Category: Commentary

Written by: Sarah W. Denton, Research Fellow, Institute for Philosophy and Public Policy, George Mason University; Research Assistant, Science and Technology Innovation Program (STIP), The Woodrow Wilson International Center for Scholars

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (NASEM) held a public briefing timed with the release of a new report titled, Biodefense in the Age of Synthetic Biology. The panel – comprised of the committee chair, Dr. Michael Imperiale, and four authors of the report, Dr. Patrick Boyle, Dr. Peter Carr, Dr. Diane DiEuliis, and Dr. Jill Taylor– gathered to present their research to the public and provide an opportunity for an in-person and online question and answer session.

During this briefing, the panel discussed the study’s concern-assessment framework (Figure 1). The framework consists of four factors that can be used to assess the level of concern for current and future synthetic biology capabilities. Notably, rather than attempting to assess the levels of concern presented by various technologies (e.g., CRISPR/Cas9), this framework focuses instead on assessing capabilities “that potentially pose a concern because of the harm they might enable.”[i]

While the framework draws on previous works (e.g., Tucker 2012and the 2004 Fink report), what makes this report unique is its use of the Design-Build-Test (DBT) process as the foundation for its capability-assessment. DBT is the “iterative process of designing a prototype, building a physical instantiation, testing the functionality of the design, learning from its flaws, and feeding that information back into the creation of a new, improved design.”[ii]Specifically, the committee found it useful to conceptualize current and future technological developments in terms of the ways in which they enable the DBT cycle, granting that it is entirely possible for some technologies to have impacts across    multiple phases of the DBT cycle.[iii]For example, the committee identified potential points of concern in all phases of the DBT process in their analysis of the level of concern relating to the re-creation of known pathogens.[iv] Continue reading “NASEM Report: Biodefense in the Age of Synthetic Biology” →

By: Alexandra Williams, GMU MS Biodefense ‘18

This past Monday, July 16, 2018, the National Academies of Sciences, Engineering, and Medicine (NASEM) held an important meeting at their headquarters in Washington, D.C. At this meeting, they discussed with U.S. government security and health agencies the future of global health security, disease surveillance, and biosecurity, as well as the challenges and gaps that exist in meeting international and domestic health security missions and mandates. This second and final NASEM committee public meeting was a follow-up to their first meeting in April 2018. In these two meetings, NASEM was charged with examining and better understanding the Cooperative Biological Engagement Program (CBEP) of the U.S. Department of Defense (DoD)’s Cooperative Threat Reduction (CTR) program—CBEP being a forefront program for biosecurity and health security—and other U.S. government stakeholders in health security. An overview of the July 16, 2018 meeting can be found here. Additional information can be found via the National Academies of Sciences project information page. Continue reading “Crucial Steps Forward: the National Academies of Science’s 2018 Study, “Enhancing Global Health Security through International Biosecurity and Health Engagement Programs”” →

Christopher Z. Lien – Biodefense, M.S. student

In late June, I attended the Science Diplomacy & Leadership Workshop 2018, a five day workshop held at the American Association for the Advancement of Science (AAAS) headquarters in Washington, D.C. Our class included 28 participants representing 15 countries including Spain, Latvia, Puerto Rico, Costa Rica, Pakistan, Austria, Portugal, Australia, and the United States. Participants came from varied professional disciplines (a large portion in the physical and biological sciences) and many are currently in graduate programs or already hold PhDs. Most of the discussions held were subject to Chatham House Rules, where the information presented may be used freely, but the speakers’ and other participants’ names and affiliations are not to be attributed to said information.

The first day posed the three main questions the workshop would address:

• How does science inform diplomacy?
• How does diplomacy inform science?
• What does science in diplomacy look like today?

The second day began with a breakfast at the Embassy of France with The Science Diplomats Club of Washington, D.C. Science and technology representatives from the embassies of Poland, Canada, France, Switzerland, Italy, and from EURAXESS Links North America spoke to us regarding their countries’ scientific diaspora communities and how engaged these communities are in taking an international approach to science. Aligning educational policy with science, gaining talent from abroad, facilitating networking across the diaspora communities – these are some of the tasks the scientists are working toward. Continue reading “AAAS Science Diplomacy & Leadership Workshop 2018” →

By Katherine Paris*

In a recent webinar hosted by the U.S. National Academies of Sciences, Engineering, and Medicine, Dr. Piers Millet and Dr. Todd Kuiken explored their work on the development of safety and security practices in non-traditional research communities (i.e., communities that are outside of private or academic research institutions). The webinar expanded on discussions from the international workshop on “Assessing the Security Implications of Genome Editing Technology” held in Germany in October 2017.  At the workshop, concerns were expressed over the extent that advancements in technology allow a greater range of people to access, and possibility misuse, genome editing technologies.  Dr. Millet and Dr. Kuiken addressed these concerns during the webinar by describing what two non-traditional research communities—the International Genetically Engineered Machine (iGEM) competition and do-it-yourself biology (DIYbio) community laboratories—are doing to foster biosafety and biosecurity.

To begin, Dr. Millet, Vice President of Safety and Security at iGEM, described the system put in place at iGEM to manage and mitigate biosafety and biosecurity risks. The iGEM competition is an international synthetic biology competition in which teams of students use standard biological parts to genetically engineer organisms to address real world problems.  Last year, approximately 6,000 participants from 45 countries were part of the iGEM competition. At iGEM, everyone is responsible for safety, so teams, supervisors, and principal investigators are expected to take an active role. Resources on the iGEM Safety and Security Hub support the projects. iGEM also has its own Safety Committee to meet the needs of participants and ensure the projects are safe. Commercial partners augment the screening process and help to flag potential risks, which are resolved directly with teams or referred to the iGEM Safety Committee.  Another commercial partner screens the parts used in the competition. Overall, parts used in the competition are not dangerous; however, parts that could pose a risk if used a certain way in a certain organism are flagged. Projects that wish to use flagged parts must provide additional justification before permission is granted. Continue reading “Genome Editing and Security: Governance of Non-Traditional Research Communities?” →

By GMU Biodefense graduate student Carlos Alvarado

On Wednesday June 13, 2018, the Nuclear Threat Initiative (NTI) hosted Dr. Reshma Shetty of Ginkgo Bioworks for a presentation on getting ahead of risk in the world of designer organisms. The presentation started off with remarks from NTI CEO Ernest J. Moniz announcing the new logo for NTI:Bio. He explained how NTI’s focus was on nuclear weapons and weapons of mass destruction however, with rapid advances in science technology NTI created a Global Biological Policy and Programs Unit. NTI:Bio’s focus is to continue to find ways to reduce threats from risks posed by advances in biotechnology. He then concluded with introducing Dr. Reshma Shetty and how her company Ginkgo Bioworks could provide insight of how these advances in biotechnology could support the future structure of biosecurity. Continue reading “NTI Presentation- Biosecurity by Design: Getting Ahead of Risk in the World of Designer Operations” →

by Stephen Taylor, Biodefense MS student

On Thursday May 17, 2018, the Center for Strategic & International Studies (CSIS) brought together health security experts from around the globe for a symposium on pandemic preparedness in the 21^stcentury.  The event opened with remarks from J. Stephen Morrison, Senior Vice President and Director of the CSIS Global Health Policy Center and Luciana Borio, Director of Medical & Biodefense Preparedness Policy for the National Security Council.  Dr. Morrison and Dr. Borio discussed the importance of lessons learned during the 2014-2016 West African Ebola pandemic to global health security.  In Nigeria, for instance, where Ebola containment efforts were successful, investments in detection and response capacities made for the Nigerian polio eradication program were instrumental in stopping Ebola. Surveillance systems and trained health care workers were embedded at the community level and field epidemiologists were ready to be deployed.  The Nigerian response was an excellent demonstration of how investments toward vaccination and eradication campaigns for one disease can have crosscutting benefits for pandemic preparedness as a whole.  Also important were the efforts that grew out of the bungled responses in Liberia, Guinea, and Sierra Leone.  In light of the massive casualties, slow and costly international response, and ruinous economic damage in these countries, the international conversation about pandemic preparedness and response was propelled forward.  The Global Health Security Agenda enjoyed an increased profile in the years following the pandemic.  National leaders committed to increasing prevention, detection, and response capacities and the international community re-evaluated its approach to emergency response efforts. Continue reading “Pandemic Preparedness in the Wake of Ebola -CSIS Symposium” →

By GMU Biodefense graduate student Janet Marroquin

The contentious debate regarding the precision of the commercially available gene-editing tool, CRISPR-Cas9, continues as Nature recently retracted a study published last year on the unintended effects of off-target mutagenesis.  The 2017 study used CRISPR-Cas9 to edit a genetic mutation causing blindness in mice but the researchers also observed CRISPR-induced mutations in other genes due to off-target editing at higher rates than previously documented.  In their report, the researchers expressed their concern over the alarming target imprecision of the widely-used gene-editing tool and its effect on unwanted mutations in gene therapy.  However, further evaluation of the study by other researchers raised questions about the validity of the study results given the possibility of natural genetic variation introducing mutations independent of CRISPR use.  After eight months of deliberation, Nature determined the cause of the unexpected mutations to be natural genetic variability, as the mice were not genetic clones, and not the pronounced off-target effects of the CRISPR-Cas9 system used, ultimately leading to the retraction of the study from the journal. Continue reading “Elevating CRISPR-Cas9” →

Anthony Falzarano, GMU Biodefense graduate student 

Last week, the National Academies of Sciences, Engineering and Medicine held another event in their monthly series on biological, chemical and health security issues. This luncheon – consisting of an open forum session with a two-member panel and a moderator – featured Dr. George W. Korch and Dr. Dana Perkins, both from the Department of Health and Human Services office of the Assistant Secretary for Preparedness and Response (ASPR). Drawing from their current roles with ASPR as well as their illustrious careers and vast experiences, two presenters made for a compelling afternoon discussing health security issues and the work being done by ASPR to prepare for and address them. Continue reading “An Afternoon with ASPR – Dr. Robert Korch and Dr. Dana Perkins” →

Overview by: Morasa Shaker, GMU Biodefense graduate student

Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention
By Center for the Study of WMD
Spotlight Speaker: Michelle Rourke

It is more than likely that most people would not be opposed to efforts conserving the critically endangered Borneo elephant found on the island of Borneo in Sabah, or the Radiated Tortoise near extinction on the island of Madagascar. However, it would take a lot more convincing to reach a unanimous consensus that we should conserve a fatal virus. While the case can be made that endangered species pose an intrinsic value to the world’s genetic diversity, it is has proven less feasible to make the same case for a virus, specifically the variola virus—the causative agent of smallpox. Nevertheless, Michelle Rourke, a Fulbright scholar at Georgetown University’s O’Neill Institute for Domestic and Global Health Law, led an in-depth educational seminar organized by the Center for the Study of Weapons of Mass Destruction to support that very case—the smallpox virus is worthy of our conservation efforts.

This discussion, based on her article “Never Mind the Science, Here’s the Convention on Biological Diversity: Viral Sovereignty in the Smallpox Destruction Debate,” published in the Journal of Law and Medicine, addressed the smallpox virus retention controversy that has ensued since the disease was declared eradicated in in 1980. Rourke, a PhD candidate at Griffith Law School in Nathan, Australia, found it increasingly more difficult to access virus samples for research purposes while studying both dengue viruses and Ross River virus. These major hindrances in her studies served as the context for her research on the international law around ‘who owns virus samples’ and then using those principles of international law and extending them to a specific case: Who owns the smallpox stocks maintained in the Centers for Disease Control (CDC) in the United States in Atlanta, GA and in Koltsovo, Russia? Continue reading “Who Owns Smallpox?: The Nagoya Protocol and Smallpox Virus Retention” →