February 24 – 26, 2016

Impetus for the Workshop

In an era of forward thinking and innovation, the world faces more complex and thought-provoking problems than it has ever dealt with before. These problems sometimes are multi-faceted and most of the time cannot be solved by exploring one avenue of thought. The constant advancement and progression of biotechnology brings with it a multitude of these unique difficulties. Gaps exist in our knowledge in the ever growing world of these technologies. Gene Drives, or genetically modifying any species’ genetic makeup for a specific desired outcome, present one example of this kind of biotechnology. We are uncertain of possible risks that come with the perceived benefits of this biotech and governmental regulatory policies have not kept up with the technological developments. Also, ethical lines have yet to be fully delineated as research pushes boldly forward into the future, spanning across various disciplines. This NSF sponsored gene drive workshop will attempt to fill these gaps in our understanding and solve some of these problems by constructing efficient and creative solutions across all disciplines of academia. One of the reasons the GES Center at NCSU wanted to host this workshop is because the technology has become the center of debate regarding ethical principles like population control of certain species, genetic modification of foods we consume and genetically altering the physical traits of our offspring, Gene drive technology, however, is also used in many medical cases and in many attempts to combat disease. With so many differing perspectives and opinions on gene drives, it was clear to us that more conversation is needed to facilitate a structure in which responsible regulations are fleshed out for the technology. Sponsored by National Science Foundation, the GES Center at NCSU, the Nanotechnology and Society Center at Arizona State University, and Synberc, this gene drive workshop will encompass some of today’s greatest international minds and innovative thinkers who come from a number of disciplines and academic pathways. These visionaries will use the knowledge of their respective disciplines to engage in discourse about effects of gene drives through the eyes of their individual fields. The goal of the workshop is to take these interdisciplinary perspectives and develop more information and strategies that can be used to improve public knowledge on the topic of gene drives. The GES Center will be a gateway where the public can then gain access to this information and make informed decisions regarding the topic.
See workshop articles from the Journal of Responsible Innovation 

Project Description

Overview

The science of advanced biotechnology is moving faster than governance considerations and actions. For example, some second generation, genetically engineered organisms are not subject to formal regulation prior to environmental release. Gene drives are a subset of second generation genetic engineering technologies that are being developed with the aim of moving synthetic gene constructs into wild animal populations to protect, suppress or eliminate them. Recent legal and policy scholarship has focused on the need for governance to “keep pace” with technological innovation in multiple domains, including biotechnology. However, we currently lack a broad evaluation of the potential ecological, political economy, ethical, and other issues to guide research and development of gene drives. This workshop will serve to fill this gap.

Agenda

Download the agenda.

Intellectual Merit

The invitation only workshop will “unpack” gene drives for more nuanced and productive conversations about governance. Participants will develop a draft typology of technologies, purposes, and contexts of gene drives, and a framework of issues and research needs for three key areas: ecological risk analysis, political economy analysis (including governance regimes), and ethical analysis. In order to cover a range of technologies, purposes, and issues, but yet be specific enough for productive dialogue, three case studies will be used to anticipate the socio-ecological-economic-ethical issues associated with gene drives. Integration of the natural and social sciences will be achieved through broad multi- disciplinary participation and thinking about the cases and the systems in which they are embedded. We propose equal representation of disciplines drawn from four meta-categories—genetics and molecular biology; ecology and ecological modeling; political economy; and STS & ethics. Practitioners and experts from government, NGOs, and industry will be included. Collaborative systems mapping will be used as a tool to assist integration of natural, social, and ethical variables, as it has been shown to be effective in creating an environment where complexities and uncertainties can be better seen and understood, and where participants are more willing to open up to alternative perspectives. The combination of the topic, approach, and outputs of the workshop make it unique, and it will contribute to deeper intellectual understanding of gene drives in societal contexts.

Broader Impacts

The structure of this invited only workshop will be designed to engage participants in working together to generate analyses and summaries useful for future decision- and policy-making about gene drives. Coming out of the workshop, there will be:
  1. A good working draft of a technologies typology;
  2. Issue analysis frameworks in ecology, political economy, and ethics that are specific to the cases and more general;
  3. A list of key research needs for cases
  4. System maps for the cases.
Papers will be drafted by workshop presenters and disseminated prior to the workshop. Following the workshop, papers will be finalized for publication in a special journal edition. A summary article will be published by the program committee that compares issues and system maps across the case studies and summarizes the key findings of the workshop. The program committee will also draft a shorter piece submitted for a high profile venue, such as a Nature or Science commentary. An editorial for major newspapers describing the technologies, uses, and issues in public-friendly terms will also be drafted to assist in broader public conversation. Dissemination of the workshop results—including the technologies typology, system maps, issue frameworks, and research-needs summaries—will serve to guide future research, innovation, and oversight of gene drive systems. In order to engage younger and under-represented (UR) (including gender under-represented) scholars, each program committee member will be expected to recruit a Ph.D. student or other junior- scholar to attend the meeting (i.e. at least 8 of the 50 attendees). UR students and junior scholars will be supported to attend by the grant’s travel budget. Back to top

Papers

Journal of Responsible Innovation | Roadmap to Gene Drives: Research and Governance Needs in Social, Political, and Ecological Context

Gene drives and the expanding horizon of governance

  • Editorial
Erik Fisher. 2018. Gene drives and the expanding horizon of governance. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 1-3. doi: 10.1080/23299460.2017.1422378. Download

Mapping research and governance needs for gene drives

  • Introduction
Jason Delborne, Jennifer Kuzma, Fred Gould
, Emma Frow, Caroline Leitschuh and Jayce Sudweeks. 2018. Mapping research and governance needs for gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1419413. Download

A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context

  • The deployment of gene drives is emerging as an alternative for protecting endangered species, controlling agricultural pests, and reducing vector-borne diseases. This paper reports on a 2016 workshop exploring the complex intersection of political, economic, ethical, and ecological risk issues associated with gene drives.
J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye and S. Stauffer. 2017. A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1410344. Download

Harnessing gene drive

  • Determining whether, when, and how to develop gene drive interventions responsibly will be a defining challenge of our time. Here we describe capabilities, safeguards, applications, and opportunities relevant to gene drive technologies.
John Min, Andrea L. Smidler, Devora Najjar, and Kevin M. Esvelt. 2017. Harnessing gene drive. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415586. Download

Gene drive to reduce malaria transmission in sub-Saharan Africa

  • Despite impressive progress, malaria continues to impose a substantial burden of mortality and morbidity, particularly in sub-Saharan Africa. A wide array of synthetic gene drive systems have been proposed to control the mosquitoes that transmit malaria.
Austin Burt, Mamadou Coulibaly, Andrea Crisanti, Abdoulaye Diabate, and Jonathan K. Kayondo. 2018. Gene drive to reduce malaria transmission in sub-Saharan Africa. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1419410. Download

Anticipating complexity in the deployment of gene drive insects in agriculture

  • Drawing on lessons from the deployment of other pest control technologies, we consider how insects containing gene drives could intersect with some of the complexities characterizing agricultural systems.
Jennifer Baltzegar, Jessica Cavin Barnes, Johanna E. Elsensohn, Nicole Gutzmann, Michael S. Jones, Sheron King, and Jayce Sudweeks. 2017. Anticipating complexity in the deployment of gene drive insects in agriculture. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407910. Download

Agricultural production: assessment of the potential use of Cas9-mediated gene drive systems for agricultural pest control

  • We provide examples of gene drives that target specific genes, including female-essential genes. Further, we discuss issues related to containment in the laboratory & eventual field testing of strains harboring a Cas9-mediated gene drive system.
Maxwell J. Scott, Fred Gould, Marcé Lorenzen, Nathaniel Grubbs, Owain Edwards and David O’Brochta. 2017. Agricultural production: assessment of the potential use of Cas9-mediated gene drive systems for agricultural pest control. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1410343. Download

Developing gene drive technologies to eradicate invasive rodents from islands

  • Gene drive methods of rodent eradication offer an alternative to killing that has the potential to be more species-specific, more humane, and more biologically safe for use around humans. Technologies in development aim to apply gene drives to influence offspring, eventually creating a population that is not reproductively viable.
Caroline M. Leitschuh, Dona Kanavy, Gregory A. Backus, Rene X. Valdez, Megan Serr, Elizabeth A. Pitts, David Threadgill and John Godwin. 2017. Developing gene drive technologies to eradicate invasive rodents from islands. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1365232. Download

Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

  • We outline methods to identify hazards and detect potentially adverse ecological outcomes at the individual, population, community and ecosystem level, when progressing Gene Drive Modified Organisms through a phased test and release pathway.
K.R. Hayes, G.R. Hosack, G.V. Dana, S.D. Foster, J.H. Ford, R. Thresher, A. Ickowicz, D. Peel, M. Tizard, P. De Barro, T. Strive and J. M. Dambacher. 2018. Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415585. Download

The roles of ethics in gene-drive research and governance

  • Ethics research queries the norms and values that shape the goals and justification for gene drive projects, and that might lead to issue or opposition to such projects. A framework for organizing ethics research is offered.
Paul B. Thompson. 2018. The roles of ethics in gene-drive research and governance. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1415587. Download

Economic issues to consider for gene drives

  • We examine four economic issues regarding gene drive applications. The potentially substantial benefits, coupled with the technical, social, and economic uncertainties, suggest that a responsible course of action is to move forward while maintaining regulatory flexibility and conducting research to resolve key uncertainties.
Paul D. Mitchell, Zachary Brown and Neil McRoberts. 2017. Economic issues to consider for gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407914. Download

Regulating animals with gene drive systems: Lessons from the regulatory assessment of a genetically engineered mosquito

  • Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives.
Zahra Meghani and Jennifer Kuzma. 2017. Regulating animals with gene drive systems: Lessons from the regulatory assessment of a genetically engineered mosquito. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407912. Download

Anomaly handling and the politics of gene drives

  • Decisions about the development and use of gene drives are framing broader debates about the need for fundamental changes to biotechnology regulatory systems. We summarize this debate and describe how gene drives are being constructed as potential anomalies within the regulatory landscape
Sam Weiss Evans and Megan J. Palmer. 2017. Anomaly handling and the politics of gene drives. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407911. Download

Gene drives and the management of agricultural pests

  • Difficulties involved in the containment of gene drives may restrict their use and require international agreements before release of approved types. The present commentary provides some thoughts on some of the issues one should consider when contemplating using gene drives in the management of agricultural pests.
Raul F. Medina. 2017. Gene drives and the management of agricultural pests. Journal of Responsible Innovation. Vol. 5, Iss. sup1, 2018. doi: 10.1080/23299460.2017.1407913. Download

Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct

Summary of Consensus Report, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016). Washington, DC: The National Academies Press. doi: 10.17226/23405. Download
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Presentation Slides

PDF image Identifying ecological and human-health issues associated with the deliberate or accidental release of gene-drive modified organisms Download PDF
PDF image Get Out the Map: Is there a route towards a social license to operate for gene drives? Download PDF
PDF image Systems mapping Download PDF
PDF image Economic issues to consider for gene drives Download PDF
PDF image Eradicating invasive rodents from islands: An assessment of current and future gene drive technologies Download PDF
PDF image Agricultural Production: Assessment of the potential use of Cas9-mediated gene drive systems for agricultural pest control Download PDF
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Workshop Videos

TitleLink
Interview with Jennifer KuzmaVideo
Interview with Kevin EsveltVideo
Interview with Aleksandra MalyskaVideo
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Leadership Team

Principal Investigator

Jennifer Kuzma Dr. Jennifer Kuzma Center Co-Director Professor, Public & International Affairs Email: jkuzma@ncsu.edu

Co-Principal Investigator

Fred Gould Dr. Fred Gould Center Co-Director Professor, Department of Entomology Email: fred_gould@ncsu.edu

Program Manager

Sharon Stauffer Center Program Assistant Email: sastauff@ncsu.edu

Research Assistant

Caroline-Leitschuh Caroline Leitschuh 2013 IGERT Fellow, PhD Student Biological Science Email: cleitsc@ncsu.edu Back to top

Program Committee

Along with the PI and Co-PI, the following people are serving on the Program Committee:
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Zachary Brown (NCSU, Env. Nat. Res. Economics) Assistant Professor in the Department of Agricultural and Resource Economics, Brown’s research focuses on the interactions between economic and biological systems, including the implications of biotechnology innovation in economic development.
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James P. Collins (ASU, Ecology, Evolution) Virginia M. Ullman Professor of Natural History and the Environment in the School of Life Sciences. Dr. Collins’s research centers on the ecology and evolution of host-pathogen biology and its relationship to the global decline of amphibians, the intellectual history of ecology’s development as a science, and ecological ethics.
Jason Delbourne
Jason Delborne (NCSU, Science and Technology Studies) Associate Professor of Science, Policy and Society in the Department of Forestry and Environmental Resources within the College of Natural Resources. Delborne’s research focuses on highly politicized scientific controversies, such as agricultural biotechnology, nanotechnology, biofuels, and climate change.
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Kevin Esvelt (Harvard, Molecular Biology) A Technology Development Fellow of the Wyss Institute for Biologically Inspired Engineering, Kevin is a co-developer of the CRISPR/Cas9 system for targeted genome editing and regulation. In 2014, he described how we might use CRISPR to build RNAguided gene drives capable of spreading genomic alterations through wild populations.
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Emma Frow (ASU, Science and Technology Studies) Assistant Professor in the School of Biological and Health Systems Engineering and the Consortium for Science, Policy &Outcomes at ASU. Her research centers on standards and governance in the life sciences, with a particular focus on synthetic biology.
KenOye
Kenneth Oye (MIT, Political Science), Kenneth Oye holds a joint appointment in Political Science and Engineering Systems, with research and teaching on international relations, political economy and technology policy. Member of the MIT Synthetic Biology Center and the MIT Center for Biomedical Innovation, and as Director of Policy and Practices for NSF SynBERC.
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Alison Wynn (NCSU Outreach/Communications/Education) Deputy Director of the Genetic Engineering and Society Center at North Carolina University. Director of the NSF funded Alliances for Graduate Education and the Professoriate (AGEP) OPT-Ed program at North Carolina State University.
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Author Attendees

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Austin Burt (Professor of Natural Sciences. Imperial College) Paper Description: Human Health: Insect/human disease transmission. Technology assessment for control of human diseases such as malaria, dengue, and trypanosomiasis.
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Max Scott (Entomology Associate Professor. NC State) Paper Description: Agricultural Production: Technology assessment for agricultural pest control, for example 1) Drosophila suzukii on fruit; 2) Screwworm; 3) Diamondback Moth, or 4) Maize Weevil.
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Kevin Esvelt (Wyss Technology Development Fellow. Wyss Institute for Biologically Inspired Engineering. Harvard Medical School) Paper Description: Typology of gene drive technologies and uses, building on the categories and features described in Esvelt et al. 2014.
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Todd Kuiken (Senior Program Associate. Science and Technology Innovation Program Science and Technology Innovation Program) Paper Description: Skeletal system maps for each of the case studies putting in place the important stocks and flows in areas of risk, economy, ecology, and principles (justice, trust), but leaving the details for further mapping at the workshop.
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Megan Palmer (Senior Research Scholar. CISAC. Stanford University) Paper Description: Political and policy issues associated with the 3 cases and beyond, and begin a framework for assessment and identifying research needs.
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Paul Thompson (W.K. Kellogg Professor of Agricultural, Food and Community Ethics. Michigan State University) Paper Description: Framework for ethical analysis of the 3 cases and beyond, and a framework for identifying research and dialogue needs.
Keith Hayes (Senior Research Scientist. CSIRO) Paper Description: Identify major ecological and human health issues associated with the cases, develop a framework for categorizing types of harms, and identify research needs
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Paul Mitchell (Associate Professor, Agricultural and Applied Economics. University of Wisconsin-Madison) Paper Description: Economic issues associated with the 3 case studies and beyond, and begin a framework for assessment and identifying research needs.
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Caroline Leitschuh (2013 IGERT Fellow, PhD Student, Biological Science. NC State) Paper Description: Conservation: Technology assessment for invasive rodent control on islands
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Zahra Meghani (University of Rhode Island) Paper Description: Integrative thinking across biology, policy, and ethics.
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