This week has been one of the most exciting that the biotechnology community has seen for some time. Plans that have been in the making for a decade are finally being brought to fruition by actions taken by the Biden administration.
On Monday, President Joe Biden launched a national biotechnology and biomanufacturing initiative through an executive order on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” Later in the week, on Wednesday, the White House hosted a Summit on Biotechnology and Biomanufacturing to present more information on the direction of the funds and the overarching goals of the mission.
“The White House Executive Order and Summit launching a national biotechnology and biomanufacturing initiative is a watershed moment for the United States,” noted Shara Ticku, CEO of C16 Biosciences. “Biomanufacturing is the future: it will create new products and services, drive economic growth and jobs, and create innovative paths to building a better, more sustainable future.”
The summit was led by Jake Sullivan, National Security Advisor, Brian Deese, Director of the National Economic Council, and Alondra Nelson, PhD, Director of the Office of Science and Technology.
During the meeting, members of the biotechnology (synthetic biology, more specifically) community took turns highlighting the potential that lies in their innovative technologies. For example, Lisa Dyson, PhD, spoke about how the company she founded, Air Protein, takes a carbon-negative approach to making meat. And Christophe Schilling, co-founder of Genomatica, spoke about the impact that their renewable bio-BDO (bio-1,4-butanediol) could have on the reduction of greenhouse gases. Tia Lyles-Williams is CEO of LucasPye BIO, a CDMO that provides contract manufacturing services like cell line development, process development and analytical development, and large-scale manufacturing operations. Lyles-Williams spoke not only about biomanufacturing, but also about the importance of equity in the future of biotech—from patients and employees, to entrepreneurs and into the C-Suite. Indeed, LucasPye BIO has a C-Suite consisting of 50% women and 85% people of color.
“I’m absolutely over the moon about the current administration’s commitment to building a strong, resilient biomanufacturing infrastructure and a well-funded diverse R&D community to support the rapid growth of America’s biotechnology capabilities,” noted Ellen Jorgeson, PhD, CSO of the Brooklyn-based synbio company Aanika Biosciences. “The new initiatives being funded are the result of years of effort on the part of the biotech community to communicate how critical this technology is to our country’s future well-being.”
As Meghan Frisk, PhD, Director for Biotechnology Risk and Biological Weapons Nonproliferation at the National Security Council noted, “Ingenuity and passion was on display” when looking at the role that the United States can play in the future of biotech and biomanufacturing—to innovate solutions in health, food security, agriculture, climate, energy, etc.
In her closing remarks, Frisk distilled the main themes of the summit meeting:
- Biotech is foundational to our economy and national security.
- We need to lead to compete to deliver innovative solutions to global challenges. We need to remain mindful of the risks and have transparent and open discussions around biosafety and biosecurity.
- We need to train a workforce that harnesses the diversity of our country, gives opportunities to all, and is built on our values.
- We need to involve and engage our societies, so we are considering people and ethics throughout the lifecycle of tech development and deployment. “Do it with care,” she said.
- There will be an ecosystem of government, academic, and industry to realize the shared vision for our bioeconomy.
- We will do this side by side, and shoulder to shoulder, with our international partners.
- Together, the community will lift up the following key steps—with funding of more than $2 billion—to advance President Biden’s Executive Order to launch a National Biotechnology and Biomanufacturing Initiative to lower prices, create good jobs, strengthen supply chains, improve health outcomes, and reduce carbon emissions.
The summit may have highlighted today’s innovations, but it focused on the promise they hold for tomorrow. “Today is a celebration. Tomorrow, our work begins,” said Carrie Wolinetz, PhD, Deputy Director for Health & Life Sciences, White House Office of Science and Technology Policy (OSTP).
As we look forward to 2050, the world faces two intersecting crises—a population growing to 10 billion people and food insecurity, noted Ticku. Biomanufacturing innovations are a necessary transition for the 21st century, she adds. The U.S. Government’s investment in this field demonstrates its commitment to achieving our ambitious climate change goals of net zero emissions by 2050 while at the same time investing in the growth of the U.S. economy, U.S. jobs, and security of our food supply.
The goals laid out in the White House’s Fact Sheet that accompanied the summit include:
Leverage biotechnology for strengthened supply chains: 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.
Expand domestic biomanufacturing: The Department of Defense (DOD) will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators.
Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines throughout the United States. These Engines will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change.
Bring bio-products to market: The DOE will provide up to $100 million for R&D for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. The DOE will also double efforts, adding an additional $60 million, to de-risk the scale up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture.
Train the next-generation of biotechnologists: The National Institutes of Health (NIH) is expanding the I-Corps program, a biotech entrepreneurship bootcamp.
Drive regulatory innovation to increase access to products of biotechnology: The FDA is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies
Advancing measurements and standards for the bioeconomy: The Department of Commerce 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.
Other objectives are to reduce risk through investing in biosecurity innovations and facilitating data sharing to advance the bioeconomy.