Gryphon Staff Outline a Framework for Assessing Benefits of Human Pathogen Research

Gryphon Staff Outline a Framework for Assessing Benefits of Human Pathogen Research

To make informed choices about performing, supporting, publishing, or regulating human pathogen research, stakeholders involved with such research must weigh its benefits to public health and scientific knowledge against biosafety and biosecurity risks. However, 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. To aid decision-makers, Gryphon staff outlined a novel 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 fields 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.

Practice Areas

Biosafety, Biosecurity, and Emerging Technologies

Gryphon Staff Evaluate Federal Grant Funding for the Bioeconomy

Gryphon Staff Evaluate Federal Grant Funding for the Bioeconomy

Defined as economic activity driven by innovation in the life sciences, the bioeconomy is poised to revolutionize global economies on the scale of the industrial revolution. Seeking to expand domestic biotechnology capabilities, President Joe Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe, and Secure American Bioeconomy in September 2022 which establishes a whole-of-government approach to supporting the bioeconomy. As agencies strive to meet the goals set forth for them in the Executive Order, development of new funding programs for biotechnology and expansion of existing ones is anticipated. As part of a broader study of the US bioeconomy, Gryphon staff undertook an analysis of U.S. grant funding for biotechnology expanding upon methods first reported in Bioeconomy.XYZ in March of 2022. The study was published in Bioeconomy.XYZ, a bioeconomy-focused platform, as a follow up to the original analysis.

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  • CLIENT | U.S. Government
  • GRYPHON STAFF | Dr. Rocco Casagrande and Bryn O’Meara
  • PARTNERS | Battelle and Kathryn Hamilton, MS from Bioeconomy.XYZ
Practice Areas

Biosafety, Biosecurity, and Emerging Technologies

Promoting Responsible Research Collaborations in Southeast Asia

Promoting Responsible Research Collaborations in Southeast Asia

Gryphon Scientific staff members developed a framework for Conducting Responsible and Productive International Research Collaborations. The framework includes vetting potential collaborators, setting goals and expectations for the partnership, analyzing the risks and benefits of the research, following institutional guidelines, and making informed decisions based on principles of responsible research. Gryphon staff hosted a workshop in Bangkok, Thailand to teach scientists about the framework and discuss best practices for research collaborations. Outputs from this work include a white-paper and a review, which can be accessed with the links below.

Gryphon Staff Analyze the State of Research on Protecting Workers Against Occupational Exposure to Opioids

Gryphon Staff Analyze the State of Research on Protecting Workers Against Occupational Exposure to Opioids

The nationwide opioid crisis continues to affect not only people who use opioids but also communities at large by increasing the risk of accidental occupational exposure to illicit opioids. In addition, the emergence of highly potent synthetic opioids such as fentanyl and carfentanil increases the need to protect workers who may encounter unknown drug substances during job activities. To support the National Institute for Occupational Safety and Health (NIOSH) Opioids Research Gaps Working Group, Gryphon Scientific examined the state of the literature concerning methods to protect workers against accidental occupational exposure to illicit opioids and have identified unmet research needs concerning personal protective equipment, decontamination methods, and engineering controls. Additional studies are needed to overcome gaps in technical knowledge about personal protective equipment, decontamination, and control methods, and gaps in understanding how these measures are utilized by workers. Increasing our knowledge of how to protect against exposure to illicit opioids has the potential to improve occupational health across communities.

Gryphon Scientific Joins Academic and Industry Experts in Calling for Professionalization of Biosecurity Competencies

Gryphon Scientific Joins Academic and Industry Experts in Calling for Professionalization of Biosecurity Competencies

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.

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  • FORMER GRYPHON STAFF | Dr. Kavita Berger (Director, Board on Life Sciences at the National Academies of Sciences, Engineering, and Medicine)
  • PARTNERS | Rebecca L. Moritz, University of Wisconsin, Barbara R. Owen, Merck and Co., and David R. Gillum, Arizona State University

Gryphon Scientists Analyze the Accelerating Pace of Biotechnology Democratization in Nature Biotechnology

Gryphon Scientists Analyze the Accelerating Pace of Biotechnology Democratization in Nature Biotechnology

Gryphon Scientists Analyze the Accelerating Pace of Biotechnology Democratization in Nature Biotechnology

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.

Antibiotic Resistance and Breastfeeding: A neglected area of study

Antibiotic Resistance and Breastfeeding: A Neglected Area of Study

Research has shown that nursing mothers being treated with antibiotics expose their babies to sub-therapeutic doses of antibiotics. Through an analysis of published literature, this paper explores whether this exposure may promote the development of antimicrobial resistance in babies. We conclude that research examining the potential effect of antibiotic use by nursing mothers on antimicrobial resistance in their babies is needed to improve efforts to reduce antibiotic resistance by reducing unnecessary or inappropriate antibiotic prescribing.

Gryphon’s Managing Director Publishes White Paper on the Need for Empirical Research in Biosafety as Part of the CSIS Commission on Strengthening America’s Health Security

Gryphon’s Managing Director Publishes White Paper on the Need for Empirical Research in Biosafety as Part of the CSIS Commission on Strengthening America's Health Security

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.

The Commission, co-chaired by former Senator Kelly Ayotte and Dr. Julie Geberding, former Director of CDC, aims to “chart a bold vision for the future of U.S. leadership in global health security at home and abroad.” Dr. Casagrande was appointed as an expert and advisor to the Commission in 2017.

Assessing the Role of U.S. and Other Foreign Engagement in China’s Biotechnology Development

Assessing the Role of U.S. and Other Foreign Engagement in China's Biotechnology Development

Overview

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.

In July 2019, Dr. Mark Kazmierczak provided expert testimony for the U.S.-China Economic and Security Review Commission hearing on exploring U.S. reliance on China's biotechnology and pharmaceutical products. Dr. Kazmierczak briefed the Commission on key findings and recommendations from Gryphon's report and answered questions on how China's advances in biotechnology applications in healthcare and other industries may affect the U.S. economy and national security.

Motivation

In the past decade, Chinese policy has placed an emphasis on the importance of biotechnology to the future economic growth of the country, and its biotechnology industry has seen tremendous growth. Much of this growth has come through increased foreign interaction with the U.S. and other countries, through investment, partnerships, and other business, scientific, and academic relationships. To identify potential economic and security ramifications to the U.S., we sought to identify what strategies Chinese biotechnology companies are using to acquire new technologies and relevant data, including U.S. healthcare-related data, and what increased competition from China could mean for the U.S. biotechnology industry.

Methods

Our approach was multi-faceted and drew on diverse data sources. Open source information was used to assess the current capabilities of China’s biotechnology industry and its likely future direction. We spoke to entrepreneurs and investors in the U.S. biotechnology industry to understand the current relationships between the two countries and the benefits and risks that collaboration and partnership may bring. Through our partner, Rhodium Group, we identified and analyzed China-based investments into U.S. biotechnology companies. Through analysis of these data streams, we assessed the potential risks to U.S. economic and national security and identified avenues through which the U.S. could secure its interests.

Results

China’s biotechnology prowess is growing at a tremendous rate, supported by policies and investments at the national and local levels. Our report describes the technologies and capabilities of Chinese biotechnology companies, their goals for growth and development, and the methods used to achieve them. With these activities in mind, an honest and objective look at the risks and benefits of growing interdependence of the U.S. and China follows, with recommendations for specific steps that could be taken to ensure continued vitality of the U.S. biotechnology industry and the security of our country.

Resources

The public report, “China’s Biotechnology Development: The Role of U.S. and Other Foreign Engagement,” was released on February 14, 2019.

The U.S.-China Economic and Security Review Commission testimony, “Exploring the Growing Reliance on China’s Biotech and Pharmaceutical Products,” was given on July 31, 2019.

Review of Cases of Occult Radiation Exposure and an Analysis of Time to Diagnosis

Review of Cases of Occult Radiation Exposure and an Analysis of Time to Diagnosis

Review of Cases of Occult Radiation Exposure and an Analysis of Time to Diagnosis

Does cutaneous radiation injury reduce the time to diagnosis in cases where radiation exposure is not known? This paper reviews eight cases of occult radiation exposures and examines the factors confounding or supporting accurate diagnoses.