On September 15, the Food and Drug Administration opened applications for a program that lets a drug company and an outside institution of its own choosing build the paperwork for putting a new molecule into its first human being, and lets the agency start signing off on that paperwork piece by piece as it comes in. The man who put his name to it is Kyle Diamantas, the acting commissioner, a Jones Day partner who represented food, beverage, and tobacco clients and the first lawyer ever to run the agency. He came up on the food side of the FDA, not the drug side. The program he just launched is about drugs, and about getting them into people faster.
The program is the Expedited Investigational New Drug Pilot, and the pitch is competitiveness. First-in-human trials can take up to 2 years to complete in the United States, the announcement says, while the same trials move faster in China and Australia. The agency picked those two countries as the benchmark, and it picked them for speed. Their safety records were not the comparison on offer.
At first-in-human, caution is not bureaucratic drag but the actual product. It is the day a molecule that has only ever been tested in preclinical models meets a living person. The industry keeps its own memory of what that day can do when the runway is short. In 2006, six healthy volunteers in a London ward were dosed with an experimental antibody called TGN1412 and went into multiorgan failure within hours. In 2016, a first-in-human trial of an experimental painkiller in Rennes left one volunteer dead and others hospitalized, two of them with lasting neurological damage. The two-year American timeline the FDA now frames as a liability is, in part, the scar tissue from mornings like those.
The pilot works like this. A sponsor pairs with what the FDA calls a Qualified Research Institution, or QRI, which can be an academic medical center, a hospital network, a contract research organization, or a regulatory advisor. The two apply together as a pair, the sponsor submits, and the QRI brings its expertise to preparing the application. The FDA then reviews the individual components on a rolling basis during the pre-IND phase rather than waiting for a complete submission, resolving issues, it says, in real time. The agency expects to select 8 to 10 sponsor-QRI pairs for the first cohort, with applications open until October 30 and the early targets being rare diseases, oncology, and cell and gene therapies.
What the pilot adds between the drug company and the first patient is not an independent check. It is a partner the drug company chose. That partner helps assemble the case for dosing a human, and the regulator moves in closer, agreeing to weigh in early and often. Everyone at the table now has a reason to want the trial to go forward.
The FDA regulatory lawyers at Hyman, Phelps & McNamara, who write the widely read FDA Law Blog, wrote down the questions the launch left open. Two of them sit right next to each other: how conflicts of interest will be addressed, and how the FDA will decide a QRI is qualified in the first place. When the institution helping design a trial is picked by the company that profits from that trial moving forward, how the two are kept at arm’s length is exactly what the launch materials do not say.
The pilot spans both of the FDA’s major drug centers, and the one that regulates the cell and gene therapies near the top of the target list is the Center for Biologics Evaluation and Research. Karim Mikhail spent more than two decades at Merck before the FDA put him in charge of the biologics review it now proposes to speed. He was named CBER’s permanent director on September 8, after a career that also included running the drugmaker Amarin. In the announcement he is quoted praising the pilot’s use of the American innovation ecosystem to accelerate the time to first-in-human trials. The agency called the program American innovation. It did not mention that its top biologics regulator spent his career on the industry side of the review he is now speeding up.
None of this came out of nowhere. The pilot grew out of a request for information the FDA published in June, the front end of a broader campaign the agency has branded around early clinical development and titled, in its own voice, America Must Address Early Clinical Development. The message never varies. Speed is the goal, other countries are the yardstick, and the friction the pilot strips out is treated as waste rather than as a safeguard someone built on purpose.
For the 8 to 10 sponsors and the institutions they bring, the pre-IND slog compresses and a molecule reaches its first human months sooner than it would have. That is worth something to a rare-disease program with patients who have run out of time, and the agency is not wrong that the current timeline is long. But the speed is bought by folding a sponsor-chosen partner into the application the FDA leans on, and by asking the regulator to give its blessing earlier, before all the pieces are in. The person who finds out whether that trade was worth it is not quoted in the announcement. It is whoever gets the first dose under a submission that a company and the partner it picked built together, on a clock the FDA has agreed to help them beat.
Sources
- FDA – Expedited IND Pilot launches, begins accepting applications (Sept 15, 2026)
- Endpoints News – FDA details expedited IND pilot, eyeing up to 10 programs
- FDA Law Blog (Hyman, Phelps & McNamara) – “FDA’s Expedited IND Pilot Comes Into Focus”: conflict-of-interest and QRI-qualification questions
- BioPharma Dive – Mikhail (20+ years at Merck) and Davis named permanent CBER, CDER directors
- Morrison Foerster – Acting FDA chief Kyle Diamantas’s law and food-industry background
- Federal Register – Expedited IND Pilot Program; Request for Information (June 24, 2026)
- FDA Voices – “America Must Address Early Clinical Development”
- NCBI/PMC – “TGN1412: From Discovery to Disaster,” the 2006 first-in-human catastrophe
- BIA 10-2474 – the 2016 Rennes first-in-human trial that killed a volunteer