Abstract
Strengthening biosecurity is critical for preventing the misuse of life sciences and achieving the goals of the Biological Weapons Convention (BWC). However, the global biosecurity landscape is hindered by fragmented efforts, inconsistent regulations, and limited resources, particularly in low- and middle-income countries and regions. Addressing biosecurity challenges requires active engagement of diverse stakeholders, including government, international organizations, academia, professional associations, industry, and civil society organizations. All of these stakeholders play key and complementary roles in different aspects of biosecurity. In this article, we examine 4 case studies for multistakeholder engagements and analyze major stakeholders for their relevant biosecurity roles, strengths, and limitations. We also provide policy recommendations and practical steps to fully realize the potential of multistakeholder engagement, including building networks and coalitions of stakeholders, creating educational and training initiatives, advocating for biosecurity standards, and improving communication channels that are suited to the interests of stakeholders. Additionally, we highlight the importance of having an inclusive and diverse representation of stakeholders. Multistakeholder engagement could enhance biosecurity and lower global risks while building robust structures to successfully handle biological threats in the future by promoting synergies while maximizing the optimal use of available resources.
Introduction
B
The advancement of biological disarmament and the implementation of broader measures to enhance biosecurity require the collaboration and support of diverse stakeholders. 7 Key stakeholders—such as governments, academia, industry, civil society organizations, international organizations, and professional associations—each play an important role in relevant activities and issues ranging from the global catastrophic biorisk to biosecurity measures within the local context. The engagement of these diverse groups is crucial because they can make complementary contributions to biosecurity, and their synergy can help promote and strengthen global biosecurity. 8 For example, governments and international organizations are critical for setting regulatory frameworks and ensuring compliance with international norms. Involvement from academia and industry ensures that scientific and technological progress can continue safely and securely. Civil society organizations and professional associations provide checks and balances, advocating for transparency and accountability in biosecurity practices.9,10
Deliberate use of biological weapons could lead to a large outbreak with significant economic and social consequences, which underscores the critical importance of enhancing current international biosecurity governance mechanisms to prevent the exploitation and misuse of life science research and to uphold international biosecurity standards.11,12 It is imperative to maintain a high level of awareness regarding biosecurity and to engage stakeholders in formulating and implementing pertinent biosecurity policies and measures to ensure effectiveness and sustainability. In the realm of biosecurity, various stakeholders play pivotal roles in ensuring the protection of public health, environmental wellbeing, and national security. These stakeholders have the authority and resources to establish comprehensive frameworks and enforce compliance but may face challenges adapting to rapidly evolving threats and coordinating across different jurisdictions. 13 In this article, we examine 4 case studies for interests and interaction of diverse stakeholders in biosecurity and analyze key stakeholders in biosecurity for their respective strengths and limitations. We highlight the potential areas for complementarities and synergies among them and, based on our analysis, provide some policy recommendations and practical steps that could help create, mobilize, and strengthen stakeholder networks for global biosecurity.
Methodology
The study adopts a qualitative research methodology combining desk research, a literature survey, open-source data collection, and practitioner insights to analyze multistakeholder engagement in global biosecurity. The research involved the development of 4 detailed case studies, a stakeholder strengths and limitations analysis, and a set of evidence-informed recommendations aimed at bolstering global biosecurity. The initial phase involved a review of the academic literature using Scopus and Google Scholar for relevant information on stakeholder engagement in biosecurity context. Grey literature—including white papers, workshop reports, policy documents and reports from relevant nongovernmental organizations (NGOs) and multilateral organizations—were also examined to capture recent developments and practical insights. Relevant open-source information was collected from the official websites of multilateral organizations (eg, United Nations Office for Disarmament Affairs [UNODA], World Health Organization [WHO], Global Health Security Agenda [GHSA]), professional associations (eg, International Federation of Biosafety Associations [IFBA], the American Biological Safety Association [ABSA International]), industry consortia (eg, International Gene Synthesis Consortium) and NGOs (eg, Nuclear Threat Initiative [NTI], International Biosecurity and Biosafety Initiative for Science [IBBIS]). This information was used to understand the current stakeholder activities, partnership dynamics, best practices, and norms.
This study employs a multiple case studies approach to analyze 4 key multistakeholder initiatives in the biosecurity domain: AIxBio Global Forum, the Youth for Biosecurity Initiative, GHSA Action Prevent Package 3 (APP3), and Nucleic Acid Synthesis Screening efforts.14,15,22,25,32,38 These cases were selected based on their diversity in thematic focus, stakeholder composition, and institutional backing, which offer a rich background for drawing insights about stakeholder interests and their interactions. Further, at least 1 team member was directly involved in each of the 4 initiatives, which provided us with insider perspectives on stakeholder interactions, motivation, and challenges. These insights were combined with information from primary and secondary materials, such as websites, official reports, and relevant academic articles, were used to develop and analyze the case studies.
A stakeholder mapping was carried out using case studies, a literature review, and open-source data collection. Stakeholders were divided into the 6 main groups: government, academia, industry, civil society, professional associations, and international organizations. Each stakeholder group’s relative strengths and limits were assessed using factors including technical expertise, policy influence, biosecurity interests, normative influence, and resource availability. Both scholarly research and case study insights influenced our analysis. Stakeholder analysis and case study findings were combined to create recommendations, which were then cross-checked against industry standards and best practices. Here, the focus was on lessons learned from previous multistakeholder platforms, operational viability, and alignment with stakeholder capacities. The practical implementation steps accompanying the recommendations were grounded in biosecurity and science policy literature and informed by the team’s direct engagement with biosecurity programs. The involvement of team members in the mentioned initiatives is acknowledged transparently to avoid potential conflicts of interest and to ensure the integrity of the analysis.
Case Studies Involving Multistakeholder Engagements
The following case studies highlight the engagements among several key stakeholders to strengthen biosecurity.
AIxBio Global Forum
Advancements in AI have wide-ranging implications across fields, and biosecurity is not an exception here. Large language models (LLMs), AI bio-design tools and increasing AI-driven automation of life sciences could create new biosecurity risks.16,17 These AIxBio capabilities could lower the barriers to malicious actors causing harm and increase the level of harm that a malicious actor could cause. 18 Moreover, the advancements in AIxBio could help circumvent the existing biosecurity measures.19,20 NTI, a US-based NGO, convened the AIxBio to address some of these challenges through active community engagement involving stakeholders including AI tool developers in industry and academia, scientists, AI safety institutes, and policymakers in the governments. 21 Biosecurity and AI experts from China, India, Nigeria, the United Kingdom, and the United States were among the participants, along with representatives from multilateral institutions and industry companies like Anthropic and Google DeepMind. 22
The goals of this forum include developing a shared understanding of AIxBio risks among different stakeholders and supporting the development and dissemination of tools and practices to guard against the AIxBio risks. 23 It further aims to promote the adoption of national and global governance mechanisms for the AIxBio capabilities. It has established 2 working groups that focus on horizon scanning for emerging AIxBio capabilities and development of guardrails for biodesign tools. These working groups meet regularly to discuss, collaborate, and share resources and best practices for safe and secure development of AIxBio capabilities.
Stakeholder Interests and Interactions
This multistakeholder forum has a platform for participants to share the latest insights from their work, share their concerns and challenges, and discuss opportunities to work together to develop solutions. It also provides opportunities for peer-to-peer learning, resource sharing, and effective communication strategy development. Notably, stakeholders have expressed their shared interest in contributing toward developing guardrails and effective governance mechanisms to reduce the risks while maintaining potential benefits. This engagement is due in part to the alignment of interests among participating AI developers, researchers, policymakers, think tanks, and NGOs, as the consequences of emerging AIxBio threats could severely impact them.
The forum is notable for having adequate representation of women and of diverse disciplines, seniority levels, and geographies, which enriches the discussion with diverse perspectives. However, some stakeholders, including academic and government actors from low- and middle income countries (LMICs), are underrepresented. Also, biosafety professionals and scientists working in high-containment labs have more limited engagement compared to AI tool developers, policy experts, and NGO representatives, who dominate the discussions. The forum could benefit greatly from further engagement of these actors. One of the major discussion items has been the development and dissemination of best practices, which could, over time, become precursors for norms and standards in the field. The involvement of diverse stakeholders from early stages ensures that their concerns and opinions are shared and can help shape the development of best practices. Through multistakeholder engagement, this forum facilitates the development of practical recommendations for the policymakers.
Key Outcomes and Future Directions
One of the major outcomes of this forum has been greater awareness among stakeholders about each other’s work and the major ongoing projects in the field, which has facilitated collaborative projects and joint actions. For example, NTI and the RAND Corporation jointly convened a side event on AIxBio safety during the Paris Action Summit in February 2025. 23 The discussions at the AIxBio forum contributed to the NTI’s report entitled “Developing Guardrails for AI Biodesign Tools.” 24 The report identifies and makes recommendations for built-in guardrails and managed access paradigms to help safeguard biodesign tools, highlighting the importance of building norms and standards. The forum is also working to develop a high-level statement and policy recommendations through extensive stakeholder consultations to facilitate shared understanding and prioritization of risk reduction efforts. However, customizing recommendations and preparing implementation steps for policymakers and AI developers across the globe will remain a challenge. Another major issue is the rapidly growing number of AI models and relevant actors, which makes it difficult to monitor the latest developments and stay inclusive of new actors. Sustaining shared interest for its goals from different stakeholders around the world over a long period will be a challenge given the rapidly evolving technology and geopolitical landscapes.
The Youth for Biosecurity Initiative
The Youth for Biosecurity initiative is a major UNODA program that provides opportunities to young scientists and biosafety professionals from LMICs to learn about, engage with, and contribute to the international biosecurity discourse. 25 Funded by the European Union, this program started in 2019 with the annual biosecurity workshops, and was later upgraded to Youth for Biosecurity fellowship combining online interactive training with in-person visit to Geneva. The stakeholders engaged in this program include the multilateral organization (the United Nations), regional organization (the European Union), biosafety professionals, academia, and NGOs. They contribute differently as speakers, participants, organizers, and funding agencies.
The program creates opportunities for the selected young leaders from LMICs to learn from leading experts in the field and to network with them to explore potential career paths. It also provides a platform for participants to come together and prepare recommendations for the BWC State Parties to address the concerns of the young people. For example, the “Youth Declaration for Biosecurity” was prepared as part of this initiative to support youth participation in global biosecurity. 25 This declaration has since been endorsed by a large number of biosecurity professionals and relevant institutions. Two of the authors participated in the workshop and are coauthors of the Youth Declaration for Biosecurity. They also contributed to the subsequent activities under the initiative as invited speakers, workshop participants and jury members. 25
Stakeholder Interests and Interactions
The program participants come from diverse backgrounds including academia, government, international organizations, NGOs, think tanks and biosafety associations. 25 The initiative has facilitated the development of a broader community of diverse stakeholders with shared interest in strengthening biosecurity. For example, a network of youth networks has been created that involves partnerships with other well-established initiatives to empower the next generation of biosecurity leaders. This broader network includes representation from the IFBA Global Mentorship Programme, the iGEM Competitions, 26 the Emerging Leaders in Biosecurity Fellowship of the Johns Hopkins University Center for Health Security, 27 and the NTI Next Generation for Biosecurity Competition. 28 This network of networks has coordinated several activities, including side events during the BWC official meetings, to advocate for shared interests such as the systematic involvement of young scientists in the BWC deliberations. 25
In addition to the youth declaration, this initiative facilitated the preparation of the Youth Recommendations for the Ninth Review Conference of the Biological Weapons Convention in partnership with other youth networks. 29 Further, there have been efforts to coordinate actions specific to particular themes and geographies. For example, several cohorts of participants from Nigeria came together to prepare the Biosafety and Biosecurity Handbook for Students in Nigeria 30 to create awareness and promote inclusion. Similarly, a video was created to place special emphasis on participation of young women scientists from the LMICs in the BWC discussions. 25 Women are underrepresented in the official BWC deliberations, and this gap has been consistently highlighted in the Youth for Biosecurity activities and outcomes including the youth declaration.
Despite the abovementioned strengths and achievements, there are several limitations of the program. For example, the number of participants is very small, which could severely undermine its overall impact on improving biosecurity. Moreover, the engagement of participants with key biosecurity actors is mostly superficial, being largely limited to online seminars and brief exchanges at in-person meetings. Most importantly, the program suffers from the overreliance on external funding sources, which limits the long-term sustainability of the program. The program could further improve by facilitating linkages between participants and the relevant actors in their own governments. Similar contacts could also be established with key stakeholders, especially with national and regional industry actors. Lastly, the initiative could substantially contribute to global biosecurity by sustaining a long-term engagement with its alumni with an active alumni network.
Key Outcomes and Future Directions
The program helps fill a resource gap in the LMICs by providing crucial biosecurity awareness-raising and training. It provides an avenue for building partnerships for education, training and communications, while also promoting regional and national networks in LMICs to address biosecurity challenges. It contributes to a more balanced geographic, age, and gender representation in the BWC discussion. In practical terms, it has created possibilities for exploring biosecurity as a career for the young experts in LMICs as they get to know about the major actors and activities in the field. Moreover, the recognition that the participants get as being part of this prestigious program could incentivize and support them in their career path in biosafety and biosecurity. Future activities could include greater alumni engagement and partnership NGOs or other UN agencies to get more participants or organize more activities.
GHSA Action Prevent Package 3
GHSA is an international initiative aimed at strengthening the world’s capacity to prevent, detect, and respond to infectious disease threats. 31 It was launched in 2014 and involves more than 70 countries, international organizations, NGOs, and private sector entities. The purpose of the GHSA is to bolster global health security to prevent pandemics like COVID-19 and other infectious diseases that could pose a significant risk to public health. GHSA APP3 aims to advance global biosafety and biosecurity, in support of international instruments and agreements, 32 including the International Health Regulations (2005) (IHR), 33 the BWC, 34 and United Nations Security Council Resolution 1540. 35 GHSA APP3 maintains that strong, whole-of-society biosafety and biosecurity systems enable countries to protect populations and counter biological threats, regardless of origin—natural, accidental, or intentional—while also fostering scientific progress and improving health security through international collaboration. One of the authors has been a regular participant in the GHSA APP3 meetings.
Stakeholder Interests and Interactions
The GHSA APP3 Biosafety and Biosecurity is a collection of experts and leaders from countries and NGOs that seek to advance global biosafety and biosecurity capacity under the auspices of the GHSA. APP3 actively encourages multisectoral engagement and collaboration to consider and address the diverse array of challenges posed by AI and emerging technologies. 32 Recognizing the growing intersection between health security and technological advancement, APP3 promotes coordinated efforts among public health, security, science, and policy sectors. This includes working in partnership with international frameworks and organizations such as the BWC, NTI, the World Organization for Animal Health, IFBA, Next Generation Global Health Security Network Mentorship Program, and the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction. These collaborations aim to enhance global awareness, strengthen biosecurity governance, and ensure the responsible and ethical use of emerging technologies, particularly where dual-use risks may impact broader biological threats.
Stakeholders in APP3 actively engage through a range of platforms, including technical working groups such as the Emerging Biological Risk Working Group, the APP3 Global South Engagement working group, regional consultations, and international conferences. These interactions facilitate the exchange of best practices, support the development of collaborative initiatives, and play a vital role in aligning national biosafety and biosecurity policies with globally recognized standards and frameworks. 36 The major limitation for GHSA APP3 has been the voluntary nature of engagement and the lack of substantial commitments from the stakeholders. Consequently, only a few practical steps have been taken to improve global biosecurity on the ground. Furthermore, there has been limited and uneven progress in implementing best practices and norms discussed at the national levels due to varied levels of interest and empowerment of government representatives. NGO, academic, and industry experts from LMICs have an oversized influence in the functioning of this program. Lastly, the initiative would require a permanent office, dedicated secretariat, and a long-term stakeholder engagement strategy to have lasting impact on biosecurity by facilitating sustained engagement with stakeholders.
Key Outcomes and Future Directions
One of the major outcomes has been the GHSA Biosafety and Biosecurity Toolkit, which serves as a centralized and accessible repository of critical tools and resources for members of the GHSA community and the broader global health and public health workforce. This comprehensive toolkit is designed to strengthen biosafety and biosecurity capacities by providing practical, evidence-based materials, including guidelines and protocols, risk assessment frameworks, laboratory safety manuals, pathogen handling procedures, information on emerging biological technologies and training materials and awareness campaigns. 36
As the global health landscape evolves post-COVID-19 and amid new technological and geopolitical risks, GHSA is shifting toward a more dynamic, inclusive, and tech-informed approach. Training and workforce development are cornerstones of APP3 within the GHSA mission. Capacity-building activities are designed not only to strengthen technical expertise but also to foster a broad-based culture of biosafety and biosecurity. Through the coordinated efforts of diverse stakeholders including governments, international organizations, academia, civil society, and the private sector. APP3 under the GHSA seeks to foster a safer global environment. APP3 aims to enhance biosafety and biosecurity measures to prevent the unintended or intentional spread of dangerous biological substances, ultimately bolstering global health resilience and security. 37
Nucleic Acid Synthesis Screening
DNA and oligonucleotide synthesis are of foundational importance in modern life science research and development as they are key to several kinds of experiments. Advances in nucleic acid synthesis have drastically reduced the costs and barriers in synthesizing nucleic acids. 38 While this has enabled breakthroughs in diverse fields like medicine and agriculture, it also creates new dual use risks such as the possibility of malicious actors ordering dangerous DNA fragments to produce or modify dangerous pathogens. Here, to reduce biosecurity risks, it is required to screen for potentially dangerous sequences and establish the legitimacy of the customers.39-41
There have been several initiatives involving the stakeholders such as industry, government, academia, biosafety associations and NGOs to address the challenges. These initiatives include the International Gene Synthesis Consortium, an industry-led group to design and apply a common protocol to screen both the sequence of synthetic gene orders and the customers who place them. 42 Another key initiative is the Common Mechanism hosted by IBBIS, a Switzerland-based international NGO. 43 The Common Mechanism is a free, open-source, globally available tool to provide resources to support each step of synthesis screening. Further, the International Organization for Standardization (ISO) has developed a standard on nucleic acid synthesis that incorporates biosecurity safeguards. 44 Several entities, including the US and the UK governments have come up with frameworks for nucleic acid synthesis screening.45-47 One of the authors has been part of several international multistakeholder discussions on the topic and is member of the IBBIS advisory board.
Stakeholder Interests and Interactions
The nucleic acid synthesis efforts have been led by the industry with the code of conduct for best practices in gene synthesis by the International Association of Synthetic Biology in 2009 and the establishment of IGSC in the same year following the fears of likely misuse of synthetic DNA. The major interest from the industry side has been to self-regulate to reduce the biosecurity and resultant commercial risks, while proactively shaping the international norms, standards and government regulations. The governments and multilateral organizations have generally lagged in coming up with detailed guidance frameworks and regulations. There have been several academic papers that have contributed to the development of technical mechanisms for screening as well as policy frameworks.48-50 Various NGOs, international organizations’, academic institutions and biosafety associations play a crucial role by promoting norms and guidelines, developing and disseminating resources, and advocating for government actions.23,51 Through conferences, workshops and expert committees, they also provide avenues for different stakeholders to come together to discuss their interests and develop a path forward based on convergences.
Key Outcomes and Future Directions
In addition to the harmonized screening protocol of IGSC and the Common Mechanism, there are several industry efforts to provide sequence screening including SecureDNA, 44 Aclid, 45 and SeqScreen. 46 Harmonizing these efforts towards development and adaptation of a common global standard would be a key challenge. Further, most of these efforts and government actions have been limited to a few geographies. A more global stakeholder-driven process to universalize the screening requirements is needed, which is vigilant of the emerging challenges that can circumvent the existing regulations. Here, the Global DNA Synthesis Mapping project of IBBIS could play a crucial role by providing a comprehensive picture of global DNA synthesis screening and regulatory landscape. 52 This could be followed up by efforts to encourage voluntary adoption of DNA synthesis screening by industry and government actors worldwide, with special emphasis on LMICs. The future challenges include potentially embedding DNA screening requirements into Biological Weapons Convention review processes, the WHO frameworks and the Australia Group protocols, and to encourage regional and national authorities to adopt binding screening measures.
Analysis of the Case Studies for Stakeholder Engagement
Table 1 lists major highlights across case studies for stakeholder engaged, strengths of the engagement, and limitations and gaps. Additionally, there are several significant observations from the 4 case studies. First, complementarity of the stakeholders that could be best utilized in a collaborative format when the interests align. For example, the industry’s technical powers combined with the academia’s independent risks assessment capabilities and civil society’s advocacy provides a strong push for gene synthesis screening. Second, there are several structural gaps in the stakeholder strengths and engagements. For example, government and international organizations often struggle to keep pace with rapid innovations such as the development of AIxBio tools. Similarly, the most active academic and civil society actors are concentrated in high-income countries requiring initiatives like Youth for Biosecurity to help bridge the gap. Third, AIxBio Global Forum and Nucleic Acid Synthesis Screening case studies demonstrate that multistakeholder dialogues can help develop norms as they prefigure formal regulatory standards, especially as multilateral treaties lag behind. Fourth, the GHSA APP3 Agenda and Youth for Biosecurity case studies demonstrate that platforms with broad and inclusive representation could generate greater stakeholder trust, which can contribute to their long-term legitimacy.
Comparative Analysis of the Case Studies for Stakeholder Engagement
Abbreviations: AI, artificial intelligence; BWC, Biological Weapons Convention; EU, European Union; IBBIS, International Biosecurity and Biosafety Initiative for Science; IGSC, International Gene Synthesis Consortium; IHR, International Health Regulations; ISO, International Organization for Standardization; LMICs, low- and middle-income countries; NGO, nongovernmental organization; NTI, Nuclear Threat Initiative; UN, United Nations; UNODA, United Nations Office for Disarmament Affairs; WHO, World Health Organization.
Analysis of Stakeholders’ Strengths and Limitations
Next, we analyzed the major strengths and limitations of the biosecurity stakeholders to better understand the existing complementarities, gaps and challenges. Table 2 shows diverse biosecurity stakeholders categorized into 6 major categories: government, academia, industry, civil society, professional associations and international organizations. Each stakeholder has unique strengths and limitations, which calls for collaborative efforts as no single stakeholder can address biosecurity challenges alone. However, while stakeholders’ interests often converge and they have overlapping objectives, different mandates, resources, and capabilities can complicate joint efforts. Further, there are large geographic variations in resources and capabilities among stakeholders. Other factors limiting the joint efforts include the coordination and communication gaps within and between stakeholder groups. Another major observation is the rapid pace of technological developments, making it difficult for stakeholders to quickly develop best practices, norms, and regulations. Finally, the enforcement and compliance are limited for even the existing few norms, standards, and regulations.
Major Biosecurity Stakeholders Key Strengths and Limitations
Abbreviations: FAO, Food and Agriculture Organization of the United Nations; GHSA, Global Health Security Agenda; NGO, nongovernmental organization; UN, United Nations; UNODA, United Nations Office for Disarmament Affairs; WHO, World Health Organization; WOAH, World Organisation of Animal Health.
Policy Recommendations and Practical Steps
Establish a Multistakeholder Coalition for the Biological Weapons Convention
As observed in the case studies and stakeholder analysis, there is a great degree of complementarities among stakeholders, which could be leveraged with formation of coalitions. There are already examples of issues-specific coalitions such as the AIxBio Global Forum and IGSC. Additionally, the coalition for the Chemical Weapons Convention (CWC) can serve as a template for the biosecurity community to come together and engage with a broad range of stakeholders to supplement national and multilateral efforts. 73 The CWC coalition was founded when several NGOs came together to establish an informal global network to encourage the participation of diverse stakeholders in official CWC meetings. A similar initial model could be explored for a BWC multistakeholder coalition based on availability of pooled resources from different stakeholders. 74
An international multistakeholder coalition of stakeholders such as academia, civil society, professional associations, and industry representatives could complement and supplement the efforts of governments and multilateral institutions in strengthening biosecurity around the world while working as an informal global network. It is important to acknowledge that in addition to issue-based coalitions, there is a BWC NGO coordinator who prepares and presents NGO statements at the BWC official meetings after consulting with relevant NGOs worldwide.13,74 However, the exchange of information is not systematic, often resulting in duplication of efforts and important gaps, and lack of substantial collaboration impedes its full potential. In this case, a multistakeholder coalition would provide a platform for different stakeholders to discuss their perspectives and focus areas, share their expertise and learnings, build partnerships, and promote best practices and standards in biosecurity. Such a coalition could bring much-needed synergy to the efforts of different stakeholders by prioritizing, reducing redundancies, and optimizing resource utilization. This coalition could facilitate national, regional, and global multistakeholder events to enhance the understanding of differences in priorities, strengths, concerns, limitations, terminologies, and timelines among stakeholders.
The process to develop a coalition could be long and complicated based on the format, priorities, and resources available. It could be a formal or informal coalition and can have a secretariat and host organization based on the community’s interest. Briefly, developing a formal and sustainable global coalition would require a reputed and neutral international organization, academic institution, or civil society organization to volunteer to serve as host and secretariat, which would be coupled with securing seed funding from governments, philanthropic organizations or civil society organizations. A small steering committee with diverse stakeholder representation could create draft terms of references to share for review and feedback by the broader global community. This could be followed by an inaugural summit to invite key stakeholders to finalize the terms of reference and charter as well as to appoint a governing board, initial leadership team and an advisory board. An executive team could then be hired based on the priority decided by the stakeholders and funds available. The coalition could then create multistakeholder working groups on specific topics and develop online workspaces for continuous information exchange. Here, a model similar to Collaboratory, an initiative of the WHO Hub Pandemic and Epidemic Intelligence, could be explored. 75 The coalition could also publish regular newsletter and post on social media about working group outputs, partnership opportunities, training resources, and relevant funding sources.
Develop Partnerships for Education, Training and Communication
The case study on the Youth for Biosecurity initiative highlights the importance of education and training. Training workshops, courses, and certifications should be promoted in partnership with academics, funding agencies, professional associations, and civil society that align with their areas of focus and expertise. Further, academic institutions could be engaged to develop and introduce study modules in their curriculum focusing on disarmament, biosafety, biosecurity, dual-use research, and gain of function research. 25 These courses and workshops could utilize more interactive and engaging pedagogical methods such as e-learning tools, simulation-based activities, case studies, and scenario exercises in partnership with civil society organizations, academia, and professional associations.75,76 Here, the partnership could be explored with the UN agencies, regional organizations, and industry for sharing resources and best practices. Special attention in these efforts should be given to countries and regions that currently have limited capacity and expertise or to countries and regions that have the highest biosecurity risks. Concentrating training resources on regions with the highest risks could also foster international partnerships that strengthen global biosecurity efforts. The effective implementation would require development of curriculum for training and university courses. Further, “train the trainer”-type of workshops and courses could be developed along with online interactive curriculum to increase the reach of biosecurity education. 77 Partnerships with military and security leaders could be explored for training and preparedness as they generally have core expertise in these areas, which could be translated to develop biosecurity training and preparedness exercises.
Similarly, the case studies on AIxBio Global Forums and GHSA demonstrate the importance of effective communication among stakeholders. There should be concerted efforts to develop communication strategies and methods that target different stakeholders based on their priorities, strengths, and limitations. For example, open and transparent dialogues with industry should be established to build trust and understanding and foster greater cooperation in strengthening biosecurity. On the other hand, partnerships with academia, civil society, and professional associations could be explored for activities such as public awareness campaigns, social media campaigns, and advocacy efforts based on their expertise and scope of work. Such partnerships could also focus on developing and utilizing innovative communication tools such as infographics, cartoons, card games, podcasts, and short movies. 78 Lastly, effective stakeholder engagement strategies would be developed to build trust with the general public and communicate during a crisis especially to counter misinformation and disinformation.
Promote and Popularize Standards, Certifications and Codes of Conduct
The AIxBio Global Forum and Nucleic Acid Synthesis Screening case studies underscore the importance of development and promotion of best practices, norms and standards. Here, engagement with biosafety associations (for technical validation), with science academies (for normative support), and industry consortia (for practical implementation) could be explored for promoting these norms and standards. Here, the harmonized promotion could address the uneven awareness in academia, industry and civil society. Biosafety associations and science academies could be engaged to create, harmonize, and popularize professional certification in biosafety and biosecurity. Here, the existing certifications by ABSA International and the IFBA could be further promoted, and other biosafety organizations could be encouraged to start their own certification programs.
Regional organizations and civil society could also be engaged to promote frameworks, codes and standards such as the WHO Global guidance framework for the responsible use of the life sciences, 67 the Tianjin Code of Conduct for Scientists, 79 and the Laboratory Biorisk Management Standard 35001:2019 from the International Organization for Standardization (ISO). 80 Here, it would be crucial to build partnerships to promote them through communication channels, social media, academic events, and bilateral and multilateral meetings on biosecurity. Implementation would also require comparison of existing frameworks and standards to identify overlaps and gaps, which could be followed by development of recommendations for different stakeholders and labs at different biosafety levels. Proactive engagement with governments and funding agencies would be needed to introduce adhering to standards and certifications as compliance requirements in research and development.
Establish Common Resource Center
The case studies underline the value of sharing resources among stakeholders as it would reduce duplications, facilitate expertise sharing, and fasten the policy and norms development process. A common online resource center could be created that combines and complements existing resource directories by governments, NGOs, academics, and international organizations. Such a resource center could have details of biosecurity-relevant publications, online courses, certification, national implementation tools, legislative tools, guidelines and best practices, case studies, and official documents. It could also provide a more detailed list of stakeholders active at the national, regional, and global levels. It would need to be regularly updated based on input from different stakeholders and the creation of new resources. Once the resource center is launched, it could be promoted through various channels, such as emails, newsletters, social media, and stakeholder websites.
The existing resource centers like the UNODA BWC “Think Zone,” 74 Global Biolabs, 81 “Map of Biosecurity Landscape,” 10 and “Biosecurity Central” 82 could also be expanded or integrated with moderated community access for developing a global resource center. Different stakeholders could have different roles in developing a global resource center. For example, academia could curate bibliographies, civil society provide case studies and ground-level data, professional associations index certification and training programs, industry share its best-practices and norms, and international organizations provide policy and governance resources. Implementation would require convening a steering committee with balanced stakeholder representation during a biosecurity event to kick start the process of linking and expanding existing resources on an open platform. This committee could slowly expand, while agreeing on content categories, quality criteria, update protocols, and review processes for the resource center. Long-term sustainability would require a neutral entity to host the research center and volunteer “curators” from different stakeholder groups to manage the sections and update new resources.
Ensure Balanced Age, Gender, and Geographic Representation
The case studies on Youth for Biosecurity and AIxBio Global Forum highlight the importance of diverse and inclusive representation in biosecurity discussions. Historically, several biosecurity deliberations have witnessed imbalanced demographic participation with certain geographies, youth and women being underrepresented. 83 Some of the major reasons for this include the lack of awareness, training, resources, and political agency for these groups. Here, partnerships should be developed to enable these groups to be part of the biosecurity discourse. Partnerships with the civil society, academia, youth and gender groups, and regional associations could play a crucial role in bringing these voices to the table. One commendable effort in this direction is the recently established ASEAN Women’s Network for Biosafety and Biosecurity that aims to empower local women to contribute to biosecurity. 84
Such partnerships and networks could focus on raising awareness, providing training and funding support for their participation. Industry and philanthropic organizations could be engaged to provide them with financial assistance for participation in important biosecurity meetings. Further efforts would be needed to connect them with the national, regional, and global networks and platforms. Other implementation steps would involve pairing junior participants with senior mentors across stakeholder groups for guidance and support during biosecurity meetings. Lastly, some of the important biosecurity meetings could also be hosted at the underrepresented regions to ensure more regional participation.
Conclusion
To reduce biosecurity risks and strengthen the BWC, a more integrated, collaborative approach among stakeholders is required. The involvement of diverse actors discussed in this study provides complementary strengths, as each stakeholder group brings unique expertise, resources, and perspectives. Effective communication and understanding of priorities, strengths, and limitations among stakeholders is vital to transparency and building trust. It involves clear, consistent, and accessible information being provided to all relevant stakeholders. Collaborative initiatives of existing organizations and multistakeholder networks can assist in recognizing potential risks, formulating thorough policies, and guaranteeing that biosecurity measures are both practical and inclusive, thereby contributing to establishing a more resilient system. This study discusses 4 case studies to demonstrate how multistakeholder initiatives can build normative consensus and fill capacity gaps, while promoting diverse and inclusive representation. The stakeholder mapping underlines the comparative strengths of each stakeholder group, while also discussing communication and coordination challenges.
Building on these insights, the study proposes 5 recommendations that could help strengthen biosecurity. Here, the methodology integrated desk research, open-source data collection, and multiple case study analysis along with the firsthand experience of the authors in several biosecurity initiatives to develop the recommendations and implementation steps. This study also provides insight into the challenges and opportunities faced by different stakeholders and future activities, including professional certification, mentorship programs, and community-led initiatives that could provide support. Further, it is important to note that not all stakeholders have sufficient knowledge of advanced biosecurity technologies, leading to disparities in preparedness and existing frameworks. Engaging diverse multiple stakeholders requires understanding cultural differences towards the risks posed by emerging threats, leading to varying approaches to biosecurity.
Addressing these gaps requires fostering open dialogue, building trust, and developing comprehensive frameworks that consider the diverse needs and perspectives of all stakeholders involved in biosecurity. This study demonstrates that collaborative efforts, shared resources, capacity building, and effective communication among stakeholders can help address biosecurity challenges. In summary, the capacity to mobilize a cohesive multistakeholder action is essential as the technological advancements and shifting geopolitical landscape drive the changes in the nature and scope of biological threats. The future of biosecurity depends on our ability to create a collaborative, transparent, and well-integrated system that leverages the expertise, resources, and dedication of all relevant actors.
Footnotes
Acknowledgments
We would like to thank Dr. Sarah Carter for her valuable feedback that helped improve the article before submission. We acknowledge the Asia Centre for Health Security, National University of Singapore, and the Emergent Ventures, Mercatus Center, George Mason University for their funding support.