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.

Countries like Saudi Arabia are building biotech ecosystems by offering conditional drug approvals. For companies with safe, promising drugs facing conservative Western regulators, this offers a faster path to market and revenue in exchange for helping build local infrastructure and expertise.

A treaty between the FDA and Brazil's health department allows clinical trials conducted in Brazil to be accepted by the FDA. This provides a pathway for biotech startups to drastically reduce R&D costs and accelerate timelines without compromising the "gold standard" of US regulatory approval.

For health tech companies, Brazil is a powerful proving ground. Its large, self-contained private market operates very similarly to the U.S. system. Validating a product and business model in Brazil provides a strong signal and a potential pathway for successful expansion.

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.

To expand cell therapy globally, building facilities is insufficient. The key is forming alliances that transfer manufacturing processes, analytics knowledge, and provide local regulatory support to enable regions like Brazil to adopt these complex treatments and build self-sufficient ecosystems.

Moving first-in-human studies to countries like Australia and China is now a core business strategy, not just a cost-saving measure. It allows U.S. biotechs to navigate a more flexible regulatory environment and accelerate development timelines.

China's ability to accelerate biotech development stems from faster patient recruitment for clinical trials. With a large, treatment-naive patient population willing to participate in studies, early-stage oncology trials can be completed in about half the time it takes in the US. This provides a significant strategic advantage for de-risking assets more quickly and cheaply.

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.