Essays · The Hillman Letter
Essays that walk through FDA regulatory strategy, frontier therapeutics, family office capital, and healthcare compliance. Thirty years of operating experience, written to read in twenty minutes each. Seven essays published. New essays weekly.
Eight years, one reversal, and a nine-page order that ends the argument.
An eight-step operator checklist for distinctive, consistent brands in regulated healthcare and biotech.
The pattern was the same across five programs. In case you are running one of the next ones.
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. The work referenced here describes published scientific literature. It does not describe an available treatment.
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
Five lessons I would tell my younger self if I could.
Andrew Jonathan Hillman
Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.