US biotechs increasingly use sites like Australia to accelerate development, as Create Medicines did by moving from concept to clinic in under 12 months. What was once viewed with suspicion is now a key strategy to generate data faster and more cheaply, competing with the speed of China's ecosystem.

The current unpredictability at the FDA is so pronounced that prominent biotech investor Peter Kolchinsky of RA Capital is now advising his portfolio companies to de-risk development by conducting early-stage clinical trials outside the United States. This marks a significant strategic shift for US-based innovators.

Through massive government investment in biotech infrastructure, China has become the global hub for early-stage clinical drug development. Both Chinese and Western companies now conduct initial human trials there to move much faster and at a significantly lower cost, giving China a strategic foothold in the pharma value chain.

The US is losing the biotech race not just at the FDA, but due to slow hospital Institutional Review Boards (IRBs) and contracting. A Phase 1 trial takes four weeks in China, while a simple university survey in the US can take over a year for approval, creating a major competitive disadvantage.

U.S. FDA requirements for early-stage trials, particularly safety margins, are considered ill-suited for genetic medicines, prompting companies to look abroad. The UK is emerging as a preferred destination, with its regulator, the MHRA, actively creating incentives and faster pathways to attract these innovative clinical programs.

Top biotech VC Bob Nelsen contends the U.S.'s competitive edge is eroding because of slow, burdensome FDA processes. He points to Australia's model, where human trials can be approved in days, as the standard the US must adopt to compete with agile global players like China.

Amidst growing uncertainty at the US FDA, biotech companies are using a specific de-risking strategy: conducting early-stage clinical trials in countries like South Korea and Australia. This global approach is not just about cost but a deliberate move to get fast, reliable early clinical data to offset domestic regulatory instability and gain a strategic advantage.

The industry's negative perception of FDA leadership and regulatory inconsistency is having tangible consequences beyond investment chilling. Respondents report actively moving clinical trials outside the U.S. and abandoning vaccine programs. This self-inflicted wound directly weakens America's biotech ecosystem at the precise moment its race with China is intensifying.

The increasing innovation and speed from China puts pressure on the U.S. biotech ecosystem. To remain competitive, the U.S. must focus on collaboration and address its own systemic issues, such as slow trial execution and the high cost of getting a drug to the IND stage.