Federal Agencies Announce Investments and Resources to Advance the National Biotechnology and Biomanufacturing Initiative | Bergeson and Campbell, PC

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As noted in our September 13, 2022 blog post, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure that we can manufacture in the United States everything what we invent in the United States.” The White House hosted a biotechnology and biomanufacturing summit on Sept. 14, 2022. According to the White House summit backgrounder, federal departments and agencies, with more than $2 billion in funding, will take the following measures:
  • Leveraging biotechnology to strengthen supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing of active pharmaceutical ingredients (APIs), antibiotics and key raw materials needed to produce essential medicines and in the response to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with an investment of more than $270 million over five years to turn research into products faster and support the advanced development of bio-based materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and shielding materials. As part of the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage estimated resources of one billion tons of biomass and of sustainable waste in the United States to provide national supply chains for fuels, chemicals and materials.
  • Develop national biomanufacturing: The DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the national bioindustrial manufacturing base accessible to American innovators. According to the fact sheet, this support will incentivize private and public sector partners to increase their manufacturing capacity for products important to commercial and defense supply chains, such as critical chemicals.
  • Fostering Innovation in the United States: The National Science Foundation (NSF) recently announced a competition to fund regional innovation engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as drug manufacturing lifelines, reducing waste and mitigating climate change. In May 2022, the USDA announced $32 million for Wood Innovation and Community Wood Grants, leveraging an additional $93 million in partner funds to develop new wood products and enable efficient use American forest resources. The DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnologies, bioproducts, and biomaterials. In addition, the US Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen the US bioeconomy by advancing regional biotechnology and biomanufacturing programs.
  • Bringing bioproducts to market: The DOE will provide up to $100 million for research and development (R&D) for the conversion of biomass into fuels and chemicals, including R&D to improve the production and recycling of bioplastics. The DOE will also redouble efforts, adding an additional $60 million, to reduce the risks associated with scaling up biotechnology and biomanufacturing that will lead to the commercialization of biorefineries producing renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transport, industry and agriculture. . The new $10 million Bioproducts Pilot Program will support activities and scale-up studies on the benefits of biobased products. US manufacturing institutes BioFabUSA and BioMADE (launched by the DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization in regenerative medicine, industrial biomanufacturing and biopharmaceuticals.
  • Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies and supports pathways to careers in biotechnology. In March 2022, the USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
  • Stimulate regulatory innovation to increase access to biotechnology products: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to take advantage of these emerging technologies. For agricultural biotechnologies, the USDA is developing new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing the USDA to review more diverse products.
  • Advanced measures and standards for the bioeconomy: DOC plans to invest an additional $14 million next year in the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards and data for the bioeconomy American.
  • Reduce risk by investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to launch a new $20 million bioinsurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks , and integrate biosafety into the development of biotechnology.
  • Facilitating data sharing to advance the bioeconomy: Through the Cancer Moonshot, the NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables the discovery of new treatments. The USDA is working with the NIH to ensure that data on persistent poverty can be incorporated into cancer surveillance. The NSF recently announced a competition for a new $20 million Biosciences Data Center to increase our understanding of small-scale living systems, which will produce new biotechnology designs to manufacture products in the areas of agriculture. , medicine and health, and materials.

A recording of the White House summit is available online.

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