April 2012

NATIONA L BIOECONOM Y 

BLUEPRINT

Table of Contents

Executive Summary 1

I. Background and Impacts of the U.S. Bioeconomy 7

The Emerging U.S. Bioeconomy 8

Impacts of the U.S. Bioeconomy 13

Foundational Technologies: Today and for the Bioeconomy of the Future 15

II. Federal Bioeconomy Strategic Objectives 17

Strengthening Research and Development 17

Advancing From Lab to the Market 24

Reducing Regulatory Barriers 29

Developing a Bioeconomy Workforce 33

Fostering Partnerships 38

Conclusion 43

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Executive Summary

“The world is shifting to an innovation economy and nobody does innovation better 

than America.”

—President Obama, December 6, 2011

Economic activity that is fueled by research and innovation in the biological sciences, the “bioeconomy,” 

is a large and rapidly growing segment of the world economy that provides substantial public benefit.1 

The bioeconomy has emerged as an Obama Administration priority because of its tremendous potential 

for growth as well as the many other societal benefits it offers. It can allow Americans to live longer, 

healthier lives, reduce our dependence on oil, address key environmental challenges, transform manufacturing processes, and increase the productivity and scope of the agricultural sector while growing 

new jobs and industries.

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 U.S. 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, U.S.

revenues in 2010 from genetically modified crops were approximately $76 billion.2 Beyond agriculture, 

based on the best available estimate, 2010 U.S. revenues from industrial biotechnology—fuels, materials, 

chemicals, and industrial enzymes derived from genetically modified systems—were approximately 

$100 billion.3

The growth of today’s U.S. 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 

1. http://www.oecd.org/document/48/0,3746,en_2649_36831301_42864368_1_1_1_1,00.html

2.  The $76 billion estimate was derived by prorating the published ERS estimates of revenue (cash receipts) from 

the relevant crops published here: http://www.ers.usda.gov/data/FarmIncome/finfidmu.htm#cashrec by the estimated 

share of GM crops for each crop.

3.  Biodesic 2011 Bioeconomy Update (Biodesic is a private consulting firm and sole source of data of this type.) 

http://www.biodesic.com/library/Biodesic_2011_Bioeconomy_Update.pdf
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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 U.S. 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 U.S.

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 5 6 7 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 U.S. 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 U.S. bioeconomy.

1. Support R&D investments that will provide the foundation for the future U.S. 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.

4. Executive Memorandum (M-10-30) http://www.whitehouse.gov/sites/default/files/microsites/ostp/fy12-budgetguidance-memo.pdf

5. http://oba.od.nih.gov/biosecurity/about_nsabb.html

6. http://bioethics.gov/cms/synthetic-biology-report

7. http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf

8. http://www.whitehouse.gov/the-press-office/2011/12/05/fact-sheet-seventh-review-conference-biological-andtoxin-weapons-conven

9. http://www.whitehouse.gov/sites/default/files/blueprint_secure_energy_future.pdf
Execu ti ve Summary

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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.

2. 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.
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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.

3. 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.
Execu ti ve Summary

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4. Update 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.

Reengineer 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 

reengineering 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.

5. 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.

10. http://www.conference-board.org/data/helpwantedonline.cfm

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I. Background and Impacts of 

the U.S. Bioeconomy

“Innovation also demands basic research.”

—President Obama, January 24, 2012

A bioeconomy is one based on the use of research and innovation in the biological sciences to create 

economic activity and public benefit. The U.S. bioeconomy is all around us: new drugs and diagnostics 

for improved human health, higher-yielding food crops, emerging biofuels to reduce dependency on 

oil, and biobased chemical intermediates, to name just a few. The public benefit gained through biological research can be seen through the eyes of a patient who receives a critical medication that did 

not exist a decade ago, a farmer whose higher-yield crops are turned into fuels, food, and intermediate 

chemicals, and a small-business owner whose innovative biobased products are breaking new ground 

in manufacturing. Increased societal needs for food and energy, combined with new knowledge/discoveries in biology and new methods for harnessing biological processes, have dramatically increased 

the economic potential of the bioeconomy.11

Today’s bioeconomy grew from several scientific and technological developments that transformed 

the practice and potential of biological research, including three of particular importance: genetic 

engineering, DNA sequencing, and robotic technologies that perform high throughput molecular 

operations rapidly and accurately. These technological advances have led to the development of many 

of the important drugs, products, and processes in widespread use today.

However, a growing U.S. population requires increased health services and more resources such as food, 

animal feed, fiber for clothing and housing, and sources of energy and chemicals for manufacturing. In 

short, it needs a new and more potent bioeconomy fueled by innovative ideas and practices that can 

help address these needs in new, more powerful ways.

The 2009 National Research Council report A New Biology for the 21st Century12 stressed the potential of 

biological research—the potential to improve health outcomes for all Americans, feed growing populations with higher-yield crops of improved nutritional value, and decrease American dependence on 

petroleum-based products while increasing domestic biomanufacturing of fuels and chemicals. The 

report examined the state of biological research in the United States and recommended that the Nation 

“capitalize on recent technological and scientific advances that have allowed biologists to integrate biological research findings, collect and interpret vastly increased amounts of data, and predict the behavior 

of complex biological systems.” The report also emphasized the benefit of coordinated Federal efforts 

to integrate biology with other sciences—namely physics, chemistry, and computer sciences—and 

with mathematics and engineering to address societal challenges in health, energy, environment, and 

agriculture that provides food, feed, fiber, and fuel.

11. http://www.oecd.org/document/48/0,3746,en_2649_36831301_42864368_1_1_1_1,00.html

12. http://www.nap.edu/catalog.php?record_id=12764
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The National Bioeconomy Blueprint describes a number of key elements that will contribute to achieving the potential of the U.S. bioeconomy. Input from government, industry, and the public has helped 

to define them.13 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 U.S. 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 U.S. 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.

The Emerging U.S. Bioeconomy

Life science research and the development of increasingly powerful tools for obtaining and using 

biological data and biobased materials have brought the Nation to the threshold of only previously 

imagined opportunities for discoveries with transformative potential. Momentum is building. Scientists 

and engineers are increasingly 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. Increasing this momentum, capitalizing on a wide 

array of multi-disciplinary knowledge and tools, and recognizing important trends promises a vibrant 

bioeconomy with vast societal benefit.

13.  To help develop the National Bioeconomy Blueprint, OSTP issued a National Bioeconomy Blueprint Request 

for Information (RFI) with 17 questions for public input.http://www.whitehouse.gov/blog/2011/10/12/buildingbioeconomy. OSTP also provided a briefing for the National Science and Technology Council’s Subcommittee on Life 

Sciences, and a number of professional societies after the RFI was released to gather input.
I. Background and Impacts of the U.S. Bioeconomy

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Imagine a world in which there are “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 needs, a drug that can cure any viral infection, and novel biosensors for real-time monitoring 

of the environment.

While achieving these visionary examples might seem daunting, current progress shows they may soon 

become reality (see examples in insets).

Bioeconomy Trends: Health

Treatment of disease is changing dramatically. Over the last 60 years, the treatment 

of disease has relied primarily on drugs 

derived from traditional chemical synthesis 

and the application of a variety of devices 

and procedures largely designed to treat 

disease symptoms rather than the underlying cause.

Many of our most promising therapies today are biologically derived molecules—proteins, antibodies, 

vaccines, and cells—specifically directed at the cause agents of disease. Examples of biology-based 

therapies include: protein therapies for the treatment of anemia, heart attacks, and stroke; antibody 

therapies that inhibit growth of cancers; and a new cell-based vaccine for prostate cancer. A fundamental 

change from treating the symptoms to treating the causes of disease was the direct result of an increased 

understanding both of biology and disease. Today there are expanding opportunities to design and 

deploy new therapies based on an ever-increasing understanding of biology and disease.

Our approaches to treatment are becoming more specialized. The Human Genome Project14 has helped 

enable an emerging new era of personalized medicine. The ability to sequence and compare genomes 

of patients cheaply and quickly has the potential to transform medicine. Instead of today’s typical treatments, which are based on how a group of individuals is predicted to respond, treatments are beginning 

to be geared to each individual’s specific conditions. The Personalized Medicine Coalition reports that 

advances in recent technologies have increased the momentum of personalized medicine—customized 

healthcare based on specific genetic or other information of an individual patient.15 16

14. http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml

15. http://www.personalizedmedicinebulletin.com/files/2011/11/Case_for_PM_3rd_edition1.pdf

16. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0022572

Broad Spectrum Anti-Viral: Researchers at the 

Massachusetts Institute of Technology’s Lincoln 

Laboratory reported in 2011 creation of a broadspectrum antiviral technology that selectively kills any 

virus-infected cell but does not harm uninfected cells.

16 
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Bioeconomy Trends: Energy

The current backbone of our energy and chemical 

industries is carbon-based fossil fuels. Today we rely 

primarily on oil, coal, and natural gas to run our cars, 

heat our homes, and provide the raw material for a 

wide range of products from drugs to plastics to fertilizers. But we need to make ourselves more secure 

and control our energy future by harnessing all of 

the resources that we have available and embracing 

a diverse energy portfolio. Furthermore, leading the 

world in clean energy is critical to strengthening the 

American economy and addressing global climate 

change. Agricultural innovation has already used 

breeding practices and biotechnology to develop 

new crop varieties tailored as raw materials for 

energy production and new processes that improve 

the conversion of biomass to fuel and chemical products. Now, technologies are advancing to better harness the potential of microorganisms and plants to 

produce fuels, intermediate chemicals (e.g., the precursors for plastics), and other biomaterials. However, 

these are just initial entrées. The application of synthetic biology and other genetic-manipulation techniques will enable the rational design of organisms 

to produce conventional products more efficiently as 

well as novel products, including: modified seed stocks that yield plants with improved oil and starch 

content for biofuel production; enzymes from engineered microorganisms that are optimized for the 

production processes and environmental conditions required for industrial-scale chemical and fuel 

production; and microorganisms designed for the production of novel chemicals and biomolecules 

difficult or impossible to produce using current technologies.

Even solar energy conversion has the potential to be transformed through increased understanding of 

biological approaches to solar-energy capture.17

Bioeconomy Trends: Agriculture

By 2030, the world population is predicted to reach 8.3 billion,18 compounding the need for food. A 

growing population and limited arable land require new approaches to meeting the world’s nutritional 

needs. A recent report by the National Research Council demonstrates that substantial progress is being 

made. In one example, the report estimated that through the use of biotechnology-enabled control of 

corn rootworm, 10 million acres of farmland produced $231 million in additional annual revenue from 

17. http://www.bio.org/articles/current-uses-synthetic-biology

18. Population Division of the Department of Economic and Social Affairs of the United Nations Secretariat, World 

Population Prospects: The 2010 Revision, retrieved 11/1/2011, from http://esa.un.org/unpd/wpp/index.htm

Diesel from CO2: Through photosynthesis, 

plants, algae, and some bacteria use the 

energy of sunlight to convert CO2 into a 

variety of organic compounds needed for 

growth and survival. A Massachusetts-based 

company re-engineered photosynthetic 

organisms to synthesize, from sunlight and 

CO2, molecules that form the chemical basis 

of diesel fuel.

Designing Biological Systems for NextGeneration Biomanufacturing: Synthetic 

biology is enabling scientists to rapidly 

design organisms that can be used in the 

production of renewable chemicals, biofuels, 

renewable specialty and fine chemicals, 

food ingredients, and health-care products. Bioacrylic acid heralds the advent of 

synthetic-biology-enabled manufacturing: 

acrylic acid ingredients are used to make 

adhesives stronger, paints more durable, and 

diapers more absorbent, and today petroleum-based acrylic is an $8 billion global 

market.

17
I. Background and Impacts of the U.S. Bioeconomy

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Allergen-Free Peanuts: Researchers at 

a number of institutions in the United 

States have made inroads towards 

eliminating or inactivating allergenic 

proteins in peanuts. If successful, these 

approaches could lead to significant 

health benefits for Americans and 

economic opportunities for the peanut 

industry.

Biodegradable Plastics from Biomass: 

A major commercial “polylactic acid” 

bioplastic is already made today from 

cellulose. However, the ability to 

replace petroleum-based plastics with 

this bioproduct is constrained by the 

limited availability of the specific cellulosic source material. To address this 

limitation, USDA scientists discovered a 

bacterium that can ferment a broader 

range of cellulosic biomass materials 

into polylactic acid, enabling commercial production on a much larger 

scale. With an estimated $375 billion 

market for chemical, plastic, and rubber 

products based on petroleum, this 

represents a substantial bioeconomy 

opportunity.

20

crop yield gains, reduced insecticide use by 5.5 million 

pounds annually, and eliminated 5.5 million gallons of 

water annually from the farming process.19 Most recently, 

in December 2011, drought tolerant corn was approved 

by the USDA, and strategies to improve other crops for 

drought-tolerance are underway. Biotechnology advancements combined with breeding techniques are expected 

in the near future to lead to crops with other desirable 

traits such as improved nutritional value, enhanced disease resistance, and higher crop yields. As research moves 

beyond the biotechnology and breeding techniques of 

today, an increased understanding of biodiversity and 

food crops as ecosystems has the potential to transform 

the management and practice of agriculture and move 

this mainstay of the bioeconomy to a new level.

Bio- and chemical-based catalytic processes will play a 

greater role in the future of agriculture. The USDA predicts 

that two types of biorefineries will emerge: those that use 

microbial catalysts to directly convert feedstock (sugar or 

lipid) into a vast array of commercially valuable products, 

and those that are feedstock-agnostic and produce a single chemical intermediate, such as lactic acid or glycerol, 

for later conversion into final products.20

Bioeconomy Trends: Environment

From clean air and water, to abundant food and raw materials for much of our building construction, to the more 

intangible benefits of nature and ecosystem services, we 

depend on the living world to support and enrich our 

quality of life. The well-being of the living world and its ability to provide sustainable resources depend 

on responsible human stewardship, which in turn requires fundamental knowledge. Basic and applied 

biological research has the potential to produce a whole generation of the new knowledge and technologies needed to understand how the living world functions, to monitor and mitigate human impact, 

and to develop informed approaches to use and restore environments. Already, modern biotechnology 

is making inroads into environmental management and restoration. Microorganisms and their constituents are being used to detoxify industrial waste and clean up ecosystems contaminated by environmentally hostile practices. The growing field of environmental restoration ultimately holds the key to 

reclaiming healthy, functioning ecosystems in heavily degraded areas (e.g., recovery of watershed 

function) and may eventually allow mitigation of some of the effects of climate change by enabling the 

19.  The Impact of Genetically Engineered Crops on Farm Sustainability in the United States, NAS/NRC, 2010, 

pg. 139

20. http://www.nist.gov/mml/polymers/upload/854_01_02a.pdf
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design of ecosystems with improved capacity for removing carbon from the atmosphere21 and sequestering it in biomass for other uses. In addition, industries such as textiles and paper have moved toward 

biobased products and away from use of petrochemical products for both manufacturing and clean-up, 

and they now use microorganisms or biologically derived industrial enzymes that are more environmentally friendly and cost effective.

From traditional plant breeding to synthetic biology, biofuels to medical treatments to petroleum replacements, 

future biomanufacturing will be greatly facilitated by the 

ability to design and use biological systems and organisms 

quickly. The modification of biological organisms and 

construction and use of organisms not found in nature 

carry potential safety and security risks if misapplied, and 

require a range of considerations for 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.

22-25 22 23 24 25

Bioeconomy Trends: Sharing

Non-traditional research collaborations that feature the 

sharing of information, resources, and capabilities are 

transforming the bioeconomy. Precompetitive collaborations—where “competitors” partner and pool resources—are growing as partners seek new ways to 

leverage constrained resources and surmount shared problems. Partnerships for innovation are increasingly observed as a response to changing economic and technological conditions.26

In agriculture, as the public and private sectors seek increased information for the bioeconomy on 

potential crop characteristics, there is increased sharing, both domestically and internationally, of genetic 

information. The sharing of genetic information enhances U.S. agricultural competitiveness for food, 

energy, chemical production in plants, and other biobased-product crop species.

In the health sector, precompetitive collaborations are having significant impacts in clinical-trial design 

and biomarker discovery, among other areas. Combined industrial R&D has contributed to transformative progress despite major challenges such as increased management costs due to “outside” collaborations and the need to develop effective communication networks across companies.

21. The July 31, 2009, issue of Science was devoted to this topic.

22. http://oba.od.nih.gov/biosecurity/about_nsabb.html

23. http://bioethics.gov/cms/synthetic-biology-report

24. http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf

25. http://www.whitehouse.gov/the-press-office/2011/12/05/fact-sheet-seventh-review-conference-biologicaland-toxin-weapons-conven

26. http://onlinelibrary.wiley.com/doi/10.1002/etc.546/full

Biosensor Pollution Monitoring: 

Biosensors are devices composed of a 

biological sensing component linked 

to a signaling component, working 

together to reveal the presence of an 

element, molecule, or organism of 

interest. In 2011, a team at the Virginia 

Institute of Marine Science reported 

creation of a portable biosensor that 

could detect marine pollutants, including oil, much faster and more cheaply 

than current technologies. If deployed 

near oil facilities, such sensors could 

provide early warning of spills and leaks 

and track dispersal patterns in 

real time.

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I. Background and Impacts of the U.S. Bioeconomy

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Impacts of the U.S. Bioeconomy

Technological innovation is a significant driver of economic growth, and the U.S. bioeconomy represents 

a growing sector of this technology-fueled economy.27

Impacts in the Biomedical Sector

Since the beginning of the twentieth century, life expectancy has nearly doubled.28 Deaths from HIV/

AIDS, initially an invariably fatal disease, have decreased by 94% in the United States.29 Biomedical 

innovation is a major strength of the U.S. research enterprise. In 2010, approximately 29% of all jobs in 

the pharmaceutical and medicine manufacturing industry were in computer, engineering, and science occupations, and 

28% were in production occupations, 

both low-skilled and high-skilled.30

The National Institutes of Health (NIH) 

invests over $30 billion annually in 

biomedical research, 80% of which is 

awarded through approximately 50,000 

competitive grants to more than 300,000 

researchers at over 2,500 universities, 

medical schools, and other research institutions. Approximately 10% of the NIH 

budget supports research conducted by 

nearly 6,000 scientists in its own laboratories. These investments are aimed to foster 

creative discoveries and research strategies and their applications as a basis for 

protecting and improving human health, 

and to expand the medical knowledge 

base to enhance the Nation’s economic 

well-being and continued high return on 

the public investment in research.

One issue that government and industry must address is that increased investment in research has 

not resulted in a concomitant increase in approved drugs. Figure 1 shows that the number of FDAapproved new molecular entities has not kept pace with the pharmaceutical sector’s spending over 

time.31Experts have cited internal drug pipeline productivity declines, delays in application review caused 

by both industry and regulators, and a decreasing number of tractable medical challenges as reasons 

27. Biodesic 2011 Bioeconomy Update (Biodesic is a private consulting firm and sole source of data of this type.) 

http://www.biodesic.com/library/Biodesic_2011_Bioeconomy_Update.pdf

28. CRS Report for Congress, Life Expectancy in the United States, Order Code RL32792, updated August 16, 2006

29. Schimerling, R., Harvard Health Publications, Harvard Medical School, 2009.

30. http://www.bls.gov/oco/cg/cgs009.htm 

31. Figure Source: IOM (Institute of Medicine). 2010. Extending the spectrum of precompetitive collaboration in 

oncology research: Workshop summary. Washington, DC: The National Academies Press

Figure 1. 30-year decline in new molecular entities 

per dollar spent on R&D. There has been a 30-year 

decline in pharmaceutical industry productivity, as 

measured by new molecular entities per dollar spent 

on R&D, normalized to 5-year rolling average of 1970 

to 1975. While R&D costs have increased 50-fold during this time period, the output of investigational new 

drug candidates and new drug application products has 

stayed flat.

31
Nati onal Bioeconomy Blueprint

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for this decline in productivity. Advances in translational and regulatory sciences, improvements in the 

transfer of technology from the public to the private sector, regulatory process improvements, Federal 

workforce enhancements, and innovative public-private partnerships have potential to help overcome 

these challenges.

Impacts in the Agricultural and Industrial Sectors

In 2010,32 agriculture, forestry, fishing, and hunting employed a total of 1.3 million wage and salary 

workers, and another 853,400 self-employed and unpaid family workers. About 85% of employment 

was in crop production and animal production, and about 80% of the establishments involved employ 

fewer than 10 workers. Decades of advancement in research areas such as plant breeding, plant genetics 

and genomics, soil science, microbiology, biological control, invasive species, and organic agriculture, 

have made modern agriculture a robust enterprise with substantial outputs in 2011 despite sub-optimal 

weather conditions.33 Industrial uses for biotechnology extend well beyond health and agriculture. The 

industrial biotechnology sector uses genetically modified microbes as “cell factories” to produce a 

diversity of commercial products including vitamins, natural preservatives, biobased polymers, and 

enzymes for cleaning and textile industries, among many others. Given the vast array of different products, accurate economic numbers that represent industrial biotechnology’s impact on these products 

are difficult to ascertain.

According to the USDA, agriculture is responsible for one 

out of every 12 jobs in America, and America’s farmers and 

ranchers are the most productive in the world. In 2011, agricultural exports reached record levels of sales—$137.4 billion, 

resulting in a $42 billion trade surplus.34 In 2010, revenues 

from genetically modified plants and microbes, a single economic indicator of the U.S. bioeconomy, were estimated in 

one assessment to account for approximately $300 billion 

in U.S. revenues, equivalent to more than 2% of gross domestic product.35 According to the USDA, U.S.

revenues from genetically modified crops were roughly $76 billion.36

Based on the best available data, U.S. revenues from industrial biotechnology were estimated to be $115 

billion.37 Compared to numbers for 2009 revenues for these same sectors—revenues from genetically 

modified plants and microbes for health, agriculture, and industrial biotechnology—these estimates 

suggest that many sub-sectors of the bioeconomy are growing rapidly.

32. http://www.bls.gov/emp/ep_table_207.htm and http://bls.gov/cew/

33. http://www.nass.usda.gov/Newsroom/2012/01_12_2012.asp

34. http://www.fas.usda.gov/info/IATR/111611_Exports/

35. Biodesic 2011 Bioeconomy Update. (Biodesic is a private consulting firm and sole source of data of this type.) 

http://www.biodesic.com/library/Biodesic_2011_Bioeconomy_Update.pdf

36.  The $76 billion estimate was derived by prorating the published ERS estimates of revenue (cash receipts) from 

the relevant crops published here: http://www.ers.usda.gov/data/FarmIncome/finfidmu.htm#cashrec by the estimated 

share of GM crops for each crop.

37.  Biodesic 2011 Bioeconomy Update. (Biodesic is a private consulting firm and sole source of data of this type.) 

http://www.biodesic.com/library/Biodesic_2011_Bioeconomy_Update.pdf
I. Background and Impacts of the U.S. Bioeconomy

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Foundational Technologies: Today and for the Bioeconomy of the Future

Decades of biological research 

have revealed detailed information about the components of 

complex systems that characterize life—genes, cells, organisms, 

ecosystems—and how they interact. As mentioned earlier, genetic 

engineering, DNA sequencing, 

and high-throughput technologies 

have transformed the practice and 

potential of biological research.

Yet, there is substantial room for 

advancement and discovery; additional scientific and technological 

revolutions are needed to fundamentally improve the approaches 

needed to confront the complex 

societal challenges of the future.

Emerging technologies such as 

synthetic biology, proteomics, and 

information technologies, including bioinformatics and computational biology, have the potential 

to create a vibrant bioeconomy.38

Synthetic Biology: The ability to quickly and cheaply read and synthesize DNA sequences has transformed biological research. As shown in Figure 2, the costs of sequencing a genome decreased dramatically from 2004 to 2011. Expansive genetic libraries, with billions of genome variants created daily, 

are now available due to huge strides in “reading and writing” DNA. While the sequencing of the first 

human genome took 13 years and cost $2.7 billion, researchers can now sequence a human genome for 

a fraction of that cost (~$7,700) and within two weeks’ time. Synthetic biology, the design and wholesale construction of new biological parts and systems, and the re-design of existing, natural biological 

systems for tailored purposes, integrates engineering and computer-assisted design approaches with 

biological research. Since natural biological systems are so complicated, a primary focus of synthetic 

biologists is developing technologies that make the engineering of biology easier, faster, and more 

predictable. This ability to quickly engineer organisms in laboratories holds vast potential for the bioeconomy, as engineered organisms could dramatically transform modern practices in high-impact fields 

such as agriculture, manufacturing, energy generation, and medicine. Much work lies ahead, including 

identifying and standardizing biological and molecular components, but this powerful new area of 

38. Wetterstrand KA.DNA Sequencing Costs: Data from the NHGRI Large-Scale Genome Sequencing Program 

Available at: www.genome.gov/sequencingcosts.

Figure 2. “Cost per Genome” – the cost of sequencing a humansized genome. Data from 2001 through October 2007 represent the 

costs of generating DNA sequence using first generation sequencing 

technology. Beginning in January 2008, the data represent the costs of 

generating DNA sequence using ‘second-generation’ (or ‘next-generation’) sequencing platforms. The change in instruments represents the 

rapid evolution of DNA sequencing technologies that has occurred in 

recent years.

38
Nati onal Bioeconomy Blueprint

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technology has immense potential. Strategic investments in synthetic biology have the potential to 

move the bioeconomy forward in all sectors.

Proteomics: Proteomics is the large-scale study of proteins, which, like DNA, are essential components 

of organisms. Proteomics is more complicated than genomics because unlike a genome that is virtually constant in a given cell, a proteome—the collection of a cell’s proteins and their various molecular 

decorations—can vary dramatically from cell to cell and even within a single cell across time. Although 

the complexity of proteomic analysis presents a technological challenge, a cell’s proteome provides an 

essential understanding of an organism’s state. This has obvious value for basic biological research, and 

a number of practical applications as well. For example, comparing the proteome from a healthy lung 

cell with one from a cancerous lung cell may help identify a protein, a missing or abnormal molecular 

decoration of a protein, or unusual combination of proteins that may be promising drug targets.

Information Technologies: Research areas such as bioinformatics (the use of computational tools for 

expanding the use of biological data) and computational biology (the use of analytical and theoretical 

methods, mathematical modeling, and simulation techniques to study biological systems) have emerged 

as essential to the bioeconomy. As biological research continues to take advantage of increasingly larger 

and more complex datasets—including whole human genome sequences, proteomic profiles of cells, 

and high-resolution image files of biological specimens—the ability to store, analyze, visualize, and 

share data has become increasingly challenging. New information technologies to enable scientists to 

handle so-called “big data” will help stimulate the next transformative step toward realizing the potential 

of biological research across sectors.

In addition to advances in basic biological research, these emerging and other as yet unimagined 

foundational technologies will provide the next quantum jump in the ability to understand biological 

systems and further realize the potential of the bioeconomy.
II. Federal Bioeconomy Str ateg ic Objecti ves

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II. Federal Bioeconomy Strategic Objectives

Strengthening Research and Development

“And if you have any doubt about the importance of this Federal investment in 

research and development, I would suggest that you talk to the cutting-edge businesses 

in your own states. They will tell you that if we want the next big breakthrough, the 

next big industry to be an American breakthrough, an American industry, then we 

can’t sacrifice these investments in research and technology.”

—President Obama, February 2011

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 (see box next page). 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. Shown 

below is a fraction of the bioeconomy projects and programs already started by Federal agencies.
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Strategic Bioeconomy R&D Agency Progress to Date

Exploring New Scientific Discoveries 

for Potential to Treat Neurological 

Diseases: After the 2007 discovery of socalled induced pluripotent (adult) stem 

(iPS) cells, NIH moved quickly to better 

understand these cells’ potential to assist 

development of cell-based models for 

drug discovery and new therapies. The 

generation of iPS cells from human somatic 

cells (such as fibroblasts, cord blood, and 

peripheral blood) has enormous potential 

for revolutionizing our understanding of 

disease mechanisms and spurring progress in therapeutic discovery. NIH funded 

three consortia to develop iPS cell lines for 

Parkinson’s disease, Huntington’s disease, 

and amyotrophic lateral sclerosis. NIH has 

built resources quickly and begun to characterize these cells as models of disease.

The data from this work are freely available 

to scientists in industry as well as academic 

researchers with the goal of spurring the 

maximum innovation from a single investment. In addition, NIH also founded a new 

center in 2011, the Center for Regenerative 

Medicine, to accelerate the development 

and testing of new clinical protocols using 

iPS-cell-based treatments.

Improving Predictions of Vaccine and 

Drug Toxicity and Efficacy: NIH, the 

Defense Advanced Research Projects 

Agency (DARPA), and the Food and Drug 

Administration (FDA) have launched a collaborative research initiative to develop 

a “chip” that reproduces human physiological responses to drugs and vaccines. Designed to engage 

academic, industry, and government scientists, this five-year, $140 million effort aims to develop technologies that quickly provide molecular signals of toxicology and efficacy. The goal is to accelerate drug 

discovery and development while decreasing the testing of drugs and vaccines in animals.

Improving Homeland Security with Biological Research: The Department of Homeland Security 

(DHS) Science and Technology (S&T) Directorate is leading the development of a genomics-based 

approach to microbial forensic analysis. This capability will allow identification and characterization 

Federal Departments and Agencies that

Support Biological Research

Department of Agriculture

•	 Agricultural Research Service

•	 National Institute of Food and Agriculture

•	 Forest Service

Department of Commerce

•	 National Oceanic and Atmospheric Administration

•	 National Institute of Standards and Technology

Department of Defense

•	 Defense Advanced Research Projects Agency

•	 Defense Science and Technology Program

•	 Office of Naval Research

•	 U.S. Army Medical Research and Materiel Command

Department of Energy

•	 Office of Science

•	 Office of Energy Efficiency and Renewable Energy

•	 Advanced Research Projects Agency-Energy

Department of Homeland Security

•	 Science and Technology Directorate

Department of the Interior

•	 Fish and Wildlife Service

•	 U.S. Geological Survey

Environmental Protection Agency

Department of Health and Human Services

•	 Centers for Disease Control and Prevention

•	 Food and Drug Administration

•	 National Institutes of Health

•	 Assistant Secretary for Preparedness and Response

National Aeronautics and Space Administration

National Science Foundation

Veteran Affairs Department

United States Agency for International Development

Smithsonian Institution
II. Federal Bioeconomy Str ateg ic Objecti ves

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of any microbial organism, including “unknown” organisms such as emerging, engineered, chimeric, 

or purely synthetic organisms. Establishment of the genomics approach involves development and 

refinement of several intersecting technologies including bioinformatic analysis, metagenomic analysis, 

and comparative genomics. DHS and the National Center for Biotechnology Information will establish 

a comprehensive catalog of genomes that covers the full diversity (phylogenetic, functional, spatial, 

and temporal) of pathogens to enable new capabilities with applications to the fields of public health, 

homeland security, food safety, and medical diagnostics.

Transforming the FDA Archives into a Driver of Discovery and Development: The FDA currently 

houses one of the largest known repositories of clinical data, including safety, efficacy, and performance 

information, and an increasing amount of post-market safety surveillance data. Integrating and analyzing these data could revolutionize the development of new patient treatments and allow researchers to 

address fundamental scientific questions about how different patients respond to a therapy. Harnessing 

the power of these data will benefit from collaborations to develop new analytical methodologies and 

better standardization of the data for integration, all while protecting proprietary information. FDA is 

rebuilding its information technology and data analytic capabilities and establishing “science enclaves” 

that will allow for the analysis of large, complex datasets while maintaining proprietary information. In 

addition to potential new therapies for patients, these efforts will result in significant and demonstrable 

reductions in costs to drug and medical device developers.

Increasing Availability of Renewable Fuels, Intermediate Chemicals, and Biobased Products: 

President Obama directed the Secretaries of Agriculture and Energy to expedite and increase production 

of and investment in biofuel development by providing funding to encourage innovative biorefineries 

that produce the next-generation of biofuels from biomass and replace fossil fuels with biomass energy 

systems. To support the President’s goal of reducing America’s oil imports by one-third by 2025, the U.S.

Department of Agriculture (USDA) and Department of Energy’s (DOE) Biomass Program committed in 

April 2011 up to $30 million over three to four years to support 

R&D in advanced biofuels, bioenergy, and high-value biobased 

products. In addition, in September 2011, USDA’s Agricultural 

and Food Research Initiative committed more than $136 million 

to develop regional Coordinated Agricultural Projects for bioenergy systems through partnerships between academia, government, and industry. The projects funded through these initiatives will help create a diverse group of sources for alternative 

renewable fuels and biobased products. Advanced biofuels 

produced from these projects are targeted to reduce lifecycle 

greenhouse gas emissions and to play an important role in 

diversifying America’s energy portfolio.

Expanding the Versatility of Biofuel Energy Solutions:  In 

2010 the Advanced Research Projects Agency-Energy (ARPA-E) 

developed and deployed “Electrofuels,” a first-of-kind biofuels 

technology program to encourage development of new biological routes to fuels that bypass the limits of both current and 
Nati onal Bioeconomy Blueprint

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various advanced approaches to biofuels. ARPA-E invested $45 million across 13 innovative projects that 

target the development of unexplored, unapplied microbiology for biofuel production. The Electrofuels 

program relies on “chemolithoautotrophic” microbes, which can use inorganic carbon as their sole 

carbon source and are capable of growth and production in the complete absence of either sunlight or 

organic food sources.  The Electrofuels program represents the first concerted effort to investigate the 

potential of chemolithoautotrophy as a platform for biofuel production.

Converting Carbon Dioxide to Liquid Fuels: Plants Engineered to Replace Oil (PETRO) is a $30 million program launched recently by ARPA-E. Current agriculture-based biofuels are limited by the small 

amount of energy captured by photosynthesis and inefficient conversion of plant mass into fuel. The 

PETRO program aims to create plants that capture more energy from sunlight and convert that energy 

directly into fuels by optimizing processes of energy capture and conversion to develop robust, farmready crops that deliver more energy per acre with less processing prior to delivery to retailers. If successful, PETRO will create biofuels from domestic sources such as tobacco and pine trees for half their 

current cost.

Improving of Biofuel and Bioenergy Crops: In August, 2011, under the USDA-DOE Plant Feedstock 

Genomics for Bioenergy Program, $12.2 million was awarded for research to improve special crops for 

biofuels by increasing their yield, quality, and ability to adapt to extreme environments. Relying on 

modern genomics to develop novel breeding strategies, researchers focused on switchgrass, poplar 

trees, sorghum, miscanthus, and energy cane, among other promising plants with potential for growth 

on marginal lands that are poorly suited for food crops. Potential benefits of this research range from 

decreasing oil consumption to increasing options for American farmers, while adding new jobs and 

driving wealth creation in rural America.

Exploring the Potential of Research for Innovations in Bioenergy and New Building Practices:

Since 2009, the National Science Foundation’s (NSF) Engineering Directorate has invested over $200 

million in bioenergy research. In 2012, the NSF will initiate a Foundation-wide Sustainable Energy 

Pathways (SEP) effort ($34 million) aimed at harvesting energy from renewable resources and discovering “nature-inspired” processes for sustainable solutions to energy challenges. Under SEP, NSF’s 

Engineering Directorate will focus on integrating new scientific advances in energy research into good 

building practices.

Developing New Agricultural Research Programs that Drive Job Creation: To further advance energy 

innovation and meet the 2022 Federal Renewable Fuels standard goal, in September 2011 USDA committed more than $136 million to five major agricultural research projects aimed at developing regional, 

renewable energy markets, generating rural jobs, and decreasing America’s dependence on oil. These 

efforts focus on a variety of projects that complement existing bioenergy efforts across government, 

academia, and the private sector, including research on converting closed timber mills into bioenergy 

development centers, using sustainably grown woody crops to produce biogasoline, and planting 

legumes with grasses to add value to marginal lands and reduce fertilizer use.

Driving State-of-the-Art Organic Agriculture: U.S. producers are increasingly turning to certified 

organic farming systems for their potential to lower input costs, decrease reliance on nonrenewable 

resources, capture high-value markets, and boost farm income. To accelerate progress in these efforts, 

the USDA committed $19 million in September 2009 to universities across the country to address criti-
II. Federal Bioeconomy Str ateg ic Objecti ves

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cal organic agriculture issues through the integration of research, education, and extension projects.

Organic agriculture challenges such as nutrient and weed management, biodiversity conservation, and 

antioxidant production in organic grains are among the issues this effort has addressed. This work assists 

organic producers in developing new practices for efficient, responsible farms while meeting rising 

consumer demand. Technological and management advances, useful for a wide range of agricultural 

systems, are also made possible as a result of this advanced organic production research.

Transforming Manufacturing through Bioinnovation: A substantial number of recent promising 

biomanufacturing opportunities led the Administration to recognize the value in investing in emerging 

technologies that can create high-quality manufacturing jobs and enhance global competitiveness. In 

support of this, DARPA launched its Living Foundries Program, which is designed to harness biology as 

a revolutionary manufacturing platform for the flexible and rapid production of new or improved highvalue materials, fuels, medicines, devices, and capabilities for the Department of Defense. This effort 

seeks to develop the tools, capabilities, and methodologies to create a transformative shift in the ability to engineer biology through the integration of ideas, tools, and 

approaches from the biological, computational, and 

engineering fields. Living Foundries aims to compress the 

biological design-build-test cycle and expand by 100-fold 

the complexity of systems that can be designed and engineered. Key to success will be opening up the biological 

design and manufacturing process to new researchers 

and novel approaches, allowing information to be readily 

shared, and establishing a design ethos founded on predictability and reproducibility.

Employing Biomanufacturing to Enhance Economic 

Growth: In line with the Administration’s interest in investing in emerging technologies that will create high-quality manufacturing jobs and enhance U.S. global competitiveness, the NSF Engineering 

Directorate is committed to investing in bio- and bio-inspired manufacturing that will catalyze innovations in energy conversion technologies and health care. In the energy sector, novel bio-membranes 

for advanced fuel cells and optimization of bio-refineries are NSF-supported activities that promise to 

enhance the development of clean energy technologies critical to U.S. economic growth and energy 

independence. For health-care applications, NSF-supported biomanufacturing research includes 

exploration of advanced tissue engineering processes to “print” replacement organs for regenerative 

medicine and organ transplantation. NSF has also supported research for bio-inspired fabrication 

methods for production of flexible bioelectronics to enable truly biocompatible retinal or cochlear 

prosthetic implants. These and other advances not only have the potential to spur significant growth in 

the “clean-tech” biotechnology and medical device sectors, but could also transform the lives of many 

individuals suffering from debilitating conditions.

Developing Foundational Technologies

Forging Scientific Advancement with Integrated Cyberinfrastructure: Increasingly, researchers need 

information technology tools to enable them to interpret large quantities of complex data from multiple 
Nati onal Bioeconomy Blueprint

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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: Highthroughput 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 a 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.

Integrating Approaches from Engineering, Physical Sciences, and Computational Sciences

Forging New Collaborations across Scientific Disciplines to Address National Challenges: BioMaPs 

and Ideas Labs: Because national challenges in health, energy, food, environment, and manufacturing 

are increasingly complex, the Administration is seeking groundbreaking ways to develop innovative 

solutions for these complex problems. Toward this goal, the NSF has developed two new programs and 

is investing $28.94 million in Fiscal Years 2011 and 2012 in pioneering research to mine potential at the 

intersections of the life and physical sciences. The first program, started in 2011, is BioMaPS, an interdisciplinary effort of NSF’s Directorates for Biological Sciences, Math and Physical Sciences, and Engineering 

to derive fundamental new knowledge at the intersections of these major disciplines. The second is Ideas 

Labs, aimed to identify the most innovative multidisciplinary research projects to address key scientific 

challenges by bringing together a diverse group of researchers from multiple fields. Bringing together 
II. Federal Bioeconomy Str ateg ic Objecti ves

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the biological sciences, mathematics, physical sciences, and engineering, these new efforts promise to 

explore the potential of multidisciplinary approaches to solving large-scale national challenges.

Inspiring New Commercial Products and Technologies through Fundamental Biological Research: 

Fundamental biological research has affected nearly every aspect of our daily lives. The Administration 

believes that the key to a prosperous U.S. bioeconomy is a constant 

influx of knowledge about the living systems that make up our 

world. Numerous examples demonstrate how discovery inspires 

new ideas and ways of thinking that not only augment future 

research but also supply entrepreneurs with a vast array of fresh 

concepts for new commercial products. One important area of 

discovery is synthetic biology, which combines biology with engineering in cutting-edge, interdisciplinary research aimed at developing innovative approaches to new product development. Early 

results from synthetic biology, including NSF-supported fundamental research in microbial metabolism that enables reengineered microorganisms to produce the anti-malarial drug artemisinin or create polyester precursors, are already being accelerated by new companies. The development 

of new rapid diagnostic tools based on synthesized “peptide chips,” supported by a National Science 

Foundation Early concept Grant for Exploratory Research (EAGER), is another example of discovery 

spurring innovation. This research led to the formation of a start-up company that produces diagnostic 

chips for detecting evidence of many infectious diseases in miniscule volumes of blood. A second EAGER 

award resulted in the Genemeter, a portable DNA identification device, which has been licensed and is 

being marketed by a small company as part of a third-generation, lower cost bench-top sequencer for 

genomics applications.

Implementing New Funding Mechanisms to Maximize the Potential of Bioeconomy Investments

Using the Power of Prizes to Drive Innovation: In his September 2009 Strategy for American 

Innovation, President Obama called on all agencies to increase their use of prizes to mobilize America’s 

ingenuity to solve some of our Nation’s most pressing challenges while advancing agency missions.39

Through a prize, an agency can articulate a goal without having to specify the approach or predict 

the team that is most likely to succeed, and, importantly, pay only for success. In September 2010, the 

Administration launched Challenge.gov, a one-stop shop where entrepreneurs and citizen solvers can 

find public-sector prizes. As a result, in its first year alone, Challenge.gov featured more than 125 prizes 

from nearly 40 agencies, generating novel solutions to problems relating to childhood obesity, advanced 

vehicle technologies, financing for small businesses, Type 1 Diabetes, and many other national priorities.

In December 2010, Congress passed the America COMPETES Reauthorization Act granting all Federal 

agencies broad authority to conduct prize competitions as called for by the President.40

Driving Interdisciplinary Ventures with New Funding Mechanisms: In Fiscal Year 2012, NSF launched 

CREATIV (Creative Research Awards for Transformative Interdisciplinary Ventures), a pilot grant mechanism to support bold interdisciplinary projects in all NSF-supported areas of science, engineering, 

and education research. A unique characteristic of this new effort is that only internal merit review is 

39. http://www.whitehouse.gov/assets/documents/SEPT_20__Innovation_Whitepaper_FINAL.pdf

40. http://www.whitehouse.gov/sites/default/files/microsites/ostp/competes_report_on_prizes_final.pdf
Nati onal Bioeconomy Blueprint

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required—addressing recent concerns that under constrained Federal research budgets, external review 

panels tend to favor conservative research projects. CREATIV is aimed to provide substantial funding to 

unusually creative high-risk/high-reward interdisciplinary proposals, and applies to all NSF-supported 

areas of research. Since the future bioeconomy relies on an increasing number of creative interdisciplinary efforts, this new funding mechanism promises to provide a new avenue for funding from which 

bioeconomy efforts may benefit.

Moving Forward: Public input supported the Administration’s priorities to develop coordinated, integrated R&D efforts to continue to strategically shape the national bioeconomy R&D agenda. For example, 

research that maximizes the value of Federal datasets and better predicts safety of bioeconomy-related 

products will help grow the bioeconomy. Multiagency collaborations for emerging foundational technologies such as synthetic biology, biology-related information technologies, and proteomics will help 

leverage agency investments to maximum impact. Additional suggestions from public input indicated 

that more inter- and multidisciplinary efforts should be prioritized, as should efforts to align research 

efforts in health with medical needs. Flexibility in the use of new and existing funding mechanisms in 

and across agencies will be vital to stimulating the discovery of new bioinventions with potential to 

grow the bioeconomy.

Advancing From Lab to the Market

“The first step in winning the future is encouraging American innovation.”

—President Obama, January 2011 

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 Innovation41 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 barrier; 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 

41. http://www.whitehouse.gov/sites/default/files/uploads/InnovationStrategy.pdf
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Federal and state governments and non-profit organizations. In partnership with other organizations, 

MEP is developing the National Innovation Marketplace42 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.43 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.44 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.

As shown below, many Federal agencies are taking actions that will promote the bioeconomy in key 

areas, such as increasing support for translational research, driving commercialization with the procurement power of the government, enhancing entrepreneurial activities at universities, and improving 

technology transfer.

Increasing Support for Translational Research

Transforming Biomedical Translational Sciences: In 2010, the NIH proposed a reorganization to allow 

the creation of a new center, the National Center for Advancing Translational Sciences (NCATS), and in 

December 2011, NCATS was formally established. As envisioned, NCATS will identify barriers to the discovery and development of drugs and diagnostics for a wide range of human diseases and conditions, 

and provide science-based solutions to reduce costs and time required to bring products to market.

Translational science solutions developed by NCATS can be further developed by the private sector for 

applications in industry. Assisted by a working group of external advisors representing venture capital 

and drug companies, academia, and the philanthropic sector, NIH will develop strategies to collaborate 

with the private sector, as well as contribute to the translational research enterprise as a whole.

Accelerating Progress to Market through a New Regulatory Science Initiative: The NIH and FDA 

are collaborating to support regulatory science research, an interdisciplinary area of biomedical research 

that serves to generate new knowledge and tools for assessing experimental therapies, preventives, 

and diagnostics. It is critical to ensure that the regulatory and research landscapes are aligned to encour42. http://innovationsupplychain.com/usa/

43. http://www.gpo.gov/fdsys/pkg/FR-2009-10-08/pdf/E9-24518.pdf

44. http://www.gpo.gov/fdsys/pkg/BILLS-112hr1540enr/pdf/BILLS-112hr1540enr.pdf
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age entrepreneurs to develop novel technologies in some of the most promising cutting-edge research 

fields. Collectively, the NIH and FDA are contributing approximately $9 million over three years to support 

four research projects in the high-priority areas of nanotechnology, microdevice development for testing 

safety and efficacy, adaptive clinical trial design, 

and a novel strategy for testing eye irritation that 

reduces dependence on animals. Over the course 

of the upcoming year, the grantees and NIH and 

FDA project leaders will discuss how to maximize 

the impact and value of anticipated research findings and how to demonstrate the applicability of 

each new or improved tool or method to the regulatory decision making process.

Catalyzing Advanced Biofuels Production 

through Consortia: In 2009, with $85 million in 

funds made available by the American Recovery and Reinvestment Act, the DOE Biomass Program 

announced two multidisciplinary consortia charged with developing technologies to accelerate commercialization of advanced biofuels and bioproducts. The consortia model brings together researchers 

from universities, National Laboratories, and industry, to address both the foundational and applied 

research needs of the biofuels industry. Applied use of synthetic biology techniques is one example of 

how both consortia are utilizing foundational knowledge to improve organism performance, leading 

to improvements in fuel yield and process economics.

Driving Innovation with the Procurement Power of the Federal Government

Advancing Biofuels for Military and Commercial Transportation: As stated in its Blueprint for a 

Secure Energy Future, the Administration recognizes the need for the Federal government to lead by 

example to help move the Nation toward a clean energy economy, given the government’s status as 

the largest energy consumer in the U.S. economy. In August 2011, the Secretaries of Agriculture, Energy, 

and the Navy announced the creation of a cooperative effort to develop drop-in advanced biofuels.

Drop-in biofuels are direct replacements to existing gasoline, diesel, and jet fuels that do not require 

changes to existing fuel distribution networks or engines. This collaboration by the three Departments 

was developed in response to the Blueprint for a Secure Energy Future, and promises to advance U.S.

efforts to reduce dependence on oil.

Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product 

Procurement: As part of a commitment to leading the way in procurement of biobased products to 

create jobs and open new markets in rural America, the President signed the Presidential Memorandum 

on Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product 

Procurement.45 Biobased product materials are typically grown and manufactured in rural areas. Their 

increased procurement will lead to increased jobs in rural areas, benefits to the environment, and overall 

use of fewer petroleum-based products. The Presidential Memorandum provides guidance to increase 

45. http://www.whitehouse.gov/the-press-office/2012/02/21/presidential-memorandum-driving-innovation-andcreating-jobs-rural-ameri
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and better track biobased procurement as well as expand the list of designated biobased products 

available to the Federal government.

Enhancing Entrepreneurial Activities at Universities

Accelerating Commercialization of University Research with Innovative New Funding Programs:

While the knowledge gained from government-supported basic research frequently advances a 

particular field of science or engineering, some results also show immediate potential for impact in 

the business world. In support of the Administration’s push to advance these promising discoveries to 

products, the NSF established in 2011 the Innovation Corps (I-Corps) program to spur transformation 

of fundamental research into useful technological innovation, to encourage collaboration between 

academia and industry in technology transfer, and to provide students with opportunities to learn about 

and participate in the process of transforming scientific and engineering discoveries into innovative 

technologies. Encouraging initial I-Corps activities by several NSF Directorates in 2011 provide a basis 

for expansion of I-Corps activities by NSF in 2012.

Improving Technology Transfer

Streamlining the Licensing of Intramural Research Inventions to Startup Companies: To speed the 

transfer of intramural technologies from the NIH to startup companies, the NIH developed new shortterm, exclusive license agreements for companies that are less than five years old, with fewer than 50 

employees and less than $5 million in capital raised. These new licenses will be offered to companies 

developing drugs, vaccines, or therapeutics from NIH-patented or patent-pending technologies. The 

start-up company must license at least one U.S. patent and commit to developing a product or service 

for the U.S. market.

Improving the Transfer of Technology from Federal Research Laboratories: A recent study suggested that transfer of technologies from Federal research laboratories to the private sector could be 

enhanced.46 In October 2011, the President issued a memo asking agencies to streamline partnership 

processes, participate in regional innovation clusters and engage in public-private partnerships, and 

share Federal laboratory facilities with high-tech startup companies.47 Each agency will design a five-year 

“lab to market” plan with tailored goals and metrics to measure progress.

Accelerating Technology Transfer through Knowledgeable Partners: Because Federal R&D agencies are limited in the services they can provide to U.S. businesses by their missions and resources, third 

parties are essential players in the transfer of government-owned technology. USDA’s Agricultural 

Research Service established the Agricultural Technology Innovation Partnership Program (ATIP) to 

strategically form geographic partnerships with well-established economic development entities to 

encourage commercialization of USDA intramural research results. In June 2010, the first meeting of all 

ATIP intermediaries was held to plan and coordinate the transfer of technologies stemming from USDA 

intramural research. Also in 2010, USDA worked with EPA to develop a “first-of-its-kind” license agreement for distribution of a USDA intramural transgenic product, the HoneySweet plum.

46.  Shipp, S., et al.Technology Transfer and Commercialization Landscape of the Federal Laboratories. Institute For 

Defense Analyses, Science & Technology Policy Institute, Arlington, VA. 2011.

47. http://www.whitehouse.gov/the-press-office/2011/10/28/presidential-memorandum-accelerating-technologytransfer-and-commerciali
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Driving Innovation by Encouraging Entrepreneurship: The evidence supports and the Administration 

recognizes the role of entrepreneurs in American innovation and economic growth. In support of this 

role, November was designated as National Entrepreneurship Month. The 2009 Strategy for American 

Innovation48 described approaches to promote competitive markets that spur and support productive entrepreneurship. In 2011, the updated Strategy for American 

Innovation built upon those approaches with additional 

detailed policy objectives, including support for innovative 

entrepreneurs and innovation hubs for entrepreneurial 

ecosystems. President Obama has called for the Research 

and Experimentation Tax Credit to be expanded, 

simplified,49 and permanently extended, creating predictable, substantial incentives for U.S. businesses to innovate.

In January 2011, the White House launched Startup America to accelerate high-growth entrepreneurship 

by unlocking access to capital and reducing barriers to entrepreneurship, among other objectives. Also 

in 2011, the President signed the America Invents Act to help American entrepreneurs and businesses 

patent inventions and get them to the marketplace more quickly, and to accelerate the creation of new 

products and new jobs.

Facilitating Commercialization of Biomedical Discoveries through Improvements to the Small 

Business Grant Program: In addition to the modifications described in the SBIR reauthorization, NIH 

has undertaken steps to investigate how changes to its own SBIR efforts might accelerate translation of 

biomedical discoveries to the marketplace. For example, in 2011, the NIH initiated a new SBIR Technology 

Transfer Program, which includes efforts to develop new exclusive license agreements for startup companies interested in discoveries generated through NIH’s intramural research efforts. In addition, NIH is 

initiating an assistance program to provide funds to help small businesses navigate the FDA regulatory 

approval processes for drugs and medical devices. More than 60 companies are expected to benefit 

from this assistance in the near future. Further, NIH’s Scientific Management Review Board, an external 

advisory body, is expected to provide recommendations to NIH for additional SBIR program implementation and management modifications that may help accelerate the translation of biomedical discoveries 

to commercial markets, especially in light of the establishment of the NCATS.

Moving Forward: A dedicated commitment to translational efforts is needed to move bioinventions 

out of laboratories and into markets. Strategic, coordinated investments in translational and regulatory 

sciences will accelerate progress in many sectors of the bioeconomy. Additional programs, such as 

I-Corps, that enhance entrepreneurial activities at universities will help academic discoveries become 

commercial realities. To capitalize on the promise of the newly reauthorized SBIR program, agencies 

need to 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. To drive the creation and 

growth of new bioeconomy markets, Federal agencies should increase procurement of biobased and 

sustainable products, as authorized by law. Public input showed significant support for Federal efforts 

to identify and disseminate “best practices” for technology transfer.

48. www.whitehouse.gov/assets/documents/SEPT_20__Innovation_Whitepaper_FINAL.pdf

49. http://www.whitehouse.gov/sites/default/files/uploads/InnovationStrategy.pdf

“Entrepreneurs embody the promise 

of America: the idea that if you have a 

good idea and are willing to work hard 

and see it through, you can succeed 

in this country. And in fulfilling this 

promise, entrepreneurs also play a 

critical role in expanding our economy 

and creating jobs.”

—President Obama, January 31, 2011
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Reducing Regulatory Barriers

“So you guys are leading the way, and we know there are some things government 

can do to help clear the way for your success. We can make sure America remains the 

best place on Earth to do business by knocking down barriers that stand in the way 

of your growth. That’s why we passed 17 different tax cuts for small businesses, why 

I proposed lowering the corporate tax rate and eliminating unnecessary regulations 

to help larger businesses create jobs.”

—President Obama, February 2011

Strategic Objective: 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 governing our health products and services, energy production, national security, food, 

and environment are protections that necessarily reduce safety and security risks. However, some 

longstanding regulations have become inadequate or unnecessarily restrictive because technology 

and its associated products and services, as well as our national interests, have evolved and regulations 

may not have kept pace. Clear, predictable, and efficient regulations that ensure safety, security, and 

efficacy of products of biological research are powerful drivers of R&D investments by all sectors. In 

addition, because externalities and social attitudes influence market opportunities in the bioeconomy 

as they do in other economic arenas, a clear understanding of the benefits and risks of bioproducts is 

critical to the future bioeconomy.

An example of balancing concern for risks while maximizing benefits occurred in 2010. After a significant advance in synthetic biology, President Obama asked the Presidential Commission for the Study 

of Bioethical Issues to develop recommendations for Federal actions to ensure that America reaps the 

benefits of synthetic biology while identifying appropriate ethical boundaries and minimizing identified risks. As the bioeconomy and its underlying science advance, Federal agencies will adopt efforts 

accordingly to maximize public benefit and minimize public harm.

In 2011, President Obama issued two Executive Orders, Improving Regulation and Regulatory Review,50

and Regulation and Independent Regulatory Agencies, to improve regulation and the regulatory review 

process. Under these Executive Orders, the President called on Federal agencies to design cost-effective, 

evidence-based regulations that are compatible with economic growth, job creation, and competitiveness while preserving safety. The Orders emphasize the principles of public participation, integration and 

innovation, flexible approaches, and scientific integrity. They also include a provision on retrospective 

review, which asks agencies to submit a plan to determine whether any regulations should be modified, 

streamlined, expanded, or repealed in order to make the agency’s regulatory program more effective 

or less burdensome. Support for these important changes was highlighted in many of the public comments received in response to a request for information issued by the Office of Science and Technology 

Policy about this Bioeconomy Blueprint.

50. http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf
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In response to the Executive Orders, 26 agencies produced reform plans, and a small fraction of the initiatives described in the plans is predicted to save more than $10 billion over the next 5 years.51 Highlighted 

here are actions agencies are taking to support a future bioeconomy while protecting human and 

environmental health through reforms that increase timeliness, predictability, and reduce costs.

Removing Barriers of Innovation in Biomedical Industries: The FDA will implement reforms that 

address immediate concerns to increase transparency, consistency, and predictability of the regulatory 

processes and help drive medical product innovation forward. Translating a new idea from discovery into 

a medical product is a complex process that involves an entire ecosystem of players, including researchers, government agencies, small businesses, large biotechnology, medical device and pharmaceutical 

companies, insurance providers or payers, physicians, patients, and the American public. To prepare for 

the challenges ahead in the biomedical industries, the FDA is conducting internal analyses and meeting 

with the major stakeholders to identify areas where the agency can improve its regulatory framework.

In response, the FDA’s new Innovation Initiative outlines major reforms within the FDA to address 

immediate concerns and drive American innovation forward. This agenda focuses on several different 

areas, such as strengthening the agency’s relationship with the small business community, facilitating 

drug development and harnessing the potential of information sharing and data mining. Discussions 

with, and feedback from, major stakeholders are essential for these reforms and to increase the potential 

for new and better medical products to promote a healthier American public and world population.

Engaging External Scientific Experts to Improve the Regulation of Medical Devices: The FDA Center 

for Devices and Radiological Health (CDRH) is taking novel approaches for leveraging the expertise of 

the private sector to streamline and make more predictable the regulatory process for medical devices.

In October 2011, CDRH announced the start of a pilot program with select health care professional 

and scientific professional organizations to rapidly identify appropriate experts to help CDRH staff 

resolve important scientific questions. In February 2011, CDRH proposed to establish an “Innovation 

Pathway,” a new approach to reviewing important devices. For Innovation Pathway 2.0, the agency is 

taking a far broader approach. Rather than build onto the existing process, the agency is considering 

the entire regulatory system and developing a new pathway from the ground up based on experience 

and new expectations and through rapid pilot testing of new approaches. In addition, what CDRH creates for Innovation Pathway 2.0 will inform related improvements to other pathways to market. CDRH 

has assembled a team of entrepreneurs in residence—made up of external experts in medical device 

development, business process improvement, and information technology—who are working with 

FDA staff and leadership to rapidly improve the regulatory process for medical devices.

Reducing Bureaucratic Burdens for Low-Risk Medical Devices: The “de novo review” program for 

medical devices at the FDA is intended to provide a pathway to market for novel low-to-moderate-risk 

medical devices for which no similar device is available. Until now, the pathway has been underutilized 

because it is overly burdensome. In September 2011, the FDA CDRH issued draft guidance to make the 

de novo process less bureaucratic, more timely, more transparent and, thereby, a more viable pathway 

to market for novel low-to-moderate risk devices. By improving the de novo process, more devices that 

are novel will reach the market in a timely fashion.

51. http://www.whitehouse.gov/the-press-office/2011/08/30/letter-president-speaker-house-representatives
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Improving Human Subjects Research Protections while Reducing Unnecessary Burden: The 

Department of Health and Human Services (HHS) is working across the government to revise regulations 

governing federally-funded research involving human subjects to enhance protections and reduce 

burden, delay, and ambiguity for investigators. These regulations, known as the Common Rule, have 

not been significantly revised in more than 20 years, 

despite dramatic changes in the nature and terrain of the 

research enterprise. For example, by more precisely calibrating the level of review to the level of risk, review 

boards overseeing research protocols could focus their 

attention on protocols that pose greater than minimal risk 

to subjects. By considering revisions to the current rules, 

HHS is leading the way in modernizing, simplifying, and 

enhancing the current system that oversees human subjects’ protections. This effort reflects the government’s 

commitment to protecting participants in research while advancing biomedical and related research—

and the public benefits that research makes possible. Public comments were sought on the proposed 

changes through an Advanced Notice of Proposed Rule Making published in the Federal Register on 

July 26, 2011.

Expanding the Coverage with Evidence Development Program to Drive Innovation: Reimbursement 

for medical treatments is a powerful driver of industry investment. Under the Coverage with Evidence 

Development (CED) program, Medicare reimburses for promising new technologies that do not currently meet the standard for full coverage. The CED program requires more evidence to be collected 

to determine full potential benefit of new technologies. The CED authority has existed for more than a 

decade but has been applied sparingly. The Centers for Medicare & Medicaid Services (CMS) is poised to 

implement the next phase of CED by better defining the parameters and guidance for CED so it can be 

used more widely and effectively as a driver of innovation. CMS believes that the lessons learned during 

the initial implementation of CED can inform its more frequent use and create predictable incentives 

for innovation while providing greater assurance that new technologies in fact fulfill their initial claims 

of benefit.

Reducing the Time to Market by Implementing Parallel Regulatory Reviews for Medical Products: 

FDA approval and CMS coverage significantly influence the development and commercial success of 

new medical products. The time required for FDA and CMS to sequentially review new medical products—often multiple years—is frequently cited as a disincentive for innovators and investors in the 

medical technology industry. A significant portion of this delay is due to the fact that most sponsors 

of new products approach each reviewing agency separately, first working to meet the evidentiary 

requirements of the FDA and only later focusing on the requirements of CMS. To address this problem, 

the FDA and CMS initiated a pilot program for the parallel review of medical devices, creating a pathway 

for new medical products to be simultaneously reviewed by both agencies. By engaging CMS earlier 

in the process, the parallel review program is expected to limit the duplication of effort on the part of 

product sponsors and agency reviewers and reduce the time it takes new products to enter the market 

and receive payments from Medicare and other providers.
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Developing tools to facilitate the continuity of business during a foreign animal disease outbreak: New DHS S&T programs on countermeasures and screening tools for foreign animal diseases 

are aimed at strengthening the defense of the U.S. agricultural infrastructure by developing new and 

next-generation countermeasures (vaccines, diagnostics, and screening tools) to protect the livestock 

industry against Foot and Mouth Disease and other high consequence foreign animal diseases. New 

and next-generation countermeasures will be developed and transitioned directly to veterinary biologic industry partners for commercialization and access by USDA. Current investments are focused 

on countermeasures for Foot and Mouth Disease, Rift Valley Fever, Classical Swine Fever, African Swine 

Fever, and Henipavirus.

Reforming Regulatory Processes to Accelerate Application Review and Open New Agricultural 

Markets: Regulatory processes can inhibit companies from initially investing in an area due to uncertain 

time delays and the lack of clear guidance for applicants. Consistent with the President’s January 2011 

Executive Order, Improving Regulation and Regulatory Review, USDA 

announced plans in November 2011 to dramatically streamline and 

improve several programmatic processes, including the USDA’s processes 

for conducting risk assessments and rulemaking. The USDA expects timesavings of more than 70% by implementing improvements to project 

management and tracking, as well as assigning and meeting deadlines 

on required steps in the risk assessment process. Expected benefits of this 

effort include reduced government costs, improved relationships with 

foreign trade partners, and new market opportunities for U.S. products 

abroad, among many others. In addition, in August 2011, USDA 

announced that its Animal and Plant Health Inspection Service would 

conduct a two-year pilot project to improve the approval process for 

genetically engineered organisms.

Improving the Regulation of Emerging Technologies: Emerging technologies, including nanotechnology and synthetic biology, will provide exciting new products to enhance our lives, grow our 

economy, and preserve and restore the environment. A quarter century ago, the Federal government 

formulated the 1986 Coordinated Framework for the Regulation of Biotechnology to ensure a robust 

regulatory system for genetically engineered products.52 Supported by studies that analyzed decades 

of research, genetic engineering has had a remarkable history of safe development and production 

of drugs, crops, foods,53 and other products. In March 2011, the Administration released Principles 

for Regulation and Oversight of Emerging Technologies.54 Under President Obama’s Executive Order, 

Improving Regulation and Regulatory Review, federal regulatory agencies have already taken steps 

to make the regulatory process for emerging technologies more transparent and predictable and will 

launch efforts to further improve the efficiency of the regulatory process while minimizing safety and 

security risks and removing unnecessary barriers to innovation.

52. www1.usgs.gov/usbiotechreg/read_file.nbii

53. http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf

54.  http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-andOversight-of-Emerging-Technologies-new.pdf
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Driving Industrial Innovation with International Standards: The bioeconomy is expanding within 

a rapidly developing global technology landscape, and international standards are a critical factor in 

driving industrial innovation and facilitating global trade. A January 2012 White House Memorandum55

clarified the role of the Federal Government in working with the private sector in standards activities to 

address national priorities. With the benefit of close ties to both industry and the regulatory enterprise, 

NIST contributes to activities in international standards setting organizations such as the International 

Organization for Standardization. This participation helps ensure that international standards, which 

will play a critical role in realizing the benefits of the bioeconomy, are based on rigorous measurement 

science and technology.

Moving Forward: Public input reinforced the Administration’s focus on improving regulatory processes 

to help achieve the promise of the future bioeconomy more rapidly and safely. Federal agencies should 

develop new, efficient regulatory processes and reform extant ones where necessary. This will reduce 

barriers to innovation and increase predictability and timeliness of regulatory processes to stimulate 

the bioeconomy in all sectors. Building and augmenting stakeholder collaborations and streamlining 

processes to reduce costs and response times while preserving safety are key objectives. When an 

emerging technology enters the regulatory process, Federal agencies must have a robust framework 

that identifies lead agency responsibility and its role in coordination, clarifies supporting agency roles, 

and delivers timely, specific guidance for applicants.

Developing a Bioeconomy Workforce

“When it comes to workforce development, one of the most important things that 

we’ve all learned is how important it is to get businesses in early with the universities 

and the community colleges—a hugely under-utilized resource—to develop the 

actual training program so that young people have confidence if they go through this 

training program, they’ve got a job; businesses have confidence that if they hire these 

young people who went through the training program, they are trained for those jobs.”

—President Obama, February 2011

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.

55. http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08_1.pdf
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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 report56 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 trainingtype 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 

56.  The U.S. Department of Commerce report is available at: http://www.commerce.gov/sites/default/files/

documents/2012/january/competes_010511_0.pdf
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positions available to PhD biomedical trainees is far below the number of those so-trained.57 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.

As highlighted below, Federal agencies are making their own moves to prepare the next generation to 

compete successfully in a bioeconomy by improving STEM education and increasing diversity, preparing 

a bioeconomy workforce for academic and non-academic jobs, and leveraging community colleges and 

industry in workforce development.

Improving STEM Education and Increasing Diversity

Investing in the Next Generation of Environmental Scientists: The Administration has stressed 

the importance of investments that will develop a strong, well-trained, and diverse workforce for a 

burgeoning bioeconomy. In direct response, the National Oceanic and Atmospheric Administration 

has awarded $10.8 million to four leading minority-serving institutions across the country to train 

students to conduct applied research in areas such as remote sensing, environmental science, marine 

resources, or atmospheric sciences. These areas are essential to understanding and predicting changes 

in our environment and to conserving and managing coastal and marine resources that are critically 

important to a bioeconomy. Furthermore, this funding recognizes the importance of STEM education 

and supports America’s ability to innovate and compete in the global economy.

Enhancing Agricultural Sciences at Minority-Serving Institutions: By 2025, nearly one-quarter of the 

Nation’s college-aged population will be Latino. To enhance the ability of Hispanic-Serving Institutions to 

support underserved students and develop a skilled bioeconomy workforce, the USDA committed $8.8 million in October 2011 to 18 HispanicServing Institutions to support programs that address efforts focused 

on climate change, biobased energy development, childhood obesity, 

and food safety, among others. In addition, USDA provides support for 

other minority-serving institutions, particularly in capacity building and 

STEM education. USDA provides at least $51 million to underrepresented 

groups in STEM. It is projected that from 2010-2015 there will be 54,400 

jobs available for agriculture graduates. Only half of these are likely to 

be filled by graduates in an agriculture discipline; the other half will be 

filled by allied disciplines. The programs mentioned above are important 

in responding to this shortage.

Expanding and Enhancing the Biomanufacturing Workforce: The 

Administration has taken a strong leadership role in manufacturing—a 

sector that has helped lead the economic recovery over the past two 

years by adding over 400,000 jobs since the beginning of 2010. In order to maintain forward progress, 

57. http://www.nature.com/news/2011/110420/full/472276a.html
Nati onal Bioeconomy Blueprint

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NSF has established two new programs to fund transformative research to address the national need 

for sustainable materials and chemicals and train the next generation of scientists and engineers to fill 

this expanding workforce. The Sustainable Chemistry Engineering and Materials (SUSCHEM) program 

will promote development of a workforce to support the growth of a new sustainable and environmentally friendly chemical and materials manufacturing sector. The Sustainable Energy Pathways (SEP) 

program, part of the NSF-wide initiative on Science, Engineering, and Education for Sustainability, will 

provide resources for training of the workforce that will lead the renewable energy industry. The new 

SUSCHEM program, as well as the existing SEP programs, emphasize the importance of building strong 

interdisciplinary networks and environments for workforce development.

Preparing a Bioeconomy Workforce for Academic and Non-Academic Jobs

Creating New Approaches to Bioeconomy Workforce Training: In 2011, the NIH’s National Institute 

for General Medical Sciences released its Strategic Plan for Biomedical and Behavioral Research Training.

The new plan recommends actions to improve student 

development and diversity and addresses several challenging realities of the current biomedical and behavioral research training landscape, including: changing 

career outcomes for trainees, increased time to scientific 

independence, and lack of diversity in the biomedical 

workforce. Also in 2011, the NIH assembled a Biomedical 

Workforce Task Force to make recommendations in 2012 

for actions that NIH should take to support a sustainable 

biomedical training infrastructure that provides incentives for updated training programs to prepare trainees 

for academic and industry careers.

Building an Entrepreneurial Bioeconomy Workforce: In October 2011, the FDA announced an 

intention to train “Young Entrepreneurs” through the provision of fellowships for business, engineering, 

and science students with entrepreneurial interests. The FDA plans to work with university business 

schools to establish a four- to six-month internship or training course within FDA small business offices 

to provide future entrepreneurs, venture capitalists and inventors with first-hand access to information 

about regulatory review and FDA approval processes.

Training and Hiring the Next Generation of Innovators: In 2011, the FDA announced its new Future 

Innovators program to bring together regulatory sciences and policy training to meet the scientific 

and technological demands of the 21st century. Under this competitive program, the FDA will expose 

candidates to important topics such as regulatory affairs, manufacturing, diagnostics, biomedical device 

engineering, and computational science, and will hire qualified candidates who show outstanding 

promise in their fields for positions within the FDA. Retention of some of the Future Innovators will help 

the FDA maintain a cadre of highly trained experts to sustain the FDA as needs and technologies evolve.
II. Federal Bioeconomy Str ateg ic Objecti ves

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Leveraging Community Colleges and Industry in Workforce Development

Inspiring Undergraduate Engineering Students for 

Biomedical Careers: In 2011, NIH founded Design by 

Biomedical Undergraduate Teams (DEBUT), a creative 

challenge program that engages engineering undergraduates (including community college students) to 

accelerate the design and application of biomedical 

technologies for human health. In 2012, the first teams 

will apply in three challenge categories: diagnostics, 

therapeutics, and technology to aid underserved populations and individuals with disabilities. Each winning 

team will receive a $10,000 prize and will be honored at an award ceremony during the 2012 Annual 

Meeting of the Biomedical Engineering Society in Atlanta, GA.

Building American Skills through Community Colleges: As the largest component of the Nation’s 

higher education system, community colleges enroll more than 7.6 million students—many of whom 

are older, working, or in need of remedial classes. Community colleges work with businesses and government to create tailored training programs that meet economic needs in areas such as advanced 

manufacturing and health information technology.

In his Fiscal Year 2013 budget request, President Obama proposed a new Community College to Career 

Fund that would provide $8 billion to the Departments of Education and Labor to support State and 

community college partnerships with businesses to build the skills of 2 million American workers. This 

new investment would build upon other Administration 

initiatives to strengthen community colleges’ capacity to 

meet employers’ need for skilled workers in high-growth 

sectors of the economy. The Trade Adjustment Assistance 

Community College and Career Training (TAACCCT) grant 

program, funded at $2 billion over four years, builds the 

capacity of community colleges, in collaboration with businesses, to create career pathways, create education partnerships, and develop online courses enabling participants 

to complete training in two years or less for high-wage, 

high-skill occupations. The first round of $500 million in 

TAACCCT grants from the Department of Labor, in collaboration with the Department of Education, was 

awarded in September 2011. Skills for America’s Future, an industry-led initiative that the Administration 

helped to launch in 2010, matches major employers with community colleges in every state to develop 

curricula and programs that will prepare graduates to excel in the workforce.

Bringing Expertise into Federal Agencies to Drive the Bioeconomy: In parallel with many of the 

comments provided by the public, the Administration identified the importance of insourcing expertise 

to empower positive change in Federal agencies. In 2011, the FDA announced its Entrepreneurs-inResidence pilot program, aimed to engage more than a dozen outside experts with state-of-the-art 

business and medical device expertise to work alongside FDA staff. This pilot effort will focus initially 

“In the coming years, jobs requiring 

at least an associate degree 

are projected to grow twice as 

fast as jobs requiring no college 

experience. We will not fill those 

jobs – or keep those jobs on our 

shores – without the training offered 

by community colleges.”

—President Obama, October 5, 2010
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on building a priority premarket review program for technologies that demonstrate potential to revolutionize disease treatment, diagnosis, or health care delivery and that target unmet medical needs.

Moving Forward: Federal agencies should develop incentives for institutions to adapt training to 

meet the needs of the 21st century bioeconomy workforce. Increasing industry participation in the 

development of training programs and education is a priority. Informing students about placement 

rates for recent graduates allows them to make educated choices about career placement. Although 

public comment was divided on whether industry or government should support professional student 

internships, there was agreement that internship opportunities are essential components of the evolving needs of a future bioeconomy workforce. In addition, training programs for PhD-level professionals 

should formally promote student awareness of PhD-level career opportunities outside of academia, 

including but not limited to industry, policy, law, finance, and journalism. Agencies should consider 

convening industry stakeholders from various sectors to assess the success of training programs to 

meet the needs of employers.

Fostering Partnerships

“We’re all familiar with clusters like Silicon Valley. When you get a group of people 

together, and industries together, and institutions like universities together around 

particular industries, then the synergies that develop from all those different facets 

coming together can make the whole greater than the sum of its parts.”

—President Obama, February 2011

Strategic Objective: 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.

The Nation’s economy has always depended, above all, on a continuous flow of new technologies 

and new ideas into the marketplace. Partnerships between companies, universities, and the Federal 

government are key to leveraging investments, knowledge and experience in emerging technologies 

required for, and generated by, a bioeconomy (see 

inset for models of collaborative partnerships).58For 

instance, many companies do not invest in early 

ideas because they are unlikely to pay off immediately. This is where the government plays a crucial 

role. The President has emphasized that universities and companies must complement Federal 

efforts by working 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.

58. http://www.iom.edu/~/media/Files/Activity%20Files/Disease/NCPF/2009-FEB-Wkshp-on-PrecompetitiveCollaboration/Altshuler.pdf

Models of Collaborative Relationships58

•	 Open-source initiatives

•	 Industry consortia for process innovation

•	 Discovery-enabling consortia

•	 Public–private consortia for 

knowledge creation

•	 Prizes

•	 Innovation incubators

•	 Industry complementors

•	 Virtual pharmaceutical companies
II. Federal Bioeconomy Str ateg ic Objecti ves

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To advance this goal, President Obama launched the Advanced Manufacturing Partnership, a national 

effort that brings companies, universities, and the Federal Government together to invest in the emerging technologies that will create high-quality manufacturing jobs and enhance our global competitiveness. This concept is also driving the Startup America initiative’s focus on building connections between 

established and new entrepreneurs. Through these efforts, the Administration is working to catalyze a 

new model of economic development.

As shown below, Federal agencies are creating opportunities to support partnerships that will contribute 

to the bioeconomy.

Supporting Public-Private Partnerships to Find New Uses for Known 

Drug Compounds: The NIH plans to fund efforts to bring together 

industry and academic researchers to accelerate the “rescue” of abandoned pharmaceutical compounds and “repurposing” of approved 

products for novel therapeutic uses. In the proposed partnership, 

companies will provide previously proprietary compounds and their 

associated data to academic researchers who, with funding from NIH, 

will explore new uses to improve human health. This approach is bold 

in its scope in that it strives to identify novel uses for known industry 

compounds in preventing, treating, and curing disease.

Building Collaborations for Smarter Drug Design: Based on a successful 2011 NIH-industry workshop 

focused on developing a strategic approach to validating promising drug targets, NIH is organizing a 

joint NIH-Industry Target Validation Consortium, composed of experts from industry, academia, and NIH.

NIH-supported scientists have created an impressively large collection of DNA and genome sequence 

data from diverse populations, including healthy people and disease patients. NIH and industry collaborators will use these data to better understand health and disease and provide high-value drug 

targets that companies can use for discovery and development of new diagnostics and therapeutics.

Seventeen pharmaceutical and biotech companies attended the workshop and expressed enthusiasm 

for joining the consortium.

Collaborating to Develop Tools to Advance Whole Genome Sequencing from the Research Lab 

to the Clinic: At an international meeting of the American Society of Human Genetics in October 2011, 

NIST convened representatives from the FDA, CDC, and NIH with private-sector stakeholders to consider 

the tools needed to integrate DNA sequencing innovations into clinical practice. The future development of these tools, including reference materials, methods, and metrics, is envisioned to benefit from 

involvement by relevant stakeholders, such as regulators, producers, and consumers.

Supporting Innovation in Manufacturing of Biotherapeutics through Measurement Research: 

The NIST and the FDA are working with the biopharmaceutical industry to develop measurements and 

standards to support development, manufacturing, and regulatory approval of new protein therapeutics. NIST is working to develop fundamental measurement science, standards, and reference data to 

enable more accurate characterization of key attributes of protein drugs that are directly linked to their 

safety and efficacy. These tools are expected to promote improved manufacturing processes for protein 

products and more firmly underpin regulatory decisions.
Nati onal Bioeconomy Blueprint

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Collaborating to Combat Alzheimer’s Disease: The NIH, FDA, other Federal agencies, more than 20 

pharmaceutical companies, and many others from the private sector created the Alzheimer’s Disease 

Neuroimaging Initiative (ADNI), a groundbreaking study to identify subtle changes that take place in 

brains of older people before symptoms of Alzheimer’s disease appear. Alzheimer’s disease is a neurodegenerative disease that affects more than 5 million Americans, and there is currently no cure for this 

devastating disease. The first stage of the study has already produced valuable outcomes: pharmaceutical companies have begun using ADNI-validated disease markers, cutting down on clinical trial expense 

and length compared to the less precise cognitive measures that have traditionally been used in trials 

of Alzheimer’s disease. As a continuation of the ADNI 

study, a team of researchers from the NIH, FDA, academia and pharmaceutical companies are collaborating to expedite the diagnosis and treatments of 

Alzheimer’s disease using biomarker panels in both 

plasma and cerebrospinal fluid samples from patients.

In February 2012, the Administration announced new 

investments in Alzheimer’s research, including an additional $50 million for cutting-edge Alzheimer’s research 

in Fiscal Year 2012 and an $80 million boost in funding 

for Alzheimer’s research in the President’s Fiscal Year 

2013 budget.

Establishing Public-Partnerships for Food Security: The Administration supports approaches that 

address the root causes of hunger and poverty and forge long-term solutions to chronic food insecurity 

and under-nutrition. Through its new Feed the Future initiative (United States Agency for International 

Development, USDA and NIH), the Administration is helping developing countries transform their 

agricultural sectors to sustainably grow enough food to feed their people. In a complementary effort 

through its Basic Research to Enable Agricultural Development (BREAD) program, NSF partnered with 

the Bill and Melinda Gates Foundation to invest a total of $48 million over 5 years to support research 

carried out at U.S. academic institutions, while the Gates Foundation supports international partners 

via sub-awards from the U.S. awardees. Of the first round of projects announced in 2010, one project 

is already revolutionizing genome-wide selection of plants with desirable traits, and a 2011 award will 

affect cassava and banana breeding. These new tools can be applied to any crop, so while they benefit 

smallholder farmers in developing countries through BREAD, they will have similar impacts here in the 

United States.

Developing Innovative Approaches to New Biofuels Feedstock: Forecasting a need for improved 

genetic diversity for the biomass industry, USDA and DOE launched a new three-year public-private 

partnership in 2011 to improve biomass feedstock. Because sugarcane is one of the most efficient grasses 

in converting sunlight into sugar and biomass, the USDA focused efforts on developing a new sugarcane 

crop with additional desired traits, including increased yields in U.S. climates. A near-term aim of this 

public-private partnership is the planting of 3.1 million acres of cane crop worth $120 million on marginal 

lands in the southern regions of the United States.
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Increasing Bioeconomy Agricultural Exports: President Obama 

supported the Renewable Energy and Energy Efficiency Export 

Initiative to spur the creation of millions of new jobs by 2015 and 

improve U.S. export competitiveness in renewable energy. One such 

industry whose exports expanded quickly is the wood pellet industry.

In 2010, the United States exported $128 million of wood pellets.

To further facilitate this export growth, in 2011 the USDA’s Market 

Access Program committed to identifying and growing additional 

market opportunities for wood pellet exports in the European Union.

Additionally, the USDA recently expanded one of its regular international market reports to include production, consumption, and trade 

statistics for wood pellets with the goal of increasing knowledge of 

the global biomass industry.

Moving Forward: Federal agencies should provide incentives for precompetitive collaborations to 

benefit the bioeconomy broadly. Federal agencies should also identify public-private partnerships in 

health, energy, agriculture, and manufacturing to leverage Federal investments and industry investments and expertise. Public input supported the creation of new public-private partnerships with shared 

risk, defined responsibilities, and deliverables to achieve mutual benefit and grow the bioeconomy. In 

addition, to promote the bioeconomy, universities should be encouraged to partner with industry to 

advance the scientific enterprise and reward faculty researchers who do so.

★ 43 ★

Conclusion

The Administration has made great strides in harnessing biological research innovations to address 

national challenges in health, energy, food, environment, and manufacturing via the commercial 

economy. But there is much more to be done. The Administration plans to explore additional creative 

ideas for promoting U.S. leadership in the bioeconomy, such as innovative financing for translational 

research, increasing the impact of the SBIR program, and improving the ability of faculty and students 

to move from “idea to IPO,” and will continue to accept public input by email at bioeconomy@ostp.gov.

By strategically shaping future R&D investments, improving commercialization of bioinventions, 

updating workforce training programs for new bioeconomy careers, reforming regulatory processes, 

and building new bioeconomy public-private partnerships, the Administration will help stimulate the 

growth of a high-wage, high-skill sector while improving the lives of all Americans.