The FDA just announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications. Applications can be submitted until October 30, after which the FDA says it plans to review and choose participants by December 18. It expects to select eight to ten sponsor-QRI pairs for the initial cohort.
The pilot is part of HHS’s Operation TrialBlazer, and its stated goal is to compress the time between identifying a drug candidate and dosing the first human.
The FDA’s framing in the announcement strikes a competitive tone. The agency says first-in-human trials may take up to two years to complete in the United States, and that comparable trials finish considerably faster in China and Australia.
What the expedited IND pilot does
In short, sponsors pair with a qualified research institution, or QRI, that brings scientific expertise to IND preparation. The pair applies together, with the sponsor submitting the application.
The “mechanism” is a rolling review. Rather than waiting for a complete IND package before starting work, FDA will review and accept individual components during the pre-IND phase. The theory is that problems surface and get resolved while there is still time to fix them, which lowers the odds of a clinical hold once the 30-day IND review begins.
Note what that does and does not change: The 30-day IND review still happens. FDA states plainly that it retains full regulatory authority throughout, including whether an investigation may proceed and whether to impose a clinical hold. The pilot is designed to reduce the risk of a hold by front-loading the conversation, not to remove the possibility of one.
The pilot also encourages running IRB review and clinical trial site activation alongside IND development rather than in sequence.
What the FDA said about the feedback it got
Endpoints News reported from a press call on launch day, and the details there are maybe the most useful part of the announcement for anyone deciding whether to apply.
On who qualifies as a QRI, the FDA is taking what Endpoints characterized as a “non-prescriptive approach.” CBER Director Karim Mikhail reportedly described eligible institutions as potentially “private or public, academic or not,” so long as they can provide partnership and consultative support to the sponsor. Per the Endpoints report, the breadth is intentional, and Mikhail said the FDA wants to diversify the types of institutions it accepts to see whether different profiles produce different results. So this does not appear restricted to academic medical centers.
Regarding conflicts of interest, which came up in public comments on the proposal, Mikhail said the FDA is not delegating authority to anyone and that review teams will continue to conduct standard IND reviews during the pilot. It’s worth noting that the pilot webpage has specific conflict-of-interest requirements, so the practical constraints are addressed there rather than in the press release.
On the sharper question of whether adding a QRI could add bureaucracy rather than remove it, Endpoints reported that CDER Director Michael Davis said the expectation is that the sponsor and institution will have already worked through internal discussion and refinement of the IND before it reaches FDA. Davis described the pilot as built to reduce “unnecessary delays at every stage of early development.”
The IRB angle is one we think is worth watching here. Endpoints reported FDA’s view that IRB review has not been running in tandem with agency IND review, which delays trial starts, and that FDA hopes CROs and other trial organizers will propose faster ways to stand up IRBs while preserving protocol evaluation, leading to quicker site activation.
One more piece of context is that Mikhail and Davis are newly named permanent directors of CBER and CDER. Both were serving in an acting capacity as recently as early September.
Again, the FDA plans to review applications and choose participants by December 18, which would put selected pairs at the starting line around year-end.
The bottom line so far
This is a small pilot, and the FDA is explicit that it is a test rather than a new pathway. Nothing about the statutory or regulatory requirements for an IND has changed, and the agency kept every decision right where it was.
What’s being tested is whether earlier, more collaborative preparation produces cleaner INDs and fewer holds. That’s a reasonable hypothesis to our eyes, and it’s worth noting that the constraint the FDA is attacking here is not review speed but submission quality and the sequencing of everything that surrounds it. Even for sponsors who do not apply, the diagnosis is worth taking seriously.
Applications close on October 30. Details on eligibility, conflict of interest requirements, and selection criteria are on the FDA’s Expedited IND Pilot program page.
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Thank you for your update. But, how is this process different from requesting a Pre-IND meeting, which anyone an ask for? As far as anyone partnering with academia or anyone they want to partner with, that too has always been a choice.