Since the U.S. Biosecure Act took effect, the visible wave of supply chain realignment has 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 also contracted.
In 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 said in unison that "the United States cannot rebuild the bio supply chain alone."
Observers 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 (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 recommends a "White House bio control tower"…"systematize cooperation with allies"
Alina Meltous, senior advisor 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 respective roles."
Launched in 2022 and set to conclude its activities at the end of this year, NSCEB presented "maximizing biotechnology cooperation with allied nations" as one of its six recommendations. Separately, it also recommended establishing a National Biotechnology Coordination Office in the White House.
Meltous explained that this organization could link the investments of 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 the office is created, cooperation channels with allies could also be further systematized, observers say.
She said, "The commission directly surveyed governments around the world on how strategically they view bio. We also analyzed existing cooperation frameworks such as NATO, and commissioners and staff visited overseas themselves," raising the need for new partnership models such as joint procurement, research data sharing, and inter-university cooperation.
◇ The United States moves to rebuild the essential medicines supply chain…"oriented toward multinational division of labor"
Earlene Joiner, 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 realignment with figures.
She said, "Spurred by the COVID-19 pandemic, the list of 86 essential medicines jointly established with the U.S. Army has since expanded to 177," adding, "While the domestic base for finished dosage forms is relatively sound, production of key starting materials (KSM) remains vulnerable." Noting that many KSMs are petrochemical-based, she also mentioned a multi-purpose 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 Indian 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 for a structure that divides API and KSM items not produced in the United States and enables mutual supply in times of crisis.
◇ "Good ideas can come from anywhere"…core technologies to be secured in the United States
John Siel, a doctor at the Advanced Research Projects Agency for Health (ARPA-H), a grantmaking body under the Department of Health and Human Services, defined the supply chain as "a structure completed only when starting materials and production capacity coexist," emphasizing, "If either side is lacking, the entire system does not work."
ARPA-H's investment portfolio consists of three pillars. The first is a "reimagining" of starting materials. Siel cited the "wheat project," which synthesizes small- and large-molecule APIs using wheat-based inputs and cell-free extract technology. The cell-free extract technology itself is old, but it could not be scaled up; ARPA-H, he said, has invested in breaking through this limitation.
The second is distributed manufacturing and multi-product production. Instead of costly centralized GMP (good manufacturing practice) facilities, it is focusing on platform technologies that flexibly produce gene therapies and RNA-based medicines at small scale.
The third is a structure that can expand the same technology in both directions—scale-up and scale-out—from rare diseases to mass production. He emphasized, "In emergencies, this technology must work in both directions."
Siel said of international cooperation, "Good ideas can come from anywhere. If allied partners can participate together, we can achieve greater results." However, he drew a line, saying that the long-term goal is to secure the technology first within the United States. He is open to international cooperation, but intends to secure core technological capabilities in-house.