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The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
An important component of the White House initiative to speed the development of innovative cancer therapies and other critical treatments for patients is to expand modern biotech manufacturing in the United States. The effort also aims to reduce US reliance on foreign sources of bioindustrial materials to avoid supply chain disruptions experienced during the pandemic. President Joe Biden unveiled the National Biotechnology and Biomanufacturing Initiative (NBBI) in a speech on Sept. 12, 2022 to promote his long-sought Cancer Moonshot, while also announcing a new director for the Advanced Research Projects Agency for Health (ARPA-H).
The plan is to spend some $2 billion on the NBBI program, with half of that coming from the Department of Defense (DOD) to help public- and private-sector entities expand biotech research and manufacturing capabilities, as spelled out at the White House NBBI Summit on Sept. 14, 2022. Among its multiple initiatives, NBBI calls on manufacturers to use biotechnology to produce new medicines and specialty chemicals, some as alternatives to petrochemical-based production of plastics, fuels, and other materials.
FDA notably will be “spearheading efforts” to advance regulatory science and to “leverage these emerging technologies” to increase medical supply chain resilience and improve patient access to new medical products. Regulatory reform is a goal, and FDA will work with the US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) to identify areas of “ambiguity” in federal regulations related to biotechnology and to devise plans for reform and for issuing added guidance. A specific provision supports the Bespoke Gene Therapy Consortium at the National Institutes of Health (NIH) in funding up to six new clinical trials focused on rare diseases that utilize streamlined manufacturing frameworks.
In addition, the Department of Health and Human Services (HHS) issued a long list of NBBI projects that will involve spending $40 million to expand biomanufacturing for APIs, antibiotics, and “key starting materials needed to produce essential medications and respond to pandemics,” according to an HHS fact sheet. There is support for advanced education programs, pilots for gene therapy manufacturing methods, expanded cell engineering, and platforms and biosafety programs to reduce risks associated with advances in the field. HHS will bolster FDA research programs for advanced manufacturing technologies and for the Advanced Manufacturing Innovation Hub in FDA’s Office of Counterterrorism and Emerging Threats to encourage platform technologies and collaborations in smart manufacturing and closed loop process controls. HHS also cites the development of guidelines under the International Council for Harmonization (ICH) to advance continuous manufacturing of drugs and to enhance safety evaluation of continuous biotech products derived from human or animal cell lines.
A stated objective for the Biden administration is to reduce US reliance on biomedical products from China and other regions. A BioPreferred Program will require federal agencies to purchase US-made biotech products related to medicine, climate change, and food and agriculture, utilizing massive federal data systems to “drive solutions” for these global issues. Such efforts will prevent future disruptions in biopharma supplies, as experienced during the COVID-19 pandemic, when dependence on imported medical products, protective materials, and test components blocked biomedical production and compromised medical services. The executive order also aims to develop a trained, diverse US workforce capable of creating bio-based products and materials.
Jill Wechsler is Washington editor for BioPharm International.