3

Strategies for Advancing
Synthetic Biology

Despite the challenges that lie ahead, both governments and nongovernmental organizations take the promise of synthetic biology seriously. During the two-year period when the three symposia were taking place, the governments of the United Kingdom and China made investments in synthetic biology a priority. Both nations advanced formal strategies and benchmarks for this purpose. Additionally, in Europe, the European Commission (EC)1 and the Organisation for Economic Co-operation and Development (OECD) have taken an active interest in the field. During the course of the symposia series, representatives from China, the United Kingdom, the United States, and the OECD discussed national plans, as well as planned and ongoing international collaborations, for stimulating progress in synthetic biology.

China

In Washington, DC, Xian-en Zhang, Director General, Basic Research Department, China Ministry of Science and Technology, stated that the People’s Republic of China is seeking to position itself as a global leader in synthetic biology. This effort, he said, is motivated by the country's urgent need to address public health, nutrition, and resource needs, as well as a national strategy to promote progress in science and technology. Beginning in 1978, with reforms launched by Deng Xiaoping, China has pursued an aggressive strategy of industrialization and technological development. Investments in bioscience and bio-

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1 As of early 2012, the EC's Sixth Framework Programme for Research, Technologic Development and Demonstration had funded 18 synthetic biology projects totaling over €24 million (Pei, Lei, Sibylle Gaisser, and Markus Schmidt, 2012. “Synthetic biology in the view of European public funding organisations,” Public Understa Sci. February; 21(2): 149-162. Online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3311122, accessed May 15, 2013).



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3 Strategies for Advancing Synthetic Biology Despite the challenges that lie ahead, both governments and non- governmental organizations take the promise of synthetic biology seriously. During the two-year period when the three symposia were taking place, the gov- ernments of the United Kingdom and China made investments in synthetic biol- ogy a priority. Both nations advanced formal strategies and benchmarks for this purpose. Additionally, in Europe, the European Commission (EC)1 and the Organisation for Economic Co-operation and Development (OECD) have taken an active interest in the field. During the course of the symposia series, repre- sentatives from China, the United Kingdom, the United States, and the OECD discussed national plans, as well as planned and ongoing international collabora- tions, for stimulating progress in synthetic biology. China In Washington, DC, Xian-en Zhang, Director General, Basic Research Department, China Ministry of Science and Technology, stated that the People’s Republic of China is seeking to position itself as a global leader in synthetic biology. This effort, he said, is motivated by the country's urgent need to address public health, nutrition, and resource needs, as well as a national strategy to promote progress in science and technology. Beginning in 1978, with reforms launched by Deng Xiaoping, China has pursued an aggressive strategy of indus- trialization and technological development. Investments in bioscience and bio- 1 As of early 2012, the EC's Sixth Framework Programme for Research, Technologic Development and Demonstration had funded 18 synthetic biology projects totaling over €24 million (Pei, Lei, Sibylle Gaisser, and Markus Schmidt, 2012. “Synthetic biology in the view of European public funding organisations,” Public Understa Sci. February; 21(2): 149- 162. Online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3311122, accessed May 15, 2013). 17

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18 Positioning Synthetic Biology to Meet the Challenges of the 21st Century technology are part of this strategy. Zhang noted that since the 1990s, Chinese leaders have prioritized economic development through science and education. China’s aggressive S&T policies have led to significant advances on many scientific fronts, including synthetic biology. China now contributes about 10 percent (some 400 papers) of the annual papers published on synthetic biology.2 These publications are ranked seventh globally in terms of citations. China has several databanks related to synthetic biology. These include a database of genes that have been identified as essential for an organism’s survival and a separate database on prokaryotic and eukaryotic genes. In China, several organizations support research in synthetic biology, Zhang said. These include the Chinese Academy of Science (CAS) (the major science policy advisor to the central government), the Chinese Academy of En- gineering, the national and local offices of the China Academy of Machinery Science and Technology (CAM), and medical universities. Funding for synthetic biology research comes from many sources, including the National Natural Sci- ence Foundation of China, state-level labs, and the CAS Knowledge Innovation Program.3 Expenditure on research now totals 800 billion Yuan per year (about $U.S. 100 billion), with 260 million Yuan allocated for synthetic biology.4 This total research budget accounts for 1.8 percent of China’s gross domestic product or GDP (though this is still less than research funding in the OECD, which ac- counts for 2 percent of GDP, and in the United States, which accounts for 2.7 percent of GDP).5 Despite the many technical challenges facing the field, China sees synthetic biology as ushering in a new era of economic growth powered by technology. According to Dr. Zhang, China has drafted a strategic roadmap that specifies de- sired achievements in technology, industrial applications, medicine, and agricul- ture in five, 10, and 20 year periods (See Box 3-1). In the case of synthetic biolo- gy, the roadmap includes goals related to the availability of comprehensive databases for synthetic parts, a timeframe for the commercial application of engi- neered parts, and a timeframe for clinical application of devices and systems. Guo-ping Zhao, Director, Laboratory of Synthetic Biology, Institute of Plant Physiology and Ecology, Shanghai Institutes for Biological Sciences, not- ed that, besides seeking technological advances, future tasks for China include addressing legal, ethical and security questions such as ensuring that the benefits of synthetic biology will be distributed equitably. Dr. Zhao noted that intellectu- al property, ownership, and sharing arrangements are another concern. Dr. Qiu, 2 Xian-en Zhang, Director General, Basic Research Department, China Ministry of Science and Technology. 3 China is also conducting multi-country research, such as a bilateral project on risk as- sessment and biosafety needs for synthetic biology in Austria and China (see http://www. markusschmidt.eu/fwf/Home.html, accessed May 15, 2013). 4 Zhang. 5 Zhang.

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Strategies for Advancing Synthetic Biology 19 BOX 3-1 Strategic Targets for Synthetic Biology in China 5 years:  Database of standardized parts and computational competency for designing parts and devices  Module design and production of chemicals and biomaterials  Validated design of devices to increase plant tolerance of drought and salinity 10 years:  Expanded database of standardized parts and devices and computational competency for design of bio-systems  Commercial production of selected chemicals and biomaterials  Validated design of synthetic devices for nitrogen fixation 20 years:  Integrated platforms for design, modeling, and validation of bio-systems  Commercial production of a range of natural compounds, drugs, chemicals, and biofuels  Clinical application of devices and bio-systems for detecting, controlling, or treating major diseases  Creation of artificial microbial life Emeritus Professor of the Institute of Philosophy and Honorary Director, Center for Applied Ethics, Chinese Academy of Social Sciences, added that protecting the health and safety of those who work in the discipline is also a priority, and Dr. Zhao stated that China seeks to work with international collaborators to de- velop approaches to all these issues. United Kingdom In Washington, DC, John Perkins, Chief Scientific Adviser, Business & Skills Group, Department for Business, Innovation & Skills, U.K. Government, stated that the U.K. government is keen to assume a leadership role in synthetic biology. According to Perkins, the U.K. government views synthetic biology as a potentially revolutionary platform with very promising commercial possibili- ties. The U.K. government is actively seeking to build a thriving synthetic biol- ogy community with strong links to industry. Further, Perkins stated that the government has made a commitment to establish a Synthetic Biology Leader- ship Council6 co-chaired by a Minister and a senior industry figure. This council 6 The Synthetic Biology Leadership Council (SBLC) was established in December 2012 under the joint chairmanship of the Right Honorable David Willets, MP and Lionel

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20 Positioning Synthetic Biology to Meet the Challenges of the 21st Century will serve as the major vehicle of “vertical policies” designed to stimulate dis- cussion and partnership among various sectors. The Cabinet of the United Kingdom sets strategic direction. The Research Councils and the Technological Strategy Board (TSB) provide independent evaluations of scientific issues. The U.K.’s TSB, a public entity focused on in- creasing innovation in technological fields with commercial potential, has in- cluded synthetic biology on its short list of the top four emerging technologies and has estimated that the field will generate a market worth up to $20 billion by 2020. This projection, Perkins said, caused an independent, industry-led group to develop a roadmap for making the U.K. a leader in synthetic biology. The roadmap, which presents five recommendations, emphasizes as a necessary first step building a strong and multifaceted community of stakeholders.7 The United Kingdom intends to make investments in synthetic biology in the following areas:  Public funding of £50 million, including up to £6.5 million to encour- age investment by industry  Funding of £6 million from the Engineering and Physical Science Re- search Council to encourage universities to investigate the commercial- ization of new products  Integration of funding for studies in both research and development and related ethical, legal, and social implications (ESLI)8  Support from the Biotechnology and Biological Science Research Council for 16 agencies for five transnational research projects  Earmarking £100 million to sequence 100,000 whole genomes of pa- tients of the National Health Service over the next three to five years. According to Perkins, the U.K. government’s next step will be to form a minis- ter-led leadership council that will manage the direction of ongoing research. Perkins noted that, from the U.K. perspective, major challenges are the management of the complexity and expectations of synthetic biology, the trans- lation of innovations in synthetic biology from “lab to life,” and the need for continued public engagement. A failure to engage the public in discussion of synthetic biology, he said will hamper the field’s future development. In Shanghai, Paul Gemmill, Director of Communications and Information Management, U.K. Biology and Biotechnology Research Council, emphasized Clarke. The Council's purpose is to coordinate interventions taken to implement the U.K.'s synthetic biology roadmap (see https://connect.innovateuk.org/web/synthetic- biology-special-interest-group/synbio-leadership-council, accessed May 14, 2013). 7 UK Synthetic Biology Strategy Group, 2012. A Synthetic Biology Roadmap for the UK. Swindon, UK: Technology Strategy Board (TSB). Online at http://www.rcuk.ac.uk/ documents/publications/SyntheticBiologyRoadmap.pdf, accessed March 27, 2013. 8 Pei, Lei, Sybille Gaisser, and Markus Schmidt, 2012. “Synthetic biology in the view of European public funding organisations,” Public Underst Sci 21(2): 149-162, February.

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Strategies for Advancing Synthetic Biology 21 the seriousness of the U.K.’s effort to engage the public by stating that doing so is an integral part of the country’s plan for synthetic biology. “We have had problems in the past explaining novel technologies,” he said. “The public thought that their questions were not properly answered.” In 2009, the U.K. government initiated a series of public dialogues on syn- thetic biology. During these dialogues, a diverse group of citizens met with sci- entists to explore questions regarding synthetic biology and to discuss mecha- nisms for oversight and governance of the field. Gemmill said that these public dialogues revealed that there is a high level of support for synthetic biology by the British public. Communities see opportunities to use synthetic biology to address numerous global problems, he said, but they also express concerns about where the technology will lead, how quickly it will proceed, and what the long- term consequences might be. The report on the dialogues addresses three broad areas:  Questions for scientists on the purpose and benefits of synthetic biology  Recommendations for regulation—including a recommendation against self-regulation, a requirement that laws stay current with changes in science, and an emphasis on alignment with international regulations  Recommended applications including medicine (approved by 80 per- cent of those polled), energy (78 percent), environment and bioreme- diation (58 percent), and food (55 percent). The last recommendation clearly indicates the public’s priorities, Gemmill said. These align, he observed, with the priorities of scientists. Gemmill stated that the next step will be to integrate the findings from the public dialogues into dis- cussions on future topics. Gemmill concluded his remarks by observing that, “These are the people who one day might, or might not, be buying your product.” United States The United States has been an early leader in synthetic biology. The American synthetic biology community plays a vital role in research and in the development of multi-country partnerships. The U.S. government has invested about $140 million annually in synthetic biology research (See Box 3-2). At the federal level, however, the U.S. government has not developed an overarching funding or governance plan for the field. Though synthetic biology is mentioned in the current administration’s National BioEconomy Blueprint, specific initia- tives for the field are not defined.9 9 The White House, 2012. National Bioeconomy Blueprint. April. Online at http:// www.whitehouse.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_ april_2012.pdf.

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22 Positioning Synthetic Biology to Meet the Challenges of the 21st Century BOX 3-2 Publicly Funded Synthetic Biology Research in the United States The U.S. government supports research in synthetic biology through a variety of national organizations and institutions. For example, the National Science Foun- dation (NSF) has invested about $72 million in research associated with synthetic biology. A 2008 event, the Ideas Factory Sandpit, brought researchers and mentors together to investigate major questions in the field and develop solutions. NSF also supports the Synthetic Biology Engineering Research Center (SynBERC), a multi- institution effort to develop foundational principles and technologies to help synthetic biology advance. Support from the Department of Defense is aimed at speeding production ca- pacity in synthetic biology. The Department’s Defense Advanced Research Project Agency’s (DARPA) Microsystems Technology Office’s Living Foundries program, launched in 2011, seeks to advance synthetic biology as a manufacturing platform. The Department of Energy has launched several initiatives around synthetic biology, including several focused on the mechanisms underlying biofuel produc- a tion. a Woodrow Wilson International Center for Scholars, Synthetic Biology Project, 2012. “Rec- ommendation 2: Support for Promising Research.” Online at http://www.synbioproject.org/score card/recommendations/research/support-for-promising-research, accessed March 27, 2013. In 2010, after the J. Craig Venter Institute publicized the creation of the first cell containing a complete, self-replicating synthetic genome, President Obama directed the Presidential Commission for the Study of Bioethical Issues to review the field of synthetic biology and develop ethical guidelines aimed at providing maximum public benefits while minimizing risks. In Shanghai, 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, reviewed the Commission’s findings and noted that the report did not find a need for new regulation or regulatory mechanisms at this time. The Commission did, however, offer 18 recommendations based on five ethical principles: 1) public beneficence, 2) responsible stewardship, 3) intellectual freedom and responsibility, 4) demo- cratic deliberation, and 5) justice and fairness.10 At the Washington, DC symposium, Jetta Wong, a staff member of the United States House of Representatives’ Committee on Science, Space, and Technology, noted that Congress has established a bipartisan caucus on synthet- ic biology but has not developed a strategic plan for the field. “Right now, Con- gress is focused on jobs, the economy, and the budget deficit. Synthetic biology is not getting much attention,” she said. 10 A follow-up report that was to provide recommendations for agency-specific actions has not been released as of June 2013.

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Strategies for Advancing Synthetic Biology 23 Wong observed that limitations in the public’s understanding of or reac- tion to scientific developments are an obstacle that may affect the advance of technology-based projects in developing areas such as biofuel production and genetically modified food. She observed that government infrastructure, includ- ing the organization of Congressional committees and the mandates and focus areas of government institutions, can also create a “stovepipe” effect. Advancing synthetic biology will require mechanisms that enable collaboration among these different entities, Wong said. An additional challenge is that, in the Amer- ican political system, action is focused on immediate concerns and expressed public interests. Without strong input from the public or interested groups, is- sues tend not to advance. Wong noted, however, that timely input by citizens and interest groups can influence legislation. This was the case with the National Research Council publication, A New Biology for the 21st Century. According to Wong, as a result of the report, the House of Representatives included provi- sions on synthetic biology in the recently passed Manufacturing Competitive- ness Act. According to Wong, funding for science—considered a vital element of economic development by the present administration and the Congress—is rela- tively strong in the United States. In the case of synthetic biology, the U.S. Na- tional Science Foundation contributed $16 million to the Synthetic Biology Engi- neering Research Center (SynBERC) based at University of California, Berkeley. A joint effort by the U.S. Department of Energy and British Petroleum (BP) creat- ed the $500 million Energy Biosciences Institute, where synthetic biology will play a significant role. Private philanthropy is also contributing to synthetic biolo- gy: the Bill & Melinda Gates Foundation have invested $43 million into medical applications of synthetic biology, for example. Organisation for Economic Co-operation and Development In Washington, DC, Gerardo Jiménez-Sanchez, Chairman, Working Party on Biotechnology, OECD and Chair, HUGO Committee on Genomics and the Bioeconomy, National Academy of Medicine, Mexico, reported that the OECD views genomics, biotechnology, and sustainable production of biomass as priori- ty development areas for the next 30 years.11,12 Jiménez-Sanchez noted that in- terest in the potential of emerging technologies (and in their potential effect on social and economic well-being) has risen among member countries. He stated that half of the OECD’s 34 countries are conducting initiatives on synthetic bi- ology. Responding to this interest, the OECD has participated or collaborated in 11 OECD, 2009. The Bioeconomy to 2030: Designing a Policy Agenda. CITY? OECD International Futures Project. Online at http://www.oecd.org/futures/long-termtechnolo gicalsocietalchallenges/42837897.pdf, accessed March 27, 2013. 12 European Scientific Advisory Council (EASAC), 2010. “Realising European Poten- tial in Synthetic Biology: Scientific Opportunities and Good Governance,” EASAC Poli- cy Report 13. Halle, Germany: German Academy of Sciences Leopoldina.

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24 Positioning Synthetic Biology to Meet the Challenges of the 21st Century a series of events designed to explore synthetic biology’s potential as a driver of economic growth. Jiménez-Sanchez stated that the OECD has strategic alliances with other international agencies conducting activities related to synthetic biology. Events and publications resulting from these collaborations include:  Opportunities and Challenges in the Emerging Field of Synthetic Biol- ogy: A Symposium (in collaboration with the U.S. National Academies and The Royal Society), 2009 and the summary report, Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biol- ogy: Synthesis Report, 2010 (Royal Society and OECD).  Workshop on genomics and the bioeconomy, May 2010, Montpelier, France. Participants reached consensus on the need for guidelines on in- ternational cooperation, innovative intellectual property management, and ways of measuring the impact of genomics.  Delivering Economic Value from Synthetic Biology, a summit in Sydney, Australia, in March 2012. Jiménez-Sanchez also reported that the OECD has also engaged in discus- sions with the international collaborative project SynBio13 and the U.S.-based BioBricks Foundation.14 As a result of these discussions, the OECD has identi- fied three areas where it might focus future attention: 1) needed infrastructure; 2) approaches for IP access and sharing; and 3) standards and interoperability.15 13 SynBio is a collaborative project to create new biologically based pharmaceutical products. It was launched in 2011 with participation from companies in Russia, the U.K., and Germany. 14 The BioBricks Foundation is a nonprofit organization that seeks to provide open- source biological parts—DNA sequences with specific structures and functions that can be introduced into living cells to create new functions. 15 OECD and Royal Society, 2010. Opportunities and Challenges in the Emerging Field of Synthetic Biology: Synthesis Report. Paris: OECD and Royal Society.