Expedited IND Pilot Targets Sequential Delays Slowing First-in-Human Trials

The FDA has announced the final design of its Expedited Investigational New Drug (IND) Pilot and is accepting applications from sponsor–qualified research institution (QRI) pairs through October 30, 2026.¹ The pilot is part of the Department of Health and Human Services' Operation TrialBlazer. It will let FDA review individual IND components on a rolling basis during the pre-IND phase instead of waiting for every component to be ready, and agency staff will choose eight to 10 projects.² China surpassed the US in phase I trials for the first time in 2021.³ China's State Council Decree No. 818 took effect May 1, 2026. It sets up a dual-track framework, adding a parallel pathway for biomedical new technologies alongside the traditional National Medical Products Administration route.

In this interview, Boyang Wang, founder, Immortal Dragons, discusses why US first-in-human timelines lag, what QRIs could change, and how developers will decide where to generate clinical data.

Access Part 1 of the video interview in which Wang discusses how the FDA's Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China's 818 Decree.

Access Part 2 of the video interview in which Wang discusses how the FDA's Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.

PharmTech: Why Is the Traditional US IND Process So Slow?

Wang: In the standard process, you need a pre-IND phase where you run the required animal studies. Then you submit the IND, and FDA is required to respond within 30 days in most cases. After clearance, an ethics committee reviews trial conduct before the first cohort of patients can be dosed. Pre-IND is very time-consuming, usually more than a year in the US, compared with about 200 days on average in other countries. The US is stricter on animal studies, ethics committees, and data standards. If the FDA issues a clinical hold, you must wait at least six months to restart the application. Even after clearance, the hospital running the trial must get through its own ethics committee. That step is uncertain: it can take as long as 13 months and usually not less than 160 days. All these steps are sequential and hard to accelerate.

How Could QRIs Under the Expedited IND Pilot Change That Sequence?

Under the accelerated IND, sponsors can find partners called Qualified Research Institutions. A QRI can do all those steps in one go within the institution and coordinate everything, which could potentially accelerate the pace.

The FDA's First Cohort Will Be Small. Does That Limit the Pilot's Impact?

The first batch will be a small number. Hopefully, though, market forces will eventually prove whether the QRI program succeeds or fails. If it proves effective, more QRIs can be added. The FDA is rolling out this pilot because it intends to accelerate. If QRI capacity becomes the throttle, we can expect QRIs to expand. What remains to be seen is how efficiently it runs.

How Did Technologies Under China's Decree 818 Move So Quickly?

A lot of the preparation happened while Decree 818 was being rolled out. Before the document was made public, there were smaller-scale panels and discussions with a small group of key stakeholders. Once they knew another track was coming, they were already preparing documentation. That's why these technologies can pass so fast. From what we know, they are well on track to implement it and potentially roll it out in two years' time.

Is China's Speed in Early-Phase Trials A Result of Cutting Corners?

China has made strides in clinical trials, contract research organizations, and pipelines. But the FDA's own announcement of the pilot compared the US with China, Australia, and other regions. That shows things in the US are probably slower than in most other countries. The FDA is the gatekeeper for the biggest market, and authorities like the EMA and Singapore's regulator look to its decisions. It's still the gold standard, but that doesn't mean it has to be the slowest. So, it isn't valid to say China is fast because it doesn't follow good practices. Everybody is faster than FDA, and we see the need for the FDA to innovate for better efficiency.

How Should Drug Developers Decide Where to Generate Early Clinical Data?

We believe drug development is fundamentally scientific discovery. If a human or animal study in one country follows proper standards and proves the molecule works, that result should be transferable. We may need to regenerate some data elsewhere, but once we know the truth, we can repeat the trial with confidence, capital, and scale. So, the region offering the fastest speed, lowest cost, and least red tape will win. The FDA's expedited program and China's new regulatory tracks represent healthy competition. The deciding factor is not where the data can get accepted, but where valid data can be generated in the fastest time.

References

1. FDA launches Expedited IND Pilot, begins accepting applications. News release. FDA. September 2026. Accessed October 15, 2026. View source

2. FDA Expedited Investigational New Drug (IND) Pilot Program. FDA. Accessed October 15, 2026. View source

3. The race for clinical trials: can the FDA's new pilot program stop the U.S. from falling behind? Foley Hoag. September 2026. Accessed October 15, 2026. View source