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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2025. The Age of AI in the Life Sciences: Benefits and Biosecurity Considerations. Washington, DC: The National Academies Press. https://doi.org/10.17226/28868.

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COMMITTEE ON ASSESSING AND NAVIGATING BIOSECURITY CONCERNS AND BENEFITS OF ARTIFICIAL INTELLIGENCE USE IN THE LIFE SCIENCES¹

MICHAEL J. IMPERIALE (Co-Chair), University of Michigan

LYNDA M. STUART (Co-Chair), Institute for Protein Design, University of Washington

PATRICK M. BOYLE, Ginkgo Bioworks

KJIERSTEN M. FAGNAN, Joint Genome Institute, U.S. Department of Energy

GIGI KWIK GRONVALL, Johns Hopkins University

HEIDI C. HOWARD, University College Cork

ETHAN JACKSON, Microsoft

SUMAN JANA, Columbia University

JENS H. KUHN, Tunnell Government Services and Integrated Research Facility at Fort Detrick

BRADLEY A. MALIN (NAM), Vanderbilt University

AMARDA SHEHU, George Mason University

ALEXANDER J. TITUS, Avidity Biosciences and In Vivo Group

Study Staff

LYLY G. LUHACHACK, Study Director, Program Officer

KAVITA M. BERGER, Board Director

JON K. EISENBERG, Senior Board Director

MICAH LOWENTHAL, Board Director

GABRIELLE M. RISICA, Program Officer

NANCY D. CONNELL, Senior Scholar

JESSICA DE MOUY, Research Associate

TRISHA TUCHOLSKI, Program Officer

CHRISTL SAUNDERS, Program Coordinator

LAYLA GARYK, Senior Program Assistant

Consultant

BRIAN HIE, Stanford University and Arc Institute

___________________

¹ All committee members serve as individuals rather than as representatives of a group or organization. The contributions of the committee members do not necessarily reflect the views of their employers or affiliated organizations.

BOARD ON LIFE SCIENCES

ANN M. ARVIN (NAM), (Chair), Stanford University

DENISE M. BAKEN, Shield Analysis Technology, LLC

TANYA Y. BERGER-WOLF, Ohio State University

FREDERIC M. BERTLEY, The Center of Science and Industry

VALERIE H. BONHAM, University of Maryland

PATRICK M. BOYLE, Ginkgo Bioworks

MAURO COSTA-MATTIOLI, Altos Labs

DIANE DIEULIIS, National Defense University

BARBARA HAN, Cary Institute

INDIA G. HOOK-BARNARD, Engineering Biology Research Consortium

JENNIFER MARTINY, University of California, Irvine

BERONDA MONTGOMERY, Grinnell College

MILAN MRKSICH, Northwestern University

LOUIS J. MUGLIA (NAM), Burroughs Wellcome Fund

LUCILA OHNO-MACHADO (NAM), Yale University

SUDIP S. PARIKH, American Association for the Advancement of Science

NATHAN D. PRICE, Buck Institute

PHYLLIS M. WISE (NAM), Colorado Longitudinal Study

SARA YEO, University of Utah

Staff

KAVITA M. BERGER, Director

ANDREW BREMER, Program Officer

JESSICA DE MOUY, Research Associate

LAYLA GARYK, Senior Program Assistant

CYNTHIA GETNER, Senior Financial Business Partner

NIA D. JOHNSON, Senior Program Officer

SARAH JUCKETT, Senior Program Officer

LYLY LUHACHACK, Program Officer

DASIA MCKOY, Senior Program Assistant

CHRISTL SAUNDERS, Program Coordinator

AUDREY THÉVENON, Senior Program Officer

TRISHA TUCHOLSKI, Program Officer

SABINA VADNAIS, Associate Program Officer

COMPUTER SCIENCE AND TELECOMMUNICATIONS BOARD

LAURA M. HASS (NAE), (Chair), University of Massachusetts Amherst

DAVID DANKS, University of California, San Diego

CHARLES ISBELL, University of Wisconsin–Madison

ECE KAMAR, Microsoft Research Redmond

JAMES F. KUROSE (NAE), University of Massachusetts Amherst

DAVID LUEBKE, NVIDIA

JOHN L. MANFERDELLI (NAE), Independent Consultant, Ex Officio

DAWN C. MEYERRIECKS, MITRE Corporation

WILLIAM L. SCHERLIS, Carnegie Mellon University

HENNING SCHULZRINNE, Columbia University

NAMBxIRAJAN SESHADRI (NAE), University of California, San Diego

KENNETH E. WASHINGTON (NAE), Medtronic

Staff

JON K. EISENBERG, Senior Board Director

SHENAE A. BRADLEY, Administrative Coordinator

THƠ H. NGUYỄN, Senior Program Officer

GABRIELLE M. RISICA, Program Officer

AARYA SHRESTHA, Senior Finance Business Partner

NNEKA UDEAGBALA, Associate Program Officer

COMMITTEE ON INTERNATIONAL SECURITY AND ARMS CONTROL

RAYMOND JEANLOZ (NAS), (Chair), University of California, Berkeley

ANDREW G. ALLEYNE (NAE), University of Minnesota

MARIANA BUDJERYN, Harvard University

MATTHEW G. BUNN, Harvard University

LINDA T. ELKINS-TANTON (NAS), Arizona State University

STEVEN A. FETTER, University of Maryland

DIANE E. GRIFFIN, Johns Hopkins Bloomberg School of Public Health

MARGARET A. HAMBURG (NAM), Self

JOHN INGLIS, U.S. Naval Academy

MORIBA K. JAH, University of Texas at Austin

ALASTAIR I. JOHNSTON, Harvard University

JAMES W. LEDUC, Galveston National Laboratory

JEFFREY LEWIS, Middlebury Institute of International Studies

HERBERT S. LIN, Center for International Security and Cooperation

DOUGLAS L. LOVERRO, Loverro Consulting, LLC

LORA LANNAN SAALMAN, Stockholm International Peace Research Institute

VICTORIA A. SAMSON, Secure World Foundation

RACHEL A. SEGALMAN (NAE), University of California, Santa Barbara

JIM TIMBIE, Retired, Department of State

ROSE E. GOTTEMOELLER, Self

Ex Officio Member

JOHN G. HILDEBRAND (NAS), University of Arizona, Tucson

Staff

MICAH LOWENTHAL, Director

RITA GUENTHER, Senior Program Officer

HOPE HARE, Administrative Assistant

CANDACE HUNTINGTON, Research Associate

CARMEN SHAW, Associate Program Officer

ALEX TEMPLE, Program Officer

NANCY D. CONNELL, Senior Scholar

Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

LEYMA P. DE HARO, Merrick & Company

SARA DEL VALLE, Los Alamos National Laboratory

DREW ENDY, Stanford University

CASEY GREENE, University of Colorado Anschutz Medical Campus

ANDY KILIANSKI, Advanced Research Projects Agency for Health

FILIPPA LENTZOS, King’s College London

T. GREG MCKELVEY, JR., RAND

DAWN MEYERRIECKS, MITRE Corporation

RUSSELL SCHWARTZ, Carnegie Mellon University

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by JEFFREY SKOLNICK, Georgia Institute of Technology, and FRED SCHNEIDER (NAE), Cornell

University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Acknowledgments

The Committee on Assessing and Navigating Biosecurity Concerns and Benefits of Artificial Intelligence Use in the Life Sciences and the National Academies of Sciences, Engineering, and Medicine staff would like to thank the study sponsor, the U.S. Department of Defense, for its support and guidance in forming the scope for the study. Additionally, we thank all speakers who participated in the open and closed sessions of our public information-gathering meetings and provided indispensable expertise to aid the committee in completing its charge (see Appendix B).

We thank John Jumper, Eric Horvitz, Yana Bromberg, Sean Ekins, David Baker, Kathy Wei, Mengdi Wang, Dan Hendrycks, Craig Wilen, Sarah Richardson, Andrew Pekosz, Pardis Sabeti, Bo Li, Jennifer Roberts, and Jimmy Gollihar for their contributions to our first information-gathering meeting. We thank Dan Stanzione and Kim Pruitt for their contributions to our second information-gathering meeting. We thank Arturo Casadevall, Jason McLellan, Emanuele Andreano, and Benjamin Brown for their contributions to our third information-gathering meeting. We also thank Brian Hie for authoring a commissioned report (see Appendix A), which provides an essential background on artificial intelligence models.

The National Academies staff thanks the committee (see Appendix C) for its participation in this study and collaboration in writing this report. The committee thanks the study staff and additional National Academies staff for their support in ensuring the successful completion and publication of this report.

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Contents

ACRONYMS AND ABBREVIATIONS

PREFACE

SUMMARY

1 INTRODUCTION

The Convergence of AI and Life Sciences

Study Scope and Approach

Report Organization

References

2 DESIGN-BUILD-TEST-LEARN: IMPACT OF AI ON THE SYNTHETIC BIOLOGY PROCESS

Ideation and Design: Large Language Models and Foundation Models

Build and Test: Automated Laboratories

Learn: Synthetic Data

References

3 AI-ENABLED BIOLOGICAL DESIGN AND THE RISKS OF SYNTHETIC BIOLOGY

Addressing Biological Complexity in Design and Engineering

Implications for Biosecurity

Broader Context for Assessing Biosecurity Risks: The 2018 Framework

References

4 PROMOTING AND PROTECTING AI-ENABLED INNOVATION FOR BIOSECURITY

AI-Enabled Infectious Disease Biosurveillance

AI-Enabled Biodesign for Countermeasure Development and Emergency Response

AI and Biodesign Security

Balancing AI-Enabled Responses to Biological Threats and Potential Risks

References

5 IMPORTANCE OF DATA IN AI-ENABLED BIOLOGICAL MODELS

Biological Datasets for Training AI Models

Infrastructure and Governance

The Data Life Cycle and National Repositories

Considerations for Building Data Infrastructure

Protecting Data Assets for AI-Enabled Biological R&D

Data-Driven Vulnerabilities and Mitigations

References

APPENDIXES

A Mapping the Landscape of AI-Enabled Biological Design

B Public Meeting Agendas

C Committee Biographies

Boxes, Figures, and Tables

BOXES

1-1 Statement of Task

3-1 AI Biological Models for Predicting Viral Fitness

3-2 Current Limitations of Using Virus Sequences as Training Data

3-3 State-Sponsored Biological Weapons Programs

3-4 Future Impact of AI Agents on Expertise and Resources Required by Actor

5-1 Protecting the Data Layer

5-2 Protecting the AI Software Layer

5-3 Protecting the Application Layer

FIGURES

S-1 Current capability uplift and limitations of AI-enabled biological tools in two biosecurity risk applications with different levels of design complexity

2-1 The impact of AI-enabled biological tools across digital and physical tasks in synthetic biology at present

3-1 Levels of complexity for bioweapon design

Acronyms and Abbreviations

Preface

At the turn of the 21st century, scientists predicted that biotechnology would play a major role in public health, medicine, agriculture, and the economy. Enabled by rapidly decreasing costs, particularly in DNA sequencing, synthesis, and engineering, many global benefits were envisioned.

Only one year into the millennium, however, we were reminded that biological agents could be used for nefarious purposes, as happened with the Amerithrax attacks in the United States. This led to heightened attention on biosecurity and, subsequently, biosafety. The term “dual-use” took on a new meaning. Whereas previously it signified technologies that had both a civilian and military purpose, the National Research Council report released in 2004, Biotechnology Research in an Age of Terrorism, redefined the term in reference to the life sciences to mean anything that had both a beneficial and harmful use. The U.S. government, and others worldwide, paid close attention to developments in the understanding of infectious agents and how other new and developing technologies might change the ability to engineer biology.

Perhaps the most recent addition to this toolbox of technologies is artificial intelligence (AI). Large amounts of data can be accessed and analyzed, and AI models can be applied to facilitate the design of biologics such as therapeutic proteins, including antibodies. Like biotechnology, however, AI is also a dual-use technology, with the potential to be harnessed by a malicious actor to do harm. One possibility would be to apply AI to bioengineering, facilitating the development of biological threats.

Recognizing the rapidity with which these technologies are progressing, the U.S. Department of Defense (DoD), as directed in Executive Order

on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, tasked the National Academies of Sciences, Engineering, and Medicine to undertake a study to examine the benefits and risks presented by the intersection of AI and biotechnology. The National Academies assembled a committee of experts in AI, infectious agents, and biosecurity to advise DoD on how to frame the benefits and address and mitigate biosecurity concerns of this rapidly advancing technology, as applied to the life sciences. This report, the product of that study, presents an overview of the issue and several conclusions and recommendations about how the United States can best reap the benefits of the AI–biotech interface while minimizing any potential threats.

Michael J. Imperiale, Co-Chair

Lynda M. Stuart, Co-Chair

Committee on Assessing and Navigating Biosecurity Concerns and Benefits of Artificial Intelligence Use in the Life Sciences