Category: Gryphon

In October 2014, the White House Office of Science and Technology Policy (OSTP) announced a funding pause on selected “Gain of Function” (GoF) research involving influenza viruses, SARS coronavirus, and MERS coronavirus, namely experiments that are “reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route” (White House OSTP Moratorium Memo). OSTP called for a deliberative process to evaluate the risks and potential benefits of this research, which would culminate in the development and adoption of a new US Government (USG) policy governing the funding and conduct of GoF research and the cessation of the funding pause. The National Science Advisory Board for Biosecurity (NSABB) served as the official federal advisory body on GoF research issues and was responsible for developing recommendations for the appropriate level of Federal oversight of GoF research. To inform the NSABB’s deliberations on this issue, Gryphon Scientific was contracted by the NIH Office of Science Policy to conduct risk and benefit assessments (RBA) of GoF research involving the pathogens subject to the funding pause. Our assessment was divided into four components: Biosafety risk assessment; Assessment of biosecurity risks due to intentional acts against the laboratory; Assessment of biosecurity risks due to misuse of information; Benefit assessment.

Supplements:

Avian Influenza-Related Supporting Information

Supplemental Information–Duck Populations

Supplemental Information–Minute Tidal Volume of Ducks

Supplemental Information–Notable and Selected Recent Avian Influenza Outbreaks

Risk & Benefit Assessment Supplemental Material

Supplemental Material–Landscape of GoF and Alt-GoF Research

Supplemental Material–Animal Models for Coronaviruses and Influenza Viruses

Supplemental Material–State of Surveillance for Influenza Viruses and Coronaviruses

Final Selected Presentations

Risk and Benefit Analysis (RBA) of Gain of Function Research

Risk and Benefit Analysis (RBA) of Gain of Function Research: Gaps and Future Considerations

Risk and Benefit Analysis (RBA) of Gain of Function Research: Summary

Risk and Benefit Analysis (RBA) of Gain of Function Research: Progress Update

Final Selected Reports

Risk and Benefit Analysis of Gain of Function Research: Draft Final Report

Risk and Benefit Analysis of Gain of Function Research: Bibliographies

Human Epidemiological and Sociological Data

Supplemental Information–Data Supporting the Disease Course of SARS and MERS

Supplemental Information–Data Supporting the Modeling of the Disease Course of Influenza

Supplemental Information–Data Supporting Antiviral and Vaccine Efficacy

Supplemental Information–Data Supporting MERS and SARS R0

Laboratory PPE, Experiment, and Animal-Related Supporting Information

Supplemental Information–Avian Influenza Titers in Mouse and Ferret Models

Supplemental Information–Approach to Estimating Salivary Titers for CoVs

Supplemental Information–Durability Assessment of Culture Flasks

Supplemental Information–Protection Afforded by PAPRs

Other Risk-Related Supplemental Information

Supplemental Information–Calculating Earthquake Risk

Supplemental Information–Protection Against Infection with 1918 H1N1 Pandemic Strain

Supplemental Information–Inactivation of Coronaviruses and Influenza A Viruses by Solar UV-B Radiation

Other Supplemental Information

Additional Interview Data: Research Proliferation, Practical Considerations for GoF Policies, and Limitations of Alternative Approaches

Case Studies to Inform Discussions about Defining and Evaluating GoF Studies of Concern

Interview Guides for Risk and Benefit Analysis of Gain-of-Function Research

Risk Assessment Parameters

Supplemental Information–Influenza and CoV Modes of Transmission and Environmental Stability

Supplemental Information–Global Demographics Supporting SEIR Modeling

Supplemental Information–Dose Response Parameters for Gain of Function Pathogens

Supplemental Information–Fomite Model

Supplemental Information–Detailed Information of the BARDA Interactive Flu Model

Supplemental Information–Detailed Parameters of the Branching Process Model

Supplemental Information–Detailed Descriptions of the Fault Tree Analyses

Event Trees

As biotechnologies mature from activities requiring substantial educational and financial investments into those requiring far less resources, the technologies can more readily be misused to cause harm. Understanding the speed at which new biotechnologies become “democratized” is important for developing regulatory and security policies and practices that safeguard against accidental or intentional misuse without unduly hampering cutting-edge research. In this publication from Nature Biotechnology, Gryphon researchers use a novel analytical method to analyze the pace of advancement of biotechnologies. Gryphon’s analysis suggests that novel biotechnologies can become democratized – that is, accessible to many individuals with relatively low levels of technical skill and financial resources – in less than 4.5 years from their discovery and may do so in less than 3.5 years by the end of the next decade. These results suggest that ongoing review of the security risks associated with biotechnologies is needed to enable proactive development of mitigation policies and oversight systems.

Advances in life sciences research and biotechnology fields, including synthetic biology, genomics, and neuroscience, are transforming the agriculture, healthcare, energy, and other sectors that rely on use of biologically derived materials. However, some of these materials, technologies, and associated information and expertise potentially could be exploited to cause harm to humans, animals, plants, the environment, public safety, or national security. Biosecurity is a multidisciplinary effort to identify and mitigate biological risks by implementing risk- and threat-based control measures to prevent the unauthorized access, misuse, loss, theft, diversion, and intentional release of such “dual use” materials, technologies, information, and expertise.

Historically, biosecurity policies and practices have focused on risks posed by pathogens and toxins, and therefore, may not address adequately the security concerns posed by emerging life sciences research and technologies. In this Policy Forum, the authors propose the establishment of a professional biosecurity credential to support the creation of a well-trained, responsible workforce with a core set of skills necessary to secure the life sciences of the future.

Access this paper here.