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Introduction

Laws and institutions must go hand in hand with the progress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions change, with the change of circumstances, institutions must advance also to keep pace with the times.

Thomas Jefferson

The turn of the millennium brought into view a new research landscape in which the biological sciences loom large and where technical possibilities barely dreamt of decades ago seem legitimately attainable. The biological sciences of this century are the product of decades of advances in, for example, genetics and genomics, molecular and systems biology, and bioengineering technologies. Modern biology also draws upon and incorporates discoveries from beyond the life sciences. Disciplines as diverse as engineering, chemistry, computing, and social science have all played important roles in shaping the biology of the 21st century.

Interconnectedness defines today’s biology and offers, in places, an unprecedented and exponentially increasing linkage of many streams of discoveries and innovations.1 Biology also has become a global endeavor, with networking technologies enabling new modes of collaboration amongst multidisciplinary teams from around the world. In this networked world, researchers have the ability to develop partnerships that foster novel approaches to scientific inquiry, ask new questions about the mechanisms of life, and address global needs in innovative ways.

But the new century brings new challenges. An ever-increasing world population means a host of new problems—climate change, increasing food and

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1 Thomas Lee, Director, Microsystems Technology Office, Defense Advanced Research Projects Agency.



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1 Introduction Laws and institutions must go hand in hand with the pro- gress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions change, with the change of circumstances, institutions must advance also to keep pace with the times. Thomas Jefferson The turn of the millennium brought into view a new research landscape in which the biological sciences loom large and where technical possibilities barely dreamt of decades ago seem legitimately attainable. The biological sciences of this century are the product of decades of advances in, for example, genetics and genomics, molecular and systems biology, and bioengineering technologies. Modern biology also draws upon and incorporates discoveries from beyond the life sciences. Disciplines as diverse as engineering, chemistry, computing, and social science have all played important roles in shaping the biology of the 21st century. Interconnectedness defines today’s biology and offers, in places, an un- precedented and exponentially increasing linkage of many streams of discover- ies and innovations.1 Biology also has become a global endeavor, with network- ing technologies enabling new modes of collaboration amongst multidisciplinary teams from around the world. In this networked world, researchers have the abil- ity to develop partnerships that foster novel approaches to scientific inquiry, ask new questions about the mechanisms of life, and address global needs in innova- tive ways. But the new century brings new challenges. An ever-increasing world population means a host of new problems—climate change, increasing food and 1 Thomas Lee, Director, Microsystems Technology Office, Defense Advanced Research Projects Agency. 1

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2 Positioning Synthetic Biology to Meet the Challenges of the 21st Century energy needs, the dispersion of existing and emerging diseases—and a host of unanswered questions about how human and natural systems might offer solu- tions. Many scientists and engineers believe that some of the challenges of the new century might be met through a young and potentially transformative field—synthetic biology—that seeks to accelerate improvements in how we partner with nature to meet our needs. In the simplest terms, synthetic biology is an emerging discipline that combines both scientific and engineering approaches to the study and manipula- tion of biology. For example, one branch of synthetic biology seeks to apply engineering principles to realize standardized biological parts that can be relia- bly reused “off the shelf” to perform specific functions. Rather than asking “How does an existing natural biological system work?,” such synthetic biolo- gists ask, “What components are necessary to encode a specific behavior within an engineered living system?” By asking different questions, synthetic biologists hope to improve our collective capacity to engineer customized biological sys- tems designed to meet specific human needs. Scientists using synthetic biology- based approaches also hope that constructive approaches to studying biology will yield a deeper understanding of natural living systems. Various approaches are being pursued so as to best practically realize “learning by building” and “scaleable engineering” in synthetic biology. For example, full genome synthesis, when combined with evolutionary screening or selection, can yield improved cellular strains for biomanufacturing while direct- ly supporting “reverse genetics” approaches to scientific discovery. It is important to note that some aspects of synthetic biology research have been technically controversial. Some ask, for example, whether genetic parts can ever be reliably standardized for reuse across changing genetic and environmen- tal contexts. Within the research community, synthetic biology fosters relationships across a unique and global assemblage of practitioners that extends beyond es- tablished academics and students working in traditional institutions and includes members of the do-it-yourself (DIY) community of amateur researchers. Fur- ther, the connectivity offered by the World Wide Web gives researchers an un- precedented opportunity to network, collaborate, and share research results across communities and nations. Although synthetic biology is still in its infancy—core research has largely been confined to efforts to identify and refine biological units that perform spe- cific genetic or biochemical functions and to improve DNA synthesis and con- struction methods—the collective vision for the field is ambitious. Progress in synthetic biology, proponents believe, will enhance human potential through an interlocked cycle in which incremental advances expand our understanding of life. Deepening our understanding of natural biological processes will, in turn, improve the biological “toolbox” that gives scientists and engineers the means to engineer organisms that offer new forms of pollution control, novel medications, and sources of energy. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do not exist in natural sys-

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Introduction 3 tems—capabilities that may ultimately be used for applications in manufactur- ing, food production, and global health. Even though research has largely been limited to work at the molecular or cellular level, governments and industries worldwide are investing significant resources in synthetic biology research and product development. Synthetic biology—unlike any research discipline that preceeds 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. Thus, while synthetic biology is still a nascent area of research, it has attracted significant attention. Many questions, however, remain:  What solutions can synthetic biology realistically offer for today’s global challenges?  How may we best prepare researchers for work in synthetic biology?  What are the commercial, industrial, and medical possibilities for syn- thetic biology?  What ethical and social concerns does synthetic biology raise, and how can they be addressed locally or collectively?  How should we best engage the public to enable understanding of the promise and risks of this emerging field?  What intellectual property, patent, sharing and ownership arrangements will best allow synthetic biology to advance?  How should synthetic biology be regulated, and what form should any oversight or governance frameworks take?  Does synthetic biology pose new biosafety and biosecurity concerns, and if so, how may they be addressed effectively? Stakeholders around the world are grappling with such questions. In the United States, for instance, the President’s Commission for the Study of Bioethical Issues has identified essential principles and recommendations for the purpose of guiding ongoing research in synthetic biology.2 And, in response to advances in synthetic biology, the National Institutes of Health has revised its guidelines on recombinant DNA3 based upon the National Science Advisory Board for Bio- security’s consideration of synthetic biology in the context of dual use research.4 2 Anita L. Allen, Henry R. Silverman Professor of Law and Professor of Philosophy, University of Pennsylvania Law School and a member of the Presidents’ Commission, discussed the commission’s recommendations at the Shanghai symposium. See page 22 of this report. 3 Department of Health and Human Services, National Institutes of Health March, 2013. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Online at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html (accessed March 27, 2013). 4 National Science Advisory Board for Biosecurity (NSABB), April 2010. Addressing Biosecurity Concerns Related to Synthetic Biology: Report of the National Science Advisory

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4 Positioning Synthetic Biology to Meet the Challenges of the 21st Century Nevertheless, as serious discussions about synthetic biology are only beginning, many questions remain about how to best manage, stimulate, and govern the continued development of the field. The resolution of these questions requires input from the public and private communities of stakeholders. Importantly, synthetic biology is 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. Inev- itably, this will affect how the field develops within nations and internationally. As science and engineering research becomes more global, international engagement on emerging technologies is critical. It has becoming increasingly difficult to place limitations on scientific advances or to expect that norms and protocols developed in one country will be followed in another. Only with an international exchange of ideas on scientific and technical challenges—as well as policy, regulatory, and legal challenges that arise around emerging scientific fields—will it be possible for the global network of scientists, engineers, and policymakers to develop mechanisms that encourage continued advances in emerging fields while increasing awareness of—and proactively addressing— challenges that may arise. As a better understanding of the global synthetic biology landscape could lead to tremendous benefits, six academies—the United Kingdom’s Royal Society (RS) and Royal Academy of Engineering (RAE), the United States’ National Academy of Sciences (NAS) and National Academy of Engineering (NAE), and the Chinese Academy of Science (CAS) and Chinese Academy of Engineering (CAE) organized a series of international symposia on the scientific, technical, and policy issues associated with synthetic biology. The symposia, which were primar- ily funded by the Alfred P. Sloan Foundation,5 built upon previous collaboration between the RS and U.S. agencies and included China because of the country's growing investment in engineering, scientific research, and biotechnology. The Organisation for Economic Co-operation and Development (OECD) also contrib- uted participants and perspectives. Board for Biosecurity (NSABB). Online at http://oba.od.nih.gov/biosecurity/pdf/NSABB% 20SynBio%20DRAFT%20Report-FINAL%20(2)_6-7-10.pdf (accessed March 27, 2013). 5 The Sloan Foundation, which supports research on science, technology, and econom- ic institutions, has supported research in synthetic biology since 2005. The foundation's grants support responsible development of synthetic biology and focus on ethical, regula- tory, and public policy implications and on risks inherent in the field. Sloan grants have included projects to articulate ethical issues, inform the policy and journalism communi- ties, assess the regulatory aspect of synthetic biology, and educate policy makers and the public. The foundation-sponsored Synthetic Biology Project provides a web-based infor- mation clearing-house that includes important events in the field; provides information and analysis on regulatory, ethical, and business developments related to synthetic biolo- gy; and a regularly updated global map of ongoing projects. The Synthetic Biology Pro- ject is hosted by the Woodrow Wilson International Center for Scholars (see http://www. synbioproject.org, accessed May 15, 2013).

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Introduction 5 The three symposia, attended by approximately 500 participants in total, brought together researchers from numerous disciplines—experts in law, proper- ty rights, and ethics; representatives from industry; policymakers; and members of the public—in the first collaboration among the United States, the U.K., and China on synthetic biology. Participants were asked to discuss synthetic biology in terms of its present and future value and to examine the scientific, engineer- ing, societal, and policy implications of this emerging field. The individual symposia, which were held in London, Shanghai, and Washington, DC, were each organized around a specific aspect of synthetic bi- ology.6 The first symposium, in London in April 2011, provided an overview of synthetic biology and developments in the past five years. Participants discussed estimates of what might be achieved in the next 5, 10, and 25 year periods, re- quirements and resources necessary for realizing value creation from synthetic biology, and conditions needed for an enabling environment. The focus of the second symposium, in Shanghai in October 2011, was the scientific and tech- nical challenges that must be met to enable further development of the field. The final symposium, in Washington, DC in June 2012, focused on next-generation tools, platforms, and infrastructure necessary for continued progress in synthetic biology and the associated policy implications. Over the course of the three symposia, the collaborating institutions and participants gained a deeper per- spective on each country's national and insitutional aspirations and accomplish- ments in synthetic biology. Further, presenters and attendees had the opportunity to witness and share in a progression of knowledge and perspective amongst the participating countries from the initial to the final symposia. This report summarizes the major topics addressed during the symposia by symposium participants. These included the development and potential of syn- thetic biology, national and regional plans for the advancement of synthetic bi- ology, and potential benefits and concerns associated with the field. The sum- mary has been prepared by the symposia rapporteurs as a factual summary of what occurred at the symposia. The statements made are those of the rapporteurs or individual symposia participants and do not necessarily represent the views of all symposia participants, the planners of the symposia, or the U.S. National Academies. 6 For details on the specific agendas, see Appendixes A-C.

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