The Permission Gap
Twelve states rewrote regenerative medicine law in eighteen months. Federal law did not move. Here is what that costs you.
The Hillman Letter
Frontier biotech, FDA regulatory strategy, and the operator playbook. Written from Dallas by Andrew Jonathan Hillman, principal of Hillman Ventures. Monthly. Free to read.
Live Last read · last published · next check
Latest posts
Direct Biologics kills ExoFlo perianal fistula trial after enrolling five patients
Direct Biologics terminated its ExoFlo trial in perianal fistula (NCT05836883) on August 11.
The False Claims Act Is the Biggest Compliance Risk in Healthcare. Most Programs Are Not Built for It.
The Department of Justice recovered 6.8 billion dollars under the False Claims Act in fiscal year 2025, the highest single year total in the statute’s history.
Paradigm Peptides Was the Warm-Up. The Tissue Grey Market Is the Real Target.
The grey market regenerative medicine days are numbered.
The CMC chasm. Why most biotech IND submissions fail at chemistry, not biology.
The biology is usually right.
What "non-toxic cancer treatment" actually means
The term gets thrown around.
Why family offices beat venture capital on early biotech. And where venture still wins.
I run a Dallas family office that invests in frontier biotech.
When RMAT designation actually helps you. And when it is a marketing pin.
The Regenerative Medicine Advanced Therapy designation is one of FDA’s best-known expedited pathways.
Voltage-gated sodium channels in cancer. The biology, explained for non-scientists.
A patient called me last week.
Your stage-4 second opinion checklist (no fluff)
Most second opinions for advanced cancer fail at the records request, not at the appointment.