THE INDUSTRY
CNS drug development is overdue for a rebuild.
Neurology and psychiatry carry some of the lowest success rates in pharma. Candidates enter human trials on the strength of compelling animal data — yet transgenic animals do not predict human brain function.
The bottleneck isn't ambition or capital. It's methodology. Mice aren't small humans, and for decades the industry has been forced to make billion-dollar bets on biology that doesn't translate.
That era is ending. Regulators, biology, and compute have all flipped at once — and a new category of human-relevant neural models is emerging to take their place.
TEAM
Built by operators who have done this before.
Case Lorance
Founder & CEO
- 10+ years of expertise with in vitro and neuro technologies, across scientific research and commercialization.
- Developed the first human cell-based in-vitro model to result in IND approval through the FDA without animal testing.
- Preclinical study result bypassed Phase I trials (SAR445088) and is now in Phase III clinical development with Sanofi (after $11.6B acquisition).
- Established the regulatory precedent for disease modeling that catalyzed the passage of the federal FDA Modernization Act 2.0.
Dr. Bradlee Heckmann
Board Member · USF Byrd Alzheimer's Institute Professor
- Professor at the USF Byrd Alzheimer's Institute, leading research at the intersection of neuroinflammation and neurodegeneration.
- Internationally recognized for work on the mechanisms driving brain disease and cognitive decline.
- Bridges frontier academic neuroscience with translational, human-relevant model development.
REGULATORY TAILWIND
The FDA is opening the door.
The FDA Modernization Act 2.0 (2022) acknowledged that animal models are no longer required for drug discovery, ushering in an era of new technologies to be adopted.
This legislation contributed to the agency's ISTAND pilot — Innovative Science and Technology Approaches for New Drugs — which gives sponsors a formal pathway to qualify new methods like organ-on-a-chip platforms as drug development tools. For the first time, human-relevant neural models have a route to the clinic.
