Since the U.S. Biosecure Act took effect, the visible wave of supply chain restructuring has also reshaped the landscape of this year's Bio USA venue. The presence of Chinese corporations has noticeably shrunk, and the size of the China pavilion has contracted.
By contrast, State Governments pavilions increased. In sessions under the theme "Partnering with the U.S. Government to support biodefense from detection to response," U.S. government and industry figures agreed that "the United States cannot rebuild the bio supply chain alone."
Analysts say the United States is shifting the center of gravity of its strategy from merely securing production bases to building an alliance-based "distributed bio manufacturing system." For Korea, which shows strength in the contract development and manufacturing organization (CDMO) field, a separate strategy will likely be required to become a partner participating from the design stage, beyond serving as a production base.
◇ NSCEB urges a "White House bio control tower"… "systematize cooperation with allies"
Alina Meltauz, senior adviser at the National Security Commission on Emerging Biotechnology (NSCEB), a congressional advisory body, on the 22nd (local time) called the bio supply chain "a structural problem that cannot be solved by a single policy or a single agency," and said, "Policymakers do not all need to be experts, but they must understand their roles."
Launched in 2022 and set to conclude its work at the end of this year, NSCEB listed "maximizing bio technology cooperation with allied countries" as one of its six recommendations. Separately, it also recommended establishing a National Biotechnology Coordination Office within the White House.
Meltauz said the office could link investments by the Advanced Research Projects Agency for Health (ARPA-H) and the Administration for Strategic Preparedness and Response (ASPR) with the State Department's commercial and regulatory diplomacy through a single window. If created, the office is expected to systematize channels for cooperation with allies.
She said, "The commission directly examined how strategically each national government views bio across the world. We analyzed existing cooperation frameworks such as NATO, and commissioners and staff visited overseas in person," while also raising the need for new partnership models such as joint procurement, research data sharing, and interuniversity cooperation.
◇ The United States moves to rebuild the essential medicines supply chain… "aiming for multinational division of labor"
Earlene Joyner, deputy assistant secretary at the Administration for Strategic Preparedness and Response (ASPR) under the Department of Health and Human Services (HHS), presented the current status of supply chain restructuring in figures.
She said, "The list of 86 essential medicines that we jointly drew up with the U.S. Army during the COVID-19 pandemic has since expanded to 177," and added, "While the domestic base for finished dosage forms is relatively sound, production of key starting materials (KSMs) remains vulnerable." Noting that many KSMs are petrochemical-based, she also mentioned a multipurpose supply chain concept that links corporations overlapping with the energetics materials needed by the Department of Defense.
On international cooperation strategy, she cited India and Mexico as examples. She said India's generic active pharmaceutical ingredient (API) manufacturers want production bases in the United States, calling them "the type of corporations we want." With Mexico, she said the two sides aim to divide API and KSM items that the United States does not produce and build a structure that allows mutual supply in times of crisis.
◇ "Good ideas come from anywhere"… secure core technology in the United States
John Siel, M.D., of the Advanced Research Projects Agency for Health (ARPA-H), a research funding agency under the Department of Health and Human Services, defined the supply chain as "a structure that is complete only when starting materials and production capacity coexist," stressing that "if either side is lacking, the entire system does not work."
ARPA-H's investment portfolio rests on three pillars. First is a "reimagining" of starting materials. Siel cited the "wheat project," which synthesizes small- and large-molecule APIs using wheat-based feedstocks and cell-free extract technologies. While cell-free extract technology itself is old, it could not scale, and ARPA-H invested to break through this limitation.
Second is distributed manufacturing and multi-product production. Instead of high-cost centralized good manufacturing practice (GMP) facilities, it is focusing on platform technologies that flexibly produce gene therapies and RNA-based medicines at small scale.
Third is a structure that expands the same technology in both directions—scale-up and scale-out—from rare diseases to mass production. He stressed, "In emergencies, this technology must operate in both directions."
Siel said of international cooperation, "Good ideas come from anywhere. If allied partners can join in, we can create bigger results." However, he drew a line by saying that, in the long term, the goal is to secure the technology first within the United States. He is open to international cooperation, but intends to secure core technological capabilities domestically.