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.

Steph Batalis, Caroline Schuerger and Vikram Venkatram explore three notable areas in the life sciences where LLMs are catalyzing meaningful advances: drug discovery, genetics, and precision medicine.

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.