Accelerating Bioindustry Through Research, Innovation, and Translation
Summary
America’s bioeconomy is entering a once-in-a-generation moment. Research and development (R&D) breakthroughs have brought us to a scientific tipping point; at the same time, health and security threats are inspiring a new level of strategic coordination. Although we now have a strong base of fundamental science, we lack the equally powerful industrial foundation needed to put the “economy” in bioeconomy. Bioindustry, encompassing less flashy products (chemicals, plastics, fuels) and bio-enabling tools and capabilities, often fails to capture the attention and investment needed to connect research with use cases, commercialize, and scale. But without solutions and capabilities that span multiple applications and sectoral silos, our bioeconomy will stall at the lab door.
Rapid progress in strengthening American bioindustry is possible, but it demands a coordinated and concerted effort that taps the federal government’s unique combination of scale and highly effective lab-to-market incentive mechanisms. Streamlined funding of open and cross-disciplinary research, prize and challenge mechanisms, and market shaping through innovative procurement have all proven highly effective in the face of market failures and applied technology gaps like those seen in our bioindustry.
To refine, tailor, and manage its unique lab-to-market toolkit in this space, the federal government should establish a single coordinating entity to accelerate bioindustry in close partnership with stakeholder agencies. The Bioindustrial Research, Innovation, and Translation Engine (BRITE), housed within National Institute of Standards and Technology (NIST), would do this by:
- Coordinating and funding accessible, open topic research opportunities tackling the most pressing blockers of bioindustrial progress
- Designing and administering open innovation competitions and challenges that de-risk and accelerate use-inspired bioindustrial solutions
- Catalyzing bioindustrial markets through advance commitments and pooled procurement of innovative products and services
- Bringing strategic clarity and cohesion to federal investments in bioindustry, maximizing returns to all stakeholders
Challenge and Opportunity
After steadily gaining mindshare and momentum among policymakers, our bioeconomy has reached a once-in-a-generation moment. This has been amplified by the urgency of biothreats revealed during the COVID-19 pandemic, as well as the role that biotechnology and biopharmaceutical innovation played in the global response. While efforts to realize a comprehensive U.S. bioeconomy vision date back to 2012, the Biden Administration’s September 2022 Executive Order provides a clear and compelling new articulation of that vision and can serve as a platform for realizing it. Moreover, recent legislative actions, including the CHIPS and Science Law, Inflation Reduction Law, and various appropriations (see FAQ), have enabled a range of federal bioeconomy initiatives and investments.
The greatest barrier to meeting our bioeconomic moment is not one of fundamental science; it is the underdevelopment of America’s bioindustry. Bioindustry encompasses both the manufacturing of biochemicals, bioplastics, and biofuels as well as the tools, kits, and services that drive and enable the wider bioeconomy. There are very real technical, capability, and incentive barriers to bioindustrial progress, including:
- The unpredictability of performance, and associated trial-and-error requirements, when scaling bioprocesses beyond the lab
- Limited demonstration testbed and intermediate-scale facilities to enable scale-up experimentation and iteration
- A high degree of specialization in existing facilities, which limits accessibility to developers unless facilities can expand or retrofit
- Few existing data and task standards, reducing the interoperability of different tools and approaches
- Cost and inertia discouraging a more systematic transition to sustainable bioeconomy
- A culture that rewards discovery and publication over applied or translational research
- Traditional federal grant structures and criteria that reinforce said culture
Given these barriers, bioindustry is particularly susceptible to two “valleys of death”—one between a scientific breakthrough and a usable product and another between a market-ready product and deployment. In these valleys, typical innovation funders are disincentivized from high-risk / high-reward investment and struggle to achieve any sort of investment coherence or cohesion. A Congressional Research Service report notes that the very definition of bioeconomy varies widely across sectors and countries. Capital tends to isolate around one thematic area (e.g., climate, advanced materials, agriculture, health) rather than fueling systems-based, cross-cutting investments that grow the overall pie. This creates a high risk of duplicated effort and repetition of missteps. A Schmidt Futures task force report estimates that without a vibrant bioindustry, the U.S. risks losing out on at least $260 billion of annual economic opportunity that will otherwise go overseas. We will also face new economic and national security threats if we fail to establish resilient domestic bioeconomic supply chains and a robust competitive landscape.
The federal government stands alone in its ability to rapidly close the gaps that hold bioindustry back. Federal agencies are uniquely incentivized to bridge the valleys of death by tapping agencies’ unique portfolios of lab-to-market, demand-pull mechanisms. These include:
- Broad agency announcements (BAAs) for research. Federal Acquisition Regulations Part 6.102(d)(2) streamlines typical procurement competition requirements for research-oriented projects. This has been most successfully applied by the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation, and Ventures (DRIVe) in the form of a BAA, calling for research projects related to biothreat mitigation. Under DRIVe’s EZ-BAA, projects that address broad and high-impact areas of interest (AOI) can receive up to $750,000 based on an abstract submission and negotiation with BARDA.1
- Prize competitions and challenges. Increasingly an alternative to traditional grants, prizes expand flexibility, reduce reporting burden, and pay only for results based on performance against defined criteria. Prizes are particularly effective where a problem and need is clear, but the innovation pathway is uncertain—and may need to be redirected or accelerated based on serendipitous findings. Prizes are also a uniquely effective mechanism to bridge the gap between fundamental research and investment-ready solutions or businesses.
- Nontraditional acquisition. Beyond its role as an innovation catalyst, government can shape markets as a foundational customer, influencing other actors and nudging a sector toward self-sustenance. Procurement practices like Other Transaction Authorities (OTA) remove red tape in deploying nondilutive federal capital, which helps innovators reach scale and attract many times more private capital in a shorter time frame. In an OTA, a consortium of commercial and other providers can be established, satisfying competition requirements while enabling faster execution of transactions compared to traditional bid processes for each action. A MITRE analysis found the Department of Defense currently runs over 30 OTA consortia, and the Department of Homeland Security and National Geospatial-Intelligence Agency have also launched consortia. Beyond OTA, tools such as advance market commitments, strategic stockpile procurement, and federal financing (e.g., loan guarantee programs, development finance corporations) can provide innovators a critical first customer or early working capital.
The barriers to bioindustrial progress—complex technical gaps, incentive and market failures, and misalignment of innovation culture—are daunting. Encouragingly, they are just the sort of barriers that these federal lab-to-market and demand-pull mechanisms were designed to overcome.
What are the broader benefits of accelerating our bioindustry?
Building a more robust industrial foundation for our bioeconomy benefits the entire nation but has particular potential to close economic gaps in regions historically left behind. A range of different production infrastructure, from dormant plants to breweries, can be retrofit more efficiently, especially in places outside traditional biotechnology hubs. Broadening the range of bioindustrial tools and processes, and moving to scale manufacturing, will create new job opportunities beyond advanced researchers in labs. There are also many advantages to locating biomanufacturing infrastructure in proximity to rural areas rich in feedstocks. The intersection of place-based innovation and bioindustry has already been brought to life through efforts like the U.S. Department of Agriculture Bioproduct Pilot Program and will no doubt accelerate through the NSF Regional Innovation Engines opportunity, which will align use-inspired research, translation, and workforce development in new self-sustaining innovation hubs across the country.
Plan of Action
Business as usual will not realize the full potential of—or avoid the many pitfalls awaiting—our national bioeconomy strategy. The pace and scale of bioindustrial progress require us to tap into all of the capabilities and resources noted above. In general, we need more coordinated action across the public and private sectors, including streamlined R&D partnerships to close gaps in health vs. industrial applications; competitions and challenges that translate breakthroughs to real-world use; market-shaping activities to achieve scale; and strategic coordination of sustainable funding to maximize investment leverage.
A new, whole-of-government entity should be established to marshal federal tools, best practices, and investments toward shared priorities that are critical to American bioindustrial leadership. The Bioindustrial Research, Innovation, and Translation Engine (BRITE) will encompass open innovation programs, market-shaping activities, and stakeholder engagement. BRITE can be housed within a new NIST Bio for America Program Office and convene relevant program owners from core agencies with bioeconomy mandates: National Science Foundation (NSF), Department of Energy (DOE), Department of Defense (DOD), Department of Agriculture (USDA), and Department of Health and Human Services (HHS).
Streamlined R&D partnerships
BRITE can take advantage of the growing body of ideas and insights coming from academic and commercial communities through open and accessible calls for projects. This could be achieved through an EZ-BAA vehicle, modeled after BARDA DRIVe’s open call for projects that address a broad set of health security problems. The BRITE EZ-BAA would offer up to $500,000 for research and commercialization projects addressing a set of announced areas of interest (AOIs). Early engagement with BRITE through this program would improve the efficiency and win rate of technology development—and incentivize success-enabling design principles, such as designing for future biomanufacturing scale versus pure scientific outcomes. Initial AOIs could focus on scientific and technical rate limiters for growth in nonhealth bio, including development of novel high-performance biomaterials with features optimized for specific industrial use cases, or tailored to replace carbon-based inputs, as well as foundry-style projects that scale known, high-potential platforms—like spider silk protein or mycelium—with a wide array of potential use cases.
Innovation competitions and challenges
Engaging the broader scientific community through a research BAA will deliver novel and surprising ideas but will not itself advance actionable ideas to solve concrete problems. To complement a research BAA, BRITE can launch, cosponsor, or administer prize competitions and grand challenges. Open innovation programs accelerate solution development for even the most complex and stubborn bioindustrial development challenges. They are most successful when a clear ‘Goldilocks’ problem can be defined—narrow enough to be addressable by the market, but broad enough that solutions are not presupposed or prescribed. BRITE team members would work with sponsoring agencies to identify “prizeable” issues and optimize problem statements for the prize mechanism. Initial prizes or challenge series could address such diverse problems as:
- Electrobiological sensing to address environmental issues (air quality, water quality, etc.). The intersection of biology and electrical engineering is not always naturally incentivized, particularly outside health applications with high-dollar market potential. The use-inspired call to action of a prize would incentivize experts to cross disciplinary silos toward an underaddressed problem.
- Novel technologies that expand testbed facility capabilities, such as multi-feedstock, multi-organism, multi-product platforms or easily implementable combination facility kits. Prizes would incentivize collaborative development and be able to provide nonmonetary support to deepen capabilities for a range of use cases.
- Workforce development and on-ramps to bioindustrial careers. The Department of Education (ED), Department of Labor (DOL), and other entities can use prizes to incentivize innovative tools and models for career preparation tailored to the coming needs in our bioindustrial workforce. Successful, analogous ED prizes have advanced project-based K-12 learning models, apprenticeship models for up- and reskilling, and innovative EdTech that helps learners develop in-demand competencies.
Once refined, problem statements can then be designed into single- or multistage competitions. Prize design parameters can be fine-tuned to the nature of the problem and the communities that have the potential to solve them. Using strategic design to balance the fidelity of solutions sought, scale and type of incentives on offer, and timeline for development or refinement maximizes the impact of prizes. One-off or series of single phase competitions can be used to quickly prime the pump and identify potential solutions and solvers. Multistage competitions that down-select to a high-potential cohort provide the added benefit of offering targeted technical assistance over and above prize funds. This form of support is often more valuable to solvers than money—and for bioindustrial challenges could include unique resources such as support for producing demonstration projects, access to third-party validation, and engagement with federal and external experts in science, standards, or regulations.
Market shaping
The quick and meaningful wins achieved through an EZ-BAA and open innovation programs need to be sustained by a robust bioindustrial marketplace. BRITE and partner agencies could draw upon nontraditional procurement mechanisms to amplify the ideas and products that emerge from research and innovation. Other Transaction Authorities could be developed to rapidly engage production capacity from a consortium of biomaterial demonstration and scale-up providers. Advance market commitments to fund procurement of biomaterials or production capacity can position agencies as tentpole customers for applied bioindustrial solutions. These could be executed through strategic national stockpiles, chemical reserves, or other critical product procurements.
Beyond procurement, BRITE can be a driving force across agencies to lower barriers to market entry development. Housed within NIST, BRITE would have a unique ability to directly translate research and innovation outcomes to inform new or revised biomanufacturing and bioindustrial standards. BRITE could also serve as a neutral party that supports alignment of incentives and development of interoperable platforms and standards, facilitating longer-term innovation while preserving private companies’ ability to succeed. Through relationships with various bioindustry regulators (Food and Drug Administration, Environmental Protection Agency, USDA), BRITE could facilitate clearer delineation and harmonization of regulatory responsibilities. This engagement could also better incorporate the current voice of science and technology in defining and refining bioindustry rules, experimental sandboxes, and optimization for different subsectors.
Finally, BRITE can shape the market from the grassroots, engaging a wider set of scientific and general communities in the growing bioindustry. As research and innovation activities ramp up, BRITE can convene prize winners to share insights and spur serendipitous collaborations. BRITE can also steer effective scientific communication on bioindustry, engage stakeholders more directly in the innovation process, and feed community insights back into future programs and priorities. BRITE can follow the example of accelerators like HHS’s LymeX, which actively engages clinical and scientific roundtables to inform prizes and strategy.
Case example: How BRITE activities coordinate for greater impact
The federal lab-to-market tools BRITE would foster are powerful in their own right. Applied in a coordinated fashion, they can rapidly bring transformative bioindustrial solutions to bear against intractable problems.
Consider how all facets of BRITE might contribute to a pressing, multifaceted problem like lead exposure:
- Through the EZ-BAA, BRITE calls for research projects that utilize cyanobacteria to remove elements and impurities in water while mitigating cytotoxic byproducts.
- In parallel, BRITE leads a prize competition for low-cost, bio-inspired tools for real-time lead monitoring and remediation, optimized for real-world use.
- Through a subsequent competition phase or new prize, BRITE runs an accelerator that advances user-centered development, optimizing for residents, school or facility administrators, and local leaders.
- BRITE coordinates an advance market commitment from EPA and the Department of Housing and Urban Development to fund procurement of novel remediation technology by local environmental agencies, housing associations, etc.
Sustainable funding
Based on analogous programs, including DOE American Made Challenges, an initial appropriation or discretionary allocation of $100–200 million is needed to catalyze BRITE’s standup and early wins. This could be assembled by pooling agency funds authorized for bioeconomy activities and/or unspent from recent appropriations (see Table A in FAQ). Private-sector partners or existing public-private partnerships (PPPs) could also support initial funding, though a new PPP likely could not be executed in the required timeframe. In the longer term, BRITE funding can be supported by one or more fit-to-purpose PPPs and should be enshrined in annual appropriations, following the example of KidneyX. Consistent funding is important to show commitment to bioindustrial innovation, enable more multiyear programs or recurring prize series, and provide resilience in the event of budget conflict. A minimum $15 million annual appropriation to sustain BRITE innovation activities could easily be input into one or a combination of bills (Agriculture, Commerce/Justice/State, and Energy and Water).
Conclusion
We are fortunate as a country to have a strong bench of talent working hard to push what is possible in our bioeconomy. They deserve tools and capabilities2 that enable them to work smart, delivering a far greater return on the dollars we invest in our bio-driven future. It is not sustainable for the federal government to be the only customer driving bioindustrial progress. But as a catalytic force that bridges valleys of death and solves chicken-and-egg dilemmas, strategic government action to nurture bioindustry out of the lab and into markets will take us farther, faster. By fully utilizing the world-class mechanisms smart policymakers of the past have provided us, we can de-risk bioeconomic investments while yielding maximum benefit for our economy, security, and society.
Multiple departments and agencies have been charged with advancing U.S. bioindustry. While the latest and most fit-to-purpose authorities were established under Title IV of the CHIPS and Science Law (42 U.S.C. §19135), agencies can draw upon multiple authorities to support and incentivize bioindustrial research, innovation, and translation. The following table is far from exhaustive, but it highlights several such authorities, as well as existing funding agencies could leverage to act on them.
Table A. Example authorities and appropriations to support bioindustry
| Agency | Bioindustry-relevant authorities | Select bioindustry-related funding (active or FY23 appropriations) |
| Department of Commerce |
|
|
| Department of Energy |
|
|
| Department of Agriculture |
|
|
| National Science Foundation |
|
|
| Department of Defense |
|
|
While initial stand-up of BRITE may require detail assignments from partner agencies, BRITE should have its own dedicated, permanent staff. Beyond strategic and operational leadership, program managers (PMs) would be needed to own particular topics or problem areas. The ideal PM profile would differ by function; for example, research PMs would have an applied research background and experience leading high-risk, high-reward activities in a government or industry capacity. Prize PMs would have experience with large-scale grant and prize authorities—as well as experience educating different agencies and functions (legal, political, communications) on the ins and outs of prize authorities. This expertise could also be accessed through support contracts or working with cross-agency centers of excellence in open innovation, such as NASA’s Center of Excellence for Collaborative Innovation.
BRITE draws on analogous entities and initiatives from different agencies. Indeed, by leaning on various precedents, BRITE will be easier for agency stakeholders (particularly general counsels) to understand and will be able to enact faster than relying on a brand-new legislative mandate. That said, BRITE’s mission to accelerate bioindustry in underaddressed spaces is inherently cross-disciplinary. The outcomes spearheaded by BRITE will benefit multiple agencies’ bioeconomy-related objectives; but outside of Commerce, any other agency would naturally prioritize its particular sector and set of use cases, even if it failed to lift all bioindustrial boats. Furthermore, housing BRITE within a NIST bioeconomy program office or entity could inform more rapid and effective development of bioeconomy standards, frameworks, and systems interoperability. An inspiring analog is NIST’s Public Safety Communications Research Division.
Any federal agency is authorized to run a prize competition under the America COMPETES Act, (see footnote 2) and federal prize activity has increased dramatically over the last decade. In addition to COMPETES, there are various agency-specific prize authorities (e.g., NSF, DOE, DOD, NASA, HHS). While agency-specific authorities sometimes have a narrow topic focus, they can add flexibility beyond COMPETES provisions (for example, DOD and NASA competitions can award monetary prizes to non-U.S. entrants, which is not possible under COMPETES). Multiagency collaboration on prizes is common—over a quarter of agency prizes were conducted with at least one other federal partner. In addition, many agencies receive expert support in prize administration from partner entities like GSA’s Challenge.gov and NASA’s Center of Excellence for Collaborative Innovation.
Prizes confer many benefits beyond the direct cash payment and in-kind support awarded to top teams. The experience of entering a competition alone is often a helpful forcing function for teams to crystallize ideas and present them in a more compelling way. But prizes can also include design elements that advance the wider field beyond the winners. In multistage prizes, non-winning teams can partner with or even provide technical assistance and expertise to the teams that advance. Honorable mention or other award categories can also provide a lift. For example, the VA’s recent Mission Daybreak challenge issued small “Promise Awards” to teams that were not named finalists but showed potential, which provides them a boost in securing future funding and support. Finally, some or all of the technical assistance provided to winners (in the form of webinars, documents, templates, etc.) can be disseminated to the general public as an open resource.
The incoming administration should work towards encouraging state health departments to develop clear and well-communicated data storage standards for newborn screening samples.
Proposed bills advance research ecosystems, economic development, and education access and move now to the U.S. House of Representatives for a vote
NIST’s guidance on “Managing Misuse Risk for Dual-Use Foundation Models” represents a significant step forward in establishing robust practices for mitigating catastrophic risks associated with advanced AI systems.
Surveillance has been used on citizen activists for decades. What can civil society do to fight back against the growing trend of widespread digital surveillance?