First-in-Human Trial Speed: Why FDA Trails China

Boyang Wang, founder of Immortal Dragons, a Singapore-based early-stage fund focused on longevity biotechnology, discusses FDA’s Expedited IND Pilot and what it signals about global competition in early clinical development.

The program pairs drug developers with qualified research institutions (QRIs) that provide pharmacology/toxicology, clinical, and chemistry, manufacturing, and controls input on first-in-human IND submissions, with sponsors able to apply until Oct. 30, 2026.

Will the First Cohort of Research Institutions Be Large Enough?

The first group of QRIs will be small, but Wang expects market forces will determine whether the model succeeds, and that FDA will likely expand the network if capacity becomes a bottleneck. “But, I’m not so concerned with the size of the batch,” he said. The open question, in his view, is how efficiently the pilot actually runs.

Why Does Speed Matter More Than Jurisdiction?

Wang discusses how once the proper work is completed on a drug, sponsors can repeat that work elsewhere with confidence, capital, and scale, regardless of where the trials were initially done. “The factor is not really where the data can get accepted, but rather where it can generate valid data in the fastest time,” he says.

He rejects the idea that China’s pace stems from cutting ethical corners, noting that FDA’s own pilot announcement benchmarked the agency against China, Australia, and other regions. “Everybody is faster than FDA,” Wang says. “Well, it’s still the gold standard, but that doesn’t mean it has to be the slowest.”