Clinical Trial Delays: FDA’s Expedited IND Pilot vs China’s 818 Decree

The path from preclinical work to first patient dosing in the US is long partly because it runs as a chain of separate approvals, according to Boyang Wang, founder of Immortal Dragons, a Singapore-based early-stage biotech fund focused on longevity therapeutics. Wang explains why that sequencing has slowed US investigational new drug (IND) applications and how FDA’s new Expedited IND Pilot aims to change it.

Wang outlines the traditional route: a pre-IND phase with required animal studies, an IND submission that FDA generally must answer within 30 days, then a separate ethics committee review at the hospital or institution running the trial before the first cohort can be dosed. “Pre-IND is very time-consuming, usually more than a year, in the context of US, compared with, about 200 days in other countries on average,” he says. He adds that a clinical hold can delay a program by months, and that institutional ethics review after IND clearance can take as long as 13 months.

“So all these steps are in a serial sequence, sequential, and is pretty hard to accelerate,” Wang says.

What Role Will Qualified Research Institutions Play?

Under the pilot, sponsors partner with qualified research institutions (QRIs), which can include academic medical centers, health networks, contract research organizations, or regulatory advisory firms. The QRIs provide pharmacology/toxicology, clinical, and CMC input on first-in-human submissions, and FDA reviews IND modules on a rolling basis.

“And then QRI can do all these, the previously mentioned steps, in one go within them, and then they coordinate everything and could potentially accelerate the pace,” Wang says.

Wang notes that the groundwork was laid well before the program was made public, through smaller stakeholder panels and early document preparation, which he believes positions the pathway for broader implementation within roughly 2 years.