Abstract
Executive Summary
Decades of life-sciences research and the development of increasingly powerful tools for obtaining and using biological data have brought us closer to the threshold of a previously unimaginable future: “ready to burn” liquid fuels produced directly from CO2, biodegradable plastics made not from oil but from renewable biomass, tailored food products to meet specialized dietary requirements, personalized medical treatments based on a patient's own genomic information, and novel biosensors for real-time monitoring of the environment. Increasingly, scientists and engineers are looking to augment biological research with approaches from other scientific disciplines for solutions to our most demanding scientific and societal challenges and seeing exciting options that will profoundly affect our future.
Technological innovation is a significant driver of economic growth, and the US bioeconomy represents a growing sector of this technology-fueled economy. Agriculture, one of the country's largest industries, is heavily based on advances in biological research and development (R&D). According to the USDA, US revenues in 2010 from genetically modified crops were approximately $76 billion. 2 Beyond agriculture, based on the best available estimate, 2010 US revenues from industrial biotechnology—fuels, materials, chemicals, and industrial enzymes derived from genetically modified systems—were approximately $100 billion. 3
Editor'S Note
This Industry Report presents the Executive Summary and additional excerpts of the “National Bioeconomy Blueprint” prepared and released by the US federal government. The full report is available at
The growth of today's US bioeconomy is due in large part to the development of three foundational technologies: genetic engineering, DNA sequencing, and automated high-throughput manipulations of biomolecules. While the potential of these technologies is far from exhausted, a number of important new technologies and innovative combinations of new and existing technologies are emerging. Tomorrow's bioeconomy relies on the expansion of emerging technologies such as synthetic biology (the direct engineering of microbes and plants), proteomics (the large-scale study and manipulation of proteins in an organism), and bioinformatics (computational tools for expanding the use of biological and related data), as well as new technologies as yet unimagined. There is also a set of emerging trends in recent research that foreshadow major advances in the areas of health, biological-based energy production, agriculture, biomanufacturing, and environmental clean-up.
In recognition of the potential of the US bioeconomy, in 2010 the Administration included, in its science and technology priorities to inform Federal agency budget submissions, 4 a priority for Federal agencies to “support research to establish the foundations for a 21st century bioeconomy.” Agencies began focusing their efforts accordingly, and have made significant early progress in building a foundation for the future bioeconomy. In addition, strategic objectives that would help to enable a future vibrant US bioeconomy with potential to deliver major economic and social benefits began to emerge.
The modification of biological organisms and construction and use of organisms not found in nature carry potential safety and security risks if misapplied, raising issues of responsible conduct including ethics, responsible use, and environmental awareness, among others. These advances raise important ethical and security issues that are also top priorities for the Administration, but go beyond the scope of this document. 5 –8
On September 16, 2011, President Obama announced that his Administration would release a National Bioeconomy Blueprint as part of his commitment to supporting scientific discovery and technological breakthroughs to ensure sustainable economic growth, improve the health of the population, and move toward a clean energy future. Modeled after the Administration's 2011 Blueprint for a Secure Energy Future, 9 this 2012 National Bioeconomy Blueprint has two purposes: to lay out strategic objectives that will help realize the full potential of the US bioeconomy and to highlight early achievements toward those objectives.
The National Bioeconomy Blueprint describes five strategic objectives for a bioeconomy with the potential to generate economic growth and address societal needs. Although progress is being made in all of these areas, much work remains if the United States is to remain competitive in a changing world. Summarized below (and described in more detail in the second chapter of this report) are the strategic objectives and the next steps that will help realize the full potential of the US bioeconomy.
Support R&D Investments That Will Provide the Foundation for The Future Us Bioeconomy
Although many studies show that research provides a healthy return on investment, a major justification for government investments in science and technology is to overcome market failures; these occur when private investors invest less in technology than the socially optimal level because they cannot reap the full benefits of their investment. In this context, scientific discovery is a public good that benefits all.
The pursuit of a greater understanding of natural systems yields knowledge, ideas, and technologies that the private sector can build on, sparking economic growth by giving rise to new products, services, and jobs. Coordination of Federal bioeconomy-related research activities can improve the efficiency and effectiveness of those investments and is especially important when budget growth is constrained. Coordinated strategic programs and targeted investments will accelerate progress in biological research and technology areas, and this in turn will drive discovery for an American bioeconomy.
Moving Forward: Coordinated, Integrated R&D Efforts Will Help Strategically Shape the National Bioeconomy R&D Agenda
Expand and Develop Essential Bioeconomy Technologies
Foundational technologies have made possible unprecedented discoveries in biological research. Multiagency collaborations for emerging foundational technologies such as synthetic biology, biology-related information technologies, proteomics, and others are being fostered in order to grow the bioeconomy.
Integrate approaches across fields
The complexity of modern research questions requires that traditional boundaries between fields of study become permeable and programs concentrate expertise from diverse disciplines around societal challenges where it is needed most. The Administration will prioritize additional multidisciplinary efforts to enable biological research at the boundaries of fields, such as physics, chemistry, engineering, computer sciences, and mathematics, that support the bioeconomy.
Implement improved funding mechanisms
Creating or modifying funding mechanisms to support creative, high-risk/high-reward research can enable researchers to pursue daring—and potentially groundbreaking—research that may be constrained by typical funding mechanisms or approaches. Agencies should further explore the use of new or modified funding mechanisms in and across agencies to stimulate the discovery of new bioinventions with potential to grow the bioeconomy.
Facilitate the Transition of Bioinventions From Research Lab to Market, Including an Increased Focus on Translational and Regulatory Sciences
If it is to be successful and thrive, the bioeconomy will be based on a steady flow of new products and services that address American needs. To ensure this flow, policies must be developed and taxpayer dollars must be used responsibly to foster an ecosystem that supports discovery, innovation, and commercialization.
Moving Forward: A Dedicated Commitment to Translational Efforts Will Accelerate Movement of Bioinventions out of Laboratories and Into Markets
Accelerate progress to market
An increased focus on entrepreneurship, translational sciences, regulatory science, and technology transfer can help ensure that ideas with potential for application move beyond the laboratory. Strategic, coordinated investments in translational and regulatory sciences will accelerate progress in many sectors of the bioeconomy. To capitalize on the promise of the newly reauthorized Small Business Innovation Research (SBIR) program, agencies should evaluate and update SBIR programs. Some relevant objectives include reducing application response times, hiring/training program staff to enhance relevant in-house experience, and increasing the use of industry experts as peer reviewers to evaluate industry proposals.
Enhance entrepreneurship at universities
Academic research is traditionally disconnected from its economic implications, making it difficult for innovative ideas to progress beyond the lab. Integrating entrepreneurship and industry involvement into the university research experience will facilitate the path from research to commercialization and help innovative ideas reach the marketplace. As an additional benefit, students can be exposed to the broader benefits of academic pursuits, as well as introduced to potential future careers in areas outside of academia. Innovative programs that enhance entrepreneurial activities at universities are needed to help academic discoveries become commercial realities.
Utilize federal procurement authority
The purchasing authority of the Federal government offers opportunities to help drive some aspects of the bioeconomy. By procuring biobased and sustainable versions of products used in agency missions, the Federal government supports markets and promotes innovation, while creating jobs in rural America where many of these businesses are located and bioproducts are manufactured. To drive the creation and growth of new bioeconomy markets, Federal agencies should prioritize procurement of biobased and sustainable products where appropriate and cost-effective.
Develop and Reform Regulations to Reduce Barriers, Increase the Speed and Predictability of Regulatory Processes, and Reduce Costs While Protecting Human and Environmental Health
Regulations are essential for protecting human health and the environment and reducing safety and security risks associated with potential misapplications of technology. When they are not carefully crafted or become outdated, however, they can become barriers to innovation and market expansion and discourage investment.
Moving Forward: Improved Regulatory Processes Will Help Rapidly and Safely Achieve the Promise of the Future Bioeconomy
Improve regulatory processes and regulations
Agencies should improve predictability and reduce uncertainty in their regulatory processes and requirements. To reduce costs and impediments to investments but without compromising safety and efficiency, attention should be given to application review times, sequential reviews by multiple agencies should be coordinated to allow parallel reviews, and specific guidance should be issued in response to stakeholder needs. When an emerging technology enters the regulatory process, Federal agencies must have a robust framework that identifies lead agency responsibilities, clarifies supporting agency roles, and delivers timely, specific guidance for applicants.
Collaborate with stakeholders
Improved agency regulatory processes rely on productive stakeholder collaborations to identify needs and impediments to progress and investment. Federal agencies should focus on building new, and augmenting existing, stakeholder collaborations to inform efforts, streamline processes, and reduce costs and response times, while preserving safety and ensuring substantive benefit to public health.
Date Training Programs and Align Academic Institution Incentives With Student Training for National Workforce Needs
Many jobs in science and technology-related businesses remain unfilled despite high rates of local unemployment. 10 Opportunities exist to enhance training efforts at all levels to keep pace with changing career pathways. At the K-12 and undergraduate levels, the Administration has made significant progress in developing approaches to improve science, technology, engineering, and mathematics (STEM) education, and to increase the number and diversity of STEM students. For example, in 2009, the President launched the Educate to Innovate campaign to move American students from the middle to the top of international rankings in STEM achievements over the next decade. Building upon and expanding these efforts, particularly with regard to graduate-level training enhancements, would help to align academic institution incentives with training for future workforce needs. Also needed is the development of metrics to measure progress over time.
Moving Forward: Federal Agencies Should Take Steps to Ensure that the Future Bioeconomy has a Sustainable and Appropriately Trained Workforce
Employer-educator partnerships
Foster increased industry participation in the development of programs and in training students at all levels for the future bioeconomy workforce.
Re-engineer training programs
Incentives for academic institutions to enhance entrepreneurship and restructure training programs would better prepare the future bioeconomy workforce, whether individuals are bound for careers in industry or academia. Federal agencies should develop incentives for institutions to adapt training to meet the needs of the 21st-century bioeconomy workforce. Following re-engineering of training programs, agencies should consider convening industry stakeholders from various sectors to assess the success of training programs to meet the needs of employers.
Identify and Support Opportunities for the Development of Public-Private Partnerships and Precompetitive Collaborations—Where Competitors Pool Resources, Knowledge, and Expertise to Learn From Successes and Failures
Partnerships enable private industry, government agencies, and academic institutions to pool resources and expertise around an idea, dramatically improving chances for success. Many companies do not invest in early ideas because they are unlikely to pay off immediately. This is one place where the government can play a crucial role. The President has emphasized that the Federal government, universities and companies should work together to invent, deploy, and scale the cutting-edge technologies that will create new jobs, spark new breakthroughs, and reinvigorate America today and in the future.
Moving Forward: Federal Agencies Should Provide Incentives for Public-Private Partnerships and Precompetitive Collaborations to Benefit the Bioeconomy Broadly
Catalyze public-private partnerships
Great potential exists for partnerships and collaborations where sharing information about successes and failures is anticipated to generate transformative outcomes. Federal agencies are encouraged to broadly pursue opportunities for effective public-private partnerships in health, energy, agriculture, and manufacturing to leverage Federal investments and industry investments and expertise.
Background and Impacts of the US Bioeconomy
The National Bioeconomy Blueprint describes a number of key elements that will contribute to achieving the potential of the US bioeconomy. Input from government, industry, and the public has helped to define them.
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They are: • a full spectrum of basic and applied R&D activities performed by academic, government, and private sectors • public-private partnerships • a supportive commercialization system for bioinventions • innovative regulatory policies that reflect government awareness of needs for and impediments to progress • a skilled and creative workforce • public support for technological advances • flexibility to accommodate the evolving needs, discoveries, and challenges
The Blueprint has two purposes: to lay out strategic objectives that address the key elements to help realize the full potential of the US bioeconomy, and to highlight early achievements toward those objectives.
This document describes a vision for the future bioeconomy and recent trends that inform that future; it provides economic information about today's bioeconomy and highlights examples of Federal agency efforts to accelerate the Federal bioeconomy agenda. The examples described in the second chapter were selected from hundreds of examples that Federal agencies submitted for this Blueprint. Efforts to promote the US bioeconomy are well underway. Real themes that drive innovation are emerging from Federal agencies through exciting new activities designed to enable new discoveries through basic research, foster economic growth, and create new jobs.
Federal Bioeconomy Strategic Objectives
Strengthening Research and Development
Strategic Objective: Support R&D Investments that Will Provide the Foundation for the Future Bioeconomy
A critical factor in leveraging biological systems to drive an innovation-based bioeconomy is the strength of the scientific enterprise investigating those systems, including basic and applied research. A robust biological/biomedical R&D enterprise, backed by government, foundations, and for profit investments, is necessary to produce the new knowledge, ideas, and foundational technologies required to develop products and services that support businesses and industries and help create jobs.
Nature has evolved countless biologically based systems with potential for new applications to address problems in health, energy, food, and the environment. Expanding basic knowledge of living systems and their molecular machinery will inspire new concepts for the creation of artificial processes and products that will address current and future needs. A sustained effort to understand and take advantage of natural living systems will produce novel solutions and encourage the growth of the bioeconomy.
Many government departments and agencies fund biological research with intramural and/or extramural funding programs. Hence, the President has called for agencies to identify strategic R&D investments, as well as increase the use of flexible funding mechanisms to improve program efficiency and provide the best opportunity to enhance economic growth. Federal agencies are answering the call. As shown below, agencies are supporting development of the bioeconomy in a variety of ways: identifying strategic R&D progress to inform future efforts to enhance the bioeconomy; developing foundational transformative technologies; integrating approaches from engineering, physical sciences, and computational sciences; and implementing new flexible funding mechanisms.
Developing foundational technologies
Forging scientific advancement with integrated cyber infrastructure
Increasingly, researchers need information technology tools to enable them to interpret large quantities of complex data from multiple disciplines. In February 2011, the NSF announced an agency-wide crosscutting effort, Cyberinfrastructure Framework for 21st Century Science and Engineering, to provide a comprehensive, integrated, sustainable, and secure infrastructure to accelerate research and education and new functional capacities in computational and data-intensive science and engineering. The future bioeconomy relies on collaborations among biologists, scientists from other disciplines, and engineers, and the ability of these teams to harness so-called “big data”—extremely large, complex datasets that are difficult to store, analyze, and visualize—in fields of direct relevance to the bioeconomy. For example, the size of DNA sequencing databases is reported to be increasing by a factor of 10 every 18 months, and doing comparisons of complex DNA datasets, such as DNA sequences of organisms found in the human gut, can take days of computing time. Realizing the full value of “big data” for the bioeconomy will require new partnerships between public and private sectors, and strategic efforts to shape the national bioeconomy research agenda.
Transforming environmental health protection with high-throughput technologies
High-throughput technologies have revolutionized DNA sequencing and drug discovery, among other labor-intensive scientific endeavors. In 2011, the Environmental Protection Agency (EPA) announced plans to test 10,000 chemical compounds for toxicity using high-throughput tests instead of animals. Whereas a person can precisely profile up to 20 compounds a year for various specific toxicities, a new robot capable of screening thousands of compounds a week was put to work in the Tox21 collaboration involving the EPA, NIH, and the FDA. The chemical compound collection contains chemicals found in consumer products, industrial processes, and food additives, as well as human and veterinary drugs. In addition to speed and scale, this high-throughput approach offers additional benefits such as significant cost savings and a reduction in the use of animals for toxicity testing purposes.
Unlocking the promise of synthetic biology
With an increasing number of new biologically derived products approaching proof-of-concept phase, the Administration recognizes the potential of biological systems to influence the future of energy production in the United States. In response, the DOE's Biological and Environmental Research program has committed $30 million to initiate research efforts to identify biological design principles that will provide understandings of plant and microbial systems to enable synthetic redesign. Combined with computer-aided design and testing, these new understandings will provide key insights relevant to the goals of reorganizing and remodeling cellular processes to accelerate exploitation of biological systems for clean energy.
Advancing From Lab to the Market
Strategic Objective: Facilitate the Transition of Bioinventions from Research Lab to Market, Including an Increased Focus on Translational and Regulatory Sciences
The Administration's Strategy for American Innovation 12 is designed to promote sustainable growth and the creation of quality jobs by fostering bioeconomy entrepreneurs and businesses. A key part of the strategy is to foster the growth of new companies and support established companies by increasing commercialization of promising new technologies and products emerging from research laboratories.
However, commercialization of these basic research discoveries has proved challenging. Too many fail to make the transition from research to market, a product-development stage that has been called the “valley of death” because of challenges related to the high and increasing cost of bringing a new therapeutic to market, scientific complexity, and the lack of experienced business management. To directly address these challenges, the Administration has launched initiatives that promote translation of ideas to products. The Startup America initiative calls on the Federal government and the private sector to take action to dramatically increase the success of entrepreneurs in moving their discoveries and ideas to commercialization. Five areas are highlighted for action: unlocking access to capital; connecting mentors with entrepreneurs; reducing regulatory barriers; tax relief; and other economic incentives for small businesses. The National Institute of Standards and Technology (NIST) Hollings Manufacturing Extension Partnership (MEP) provides technical and business assistance to smaller manufacturers through a nationwide network in all 50 states and Puerto Rico through grant-supported partnerships between Federal and state governments and non-profit organizations. In partnership with other organizations, MEP is developing the National Innovation Marketplace 13 to facilitate supply chain connections between original equipment manufacturers and potential suppliers, to encourage technology translation and adoption. The America Invents Act provides entrepreneurs the tools they need to obtain patents more quickly and to defend them against litigation challenges, both at lower costs. The BioInnovation Initiative aims to accelerate development of medical advances through historic collaborations between NIH, FDA, and the private sector—notably biotechnology, pharmaceutical, and device companies. In Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, the President called on Federal agencies to be leaders in environmental, energy, and economic performance. 14 As part of this Executive Order, the Administration committed to leveraging agency acquisitions to foster markets for sustainable technologies and environmentally preferable materials, products, and services. In December 2011, the President signed HR1540, the bill that reauthorized the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for another 6 years. 15 From 2002-2006, approximately 25% of R&D Magazine's top 100 annual innovations came from companies that had received SBIR grants. The recent reauthorization brought significant changes to the SBIR program, including allocation and award increases, as well as authority to provide SBIR grants to small companies owned in majority by multiple venture capital operating companies, hedge funds, or private equity firms. Specifically, the SBIR allocation is slated to increase 0.1% annually from 2011 to 2017, from 2.5% to 3.2%. The NIH, DOE, and NSF are authorized to grant up to 25% of SBIR funds to small companies owned in majority by multiple venture capital companies, whereas all other agencies are allowed to grant up to 15% of SBIR funds to such companies.
Developing a Bioeconomy Workforce
Strategic Objective: Update Training Programs and Align Academic Institution Incentives with Student Training for National Workforce Needs
A vibrant bioeconomy depends on the education and skills of its workers. Therefore, directing resources to the training and development of specialized skills in the biological sciences, biotechnology, and bioengineering is one of the best investments the government can make. An expanding bioeconomy will require substantial biobased production of raw industrial materials such as oils and specialty chemicals, as well as products such as plastics, polymers, lubricants, and enzymes. These new raw materials and products will not only require a biotechnology/bioengineering workforce for their production, but also provide the basis for growth in manufacturing downstream products that use these items as building blocks.
While the manufacturing sector has faced challenges in recent years, it continues to be the lifeblood of the American economy. The manufacturing sector currently employs over 11 million Americans, and by itself, would be one of the 10 largest economies in the world. Recognizing the importance of the manufacturing sector, in 2010, the Administration launched the Skills for America's Future initiative in partnership with the Aspen Institute. This initiative brings together companies and community colleges around a simple idea: make it easier for workers to gain new skills that will make America more competitive in the global economy. Achieving this goal is especially important, given that 2.7 million manufacturing employees are nearing retirement and will likely leave the labor force within 10 years.
A January 2012 Department of Commerce report 16 highlighted the critical role that science, technology, engineering, and math (STEM) education plays in maintaining national competitiveness and growing the economy. Early in the Administration, the President announced a number of initiatives to improve and increase diversity in STEM education. In November 2009, the President launched the Educate to Innovate campaign for excellence in STEM education. The program aims to move American students from the middle to the top of international rankings in STEM achievements over the next decade. Its three priorities are (1) increasing STEM literacy to enable all students to think critically in STEM-related activities, (2) improving the quality of math and science teaching for American students, and (3) expanding STEM education and career opportunities for underrepresented groups, including women and minorities. The Administration's Race to the Top competition, an effort to create incentives for comprehensive state and local education reform, encourages making STEM education a priority in K-12 programs and specifically mentions addressing the needs of underrepresented groups and girls in STEM programs. These STEM education efforts are expected to contribute broadly to the development of a bioeconomy workforce for the 21st century.
Opportunities exist to improve training at the professional level as well. Approximately two-thirds of Federally-supported professional-level trainees are supported by research grants rather than training-type grants. When Federal funding for research increases, the number of research grants and the capacity to train more PhDs also increases, regardless of whether there is an increased demand in the workforce for individuals with such training. Moreover, most university departments that specialize in biomedical training provide little or no information about career outcomes for recent graduates who have been hired into relevant positions. In addition, the training provided to university students via research and training-type grants is generally directed toward academic positions. The number of tenure-track academic positions available to PhD biomedical trainees is far below the number of those so-trained. Many biomedical doctorate recipients are being employed in positions other than those for which they were trained. A significant number of public comments in response to the Bioeconomy Blueprint Request for Information emphasized the importance of updating training programs to more effectively meet the needs of the careers into which trainees will eventually move. While the workforce needs within and outside of academia will continue to evolve as the bioeconomy develops, training programs and academic incentives should be aligned to meet the full spectrum of workforce demands.