This page serves as a repository for a selection of reports and publications from Gryphon Scientific, a research and policy consultancy that performed cutting-edge work in biosafety, biosecurity, and all-hazards preparedness and response. Over the past two decades, Gryphon supported senior decision makers within government and the commercial sector in evaluating emerging technologies and understanding how to enable their rapid development while safeguarding against their associated risks. Notably, Gryphon was commissioned by the NIH in 2016 to conduct an extensive risk-benefit analysis of gain-of-function research with potential pandemic pathogens. Gryphon was also at the forefront of AI safety, with a particular focus on the intersection of AI and biological and chemical threats. Gryphon is now continuing and expanding its work as part of Deloitte Consulting LLP. For more information about the reports below, please contact Rocco Casagrande at rcasagrande@deloitte.com.
A Call for a National Agency for Biorisk Management (2022)
Current oversight of biorisk management in the United States is determined by a patchwork of federal, state, and local regulations, resulting in major gaps. Infectious diseases do not respect state and local borders, and a national agency for biorisk management could coordinate relevant regulations.
Concepts to Bolster Biorisk Management (2022)
The rapid increase in the power of the life sciences has not been accompanied by a proportionate increase in the sophistication of biorisk management. Through conversations with thought leaders in biosafety and biosecurity, we have identified 19 concepts that are critical for biorisk management to continue to ensure the responsible and safe conduct of the life sciences in the future. Our work is not meant to be a comprehensive list, but rather a collection of topics that we hope will spark dialogue in the policy, research, and biorisk management communities.
A Simple Benefit Assessment Framework to Support Decisions on Human Pathogen Research (2022)
(NOTE: This white paper is from an unfinished project. Further funding is needed to circulate the benefits assessment framework among expert stakeholders.) Assessing the public health benefits of research is difficult because benefits typically unfold over long time scales, with great uncertainty, and unevenly across the global population, and they depend upon disputable technical details of the research in question. As a result, the claimed public health benefits of human pathogen research are often vague or underspecified, complicating a comparison to risks. To aid decision-makers, we describe a framework for qualitatively estimating a research project’s maximum expected public health benefits. The framework is deliberately designed as a set of six simple yes-or-no questions that can be answered by reviewers who are not experts in the scientific field at issue. Underpinning the framework is the idea that the expected benefits of human pathogen research are larger when the pathogen (and the specific variants under study) are or will be circulating in humans and domestic animals. For example, the maximum benefits of research are larger (and tolerance for risk is therefore higher) when that research involves pathogens that are present threats to humanity, and benefits are smaller for research on pathogens that are unlikely to naturally evolve. We intend for this framework to be implemented alongside existing methods to evaluate scientific merit, biosafety risks, and biosecurity risks to strengthen the risk-benefit assessment process for pathogen research.
Promoting Biosecurity by Professionalizing Biosecurity (2020)
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.
The Accelerating Pace of the Democratization of Biotechnology (2019)
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.
China’s Biotechnology Development: The Role of U.S. and Other Foreign Engagement (2019)
In the past decade, China’s biotechnology industry has grown tremendously, fueled by Chinese government policies promoting the biotechnology sector as a driver of economic growth and increased foreign interaction with the U.S. and other countries. Gryphon Scientific, in partnership with Rhodium Group, performed an extensive investigation of China’s biotechnology industry and the role of U.S. companies in its development to assess the economic and security implications for the U.S. Our report provides a comprehensive look at a growing power in the global biotechnology industry and includes recommendations for specific steps to ensure continued vitality of the U.S. biotechnology industry and the security of our country.
Federal Funding for Biosafety Research is Critically Needed (2019)
Dr. Rocco Casagrande, Gryphon’s managing director and an advisor to the Center for Strategic and International Studies (CSIS) Commission on Strengthening America’s Health Security, recently published a white paper with CSIS on the need for empirical research to support laboratory biosafety. In this paper, Dr. Casagrande argues that the life sciences have advanced much faster than our knowledge of biosafety, the practice and knowledge needed to prevent accidents in life science laboratories. Research is needed into how accidents occur and the effectiveness of training and equipment to prevent or mitigate accidents. Dr. Casagrande suggests that seminal research could be funded for merely $10M a year and that this research is best housed at the National Institute for Occupational Safety and Health.
Roadmap for Biosecurity and Biodefense Policy in the United States (2018)
The U.S. policy landscape for countering biological threats is split into two main groups: 1) biosecurity, which specifically focuses on preventing theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies to cause harm; and 2) biodefense, which involves the development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats. This project involved the first ever systems-based analysis of the entire U.S. biosecurity and biodefense policy landscape, which enabled greater understanding of the functional relationships between policies as of 2017. These analyses, along with reviews of methodologies for measuring policy implementation and historical case studies to better understand factors that lead to opportunity costs, informed the development of a roadmap for implementing biosecurity and biodefense policies that leverages science and technology advances and minimizes security risks. In addition to the roadmap, this study presents two analytic frameworks for evaluating policy implementation and analyzing opportunity costs.
Assessing the Risks and Benefits of Conducting Research on Pathogens of Pandemic Potential (2016)
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.
The Pandora Report 