Previous Chapter: 3 Current Frameworks and Policy Challenges
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

4

Challenges and Opportunities

During the workshop series, planning committee members and participants discussed many challenges and opportunities related to existing policy frameworks, including the challenges they encounter in their research and the opportunities they offer. The discussions are categorized into three areas: A Viewpoint of Benefits; Data Management; and Policy Development, Engagement, and Entrepreneurship.

A VIEWPOINT OF BENEFITS

What Are the Risk/Benefit Indicators?

Participants considered what indicators could be used to evaluate the benefits of a technology. Without such indicators, “how do you know when you’ve been successful?” asked Sarah Juckett, National Academies. Espona suggested that each scientific project should incorporate risk/benefit indicators to measure its impact.

Each nation will have its own particular risk/benefit calculations regarding development of new technologies, said Lemus. Because of these differences and each nation’s particular political environment, the regulations regarding these technologies may be country-specific, and these regulatory differences will affect the risk/benefit calculation. For example, the regulations that govern genetically modified organisms in Mexico are mostly focused on agriculture, while health-related legislation is very general, he said, leaving multiple technologies in need of regulation. Furthermore, current regulations do not require academics working in universities to implement security protocols. The

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

government audits private laboratories but not universities, he said. Without a requirement, universities may not make the investment. Indeed, he added, only a few universities in Mexico have applied biosecurity protocols widely, which raises the security risks for multi-omics research.

“Unfortunately, governments, at least in Mexico, are not interested in these issues…risk or benefit is not within their radar…I truly doubt the government will regulate scientific efforts,” said committee member Mónica Chávez González, Autonomous University of Coahuila. Nonetheless, she said, scientists have a “moral responsibility” to go beyond the practical aspects of their research when it has dual-use potential and to engage the politicians in these issues. “In the academy, we need to approach others” in a collective manner, she said. “It’s not easy, but the work needs to be done…to start having greater control over what is happening in our laboratories.”

“Although the goal of researchers is to produce technology for peaceful purposes, it has dual use,” emphasized Lemus, who works in criminal investigation. “We can see the evil in some of these persons that I cannot ignore…when we talk about data generation, it’s important to see the other side of the coin.” Naik noted that potential biological weapons, such as anthrax or Ebola virus, already exist and do not require engineering, so worries about misuse of omics data need to be put into context. “An actor who means to do bad things has multiple different avenues to do those bad things, and we might be stopping a good thing because we believe that they’re going to come after [it],” she said.

Benefit Assessment May be a Crucial (and Missing) Component of the Risk-Benefit Equation

None of the frameworks governing data security in India define benefit assessment, noted Adlakha. Evaluating benefits is important, she said, because the benefits need to outweigh the risks to justify the work, but policies focus on risk to reduce potential harms. For example, making human health datasets more accessible to researchers could facilitate personalized medicine. Therefore, she suggested, policies should include a requirement for benefit assessment.

The Biological Weapons Convention focuses on the risks of harmful biological materials, and risks are often viewed by security experts as being more tangible than benefits, said Berger. However, scientists who are engaged with the BWC note that the same emerging technologies that created those risks also have beneficial applications for society and suggest focusing on tipping the balance in favor of the benefits. Nonetheless, few international biosecurity frameworks on benefits exist, “and none of them are ever used,” she added.

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

The WHO (2022) publication, Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research, provides valuable guidance in the context of omics for human health, said Espona. This document offers a context for analyzing new technologies, both current and future, she said. It establishes a governance framework, identifies the various stakeholders and their roles, and provides guidance on how to implement its recommendations. It lists scenarios and case studies, with specific guidance on discussing complex topics like gene therapy or DNA synthesis with a lay audience. It also offers advice on how to keep international collaborations safe and secure, she added, noting that data security is “less tangible than working with cells or organisms.”

Usually the benefits of technologies like gene editing are more tangible but the risks are uncertain, countered Naik, who frequently uses uncertainty as a proxy for risk and more tangible outcomes for the benefits. However, she added, the benefits of a particular technology tend to vary case-by-case and country-by-country. For example, gene editing to treat β-thalassemia has to be cheaper than the current available treatment, which is a bone marrow transplant, in order for it to be truly useful in India.

A policy framework that includes assessment of benefits and risks is needed, said Adlakha, noting that the benefits may need to be evaluated on a case-by-case basis, and also that the perception of benefits can change over time. For example, transgenic plants initially faced a lot of resistance in India and their production was prohibited. However, seeing how other countries were benefiting from transgenics, India changed its regulations to allow the generation of single point mutations with a site-directed nuclease. In the absence of a discussion of the benefits, these technologies struggle to gain Institutional Biosafety Committee (IBSC) approval and cannot move forward, she added.

These technologies have broader benefits that extend to multiple sectors, added Lemus. Peaceful technologies may enable solutions that extend beyond healthcare to other priorities such as food production, and the benefits can extend beyond the immediate aim to enhance a country’s economy and stability. However, the benefits may need to be balanced against the risks of “what the technology could do if it fell into the wrong hands.” Therefore, to see the benefits, each country must juggle its own security needs and legal frameworks, he said, and “whatever I can apply in Mexico is not applicable in the US, India, or Argentina.”

The question of how to realize the benefits from emerging biotechnology was also discussed in the third workshop. Peruvian crop research is in a similar situation to that of Mexico, said Gálvez Ranilla. As a result of political decisions that did not include scientific experts, she said, and “without considering any objective information about the benefits,” Peruvian law has imposed a moratorium on transgenic seeds until 2035. While this moratorium is in place she plans to continue studying Peruvian maize by integrating

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

data from a variety of omics-based technologies, such as genomics and transcriptomics, and has begun to identify genes linked to the biosynthesis of phenolic and carotenoid compounds.

Lemus served on the Mexican Commission on Biosecurity of GMOs (CIBIOGEM), which develops policy on biosecurity, biosafety, and GMOs with support from the National Council for Science and Technology (CONAHCYT) (Gobierno de México, n.d.). He coordinated a council that included members from private, agricultural, biotechnology, production, and social sectors. The council proposed a multipronged approach to address economic challenges posed by emerging threats, such as environmental hazards and hunger. However, public policy changed over time and support for the commission’s activities eroded, said Lemus. Government officials were unwilling to address the complex nature of national problems like food insecurity, focusing on narrow policy decisions instead. They withdrew support for the development and marketing of GMOs, a move that Herrera-Estrella ascribed to political motivations.

Such fractured policy-making affects both crop production and economic and social progress, said Herrera-Estrella. For example, “we’re trying to guarantee heirloom strains in Mexico without considering the impact that could have,” such as lowering crop yield. Another example is the government’s ban on glyphosate, which was enacted by presidential decree without offering the farmers any alternative forms of weed control, said Herrera-Estrella. “And the farmers say, ‘what do we use then?’–‘oh that’s your problem.’” Herrera-Estrella and colleagues developed a transgenic technology that enables weed control using nutrition alone, without herbicides. This is a patented technology that he offered to the Mexican Secretary of Agriculture for free to use in any crops they wanted, but he was told no, “it’s transgenic, we don’t want it.” Ultimately the moratorium on glyphosate use in Mexico was never implemented despite the demonstrated health risks, because without glyphosate, “you have to use even worse herbicides,” he said. Progress is also stalled for indigenous communities in the Andean regions that grow native types of corn and potato, added Gálvez Ranilla. Research focused on crop preservation and improvement offers important benefits, she said, and the advances and income that result from this research could be reinvested back in the communities themselves.

DNA Screening may Benefit Everyone

Companies that produce synthetic DNA may need to understand that screening the DNA and knowing their customers is for their own benefit, said Espona. This can be considered under the rubric of “strategic trade management,” where economic, political, and reputational benefits all flow together. Rather than a barrier to trade, she said, screening is a way to keep growing while balancing risk and benefit. Scientists could also be trained to consider the ethical implications of their work, and both sides–customer and

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

provider– can communicate, she said. Regarding the countries that serve as the focal point of this workshop–Mexico, Argentina, Peru, and India–how existing regulations are enforced and even whether the scientists know they exist is unclear, said Espona: “my experience is that they know very, very little…but they [are] willing to implement whatever is needed” and to teach their students about the potential dangers inherent in dual-use research, which “brings a lot of hope to communities like ours.”

DATA MANAGEMENT

Regulatory Structures

Data management was a recurring theme throughout the discussion. Regarding regulatory structures, Adlakha noted that policies that facilitate the dissemination of omics data while keeping the data secure could be useful. Securing the technology is also important because “the biotechnology is the core…driving any biological intervention related to omics,” she said. In India, the route for balancing risk and benefit runs through several regulatory layers. For example, regulation of genetically modified plants starts with DBT, then goes to the Review Committee on Genetic Manipulation (RCGM), and then to the Ministry of Forest Affairs for final approval. The risk/benefit relationship needs to be mitigated all along this pipeline, she said.

Planning committee members cited the following articles on the risks pertaining to human genomic data: Strengthening India’s Genomic Data Security, which also highlights the importance of omics data security in the region (Tom, 2025); and Confidentiality and data sharing: vulnerabilities of the Mexican Genomics Sovereignty Act (Rojas-Martínez, 2015). This act established regulations for the exportation of DNA samples from Mexican nationals for population genetics studies.

Data Security

How Can Researchers and Data Experts Work Together to Secure the Data?

In the United States, many of the policies governing potential dual-use research of concern were driven by concerns of terrorism, said Berger. Nonetheless, when the science is moving quickly, scientists constitute the front line of risk/benefit management, whether that be in academic research institutions, non-academic research institutions, or the private sector. In discussing risks and benefits, therefore, she suggested “think[ing] about what would be realistic and feasible for scientists and institutions to do to…manage this particular set of very tough challenges,” particularly when the analysis uses large amounts of data.

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

Espona noted that data management communities have experience in data governance, data management, quality, safety, and security. Linking the research community with the data community could address these concerns, said Espona. “We don’t talk to each other,” she said. The synergy of AI and biology (with biology data being fed to AI) ought to have forged this link, she added, but it has not occurred. The data community has been developing models that are applicable to the security needs for biology; “we only need to connect the dots.” Programs like the NTI Biosecurity Competition offer opportunities to bridge policies for science and security (NTI, n.d.), noted Berger. The competition brings together rising young leaders from around the world to develop innovative solutions to reduce global catastrophic biological risks.

Anticipating a Data Security Breach

Data breaches can be anticipated, suggested Adlakha; “when we talk about anything digital, a breach is something that comes automatically.” Although no multi-omics data breaches have been reported in India, she cited other data breaches, such as when large amounts of patient data were obtained from Indian health providers by cyber phishing on at least two separate occasions. When India considered establishing a forensic data bank, mitigating the impact of a security breach was the focus, said Naik, as planners agreed that data security could not be guaranteed. “Think of what’s the worst that can happen and figure out ten ways of reducing the chances of the worst that can happen, and then compare that to the benefits of a database. That would probably give you a much better perspective on whether to go ahead with it or not,” she said. Lemus noted that Mexico’s military has been hacked, and so has a national database containing information on millions of Mexicans. Meanwhile, multiple programs are proposing to collect genetic information on a population level. For example, the Mexican government is promoting genetic profiles for every newborn child to test paternity. “How can we guarantee that all this new information from children will be safe?” he asked.

Data Access and Potential Challenges

Biotechnologies that were developed with peaceful purposes may be used in criminal endeavors, so it is very important to consider the risks, which can be effectively mitigated only through national legislation, said Lemus. The Mexican government is promoting development of a national bank of genetic profiles to identify missing persons. “How can we guarantee that these genetic profiles…don’t reach criminal elements?” he asked, noting that genetic information can be created to frame innocent people. “If [criminals] have a genetic footprint, they can create artificial DNA” and plant incriminating evidence, he said. Lemus has already handled cases where authorities generated genetic evidence to incriminate innocent people for political and criminal aims. Organized crime in Mexico is well-funded, said Lemus, enabling criminals to build laboratories and hire

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

the best scientists from multiple spheres. Clandestine chemistry labs are generating ever more potent drugs, and “the damage they do is brutal and lethal,” he said. “We also have to consider this in biology, we cannot ignore it.” Corruption affects all sectors (social, economic, and government) and is facilitated by the lack of effective public policies to address it, he added. “Terrorism is a crime, so you have to think like a criminal” to mitigate this behavior. A criminal might choose to synthesize a sequence of concern in fragments to avoid detection and then use genetic engineering to assemble it, install synthesis capabilities on their own premises, or create fronts with the appearance of legality.

Countries need to work together to develop national regulations and strict policies to address criminal uses of genetic information, said Lemus. In Mexico, rigorous policies to secure data could include screening public servants to prevent those with known ties to criminal groups from gaining access. The scientific community can work together to establish norms and practices to reduce potential risks, said Berger, noting calls for policies aimed at companies that synthesize DNA. However, fighting malicious activity may require a much more multi-sectoral partnership, in which scientists share information about risk management more broadly with government and industry. As one example of cooperative information sharing to reduce risks, Berger described an FBI advisory group where heads of research universities shared their risks related to counterintelligence.

For preventing criminal misuse of biological constructs, any legal remedy will rely on a multidisciplinary team that includes intelligence agents, lawyers, and other experts, and its ability to carry out an effective investigation depends on national intelligence policies, said Lemus. It may be necessary to establish a legally binding framework that forces all sectors–commercial, academic, government–to report what research is being conducted. In Mexico, Lemus said, this would require a new initiative to establish the framework and policies, which could conflict with existing laws regarding data security. The resulting policies can vary widely, depending on each country’s priorities; so even though terrorism is a priority for both the United States and Mexico, their policies for addressing this concern may differ.

POLICY DEVELOPMENT, ENGAGEMENT, AND ENTREPRENEURSHIP

Espona emphasized the importance of international collaboration to share best practices and learn from one another’s experiences. She noted that these collaborations can also address the United Nations’ Sustainable Development Goals1–to improve health and

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1 See https://sdgs.un.org/goals (accessed on January 5, 2026).

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

reduce hunger; to support industry, investment, and infrastructure; reduce inequalities; respond to environmental hazards; and preserve biodiversity. She highlighted the importance of developing indicators of risk and benefit and collecting indicator baseline data as soon as possible, so the effects of the new technologies may be assessed. Berger stressed the importance of international cooperation on a global scale, citing OECD efforts on harmonizing regulations. Though national priorities may differ, said Berger, nations still can cooperate to establish safeguards that are consistent across countries.

Role of Strategic Plans for Science and Technology

Participants discussed the role of strategic plans for science and technology in enabling responsible research and the development of biotechnologies. “The first problem is that there is not a clear diagnosis of what we have and what we need,” said Espona. Argentina has had only two strategic plans for science and technology, she said: the first in the 1950’s and the second about 20 years ago [CONICET had a 2022-2025 Strategic Plan (OECD, 2025)]. The strategic planning process enabled technology problems to be detected and addressed, she added.

National Policies can Enable Access to Transgenic and Gene Editing Technologies

Governments can develop long-term national policies for food security that fund crop improvement research, development, extension, and distribution of seeds to farmers, to ensure the appropriate use of omics science in plants, said Herrera-Estrella. Mexico’s National Institute for Forestry, Agriculture, and Livestock Research (INIFAP)2 ran a successful program in the 1950’s and 60’s, he said. The government also had a seed company, PRONASE, which commercialized the varieties that were produced, but the government dissolved PRONASE in 2007 and let companies take over (Mexico Business News staff, 2025), he said. The plant breeding institute collapsed, and “breeding in Mexico is… almost nonexistent,” he added, while commercial varieties are concentrated in the hands of the relatively few large farmers who can afford them.

Herrera-Estrella cited Brazil’s Agricultural Research Corporation (Embrapa)3 as a model. Embrapa has active research centers and contributes value to the country’s agriculture. He noted that Brazil and Argentina have flexible laws regarding gene editing, which permit generating mutations that can happen naturally, such as point mutations or small insertions or deletions. The final lab-edited products are indistinguishable from naturally mutated products, he said. Brazil has a strict law (Brazil, 2005) concerning biosafety and biosecurity4 of GMOs that serves them well, added Espona. Mexico had a

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2 See https://www.gob.mx/inifap (accessed on October 9, 2025).

3 See https://www.embrapa.br/en/international (accessed on October 9, 2025).

4 The term ‘biosecurity’ means plant gene modification (or GMO) safety in this context.

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

similar law (Juarez and Kuss, 2009), replied Herrera-Estrella, “but then they said no that’s not enough, we have to completely stop projects.”

Herrera-Estrella suggested reinstating the committees (such as CONAHCYT) that were headed by Lemus and others, to contribute to national policy development in Mexico. “They started working very well until [transgenics] were blocked and we couldn’t test them anymore,” he said. The previous laws allowed production of GMOs while requiring very strict testing: “a lot of tests, evaluations, assessments,” but the evaluations were done on a case-by-case and step-by-step basis depending on the specific varieties of crops, and the decisions were made “based on scientific knowledge and not on short-term politics.” National policies also could enable data standardization, said Gálvez Ranilla, noting the lack of standardization of omics technologies in Peru. Metabolomics and other omics platforms are used in research all around Peru. Each lab’s data tend to be held separately, and integrating data from the different labs and technologies will take a lot of work, she said.

How can we ensure that these multi-omic technologies will be available to poor countries, and how will this impact food security? asked Florez-Cuadros. The most difficult thing, she said, is ensuring that everyone will have access, so what seems like a great innovation does not end up further expanding the gulf between rich and poor countries. Gene editing is “traditional breeding a thousand times better, faster, more precise, directed,” answered Herrera-Estrella. Access is an issue, but this is not the fault of the technology, he argued. The technology for producing transgenic crops was largely developed in Europe and ended up in the hands of American companies and with multinational consortia. To avoid limiting access to technology for orphan crops, he suggested that “our countries do their own research and develop their own [strains],” noting that the multinationals are not interested in crops like chia or amaranth. “We cannot oppose the technology just because politics and economics are involved,” he said.

Emerging Biotechnology: Innovation and Policy Flexibility

For many emerging technologies, “India creates policies, not laws,” said Naik, noting that India’s use of a framework that relies on policies rather than laws enables an agile approach that can evolve with the science. She compared the personal data law, the 2023 Digital Personal Data Protection (DPDP) Act,5 with the National Health Data Management Policy6 of the Ayushman Bharat Digital Mission (ABDM). The DPDP Act is a law—and not entirely clear regarding health-related data, she said—whereas the ABDM National Health Data Management Policy is not a law but is flexible. Several participants considered how India’s policy frameworks began in other research and industry areas

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5 See https://www.meity.gov.in/static/uploads/2024/06/2bf1f0e9f04e6fb4f8fef35e82c42aa5.pdf.

6 See https://www.india.gov.in/health-data-management-policy-ayushman-bharat-digital-mission-abdm (accessed on January 5, 2026).

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

but have translated to health technology, and how easily they can be updated with new information on risks and benefits based on advances in technology. Although policy agility enables new biotechnology challenges to be addressed as they arise, Naik noted some operational challenges. For example, maintaining policies requires collaborative, routine input, but circumstances sometimes make this difficult. When the guidelines on gene editing for human health were first released, the plan was to form individual working groups for each disease that would meet every year to update the guidelines in response to advances in technology. However, the Covid-19 pandemic derailed this effort and it was never reinstated.

Discussions around human health multi-omic governing organizations were similar to those around nucleic acid screening, where different stages of research and levels of compliance are governed by different agencies. Naik cited the example of gene editing of plants or insects in India, where DBT guidelines apply to the research but the responsibility for final approval of field trials rests with the Ministry of Forest and Environmental Affairs. This final approval is subject to “a very different government structure… as a consequence, even though the Department of Biotech [DBT] holds a lot of data, and they might put on controls and be able to think about best interests, the actual product that the industry rolls out is often not under their control,” she said. Agility is valued for research and development, she said, but “when it’s a product that’s ready for commercialization, the outlook is very different.”

Multiple Ways to Incentivize Screening

During the DNA synthesis discussion, Mackelprang noted that it’s not always necessary to pass a law in order to improve security; establishing flexible policies can also help. For example, when individuals receiving federal research money are required to purchase their nucleic acids from providers that screen, more providers decide to screen. Companies adopt screening procedures for three reasons: compliance, commercial, and reputational, said Alexanian. Companies seek to comply with policies that “implicitly require DNA synthesis screening,” including certain export control regulations. The commercial incentive comes from countries like the United States and United Kingdom that have adopted frameworks that require screening. This incentive extends to companies based in other countries that sell to customers in countries with a framework. The reputational incentive is very important, she said, though it does not get discussed much; “no company wants a story published about a criminal who caused harm using DNA they supplied.” Companies can showcase that they are using best practices, added Espona, who noted that establishing a screening requirement can increase the reputation not only of the company but of the country.

In the future, if screening is required more broadly, it would likely establish more advanced regulatory compliance incentives, said Alexanian. For example, if an

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

assessment process is instituted, that creates the potential to fine companies that do not screen. Another possibility is for insurance companies to require liability coverage in case a customer uses the DNA for criminal activities, with lower premiums for companies that screen. Increasing awareness among scientists is also important. “If you [source DNA from] companies that are doing this screening, you… safeguard the future of biotechnology,” added Espona.

Opportunities for Science Communication

Several participants in the multi-omics scenario meetings observed opportunities to engage with policy makers for biotechnology policy development. Public policies can be flexible enough to adapt to scientific and technological developments, but politicians responsible for creating biotechnology policies and laws often do not understand the scope of emerging technologies, said Lemus. Biotechnology education is “a huge challenge for many countries,” he said. Policies surrounding intelligence and security matters can be easier to develop, but “if the country does not consider [biotechnology] a priority…it will be complicated” for legislative bodies to generate binding initiatives, he added. Without these initiatives, developments in science and technology can be stalled.

In the innovation cycle, “it’s like the science goes on one side and the politics on the other, and in many cases we don’t understand each other,” agreed Espona. Biotechnology development moves extremely fast, while regulatory bodies move slower and struggle to keep up. Researchers can make the authorities understand that they welcome regulation, she said, allowing science to proceed in a safer environment that is better for patients. Scientists can also educate the authorities to balance the risks and benefits, said Espona. The two communities can work together to identify the gaps, debunk “the myth of how risky everything is,” communicate the benefits, and delineate the need for good regulatory frameworks to stimulate safe and secure science. Right now, the lack of a regulatory framework leads to missed opportunities in many countries.

All scientific researchers need to contribute to the education of both politicians and the public, agreed Herrera-Estrella, to help them understand “the basis and the implications, both good and bad, of the technology we are developing” and ways to take care of their native resources. Researchers can promote policies aimed at ensuring that scientific discoveries are fully realized toward benefitting society, he added. “We need to improve the dialogue between the scientific community and the politicians,” said Espona, “because we are expecting them to do something that they don’t have a clue about.” This may require scientists to communicate better about the benefits of and need for research.

Effective communication has been especially difficult in Peru, said Gálvez Ranilla, noting that the country had five presidents within a six-year period. Each administration brought new political appointees, and many efforts at improvement that were initiated

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

under one president were abandoned by the next. Furthermore, scientists in Peru are overwhelmed with paperwork, which is required by law to maintain access to genetic resources. Although they need to work together to open a dialogue with the government, they may not have time to meet as a group and develop a common strategy, she said.

Observed Challenges with Anti-GMO Legislation, Risk, Cultural Bias, and Misinformation

Regarding the anti-GMO legislation in Mexico, Espona noted that the perceived balance often seems tipped towards risk and cultural bias, while the benefits of new technologies tend to be undervalued—a recurring theme of this workshop series. Public outreach may be needed, she said, to increase awareness of the benefits of transgenic methods for crop improvement.

Herrera-Estrella had a different observation. “It’s not the lack of information,” he said, “it’s groups of people who actively work to provide wrong information. They say [transgenics or GMOs] cause health problems, they damage the environment, they contaminate nature, and it’s very difficult to fight with them.” He developed technology for producing transgenic plants during his PhD in Belgium and returned to Mexico to develop transgenic systems that could help small farmers. Then people started to oppose GMOs. “I went to many meetings to discuss this, but…they are organized, and they have 100 people there, all organized to torpedo you, to try to make you fall, so it became really difficult,” he said. Herrera-Estrella noted that the biological insecticide produced by BT (Bacillus thuringiensis) corn is specific to certain types of insects and is far safer than chemical insecticides that can sicken a wide range of animals and farmers. “This [biological insecticide] is completely innocuous to human health and…has been shown effective in maize, soybean, cotton, and I thought, this technology is perfect for subsistence farmers in Mexico who have no money to buy insecticides…but people said no, this was against Mexicans, and poor farmers should not use the technology.” Due to this organized opposition, transgenesis is not being used anywhere in the world besides what already exists for maize, soybean, cotton, and canola, he said. Scientists may be reluctant to develop new transgenic strains because “public acceptance is so bad that there’s no point in investment.” The scientific community can organize to protect these new developments, he said, and to be very active in communicating the real risks and the real benefits to people.

Enabling Science Entrepreneurs Through Policy

Support for sustainable research was a theme in the crop improvement multi-omics meeting. Discussion centered on enabling biotechnology to be commercially viable and on attracting and maintaining scientific talent. Lemus remarked that attracting investment in science and technology is difficult for Mexico in particular, and Latin America

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

in general, which impedes scientific progress. Part of this limited engagement results from a lack of trained scientific entrepreneurs, and several organizations are addressing this problem by promoting entrepreneurship among scientists in developing countries, with the goal of helping them produce a profitable product to continue funding their research. Lemus is involved with one such program, which provides business tools to early-career scientists returning to Latin America after training elsewhere. Many scientists end up abandoning their research due to an inability to get funded, he said, citing instances of researchers whose projects were approved by government agencies but never funded. Teaching scientists about entrepreneurship can provide an opportunity to overcome these limitations and keep the research alive, he added.

In Peru, the entity7 distributing funding for science and technology primarily focuses on technology transfer, said Gálvez Ranilla. This approach puts the cart before the horse, she said: “how can you transform corn into a profitable product if you haven’t rescued its DNA?”

Researchers at universities in the United States and Europe are accustomed to working towards products than can be patented, said Espona, while Latin America is not. University students could be trained from the beginning to aim for products that can be commercialized, she said. Turning research into a successful commercial venture is “a completely different game, which we are not used to,” agreed Herrera-Estrella, who has gone through this process three times. Numerous factors determine which products have a future, he said. “Most scientists, we are not prepared for that, and our institutions, unfortunately, are not interested.” Furthermore, he added, the amount of work involved can be overwhelming. “They expect us to train students, do research, publish papers, make patents, make a business model, find investors, create a company, all at the same time.” Meeting all these expectations is impossible, added Espona, noting that “we are human beings…not just machines that work.”

To advance new technologies, governments in Latin America could develop a process facilitating the transitions from basic research to commercial products, said Herrera-Estrella. “When are our countries going to consider science an important component in society and the economy of the countries? When they see that we produce something useful.” But it is very hard to get there, he said, without a policy to support the process. Mexico has gone backwards in this respect, he added. In the past, when Mexico CONAHCYT programs funded state science agencies, the state of Guanajuato helped him create a couple of companies, but that program has been shut down, he said. Some corruption occurred in administering the program, he noted, “and that backfires to everybody… no more support to companies, no more support to startups, no more support for patents.”

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7 See https://prociencia.gob.pe/ (accessed on October 10, 2025).

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

The innovation process involves more than drawing a line from basic science to applied research to pilot to industry, added Espona. Citing the Argentinian philosopher Mario Bunge,8 she said that what happens during the innovation cycle also depends on philosophy and ideology. This can be seen in many countries where the pendulum swings from one ideology to another. “One day, they want one thing and the other, another,” and the science gets lost. Revisiting science philosophy could help us better understand how to address these problems, she suggested.

As a member of the Global Young Academy,9 Florez Cuadros is studying the situation of young researchers around the world. Scientists struggle everywhere with difficulties of employment and pay, she said. She asked about the additional burden of administrative corruption, clarifying that the money is not being taken by the scientists but appears to disappear inside the government and academic institutions charged with distributing funds for science. Herrera-Estrella concurred that where he had seen corruption it was never from scientists, but he was aware of misuse of funds that had been earmarked for creating companies. Money for science also is lost through “bad organization,” said Espona, who recalled multiple instances in Argentina when scientists produced something of value and received a patent, but when the money arrived, it was not given to the research group. In one case, the scientists ended up leaving the university and establishing their own private company. “If you are not acknowledged because of the work you are doing, you will move,” she said, observing that biotechnology policy outreach is needed not only to politicians but also to university administrators, in order to improve their internal processes and enable profitable biotechnology research.

Policies may Correct or Amplify Resource Imbalances

Gálvez Ranilla highlighted resource imbalances in Peru between basic research funding and laboratory infrastructure. Basic research can identify the genes associated with synthesizing a metabolite of interest or withstanding different types of environmental stress, she said, yet little support exists for these efforts. When funding does exist, it can be woefully inadequate. A grant of $100,000-$150,000 is intended to support the activities of multiple researchers for three years, who also are expected to train students, publish papers, and comply with the immense amount of paperwork required to access genetic resources, stretching their capacity beyond reasonable limits. “The funds are the limit to making progress,” she said. Furthermore, she added, the political situation in Peru has placed limits on capacity-building. “It’s not attractive to do research here,” she said, because the life of a scientist is very difficult, so high-level researchers prefer to remain in the United States or Europe. In contrast, she said, physical infrastructure is not

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8 See https://philarchive.org/archive/MAUIMB-2v1 (accessed on November 12, 2025).

9 See https://globalyoungacademy.net (accessed on October 10, 2025).

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.

a problem. All over Peru, even in Arequipa, the national universities are well-funded by money from mining. “So national universities have beautiful facilities without high-level researchers,” she said.

The administrative hurdles for making laboratory purchases in Mexico are extreme, added Herrera-Estrella. “We count every penny to get the best prices,” he said. Nonetheless, his laptop computer in Mexico is 12 years old and the operating system is obsolete, but he has been denied permission to replace it for three years. Even though his budget was approved by Mexico’s National Research Council that funded his grant and CONAHCYT, he said, “I need a special permit from somebody in the Ministry of Economy…and I’m not allowed to buy a new [laptop]…even a $10 pen drive, I need authorization from the Ministry of Economy…somebody, I don’t know who, has to approve my purchase.” On top of that, half the money he receives in his grant is returned to the government as import taxes.

FINAL WORKSHOP REMARKS

The first workshop revealed how differently various countries are approaching the bioeconomy–with different frameworks, activities, documents, and priorities, said Espona. Communities are using diverse strategies to address the potential problems related to their particular bioeconomic activities and interests. The OneHealth focus of WHO’s framework is “a great inspiration,” she added, noting that the “bioeconomy is inherently OneHealth.” Espona also emphasized the importance of having meetings like this that facilitate collaboration among experts from different countries with different perspectives, because addressing the multiple issues around the bioeconomy demands a multidisciplinary and multicultural approach.

During the human health multi-omics meeting, Espona observed that “we forget about the importance of the benefits, but this is why science is moving forward so fast, trying to help people.” The costs of technologies like DNA synthesis have plummeted over time, and she anticipated that the same would happen for treatments using tools like gene editing, making them more accessible to the general population. The scientific community could maintain a wide perspective that views these technologies in the context of larger systems, including the cultural component, she said. She also emphasized the utility of sharing best practices. A harmonious international environment is important for generating the conditions for progress, including establishment of multilateral agreements, added Lemus. Although the preponderance of policies over laws governing human health multi-omics research in India enables the frameworks to be agile, said Adlakha, “it’s equally important to have a few laws in place so that we can make the entire system secure.”

Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
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Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
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Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 54
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 55
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 56
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 57
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 58
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 59
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 60
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 61
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 62
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 63
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 64
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
Page 65
Suggested Citation: "4 Challenges and Opportunities." National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/27767.
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Next Chapter: References
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