCIO Media & Research’s 2024 Health IT summit. Read more and watch here.

“COVID-19: HHS Needs to Identify Duplicative Pandemic IT Systems and Implement Key Privacy Requirements”

This new study from the Government Accountability Office (GAO) reviews HHS’ efforts to “reduce unnecessary duplication, overlap, or fragmentation in the systems it uses to collect this kind of data, and its efforts to protect personal information.” It finds that HHS lacks a comprehensive list of these systems, and that it has not identified nor reduced unnecessary duplication. Furthermore, GAO finds that HHS has not fully implemented key privacy safeguards for the nine systems the Office reviewed.

“Strengthening Democracy and Pandemic Preparedness Go Hand in Hand”

This article in The Bulletin of the Atomic Scientists was authored by John Bridgeland, Elizabeth (Beth) Cameron, J. Stephen Morrison, Jennifer B. Nuzzo, and Aquielle Person. In it, they argue “American democracy and public health effectiveness are inextricable. American health security depends on maximizing the ability to live in a free, pluralistic society able to coherently manage a public health emergency. In turn, the health of US democracy depends on citizens’ faith and trust in institutions—especially government—to protect them in a crisis such as a pandemic. Given disease threats like mpox or H5N1 avian flu, the looming potential for a worst-case biological crisis begs for a well-prepared nation. Unfortunately, the United States, because of or despite the challenges of the COVID pandemic, is now more politically polarized and less prepared to mount a united response to a major health emergency. That is a collective danger that threatens Americans and imperils the world.”

“The 2024 U.S. Elections: An Existential Crossroads for Global Health Policy”

Benjamin Mason Meier, Neha Saggi, Muhammad Jawad Noon, and Xinshu She breakdown the United States’ importance in global health and what all is on the line in this regard during the upcoming presidential election in this article for Global Health Now: “The 2024 U.S. elections will shape the future of global health policy, determining whether the nation will continue to provide crucial leadership to advance global health. Yet, with only passing mention of the field’s challenges in the presidential debate, the global health community must raise awareness of the global health positions of U.S. political candidates.”

“Republican Governors on International Pandemic Plan: We Will Not Comply”

Route Fifty’s Kaitlyn Levinson discusses a recent joint statement from 24 republican governors regarding the WHO’s pandemic agreement in this article: “In yet another example of how all things related to the pandemic have become political, nearly all of the country’s Republican governors have expressed their staunch opposition to a World Health Organization agreement about how nations should collectively prevent, prepare and respond to future global public health emergencies.”

“‘Not Enough Progress’ Made at 11th Round of Pandemic Agreement Talks”

Kerry Cullinan breaks down recent rounds of negotiations on the WHO’s pandemic agreement in this piece for Health Policy Watch. Cullinan explains in part, “According to the latest draft of the pandemic agreement, the most controversial part of the agreement – developing a pathogen access and benefit-sharing (PABS) system (Article 12) – will now be addressed via a separate “instrument”…The provisions governing the PABS system – described as a “multilateral system for safe, transparent, and accountable, access and benefit sharing for pathogens with pandemic potential” – will be developed by the Conference of the Parties (COP). This COP will be set up after the World Health Assembly has adopted the pandemic agreement.”

“How to Prevent the ‘Grand Pandemic'”

This Devex article summarizes a recent World Bank report-“Stopping the Grand Pandemic: A Framework for Action.” In the report, “…the World Bank argues that addressing AMR must become a critical priority for governments and their development- and private-sector partners. It also highlights strategies for helping address AMR through holistic and sector-led interventions and unlocking finance to fund them. A menu of specific technical, operational, and financial considerations helps guide government action to prevent AMR.”

“Modern Biosurveillance Methods: A Lay Introduction to Effective Use of Nucleic Acid Methods”

From the RAND Corporation: “The devastating impact of the coronavirus disease 2019 (COVID-19) pandemic has led governments, health care institutions, and researchers to intensify their focus on developing improved means to detect, contain, and manage potential future outbreaks. As part of these efforts, policymakers and other nontechnical personnel need to understand available biosurveillance technologies. In this report, the authors summarize how current and emerging nucleic acid biosurveillance techniques work, describe their capabilities and limitations, and discuss the promise of emerging technologies.”

“Biosurveillance systems are used to detect, monitor, and characterize health threats, or pathogens, in human and animal populations, food, wastewater, and the environment. Nucleic acid testing assesses nucleic acids, comprising deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), to determine the biologic agents present in clinical samples (i.e., a sample collected by a medical laboratory from a symptomatic human) or environmental samples (e.g., wastewater).”

“The authors describe a scenario of testing for pathogens in wastewater that uses detection technology within a comprehensive and pathogen-agnostic biosurveillance system. Wastewater testing offers a method for collecting samples without needing symptomatic individuals to present at clinics for care. Such testing can, therefore, offer data prior to symptoms and from those who have less access to clinical care. The case study demonstrates the advancements needed to develop a truly pathogen-agnostic, cost-effective wastewater biosurveillance system.”

“The authors conclude that policymakers interested in establishing a biosurveillance program should carefully evaluate their specific research questions and their resource limitations to determine which technology is best suited to their needs.”

CEPI Biosecurity Strategy

The Coalition for Epidemic Preparedness Innovations recently released its new Biosecurity Strategy “…aimed at bolstering global health security and underscoring its commitment to tackling emerging epidemic and pandemic threats, whether they arise naturally, accidentally or through deliberate misuse.”

According to the coalition, “The strategy, published during United Nations General Assembly High-level Week 2024 in New York, will harness cutting-edge technologies and foster international collaboration to mitigate the risks posed by emerging pathogens. Its launch is a significant step in CEPI’s evolution, positioning it as a thought leader in the rapidly-developing fields of biosafety and biosecurity.”

“Team-Based Learning and Threshold Concepts in Biological Security and Dual-Use: Toward a Transformative Biological Security Pedagogy—The Game Changing Implications of CRISPR/Cas and the Design of a Novel Methodology for Influencing the Culture of Life and Associated Science through Awareness Raising and Education”

Simon Whitby, Malcolm Dando, Rebecca McCarter, and Simon Tweddell published this article in Creative Education: “CRISPR (clustered regularly interspaced short palindromic repeats) gene editing technologies appear to be a game-changer and suggest great potential for genome manipulation and for developments in next-generation therapeutics. Ethical, legal and social concerns have been raised in light of recent applications in humans. Concern also arises in relation to the potential of such developments for misuse. In addressing the post-COVID19 challenges raised by responsible research innovation and in confronting what to do about the vexed question of “dual-use”, we contend that awareness-raising and education concerning the ethical, legal and social implications of scientific research innovation represents a welcome and empowering alternative to top down regulatory responses that may serve to stifle innovation. The design and subsequent implementation of a novel transformative pedagogy combining Team-Based Learning and Threshold Concepts yields both empirical evidence-based metrics for real-time learning. As well as generating novel empirical data-sets for the identification of subject-specific threshold concepts across discrete specialisms in the life sciences, we argue that this hybrid methodology can be used to engage science professionals and students alike in meaningful and much-needed dialogue about developments relating to genome manipulation. We demonstrate how evidence-based threshold concepts can inform the design of bespoke subject-specific training as we suggest was the case from our deployment of team-based learning and threshold concepts during our proof of concept application, prior to the pandemic, during the course of two European Union Human Brain Project training programmes undertaken in 2017 and 2018, with experts in neuroscience research at the Karonlinska Institutet, Stockholm, Sweden.”

“A New Risk Index to Monitor AI-Powered Biological Tools”

This post from RAND Europe discusses a collaboration with the Centre for Long-Term Resilience, explaining that the two organizations “…are collaborating to develop a new approach to assess the risks posed by AI-enabled biological tools. We will develop a risk index that assesses current risks from tool capability, tool evolution and maturity, to enablement of bioweaponisation that could result in biosecurity risks. Our index also takes into account how these risks may change over time in this rapidly evolving area. Our work will expand upon and update previous work conducted by CLTR on tool categorisation (Rose & Nelson 2023) and risk assessment (Moulange et al. 2024).”

“Food, Climate Change and National Security: The Feeding Resilience Plan and USAID’s Feed the Future Accelerator”

Tom Ellison and Noah Fritzhand recently published this Council on Strategic Risks blog post discussing the Council’s new Center for Climate and Security (CCS) report and the new US food security policy initiative. They explain in part “Attendees and panelists discussed the stability benefits of US agricultural innovation, the role of international legal frameworks on weaponization of food, the role of food security in US-China relations, and the criticality of US interagency collaboration on food security. Read the Feeding Resilience storymap and full report for analysis and recommendations endorsed by 30+ national security leaders, including former US combatant commanders, ambassadors, intelligence leaders, and heads of USAID and the World Food Program.”

“Strategic Stockpiling: How New State Policies will Impact Emergency Preparedness”

Maggie Nilz offers an overview of the Strategic National Stockpile in this blog post from the Association of State and Territorial Health Officials: “Preparedness is a vital component of public health, especially in the wake of the Mpox response and ongoing H5N1 outbreak. As states work to implement lessons learned from these events, stockpiling essential supplies is a critical part of the discussion. Stockpiling ensures that resources are available during emergencies allowing for a swift and effective response. To enhance preparedness policy, it’s important to understand the history of the Strategic National Stockpile (SNS) and how it has shaped recent state readiness legislation.”

“23andMe Is in Trouble. What Happens to All the DNA Data?”

The hosts of NPR’s All Things Considered talk 23andMe’s potentially looming collapse and what is likely to happen to the data of its more than 14 million customers if the company goes under in this clip.

ICYMI: Capitol Hill Steering Committee on Pandemic Preparedness and Health Security-The Current Mpox Crisis and Congress’s Role in Protecting the US from Health Security Threats

This event was hosted by the Johns Hopkins Center for Health Security on September 18. At it, a panel of experts from government, industry, and academia discussed the US government’s response to the current mpox emergency. Learn more and watch the event recording here.

NEW: Bio and Beer (October 10)

Our panelists include:

Deborah Hemingway, Managing Partner, Ecphora Capital
Bibhash Mukhopadhyay, Managing Partner, Sound Bioventures
Kevin O’Connell, Senior Vice President, In-Q-Tel

Location: JLL Tysons Office, 1800 Tysons Boulevard, McLean, Virginia 22102

Hosted by: The Northern Virginia BioHub

Signature Sponsor: JLL

Additional Sponsors: Virginia Bio, the Prince William County Department of Economic Development, and George Mason University’s Institute for Biohealth Innovation

Responsible AI: Design, Development, and Use

FLUency: True Expertise and Effectiveness in the Battle Against Influenza

This event will take place in-person on October 8 from 9:20 am to 2 pm EST. Learn more and register here.

External Review of Ethical, Legal, Environmental, Safety, Security, and Societal Issues of Engineering Biology Research and Development

“NASEM will produce a consensus report presenting the results of its work and offering its findings, conclusions, and recommendations.”

“We invite you to submit suggestions for experts to participate in this activity. The call for experts closes on October 16, 2024 at 11:59 (ET).”

Recommend an expert here.

DARPA Invites Proposals for AI Biotechnology Pitch Days Dec. 5-6

Foundational technologies that promote simulation and prediction of biological systems and outcomes, like simulation, foundational models, and data generation,
Warfighter readiness, health, and recovery, such as medical countermeasures, diagnostics, health IT and medical devices, and
Operational support of U.S. forces to enable their execution of missions across the spectrum, ranging from fibers for garments to distributed, point-of-need manufacturing.”

Prediction and Health
Autonomous Science
Biomanufacturing/Synthetic Biology
Challenges with Scale
Exciting Frontiers”

Pitch Days

“DARPA will notify offerors if they are selected for further evaluation via an in-person Pitch Day presentation to a panel of BTO program managers at the AI BTO Pitch Day event.”

“To submit a white paper, register at https://usg.valideval.com/teams/aibto_2024/signup. The deadline is Friday, October 9, 2024 by 4:00PM EDT. Late applications will not be accepted.”

“Additional information is available on SAM.gov.”

BWC Advanced Education Course

“State Parties, particularly from the Global South, often lack the resources, knowledge, and expertise to participate in the Biological Weapons Convention (BWC) diplomatic process more meaningfully. To address this challenge, UNIDIR, Diplo Foundation and FRS are organizing the BWC Advanced Education Course (BWCedu).”

“The course will equip key stakeholders – government officials in capital with responsibilities in BWC implementation, aspiring and active diplomats and life scientists working on BWC issues and biological threats – with the essential knowledge, skills and expertise to actively participate in the BWC diplomatic process and thus contribute to a stronger and more effective Convention.”

“The BWCedu comprises a five-month advanced education programme. Through this programme, 25 participants will gain in-depth knowledge of the Convention, the diplomatic landscape and relevant scientific advancements.”

“The course will employ diverse learning methods, including online lectures, real-time engagement through webinars with experts and Working Group delegates and a week-long interactive in-person session in Geneva. Course participants will be provided with access to a collection of resources and information to support independent study on aspects of the BWC.”

“In its first iteration, the comprehensive programme will focus on the current Working Group agenda items, including the two mechanisms on science & technology and international cooperation and assistance being developed for consideration at the Tenth Review Conference, or earlier at a Special Conference if requested by a majority of State Parties. The course will prepare participants for ongoing engagement in the evolving framework of the BWC, empowering them to contribute to informed decision-making.”

Applications close on September 29. Learn more and apply here.

Call for Experts – Technical Advisory Group on Laboratory Services, Systems and Diagnostics in Health Emergencies

“The World Health Organization (WHO) is seeking experts to serve as members of the WHO Technical Advisory Group on Laboratory Services, Systems and Diagnostics in Health Emergencies (TAG-LAB). This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection.”

“Well-functioning and sustainable laboratory services, systems and diagnostics, operating according to international principles of equity, quality and safety, are essential to implement the International Health Regulations (2005)1 and achieve global health security. The World Health Organization (WHO) recently published the health emergency prevention, preparedness, response and resilience (HEPR) framework, describing the critical role of the laboratory to implement Collaborative Surveillance.”

“Laboratories also provide essential data to guide clinical care and inform coordination operations, as well as public health and social measures, in a range of emergency situations including outbreaks of pandemic and epidemic prone pathogens and humanitarian settings involving conflict, protracted crises and natural or man-made disasters. Considering this, a global strategy focused on laboratory services, systems and diagnostics for health emergencies is needed to address all of these contexts.”

“This strategy will connect global efforts and advance implementation of the laboratory components of the HEPR framework and World Health Assembly (WHA) Resolution 74.7 on strengthening WHO preparedness for and response to health emergencies that called for countries to “strengthen laboratory-based detection capacities”.”

“In this context, WHO is establishing a Technical advisory group on laboratory, services, systems and diagnostics for health emergencies (“TAG-LAB”). The TAG-LAB will act as an advisory body to WHO in this field.”

“The TAG-LAB is multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to virus evolution. Up to 25 Members may be selected. WHO welcomes expressions of interest from experts in laboratory services, systems or diagnostics, clinical scientists, academic researchers, healthcare professionals, or others with expertise in one or more of the following areas:

Laboratory Systems
Laboratory Services
Diagnostics
National and International Policy, Regulation and Guidance
Biosafety
Biosecurity
Bioinformatics
Clinical Management
Outbreak Preparedness, Response and Resilience
Emergency response in humanitarian settings involving conflict, protracted crises and natural or man-made disasters
Academic Research
Public Health
Virology, Microbiology, Mycology, and Emerging or Re-emerging diseases”

Learn more and submit and expression of interest here by September 30.

Call for Experts: Health-Security Interface Technical Advisory Group (HSI-TAG)

“The HSI-TAG is multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to the Health-Security Interface.”

Bioterrorism experts (knowledge on pathogens of security concern, their microbiological characterization and application/modification for weaponization, diagnostics, countermeasures and containment measures),
Decision/policy makers with hands-on experience dealing with significant deliberate event(s) (biological/chemical) response at the local, regional, or national level.”

Learn more about the HSI and express interest by October 7 here.

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