Testing Human Biology on Human Data

This week, we officially launched the National Center to Accelerate Cures (NCAC) in Baltimore! We are finally building the national infrastructure to validate non-animal tools for the FDA.

For decades, drug discovery has lived with a brutal failure rate: over 90% of clinical trials fail, largely because mice do not predict human biology. Curing a disease in a mouse rarely translates into the clinic.

I have spent my career at the intersection of tech and bio, long before anyone gave it a clean acronym. Back then, talking about organ-on-a-chip platforms was treated like a fringe experiment.

When Donald Ingber, M.D., Ph.D. at Wyss Institute at Harvard University first submitted his breathing lung-on-a-chip paper to Science, they rejected it and told him to validate it in mice first. Animal testing was so entrenched as the default that even a functional human tissue model had to prove itself in rodents.

Today, that standard is coming full circle. The FDA is actively pushing back on animal-only submissions and requesting organ-chip and NAM data instead.

Now we call them NAMs (New Approach Methodologies). To satisfy regulators, these platforms must be reproducible, standardized, and commercially validated.

When Congress passed legislation in 2022 allowing alternatives to animal testing, many expected the floodgates to open overnight.

They did not.

Authorization removed the legal barrier, but qualification remains the real hurdle. An early-stage founder cannot simply hand an FDA reviewer raw data from a novel microphysiological system and expect a green light. Regulators need standardized validation frameworks.

That is why NCAC exists. Housed at Blackbird BioHub and backed by $3M in federal funding, the initiative brings together Critical Path Institute (C-Path), Blackbird Laboratories, and Arrowpoint Labs Foundation.

As a board member at C-Path, this hits close to home. C-Path has spent nearly two decades building the consensus science that turns complex biology into vetted regulatory tools. Bringing that together with Blackbird and Arrowpoint gives founders the physical and regulatory infrastructure to validate these platforms.

Proud to work alongside everyone at C-Path in this photo. There is so much more to come as our team continues to lead this space.

We are finally building the tools to test human biology on human data.

Originally posted on LinkedIn.