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Building the Bioeconomy with Transparency: Revisiting Grant Funding

Expanded Analysis of Federal Grant Funding Identifies Billions of Dollars of Additional Funding for the Bioeconomy

Bryn O'Meara
Bioeconomy.XYZ

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Biotechnology is the next industrial revolution

Defined as economic activity driven by innovation in the life sciences, the bioeconomy is poised to revolutionize global economies on the scale of the industrial revolution. The bioeconomy spans nearly all industrial sectors, including pharmaceuticals, agriculture, fuels, and materials, not only developing new products but also improving upon existing ones. Biotechnology can create more efficient, safe, and sustainable products to transform our economies and quality of life.

As biotechnology continues to grow as a major economic contributor, early leadership in the bioeconomy will advance broader economic interests. Countries have begun positioning themselves to expand domestic biotechnological capabilities to this end. In addition to contributing to national economic fitness, biotechnological capacity improves supply chain resiliency in key areas such as population health, food security, and energy independence.

Photo by Braňo on Unsplash

Consider, for example, the COVID-19 vaccine. Existing R&D infrastructure and expertise in the United States enabled the prompt development of a COVID-19 vaccine. However, the shortage of domestic production facilities to manufacture the vaccine reduced the speed at which it could reach the arms of the population. Continued investments in R&D and additional investments in biomanufacturing will further enable innovation.

Recent federal efforts seek to bolster biotechnology R&D

On September 12th, 2022, President Joe Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy to foster and protect the American bioeconomy. The executive order establishes a whole-of-government approach and states commitments to increase funding for biotechnology and biomanufacturing, create market opportunities, improve data access, and advance biosafety and biosecurity.

The Department of Health and Human Services (HHS), Department of Energy (DOE), Department of Agriculture (USDA), the Department of Commerce (Commerce), and the National Science Foundation (NSF) were directed to identify high-priority biotechnology R&D and develop “Bold Goals” for advancing American biotechnology innovation. Responses submitted to the Office of Science and Technology Policies were released in March 2023 in “Bold Goals for U.S. Biotechnology and Biomanufacturing.” The document lays out bold goals to make biotechnology a significant economy contributor in the US economy, as well as recommendations on R&D investments to achieve those goals. Key areas for further biotechnology development were identified.

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Department of Energy: Transportation and stationary fuels, chemicals and materials (Industrial Heat Shot, Strategy for Plastics Innovation), climate-focused agricultural systems and plants, carbon dioxide removal (Carbon Negative Shot)

Department of Agriculture: Improving sustainability while increasing agricultural productivity, improving nutrition and quality, detecting and mitigating pest and pathogens, overarching R&D needs

Department of Commerce: Alternative supply chain pathways, supply chain resilience, standards and data infrastructure

Department of Health and Human Services: Accessible health monitoring, precision multi-omics medicine, biomanufacturing of cell-based therapies, AI-driven bioproduction of therapeutics, advanced techniques in gene editing

National Science Foundation: Leverage biodiversity, predictive modeling and engineering design, build and measure performance and quality, scale-up and control of biological systems, innovative biomanufacturing approaches, ethical, safe, and equitable co-generation and translation

Since the development of the National Biotechnology and Biomanufacturing Initiative (NBBI), programs and funding initiatives have been created to meet the R&D needs listed above. DOE announced $100 million towards R&D for biofuels and bio-based chemicals and $60 million towards de-risking biomanufacturing scale-up. USDA announced a $500 million grant program for innovative fertilizers to increase productivity and the Bioproduct Pilot Program, which seeks to study the benefits of bio-based materials. Commerce will be expanding the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and will invest $14 million towards the development of measurement technologies and standards. HHS will invest $40 million towards biomanufacturing of APIs and antibiotics and expand the I-Corps program for entrepreneurship training. Finally, NSF announced the NSF BioFoundries Program, which seeks to build biomanufacturing research capacity and infrastructure through the creation of new Biofoundries at research institutions across the country.

As agencies strive to meet their bold goals, development of new funding programs and expansion of existing ones is anticipated.

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Federal investments will greatly support biomanufacturing

The investments listed above will help address many of the challenges facing biomanufacturers today, particularly the challenges and risks of scale-up and access to qualified talent. Scale-up of biomanufacturing processes is particularly difficult, as cells often behave differently at scale compared to in a petri dish. Optimization of cell growth and yields is also critical to meet the price point of conventional materials. Investments in research, infrastructure, and standards will foster an understanding of these systems to optimize biomanufacturing. Start-ups in particular will benefit from access to public BioFoundries as they develop and scale-up new technologies for commercialization.

At the same time, a new workforce in biomanufacturing will be trained by these programs. Specialized process engineers and biomanufacturing technicians are particularly difficult to find, as current training programs are not geared towards biomanufacturing applications. Expansion of academic study on biomaterials and public BioFoundries will provide hands-on training for the biotechnology workforce, providing biomanufacturers with an expanded and experienced talent pool that is currently lacking.

Additionally, grants provided by the federal government can aid start-ups in bridging the “valley of death” — where research has expanded past academic funding but not yet developed enough to seek seed or venture capital funding. The valley of death, as implied, represents a difficult transition out of the lab which proved critical for many biotechnology start-ups. Government support from various agencies during this period can help new technologies further develop and reach commercialization.

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Federal grant spending can be queried through USASpending.gov

Moving towards the goals of NBBI first requires an understanding of federal funding for biotechnology R&D today. The source for US spending data is USASpending.com, which compiles contracts and grants across federal agencies into a single database that is accessible to the public. Funding can be searched by agency, recipient, product service code, and keywords among others.

Due to the lack of bioeconomy specific North American Industry Classification System (NAICS) or Product and Service (PSC) codes (note that this is distinct from North American Product Service Codes), data must be queried by bioeconomy keywords. These methods were first reported in Bioeconomy.xyz in March of 2022. The present analysis expands upon the original keywords to incorporate additional funding related to synthetic biology, DNA sequencing, and biomanufacturing. The data presented here were collected between April and May of 2022.

Of note, we manually curated funding for DNA sequencing and synthesis to better reflect applied, rather than basic, research activities which are more likely to feed into the bioeconomy. For example, a grant titled “mutational signature(s) of human genomic rearrangement mechanisms” was not included, while “a marker-free technology for mapping the epigenome of cell types in mammalian tissues” was included. Additionally, funding for multidisciplinary centers was scaled based on known research activities to ensure that non-bioeconomy funding was not included in the database. Examples include the International Space Station National Laboratory which funded nine projects in the life sciences, while the remaining 33 projects were centered on physical sciences and other technology development.

Photo by National Cancer Institute on Unsplash

Billions in grant funding identified with additional keywords

The analysis presented here covers funding from 2008 through spring of 2022, thus serves as a benchmark from which funding related to NBBI can be measured. A total of $31 billion in bioeconomy-related grant funding was identified, an increase from the original keyword analysis. The additional funding identified can be attributed to both the additional several months of data as well as the new keywords. Cell engineering, enzyme discovery, and DNA sequencing/synthesis primarily contributed to the increase, with cell engineering alone identifying $9 billion in grant funding.

Annual grant funding (billions USD) by U.S. federal agencies to the bioeconomy. Data in 2022 include Q1 only.

Several trends in bioeconomy funders, as well as recipients, were identified from this data:

· Bioeconomy grants were initially dominated by the DOE, which primarily funded efforts to develop biofuels, carbon capture, and other energy related projects. Notably, funding peaked in 2010 when advanced biofuels were first required to be blended in transportation fuels under the Renewable Fuels Program. Grant funding from the DOE has slowly decreased since then.

· HHS is currently the leader in bioeconomy grants, after a sharp increase in funding in 2021. Surprisingly, the funding spike was not attributed to research efforts surrounding the SARS-CoV-2 pandemic. Increases in funding for cell engineering (+500%), enzyme discovery (+5,000%), and DNA sequencing/synthesis (+5,000%) primarily contributed to the dramatic increase.

o The vast majority of HHS funding arises from NIH, particularly the National Cancer Institute ($5 billion), the National Institute for General Medical Sciences ($3.6 billion), the National Institute of Allergy and Infectious Disease ($2.5 billion), and the National Heart, Blood, and Lung Institute ($2.2 billion).

o HHS funding for industry largely focuses on therapeutics, including treatments for opioid-use disorder, vaccines for flavivirus, and production of therapeutics in plants. Other major recipients of funding are working towards optimizing drug formulations and preserving organs for transplantation without ice.

· NSF, USDA, and DOD are also consistent funders of the bioeconomy.

Funding from these agencies will continue increasing, as grants and other funding programs seek to meet the goals of the NBBI.

Photo by Wesley Tingey on Unsplash

Looking forward: federal funding reporting needs an upgrade

The additional bioeconomy funding identified in this analysis highlights the need for an updated approach to grant funding reporting to properly capture the US government's contributions to the bioeconomy. Keyword searches, while useful, cannot generate a robust dataset of all bioeconomy grant funding. This analysis certainly missed relevant data, and to capture all data would require a comprehensive list of bioeconomy keywords. Yet, a comprehensive list would all but certainly require manual screening to ensure that outputs were focused on applied research — such an effort was undertaken for the DNA sequencing and synthesis search terms for this analysis and was extremely laborious.

Reductions in human effort could be achieved through machine learning, which could automate a scan of individual grants and provide a more robust assessment. That said, manual scanning would still be required for training data. The datasets generated here and in the previous analysis would unfortunately likely bias an ML program towards the funding already captured by the keyword method. Ultimately, these efforts cannot replace better reporting criteria and methods by the federal agencies themselves. As the government continues its efforts to promote and expand the US bioeconomy, transparency in federal funding for biotechnology research and development is necessary to measure contributions and impacts.

Notably, the previous analysis of grant funding recommended the standardization of NAICS and PSC and the modernization of requirements for reporting federal funding — two recommendations wholeheartedly seconded here.

Performed under Contract No. T21–7–006

Original post: Building the Bioeconomy with Transparency: A Grant Funding Primer | by Kathryn Hamilton | Bioeconomy.XYZ | Medium

Bryn O’Meara is a biotechnology analyst, whose interests lie at the intersection of science policy, biotechnology, and business. She holds a B.S. in Molecular, Cellular, and Developmental Biology and is pursuing a M.S. in Biotechnology with a focus on Enterprise and Regulatory Affairs.

Follow Bioeconomy.XYZ, in order to learn more about all the ways biotech is shaping the world around us.

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