Increasing Gene Synthesis Security Risk Awareness Through Global Engagement and Collaborative Exercise Development

Abstract

Gene synthesis technologies are broadly useful and increasingly ubiquitous tools for life sciences research and development of medical countermeasures. The growth of the global commercial nucleic acid synthesis market has raised concerns that these technologies might undermine measures intended to reduce biological risks, including by preventing the theft, diversion, or misuse of high-consequence pathogens. Although the members of the International Gene Synthesis Consortium have voluntarily adopted sequence and customer screening for commercial gene synthesis orders, national frameworks and institutional capacities to assess and mitigate the potential risks of misuse of gene synthesis vary widely. In this case study, we describe the use of collaborative development of simulation exercises as an approach to raise awareness among key stakeholders of potential biosecurity risks associated with use of gene synthesis, while identifying context-specific, multilayered approaches to biosecurity that can be implemented at the national and institutional level. Experts from India, Indonesia, Kenya, and the Philippines worked in mentored, virtual breakout sessions to develop simulation exercises based on first-hand knowledge of local context to inform appropriate, sustainable approaches to measures to enhance oversight of nucleic acid synthesis procurement at the institutional level or to promote adoption of national frameworks. This project reinforced the proof-of-principle that collaborative exercises can be used to address a broad variety of research governance gaps to enhance national and institutional biosecurity.