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Ensuring a brighter future for U.S. biotech requires modernizing the Food and Drug Administration (FDA) and addressing challenges from China, according to Kelly Seagraves, VP for National Security and International Affairs at the Biotechnology Innovation Organization (BIO).
Seagraves explained these and other BIO priorities at an April 1 online panel on “the future of U.S. biotech” hosted by Research!America, a non-profit medical and health research advocacy alliance. In laying out the goals of the panel, moderator Jenny LaRay of Research!America explained, “We’re going to explore biotech’s importance to patients, to our economy, current challenges, and policy priorities.”
While the second panelist, Garrett Dunlap of the Engineering Biology Research Consortium (EBRC), discussed engineering using biotech, Seagraves focused on health biotech and the concerns of BIO’s members. Seagraves was asked to explain the biggest challenges to the industry that BIO is seeking to address.
“Any policies that bring in uncertainty are big concerns for our members,” she said, “international reference pricing policies, tariffs, and other trade-related policies, the uncertainty and the kind of back and forth there really hinders our members from making business decisions.”
She also mentioned the need for FDA reform and the need to compete with China, two subjects she expanded upon during the rest of the panel.
“One of my roles at BIO is leading on national security,” Seagraves explained. “We’re really trying to make sure that we are advocating for advancing American biotech in order to compete with China and make sure that we can keep American biotech leadership here at home.”
Concerns regarding competition with China
“China’s multi-decades-long concerted policy to try and really dominate the biotech ecosystem is leading to successes,” Seagraves said. “They’re really becoming a serious and very accelerated competitor in the biotech ecosystem. And from BIO’s perspective, we want to make sure that we are addressing potential risks.”
She explained that China’s advances in biotech raise two key concerns: continued access to the latest healthcare innovations for American patients and potential national security threats.
“We’re trying to figure out how to find solutions that will solve those problems and create resiliency,” Seagraves said. “One of the key partners that we use there to try and find some of those ideas is the National Security Commission on Emerging Biotechnology. I think their report really provides us with a good overview of the situation and a good roadmap for solutions.”
Established with bipartisan support as part of the 2022 defense budget, the NSCEB was tasked by Congress to conduct “a comprehensive review of emerging biotechnology’s impact on national security and provide practical recommendations to preserve American dominance in this field.”
Seagraves said the report and its conclusions provide necessary guidance for addressing challenges from China. The solutions that are put in place cannot involve completely eliminating that country from the supply chain. “Decoupling from China is not simple,” she said. “The biotech ecosystem is really globally integrated.”
Nonetheless, biotech can be used to strengthen America’s domestic supply chain. One potential tool for achieving this, according to Seagraves, is the Genesis Mission, which was created by an Executive Order and is led by the Department of Energy (DOE) and the 17 DOE national laboratories. In collaboration with industry, academia, and other stakeholders, the Genesis Mission is harnessing AI for breakthroughs in discovery science, energy, and national security. Seagraves said the NSCEB has recommendations that could be implemented through the Genesis Mission initiative that could help improve biotech supply chains when needed, such as in emergencies.
“Making biotechnology predictably engineerable and solving these kinds of problems at speed and at scale would be really fantastic to help the United States be able to pivot in these types of events, whether it’s from a war or major weather events or something else,” she said. “We’re really hoping at BIO that the Genesis Mission will continue to form partnerships with other departments and agencies around the US government, such as NIH (National Institutes of Health) that have more human health focus.”
FDA modernization
China’s competition with America also extends to clinical trials, where the ability to expedite trials is giving China an advantage, Seagraves said. Improvements at FDA would help America in this competition, and it would provide an essential boost to biotech in general, she said.
“BIO sees modernization of the FDA as absolutely critical to American biotechnology, human health and biotechnology competitiveness,” according to Seagraves.
She cited a BIO white paper, “Strategies for enhancing FDA as global gold standard,” which highlights three primary recommendation areas:
- reducing the time and cost of early drug development, including through streamlining clinical trials;
- strengthening regulatory review to make it more predictable and efficient, “which really ensures that the U.S. system for clinical development remains globally competitive”;
- supporting new models for external engagement and transparency.
Seagraves concluded her remarks by agreeing with her fellow panelist about the importance of explaining the needs of biotech to lawmakers.
“What Garrett just said about the power of biotechnology as a tool, and trying to encourage bio-literacy around thinking of [biotechnology] as a tool, I think, is really important for advancing biotech innovation and the policies that we want to see happen,” she said.
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