Gain- and loss-of-function research have contributed to breakthroughs in vaccine development, genetic research, and gene therapy. At the same time, a subset of gain- and loss-of-function studies involve high-risk, highly virulent pathogens that could spread widely among humans if deliberately or unintentionally released. In this report, we map the gain- and loss-of-function global research landscape using a quantitative approach that combines machine learning with subject-matter expert review.

Vaccines keep the U.S. public healthy while safeguarding economic stability and biosecurity. This report assesses the domestic vaccine manufacturing landscape and identifies two major vulnerabilities: a reliance on foreign manufacturers and a lack of manufacturing redundancy. Maintaining a resilient vaccine supply will require the U.S. government to take steps to protect the existing supply, identify and monitor manufacturing vulnerabilities, and create a stronger domestic production base.

Pandemic threats are increasing as globalization, urbanization, and encroachment on animal habitats cause infectious outbreaks to become more frequent and severe. It is imperative that the United States build a pipeline of medical countermeasure development, beginning with basic scientific research and culminating in approved therapies. This report assesses preparedness for families of viral pathogens of pandemic potential and offers recommendations for steps the U.S. government can take to prepare for future pandemics.

CSET's Dr. Caroline Schuerger, Dr. Steph Batalis, and Vikram Venkatram submitted this comment with recommendations for the National Biotechnology and Biomanufacturing Initiative.

Biosafety Level-3 laboratories (BSL-3) are an essential part of research infrastructure and are used to develop vaccines and therapies. The research conducted in them provides insights into host-pathogen interactions that may help prevent future pandemics. However, these facilities also potentially pose a risk to society through lab accidents or misuse. Despite their importance, there is no comprehensive list of BSL-3 facilities, or the institutions in which they are housed. By systematically assessing PubMed articles published in English from 2006-2021, this paper maps institutions that host BSL-3 labs by their locations, augmenting current knowledge of where high-containment research is conducted globally.

China is banking on applying AI to biotechnology research in order to transform itself into a “biotech superpower.” In pursuit of that goal, it has emphasized bringing together different aspects of the development cycle to foster multidisciplinary research. This data brief examines the emerging trend of co-location of AI and biotechnology researchers and explores the potential impact it will have on this growing field.

CSET Research Fellow Caroline Schuerger testified before the Bipartisan Commission on Biodefense hearing on "The Biological Threat Expanse" Current and Future Challenges to National Biodefense." She discussed threats to the bioeconomy and steps the U.S. and its allies can take to harness biotechnology's capabilities and raise awareness of risky research.