The most significant shift in the new U.S. National Security Science and Technology Strategy (NSSTS) may be conceptual: scientific and technological leadership is no longer simply a prerequisite for economic competitiveness. It is itself a national security objective.
The strategy, designed to support the goals of the 2025 U.S. National Security Strategy, reframes the relationship between research, innovation, industry and security. Biotechnology sits alongside artificial intelligence and quantum technologies among the fields Washington sees as potentially most transformative in the years ahead.
Why it matters: The underlying assumption is that great-power competition increasingly depends on the ability to generate knowledge, rapidly turn it into technology and protect research, data, infrastructure and supply chains from dependence on — or interference by — adversaries.
- Life sciences occupy a particular place in this new security landscape. Synthetic biology, genomic and epigenomic engineering, protein design, new therapy development and manufacturing, biomanufacturing and neurotechnologies all appear on the U.S. list of critical and emerging technologies.
- What is changing, in other words, is not just how research is conducted. It is the strategic weight attached to it.
Research as a source of power. “The new NSSTS explicitly frames scientific and technological leadership as a national security objective, placing biotechnology, together with AI and quantum computing, among potentially transformative technologies — and I would add disruptive ones,” Professor Novelli says.
- According to Novelli, that recognition reflects “a profound transformation of biotech’s role in the geopolitical arena.”
- Covid-19 marked a turning point. The pandemic demonstrated both the power of biomedical research and the vulnerability of systems heavily dependent on global supply chains for medicines, active pharmaceutical ingredients and medical devices.
- “The pandemic acted as an accelerator, revealing the fragility of global supply chains for medicines and medical devices and turning biomedical research capacity into an issue of national resilience and strategic autonomy,” Novelli says. “Today, biotechnology is considered critical infrastructure, on a par with semiconductors or energy.”
That is the conceptual leap running through the U.S. strategy. Having strong laboratories and producing high-quality research is no longer enough. A country’s ability to generate knowledge, turn it into applications, manufacture at scale and control the relevant supply chains becomes part of its capacity to respond to crises and preserve its autonomy.
- In the United States, that approach is also reflected in the debate over the Biosecure Act, a proposal aimed at restricting federal government relationships with certain biotechnology providers considered a risk.
- Europe is moving differently, but it increasingly recognizes the same underlying problem. The European Commission has proposed a European Biotech Act to strengthen research, manufacturing capacity and biomanufacturing, facilitate the use of AI and data, and introduce biosecurity safeguards. The proposal itself describes biotechnology and biomanufacturing as essential to the EU’s competitiveness, strategic autonomy and economic security.
- “A state’s ability to conduct advanced biotech research,” Novelli says, “is no longer only a matter of scientific progress or economic competitiveness: it is a central element of its ability to ensure the continuity of its population, economy and national security in an age of crises.”
When AI meets biology. The convergence between biotechnology and artificial intelligence is making that shift even deeper.
- The U.S. NSSTS includes not only AI and foundation models among critical technologies, but also multi-agent systems, robotics, embodied intelligence and tools for reasoning and decision-making. On the biotech side, it identifies research frontiers ranging from synthetic biology and genome engineering to protein design and new therapies.
- For Novelli, the crucial development is precisely the intersection of these two worlds. “AI is transforming biology from a descriptive science into a predictive and design-oriented one.”
- The ability to generate and analyze enormous volumes of multi-omics data — DNA, RNA and proteins — and combine them with AI models can accelerate drug discovery, protein design and personalized therapies.
But it also opens another frontier. “It becomes possible to design biological sequences in silico and rapidly convert them into physical material, synthetic DNA or RNA, through specialized supply chains,” Novelli says.
- He describes this as a “short circuit between digital data and biological material.”
- The result is significant: “Biotech is becoming increasingly similar to an information industry, in which control over data and design algorithms is just as crucial as control over laboratories.”
- AI, then, does more than accelerate existing processes. “It is an enabler that makes previously unthinkable approaches possible,” creating new therapeutic opportunities but inevitably raising new security challenges as well.
Protecting research without closing it off. This is where one of the central tensions in the U.S. strategy emerges.
- If scientific knowledge becomes a strategic asset, protecting it becomes a national security requirement. But science depends on the circulation of knowledge, researcher mobility and international collaboration.
The NSSTS seeks to reconcile the two. On one side, it calls for stronger research security, tighter controls on recipients of federal funding, risk-based assessment criteria, cybersecurity protections for researchers and institutions and, where appropriate, automated systems to screen funded projects.
- On the other, it states that protecting the scientific ecosystem should not undermine its productivity and agility.
- The tension is particularly acute in life sciences, where the issue is not just intellectual property or technology but vast quantities of biological information. The U.S. strategy explicitly includes genomic, biometric and health data among the sensitive information that should be protected from access and exploitation by foreign adversaries.
The answer cannot be indiscriminate closure. “Research security, if taken to the extreme, risks fragmenting the scientific community, slowing discoveries and creating bureaucratic inefficiencies.”
- The challenge is to build protection that is “selective and risk-based”: identifying genuinely sensitive technologies and data — from synthetic DNA sequences to large genomic datasets — without turning, in Novelli’s words, “every international collaboration into an intelligence operation.”
- Different models are already emerging. The United Kingdom has focused more heavily on establishing a regulatory framework for research security, while Germany has also developed an approach centered on awareness and responsibility among institutions and researchers.
- In both cases, the objective remains the same: finding the right balance between openness and protection.
Europe has grasped the challenge. The European Union has also begun to place biotechnology within a broader framework of strategic autonomy.
- The European Biotech Act proposed by the Commission explicitly seeks to strengthen the industrial ecosystem, manufacturing and R&D, expand access to capital, facilitate the use of AI and data, and introduce safeguards against the misuse of biotechnology.
- On pharmaceuticals, the Critical Medicines Act addresses supply-chain vulnerabilities. The European Parliament and Council reached a provisional agreement in May on new rules aimed at diversifying supply chains and strengthening EU manufacturing capacity for critical medicines and their active ingredients. The agreement still has to complete the formal adoption process.
- “Europe is beginning to understand what is at stake, but it starts from a position of complexity,” Novelli says.
The difference with Washington also lies in the approach. “The European approach is more oriented toward competitiveness and building industrial capacity, while the American one is more markedly prohibitive and focused on security.”
- That does not mean Brussels is ignoring security. The European Biotech Act itself includes biosecurity among its objectives. But Europe continues to seek its own balance among competitiveness, strategic autonomy, the precautionary principle and regulation.
Italy’s challenge: turning excellence into a system. For Italy, the question becomes more concrete. “We are a country with excellence in basic research and a leading role in clinical trials,” Novelli says.
- The problem is turning that scientific capacity into a strategy that connects research, manufacturing, supply chains, data and security.
- “Italy is at a crossroads: on the one hand, it is a scientifically relevant country in biotech; on the other, it risks being exposed to dependence on foreign suppliers and still lacks a clear national strategy capable of transforming its scientific capacity into strategic and industrial autonomy.”
Italy is not starting from scratch. Novelli first points to the National Committee for Biosafety, Biotechnology and Life Sciences, which supports the government from within the Prime Minister’s Office, as a potential strategic coordination hub capable of bringing greater coherence to biotechnology and life-sciences policy.
- Then there is funding. Italy’s National Recovery and Resilience Plan has enabled significant investment in advanced research, including the National Center for Gene Therapy and Drugs based on RNA Technology.
- But Novelli argues that Italy needs to move beyond temporary interventions toward “structural and multi-year investment” in technologies considered strategic — from synthetic biology and protein design to biomanufacturing and capabilities to respond to biological threats.
Another tool is the Biotechnology Internationalization Working Group at the Foreign Ministry. Novelli says it could take on a broader role: mapping Italian companies and capabilities, identifying emerging biotechnologies of greatest national interest and incorporating assessments of technology-transfer risks into internationalization policies.
- Finally, there is research security. Italy has already started developing its own approach through a national model and guidelines for research security and integrity. But biotech, Novelli argues, requires specific attention to transfers of know-how and genomic data, as well as a national capacity to assess the risks associated with international scientific partnerships.
The bottom line: The challenge is not to choose between scientific openness and security, or to turn biomedical research into an extension of defense policy. It is to recognize that the ability to produce knowledge, translate it into innovation and retain control over its most strategic stages has become a component of national autonomy.
- “Italy is not starting from scratch,” Novelli concludes. It has scientific expertise, infrastructure and institutions capable of playing a coordinating role.
- What is still needed is the shift “from fragmentation to integration”: a vision capable of turning biotech research from scientific excellence into a strategic national security asset.
