ItemEditing Biosecurity: Needs and Strategies for Governing Genome Editing, Executive Summary(George Mason University, 2018-12) Kirkpatrick, Jesse; Koblentz, Gregory D.; Palmer, Megan J.; Perello, Edward; Relman, David A.; Denton, Sarah W ItemEditing Biosecurity: Needs and Strategies for Governing Genome Editing(George Mason University, 2018-12) Kirkpatrick, Jesse; Koblentz, Gregory D.; Palmer, Megan J.; Perello, Edward; Relman, David A.; Denton, Sarah W ItemBiotechnology Risk Assessment: Landscape and Options(George Mason University, 2018-03) Kirkpatrick, Jesse; Koblentz, Gregory D.; Palmer, Megan J.; Denton, Sarah W; Tiu, Bruce ItemCRISPR Genome Editing: A Technical & Policy Primer(2018) Perello, Edward ItemThe CRISPR Revolution: Potential Impacts on Global Health Security(2018) Watters, KyleBiotechnology and medicine are constantly battling threats to global health security. Many modern techniques exist for detecting and predicting where outbreaks might occur and between small molecule drugs, like antibiotics, biologics, and vaccines, much progress has been made in treating diseases globally. However, outbreaks still frequently occur, and many pathogens exist for which there are no treatment. In this review, we paint a picture of the challenges faced in maintaining global health security and how a new wave of gene editing technologies can overcome them. We discuss a number of technologies that are actively developing CRISPR as a treatment or diagnostic tool as well as how CRISPR tools can affect drug development indirectly and speculate on what the near future for these research directions holds. Last, some of the risks associated with gene editing technologies and the efforts scientists are undertaking to mitigate them are covered. Overall, CRISPR and gene editing technologies are likely to have a positive influence on our global health security outlook, both as a form of treatment and detection tool as well as a force for increasing the rate of biological and drug discovery. ItemGene Drive Technology: The Thing to Fear is Fear Itself(George Mason University, 2018-12) Esvelt, KevinCRISPR gene drive systems have raised concerns due to their ability to spread through wild populations over generations, but the technology is slow, easily detected by sequencing, and readily countered by overwriting unwanted changes. Populations of humans and other organisms with long generation times cannot be directly affected, agriculture is highly resistant thanks to seed farms and selective breeding programs, and population suppression drives that might affect wild ecosystems are the most trivial to counter. The primary hazard of gene drive technology is not physical, but social: that unethical closed-door research, overhyped fears, or an unauthorized release into a wild population will damage public trust in science and governance. Sunlight, in the form of new incentives favoring pre-registration of all proposed gene drive research, is the best way to dispel the clouds of fear and uncertainty. Ensuring that research is conducted in the open could lead to external scrutiny of research plans in other fields, potentially enabling nascent technological hazards to be identified early enough to intervene. ItemGenome Editing, The Bioeconomy, and Security(George Mason University, 2018-12) Carter, Sarah R.The landscape of genome editing technologies, capabilities, and applications is rapidly changing, which creates critical challenges in identifying and addressing biosecurity risks. The commercial opportunities for genome editing and its regulatory context will be key factors in determining how these tools are developed, disseminated, and used. This paper looks at these complex links and what they might mean for biosecurity and governance. The first section discusses commercial opportunities for genome editing with a focus on animal engineering, plant engineering, and industrial applications for engineered microbes. Therapeutic applications, though an important part of both the bioeconomy and the potential biosecurity risks that arise from genome editing, have been covered elsewhere and are discussed only briefly. The second section discusses the regulatory context in the U.S. for genome editing applications. Some genome edited products (e.g. many plants) are unlikely to be regulated in the same way as earlier generations of biotechnology, while there is a great deal of uncertainty for other products (e.g. many animals). The regulatory process has played an important role in the shape of the biotechnology industry to date, and recent developments could have major implications for how products are pursued (and by whom) in the future. The last section discusses some of the biosecurity and governance challenges that arise from the use of genome editing. The widespread and diffuse nature of the technology and how it is used will make it difficult to identify, scope, and prioritize biosecurity risks that deserve attention. To be successful, governance mechanisms must rely on the community (including researchers, industry, and broader scientific stakeholders) in their development and implementation.