Building our Biofuture: Policy issues and opportunities for next generation biotechnologies

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Global Forum on Technology

Building our Biofuture

Event summary

Building our Biofuture: Policy issues and opportunities for next generation biotechnologies

22 April 2024

Note from the Secretariat

This document provides a summary of the panel discussions at the OECD Global Forum on Technology (GFTech) event “Building our Biofuture: Policy issues and opportunities for next generation biotechnologies” [DSTI/DPC/STP(2024)2] held on 22 April 2024 in the margins of the OECD Scientific and Technological Policy Committee (CSTP) meeting at the Ministerial level at the OECD Headquarters in Paris, France. This event summary has been drafted by Douglas Robinson and Daniel Nadal of the OECD Secretariat and reviewed by speakers. The opinions reflected below are those of the speakers and do not necessarily reflect the views of the OECD and its Committees.

Over 200participants,includingseniorpolicymakersattheMinisterlevel,frontlinenatural and social scientists, industrial actors and civil society – covering over 50 countries –attended the event onsite and online. The Secretariat wishes to thank the moderators and speakers, as well as the participants, for making the day’s discussions extremely engaging.

Synthetic biology promises a revolution across many sectors and is already providing breakthrough innovations for current and future global challenges. This event aimed to deep dive into the promise of next generation biotechnologies, the associated policy challenges and the opportunities to address them. It builds on the work of the GFTech expert focus group on synthetic biology - which brings 65 experts from governments, academia, industry and non-governmental organisations from 32 countries across 5 continentstocollect insights andprovideevidence onthetechnical,social andpolicyissues facing synthetic biology – whose insights helped shaped the event agenda and content, and to which many of the speakers belong.

Following opening remarks by high-level policymakers on the role of policy and international collaboration, as well as an industry keynote on the promise of synthetic biology, the discussions moved to 4 panels under Chatham House Rule to deep dive into four key areas of synthetic biology: human health, agrifood and environment, anticipatory governance and responsible innovation, and sustainable production. A final session collected closing remarks from selected speakers and attendees, highlighting what they found the most striking from the day’s discussions and how to take the conversation forward.

Launched at the December 2022 OECD Digital Economy Ministerial meeting, the OECD Global Forum on Technology is a venue for regular in-depth dialogue to foresee and get ahead of long-term opportunities and risks presented by technology. It facilitates inclusive, multistakeholder and values-based discussions on specific technology policy topics, responding to gaps in existing fora. Its outputs feed OECD policy discussions and can lead to the development of analytical work, standard-setting, and policy recommendations.

More information about the GFTech and its events is available at http://oe.cd/gftech. More information about the Building our Biofutures event, including the recordings of the public sessions, is available at https://www.oecd-events.org/gftech-building-our-biofuture

Executive Summary

In the face of growing global societal challenges, from climate change to health and food crises, biotechnology has positioned itself as a powerful motor to tackle them by revolutionizing a range of sectors, from healthcare to agriculture to manufacturing. In fact, speakers shared examples of how it is already providing game changing solutions to treat infectious and non-communicable diseases, improve environmental health and enable industry’s shift to sustainable biomanufacturing. Its convergence with artificial intelligence, big data and automation was seen as further expanding the boundaries of what ispossibleandrapidlyacceleratingthepaceofinnovation.Thekeynoteaddress highlighted that synthetic biology is expected to be as impactful as the digital revolution

A growing number of governments - realizing the potential of bioeconomies - are establishing strategies to support this transition Developing national biomanufacturing capacity and scaling were identified as the biggest bottlenecks, with speakers calling for policies promoting further foundational research, addressing imbalanced subsidies for fossil-based and bio-based products, and building a skilled workforce. Additional solutions proposed in the panels include integrating traditional knowledge and modern biotechnological techniques, as well as maximising data sharing via policies and investments into trusted networks, infrastructures and harmonised standards.

Panelists agreed the key to the transition’s success will be how the positive innovation synthetic biology could bring is balanced with mitigating the risks it carries as a dualusetechnology (suchas biosafetyandbiosecurity). They suggestedthereisa pressing need for soft law approaches and robust regulatory frameworks that keep pace with rapid technologicaladvances,withthegoalofspeedingupimplementationwhilst ensuringsafety and efficacy. By incorporating anticipatory governance - which integrates foreseen risks, new scientific knowledge, and societal values into decision-making processes –speakers argued actors can stay ahead and adapt to novel advancements.

Echoing one of the three cross-cutting themes of the GFTech, the discussions agreed the promise of emerging technologies like synthetic biology can only be achieved if they bridge societal divides. For example, infrastructure development in low-resource settings could help local researchers participate in technological advancements or the rapid scaling and deployment of innovations to reachthose that need it as quickly as possible -especially important when lives are at risk. Inclusive conversations with the broadest range of stakeholders were deemed essential to understand how to tackle existing barriers and ensure equitable access. This included engaging the public: education efforts and meaningful two-way communication about the promises and risks of synthetic biology can help build trust and bring them on board, empowering them to participate in inclusive decision-making processes and shape R&D agendas to ensure science tackles local challenges and needs.

A recurrent theme throughout the day was that global challenges and global solutions require global conversations. Cross-border collaboration and evidence-based strategic dialogues were deemed critical to foster agreements on the values guiding technological advancements, as well as foster practical measures like common standards, guidelines and capacity building which are critical for technology to develop and deliver solutions. Speakers welcomed international organisations like the OECD acting as knowledge hubs and norm-setters to generate concrete recommendations, and venues like the Global Forum on Technology bringing actors together to facilitate these discussions.

Table 1.1. Panellists

Box 1.1. Key Insights

• Biotechnology's potential as a powerful ally: Aligning technological advancements with societal challenges, like climate change or the food crisis, showcases their great promise in tackling them and revolutionizing all sectors, from healthcare to agriculture to manufacturing, but mitigating risks remains a priority.

• Building governmental anticipatory capacity: To help policymakers keep regulations up to date with rapidly evolving technologies - in times when they are often focused on daily emergenciesthey need strategic intelligence. Governments have a role in investing in infrastructure and research to promote technological development, but they also need to invest internally to ensure they can process trusted advice and enforceable policies.

• Tackling global divides: The promise of STI to dynamically transform societies can only be fulfilled if emerging technologies do not deepen existing societal divides. Inclusive conversations

with the broadest range of stakeholders are needed to ensure equitable access to the technology and its benefits.

• The key role of international collaboration: Given the cross-border nature of biotechnologies and their implications, global evidence-based strategic dialogue is a must, with international organisations acting as knowledge hubs and norm-setters to generate concrete recommendations.

OECD DeputySecretary-General Vestergaard Knudsen welcomedparticipantstothe event by highlighting the value of the GFTech as an inclusive, multistakeholder forum to discuss the opportunities and risks presented by emerging technologies and help policymakers stay ahead. It is designed to prepare for new technology developments through a multidisciplinary approach that aligns emerging technologies with shared values, promotes growth, well-being, and sustainability, and ensures responsible, values-based development to build necessary trust.

Aligning technological advancements with societal challenges, like climate change or the food crisis, showcases the technology's potential as a powerful ally in the fight against grand societal challenges. New biotechnologies hold great promise to tackle these issues andrevolutionizeall sectors, andinfact,itsbenefitscanalreadybeseeninthedevelopment of new treatments against infectious diseases, reducing carbon emissions by developing synthetic meats, or fostering sustainable manufacturing using biobased feedstocks. However,biosafety and biosecurityrisks remain,andthus necessitatea credibleandtrusted risk analysis system.

As policymakers, panellists shared the challenge of making regulations that can stay up to date with constantly evolving technologies, finding the balance between ensuring the highest standards of consumer and environmental protections whilst promoting innovation is essential. Acknowledging government’s role in investing in infrastructure, research funding and supporting start-ups, they also raised the need to build intra-governmental capacitytounderstandthetechnologyanddevelopenforcement abilities. Anticipationwas deemed key, although difficult for policymakers as they are often required to deal with day-to-day emergencies. As Aisén Etcheverry Escudero, Minister of Science, Technology, Knowledge and Innovation for Chile, said “We are facing contingencies, we are facing emergencies, we are facing a world that is changing extremely fast […] but we need to incorporate within all those tasks the capacity to anticipate.” The value of fora like the GFTech was clear, in fostering expert discussions and providing much needed strategic intelligence to governments to guide values-based technology development.

One of these key values, and a tenet ofthe GFTech, is the importance of addressing digital divides. The promise of science and technology to dynamically transform societies can onlybefulfilledifemergingtechnologiesdonot deepenexistingsocietaldivides.Toensure an equitable transformation and access to the technology and its benefits is provided across the world, speakers stressed the need to involve all stakeholders in governance conversations, and to consider questions on technology transfers, knowledge sharing and guiding technology development to address the needs of all communities. In the words of Mohammed Belhocine, Commissioner for Education, Science, Technology and Innovation at the AfricanUnionCommission: “Collaboration is an all-inclusive undertaking that must cover the broadest compass of stakeholders.”

Speakers also agreed on the importance of international partnerships and evidencebased strategic dialogue to deal with the challenges of technology governance, especially given their cross-border implications. As Kitipong Promwong, President of the Office of National Higher Education Science Research and Innovation Policy Council (NXPO) in

Thailand said, “The challenges we face today cannot be tackled by any single nation alone; they demand collaboration on a global scale.” The role of international organisations as knowledge hubs and norm-setters was seen as essential to foster this collaboration. Speakers supported the GFTech in creating a space for these discussions and looked forward to concrete outcomes which countries could leverage to improve their technology governance capacities.

2. Keynote Address

Table 2.1. Speaker

Box 2.1.

Key Insights

• Synthetic biology could be as impactful as the digital revolution: A growing number of governments, realizing the potential of bioeconomies - to transform all sectors, tackle grand challenges like sustainability and drive economic growth – are developing strategies to foster this transition.

• Convergence is accelerating research: Lab automation, cheaper DNA synthesis and gene editing tools are transforming the way scientists carry out research and expanding the boundaries of what is possible, drastically accelerating the pace of innovation.

• AI as a gamechanger: Digital tools like GenAI and Large Language Models are revolutionizing synthetic biology, but the key is training them with as much data as possible. New genetic material, better understanding of gene functionalities, and automation can help provide new data sources.

• Developing national bioeconomy and biosecurity capacity: As a key infrastructure underpinning the bioeconomy, countries need to develop flexible biomanufacturing capacity at scale domestically, focusing on multi-purpose facilities that can be leveraged during emergencies. Governments should also learn from COVID and developed stronger detection and attribution abilities, as well as infrastructure for faster medical countermeasure responses.

The transition to bioeconomies promises to transform all sectors, tackle global social challenges, and drive sustainable economic growth. Given its potential role in helping meet carbon emission reduction targets, increase the resilience of supply chains, enhance food security,andreducerelianceonfossil fuels,itisexpectedtobe asimpactfulasthecurrent digital revolution. In fact, estimates state it could create a direct economic impact of 2 to 4 USD trillion in the next 10 to 20 years. Many governments (like the United States, China and Japan) as well as the EU, are realising the potential of synthetic biology and have started setting out dedicated strategies and action plants to foster the transition. The full promiseof synthetic biologyis accelerating due toits convergence witha series of technologies, which is transforming the way scientists carry out research. Firstly, increasedlaboratoryautomation isbreakingthelimitsofhand-designedexperimentation, increasing the number of tests and data that can be generated. By using plug-and-play frameworks, instruments can be used in a reconfigurable fashion to set up new workflows

Reshma Shetty
Chief Operations Office and Co-Founder
Ginkgo Bioworks

faster,allowingscaleandflexibility.Secondly,withtheadvent DNAsynthesis,researchers no longer need direct access to natural genetic material and can instead synthesize the required sequences in their lab using only the genetic code. Paired with gene editing tools like CRISPR, the DNA can then be edited and inserted into any organism, unlocking new realms of research. Thirdly, the pace at which these sequencing and synthesis technologies are becoming faster and cheaper is enabling unprecedented genomics-scale biological learning.

Lastly, the convergence of synthetic biology with artificial intelligence tools like GenAI and Large Language Models has been a gamechanger. Current limits are set not so much by the AI models themselves but by the data available to train them, and in this regard,therearestill manydatasourcesthat haven’t beentakenfull advantage of,including new genetic material in the natural world and better understanding of gene functions. Combined with lab automation, there is unlimited potential.

Platform companies like Ginkgo aim to empower the health, agriculture, and manufacturing industries to take full advantage of these technologies by outsourcing R&D and further accelerating the rate of innovation. They have amassed a huge database of strains and genes to train their AI models, as well as the computing power to do so. With the insight gained from being a leading company in the synthetic biology field, Ginkgo shared several recommendations for policymakers to make the most of the bioeconomy.

Countries need to develop flexible, domestic biomanufacturing capacity at scale. As a key infrastructure that underpins the bioeconomy, it should be considered a national asset, especially in order to secure future supply chains. Previous public and private efforts have developed single-purpose facilities, but going forward governments should think with foresight about multi-purpose ones - for example, to be used during pandemics to manufacture vaccines but which in normal times can be used by SMEs. Another recommendation relates to biosecurity: whether biological threats come from nature, from an accident in the lab, or as intentional attacks, governments have a role to play in developing defensive capacity. Learning from the COVID experience, this includes detection and attribution (such as disease monitoring networks) and infrastructure for rapid medical countermeasure response.

Table 3.1. Panellists

Name

Delphine Thizy (Moderator)

Stakeholder Engagement and Policy Consultant

Outreach Network for Gene Drive Research

Krystal Mwesiga Birungi Field Entomology Coordinator Target Malaria

Livija Deban

Chief Scientific Officer

David Del Bourgo CEO and Co-Founder

Marc Güell

Prokarium

WhiteLab Genomics

Chief Scientific Officer & Professor Integra Therapeutics & University of Pompeu Fabra

Judith Collins (First Intervenor) Minister for Science, Innovation and Technology

Belgium

Uganda

United Kingdom

France

Spain

Government of New Zealand New Zealand

3. Human Health Innovation and Resilience

Box 3.1. Key Insights

• Health revolution: Synthetic biology can help develop novel treatments for infectious diseases like malaria and non-communicable diseases like cancer. Its convergence with new technologies, such as data and AI, can further accelerate the development and implementation of new medical solutions.

• Agile regulatory frameworks across borders: There is a pressing need to update regulatory frameworks to keep pace with and integrate technological advances, providing legal clarity for developers and speeding up implementation whilst ensuring safety and efficacy. Given the transnational impact of diseases and cross-border synthetic biology solutions, is crucial to have strengthened global collaboration and consistency in regulations across borders.

• Infrastructure development: Particularly in low-resource settings, this can support the rapid deployment and scaling of health innovations to reach those that need it the most as quickly as possible, especially important when lives are on the line.

• Public engagement to foster trust: Transparent communication, education efforts and inclusive decision-making processes are essential to have the public support novel technologies and ensure speedy implementations. A balance should be maintained between rapid innovation and thorough ethical considerations, including the impacts on ecosystems and communities.

Health underpins every aspect of our well-being. The discussion centred around how synthetic biology technologies can be applied in healthcare settings to improve patient outcomes and save lives, if we address the technological, regulatory, infrastructure and social challenges.

Malaria is a major health issue in many tropical regions, particularly in sub-Saharan Africa wheremillionsoflivesarelostannuallytothedisease.Onepotential approachis tocombat malaria with synthetic gene drives: genetically engineering mosquitoes are released into theenvironmenttomatewithwildpopulationsandspreadgeneticmutationsthatbiasfuture mosquito populations towards males (which do not bite and transmit malaria) or reduce female fertility (decreasing mosquito populations and interrupting malaria transmission), thereby significantly reducing disease incidence. Despite its promise, it has been difficult to move this technology outside of the lab. Speakers highlighted as the main issue the lack of regulatory frameworks for gene drives, which are newer and more dynamic than traditional genetic modifications. This is especially difficult given the cross-border impacts of modified mosquitoes, and thus consensus and international cooperation are essential to move towards implementation. However, this is hindered by misinformation and public resistance, which in turn calls for further public engagement and education.

These challenges are echoed in other potentially revolutionary applications of synthetic biology shared by speakers. Genetically engineered pigs can be designed to grow human-compatible transplant organs, addressing one of the most critical shortages in healthcare, significantly reducing waiting times for transplant patients and potentially increasing success rates due to improved compatibility. Skin bacterial communities can be genetically engineered to treat skin conditions by delivering therapeutic agents directly to the skin. These treatments could be more effective and less invasive than chemical-based therapies, improving patient outcomes and potentially reducing healthcare costs associated with long-term treatment strategies. However, regulatory barriers remain - demonstrating safety and efficacy of such novel approaches is difficult - and obtaining public acceptance is crucial. Ethical concerns, such as the welfare of genetically modified

pigs and the broader implications of using animals as organ sources, also need to be considered.

Another promising application presented by speakers was the use of synthetic biology to develop "living cures" for cancer: engineered bacteria to deliver therapeutic agents directly to tumour cells. These could revolutionise cancer treatment by enhancing the safety and precision of therapy delivery, reducing side effects associated with traditional chemotherapy that often also damages healthy cells. It also aims to make cancer treatments more accessible and affordable, particularly by enabling decentralised manufacturing processes that reduce transport times and costs. Regulatory hurdles are again a challenge, as well as establishing the infrastructure for such distributed manufacturing (especially in low-resource countries) and the need for extensive clinical trials to ensure safety and efficacy. The high cost of research and development can also impede the rapid deployment of these therapies.

A key enabler of these and further synthetic biology research is its convergence with data and AI. For example, AI can analyse vast amounts of genomic and multi-omic data to identify optimal drug targets and design therapeutic agents tailored to individual patients’ specific genetic profiles, making them more effective and with fewer side effects. It can also significantly accelerate the drug discovery process, making it faster and less expensive to bring new drugs to market. Speakers highlighted the challenges of ensuring high quality and standardised genomic and phenotypic data, which can often vary widely and can affect the outcomes of AI analyses. Regulatory issues arise with regards to data privacy and the ethical use of genetic information, necessitating secure and compliant data handling practices to protect against potential misuse.

4. Agrifood and Environmental Resilience

Table 4.1. Panellists

David Winickoff (Moderator) Senior Policy Analyst

Eriko Takano Professor of Synthetic Biology

Halima Benbouza Director for Science and Technology

Zaira Lanna Strategy Director

Jens Lundsgaard Deputy Director, Directorate for Science, Technology and Innovation

Joonho Keum CEO

Melis Kocatürk (First Intervenor) Head of Unit, STI Policy

OECD

N/A

Manchester Institute of Biotechnology, University of Manchester United Kingdom

National Council of Scientific Research and Technologies Algeria

Emerging Ag Brazil

OECD

N/A

SeaWith, Inc. Republic of Korea

TÜBİTAK Turkey

Box 4.1. Key Insights

• Enabling environmental sustainability: Synthetic biology can play a key role in a transition of agriculture and food production towards less claim on land, thereby leaving more room for nature. Genetically modified organisms (GMOs) and synthetic microbial communities can be leveraged to enhance soil health and agricultural productivity, aid in conservation efforts, and reduce

environmental impact of food production by developing alternatives like cultured meat to reach net zero targets.

• Regulatory barriersforenvironmentalrelease:SolutionsinvolvingGMOsreleasefaceextensive regulatory hurdles fragmented across jurisdictions. Agile regulatory frameworks (incorporating anticipatory governance) and scientifically sound case-by-case risk assessments are needed to address risks early in the technology development cycle to ensure safe yet speedy implementation to realise their many benefits.

• Dialogues to address social reticence: Ethical concerns, sometimes due to lack of understanding or misconceptions, are slowing down the application of GMOs. To build trust and bring the public on board, we need to empower them to shape R&D agendas to ensure science tackles local challengesandneeds.Forthis,weneedtransparentandopencommunication,two-way engagement, and education initiatives that raise awareness about the promises and risks of synthetic biology, as well as the potential impacts.

• International partnerships: Global dialogue is needed to foster practical measures like common standards, guidelines and capacity building that support technology development and implementation - particularly for technologies that cross borders - but also to promote equitable access to biotechnologies and its benefits across all countries.

In the face of the growing food and climate crises and deteriorating soil and environmental health, urgent measures are needed to combat these trends. The discussion focused on the role of synthetic biology in achieving environmental sustainability. In agriculture and food production, for example, engineered microbial communities can enhance soil health to in turn improve agricultural productivity and broader environmental health. Bioengineered crops can also revolutionise current practices by increasing efficiency and sustainability of farming, leading to less claim on land and thus more room for nature. Culturedmeatcanbeasustainablealternativetotraditionalmeat productiongivenitslower environmental impact. Gene drives can potentially be used in conservation efforts to control invasive species and preserve biodiversity, particularly in island ecosystems. These examples showcase synthetic biology’s role in reversing biodiversity loss, improving carbon management and enabling a bioeconomy that achieves environmental sustainability and net-zero targets.

However,ethical,social, and regulatory challengesremain whichmust betackledto realize the benefits. Regulatory and commercialization hurdles, particularly when introducing GMOs into the environment, are extensive and fragmented across jurisdictions.Speakerscalledforincreased clarityandinteroperabilitybetween regions,but recognized this is understandably difficult in industries such as lab-grown meat where the lack of common approaches or guidelines means every company may have different production methods, or in the case of gene drives where risk assessment must be on a caseby-case basis according to the type of constructs or uses.

Basedontheseidentifiedpromisesandchallenges,speakersoffered severalideasforpolicy solutions. They agreed on the need for making regulatory frameworks more agile to foresee technological advancements and evolve with them, preventing legal and ethical barriers. For this, anticipatory governance frameworks would be key – mobilising strategic intelligence such as the use of horizon scanning and forward-looking technology assessment – in helping to systematically assess and manage the risks and benefits of emerging technologies early in the development cycle. These assessments, including regular reviews of scientific advancements and societal needs, should be incorporated into a more dynamic policy-making process that allows for timely updates to regulations.

Tackling global challenges like food security and governing technologies with transnational impacts necessitates international partnerships. Global discussions, in fora like the OECD, are needed not just for practical measures like developing common standards and guidelines for safety and efficacy in synthetic biology processes (e.g. production of cultivated meat) but also to promote common values like equitable access to using biotechnologies, especially in developing countries.

Speakers agreed that these dialogues need to go beyond experts and policymakers to also engage all affected stakeholders. This should be underscored by investments in educational programs as well as increased transparency by the scientific community, toimprove publicunderstandingof synthetic biology and itspotential positiveandnegative impacts. By making this two-way communication and welcoming the public’s view, they can be actively engaged in shaping the research and development process to align it with societal values and ethics. Not only would this ensure more buy-in for implementing synthetic biology solutions, but also that these are developed to address specific, local environmental and agricultural challenges and needs. Moreover, scientifically sound risk assessments and mechanisms for ongoing monitoring and oversight are needed to allay concerns about environmental releases and prove their safety and effectiveness.

5. Anticipatory Governance and Responsible Innovation

Table 5.1. Panellists

Isabel Webb (Moderator) Deputy Director for Technology Strategy and Security

Department for Science, Innovation and Technology, Government of the United Kingdom

United Kingdom

Fanny Ewann Specialized Officer, Bioterrorism Prevention Unit INTERPOL France

Alonso Flores Safety and Security Program Officer iGEM Foundation Mexico

Sophie Peresson University Lecturer Sciences Po France

Eefje Cuppen Director Rathenau Instituut The Netherlands

Shi'an Tay (First Intervenor) Director, Innovation, Research & Development Division Ministry of Trade and Industry Singapore

Box 5.1. Key Insights

• Balancingrisk mitigationwithfosteringpositiveinnovation:Syntheticbiology canbothincrease risks, such as biosecurity concerns, whilst also developing new tools to combat them. Fostering these positive elements whilst mitigating the risks is an ongoing governance challenge to continue discussing in future dialogues.

• Anticipatory governance to deal with fast pace of technology development: Agile regulatory frameworks - which integrate foreseen risks, new scientific knowledge and societal values into the policymaking processes - are key to adapting governance to novel advancements but must be supported by adequate resourcing and international collaboration.

• Democratize the anticipation of technology futures: Inclusive governance which engages the public can help incorporate their diverse views on synthetic biology, ensure scientific developments tackle society’s needs and address any public fears for safe and speedy implementation.

• Engage future scientists to foster a culture of responsibility: Initiatives educating future scientists to prioritize safety and security are crucial to ensure the technological developments of tomorrow follow responsible innovation principles.

Previous panels illustrated the potential for synthetic biology solutions to revolutionise key sectors, but only if proper governance structures are set in place that encourage beneficial applications whilst preventing misuse. This discussion explored open questions on how to achieve this balance to foster responsible innovation, which remains a significant governance challenge and thus needs to be part of ongoing dialogues within the synthetic biology community.

Biosecurity is a prime example of this balance. Given the dual-use nature of synthetic biology and thus its potential to be exploited by criminals and terrorist networks, concerns around biosecurity are often top of mind. At the same time, synthetic biology can also be leveraged to tackle some of these risks. Tools like reverse engineering genetic modifications have been integrated by law enforcement agencies to improve forensic capabilities, allowingformore effective crime solvingand prevention, and enhancing these agencies’ ability to respond to biological threats and criminal activities, thereby increasing public safety and security.

The fast pace of technological developments presents a challenge for policy frameworks, which need to be adaptable and rapidly integrate new scientific knowledge and societal values. Speakers strongly advocated for anticipatory governance as crucial for foreseeing strategic risks and proactively addressing them, whilst also leveraging emerging opportunities. Adequate resources must be allocated to this, including investments in education, capacity building, and the development of advanced analytical tools to monitor and manage emerging risks. Given the transboundary nature of biological risks and technological impacts, there is a significant challenge but also great opportunity in fostering effective international collaboration and coordination in policymaking.

In addition, effectivegovernanceframeworksmust be aboveallinclusive.Collaborative platforms, bringing in diverse perspectives - from scientists to policymakers to the publicare key for speedy knowledge creation to feed into policy discussions. One of the speakers shared an example of a project engaging the public with the concept of synthetic cells, which aimed to gather diverse perspectives on synthetic biology's future implications. The initiativedemonstratedtothe publicthepotentialof syntheticbiology toaddresssignificant societal issues, such as health and environmental sustainability, but at the same time revealed the public's diverse and sometimes conflicting views on the technologyhighlighting fears about misuse and ethical concerns – and the risk that misconceptions can fuelconspiracytheoriesandfurtherfeedthesefears.Thisunderscorestheneedforinclusive governance frameworks that can understand the societal challenges that science needs to solve, the public fearsthat need to be addressed, and thevaluesthat needto be incorporated – to democratize the anticipation of technological futures

Since fostering responsible innovation is a long-term objective, speakers stressed the need to specifically involve the scientists of tomorrow. The synthetic biology community is fairly unique in that it annually coalesces around the iGEM Foundation's global student competitions, which prioritize and reward safety, security, and responsible innovation. By engaging young scientists, it is fostering a culture of responsibility in those who will drive future technological advancements. It also serves to illustrate the challenges of varying local regulations and capabilities in ensuring consistent safety and security

practices across all participating teams, and the need for universal guidelines that accommodate diverse international regulations and ethical standards.

6. Sustainable Production: The Bioeconomy and Beyond

Table

6.1. Panellists

Name

Christina Smolke (Introductory Talk) Co-Founder and CEO

Fiona Mischel (Moderator) Director of International Outreach

Gwenaël Servant Executive Board Member

Kittiphong Limsuwannarot President and Chief Executive Officer

Yoshiyuki Fujishima Global Chief Researcher

Michael O'Donohue Head of Division

Geoffrey Otim Founder & CEO

Box 6.1. Key Insights

Antheia Inc. United States

SynBioBeta United States

Abolis Biotechnologies France

BBGI Company Limited Thailand

Norinchukin Research Institute Japan

Industrial Biotechnology Innovation and Synthetic Biology Accelerator (IBISBA) and the French National Institute for Agriculture, Food and the Environment (INRAE) France

SynBio Africa Uganda

• Advanced biomanufacturing promises to transform production: Microorganisms can be genetically engineered to with programmable synthesis properties to produce pharmaceutical molecules. These have been proven in industrial settings to speed up production timelines, increase yields, reduce land use and costs – providing much needed resiliency, sustainability, adaptability and scalability to pharmaceutical supply chains.

• Improving industry’s sustainability: Synthetic biology can help replace petrochemicals for biobased chemicals, promote localized manufacturing that reduces carbon footprint, and enable the shift to green energy sources like biofuels.

• Scaling remains the biggest challenge: Maintaining efficiency and profitability from laboratory settings to industrial-scale production is often a bottleneck. Further foundational research is needed, as well as policies addressing the imbalance in subsidies for bio-based and fossil-based products, developing a trained workforce and start to invest in biomanufacturing capacities.

• Integrating traditional knowledge and modern biotechnological techniques: Doing so can leverage local resources and cultural heritage, revitalizing local economies. Key challenges include ensuring quality and consistency at larger scales without losing the unique characteristics of traditional products and tackling resistance from traditional sectors.

• Maximising the benefits of data sharing: Policies and investments are required, including the creation of trusted innovation networks with clear rules for data use and shared visions, digital infrastructures, and standards for quality. Foundational research and public-private partnerships are also critical.

A flourishing bioeconomy promises to enable more sustainable societies. In fact, synthetic biology is already being used as an alternative to petrochemicals with renewable biobased feedstocks being used in various fields (including cosmetics and nutrition) to

produce high-value products locally,minimizing global transportation ofintermediates and finished goods. This reduces carbon emissions and environmental degradation, promoting more sustainable industrial processes, although further efforts are needed to expand these practices, as currently much of the initial research is being done in Western economies whilst products are made in Asia and shipped back. Another shift to green business practices is the use of sustainable energy sources like biofuels. Not only does this reduce reliance on fossil-fuel sources, but biofuels can also reduce overall greenhouse gas emissions. Existing companies are already navigating this shift, showing that traditional industries can evolve to meet modern environmental standards whilst even leading to economic revitalization and job creation.

Across these examples, speakers agreed the main obstacle lies in scaling these processes from the lab to commercial scales, which often involves inefficiencies and increased costs, and maintaining economic viability of these bioproducts compared to cheaper, subsidized fossil fuels. Technological advancements are still needed to convert biological materials at a competitive cost without compromising performance. This requires continuous foundational research as well as levelling the economic playing field between bio-based and fossil-based fuels, especially in terms of subsidies, tax incentives and tax breaks.

At a global level, further public and private investments in biotech-specific facilities and systems could help develop the infrastructure for this transition. Policies developing educational programs and training opportunities are needed to equip the current and future workforcewithnecessaryskillsandensurenoregionsorstakeholdergroupsareleft behind. Additionally, rapidinnovation in bioprocess technologies requires agileregulationsto keep pace to support rapid deployment and acceptance in the market.

Japan, which has a long history of fermentation processes (e.g. in the production of traditional products like sake and soy sauce) has evolved these practices into sophisticated bio-manufacturing techniques that are now used in various industrial applications. Integrating traditional knowledge and modern biotechnological techniques can lead to innovative and sustainable production methods that leverage local resources and cultural heritage. Speakers argued that this approach not only preserves biodiversity but also promotes local economies through unique products that can be marketed globally. The main challenges include ensuring quality and consistency at larger scales without losing the unique characteristics of traditional products. Additionally, there may be resistance from traditional sectors towards modernization and commercialization, which can slow down innovation and which calls for engaging them in multistakeholder dialogues.

These biomanufacturing examples and beyond can be enhanced by converging synthetic biology with digital technologies like big data analytics, artificial intelligence and cloud computing. However, the discussion identified key issues that need to be tackled. Firstly, data sharing between players is crucial to advance research, but significant barriers exist such as intellectual property and competitive advantages. Establishing trust and a framework for data sharing is therefore key. Secondly, the shared data needs to be highquality, reproducible, and interoperable – which necessitates international efforts to promote standardization of data formats and quality control measures. Lastly, the digital infrastructure to support effective data collection, storage, and analysis should be developed. This is costly, complex, and requires robust governance systems for safety, so efforts need to be backed by policy support and investment.

Several potential approaches to this were discussed by speakers. Creating trusted innovation networks with clear rules for data use and shared visions can facilitate collaboration. A speaker provided an example of a federated network of R&D institutions across Europe, which creates potential to pool resources, share knowledge, and standardize

methodologies, thus accelerating innovation and application of synthetic biology. Sharing digital resources like data could also be an excellent entry point for further cross-border collaboration as it is easier to distribute than physical goods and can be a way of including Global South countries to avoid them being left behind in the bioeconomy. Further funding for fundamental, often overlooked aspects of scientific research (such as standardization, metrology, and quality control) can significantly improve the reliability and utility of data. Finally, public-private partnerships can fund and manage the necessary digital infrastructure, distributing costs and enhancing resource utilization.

7. International and Multistakeholder Comments

Table 7.1.

Panellists

Douglas Robinson (Moderator) Policy Advisor

Reshma Shetty President, Chief Operations Office and Co-Founder

Krystal Mwesiga Birungi Field Entomology Coordinator

Eefje Cuppen Director

Anne-Gaelle Collot Director Industrial Biotech

Aida Ponce Del Castillo Senior Researcher

Alexandros Skouris PhD Fellow

Salvatore Aricò CEO

Ginkgo Bioworks

Target Malaria

Rathenau Instituut

EuropaBio

European Trade Union Institute

Rutgers University & Youthwise (OECD's Youth Advisory Board)

United States

Uganda

The Netherlands

Belgium

Belgium

Greece

International Science Council (ISC) N/A

The event wrapped up with concluding remarks from selected speakers and the audience, hailing from a broad range of countries and stakeholder perspectives. They emphasised the transformative potential of synthetic biology to tackle grand challenges, from the climate crisis to global health, and to be an engine for economic development. The convergence with digital tools and artificial intelligence was identified as particularly promising. Immediate action at the national and international level is needed maximise these benefits - whilst remaining aware of potential risks and misuse - and save both lives and the environment as quickly as possible.

To foster a strong synthetic biology innovation industry, speakers stressed the importance of clear regulatory pathways to boost investment and market access, aligning regulation internationally and with scientific progress. Governments have an essential role to play, for example in establishing biosecurity measures to handle biological threats as industry alone cannot address this. Other key policy measures needed include standardization to enhance data reliability (crucial for integrating AI advancements), and strategic allocation of research funding. At the same time, speakers called for a nuanced understanding of what needs regulation. Comprehensive technology assessments and analytical frameworks can assess the impacts of biotechnologies, and informed democratic debate can help guide regulation and public discourse.

Echoing a theme heard throughout the day, speakers agreed collaboration and effective communication across all stakeholders are key for societal acceptance. They advocated for moving beyond traditional consultation with the public to instead engage in meaningful two-way communication that democratizes decision-making aroundresearch and technology applications, making these more transparent and incorporating ethical considerations. For example, equity and access should be front and centre to avoid

technology divides, particularly for regions most affected by the problems synthetic biology aims to solve, and tools like technology transfers should be promoted. Overall, speakers welcomed the day’s discussions and agreed on the importance of continuing these dialogues further, with key fora like the OECD Global Forum on Technology having value in bringing a wide variety of stakeholders together.

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