Strategic Report on Research and Development in Biotechnology for Defense Innovation (2025)
Chapter: 4 Future Defense Capabilities through Innovative Biotechnologies
4
Future Defense Capabilities through Innovative Biotechnologies
Science and technology have been a cornerstone of the U.S. defense enterprise for more than a century. The Defense Science Board (DSB) was created in the mid-1950s to leverage science and technology for defense mission and operational needs. In 2021, DSB was directed to assess current capabilities in biotechnology, associated risks, and interagency cooperation related to emerging biotechnologies and to provide recommendations for using biotechnology—namely, to improve or create new materials, generate advanced warning of infectious diseases, enhance warfighter performance and medical care, and inform operational and intelligence needs. In addition, national-level guidance (i.e., the National Security Strategy, National Defense Strategy, the U.S. Department of Defense (DoD) Biomanufacturing Strategy, and DoD Biodefense Posture Review) have emphasized the need for modernizing the use of biotechnology throughout the DoD to address long-standing challenges and provide new capabilities to the military. These modernization efforts focus on development of living systems designed to produce critical materials and products, and/or to have unique functions (e.g., biohybrid systems with unique functions) to address DoD capabilities for non-health purposes (e.g., shoring up infrastructure, improving body armor, enhancing learning and focus, detecting contaminants in the environment), which is the primary focus of this report.
Across the full biotechnology research and development enterprise in the DoD, which includes the service laboratories, the Defense Advanced Research Projects Agency, Office of the Secretary of Defense for Research and Evaluation, and Defense Innovation Unit, challenges to realizing the end-to-end development of usable biotechnologies and/or biotechnology products exist. The intelligence community also invests in biotechnology R&D to meet mission needs (Office of the Director of National Intelligence, 2024, n.d.). Where biotechnology innovations are being applied to existing technologies and products, the end product must comply with existing requirements and demonstrate comparative or better performance than existing products, which can be expensive and time-consuming though achievable. For novel biotechnology products or capabilities, requirements may not exist, which means they must be built as the technology is developed. In addition, AI/ML may be used to inform the DoD’s development of requirements, for example, by revealing emerging research on biotechnologies that show promise for addressing a capability need.
Further, many innovations in biotechnology lack transition partners (i.e., entities that have the interest and funds to support advanced development, testing and evaluation, and/or eventual use in operational settings), in part because of the need to re-demonstrate requirements or a lack of requirements and because of a lack of interest, financial incentive, manufacturing standards, or ready platforms. Whereas some of the challenges for technology adoption are technological, others are more behavioral, focusing understanding on how technology transitions from early adoption through mass use. Social scientists have identified factors that influence adoption and diffusion of technologies: (a) technological or product advantage; (b) compatibility of the technology or product with existing values and practices of the individual or organization;
(c) complexity of the technology to understand and use; (d) ability to test and assess or reduce uncertainty and risk of the technology or product; and (e) opportunity for technology and product use to produce observable results (Rogers, 2003). Understanding and integrating plans for addressing these factors may help to address some of the challenges currently observed with leveraging biotechnology R&D. In addition, biotechnology innovations, their capabilities, their limitations, and associated uncertainties must be described accurately to reduce the risk of hype and increase trust in those products. Overstatements and incorrect statements could result in ineffective technologies or products, which could erode user trust in the biotechnology industry, specific products, and public confidence in DoD investments in these innovations.
Although many of the efforts in biotechnology modernization across the DoD are shared within a Biotechnology Community of Interest, coordination of capabilities across both DoD and other U.S. government agencies investing in biotechnology for national security is lacking. The BioCATALYST network could build on and leverage ongoing, synergistic research and biotechnology development across the U.S. government (e.g., research conducted by the Agile BioFoundry consortium of the U.S. Department of Energy and National Science Foundation biofoundries), tailoring promising advances to address national security and defense capability needs. BioCATALYST could bring together these agencies and provide shared infrastructure that can maximize the development of capability across both military and intelligence mission needs and enable access to developed biotechnologies to other agencies. DoD-specific science and technology needs are guided by agency- and national-level strategies and the Program Objective Memorandum (POM) process, which in turn, determines budgets and planning guidance. Similarly, science and technology needs for the intelligence community are driven by mission needs for collection and analysis and align with national-level strategies (e.g., National Intelligence Strategy and the Office of the Director of National Intelligence’s Science and Technology Strategic Plan). Mission needs and priorities, together with availability of financial resources, support at various institutional levels, and systematic approach to demonstrating comparative advantage and results, can stimulate interest by agencies to serve as transition partners for basic and applied research investments (U.S. Department of Defense Biomanufacturing Strategy, 2023).
Recently, the National Academies held a workshop to discuss the intersection of AI, automated experimentation, and biotechnology, during which participants highlighted broad areas of opportunity including optimizing directed evolution, accelerating basic scientific discovery, and aiding therapeutic development (NASEM, 2024). The BioCATALYST network could leverage expertise and technical capabilities to advance innovation, research, and development of a more specific set of defense capabilities across both the traditional and novel domains of biotechnology and are enhanced through coupling of AI/ML and automated experimentation. Examples of possible applications include early warning of biological events; forecasting and horizon scanning to predict technological surprise; securing of biomanufacturing supply chains for materials critical to national security and defense; risk and vulnerability assessment; threat awareness, specifically for advances involving synthetic or engineering biology; protein and small molecule prediction and design; and other similar areas that increasingly use AI/ML in research and development.
However, if funds are not available to transition basic and applied research to advanced development and prototyping and if leaders and/or their staff are not interested in using biotechnologies for non-health purposes, then transition partners for basic and applied biotechnology research may not exist. This outcome could lead to perceptions that biotechnologies are overhyped or not ready for operational use, that they cannot provide the types of solutions needed to meet a diverse array of defense and intelligence needs (not only medical or environmental sensing and remediation), or that their risks outweigh the benefits. In late 2023 and early 2024, the commercial market for biotechnology companies had fallen to pre-pandemic levels and had become volatile (Mulero, 2024; Shah-Neville, 2023). However, biotechnology companies are starting to recover through the use of novel funding strategies and with increased selectivity of venture capital investments (Mulero, 2024; Wu, 2024). Pilot projects implemented through the BioCATALYST network could enable head-to-head performance tests of bio-based materials in operational settings; demonstrations of safety, security, and risk mitigation of bio-based products intended for environmental or personnel use; and training opportunities for personnel to gain skills and knowledge on using bio-based products among other possible approaches.
Conclusion 5: AI-driven biotechnologies can enhance U.S. military and intelligence advantage (Maintaining Military Advantage Through Science and Technology Investment, 1995) by innovating traditional biotechnology capabilities, filling critical vulnerabilities in supply chains or resources, or driving technology surprise by the United States. AI tools can also be used to forecast and predict technology surprise by adversaries and generate novel biotechnology solutions for mission and operational needs.
Conclusion 6: AI/ML-enabled biotechnology R&D efforts hold great promise for addressing defense needs. However, the use of biotechnologies for defense may lack support resulting from perceptions among transition partners and/or end users that the technology is currently infeasible, may not achieve the same performance as existing technologies for well-tested conventional capabilities, or may be high risk.
Conclusion 7: The lack of transition partners with available interest and financial resources to support advanced development and prototyping of biotechnologies developed during basic and applied research phases results in limited ability to demonstrate comparative utility or advantage to existing technologies and limited anticipated sustainability in the commercial market that are practical barriers to leveraging biotechnologies for various defense and intelligence mission and operational needs.
Recommendation 3: The U.S. Department of Defense (DoD) should have the BioCATALYST network implement pilot test beds that enable requirements mapping for needs that are not pre-defined and demonstration of comparative technological advantage, usability and results, and commercial viability. These test beds should include experts from the DoD service laboratories, particularly those involved in T-BRSC (Tri-Service Biotechnology for a Resilient Supply Chain); the DoD biomanufacturing entities; relevant biotechnology industry and academia; and potential transition partners and/or end users. These test beds should incorporate knowledge about research and development trends in artificial intelligence/machine learning, automated experimentation, biotechnologies, and the biofoundaries to inform and appropriately tailor requirements that could leverage these advances to address DoD needs.
Recommendation 4: To address the lack of transition partners, the BioCATALYST network should create a process for transitioning basic and applied research to advanced development to U.S. government and/or private-sector partners, including engagement of partners and management of research and development at the earliest possible stage of product development. This process should involve active engagement with the U.S. Department of Defense and other U.S. agencies whose primary mission is national security and with relevant investors and companies to understand and work together to overcome specific concerns or perceptions about the biotechnologies that show promise in addressing national security and defense needs.
Recommendation 5: The U.S. Department of Defense (DoD) should work with the Bioindustrial Manufacturing and Design Ecosystem (BioMADE) and other biomanufacturing institutes to add artificial intelligence/machine learning to their focus areas to enhance their ability to improve biomanufacturing processes and product development for DoD needs.
