Strategic Report on Research and Development in Biotechnology for Defense Innovation (2025)
Chapter: 1 Study Scope and Approach
1
Study Scope and Approach
Congress established the National Security Commission on Emerging Biotechnology (NSCEB) in the Fiscal Year 2022 National Defense Authorization Act “to examine and make recommendations with respect to emerging biotechnology as it pertains to current and future missions and activities of the Department of Defense” (Congress.gov, 2021). In 2023, the NSCEB asked the National Academies of Sciences, Engineering, and Medicine (National Academies) to conduct a study on anticipating and leveraging advances in transdisciplinary biotechnologies for national security, building and drawing on research hubs, and navigating the complex policy landscape around biotechnologies to enhance U.S. national security. The NSCEB requested that these concepts be examined within the context of artificial intelligence and machine learning (AI/ML) and automated experimentation in biotechnology to enhance defense innovation. The committee was asked specifically to consider the use of AI/ML and automated experimentation for various biotechnology applications; the feasibility of developing a domestic research and development network for such technologies, and associated data needs and practical or operational factors for such a network; ways in which such technologies could enhance future defense capabilities; and approaches for preventing the misuse of these biotechnologies. The full statement of task is provided in Box 1-1.
Reflecting on the topics in its charge, the committee consisted of seven individuals from diverse sectors and areas of expertise including biotechnology, computer sciences, national security, ethics, and policy. The committee’s views were informed by conversations with various U.S. government and scientific experts, review of literature, and participation in the workshop and meetings of experts of the Standing Committee on Advances and National Security Implications of Transdisciplinary Biotechnology.
The committee approached its charge by concentrating on a specific segment of biotechnology innovations relevant to national defense, directing much of its effort toward advancements and applications on design and development of bio-based materials and living systems with novel functional activities that are outside of the traditional domains of health and biodefense (Figure 1-1). The committee’s recommendations are directed at a broad array of actors including the U.S. Department of Defense (DoD) and other U.S. government agencies with primary missions in national security and defense, reflecting its recognition, shared by the sponsor, that the DoD does not operate in isolation in its national security mission. Throughout the report, the term “national security” is used to refer to a defined set of problems that the nation faces that could be enhanced or challenged by advances in biotechnology and biomanufacturing of bio-based materials.
The sponsor of this study, the National Security Commission for Emerging Biotechnology, is a Congressionally chartered Commission tasked with evaluating and recommending to Congress “how advances in emerging biotechnologies and related technologies will shape the current and future activities of the Department of Defense.”1 In its charge to the National Academies, the Commission requested the committee
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1 See NSCEB Mission: https://www.biotech.senate.gov/ (accessed August 22, 2024).
to focus its deliberations on a subset of research at the intersection of AI, automated laboratories, and biotechnology. The objective was to explore how the DoD and other U.S. government agencies focused on national security could leverage and tailor these advancements to enhance national defense capabilities, while mitigating risks of adversary use.
BOX 1-1
Statement of Task
The National Academies of Sciences, Engineering, and Medicine will convene an ad hoc study Committee on Biotechnology Capabilities for National Security Needs—Leveraging Advances in Transdisciplinary Biotechnology, which is associated with the Standing Committee on Advances and National Security Implications of Transdisciplinary Biotechnology, to produce a brief unclassified consensus report and brief, restricted addendum highlighting specific actions for:
- The applicability of AI/ML and automated experimentation for biotechnology discovery and development for various applications, including health and medicine, food and agriculture, industrial materials and chemicals, environmental remediation, and energy production for defense.
- The feasibility of developing a research and development network in the United States that drives biotechnology innovation through the combined application of AI/ML, automation, and biology; development and securing of large volumes of high-quality data sets that can support AI/ML for biotechnology defense innovation; and examples wherein the government communicated its needs and specific requirements clearly and effectively, or ineffectively.
- Future defense capabilities, as forecasted by the Defense Department, that could be achieved through innovative biotechnologies.
- Opportunities for using AI/ML and experimental/laboratory automation to prevent misuse of biotechnology.
- Practical or operational factors (e.g., expertise, infrastructure, laboratory capacity, data sources, computing infrastructure, and policy/governance) needed to enable investments needed to reach the goal of a nationwide network research hubs wherein highly innovative research and development on AI/ML, automation, and biotechnology tools are conducted to address defense problems.
The ad hoc study committee will build on the work from the Standing Committee, which will explore related topics in a series of convenings (e.g., workshop and meetings of experts). The ad hoc study committee’s report will focus on artificial intelligence and experimental/laboratory automation in biotechnology research.
Recognizing the Commission’s charge, the committee adopted a strategic lens in its deliberations in acknowledgement of Congress’s critical role in enabling the implementation of its recommendations. The committee chose not to address issues such as biosecurity risks associated with the use of AI/ML in designing novel or modified pathogenic microorganisms, proteins, or molecules—topics that could raise con-
cerns about dual-use research or pathogens with enhanced pathogen potential. This decision was made, in part, because the National Academies is conducting a separate, complementary study on this issue in response to the 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.
SOURCE: Created by the National Academies Staff.
Furthermore, the committee recognizes the expanding roles that AI/ML and automation play across various sectors of life sciences including health, agriculture, and environmental sciences. However, these areas were deemed totally beyond the scope of the current study. Instead, the present study focuses on a defined subset of biotechnologies, specifically those enabled by AI/ML and automated experimentation aimed at enhancing design and development of living systems that produce biomaterials or have unique functions outside of health, agriculture, and traditional biodefense that are related to national security and defense.
Chapter 2 summarizes key applications at the intersection of AI/ML and biotechnologies. Chapter 3 describes a vision of an R&D network at the intersection of AI/ML, automated experimentation, and biotechnology to meet national security needs; the governance framework and administrative structure for implementation of that network; and the operational factors to ensure the network’s success including laboratory needs, digital and physical infrastructure, and sustained funding. In Chapter 4, the committee discusses opportunities for preventing the misuse of biotechnology, the role of AI/ML and automated experimentation in identifying and mitigating these risks, and the ethical considerations, misinformation, and policy issues related to multi-use biotechnologies.
