Not long ago, growing a human brain in a lab was science fiction. Today, brain organoids can test drugs, model neurological diseases, and even play Pac-Man! 89% of drugs manufactured through animal testing fail. That number rises to 94% in neurology, but still, animal testing has remained the industry default for over a century. Lowry Curley, PhD, founder of Luna LifeSci and founder and former CEO of 28bio (formerly AxoSim), argues that the FDA is now at an inflection point where lab-grown human mini-brains and organ-on-a-chip systems stop being a niche and become the way drugs are cleared. Curley built the neural microphysiological system platform that nearly every top-25 pharma company adopted, licensing brain-organoid intellectual property from Johns Hopkins and acquiring StemoniX’s microBrain technology in a 2023 all-cash deal. He explains what New Approach Methodologies (NAMs) are, why the FDA’s April 2025 roadmap and March 2026 draft guidance changed pharma’s posture, and why the open question for investors is who consolidates the space.
⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.
About Our Guest:
Lowry Curley is a scientist-entrepreneur and developer of foundational neural microphysiological systems (MPS) technology that became the core platform of the first company he founded, AxoSim, which is now 28bio. He took AxoSim from a Tulane University spinout to a venture-backed company that counted nearly every top 25 global pharma company as a customer, translating early-stage neuroscience research into a validated, human-relevant platform for neurological drug discovery. As founder and CEO, he built a product pipeline on IP licensed from Johns Hopkins, UC San Diego, and Tulane, and led two acquisitions to expand the platform. He now runs Luna LifeSci, helping pharmaceutical and biotech companies adopt New Approach Methodologies (NAMs) in their preclinical programs and advising life science founders across commercialization and fundraising.
Lowry holds a PhD in biomedical engineering from Tulane University, sits on the 3Rs Collaborative and FNIH Validation and Qualification Network, and has authored 6 patents, 20+ publications, and 100+ scientific presentations.
Key Topics
Why nearly 90% of drugs and 94% of neurological therapies fail despite successful animal testing
Dr. Curley’s journey from academic biomedical engineering to founding AxoSim and Luna LifeSci
The science behind organoids, organ-on-a-chip systems, and human microphysiological systems (MPS)
How New Approach Methodologies (NAMs) are changing the future of preclinical drug development
Why the FDA’s recent guidance is accelerating the adoption of human-relevant testing technologies
How brain organoids are helping researchers model disease and predict drug responses
The challenge of translating promising academic technologies into scalable commercial platforms
How licensing university intellectual property fueled the growth of AxoSim’s technology platform
Why pharmaceutical companies are investing in predictive human tissue models over traditional animal studies
The acquisition of StemoniX and the evolution of the microBrain platform
How advances in tissue engineering are bringing human biology closer to the laboratory bench
The role of AI, automation, and advanced imaging in the next generation of drug discovery
Why commercialization, validation, and industry adoption remain the biggest hurdles for emerging life science technologies
Dr. Curley’s vision for a future where human tissue models reduce reliance on animal testing and improve clinical success rates
Timestamps:
00:00:00 – Welcome And Guest Background
00:01:14 – What NAMs Actually Mean
00:02:56 – Why Animal Models Fail Humans
00:06:24 – A Seizure That Changed Everything
00:10:32 – Funding A Platform With Proof
00:11:36 – Licensing And Acquiring To Scale
00:13:55 – Explaining Organoids To Skeptics
00:16:32 – Electrophysiology Readouts That Matter
00:20:04 – How A Brain Organoid Learns
00:22:02 – Organoid Intelligence And Ethical Lines
00:24:23 – FDA Pathways And ISTAND Momentum
00:32:56 – Startup Playbook For Faster Adoption
00:34:25 – Data Sharing And The Devil’s Case
00:43:21 – Luna LifeSci And Founder Focus
00:46:06 – Milestones To Watch Next
00:48:36 – How To Reach Dr. Curley
00:49:14 – Disclaimer
Resources
🔗 Contact Dr. Lowry Curley
- Dr. Lowry Curley on LinkedIn
- Dr. Lowry Curley Email
- Luna Life Sci
- 28bio (formerly AxoSim)
- Digitalis Commons Expert-in-Residence Profile
🔗 Technologies & Research Discussed
- The Clumps of Brain Cells That Can Play Pac-Man
- FDA Plan to Phase Out Animal Testing (April 2025)
- FDA Draft Guidance on Alternatives to Animal Testing (March 2026)
- FDA ISTAND Accepts the First Organ-on-a-Chip Platform
- AxoSim Acquires StemoniX microBrain® Platform
- Organoid Intelligence Workshop (Frontiers in AI, 2023)
- Nerve-on-a-Chip Platform (Scientific Reports, 2019)
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