Dr. Megan J. Palmer is the Executive Director of Bio Policy & Leadership Initiatives at Stanford University. In this role, Dr. Palmer leads integrated research, teaching and engagement programs to explore how biological science and engineering is shaping our societies, and to guide innovation to serve public interests. Based in the Department of Bioengineering, where she is also an Adjunct Professor, she works closely both with groups across the university and with stakeholders in academia, government, industry and civil society around the world.
In addition to fostering broader efforts, Dr. Palmer leads a focus area in biosecurity in partnership with the Freeman Spogli Institute for International Studies (FSI) at Stanford. Projects in this area examine how security is conceived and managed as biotechnology becomes increasingly accessible. Her current projects include assessing strategies for governing dual use research, analyzing the diffusion of safety and security norms and practices, and understanding the security implications of alternative technology design decisions.
Dr. Palmer has created and led many programs aimed at developing and promoting best practices and policies for the responsible development of bioengineering. She currently co-chairs the World Economic Forum Global Future Council on Synthetic Biology and in a member of the Council of the Engineering Biology Research Consortium (EBRC). For the last ten years she has led programs in safety, security and social responsibility for the international Genetically Engineered Machine (iGEM) competition, which in 2019 involved over 6000 students in 353 teams from 48 countries. She also founded and serves as Executive Director of the Synthetic Biology Leadership Excellence Accelerator Program (LEAP), an international fellowship program in biotechnology leadership. She advises and works with many other organizations on their strategies for the responsible development of bioengineering, including serving on the board of directors of Revive & Restore, a nonprofit organization advancing biotechnologies for conservation.
Previously, Megan was a Senior Research Scholar and William J. Perry Fellow in International Security at the Center for International Security and Cooperation (CISAC), part of FSI, where she is now an affiliated researcher. She also spent five years as Deputy Director of Policy and Practices for the multi-university NSF Synthetic Biology Engineering Research Center (Synberc). She has previously held positions as a project scientist at the California Center for Quantitative Bioscience at the University of California Berkeley (where she was an affiliate of Lawrence Berkeley National Labs), and a postdoctoral scholar in the Bioengineering Department at Stanford University. Dr. Palmer received her Ph.D. in Biological Engineering from M.I.T. and a B.Sc.E. in Engineering Chemistry from Queen’s University, Canada.
Faculty Affiliate, Institute for Human-Centered Artificial Intelligence (HAI)
Making Security Viral: Shifting Engineering Biology Culture and Publishing.
ACS synthetic biology
2022; 11 (2): 522-527
The ability to construct, synthesize, and edit genes and genomes at scale and with speed enables, in synergy with other tools of engineering biology, breakthrough applications with far-reaching implications for society. As SARS-CoV-2 spread around the world in early spring of 2020, researchers rapidly mobilized, using these tools in the development of diagnostics, therapeutics, and vaccines for COVID-19. The sharing of knowledge was crucial to making rapid progress. Several publications described the use of reverse genetics for the de novo construction of SARS-CoV-2 in the laboratory, one in the form of a protocol. Given the demonstrable harm caused by the virus, the unequal distribution of mitigating vaccines and therapeutics, their unknown efficacy against variants, and the interest in this research by laboratories unaccustomed to working with highly transmissible pandemic pathogens, there are risks associated with such publications, particularly as protocols. We describe considerations and offer suggestions for enhancing security in the publication of synthetic biology research and techniques. We recommend: (1) that protocol manuscripts for the de novo synthesis of certain pathogenic viruses undergo a mandatory safety and security review; (2) that if published, such papers include descriptions of the discussions or review processes that occurred regarding security considerations in the main text; and (3) the development of a governance framework for the inclusion of basic security screening during the publication process of engineering biology/synthetic biology manuscripts to build and support a safe and secure research enterprise that is able to maximize its positive impacts and minimize any negative outcomes.
View details for DOI 10.1021/acssynbio.1c00324
View details for PubMedID 35176864
iGEM and Gene Drives: A Case Study for Governance.
Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.
View details for DOI 10.1089/hs.2021.0157
View details for PubMedID 35020492
- Protocols and risks: when less is more. Nature protocols 2021
Rapid Proliferation of Pandemic Research: Implications for Dual-Use Risks.
The COVID-19 pandemic has demonstrated the world's vulnerability to biological catastrophe and elicited unprecedented scientific efforts. Some of this work and its derivatives, however, present dual-use risks (i.e., potential harm from misapplication of beneficial research) that have largely gone unaddressed. For instance, gain-of-function studies and reverse genetics protocols may facilitate the engineering of concerning SARS-CoV-2 variants and other pathogens. The risk of accidental or deliberate release of dangerous pathogens may be increased by large-scale collection and characterization of zoonotic viruses undertaken in an effort to understand what enables animal-to-human transmission. These concerns are exacerbated by the rise of preprint publishing that circumvents a late-stage opportunity for dual-use oversight. To prevent the next global health emergency, we must avoid inadvertently increasing the threat of future biological events. This requires a nuanced and proactive approach to dual-use evaluation throughout the research life cycle, including the conception, funding, conduct, and dissemination of research.
View details for DOI 10.1128/mBio.01864-21
View details for PubMedID 34663091
Guiding Ethical Principles in Engineering Biology Research.
ACS synthetic biology
Engineering biology is being applied toward solving or mitigating some of the greatest challenges facing society. As with many other rapidly advancing technologies, the development of these powerful tools must be considered in the context of ethical uses for personal, societal, and/or environmental advancement. Researchers have a responsibility to consider the diverse outcomes that may result from the knowledge and innovation they contribute to the field. Together, we developed a Statement of Ethics in Engineering Biology Research to guide researchers as they incorporate the consideration of long-term ethical implications of their work into every phase of the research lifecycle. Herein, we present and contextualize this Statement of Ethics and its six guiding principles. Our goal is to facilitate ongoing reflection and collaboration among technical researchers, social scientists, policy makers, and other stakeholders to support best outcomes in engineering biology innovation and development.
View details for DOI 10.1021/acssynbio.1c00129
View details for PubMedID 33977723
- Intended consequences statement CONSERVATION SCIENCE AND PRACTICE 2021
- Exploring the intersections of governance, constituencies, and risk in genetic interventions CONSERVATION SCIENCE AND PRACTICE 2021
- Conservation science and the ethos of restraint CONSERVATION SCIENCE AND PRACTICE 2021
The CRISPR revolution and its potential impact on global health security.
Pathogens and global health
Global health security is constantly under threat from infectious diseases. Despite advances in biotechnology that have improved diagnosis and treatment of such diseases, delays in detecting outbreaks and the lack of countermeasures for some biological agents continue to pose severe challenges to global health security. In this review, we describe some of the challenges facing global health security and how genome editing technologies can help overcome them. We provide specific examples of how the genome-editing tool CRISPR is being used to develop new tools to characterize pathogenic agents, diagnose infectious disease, and develop vaccines and therapeutics to mitigate the effects of an outbreak. The article also discusses some of the challenges associated with genome-editing technologies and the efforts that scientists are undertaking to mitigate them. Overall, CRISPR and genome-editing technologies are poised to have a significant positive influence on global health security over the years to come.
View details for DOI 10.1080/20477724.2021.1880202
View details for PubMedID 33590814
Bioengineering horizon scan 2020.
Horizon scanning is intended to identify the opportunities and threats associated with technological, regulatory and social change. In 2017 some of the present authors conducted a horizon scan for bioengineering (Wintle et al., 2017). Here we report the results of a new horizon scan that is based on inputs from a larger and more international group of 38 participants. The final list of 20 issues includes topics spanning from the political (the regulation of genomic data, increased philanthropic funding and malicious uses of neurochemicals) to the environmental (crops for changing climates and agricultural gene drives). The early identification of such issues is relevant to researchers, policy-makers and the wider public.
View details for DOI 10.7554/eLife.54489
View details for PubMedID 32479263
- Learning to deal with dual use. Science (New York, N.Y.) 2020
- Embrace experimentation in biosecurity governance. Science (New York, N.Y.) 2020; 368 (6487): 138–40
Developing a Comprehensive, Adaptive, and International Biosafety and Biosecurity Program for Advanced Biotechnology: The iGEM Experience.
Applied biosafety : journal of the American Biological Safety Association
2019; 24 (2): 64-71
The international synthetic biology competition iGEM (formally known as the international Genetically Engineered Machines competition) has a dedicated biosafety and biosecurity program.A review of specific elements of the program and a series of concrete examples illustrate how experiences in implementing the program have helped improved policy, including an increasing diversity of sources for genetic parts and organisms, keeping pace with technical developments, considering pathways toward future environmental release, addressing antimicrobial resistance, and testing the efficacy of current biosecurity arrangements.iGEM's program is forward-leaning, in that it addresses both traditional (pathogen-based) and emerging risks both in terms of new technologies and new risks. It is integrated into the technical work of the competition-with clearly described roles and responsibilities for all members of the community. It operates throughout the life cycle of projects-from project design to future application. It makes use of specific tools to gather and review biosafety and biosecurity information, making it easier for those planning and conducting science and engineering to recognize potential risks and match them with appropriate risk management approaches, as well as for specialists to review this information to identify gaps and strengthen plans.Integrating an increasingly adaptive risk management approach has allowed iGEM's biosafety and biosecurity program to become comprehensive, be cross-cutting, and cover the competition's life cycle.
View details for DOI 10.1177/1535676019838075
View details for PubMedID 36033940
View details for PubMedCentralID PMC9387731
Multi-cellular engineered living systems: building a community around responsible research on emergence.
Ranging from miniaturized biological robots to organoids, Multi-Cellular Engineered Living Systems (M-CELS) pose complex ethical and societal challenges. Some of these challenges, such as how to best distribute risks and benefits, are likely to arise in the development of any new technology. Other challenges arise specifically because of the particular characteristics of M-CELS. For example, as an engineered living system becomes increasingly complex, it may provoke societal debate about its moral considerability, perhaps necessitating protection from harm or recognition of positive moral and legal rights, particularly if derived from cells of human origin. The use of emergence-based principles in M-CELS development may also create unique challenges, making the technology difficult to fully control or predict in the laboratory as well as in applied medical or environmental settings. In response to these challenges, we argue that the M-CELS community has an obligation to systematically address the ethical and societal aspects of research and to seek input from and accountability to a broad range of stakeholders and publics. As a newly developing field, M-CELS has a significant opportunity to integrate ethically responsible norms and standards into its research and development practices from the start. With the aim of seizing this opportunity, we identify two general kinds of salient ethical issues arising from M-CELS research, and then present a set of commitments to and strategies for addressing these issues. If adopted, these commitments and strategies would help define M-CELS as not only an innovative field, but also as a model for responsible research and engineering.
View details for DOI 10.1088/1758-5090/ab268c
View details for PubMedID 31158828
- Anomaly handling and the politics of gene drives JOURNAL OF RESPONSIBLE INNOVATION 2018; 5: S223–S242
Considerations for the governance of gene drive organisms
PATHOGENS AND GLOBAL HEALTH
2018; 112 (4): 162–81
Governance is a broader and more flexible concept than statute-driven regulations as it incorporates components outside the latter's remit. Considerations of governance are critical in the development of emerging biotechnologies such as gene drive organisms. These have been proposed or are being developed to address public and environmental health issues not addressed easily by conventional means. Here, we consider how the concept of governance differs from statute-driven regulation with reference to the role each may play in the development of gene drive organisms. First, we discuss existing statute-based regulatory systems. Second, we consider whether novel risks or different concerns derive from gene drive organisms, concentrating on characteristics that contribute to public health or environmental risk and uncertainties that may affect risk perceptions. Third, we consider public engagement, outlining how existing statute-driven regulatory systems and other governance mechanisms may provide opportunities for constructive interactions. Finally, we provide some observations that may help address science- and values-based concerns in a governance space larger than that of statute-driven regulatory systems.
View details for PubMedID 29975593
Challenges and recommendations for epigenomics in precision health
2017; 35 (12): 1128–32
View details for PubMedID 29220033
ISSUES IN SCIENCE AND TECHNOLOGY
2017; 33 (2): 13
View details for Web of Science ID 000391903400008
- On Defining Global Catastrophic Biological Risks. Health security 2017; 15 (4): 347–48
Dealing with dual use: Risk governance in synthetic biology
AMER CHEMICAL SOC. 2016
View details for Web of Science ID 000431460204545
- SCIENCE GOVERNANCE. A more systematic approach to biological risk. Science 2015; 350 (6267): 1471-1473