To de-risk clinical programs from recruitment and activation hurdles within the UK's strained NHS, companies like Resolution Therapeutics run an equal number of trial sites in other countries, like Spain. This geographic diversification provides a valuable real-time benchmark and a hedge against single-country operational delays.
With a highly concentrated population, a single-payer system, and vast hospital capacity (90,000 beds in Seoul vs. 4,000 in Boston), South Korea offers a significant advantage for clinical development. This infrastructure allows trials to be completed 40% faster and at 40% lower cost compared to the US.
While the UK's world-class universities provide a rich pipeline of scientific talent for biotechs, the country's clinical trial infrastructure is a significant hurdle. Immense pressure on the NHS creates delays in site opening and patient recruitment, creating a fundamental friction point in the biotech value chain.
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.
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.
Eli Lilly ran the fastest-accrued Alzheimer's study in history by going direct-to-patient. This model, using televisits and centralized diagnostics, is highly effective for preventative medicines where motivated patients can be recruited online.
Contrary to market convention, a trial delay can be a bullish signal. When an independent data monitoring committee (IDMC) recommends adding more patients, as with Bristol's ADEPT-2 study, it implies they've seen a therapeutic signal worth salvaging, potentially increasing the trial's ultimate chance of success.
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 company intentionally makes its early research "harder in the short term" by using complex, long-term animal models. This counterintuitive strategy is designed to generate highly predictive data early, thereby reducing the massive financial risk and high failure rate of the later-stage clinical trials.
For final drug product manufacturing, Actuate engaged two separate US-based partners. This parallel track strategy provided crucial redundancy during the COVID pandemic, ensuring that a shutdown or material shortage (e.g., glass vials) at one plant wouldn't derail their clinical programs.
The median $40,000 cost per trial enrollee is high because pharma companies essentially run a parallel, premium healthcare system for participants. They pay for all care and level it up globally to standardize the experiment.