September 14, 2022 -- The White House announced on Wednesday federal funding of more than $2 billion to advance President Joe Biden's executive order intended to enable the U.S. to harness the full potential of biotechnology and biomanufacturing.
Biden's executive order, signed on Monday, launched a National Biotechnology and Biomanufacturing Initiative aimed at reducing U.S. reliance on foreign materials and bioproduction, while directing federal agencies to identify priority R&D needs to translate bioscience and biotech discoveries into medical breakthroughs and to strengthen domestic supply chains.
Of the more than $2 billion in funding for the initiative, the Department of Defense (DoD) will invest $1 billion in U.S. manufacturing infrastructure over five years to "catalyze the establishment of the domestic bioindustrial manufacturing base" and "provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals," states a White House fact sheet.
To strengthen supply chains, the Department of Health and Human Services will invest $40 million to "expand the role of biomanufacturing for active pharmaceutical ingredients, antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics," according to the announcement.
The Department of Commerce (DOC) plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
"This support will catalyze development of capabilities for engineering biology, advance biomanufacturing processes and technologies, and help utilize artificial intelligence to analyze biological data," states the White House fact sheet.
BioFabUSA and BioMADE, part of the Manufacturing USA network which was launched by the DoD, and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), launched by the DOC, will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
"NIIMBL will launch a biomanufacturing initiative that will engage the institute's 200 partners across industry, academic, nonprofit, and federal agencies to mature biomanufacturing technology needed to improve patient access to gene therapies," according to the announcement.
The White House also said that the National Institutes of Health's Accelerating Medicines Partnership Bespoke Gene Therapy Consortium will support up to six new clinical trials, each focused on a different rare disease, to streamline manufacturing and regulatory frameworks.
In a written statement, the Alliance for Regenerative Medicine (ARM) said it welcomed the Biden administration’s efforts to accelerate patient access to gene therapies as part of its National Biotechnology and Biomanufacturing Initiative.
“The Administration recognizes that gene therapy is vital for the U.S. bioeconomy and that addressing manufacturing and regulatory frameworks is crucial to ensuring patient access. ARM and NIIMBL -- a key stakeholder in the initiative -- partnered on Project A-Gene, a multistakeholder collaboration to bring best practices to gene therapy manufacturing through the application of quality-by-design principles,” said Stephen Majors, ARM’s senior director of public affairs.
Majors noted that ARM is also a partner in the Bespoke Gene Therapy Consortium, which seeks to develop gene therapies for ultra-rare diseases and to streamline manufacturing and regulatory frameworks for future gene therapies and patients.
The Biden administration made the funding announcement on Wednesday to coincide with a summit the White House is hosting on biotech and biomanufacturing.