Synthetic Biology 2020: Frontiers in Risk Analysis and Governance
Synthetic Biology 2020: Frontiers in Risk Analysis and Governance

Author: Benjamin D. Trump

Publisher: Springer Nature

Published: 2019-11-28

Total Pages: 434

ISBN-13: 3030272648

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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.

Regulation of Synthetic Biology
Regulation of Synthetic Biology

Author: Alison McLennan

Publisher: Edward Elgar Publishing

Published: 2018-04-27

Total Pages: 283

ISBN-13: 178536944X

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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.

Biodefense in the Age of Synthetic Biology
Biodefense in the Age of Synthetic Biology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-01-05

Total Pages: 189

ISBN-13: 0309465184

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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.

Preparing for Future Products of Biotechnology
Preparing for Future Products of Biotechnology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-28

Total Pages: 231

ISBN-13: 0309452058

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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.

Emerging Policy Issues in Synthetic Biology
Emerging Policy Issues in Synthetic Biology

Author: Organization for Economic Cooperation and Development

Publisher: OCDE

Published: 2014

Total Pages: 0

ISBN-13: 9789264208414

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Synthetic biology is at such an early stage of development that there is no uniform agreement as yet about what it actually is. To some, it represents a natural extension of genetic engineering, and therefore is "business as usual". For others, it is a way to bring mass manufacturing out from the decades of biotechnology research. Currently the discipline is limited by the ability to synthesise DNA cost-effectively but this is a technical barrier that it is anticipated will be overcome. Synthetic biology raises a number of policy issues around R&D funding, company investment, PPP arrangements and innovative financing, infrastructure requirements, education and training, intellectual property (IP), regulation, and public engagement. In preparation for the continuing development and greater use of synthetic biology, some countries have started to prepare synthetic biology technical roadmaps and a global roadmap for the medium term would be an extremely useful policy tool. Technical roadmaps could both identify likely future policy requirements, and be a useful vehicle in public engagement.

Strange Natures
Strange Natures

Author: Kent H. Redford

Publisher: Yale University Press

Published: 2021-06-22

Total Pages: 296

ISBN-13: 0300230974

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A groundbreaking examination of the implications of synthetic biology for biodiversity conservation Nature almost everywhere survives on human terms. The distinction between what is natural and what is human-made, which has informed conservation for centuries, has become blurred. When scientists can reshape genes more or less at will, what does it mean to conserve nature? The tools of synthetic biology are changing the way we answer that question. Gene editing technology is already transforming the agriculture and biotechnology industries. What happens if synthetic biology is also used in conservation to control invasive species, fight wildlife disease, or even bring extinct species back from the dead? Conservation scientist Kent Redford and geographer Bill Adams turn to synthetic biology, ecological restoration, political ecology, and de-extinction studies and propose a thoroughly innovative vision for protecting nature.

Industrialization of Biology
Industrialization of Biology

Author: National Research Council

Publisher: National Academies Press

Published: 2015-06-29

Total Pages: 158

ISBN-13: 0309316553

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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.

Gene Drives on the Horizon
Gene Drives on the Horizon

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-08-28

Total Pages: 231

ISBN-13: 0309437873

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Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.

Responsible Innovation
Responsible Innovation

Author: Richard Owen

Publisher: John Wiley & Sons

Published: 2013-03-21

Total Pages: 361

ISBN-13: 1118551400

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Science and innovation have the power to transform our lives and the world we live in - for better or worse – in ways that often transcend borders and generations: from the innovation of complex financial products that played such an important role in the recent financial crisis to current proposals to intentionally engineer our Earth’s climate. The promise of science and innovation brings with it ethical dilemmas and impacts which are often uncertain and unpredictable: it is often only once these have emerged that we feel able to control them. How do we undertake science and innovation responsibly under such conditions, towards not only socially acceptable, but socially desirable goals and in a way that is democratic, equitable and sustainable? Responsible innovation challenges us all to think about our responsibilities for the future, as scientists, innovators and citizens, and to act upon these. This book begins with a description of the current landscape of innovation and in subsequent chapters offers perspectives on the emerging concept of responsible innovation and its historical foundations, including key elements of a responsible innovation approach and examples of practical implementation. Written in a constructive and accessible way, Responsible Innovation includes chapters on: Innovation and its management in the 21st century A vision and framework for responsible innovation Concepts of future-oriented responsibility as an underpinning philosophy Values – sensitive design Key themes of anticipation, reflection, deliberation and responsiveness Multi – level governance and regulation Perspectives on responsible innovation in finance, ICT, geoengineering and nanotechnology Essentially multidisciplinary in nature, this landmark text combines research from the fields of science and technology studies, philosophy, innovation governance, business studies and beyond to address the question, “How do we ensure the responsible emergence of science and innovation in society?”

Innovation, Dual Use, and Security
Innovation, Dual Use, and Security

Author: Jonathan B. Tucker

Publisher: MIT Press

Published: 2012

Total Pages: 367

ISBN-13: 0262017172

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Recent advances in disciplines such as biotechnology, nanotechnology, and neuropharmacology entail a "dual-use dilemma" because they promise benefits for human health and welfare yet pose the risk of misuse for hostile purposes. The emerging field of synthetic genomics, for example, can produce custom DNA molecules for life-saving drugs but also makes possible the creation of deadly viral agents for biological warfare or terrorism. The challenge for policymakers is to prevent the misuse of these new technologies without forgoing their benefits . Innovation, Dual Use, and Security offers a systematic approach for managing the dual-use dilemma. The book presents a "decision framework" for assessing the security risks of emerging technologies and fashioning governance strategies to manage those risks. This framework is applied to fourteen contemporary case studies, including synthetic genomics, DNA shuffling and directed evolution, combinatorial chemistry, protein engineering, immunological modulation, and aerosol vaccines. The book also draws useful lessons from two historical cases: the development of the V-series nerve agents in Britain and the use and misuse of LSD by the U.S. Army and the CIA. Innovation, Dual Use, and Security offers a comprehensive, multifaceted introduction to the challenges of governing dual-use technologies in an era of rapid innovation. The book will be of interest to government officials and other practitioners as well as to students and scholars in security studies, science and technology studies, biology, and chemistry.