This piece developed in concert with the Moonshots and Metascience event made possible by the Alfred P. Sloan Foundation.

On April 23, FAS held a workshop on moonshots for science which included  a Q&A with Lee Hood, the CEO of Phenome Health where he proposed that the next audacious “moonshot” in biomedical research be The Human Phenome Initiative. This focused effort will  develop clinically-validated actionable possibilities that improve health or facilitate early disease detection. The Initiative will also develop technologies necessary to measure more of what is going on in our bodies to enable a shift in medicine from largely diagnosis and treatment (i.e., ‘disease-care’) to one where wellness and chronic disease avoidance are dominant. 

Lee is a pioneer in biomedical research and early leader in the Human Genome Project. Lee co-founded the Institute for Systems Biology, is the recipient of the National Medal of Science, the Lasker Award, and the Kyoto Prize. He has co-founded 17 biotech companies including Amgen, Applied Biosystems, Rosetta, and Arivale, and is one of only 20 people elected to all three National Academies. In 2026 Forbes selected him as 41^st among the 250 most innovative, living Americans. He currently serves as the CEO of Phenome Health, a non-profit research organization focused on developing the tools that power data-driven personalized health. 

MS. What does it take for a moonshot to be successful and how did you see this play out during the Human Genome Project?

LH. The Human Genome Project is a great example of a moonshot that required government coordination and support and resulted in a fundamental shift in our understanding of biology and genetic diseases. In essence it provided for each individual the upper and lower limits of their trajectories. One’s phenotype from birth to death is determined primarily by their personal behavior and environment—which can be assessed by quantification of blood proteins, metabolites and clinical chemistries, the gut microbiome and digital health devices for body and brain—examples of measurements of the “phenome”.  In many ways it created the modern biotechnology industry and provided an absolutely staggering economic return on investment of several orders of magnitude. Most people don’t know that it was originally initiated by the Department of Energy. 

MS. What do you see as the government’s primary role in moonshots and why is that important?

LH. The government’s primary roles in moonshots are to coordinate government, academic, and private sector leaders to develop goals for the effort, drive participation, and to coordinate to ensure that the goals are reached on budget and ahead of schedule. It is important that people understand that while there may be an overarching goal–going to the moon is the clearest example–there are actually a series of shorter-term clear goals that must be developed, financially supported, and coordinated across the effort. Without coordination and financial support, it is extremely difficult to keep a series of discrete efforts focused and on schedule.  A key point is that with government support the data from the Human Phenome Initiative is open and available to all, academics, industry, healthcare systems and other interested parties. This is critical to maintaining U.S.’s leadership in healthcare, biotechnology, and many academic departments.

MS. Looking to the future, what do you think is the next moonshot in biomedicine? 

LH. The future of biomedicine is crystal clear. I started calling it P4 medicine, which stands for Predictive, Preventive, Personalized and Participatory. In essence, if we can measure and collect far more data from people from blood, for example, in a typical doctor’s office visit, we can start to develop real signatures of health trajectories (e.g., biological age, biological BMI, frailty, immunity and brain cognition) and know precisely what is going on in an individual and thereby use an individual’s own data to  tailor unique treatment for each person. When we do this for a large population of people, we can slowly shift medicine from diagnosis and the treatment of disease to optimizing individual wellness, avoiding disease and extending one’s healthspan into the 90s or beyond. People will be healthier longer. That will save the country trillions of dollars in disease treatment as they steer clear of chronic disease. And it will add significantly to the workforce with physically healthy and mentally agile individuals This is what wellness is all about. 

We call it the Human Phenome Initiative because the goal is to be able to measure what is going on in the human body at any given time with far more fidelity than we can now. We need to understand the phenome. To achieve this, we must take decisive steps that require moonshot-like coordination of efforts and set a goal of understanding what is going on in the human body at a molecular level using systems-biology and AI-driven approaches to individual data. First, we need new technologies that can measure more molecules in the blood of people and lower the cost of measuring proteins, metabolites, the gut microbiome and digital health devices so it can be cost effective in the clinic. This is akin to what we did with genome sequencing. The first human genome sequence was estimated to cost a billion dollars, but now it costs around $100 to have your genome sequenced. We need the same focused efforts on building technologies that can make phenomic measurements throughout the body and blood. Next we need to take advantage of some of the already existing large cohort studies and offer participants the possibility of knowing and deploying “actionable possibilities” derives from their own data—to improve their health and to insure they stay in the program long term.

MS. Why is now the moment to launch this effort?

LH. This really is a unique moment for the country to launch the Human Phenome Initiative. First, we have an administration that has set a fantastic goal of making Americans healthier—focusing on wellness and disease prevention. That really can’t be done without having more data on what is going on in our bodies and better understanding how to bend human behavior towards healthier lifestyle choices. Second, we are at the dawn of a new era with AI. But the use of AI in medicine is always going to be limited by the data that can be used to train them. For us to really make the best use of AI to understand health and biological complexity at a much deeper level, we need a tremendous amount of new data on what is going on in humans. It can’t be done with just data from electronic health records and wearables. We simply need to know what is going on in the human body at a molecular, imaging, environmental and personal behavior levels. Once we have data from a large and diverse cohort of people, we will be able to get real signatures or trajectories of health that can empower people with personalized health information which, in turn allows them to make specific lifestyle choices. And finally, if we don’t launch an effort to do this soon, we will lose a compelling opportunity to be the leaders in a health revolution—transforming healthcare from our current ‘sick care’ to a future of wellness and disease prevention. If we don’t do it, other countries will. China is already driving in this direction and I would hate to see the U.S. pass on an opportunity to lead in the innovation breakthroughs that are going to redefine both medicine and healthcare. 

MS. OK, so the key to driving a sea change in medicine is going to be a plethora of new data that tell us what is going on in the human body at a given time. Walk me through how metascience plays a part. 

LH. Metascience is going to be a critical part of any program that intends to upend an entrenched system, in this case, medicine. Based on individual data from the Human Phenome Initiative, wearables, electronic health records, clinical trials, blood analytes, the gut microbiome and more, we will be able to ask real questions on standards of care at an individual level, clinical trial design, behavioral regimens and more. It is not just medicine that is going to be upended, it is how we even study medicine, health, healthcare, and disease that are going to be radically transformed based on understanding what is going on in the bodies of patients and clinical trial participants. We are going to look back on the way we do biomedical research today as if it was the stone age. 

MS. What can the public expect in terms of returns on investment if the Human Phenome Initiative is launched?

LH. One really novel aspect of The Human Phenome Initiative is that new insights into health will be returned to participants as prioritized actionable possibilities so they can immediately start benefiting from their participation in the study. This is very different from the way most studies are designed where participants rarely hear back news of findings that can help them directly. That creates a really dynamic system where participants learn about their health and can take action to improve it while the study is ongoing. We will then be able to see how receiving that information transforms their health trajectories. That is new and exciting and has never been done for a large cohort study. 

This kind of public investment will turn healthcare on its head. As we develop new signatures of health and interventions to stave off chronic disease, healthcare will transform from an enterprise focused on billing codes for diagnosing and treating disease to a system that empowers people based on their own health data to live healthier longer. As I mentioned earlier, the future will be 4P Medicine— that is, a healthcare system that is Predictive, Preventive, Personalized, and Participatory. Your health trajectory will be powered by data from you and insights will be driven by the collective data and insights from millions of other people. That is a revolution worth getting behind.  A critical driver of this will be AI which will have the capacity to discover, delineate clinical support and deliver to patients and their doctors the individual prioritized actionable possibilities that will enhance wellness, prevent disease and expand one’s healthspan into the 90s.  AI will make individual physicians domain experts in most fields of medicine and will provide them with the ability to treat patients as never before been possible.

At a macro level, the return on investment will be an explosion of new services and companies that will be able to take an evidence-based approach to guiding your health based on what is going on yin your body. As I mentioned, the Human Genome Project drove an economic return on investment of several orders of magnitude—for a $3 billion dollar investment, the Battelle Organization calculated 10 years after the project was finished it returned $800 billion—a striking ROI. The Human Phenome Initiative will dwarf that in both economic growth through new industries but will also save us extraordinary amounts of money by having people steer clear of chronic disease that represents the majority of our healthcare expenditures each year. The U.S. spend over $5 trillion dollars on healthcare each year and 86% of it is focused on chronic diseases. If we can steer even a small percentage of the population from developing a chronic disease, it will pay for itself in no time at all. 

Right now, the wellness industry is in its infancy. People are taking supplements and using wearables to try to improve their health, but often that is based on wide generalizations without really understanding in detail what is going on in your own body. The good news is that people are interested in maintaining and improving their health. We just need to develop the technologies and systems to provide a more solid evidence-based possibilities for creating and delivering health trajectories with actionable recommendations based on what is actually going on in your body. 

MS. Why can’t the private sector and academic community just move forward and do this? 

LH. In a sense, some parts of the Human Phenome Initiative are happening now just like there were scientists studying genomes before the Human Genome Project. What is needed is broad coordination and support that can only come from the government. We need a coordinated federal blueprint for The Human Phenome Initiative, including targeted investments to be made by federal agencies in support of the development of technologies and research that meet the goal of creating the data needed to be able to really use AI to get actionable insight into health at a far greater scale than possible today. We need those investments to not just develop the technologies to measure more in people, proteins and metabolites in blood, in particular. We need a coordinated effort to drive all of the genome and phenome data to academic and private sector researchers so we can unleash the U.S. innovation machine on changing medicine. Without that data from a large group of people, we are really going to be limited as to what AI can do for healthspan and wellness. This gives us the possibility of N=1 medicine—where each individual is treated precisely in an optimized, systems-driven manner.

Cell-free expression (CFE) is a biomanufacturing platform capable of producing diverse biomolecules, including proteins, enzymes, and mRNA, outside of (or “without needing”) living cells. Because CFE extracts can be freeze-dried, stored at room temperature, and reactivated on demand, they enable rapid, portable, and decentralized production of diagnostics, vaccines, and therapeutics with minimal infrastructure. These properties make CFE a powerful tool for preparedness, point-of-need healthcare, and defense applications. The same properties, however, also create an underappreciated biosecurity risk. Commercially available CFE kits already support the production of toxins, bacteriophages, and virus-like particles, with no oversight of who is purchasing them or why. As CFE becomes more sophisticated and accessible, DNA synthesis and export controls remain the primary regulatory safeguards against de novo production of harmful biological agents, yet governance frameworks lack the situational awareness and enforcement capacity to keep pace with rapidly falling technical barriers.

The United States (U.S.) faces a dual imperative: invest in CFE to secure strategic leadership in next-generation biomanufacturing, and close the governance gap to prevent misuse and to ultimately enable American innovation to advance even more rapidly. We recommend two coordinated actions:

1. A tiered oversight framework that includes know-your-customer measures for all CFE vendors and biosafety-level grading for extracts with different capabilities.
2. Federal investment to improve CFE yield, reliability, purification, and portable GMP-compatible manufacturing. 

Acting now, while norms are still forming, gives the U.S. the opportunity to lead both in the technology and in its governance.

Challenge and Opportunity

CFE enables new production methods that outpace traditional cell-based and chemical synthesis by minimizing the need for specialized infrastructure such as sterile culture systems, bioreactors, and technical expertise to maintain living cells. This makes it the preferred method of production for malicious actors, particularly lone-wolfs or small groups that may be under-resourced.
In parallel, CFE technology is rapidly moving from the research lab into the real world, with improvements in yield being further accelerated by AI, yet U.S. policy has not kept pace on multiple fronts. 

Biomanufacturing is a strategic national asset

The challenge is compounded by intensifying international competition in advanced biomanufacturing. Nations that move first to translate CFE into deployable bioproduction infrastructure will gain durable advantages across pharmaceutical supply chains, emergency response capacity, and industrial biotechnology. China, in particular, has moved aggressively to secure intellectual property and scale capabilities in cell-free systems, signaling that CFE is viewed not merely as a scientific tool but as a strategic national asset in China’s race to close the gap with the United States. Absent timely policy engagement, the U.S. risks ceding leadership in a foundational biomanufacturing modality while simultaneously inheriting its downstream security risks. In this context, reactive governance is doubly damaging: it increases both strategic vulnerability and potential biosecurity risks.

The core policy problem is therefore twofold: first, to prevent the unintended security consequences of increasingly accessible synthesis technologies; and second, to do so in a way that enables the innovation needed to maintain U.S. leadership. Addressing only one side of this problem, through either permissiveness or restriction, would undermine the other.

CFE changes the threat landscape

Historically, biological attacks have been rare, in part because the technical and economic barriers to producing dangerous agents were high, and in part because biosecurity itself occupied a relatively narrow space in public consciousness. Lone actors who pursued biological harm tended to default to comparatively crude options, such as ricin, precisely because more sophisticated agents required infrastructure, expertise, and resources that placed them out of reach. This historical pattern has shaped policymakers’ intuitions about biorisk, but it is increasingly a poor guide to the present threat landscape.

Commercially available CFE kits, which are enabling researchers to massively accelerate the design of protein-based therapeutics, can already be used to produce toxins, bacteriophages, and virus-like particles, with no requirement to verify who is purchasing them and why. CFE has also been demonstrated to support the production of non-enveloped mammalian viruses such as polio. This ease of use and commercial access lies in contrast to traditional bioproduction, which requires sterile culture systems, bioreactors, and transfection reagents. In fact, CFE is an increasingly common component of high school and undergraduate biology education. Increased access to such kits eliminates the specialized equipment and expertise that historically served as barriers to entry into biological engineering. To ensure that the U.S.’ industry and education systems can fully capitalize on the promise offered by CFE, biosecurity frameworks need to be reviewed and updated to establish proper guardrails to prevent acquisition by malicious actors. 

Two shifts are eroding the conditions that kept the historical incidence of bioattacks low. First, the rise of large language models and broader public discourse around AI-enabled threats has dramatically raised general awareness of biological weapons as a category of weapon of mass destruction. Even when frontier models decline to provide synthesis instructions, they readily communicate which agents are dangerous and why, effectively lowering the informational barrier to identifying high-consequence targets. Second, and more critically, CFE collapses the economic and infrastructural gap between “crude” and “sophisticated” biological agents. Producing a functional non-enveloped virus using a commercial CFE kit is approaching the same order of magnitude in cost and complexity as producing a classical toxin, while yielding an agent with vastly greater potential for harm and transmissibility. Additionally, directly purchasing the toxin itself is now more expensive than purchasing the CFE and DNA needed to synthesize the same amount of toxin. The historical logic that pushed bad actors toward cheaper, lower-impact agents no longer holds: when the cheapest option is also among the most dangerous, the deterrent effect of cost and complexity disappears.

This is the heart of why CFE warrants near-term policy attention rather than deferred study. Unlike scenarios in which an AI model must walk a malicious actor through a difficult synthesis, CFE provides the production capability directly out of the box. 

The need to update regulatory frameworks

Regulating CFE research, however, will require a different approach than that of regulating CFE distribution. Existing biosafety rules, such as BSL designations and previous guidelines regarding dual-use research of concern, govern how scientists work with dangerous material inside institutions. They do not govern what biological templates scientists use with these commercial CFE kits, or whether a given kit can support the synthesis of harmful agents. A researcher using CFE to produce a pathogenic virus might not trigger any regulatory review today, especially if the virus is not on the Select Agents list, and a non-state actor utilizing the same kit could potentially fly completely under the radar. 

DNA synthesis screening, the main current safeguard, addresses the template but not the production machinery. This means that in cases where synthesis orders circumvent existing regulatory measures, a malicious actor could still use CFE to rapidly synthesize harmful biological material. While new legislation such as the Biosecurity Modernization and Innovation Act of 2025 introduces important guidelines for DNA synthesis screening that could also protect against misuse of CFE, uneven international standards, AI-driven protein design, and the ability to split orders across multiple vendors mean this protection is insufficient. In the meantime, benchtop and unregulated DNA synthesis capabilities coupled with CFE exacerbate the need for near-term policy. 

This gap is also not easily addressable by simply applying expanded DNA synthesis guidelines to a new tool. CFE systems will likely vary in risk profile depending on their composition: mammalian cell extract with intact translation machinery can support the production of pathogens that a minimal reconstituted system optimized for protein product cannot. Addressing this requires a new, capability-based approach to oversight that is proportionate to the actual risk of each type of CFE formulation.

CFE can strengthen biodefense and health security

CFE’s portability and on-demand production capability make it directly relevant to homeland defense, supply chain resiliency, and health security. CFE has been demonstrated as an effective diagnostic platform, and recent work has shown that full-scale production of mRNA vaccines formulated in lipid nanoparticles can be achieved using benchtop microfluidic devices. Additional work has shown the incorporation of CFE into Zika virus detection assays, zinc level quantification, and portable GMP-grade therapeutic production. These capabilities establish that CFE can operate at clinically relevant scales in compact, field-deployable formats — enabling diagnostics, vaccines, and other critical biologics to be produced closer to the point of need. This reduces vulnerability to supply chain disruptions and could dramatically accelerate response timelines in a national security emergency. As costs decline with scale and standardization, CFE becomes increasingly cost-competitive with traditional biomanufacturing for time-sensitive and distributed applications.

Critically, CFE offers a rare opportunity to build security in from the start rather than bolt it on later. Because CFE operates in test tubes rather than inside replicating living organisms, production platforms can be engineered with intrinsic safety features. For example, bioorthogonal genetic systems that use reassigned or non-natural molecular components incompatible with standard biological systems are made possible by CFE. Such systems would make any agent produced within them unable to function in natural biological contexts, providing a built-in containment mechanism. Importantly, these same modifications are already required to push CFE into its most commercially valuable applications, such as producing proteins incorporating non-natural amino acids. This means that investing in safety-by-design CFE simultaneously advances biosecurity and commercial competitiveness: a rare alignment of incentives that policymakers should move quickly to capitalize on.

The window for proactive governance is open, but it will not remain so. CFE capabilities are expanding rapidly, and both the norms and commercial infrastructure around these systems are still being formed. Policymakers must act now to enable the United States to shape those norms, lead in establishing global standards, and position our nation as a leader in responsible next-generation biomanufacturing. The recommendations below outline a two-pronged strategy: tiered regulatory oversight calibrated to actual CFE capabilities, and targeted federal investment to accelerate safe, scalable CFE infrastructure that supports decentralized biomanufacturing.

Plan of Action

CFE enables a new model of biomanufacturing that is faster, more flexible, and less dependent on centralized infrastructure traditionally needed for cell culture. Those same features also introduce novel risks, especially since CFE is currently commercially available and has demonstrated the ability to produce functioning viruses and toxins. Due to the unique technical makeup of the technology, the traditional trade-off between innovation and regulation does not apply, as safety-improving technological measures, such as bioorthogonality, can also boost CFE’s manufacturing capacity. Thus, harmonizing these efforts with other dominant biosecurity measures, DNA synthesis screening, will safely unlock this technology to its full capacity. 

Because CFE risk depends not only on the DNA template but also on the CFE system’s functional capabilities, governance should focus on tiering, standards, and capability-based controls. We recommend: 

1. a tiered oversight framework anchored by NIST standards, integrated into NIH/CDC biosafety tiering, and linked to export controls and industry know-your-customer measures through a Cell-Free Expression Oversight Consortium modeled after the IGSC.

2. A federal investment strategy to improve CFE yield, reliability, purification, and portable GMP-compatible manufacturing. CFE is unusually well-suited for safety-by-design: the same modifications that improve performance and commercial competitiveness, including the use of biological orthogonalization, can also constrain misuse by reducing compatibility with uncontrolled biological contexts.

Recommendation 1. Enable Safe Scaling of CFE Through Capability-Based Tiering and Export Alignment

Establishing clear, capability-based tiers for CFE systems would not only improve biosecurity but also provide regulatory clarity that enables innovation, commercialization, and responsible scaling. While different types of CFE can share similar material components, characteristics such as yield, the ability to produce modified proteins, and the capacity to support viral production can differ substantially. These differences depend not only on the DNA template but on the properties of the CFE system itself, and those should be taken as a central consideration for classification, especially given the proliferation of benchtop DNA synthesizers. The National Institute of Standards and Technology (NIST) synthetic cell laboratories can support the technical validation and calibration of these tiering frameworks, utilizing the National Agile Biomanufacturing Initiative , enabling standardized evaluation of systems with different functional properties, including those incorporating orthogonal biological components.

1. Given that the main biosafety risk CFE poses currently comes from malicious activity from lone wolf actors, the Department of Commerce should convene a Cell-Free Expression Oversight Consortium, modeled on the International Gene Synthesis Consortium, to encourage sellers of CFE mixes to implement know-your-customer measures and harmonize customer screening internationally, implement export controls, and international standards. 
2. The NIH should be engaged to update dual-use research of concern (DURC) guidelines, ensuring that emerging CFE-based research on mammalian viral synthesis is flagged early for ethical and security review. 
3. The Department of Commerce’s Bureau of Industry and Security (BIS), in coordination with the Departments of State and Energy, should explicitly classify advanced cell-free expression (CFE) systems under the Export Administration Regulations (EAR), harmonized with the Australia Group control lists, establishing clear export control thresholds based on functional capabilities (such as the ones relevant for the biosafety framework). This classification should enable licensing requirements, end-user verification, and international alignment without impeding benign academic or industrial research.

Recommendation 2. Invest in Safe, Scalable, GMP-Compatible CFE Infrastructure

Congress should establish a National Agile Biomanufacturing Initiative, housed within the Office of Science and Technology Policy (OSTP), with a five-year mandate and an option for renewal, to accelerate the development of distributed, GMP-compatible manufacturing infrastructure. For the initiative to be effective, it will require appropriations of at least 40 million USD annually, with coordinated investment across NASA, the Department of Defense (including DARPA and DEVCOM-CBC), NIST, and NSF. Cell-free expression is a critical enabling technology within this strategy, but the initiative should encompass the full portfolio of agile biomanufacturing modalities for distributed deployment in public health, defense, and emergency-response settings.

1. NIST should receive 10 million USD annually to deliver measurements and standards that support quality and performance benchmarks, safety requirements, and compliance metrics for cell-free manufacturing systems (as listed in recommendation 1). This will inform risk and performance tiers for cell-free manufacturing, in alignment with NSCEB recommendation 4.1a (appendix C). 
2. NSF should expand its Cell-Free Innovations in Research and Engineering (CFIRE) program by doubling its $40 million budget and extending its duration by five years. The expanded program should fund projects that develop and test modular, GMP-compatible CFE units, while incentivizing the integration of safety-constraining design features into federally funded systems. Progress can be tracked through concrete indicators such as improvements in CFE yield and demonstrated advances in safety-by-design bioorthogonalization (e.g., genetic code reassignment, orthogonal ribosomes).
3. Congress should direct DARPA, or another suitably equipped laboratory within the DoD research ecosystem, to fund the development of field-deployable, GMP-compliant manufacturing platforms built on CFE technologies. In parallel, NASA should pursue complementary work on cell-free systems for space applications, where its operational environments can serve as a testbed for autonomous, remote biomanufacturing.

Conclusion

CFE represents a unique opportunity to both strengthen American competitiveness and preparedness in bioproduction while anticipating and preventing biorisks posed by lone actors. Targeted government investments in developing CFE could position the US as a global leader in next-generation biomanufacturing and reduce dependence on foreign pharmaceutical innovation and supply chains. Prioritizing this research would also transform pandemic preparedness infrastructure from centralized, vulnerable systems to resilient, rapid-response networks. In the future, we envision standardized, GMP-compliant CFE units capable of rapidly scaling production for various vaccines and therapeutics within days, rather than months, of pathogen detection. The freeze-dried and shelf-stable nature of CFE extracts also means that these systems can even be poised for autonomous deployment. Importantly, developing bioorthogonal CFE will fundamentally alter the risk calculus by making any potential replicative product incompatible with natural biological systems. Combined with tiered access controls, this approach would rebalance the traditional tradeoff between beneficial innovation and security concerns.

The authors thank Kata Adamala for her ongoing support, as well as Janika Schmitt and Kimberley Ma for their helpful discussion and feedback.

Frequently Asked Questions

What are the alternative methods of biomolecule production, and how does CFE compare?

Cell-based production in bacteria, yeast, or mammalian cells requires sterile culture systems, bioreactors, and sustained technical expertise, and struggles to produce toxins. Chemical synthesis is limited to short peptides and demands costly, specialized reagents. CFE works differently: cells are lysed and processed to retain the core transcription and translation machinery (ribosomes, tRNAs, enzymes) while removing genomic DNA and debris. The extract is supplemented with energy substrates, amino acids, and cofactors, then freeze-dried into shelf-stable kits that activate upon rehydration with a DNA template. No living cells, no sterile infrastructure, no specialized expertise required. This is why CFE is the most accessible production route for malicious lone actors.

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Why won’t this proposal repeat the mistakes of past biotechnology policy?

Past frameworks, including gain-of-function oversight and gene synthesis controls, were established after the technology was already widespread, resulting in contested and unevenly enforced rules. This proposal intervenes before norms have hardened. Additionally, a primary proposed safety mechanism is bioorthogonality, which replaces standard molecular components with synthetic ones incompatible with normal biological systems. These modifications do not constrain CFE performance. They are the same changes required to increase CFE’s competitiveness in its most commercially valuable applications, specifically the bioproduction of pharmaceuticals. Security and competitive advantage are the same investment.

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The Federation of American Scientists (FAS) Makes Five Policy Recommendations to Maximize Opportunity and Minimize Risk at the Intersection of Biology and Artificial Intelligence

Washington, DC – December 12, 2023 – Today the Federation of American Scientists (FAS) released federal policy recommendations to address potential threats AI poses to bioscience and the surging bioeconomy. The five recommendations presented by experts are detailed in these memos:

• Develop a Screening Framework Guidance for AI-Enabled Automated Labs by Tessa Alexanian

• An Evidence-Based Approach to Identifying and Mitigating Biological Risks From AI-Enabled Biological Tools by Richard Moulange and Sophie Rose

• A Path to Self-governance of AI-Enabled Biology by Oliver Crook

• A Global Compute Cloud to Advance Safe Science and Innovation by Samuel Curtis

• Establish Collaboration Between Developers of Gene Synthesis Screening Tools and AI Tools Trained on Biological Data by Shrestha Rath

Read each of these recommendations, plus an introduction from Nazish Jeffery at this link.

ABOUT FAS

The Federation of American Scientists (FAS) works to advance progress on a broad suite of contemporary issues where science, technology, and innovation policy can deliver dramatic progress, and seeks to ensure that scientific and technical expertise have a seat at the policymaking table. Established in 1945 by scientists in response to the atomic bomb, FAS continues to work on behalf of a safer, more equitable, and more peaceful world. More information at fas.org.

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