Download or read book Synthetic Biology and the U S Biotechnology Regulatory System written by and published by . This book was released on 2014 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options Sarah R. Carter, Ph.D., J. Craig Venter Institute; Michael Rodemeyer, J.D., University of Virginia; Michele S. Garfinkel, Ph.D., EMBO; Robert M. Friedman, Ph.D., J. Craig Venter Institute In recent years, a range of genetic engineering techniques referred to as "synthetic biology" has significantly expanded the tool kit available to scientists and engineers, providing them with far greater capabilities to engineer organisms than previous techniques allowed. The field of synthetic biology includes the relatively new ability to synthesize long pieces of DNA from chemicals, as well as improved methods for genetic manipulation and design of genetic pathways to achieve more precise control of biological systems. These advances will help usher in a new generation of genetically engineered microbes, plants, and animals. The JCVI Policy Center team, along with researchers at the University of Virginia and EMBO, examined how well the current U.S. regulatory system for genetically engineered products will handle the near-term introduction of organisms engineered using synthetic biology. In particular, the focus was on those organisms intended to be used or grown directly in the environment, outside of a contained facility. The study concludes that the U.S. regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed by these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. However, the study also identified two key challenges for the regulatory system, which are detailed in the report. First, USDA's authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic engineering techniques will leave many engineered plants without any pre-market regulatory review. Second, the number and diversity of engineered microbes for commercial use will increase in the near future, challenging EPA's resources, expertise, and perhaps authority to regulate them. For each of these challenges, the report sets out a series of options, including an analysis of the advantages and disadvantages of each option from a variety of perspectives, for policy makers to consider. Policy responses will depend on the trade-offs chosen among competing considerations. This report, funded by the Department of Energy with additional funds from the Alfred P. Sloan Foundation, is the result of a two-year process that included interviews, commissioned background papers, discussions, and two workshops that sought input from a wide range of experts, including U.S. federal agency regulators, legal and science policy experts, representatives from the biotechnology indusƠtry, and non-governmental organizaƠtions. This cross-section of views informed this report, but the conclusions are solely those of the authors. An Executive Summary, full Report, and background papers are available at: http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-system/overview.
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-06-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Download or read book The Science and Applications of Synthetic and Systems Biology written by Institute of Medicine and published by National Academies Press. This book was released on 2011-12-30 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many potential applications of synthetic and systems biology are relevant to the challenges associated with the detection, surveillance, and responses to emerging and re-emerging infectious diseases. On March 14 and 15, 2011, the Institute of Medicine's (IOM's) Forum on Microbial Threats convened a public workshop in Washington, DC, to explore the current state of the science of synthetic biology, including its dependency on systems biology; discussed the different approaches that scientists are taking to engineer, or reengineer, biological systems; and discussed how the tools and approaches of synthetic and systems biology were being applied to mitigate the risks associated with emerging infectious diseases. The Science and Applications of Synthetic and Systems Biology is organized into sections as a topic-by-topic distillation of the presentations and discussions that took place at the workshop. Its purpose is to present information from relevant experience, to delineate a range of pivotal issues and their respective challenges, and to offer differing perspectives on the topic as discussed and described by the workshop participants. This report also includes a collection of individually authored papers and commentary.
Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.
Download or read book Regulation of Synthetic Biology written by Alison McLennan and published by Edward Elgar Publishing. This book was released on 2018-04-27 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
Download or read book Synthetic Biology written by Bernd Giese and published by Springer. This book was released on 2014-09-27 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic Biology is already an object of intensive debate. However, to a great extent the discussion to date has been concerned with fundamental ethical, religious and philosophical questions. By contrast, based on an investigation of the field’s scientific and technological character, this book focuses on new functionalities provided by synthetic biology and explores the associated opportunities and risks. Following an introduction to the subject and a discussion of the most central paradigms and methodologies, the book provides an overview of the structure of this field of science and technology. It informs the reader about the current stage of development, as well as topical problems and potential opportunities in important fields of application. But not only the science itself is in focus. In order to investigate its broader impact, ecological as well as ethical implications will be considered, paving the way for a discussion of responsibilities in the context of a field at a transitional crossroads between basic and applied science. In closing, the requirements for a suitable regulatory framework are discussed. The book is intended as a source of information and orientation for researchers, students and practitioners in the natural sciences and technology assessment; for members of scientific and technological, governmental and funding institutions; and for members of the general public interested in essential information on the current status, prospects and implications of synthetic biology.
Download or read book Synthetic Biology written by Lewis D. Solomon and published by Routledge. This book was released on 2017-09-08 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: For nearly forty years, using recombinant DNA tools, researchers, and then businesses, have genetically engineered organisms by transferring naturally occurring genes from one organism into another. Doing so modifies the genetic code of living cells, imparting new traits and achieving desired results; this is done in the production of proteins, pharmaceuticals, and seeds. Synthetic biology, argues Solomon, could free scientists from the need to find natural genes to make such desired modifications. Synthetic biology permits more complex and sophisticated bioengineering than what can be achieved through previous genetic modification techniques. Drawing on non-biological scientific and engineering disciplines, including information technology and nanotechnology, synthetic biology strives to rearrange an organism's genes on a far wider scale by rewriting its genetic code, the chemical instructions need to design, assemble, and operate a species. By allowing the writing of artificial genetic codes, synthetic biology can transform existing industries and spawn new ones, creating new products as well as radically reshaping existing items. Arguing for self-regulation by the scientific and business communities, Lewis D. Solomon recommends a policy framework that would guard against governmental overregulation, which could create a barrier to innovation. Although synthetic biotechnology holds considerable social and economic potential, absent a nurturing regulatory climate, it may prove difficult to translate research discoveries into commercially viable applications.
Download or read book Industrialization of Biology written by National Research Council and published by National Academies Press. This book was released on 2015-06-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
Download or read book Positioning Synthetic Biology to Meet the Challenges of the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2013-08-05 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic biology-unlike any research discipline that precedes it-has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do not exist in natural systems-capabilities that may ultimately be used for applications in manufacturing, food production, and global health. Importantly, synthetic biology represents an area of science and engineering that raises technical, ethical, regulatory, security, biosafety, intellectual property, and other issues that will be resolved differently in different parts of the world. As a better understanding of the global synthetic biology landscape could lead to tremendous benefits, six academies-the United Kingdom's Royal Society and Royal Academy of Engineering, the United States' National Academy of Sciences and National Academy of Engineering, and the Chinese Academy of Science and Chinese Academy of Engineering-organized a series of international symposia on the scientific, technical, and policy issues associated with synthetic biology. Positioning Synthetic Biology to Meet the Challenges of the 21st Century summarizes the symposia proceedings.
Download or read book Regulation of Agricultural Biotechnology The United States and Canada written by Chris A. Wozniak and published by Springer Science & Business Media. This book was released on 2012-10-05 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: Agricultural biotechnology takes many forms and applications, with the number and diversity of products ever increasing. With this rapid development, regulatory authorities have sought to keep pace through regulatory adjustments and advances to ensure the safe and beneficial use of this critical technology. The regulatory systems for the U.S. and Canada are not static and must evolve in order to maintain relevance, efficiency and applicability to the challenges encountered. The diverse authors, drawn from the biotechnology industry, academia, government research and regulatory agencies, offer their perspectives of the historical and current system and suggest where it can be improved in the future. Based upon vast experience interacting with the regulatory system, the editors and authors offer demystifying views of the US and Canadian regulatory structures and how they came to be. We know of no other effort to present the biotechnology regulatory systems of the US and Canada in an open forum which will benefit those in the regulated community as well as those charged with oversight of the products of biotechnology, and ultimately the consumer!
Download or read book Emerging Threats of Synthetic Biology and Biotechnology written by Benjamin D. Trump and published by Springer Nature. This book was released on 2021 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic biology is a field of biotechnology that is rapidly growing in various applications, such as in medicine, environmental sustainability, and energy production. However these technologies also have unforeseen risks and applications to humans and the environment. This open access book presents discussions on risks and mitigation strategies for these technologies including biosecurity, or the potential of synthetic biology technologies and processes to be deliberately misused for nefarious purposes. The book presents strategies to prevent, mitigate, and recover from 'dual-use concern' biosecurity challenges that may be raised by individuals, rogue states, or non-state actors. Several key topics are explored including opportunities to develop more coherent and scalable approaches to govern biosecurity from a laboratory perspective up to the international scale and strategies to prevent potential health and environmental hazards posed by deliberate misuse of synthetic biology without stifling innovation. The book brings together the expertise of top scholars in synthetic biology and biotechnology risk assessment, management, and communication to discuss potential biosecurity governing strategies and offer perspectives for collaboration in oversight and future regulatory guidance.
Download or read book Positioning Synthetic Biology to Meet the Challenges of the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2013-09-05 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic biology-unlike any research discipline that precedes it-has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do not exist in natural systems-capabilities that may ultimately be used for applications in manufacturing, food production, and global health. Importantly, synthetic biology represents an area of science and engineering that raises technical, ethical, regulatory, security, biosafety, intellectual property, and other issues that will be resolved differently in different parts of the world. As a better understanding of the global synthetic biology landscape could lead to tremendous benefits, six academies-the United Kingdom's Royal Society and Royal Academy of Engineering, the United States' National Academy of Sciences and National Academy of Engineering, and the Chinese Academy of Science and Chinese Academy of Engineering-organized a series of international symposia on the scientific, technical, and policy issues associated with synthetic biology. Positioning Synthetic Biology to Meet the Challenges of the 21st Century summarizes the symposia proceedings.
Download or read book Systems and Synthetic Biology written by Vikram Singh and published by Springer. This book was released on 2014-12-15 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook has been conceptualized to provide a detailed description of the various aspects of Systems and Synthetic Biology, keeping the requirements of M.Sc. and Ph.D. students in mind. Also, it is hoped that this book will mentor young scientists who are willing to contribute to this area but do not know from where to begin. The book has been divided into two sections. The first section will deal with systems biology – in terms of the foundational understanding, highlighting issues in biological complexity, methods of analysis and various aspects of modelling. The second section deals with the engineering concepts, design strategies of the biological systems ranging from simple DNA/RNA fragments, switches and oscillators, molecular pathways to a complete synthetic cell will be described. Finally, the book will offer expert opinions in legal, safety, security and social issues to present a well-balanced information both for students and scientists.
Download or read book Synthetic Biology Analysed written by Margret Engelhard and published by Springer. This book was released on 2016-04-15 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic biology is a dynamic, young, ambitious, attractive, and heterogeneous scientific discipline. It is constantly developing and changing, which makes societal evaluation of this emerging new science a challenging task, prone to misunderstandings. Synthetic biology is difficult to capture, and confusion arises not only regarding which part of synthetic biology the discussion is about, but also with respect to the underlying concepts in use. This book offers a useful toolbox to approach this complex and fragmented field. It provides a biological access to the discussion using a 'layer' model that describes the connectivity of synthetic or semisynthetic organisms and cells to the realm of natural organisms derived by evolution.Instead of directly reviewing the field as a whole, firstly our book addresses the characteristic features of synthetic biology that are relevant to the societal discussion. Some of these features apply only to parts of synthetic biology, whereas others are relevant to synthetic biology as a whole. In the next step, these new features are evaluated with respect to the different areas of synthetic biology. Do we have the right words and categories to talk about these new features? In the third step, traditional concepts like “life” and “artificiality” are scrutinized with regard to their discriminatory power. This approach may help to differentiate the discussion on synthetic biology. Lastly our refined view is utilized for societal evaluation. We have investigated the public views and attitudes to synthetic biology. It also includes the analysis of ethical, risk and legal questions, posed by present and future practices of synthetic biology.This book contains the results of an interdisciplinary research project and presents the authors’ main findings and recommendations. They are addressed to science, industry, politics and the general public interested in this upcoming field of biotechnology.
Download or read book Synthetic Biology 2020 Frontiers in Risk Analysis and Governance written by Benjamin D. Trump and published by Springer Nature. This book was released on 2019-11-28 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic biology offers powerful remedies for some of the world’s most intractable problems, but these solutions are clouded by uncertainty and risk that few strategies are available to address. The incentives for continued development of this emerging technology are prodigious and obvious, and the public deserves assurances that all potential downsides are duly considered and minimized accordingly. Incorporating social science analysis within the innovation process may impose constraints, but its simultaneous support in making the end products more acceptable to society at large should be considered a worthy trade-off. Contributing authors in this volume represent diverse perspectives related to synthetic biology’s social sciences, and reflect on different areas of risk analysis and governance that have developed for the field. Such perspectives include leading scholarly discussion pertaining to risk assessment, governance, ethics, and communication. The chapters of this volume note that while the first twenty years of synthetic biology development have focused strongly on technological innovation and product development, the next twenty should emphasize the synergy between developers, policymakers, and publics to generate the most beneficial, well governed, and transparent technologies and products possible. Many chapters in this volume provide new data and approaches that demonstrate the feasibility for multi-stakeholder efforts involving policymakers, regulators, industrial developers, workers, experts, and societal representatives to share responsibilities in the production of effective and acceptable governance in the face of uncertain risk probabilities. A full consideration of such perspectives may prevent a world of draconian regulations based on an insufficient or incomplete understanding of the science that underpins synthetic biology, as well as any hesitancy or fear by the public to adopt its eventual products.
Download or read book Synthetic Biology written by Huimin Zhao and published by Academic Press. This book was released on 2013-03-21 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthetic Biology provides a framework to examine key enabling components in the emerging area of synthetic biology. Chapters contributed by leaders in the field address tools and methodologies developed for engineering biological systems at many levels, including molecular, pathway, network, whole cell, and multi-cell levels. The book highlights exciting practical applications of synthetic biology such as microbial production of biofuels and drugs, artificial cells, synthetic viruses, and artificial photosynthesis. The roles of computers and computational design are discussed, as well as future prospects in the field, including cell-free synthetic biology and engineering synthetic ecosystems.Synthetic biology is the design and construction of new biological entities, such as enzymes, genetic circuits, and cells, or the redesign of existing biological systems. It builds on the advances in molecular, cell, and systems biology and seeks to transform biology in the same way that synthesis transformed chemistry and integrated circuit design transformed computing. The element that distinguishes synthetic biology from traditional molecular and cellular biology is the focus on the design and construction of core components that can be modeled, understood, and tuned to meet specific performance criteria and the assembly of these smaller parts and devices into larger integrated systems that solve specific biotechnology problems. - Includes contributions from leaders in the field presents examples of ambitious synthetic biology efforts including creation of artificial cells from scratch, cell-free synthesis of chemicals, fuels, and proteins, engineering of artificial photosynthesis for biofuels production, and creation of unnatural living organisms - Describes the latest state-of-the-art tools developed for low-cost synthesis of ever-increasing sizes of DNA and efficient modification of proteins, pathways, and genomes - Highlights key technologies for analyzing biological systems at the genomic, proteomic, and metabolomic levels which are especially valuable in pathway, whole cell, and multi-cell applications - Details mathematical modeling tools and computational tools which can dramatically increase the speed of the design process as well as reduce the cost of development
