Engineering Faster Cures at the FDA

New plans to upend America's health bureaucracy

The FDA headquarters in Silver Spring, Maryland

Two decades as an entrepreneur have taught me a simple rule: the fastest way to get a sluggish system moving is to parachute top engineers into the zone and let them build.

The FDA, despite its brilliant scientists and recent efforts to start incorporating AI, still relies on too many workflows created before the internet. Every delay means a patient waits longer for life-saving treatments, while each extra cost of time or money means fewer promising US biotech startups get started.

The Abundance Institute, in partnership with Stand Together, is raising $4 million to place a strike team of 15-20 AI-native software engineers, data scientists, and product leaders inside the FDA to accelerate the FDA's latest AI initiatives and bring outsider perspectives on new areas to iterate on fast. These leaders will remain Abundance employees, but under the Intergovernmental Personnel Act they can sit desk‑to‑desk with reviewers, wire modern data pipes into legacy silos, and automate the mind‑numbing paperwork that turns months into years.

China is plowing ahead with CRISPR gene therapies and advanced cell therapies, precisely because its regulators do not carry our legacy burdens, instead they enable movement at double the speed of our FDA. If we let that gap widen, we will wake up one morning and discover that most of our children's drugs are made in, and controlled by, China. Meanwhile, American patients will be forced to travel overseas for many cures invented here, and China will end up stealing away a large percent of the economic activity in our biotech economy.

A nimbler FDA can reclaim lost ground. It would also give investors the confidence that timelines in US biotech no longer hinge on whether a PDF lands on the right desk, and make the interaction with regulators faster and more dynamic, with data-driven common sense.

The Abundance Institute pilot focuses on concrete wins: real‑time replication of center data so reviewers are never stuck waiting for a courier, an AI layer that flags anomalies instead of forcing every human to read every page, and a unified portal that replaces the tangle of safety systems that currently hide recalls until CNN notices. None of this is moon‑shot science. It is the kind of trench work start‑ups do every day — but it has never found its way past the FDA’s bureaucratic front gate.

Several friends and allies already deserve credit. Derek Johnson and Brian Hooks have shepherded the policy flank. Secretary Kennedy and Commissioner Marty Makary are pushing bold leadership to embrace new ideas and update government to what's possible today, undeterred by naysayers; and the courageous veteran civil servants actually willing to open their doors to outsiders are the quiet heroes of reform.

One example that should inspire the FDA is our DoD special forces. Innovation in the defense world happens in many ways — but a large percent of top new technologies are tried and perfected by nimble, elite special forces teams, following in the original tradition of the UK SAS, our Army Rangers, Navy SEALs, and others. These teams, out of existential necessity to go fast and get hard things done and save lives, try key new technology and iterate on new possibilities long before larger forces end up adopting them. It's hard to implement major new AI processes all at once for an entire agency, but a test with a group shepherded carefully by the leaders which goes after some of the most promising rapid processes tied to saving lives, perhaps aligned with a Fast Track mechanism or the Commissioner’s National Priority Voucher Program would be a great way to start. Let's boldly push through narrower AI wins that save lives, then expand upon those wins.

America still leads the world in biotech research. Whether we lead in translation to patient outcomes, and retain our biotech leadership, will depend on how quickly we graft a builder DNA onto our public institutions. This fellowship is one way to start. I'm proud to be donating personally to sponsor one of these AI engineers to start, and bringing in other friends to support more of them. Please consider fighting for the USA and patients' lives by standing alongside us. Let's make the FDA Great Again!