Pres. Biden Issues Executive Order on Advancing Biotechnology and Biomanufacturing

By MedTech Intelligence Staff
September 12, 2022


• Categories: 02-MedTech Economics, 04-Product Design & Development, Capitalization & Funding, Manufacturing, Regulatory

On September 12, President Joe Biden issued an executive order, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

The order outlines a “whole-of-government approach” to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience and national and economic security.

The executive order is part of the administration’s efforts to strengthen U.S.-based manufacturing and keep the country at the forefront of innovation in bioengineering.

In a press briefing, senior administration officials announced that on Wednesday (9/14), the White House would host a summit on the bioeconomy and biomanufacturing, during which the administration will announce new investments and resources across a wide range of agencies to support biotechnology and biomanufacturing.

In addition to federal investments, the initiative will include actions “to create more robust markets for bio-based products at home and globally to expand access to biotechnology and to translate research and development into vital products and services faster,” said the official.

The key areas of focus for the administration include:

• Strengthening supply chains and lowering prices through bio-based production of active pharmaceutical ingredients, biomanufacturing facilities that do not rely on foreign suppliers and biomining of rare earth elements. The goal of these efforts is to provide consumers access to products made in America at lower prices, even in times of global supply chain disruptions.
• Expanding domestic biomanufacturing capacity so more of what is invented in America is made in America.
• Facilitating more data sharing and data access to advance the development of biotechnology and the bioeconomy writ large.
• Creating jobs and growing the strength and diversity of the bioeconomy, including by supporting a diverse workforce and ensuring the benefits of these initiatives are distributed across the country.
• Expanding training and education opportunities in community colleges, Historically Black Colleges and Universities, and other minority-serving institutions.
• Improving food security and driving agricultural innovation through new technologies that protect crops from disease, and enhance seeds and fertilizers and foods made with cultured animal cells.
• Creating personalized medicines, less invasive tools for disease detection, efficient vaccine and therapeutic manufacturing, and more effective and safer therapies.
• Reducing the impact of climate change on America’s families and workers, including through replacing foreign petrochemicals with locally produced bio-based chemicals, using biofuels to cut greenhouse gas emissions, and developing soil microbes and crops that remove more carbon dioxide from the atmosphere.

During the White House Summit on September 14, federal agency leaders announced new investments to advance directives of the executive order.  They include:

• The Department of Health and Human Services will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics and the key starting materials needed to produce essential medications and respond to pandemics.
• The Department of Energy (DOE) announced new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts and biomaterials.
• The U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy. This will include investments in New Hampshire, Virginia, North Carolina, Oregon and Alaska to help expand the bioeconomy by advancing regional biotechnology and biomanufacturing programs.
• DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also add an additional $60 million to de-risk the scale up of biotechnology and biomanufacturing, leading to commercialization of biorefineries that produce renewable chemicals and fuels that reduce greenhouse gas emissions from transportation, industry and agriculture.
• The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will launch a biomanufacturing initiative to 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.
• BioMADE will launch hubs to support equitable regional development, create jobs nationwide and enhance American economic competitiveness. BioFabUSA is developing the BioFab Foundries, a first-of-its-kind U.S. facility that integrates engineering, automation and computation with biology. BioFab Foundries will be accessible to U.S. innovators to enable manufacturing of preclinical and early-stage clinical products.
• The National Institutes of Health (NIH) is expanding the I-Corps biotech entrepreneurship bootcamp, and NIIMBL will continue to offer its summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, to connect underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology.
• The FDA will spearhead efforts to support advanced manufacturing through regulatory science, technical guidance and increased engagement with industry seeking to leverage emerging technologies. The goal of these efforts is to increase medical supply chain resilience and improve patient access to new medical products.
• NIH’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.
• Through the Cancer Moonshot, the National Institutes of Health (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 discovery of new treatments.  USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance.

(This article was updated to include the investments announced on September 14.)