Keywords: gene drive guidance
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The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene driveJ. Romeis, J. Collatz, D. C. M. Glandorf and M. B. Bonsall, Environmental Science & Policy, 108:19-36. 2020.
The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive ... |
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What is gene drives about?EFSA, EFSAchannel, 2020.
EFSA expert Les Firbank, specialised in sustainable agriculture, talks about gene drives. Recent development in molecular biology are allowing scientists to engineer gene drives and use them to push desirable genes into target populations. How does that work? Learn more about ... |
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Regulation of GM Organisms for Invasive Species ControlH. J. Mitchell and D. Bartsch, Frontiers in Bioengineering and Biotechnology, 7:1-11. 2020.
Invasive species can cause significant harm to the environment, agriculture, and human health, but there are often very limited tools available to control their populations. Gene drives (GD) have been proposed as a new tool which could be used to control or eliminate such ... |
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When Humankind Overrides EvolutionM. Skipper, World Economic Forum, Davos 2020. 2020.
Advances in synthetic biology and other novel genetic procedures could resurrect extinct species or eliminate dangerous pests. What actions are needed now to ensure the ethical and responsible application of new genetic techniques? |
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The gene drive dilemma: We can alter entire species but should we?J. Kahn, New York Times Magazine, 2020.One early summer evening in 2018, the biologist Anthony James drove from his office at the University of California, Irvine, to the headquarters of the Creative Artists Agency, a sleek glass-and-steel high-rise in Los Angeles. There, roughly 200 writers, directors and producers ... |
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Scenario analysis on the use of rodenticides and sex-biasing gene drives for the removal of invasive house mice on islandsM. E. Serr, R. X. Valdez, K. S. Barnhill-Dilling, J. Godwin, T. Kuiken and M. Booker, Biological Invasions, 2020.
Since the 1960s conservation efforts have focused on recovering island biodiversity by eradicating invasive rodents. These eradication campaigns have led to considerable conservation gains, particularly for nesting seabirds. However, eradications are complex and lengthy endeavors ... |
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Beyond Mendelian genetics: Anticipatory biomedical ethics and policy implications for the use of CRISPR together with gene drive in humans.M. W. Nestor and R. L. Wilson, Journal of Bioethical Inquiry, 2020:1-12. 2020.
Clustered regularly interspaced short palindromic repeats (CRISPR) genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. ... |
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Technology Factsheet: Gene DrivesJ. Lunshof, C. Shachar, R. Edison, A. Jayanti, Belfer Center for Science and International Affairs, 2020.
Gene drives can be defined as genetic elements that pass from parents to unusually high numbers of their offspring due to biased inheritance (sometimes referred to as the possession of “selfish” genetic elements).1,2 There are different ways of achieving this biased ... |
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A typology of community and stakeholder engagement based on documented examples in the field of novel vector controlC. E. Schairer, R. Taitingfong, O. S. Akbari and C. S. Bloss, PLoS Neglected Tropical Diseases, 13:e0007863. 2019.
Background Despite broad consensus on the importance of community and stakeholder engagement (CSE) for guiding the development, regulation, field testing, and deployment of emerging vector control technologies (such as genetically engineered insects), the types of activities ... |
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Gene drives for schistosomiasis transmission controlT. Maier, N. J. Wheeler, E. K. O. Namigai, J. Tycko, R. E. Grewelle, Y. Woldeamanuel, K. Klohe, J. Perez-Saez, S. H. Sokolow, G. A. De Leo, T. P. Yoshino, M. Zamanian and J. Reinhard-Rupp, PLoS Neglected Tropical Diseases, 13:e0007833. 2019.
Schistosomiasis is one of the most important and widespread neglected tropical diseases (NTD), with over 200 million people infected in more than 70 countries; the disease has nearly 800 million people at risk in endemic areas. Although mass drug administration is a ... |
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Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drivesGeorge, D. R., T. Kuiken and J. A. Delborne, Proceedings of the Royal Society B: Biological Sciences, 286:20191484.. 2019.
Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land ... |
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A cross-sectional survey of biosafety professionals regarding genetically modified insectsO’Brochta, D. A., W. K. Tonui, B. Dass and S. James, Applied Biosafety, 2019:1-9. 2019.
Background:Genetic technologies such as gene editing and gene drive create challenges for existing frameworks used to assess risk and make regulatory determinations by governments and institutions. Insect genetic technologies including transgenics, gene editing, and gene drive ... |
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Plasmodium falciparum (Haemosporodia: Plasmodiidae) and O’nyong-nyong virus development in a transgenic Anopheles gambiae (Diptera: Culicidae) strainMumford, J. D., C. A. Long, S. C. Weaver, K. Miura, E. Wang, R. Rotenberry, E. M. Dotson and M. Q. Benedict, " Journal of Medical Entomology, 56:936-941. 2019.
ransgenic Anopheles gambiae Giles (Diptera: Culicidae) mosquitoes have been developed that confer sexual sterility on males that carry a transgene encoding a protein which cuts ribosomal DNA. A relevant risk concern with transgenic mosquitoes is that their capacity to transmit ... |
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Genetically engineering wild mice to combat Lyme disease: An ecological perspectiveSnow, A. A., BioScience, 69:746-756. 2019.
Genetic engineering of wild populations has been proposed for reducing human diseases by altering pathogens’ hosts. For example, CRISPR- based genome editing may be used to create white-footed mice (Peromyscus leucopus) that are resistant to the Lyme disease ... |
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What risk assessments of genetically modified organisms can learn from institutional analyses of public health risksRajan, S. R. and D. K. Letourneau, Journal of Biomedicine and Biotechnology, 2012:8. 2019.
The risks of genetically modified organisms (GMOs) are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO ... |
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Gene drives in Africa – A PodcastWakeford, T., etc Group, 2019.
In Episode #1 ETC's Tom Wakeford speaks with Ugandan lawyer and advocate Barbara Ntambirweki about gene drives, a powerful new genetic technology that can change species in the wild and make species go extinct. |
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Efforts to enhance safety measures for CRISPR/Cas-based gene drive technology in JapanT. Tanaka, N. Tanaka, Y. Nagano, H. Kanuka, D. S. Yamamoto, N. Yamamoto, E. Nanba and T. Nishiuch, Journal of Environment and Safety, 2019.
Gene drive is a powerful system that can spread a desirable genetic trait into an entire species and/or population of a certain region, bypassing Mendelian rules of inheritance. Recently, one of the genome editing technologies, CRISPR/Cas, has been developed, making it easier to ... |
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Threshold-Dependent Gene Drives in the Wild: Spread, Controllability, and Ecological UncertaintyG. A. Backus and J. A. Delborne, BioScience, 69:900-907. 2019.
Gene drive technology could allow the intentional spread of a desired gene throughout an entire wild population in relatively few generations. However, there are major concerns that gene drives could either fail to spread or spread without restraint beyond the targeted ... |
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Gene Drives: Experience with gene drive systems that may inform an environmental risk assessmentRüdelsheim, PKJS, G., COGEM, 2019.
Gene drives are genetic mechanisms that allow for a trait to be propagated throughout a population; beyond Mendelian inheritance. Active in sexually-reproducing species, they are powerful tools to “drive”; a gene, i.e. increase its frequency, independent of external selection ... |
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Gene Drives: A report on their science, applications, social aspects, ethics and regulationsH. Dressel, Critical Scientists Switzerland; European Network of Scientists for Social and Environmental Responsibility; Vereinigung Deutscher Wissenschaftler, 2019.
Engineered Gene Drives are a new form of genetic modification that provides the tools for permanently modifying or potentially even eradicating species or populations in the wild. Unlike the previous genetically modified organisms (GMOs), gene drive organisms (GDOs) are not meant ... |
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Gene drives and the international biodiversity regimeF. Rabitz, Review of European, Comparative & International Environmental Law, 2019.
Gene drives are genetic modifications designed for rapidly diffusing traits throughout a target population. They are currently being proposed as biological control agents to combat, for instance, invasive alien species and disease vectors. They also raise concerns regarding their ... |
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Gene drive organisms: What Africa should know about actors, motives and threats to biodiversity and food systemsSirinathsinghji, E., African Centre for Biodiversity., 2019.
In this briefing paper, we set out the key issues that our governments should have addressed with African civil society before endorsing positions and setting the benchmark for Africa-wide policy. In this regard, we point out that, while the impetus for the AU position might well ... |
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An overview of OECD activities related to modern techniques of biotechnology and genome editingKearns, P, Transgenic Research, 28:41-44. 2019.
Since commercial use of genetically-engineered (genetically- modified) plants started in 1996, many agricultural products have been developed to improve crop traits. The foods and feeds derived from these commodities have drastically increased worldwide. However, answering health ... |
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Molecular safeguarding of CRISPR gene drive experimentsChamper, JC, Joan; Lee, Yoo Lim; Liu, Chen; Yang, Emily; Wen, Zhaoxin; Clark, Andrew G.; Messer, Philipp W., eLife, 8:e41439. 2019.
CRISPR-based homing gene drives have sparked both enthusiasm and deep concerns due to their potential for genetically altering entire species. This raises the question about our ability to prevent the unintended spread of such drives from the laboratory into a natural population. ... |
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Population management using gene drive: molecular design, models ofspread dynamics and assessment of ecological risksRode, NOE, A.; Bourguet, D.; Courtier-Orgogozo, V.; Debarre, F., Conservation Genetics, 20:671-690. 2019.
CRISPR gene drive has recently been proposed as a promising technology for population management, including in conservation genetics. The technique would consist in releasing genetically engineered individuals that are designed to rapidly propagate a desired mutation or transgene ... |
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The revised arthropod containment guidelinesHiggs, S, Vector-Borne and Zoonotic Diseases, 19:149-151. 2019.
In 2003, just a few months after I became editor of Vector-; Borne and Zoonotic Diseases, we published the Arthropod; Containment Guidelines, likely our first of what would become; known as an Open Access publication. The concept to; produce the guidelines resulted from a ... |
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Gene drive gone wild: exploring deliberative possibilities by developing One Health ethicsCapps, B, Law, Innovation and Technology, 11:231-256. 2019.
Gene editing may be used to engineer organisms that are better or worse adapted to survival. Coupled with gene drives ? molecular genetic strategies that perpetuate specific phenotypes in a target species ? it would now be possible to edit wild animal populations that impact on ... |
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Knowledge engagement in gene drive research for malaria controlHartley, ST, D.; Ledingham, K.; Coulibaly, M.; Diabate, A.; Dicko, B.; Diop, S.; Kayondo, J.; Namukwaya, A.; Nourou, B.; Toe, L. P., PLOS Neglected Tropical Diseases, 13:e0007233. 2019.
Scientists and funding bodies have made repeated calls for public engagement in gene drive. In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) published its report, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning ... |
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Safe CRISPR: Challenges and Possible SolutionsPineda, ML, A.; Collins, J. P.; Kiani, S., Trends in Biotechnology, 37:389-401. 2019.
Applications of CRISPR in human health and in gene drives are at the forefront of biological research as tools. This technology will affect humankind and our environment, so as this technology pushes forward, the design and implementation of safety measures is imperative. Novel ... |
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The ethical landscape of gene drive researchCallies, DE, Bioethics, 33:1091-1097. 2019.
Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social ... |
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CRISPR in sub-Saharan Africa: Applications and educationOgaugwu, CEA, S. O.; Adekoya, M. A., Trends in Biotechnology, 37:234-237. 2019.
Clustered regularly interspaced shortpalindromicrepeats (CRISPR) technology has enabled genetic engineering feats previously considered impracticable, offering great hopes for solutions to problems facing society. We consider it timely to highlight how CRISPR can benefit public ... |
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CRISPR-Cas9. The greatest advancement in genetic edition techniques requires an ethical reflectionGomez-Tatay, LA, J., Cuadernos De Bioetica, 30:171-185. 2019.
The adaptation of the CRISPR system as a genetic editing tool has led to a revolution in many fields of application, as this technique is considerably faster, easier to perform and more efficient than predecessor techniques. However, some of these applications raise objective ... |
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The EU regulatory framework on genetically modified organisms (GMOs)Bruetschy, C, Transgenic Research, 28:169-174. 2019.
The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their ... |
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Promises and perils of gene drives: Navigating the communication of complex, post-normal scienceBrossard, DB, Pam; Gould, Fred; Wirz, Christopher D., Proceedings of the National Academy of Sciences of the United States of America, 116:7692-7697. 2019.
In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss ... |
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CRISPR ethics: Moral considerations for applications of a powerful toolBrokowski, C. and Adli, M., Journal of Molecular Biology, 431:88-101. 2019.
With the emergence of CRISPR technology, targeted editing of a wide variety of genomes is no longer an abstract hypothetical, but occurs regularly. As application areas of CRISPR are exceeding beyond research and biomedical therapies, new and existing ethical concerns abound ... |
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Gene drives as a new quality in GMO releases-a comparative technology characterizationFriess, JLvG, A.; Giese, B., Peerj, 7:e6793. 2019.
Compared to previous releases of genetically modified organisms (GMOs) which were primarily plants, gene drives represent a paradigm shift in the handling of GMOs: Current regulation of the release of GMOs assumes that for specific periods of time a certain amount of GMOs will be ... |
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Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018Teem, JLA, Aggrey; Glover, Barbara; Ouedraogo, Jeremy; Makinde, Diran; Roberts, Andrew, Malaria Journal, 18:347. 2019.
Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an ... |
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Governing extinction in the era of gene editingMonast, JJ, North Carolina Law Review, 97:1329-1358. 2019.
CRISPR-Cas9 genome-editing technology (“CRISPR”) offers a potential solution for some of the world’s critical conservation challenges. Scientists are harnessing CRISPR to expand genetic diversity of endangered species, control invasive species, or enhance species’ ... |
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Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressorsDevos, YC, W.; Devlin, R. H.; Ippolito, A.; Leggatt, R. A.; Romeis, J.; Shaw, R.; Svendsen, C.; Topping, C. J., EFSA Journal, 17:e170708. 2019.
Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally ... |
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Gene drives in plants: opportunities and challenges for weed control and engineered resilienceBarrett, LGL, Mathieu; Kumaran, Nagalingam; Glassop, Donna; Raghu, S.; Gardiner, Donald M., Proceedings of the Royal Society B: Biological Sciences, 286:9. 2019.
Plant species, populations and communities are under threat from climate change, invasive pathogens, weeds and habitat fragmentation. Despite considerable research effort invested in genome engineering for crop improvement, the development of genetic tools for the management of ... |
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Gene driving the farm: who decides, who owns, and who benefits?Montenegro de Wit, M, Agroecology and Sustainable Food Systems, 43:1054-1074. 2019.
This commentary essay explores the social and ecological implications of gene-driving agriculture. |
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Sustainability as a framework for considering gene drive mice for invasive rodent eradicationBarnhill-Dilling, SKS, M.; Blondel, D. V.; Godwin, J., Sustainability, 11:1334. 2019.
Gene drives represent a dynamic and controversial set of technologies with applications that range from mosquito control to the conservation of biological diversity on islands. Currently, gene drives are being developed in mice that may one day serve as an important tool for ... |
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The ethics of genome editing in non-human animals: a systematic review of reasons reported in the academic literaturede Graeff, NJ, K. R.; Johnston, J.; Hartley, S.; Bredenoord, A. L., Philosophical Transactions of the Royal Society B-Biological Sciences, 374:1-25. 2019.
In recent years, new genome editing technologies have emerged that can edit the genome of non-human animals with progressively increasing efficiency. Despite ongoing academic debate about the ethical implications of these technologies, no comprehensive overview of this debate ... |
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Informed consent and community engagement in open field research: lessons for gene drive scienceSingh, JA, BMC Medical Ethics, 20:54. 2019.
The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically ... |
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Two minutes to midnight-what international law can do about genome editingLee, TL, Asian Journal of Wto & International Health Law and Policy, 14:227-265. 2019.
With its ability to transform the ecosystem, gene drives, a powerful genome-editing technology, poses nuanced regulatory challenges. In particular, as gene drives can override the normal rule of inheritance, where the impacts of gene-drive modified organisms on the environment ... |
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Evaluating the Probability of CRISPR-based Gene Drive Contaminating Another SpeciesCourtier-Orgogozo, VD, Antoine; Gouyon, Pierre-Henri; Boëte, Christophe, bioRxiv, 776609:27. 2019.
The probability D that a given CRISPR-based gene drive element contaminates another, non-target species can be estimated by the following Drive Risk Assessment Quantitative Estimate (DRAQUE) Equation: D = (hyb+transf).express.cut.flank.immune.nonextinct withhyb = probability of ... |
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An introduction to the proceedings of the environmental release of engineered pests: Building an international governance frameworBrown, Z. S., L. Carter and F. Gould, BMC Proceedings, 12:10. 2018.
In October 2016, a two-day meeting of 65 academic, government and industry professionals was held at North Carolina State University for early-stage discussions about the international governance of gene drives: potentially powerful new technologies that can be used for the ... |
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Means and ends of effective global risk assessments for genetic pest managementTurner, G., C. Beech and L. Roda, BMC Proceedings, 12:13. 2018.
The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, ... |
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Towards inclusive social appraisal: risk, participation and democracy in governance of synthetic biologyStirling, A., K. R. Hayes and J. Delborne, BMC Proceedings, 12:15. 2018.
Frameworks that govern the development and application of novel products, such as the products of synthetic biology, should involve all those who are interested or potentially affected by the products. The governance arrangements for novel products should also provide a ... |
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Public engagement pathways for emerging GM insect technologiesBurgess, M. M., J. D. Mumford and J. V. Lavery, BMC Proceedings, 12:12. 2018.
Policy and management related to the release of organisms generated by emerging biotechnologies for pest management should be informed through public engagement. Regulatory decisions can be conceptually distinguished into the development of frameworks, the assessment of the ... |
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GM insect pests under the Brazilian regulatory framework: development and perspectivesAndrade, P. P., M. A. da Silva Ferreira, M. S. Muniz and A. de Casto Lira-Neto, BMC Proceedings, 12:15. 2018.
The emergence of new technologies for genetic modification has broadened the range of possible new products. The regulations of many countries that could benefit from these new products may not be prepared to assess risks and enable science-based decision-making. This is ... |
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Regulation of emerging gene technologies in IndiaAhuja, V., BMC Proceedings, 12:14. 2018.
In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under ... |
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Gene drive research: Why it mattersThe Royal Society, Royal Society Statement, 2018.
Gene drives are systems that bias the inheritance of a particular DNA sequence. Many such systems occur naturally and scientists are now investigating the potential to develop new ones using synthetic biology techniques. Synthetic gene drives are being developed for a range of ... |
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EU Adopts Negotiating Position for 2018 Biodiversity ConferenceTsioumani, E, International Institute for Sustainable Development, 2018.
The Council of the EU calls for increased efforts to fully achieve the Aichi Biodiversity Targets, and for the adoption of an ambitious follow-up to the Strategic Plan for Biodiversity 2011-2020, to strengthen implementation of the CBD and its Protocols, as well as of other ... |
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Gene drive organisms: Warning of risks due to uncontrolled releasesThen, C, Testbiotech, 2018.
The German Ministry for the Environment has in response to an open letter sent by several civil society organisations issued a statement very critical of genetically engineered organisms carrying a so-called gene drive. The ministry announced that it will take action on an ... |
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Forcing the Farmetc group, etc group, 2018.
This report is being issued as an alert to governments, civil society organisations and grassroots movements. It points to how gene drives, while promoted as a tool for medicine and conservation, will find their real use in food and farming by agribusiness. It calls for a pause ... |
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Existing rules cover gene-drive usageStrassheim, S.S., W., Nature, 2018.
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Considerations for the governance of gene drive organismsRudenko, L.P., Megan J.; Oye, Kenneth, Pathogens and Global Health, 2018.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 ... |
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Editing nature: Local roots of global governanceKofler, N.C., James P.; Kuzma, Jennifer; Marris, Emma; Esvelt, Kevin; Nelson, Michael Paul; Newhouse, Andrew; Rothschild, Lynn J.; Vigliotti, Vivian S.; Semenov, Misha; Jacobsen, Rowan; Dahlman, James E.; Prince, Shannon; Caccone, Adalgisa; Brown, Timothy, Science, 2018.
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Gene DrivesSciLine, SciLine, 2018.
For many years now, scientists have been able to alter genes inside microbial, plant, and animal cells to change organisms’ traits, creating, for example, plants that produce their own protective insecticides and fish that grow to maturity almost twice as fast as normal. But ... |
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Gene Drive TechnologyRick Weiss, SciLine, 2018.
Gene drives represent a new take on genetic engineering offering previously impossible means of fighting disease-spreading insects and invasive species but also raising the specter of ecological disruption. This briefing reviews the current status of gene-drive technology, ... |
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Population modification of Anopheline species to control malaria transmissionR. Carballar-Lejarazú and A. A. James, Pathogens and Global Health, 111:424-435. 2018.
Vector control strategies based on population modification of Anopheline mosquitoes may have a significant role in the malaria eradication agenda. They could consolidate elimination gains by providing barriers to the reintroduction of parasites and competent vectors, and allow ... |
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A Framework for the risk assessment and management of gene drive technology in contained usevan der Vlugt, CJBB, David D.; Lehmann, Kathleen; Leunda, Amaya; Willemarck, Nicolas, Applied Biosafety, 23:25-31. 2018.
The utilisation of the CRISPR/Cas9 technology has sparked a renewed interest in gene drive mechanisms. These mechanisms of biased inheritance may yield promising applications in the fields of vector control and nature conservation. However, the same properties that will enable ... |
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Gene drive to reduce malaria transmission in sub-Saharan AfricaBurt, AC, Mamadou; Crisanti, Andrea; Diabate, Abdoulaye; Kayondo, Jonathan K., Journal of Responsible Innovation, 5:S66-S80. 2018.
Despite impressive progress, malaria continues to impose a substantial burden of mortality and morbidity, particularly in sub-Saharan Africa, and new tools will be needed to achieve elimination. Gene drive is a natural process by which some genes are inherited at a ... |
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Using gene drive technologies to control vector-borne infectious diseasesJames, ST, K. H., Sustainability, 10:4789. 2018.
After years of success in reducing the global malaria burden, the World Health Organization (WHO) recently reported that progress has stalled. Over 90% of malaria deaths world-wide occurred in the WHO African Region. New tools are needed to regain momentum and further decrease ... |
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Current CRISPR gene drive systems are likely to be highly invasive in wild populationsNoble, CA, Ben; Church, George M.; Esvelt, Kevin M.; Nowak, Martin A., eLife, 7:e33423. 2018.
Recent reports have suggested that self-propagating CRISPR-based gene drive systems are unlikely to efficiently invade wild populations due to drive-resistant alleles that prevent cutting. Here we develop mathematical models based on existing empirical data to explicitly test ... |
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Means and ends of effective global risk assessments for genetic pest managementTurner, GB, Camilla; Roda, Lucia, BMC Proceedings, 12:13. 2018.
The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, ... |
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Pathway to deployment of gene drive mosquitoes as a potential biocontrol tool for elimination of malaria in sub-Saharan Africa: Recommendations of a scientific working groupJames, SC, Frank H.; Welkhoff, Philip A.; Emerson, Claudia; Godfray, H. Charles J.; Gottlieb, Michael; Greenwood, Brian; Lindsay, Steve W.; Mbogo, Charles M.; Okumu, Fredros O.; Quemada, Hector; Savadogo, Moussa; Singh, Jerome A.; Tountas, Karen H.; Touré, American Journal of Tropical Medicine and Hygiene, 98:1-49. 2018.
Gene drive technology offers the promise for a high-impact, cost-effective, and durable method to control malaria transmission that would make a significant contribution to elimination. Gene drive systems, such as those based on clustered regularly interspaced short palindromic ... |
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Can We Engineer Social Ecosystems?TEDxCambridgeSalon, , 2018.
Kevin Esvelt is director of the Sculpting Evolution group, which invents new ways to study and influence the evolution of ecosystems. By carefully developing and testing these methods with openness and humility, the group seeks to address difficult ecological problems for the ... |
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Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as casesTrump, BF, C.; Rycroft, T.; Wood, M. D.; Bandolin, N.; Cains, M.; Cary, T.; Crocker, F.; Friedenberg, N. A.; Gurian, P.; Hamilton, K.; Hoover, J.J.; Meyer, C.; Pokrzywinski, K.; Ritterson, R.; Schulte, P.; Warner, C. ; Perkins, E.; Linkov, I., Environmental Systems and Decisions, 38:517-527. 2018.
Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly ... |
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Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organismsHayes, KRH, G. R.; Dana, G. V.; Foster, S. D.; Ford, J. H.; Thresher, R.; Ickowicz, A.; Peel, D.; Tizard, M.; De Barro, P.; Strive, T.; Dambacher, J. M., Journal of Responsible Innovation, 5:S139-S158. 2018.
Synthetic gene drives could provide new solutions to a range of old problems such as controlling vector-borne diseases, agricultural pests and invasive species. In this paper, we outline methods to identify hazards and detect potentially adverse ecological outcomes at the ... |
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Identifying knowledge gaps for gene drive research to control invasive animal species: The next CRISPR stepMoro, DB, Margaret; Kennedy, Malcolm; Campbell, Susan; Tizard, Mark, Global Ecology and Conservation, 13:e00363. 2018.
Invasive animals have been linked to the extinctions of native wildlife, and to significant agricultural financial losses or impacts. Current approaches to control invasive species require ongoing resources and management over large geographic scales, and often result in the ... |
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Public engagement and communication: who is in charge?Boëte, C, EMBO reports, 19:1. 2018.
The discovery of CRISPR has led to the development of gene drive systems that could be used to spread desired traits in a target species or to exterminate a population within a few generations. It is no surprise then that such a controversial and disruptive technology has raised ... |
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Anticipating complexity in the deployment of gene drive insects in agricultureBaltzegar, JCB, Jessica; Elsensohn, Johanna E.; Gutzmann, Nicole; Jones, Michael S.; King, Sheron; Sudweeks, Jayce, Journal of Responsible Innovation, 5:S81-S97. 2018.
Insects cause substantial losses to agricultural crops each yearand require intensive management approaches. Genetic pestmanagement has emerged as a viable, non-chemical alternative formanaging insect pests. The development of engineered genedrives for agricultural use is ... |
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Existing rules cover gene-drive usageStrassheim, SS, W., Nature, 554:169. 2018.
Gene-drive technology is not; unregulated, as you imply; (Nature 552, 6; 2017). Because; it involves genetically modified; (GM) organisms, it is covered in; countries that have regulations; on gene modification and; internationally by the Cartagena; Protocol on Biosafety. |
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Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in AfricaGlover, BA, Olalekan; Savadogo, Moussa; Timpo, Samuel; Lemgo, Godwin; Sinebo, Woldeyesus; Akile, Sunday; Obukosia, Silas; Ouedraogo, Jeremy; Ndomondo-Sigonda, Margareth; Koch, Muffy; Makinde, Diran; Ambali, Aggrey, BMC Proceedings, 12:1-10. 2018.
The New Partnership for Africa’s Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology ... |
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Synthetic gene drive: between continuity and novelty: Crucial differences between gene drive and genetically modified organisms require an adapted risk assessment for their useSimon, SO, Mathias; Engelhard, Margret, EMBO Reports, 19:e45760. 2018.
Gene drive organisms differ from “classical” genetically modified organisms in several crucial aspects. It would require new approaches for risk assessment to gauge their potential impact on the environment. While some argue that current risk assessment frameworks can ... |
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Genetically engineered mosquitoes, Zika and other arboviruses, community engagement, costs, and patents: Ethical issuesMeghani, ZB, Christophe, PLOS Neglected Tropical Diseases, 12:e0006501. 2018.
We discuss here key ethical questions raised by the use of GE insects, with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by ... |
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Considerations for the governance of gene drive organismsRudenko, LP, Megan J.; Oye, Kenneth, Pathogens and Global Health, 112:162-181. 2018.
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 ... |
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Gene drives in our future: challenges of and opportunities for using a self-sustaining technology in pest and vector managementCollins, JP, BMC Proceedings, 12:9. 2018.
Gene drives are systems of biased inheritance that enhance the likelihood a sequence of DNA passes between generations through sexual reproduction and potentially throughout a local population and ultimately all connected populations of a species. Gaps in our knowledge of gene ... |
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Editing nature: Local roots of global governanceKofler, NC, James P.; Kuzma, Jennifer; Marris, Emma; Esvelt, Kevin; Nelson, Michael Paul; Newhouse, Andrew; Rothschild, Lynn J.; Vigliotti, Vivian S.; Semenov, Misha; Jacobsen, Rowan; Dahlman, James E.; Prince, Shannon; Caccone, Adalgisa; Brown, Timothy; Schmitz, Oswald J., Science, 362:527. 2018.
The end of malaria. Restored island habitats. Resiliency for species threatened by climate change. Many envisioned environmental applications of newly developed gene-editing techniques such as CRISPR might provide profound benefits for ecosystems and society. But depending on the ... |
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Community engagement and field trials of genetically modified insects and animalsNeuhaus, C. P., Hastings Center Report, 48:25-36. 2018.
New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally?and has attempted to conduct field trials in the United States?of a ... |
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Making policies about emerging technologiesKaebnick, G. E. and M. K. Gusmano, Hastings Center Report, 48:S2-S11. 2018.
Can we make wise policy decisions about still-emerging technologies?decisions that are grounded in facts yet anticipate unknowns and promote the public's preferences and values? There is a widespread feeling that we should try. There also seems to be widespread agreement that the ... |
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Open, Local, and ObligatedYale University, , 2017.
Kevin Esvelt, PhD, assistant professor at the MIT Media Lab and leader of the Sculpting Evolution Group talks about the need for new scientific structures based on transparency and open. This lecture was given at the 2017 Editing Nature Summit. |
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Open until dangerous: gene drive and the case for reforming research to reduceK. Esvelt, N. Labenz, G. Church, Centre for Effective Altruism, 2017.
The wisdom with which we develop and deploy new technologies will define the future of our civilization. Why do we conduct reseearch in small teams of specialists who cannot reliably anticipate consequences on their own? Might it be better to share our best ideas and plans with ... |
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Principles for gene drive researchEmerson, CJ, Stephanie; Littler, Katherine; Randazzo, Filippo, Science, 358:1135. 2017.
The recent outbreak of Zika virus in the Americas renewed attention on the importance of vector-control strategies to fight the many vector-borne diseases that continue to inflict suffering around the world. In 2015, there were ?212 million infections and a death every minute ... |
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Unintended consequences of 21st century technology for agricultural pest managementYoung, SL, EMBO reports, 18:1478-1478. 2017.
Comment on Agricultural pest control with CRISPR-based gene drive: time for public debate by Courtier-Orgogozo et al. |
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Adaptive risk management of gene drive experiments: Biosafety, biosecurity, and ethicsLunshof, JEB, A., Applied Biosafety, 22:97-103. 2017.
Emerging technologies in the life sciences call for new models of biosafety risk management. We examine the question of how to; address new developments in the life sciences and biosciences in a bottom-up manner—that is, from the concrete level of; biosafety practice with a ... |
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A transatlantic perspective on 20 emerging issues in biological engineeringWintle, BCB, C. R.; Rhodes, C.; Molloy, J. C.; Millett, P.; Adam, L.; Breitling, R.; Carlson, R.; Casagrande, R.; Dando, M.; Doubleday, R.; Drexler, E.; Edwards, B.; Ellis, T.; Evans, N. G.; Hammond, R.; Haseloff, J.; Kahl, L.; Kuiken, T.; Lichman, B. R.; Matthewman, C. A.; Napier, J. A.; OhEigeartaigh, S. S.; Patron, N. J.; Perello, E.; Shapira, P.; Tait, J.; Takano, E.; Sutherland, W. J., eLife, 6:21. 2017.
Advances in biological engineering are likely to have substantial impacts on global society. To explore these potential impacts we ran a horizon scanning exercise to capture a range of perspectives on the opportunities and risks presented by biological engineering. We first ... |
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Gene Drive 101: A Basic Guidance Resource for Biosafety ProfessionalsKrishnan, PG, David, Applied Biosafety, 22:181-184. 2017.
Biosafety risk assessment and containment framework strategies for research involving gene drives pose a challenge, as there are no published guidelines or regulatory information yet written specifically addressing biosafety and gene drive use. Since the risk is more at an ... |
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Recommendations for Laboratory Containment and Management of Gene Drive Systems in ArthropodsBenedict, MQB, Austin; Capurro, Margareth L.; De Barro, Paul; Handler, Alfred M.; Hayes, Keith R.; Marshall, John M.; Tabachnick, Walter J.; Adelman, Zach N., Vector-Borne and Zoonotic Diseases, 18:2-13. 2017.
Versatile molecular tools for creating driving transgenes and other invasive genetic factors present regulatory, ethical, and environmental challenges that should be addressed to ensure their safe use. In this article, we discuss driving transgenes and invasive genetic factors ... |
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Results from the Workshop “Problem Formulation for the Use of Gene Drive in Mosquitoes”Roberts, ADA, P. P.; Okumu, F.; Quemada, H.; Savadogo, M.; Singh, J. A.; James, S., American Journal of Tropical Medicine and Hygiene, 96:530-533. 2017.
Reducing the incidence of malaria has been a public health priority for nearly a century. New technologies and associated vector control strategies play an important role in the prospect of sustained reductions. The development of the CRISPR/Cas9 gene editing system has generated ... |
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Advances in vector control science: Rear-and-release strategies show promise… but don’t forget the basicsRitchie, SAJ, B. J., Journal of Infectious Diseases, 215:S103-S108. 2017.
Both chikungunya and Zika viruses have recently swept from Africa across the Pacific to the Americas, causing major outbreaks of disease in humans. In the meantime, dengue epidemics continue throughout the tropics. Traditional vector control programs based on strategies from ... |
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Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public ValuesU. S. National Academies of Sciences, Engineering, and Medicine, The National Academies Press, 2016.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the ... |
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Gene Drive Technology: Where is the Future?National Academy of Sciences Engineering Medicine, BioScience Talks, 2016.
Gene drives have the potential to revolutionize approaches to major public health, conservation, and agricultural problems. For instance, gene drives might one day prevent mosquitoes from spreading a variety of deadly diseases, including Zika virus, malaria, and others. A form of ... |
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Openly Engineering Our EcosystemsTEDxCambridge, , 2016.
Which technologies should we develop and how? Kevin Esvelt, leader of the Sculpting Evolution group and a professor at the MIT Media Lab, describes how CRISPR 'gene drives' can single-handedly alter entire wild populations and the critical importance of requiring powerful ... |
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Engineering the wild: Gene drives and intergenerational equityJ. Kuzma and L. Rawls, Jurimetrics, 56:279-296. 2016.New genetic engineering methods are allowing scientists to insert genes into organisms that have the potential to spread themselves throughout natural populations upon the release of individuals carrying those genes. Gene drive technology is being researched and developed for ... |
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National Academies of Science, Engineering and Medicine’s Gene Drive Workshop: Science, Ethics, and Governance Considerations for Gene Drive Research – October 28, 2015National Academy of Sciences Engineering Medicine, National Academy of Sciences, 2015. |
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Can systematic reviews inform GMO risk assessment and risk management?Kohl, CF, G.; Sweet, J.; Spok, A.; Haddaway, N.R.; Wilhelm, R.; Unger, S.; Schiemann, J., Frontiers in Bioengineering and Biotechnology, 3:113. 2015.
Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and ... |
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Opinion: Is CRISPR-based gene drive a biocontrol silver bullet or global conservation threat?Webber, BLR, S.; Edwards, O. R., Proceedings of the National Academy of Sciences of the United States of America, 112:10565-10567. 2015.
Scientists have recognized the potential for applying gene drive technologies to the control of invasive species for several years, yet debate about the application of gene drive has been primarily restricted to mosquitoes. Recent developments in clustered regularly interspaced ... |
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Safeguarding gene drive experiments in the laboratoryAkbari, OSB, H. J.; Bier, E.; Bullock, S. L.; Burt, A.; Church, G. M.; Cook, K. R.; Duchek, P.; Edwards, O. R.; Esvelt, K. M.; Gantz, V. M.; Golic, K. G.; Gratz, S. J.; Harrison, M. M.; Hayes, K. R.; James, A. A.; Kaufman, T. C.; Knoblich, J.; Malik, H. S.; Matthews, K. A.; O'Connor-Giles, K. M.; Parks, A. L.; Perrimon, N.; Port, F.; Russell, S.; Ueda, R.; Wildonger, J., Science, 349:927-929. 2015.
Gene drive systems promote the spread of genetic elements through populations by assuring they are inherited more often than Mendelian segregation would predict (see the figure). Natural examples of gene drive from Drosophila include sex-ratio meiotic drive, segregation ... |
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Concerning RNA-guided gene drives for the alteration of wild populationsEsvelt, KMS, Andrea L.; Catteruccia, Flaminia; Church, George M., eLife, 3:e03401. 2014.
Gene drives may be capable of addressing ecological problems by altering entire; populations of wild organisms, but their use has remained largely theoretical due to technical; constraints. Here we consider the potential for RNA-guided gene drives based on the CRISPR; nuclease ... |
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Regulatory experience and challenges for the release of GM insectsBeech, C, Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety, 9:S71-S76. 2014.
Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. ... |
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Regulating gene drivesOye, KAE, K.; Appleton, E.; Catteruccia, F.; Church, G.; Kuiken, T.; Lightfoot, S. B. Y.; McNamara, J.; Smidler, A.; Collins, J. P., Science, 345:626-628. 2014.
Regulatory gaps must be filled before gene drives could be used in the wild |
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Guidance on the environmental risk assessment of genetically modified animals.EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), EFSA Journal, 11:3200. 2013.
This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive ... |
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The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on BiosafetySecretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2011:1-16. 2011.
Adopted as a supplementary agreement to the Cartagena Protocol on Biosafety, the Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to ... |
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Deployment of innovative genetic vector control strategies: progress on regulatory and biosafety aspects, capacity building and development of best-practice guidanceBeech, CV, S.S.; Quinlan, M.M.; Capurro, Margareth L.; Alphey, L.; Bayard, V.; Bouare, M.; McLeod, M.C.; Kittayapong, P.; Lavery, J.; Lim, L.H.; Marrelli, M.T.; Nagaraju, J.; Ombongi, K.; Othman, R.Y.; Pillai, V.; Ramsey, J.; Reuben, R.; Rose, R.I.; Tyagi, B.K.; Mumford, J., AsPac J. Mol. Biol. Biotechnol., 17:75-85. 2009.
In the ongoing fight against vectors of human diseases, disease endemic countries (DECs) may soon benefit from innovative control strategies involving modified insect vectors. For instance, three promising methods (viz. RIDL® [Release of Insects with a Dominant Lethal], ... |
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Guidance for contained field trials of vector mosquitoes engineered to contain a gene drive system: Recommendations of a scientific working groupBenedict, MDA, P.; Dobson, S.; Gottlieb, M.; Harrington, L.; Higgs, S.; James, A.; James, S.; Knols, B.; Lavery, J.; O'Neill, S.; Scott, T.; Takken, W.; Toure, Y.; Core Working Grp Guidance, Containe, Vector-Borne and Zoonotic Diseases, 8:127-166. 2008.
The following recommendations represent the response of a group of involved scientists to the need for guidance to aid researchers, government authorities, and community leaders as they consider the design and implementation of field trials to assess the safety and efficacy of ... |
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General principles for risk assessment of living modified organisms: Lessons from chemical risk assessmentHill, RAS, C., Environ. Biosafety Res, 2:81-88. 2003.
Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the ... |
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Cartagena Protocol on Biosafety to the Convention on Biological DiversitySecretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2000:1-19. 2000.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on ... |
