Safeguarding the Bioeconomy (2020) / Chapter Skim
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5 The Ecosystem of the U.S. Bioeconomy
5 The Ecosystem of the U.S. Bioeconomy
Pages 183-232
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• The bioeconomy is an increasingly data-driven enterprise. The development of diagnostics, drugs, synthetic biology products, and more benefits from access to information resources.
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. As the pace of scientific discovery has accelerated and discoveries have evolved into practical applications for commercial products and services, the United States has realized the benefits of a national innovation ecosystem capable of transforming research discoveries into economic and societal benefits.
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Federal sources generally provide support for the earlier stages of these pathways and can be supplemented with philanthropic support, with venture capital investment and commercial funding supporting later stages in the process. Translation into commercial products does not necessarily happen on identical timescales for applications in the health, agriculture, environment, energy, and industrial biotechnology sectors, represented by branching points along the pathway (illustrative only)
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. Supported by federal funding for world-class universities, research nonprofits, and federal research laboratories, the nation's life sciences research enterprise has helped create the foundation for discovery that is required to realize benefits across a variety of applications in health, agriculture, environment, energy, and industrial biotechnology (see Chapter 3 for detail on data and measurement strategies for capturing the scope of the U.S.
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This paradigm has been used to develop enzymes capable of synthesizing new molecules, new routes to biofuels, enzymes used in laundry detergents, and medicines for treating type 2 diabetes. Arnold's approaches are being used broadly by both academic scientists trying to understand basic biological phenomena and industrial scientists bringing new products to market.
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Some enabling technologies (such as next-generation DNA sequencing technology or advanced genome-editing tools) are derived directly from the life sciences community, while others (such as automated liquid handling or machine learning algorithms for data analysis and inference)
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In the life sciences, multiple application areas including human health, agriculture, energy, industrial biotechnology, and the environment are relevant to the bioeconomy. In some cases, diverse applications can arise in the context of a particular biological discovery.
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Federal Agencies Addressing Aspects of Life Sciences Research At least 25 agencies and departments support research and development (R&D) in areas of the life sciences (see Box 5-2, which lists the agencies and departments involved in preparations for the 2012 National Bioeconomy Blueprint)
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THE ECOSYSTEM OF THE U.S. BIOECONOMY 191 BOX 5-2 Examples of Federal Departments and Agencies That Support Biological Research National Aeronautics and Space Administration National Science Foundation Smithsonian Institution U.S.
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However, the endpoint of this basic research phase is typically too early in the maturation of a technology for it to move into the marketplace as a new product or service. At least two sources of investment support businesses seeking to mature technologies into commercial products and processes: the venture capital community and public–private partnerships.
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, after which the technology described in the patent enters the public domain (Title 35 of the U.S. Code -- Patents; NRC, 2004)
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. 7The Q3 2019 Global Venture Capital Report, 07 October 2019, https://news.crunchbase.
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Growth of biotechnology-relevant innovations in the public domain also occurs through the creation of prior art that precludes subsequent patenting. Prior art is information that has been disclosed to the public, before the earliest priority date of a patent application, that would
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In building the set of relevant innovations in the public domain, it is important to recognize that patents are not the only type of IP protection that may limit, albeit temporarily, the use of a technology. Material transfer agreements, or MTAs, are commonly used in the life sciences to govern the use of research materials such as plasmids, antibodies, cell lines, and more.
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bioeconomy, it will be important to ensure that scientists and engineers and the companies and research institutions that employ them are able to effectively leverage and build on technologies in the public domain. USPTO already provides a number of resources and training opportunities to assist inventors, entrepreneurs, and other stakeholders in better understanding and utilizing the patent system.16 In addition, nonprofit organizations such as the Public Intellectual Property Resource for Agriculture (Chi-Ham et al., 2012)
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This regulatory space has the potential for broad impact on the bioeconomy.17 17According to the 2017 Update to the Coordinated Framework: "Examples of TSCA [Toxic Substances Control Act] applications include intergeneric microbial biotechnology products for biomass conversion for chemical production; microbial fuel cells; mining and resource extraction; building materials; waste remediation and pollution control; non-pesticidal agriculture applications such as bio-fertilizers; weather and climate modification; various consumer products and all other applications of intergeneric microbial biotechnology products not otherwise excluded under TSCA" (EOP, 2017, p.
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. In 2019, an Executive Order was released that was aimed at capitalizing on benefits from agricultural biotechnology by modernizing regulatory oversight frameworks (White House, 2019)
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for the Regulation of Biotechnology Products Agency Statute Protection Goal EPA Federal Insecticide, Prevent and eliminate unreasonable Fungicide, and Rodenticide adverse effects on the environment.
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A number of different types of open and proprietary standards and reference materials exist across the life sciences and enabling technologies that contribute to the bioeconomy. These include such diverse examples as the NIST monoclonal antibody reference material standard (NIST RM8671)
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. Targeted Use of Government Purchasing Power and Incentive Programs for Biobased Products The U.S.
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In 2005, USDA designated six product catego ries for the program; in February 2016, the Secretary of Agriculture announced that USDA had certified more than 2,500 biobased products in 100 product categories.b Also in 2016, an economic analysis of the U.S. biobased products industry deter mined that in 2014, it contributed 4.22 million jobs to the U.S.
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In addition to building scientific skills and interest in engineering biology, iGEM emphasizes responsible conduct of the scientific experiments undertaken by teams and promotes such norms.21 IGEM awards are given annually for a large range of topics, 20See http://diy-bio.com/synthetic-biology-graduate-programs. 21See www.igem.org.
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and international bioeconomy workforce. TRENDS AND CHANGES IN THE BIOECONOMY Moving forward, the life sciences communities will likely continue to experience change in the form of growing transdisciplinary and teambased science; an increasing shift toward applying engineering approaches to biology; a global environment for science that is driven by sharing, accessing, and analyzing large amounts of data; and changing stakeholders, workforce, and supply chains.
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Shift Toward Engineering Approaches Research in biology has traditionally focused on small-scale, by-hand experimentation aimed at better understanding of biological phenomena. Breakthroughs in technology have enabled a shift to engineering biology for the manufacture of products.
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The effort resulted from a collaboration between the biopesticide start-up company Mos quitoMateb and Alphabet-backed Verily Life Sciences (Gilbert and Melton, 2018)
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Cost efficiency in clinical characterization (also termed phenotyping) of a population has been driven by secondary use of clinical annotations that are available in electronic health records (EHRs)
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It quickly became apparent that this finding provided an opportunity to engineer a "biological" (i.e., intravenously delivered monoclonal antibody) that would reproduce the effect of the genetic variants.
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; blood and urine chemistries; clinical assessments, including those abstracted from the volunteers' health records; and for subsets of these patients, imaging studies (e.g., cranial magnetic resonance imaging) , genotyping, and whole-exome sequencing.
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The first sequences of a human genome, simultaneously published by the for-profit company Celera Genomics and by the public international Human Genome Sequencing Consortium, depended heavily on the use of data generated by the U.S. government–led Human Genome Project (International Human Genome Sequencing Consortium, 2001; Venter et al., 2001)
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For example, Indigo Ag, a company that develops microbial treatments for crops, purchased satellite imaging company TellusLabs in 2018. According to the two companies, this merger brings together datasets that can be leveraged via machine learning to better target products to individual farms.29 Contribution of Establishing Standards and Frameworks to the Utility of Life Sciences Datasets Establishing common standards and frameworks is important to enable taking advantage of data that can advance basic science discovery and innovation.
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dissemination. Such investments are typically not aligned with the mission of industry; therefore, government support for such infrastructure investments may be justified when considered relative to the cost, in terms of leadership and R&D productivity, of not having such data available.
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in the United States, the European Bioinformatics Institute, and the Swiss Institute of Bioinformatics. The mission of UniProt is to provide the scientific community with a comprehensive, high quality, and freely accessible resource of protein sequence and functional information.a The consortium was launched in 2002 at a time when there was a growing and diverse number of freely accessible databases of information related to proteins, all of which were independently administered and had different underlying schemas and different strengths and weaknesses.
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An example of such a stack used to advance synthetic biology is shown in Figure 5-2. These tool and service provider companies form a life sciences supply chain that can be globally distributed.
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The Changing Bioeconomy Workforce The rapid pace of research and reliance on enabling technologies and data sharing also pose challenges to how life sciences undergraduate and graduate students are trained, indicating that new approaches to education and training will be needed within universities. In addition, R&D activities are no longer limited to university laboratories.
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Within the United States, fermentation capacity is predominantly for bioethanol production. Total production of bioethanol exceeded 15 billion gallons (approximately 57 billion liters)
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corn usage has more than doubled, with the vast majority of that growth going to bioethanol production, and corn usage for feed remaining effectively flat (see Figure 5-5)
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. This trend is mirrored by venture capital funding, which is overwhelmingly concentrated on the coasts, regardless of sector.37 Start-ups in both such traditional sectors as biopharmaceuticals and such emerging sectors as synthetic biology have 36See https://report.nih.gov/award/index.cfm.
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. While bioethanol fermentation and biotech R&D represent just two facets of the bioeconomy, they illustrate the complexities of investing in the bioeconomy's growth.
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STRATEGIC PLANNING IN SUPPORT OF THE U.S. BIOECONOMY The pace of advances in the life sciences and converging scientific and technical fields continues to grow through the efforts of diverse stakeholders in public and private organizations in the United States and around the world and supported by multiple funding sources, as well as a growing system of supply and service provider companies.
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, where evaluation criteria include funding applicants presenting their project outputs in the area of technological and economic development "by describing an envisioned plan to achieve a higher TRL of the processes and technologies."38,39 In another example, the UK Engineering and Physical Sciences Research Council has also applied TRLs to its health care investment framework.40 The concept of TRLs figures explicitly in the definition of the UK National Industrial Biotechnology Strategy for 2030. "The vision 38See https://www.cobiotech.eu/lw_resource/datapool/systemfiles/elements/files/85 886BE9C7161C71E0539A695E865A64/live/document/ERA_CoBioTech_RRI_Framework.
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bioeconomy; trends in the pace, nature, and scope of developments that support life sciences innovation; and a number of areas in which federal and private-sector policies and practices support and sustain U.S. leadership in the bioeconomy.
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224 SAFEGUARDING THE BIOECONOMY FIGURE 5-6 Mapping research generally undertaken or supported by the federal government and universities along a TRL axis. These entities fund primarily TRLs 1–4, basic research to proof of feasibility.
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However, the expanded use of such planning tools as Technology Readiness Levels, bio based procurement programs, and other strategies would provide opportunities to support and grow the bioeconomy across all regions of the United States, enabling bioeconomy development to contribute to both urban and rural prosperity. This chapter of the report has explored how best to sustain the ecosystem of stakeholders within the bioeconomy.
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Presentation to the Committee on Safeguarding the Bioeconomy, January 28. http://nas-sites.org/dels/studies/bioeconomy/meeting-1 (accessed October 30, 2019)
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Executive Order 13563, January 18, 2011. https://obamawhitehouse.archives.gov/the press-office/2011/01/18/executive-order-13563-improving-regulation-and-regulatory review (accessed October 1, 2019)
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energy.gov/sites/prod/files/2019/03/f60/Day%201_Plenary_Male_BETO_Overview. pdf (accessed October 14, 2019)
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University of Dayton Law Review 28:215. https://digitalcommons.law.scu.edu/facpubs/80 (accessed October 14, 2019)
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Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture, July 2. https://www.epa.gov/sites/production/ files/2016-12/documents/modernizing_the_reg_system_for_biotech_products_ memo_final.pdf (accessed October 30, 2019)
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com/abstract=2426235 (accessed October 14, 2019)
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