Biden Administration Announces New Goals and Priorities to Advance Biotechnology and Biomanufacturing

As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.

• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, DOD announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.

• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.

According to the fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.