Pandora Report 9.27.2024

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

Source: APHIS

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:

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.”
  5. “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.”
  6. “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.”
  7. “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)

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

Register to attend for free at: https://ibi.gmu.edu/event/october-2024-bio-beer/

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

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.

Register now: https://bit.ly/3zMvZOR

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.

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.”

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 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: 2.26.2016

It’s been quite a week for global health security. Even the X-Files covered worldwide pandemics (that’s right, multiple diseases), CRISPR-Cas9, and military vaccination programs. Measles is hitting Nigeria hard as Lagos state officials announced the deaths of 20 children related to the outbreak. A recent study released by the University of Pennsylvania’s Annenberg Public Policy Center found that more than one third of participants believed Zika virus was a conspiracy theory related to genetically modified mosquitoes. Maybe they were also watching the X-Files? Before we begin, meningitis vaccine efforts were celebrated at the Meningitis Vaccine Project (MVP) conference, due to success within Africa’s meningitis belt.

GMU Biodefense Students Awarded UPMC Biosecurity Fellowship
We’re happy to announce that two GMU Biodefense students have been selected as Fellows for the UPMC Emerging Leaders in Biosecurity Initiative (ELBI)! Congrats to biodefense MS alum Francisco Cruz, and PhD candidate Siddha Hover! “The Emerging Leaders in Biosecurity Initiative is a competitive fellowship program designed to create and sustain an energetic, multidisciplinary, and intergenerational biosecurity community made up of motivated young professionals as well as current leaders. UPMC has selected 28 US and international emerging leaders in biosecurity from a wide array of backgrounds, including biological science, medicine, policy, the military, law, public health and the private sector.” Siddha Hover works for BAI, Inc. as an embedded contractor with the Department of Homeland Security, where she serves as DHS’s sole treaty analyst. In her role, she is responsible for reviewing all relevant DHS-sponsored research and activites for compliance with applicable arms control agreements. Siddha is currently pursuing her PhD in Biodefense. She holds a MSc in Biodefense from George Mason University and a MSc in International Relations from the London School of Economics. Siddha notes that, “the GMU Biodefense program provided me with the foundational knowledge necessary to confidently begin a career in biodefense and enabled me to successfully apply for the ELBI Fellowship.” Francisco is a biologist in the Field Operations Branch of the U.S. Environmental Protection Agency’s (EPA) Chemical, Biological, Radiological, and Nuclear Consequence Management Advisory Division (CBRN CMAD). As CBRN CMAD’s Biologist, Francisco provides operational guidance to federal, state, and local responders in the areas of decontamination and emergency response related to biological incidents. Francisco holds a B.A. in Biological Sciences from the University of Delaware. During his time at GMU, Francisco earned a Graduate Certificate in Critical Analysis and Strategic Responses to Terrorism, and earned his M.S. in Biodefense in December 2015. Congrats to Siddha and Francisco in their work furthering the field of global health security and representing GMU Biodefense in the ELBI program!

GMU Biodefense Course Sampler- “Biosecurity as a Wicked Problem”
If you’re on the fence about going back to school, curious about our program, or just want to hear what a class in biodefense would be like, check out our course sampler on Wednesday, March 2nd, at 7pm, in our Arlington Campus in Founders Hall, Room 502. “The United States and the world face unprecedented threats to global biosecurity, including emerging infectious diseases, pandemics, natural disasters, bioterrorism, and laboratory accidents. Find out about the challenges posed by these threats and strategies for enhancing global health security.” How many times can you sample a course from not only an expert in the field, but also the director of the program? Dr. Koblentz will be your host for this evening lecture on biodefense, dual-use research, CRISPR-Cas9, biosecurity, and much more. Can’t attend in person? Don’t worry – we’re also live-streaming here. Come join us for a look behind the curtain of not only our GMU graduate programs, but also the world of global health security.

CRISPR and The Battle of Genetically Modified Mosquitoes 
CRISPR-Cas9 technology has been a hot topic since it was discovered and things have only ramped up since a Chinese research team announced last Spring that they successfully edited human embryo genes. While many raised concerns over “designer babies” and genetically modified livestock, the case for genetically modified mosquitoes has also been discussed. What if science could modify mosquito capabilities to carry disease? CRISPR-Cas9 research is getting much closer to making this a reality with the help of two research teams. “The first group, led by Valentino Gantz and Ethan Bier at the University of California–San Diego, and Anthony James at the University of California–Irvine, engineered a gene drive carrying a pair of genes designed to kill the malaria parasite inside the mosquito.The second group, led by Nikolai Windbichler, Andrea Cristanti, and Tony Nolan at the Imperial College London, developed a more brute force approach, building a gene drive that breaks an important mosquito gene and renders the females sterile—a strategy designed to decimate a mosquito population. Both groups reported that, when the genetically modified insects were crossed with wild ones, as much as 99 percent of the offspring carried the modified genes, a clear sign that the gene drives were working.” While field tests are still necessary to establish efficacy, it’s important to note the researchers are taking great strides to ensure public buy-in given the sensitivity of such work. Gene drive is becoming more accessible and the applications appear limitless however, ethical use of this pioneering innovation is crucial for future work.

Climate Change & Zika Virus – What’s the Link?
Somewhere between reporting on CRISPR-Cas9 mosquitoes and Zika updates, it seems like a perfect place to discuss what kind of impact climate change is having on infectious diseases…especially Zika virus. GMU Biodefense MS student and one of our contributors, Greg Mercer elaborates on the role climate change may have on the growing geographical distribution of mosquitoes that pose some of the biggest threats. Greg points out that “exactly how climate change drives the spread of Zika and other diseases is hard to define. In 2013, researchers at the University of Arizona published a paper examining the effect of climate factors on dengue and its Aedes vectors. Their conclusion highlighted just how far scientists still have to go in understanding the climate-disease link: ‘Climate influences dengue ecology by affecting vector dynamics, agent development, and mosquito/human interactions,’ they wrote, but ‘although these relationships are known, the impact climate change will have on transmission is unclear.’ Climate change introduces additional complications into an already complex system, the study authors explained: It’s difficult enough to understand how weather, climate, human interaction, or mosquito behavior contribute to the spread of a virus.” Researchers are now comparing the global distribution of Aedes mosquitoes and the spread of Zika, which leaves many to wonder if the threat of global disease will evolve with that of global climate change.

BARDA Seeks Advanced Public Health Consequence Modeling
The Biomedical Advanced Research and Development Authority (BARDA) is currently working to find partners that can aid in the development of a modeling system that would support federal decision makers in their planning and response to CBRN events. “The tools developed under this acquisition will assist Federal decision makers with medical and public health decision making for the advanced development and implementation of an integrated National medical countermeasures infrastructure (e.g., vaccines, therapeutics, diagnostics, and medical devices).” They’re hoping to build partnerships to establish a network for medical consequence modeling, simulation, visualization, and decision support. BARDA plans to include two functional areas within the network, 1- decision support, reach back, analysis, and modeling (DREAM), and 2- professional services and systems integration (PSSI). “These activities include assisting government decisions makers during the development of preparedness plans, the implementation of response strategies, and communications with a wide variety of stakeholders, both during day to day operations and in the course of declared public health emergencies as part of the BARDA Modeling Coordination Group.” Each functional area will have multiple Indefinite Delivery/Indefinite Quantity (IDIQ) awards that can be earned and they are encouraging interested stakeholders to submit proposals.

To Zika and Back 

Courtesy of the Council on Foreign Relations
Courtesy of the Council on Foreign Relations

As Zika virus continues to spread and South Africa reports the first of their cases, many are wondering how these outbreaks tend to go from 0-60 in a hot minute. NIAID director, Anthony Fauci, discusses the reality of disease surveillance and revealed this slide during an interview, of which you can see the global examples of emerging and re-emerging infectious diseases. Dr. Fauci points to the unpredictable nature that is public health and global health security. Global public health is still reeling from the effects and imperfect response of Ebola 2014, coupled with the scrutiny of a response to H1N1 that was considered too zealous. I’ve always considered public health and disease prevention to be the kind of work where few realize when you’ve done your job correctly but when you fail, it’s something you’ll be hearing about for decades. Global health security is challenging on a good day and public health tends to get little funding, especially in the countries that need it most. After the devastation of Ebola and all the after-action reports, many are wondering how did we miss the rise of Zika virus? Dr. Ken Stuart, director of the Center for Infectious Disease Research in Seattle, says, “We were unaware of the severity of the disease … [and] were unaware this virus had the capability for getting distributed so rapidly.” Regarding the funding issues that often plague infectious disease efforts, he noted that “this really goes back to funding priorities. Much of the funding devoted to infectious disease today is in reaction to outbreaks. Therefore, we’re not generally prepared to respond quickly. In other cases there are diseases that are very rare but they have an advocacy group that generates research activities. In the case of diseases like Zika, which were isolated in remote areas of the world where that population had no resources or advocacy group, there was no push to do research.We’re not stuck with what we’ve got. There are conversations between federal funding agencies and private organizations to try to prioritize the utilization of their resources, and I would say the NIH has been a leader in supporting the fundamental research that actually, probably positions us best to be prepared to respond to these disease outbreaks.” In other Zika news, a CDC team just arrived in Brazil to study the associated birth defects and the White House is urging Congress to provide emergency funds to support Zika response efforts, rather than just re-directing funds from Ebola-related projects. You can also see a map tracing the spread of Zika and some background here. As of February 24, the CDC has reported 107 travel-associated cases in the U.S.

The Rise of Chikungunya
I always thought it sounded like the name of a monster and in some ways, that’s pretty spot on. The Pan American Health Organization (PAHO) reported 16,668 confirmed and suspected cases of Chikungunya in 2016 so far. Colombia shouldered the majority of 2016 disease burden, with a spike of 1,189 new cases added to their previous count of 5,752. The PAHO is still playing catch-up on their year-end reporting for 2015, but it looks like 28,722 additional infections were added to their 2015 data. These updates mean that this region experienced 726,478 cases in 2015, and with the the new cases reported as of February 19, this current outbreak has been responsible for 1.89 million infections. Starting in 2013, this outbreak began on St. Martin and has been gaining traction ever since. Hopefully with the mosquito-control efforts related to Zika virus, the mosquito population also responsible for Chikungunya will begin to decline.

Stories You May Have Missed:

  • Breaking Down the Barriers of MDRO’s:  Scientists in the UK have discovered how drug-resistant bacteria create and maintain their defensive wall. Using the Diamond Light Source machine to “investigate in tiny detail a class of bugs known as Gram-negative bacteria”, they were able to find a defensive wall and it’s assembly beta-barrel machinery (BAM). This new research means that future treatments can aim at preventing bacteria from building these defense measures versus just attempting to attack the bacteria itself.
  • Melbourne Measles Outbreak – 14 cases have already been confirmed in the suburb of Brunswick, of which 2 were children from a primary school. Students that attend the same school and are not fully immunized were instructed to stay home to avoid exposure.
  • E. coli Outbreak in Raw Milk – Not surprisingly, a recall has been issued related to unpasteurized raw milk from a local dairy farm in Fresno, CA. 10 people have been confirmed with Shiga-toxin producing E. coli 0157:H7. Thankfully the shelf-life of the product has passed and public health officials, while stating that the investigation is on going, have confirmed that no health alert was issued since the product is believed to no longer be within the marketplace. Moral of the story – avoid raw, unpasteurized milk.

Enjoying your weekly dose of the Pandora Report? Sign up to receive it every week so the fun never ends! 

Pandora Report 4.11.15

It’s a public health weekend here at Pandora Report as we check out stories on TB and Polio. We also have other stories you may have missed.

Have a great week and see you back here next weekend!

Ancient Hungarian Crypt Offers Clues to Tuberculosis Origins

As one of the leading infectious disease killers, Tuberculosis, a bacterial infection, holds interest for scientists who disagree over the origins of the human disease. However, a new study in Nature Communications uses a cutting-edge approach called metagenomics to analyze corpses that were naturally mummified in a Hungarian crypt. Of 14 genomes found in eight of the corpses, researchers discovered that multiple strains were circulating in Hungary in the 18th century when these people died.

The Toronto Star—“‘All the historic genomes belonged to lineages that we see today,” said senior author Dr. Mark Pallen, a professor of microbial genomics at the University of Warwick. “So TB hasn’t changed much in 200 years … (and) it turns out that the most common ancestor of the Euro-American lineage that all our (tuberculosis) genomes belonged to dates back to late Roman times.’”

Polio, Cancer—One Nemesis May Counter the Other

Tomorrow, April 12, is the 60th anniversary of when Dr. Jonas Salk’s polio vaccine was declared to be effective. Today, as the world inches closer to full polio eradication, interesting news highlighted on “60 Minutes” looks at the polio virus’ ability to kill another lethal illness—Cancer. A genetically engineered strain of polio virus appears to thwart lethal brain cancer tumors.

The Huffington Post—“The modified polio virus seems to deactivate the cancer tumor’s ability to defeat immune capacities. Freed up, the immune system works at defeating the tumor. Miraculously, the immunotherapy workings spare healthy tissues, while killing cancer cells.”

Stories You May Have Missed

Image Credit: Pudelek

The Epidemiologist: Dark Horse of Public Health

By Chris Healey

Many identify physicians as the preeminent professional in the health field – followed by dentists, physical therapists, pharmacists, and nurses – to name a few. However, one of the most important cogs in the health infrastructure mechanization is publicly obscure, yet works almost exclusively with the public. The epidemiologist is the most important health professional you may never meet.

An epidemiologist is not intentionally obscure. The occupation simply does not require as much face-to-face interaction as other health professionals. Instead, epidemiologists analyze data collected by healthcare providers to discern patterns overlooked on a patient-by-patient basis. That data is often analyzed offsite, away from patients. While physicians are treating the individual, epidemiologists are looking at the big picture.

State and federal regulations require physicians and other health professionals to report pertinent diagnosis and patient information to local health departments. That data is collected and analyzed by regional and district epidemiologists to detect unusual disease instances or patterns in their respective regions and districts. Data from local health departments is collected and further consolidated on the state and federal level by state health departments and the Centers for Disease Control respectively.

Epidemiologists serve as the vanguard in outbreak and bioterrorism detection. A clandestine bioterrorism event will likely be detected first by epidemiologists. For example, while several physicians may treat several different E. coli casesin the same day, they are unlikely to communicate mutual diagnoses among themselves. However, an epidemiologist whom analyzes all E. coli diagnoses that day may be able to discern unusual incidence. A physician can identify a single illness, but epidemiologists identify outbreaks and epidemics.

Incidence and pattern detection is only one function of the typical epidemiologist. Once pathogens of interest are detected, epidemiologists investigate patients to determine how they became infected with the respective agent. While physicians can serve in an investigative capacity, diagnosis and treatment of the patient at hand is often their focus. Epidemiologic investigations typically include patient interviews and environmental sample collection. In instances of foodborne illnesses, those investigations are critical to identify the tainted food and water sources. Product recalls and water treatment advisories are often the result of epidemiologic investigations.

Epidemiologists are often marginalized in popular culture and cinema. They are conflated, and often completely replaced, with physicians. However, the 2011 film Contagion portrayed epidemiologists as discrete health professionals with accurate—though dramatized—job functions.

Epidemiology is a growing field. According to the Bureau of Labor Statistics, epidemiologist employment is projected to grow 10 percent from 2012 to 2022, which is about as fast as the average for all occupations.

 

(Image Credit: Contagion)