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
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.
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.
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
“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.
NEW: 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.
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
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.
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.”
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
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.”
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.
The Pandora Report 