Long-form writing.
The Hillman Letter
Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions in healthcare. Subscribe at thehillmanletter.substack.com.
The 351 vs 361 Question
Why most exosome programs choose the wrong FDA pathway and what that costs them. Published essay covering minimal manipulation, homologous use, and the BLA route.
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.
Family Office Capital
Why patient capital fits FDA-regulated biotech better than venture timelines. Structuring investments around regulatory milestones rather than fundraising rounds.
Six Compliance Patterns
Six documentation patterns that show up before federal healthcare enforcement. Practical content for compliance officers and in-house counsel.
TOL Mechanism
Targeted Osmotic Lysis explainer. The mechanism behind TOL, the an academic medical foundation partnership, and the regulatory pathway it follows.
Targeted Osmotic Lysis is investigational. It has not been approved by the FDA for any indication and it is not available as a treatment.
Building Frontier From Dallas
The Dallas biotech ecosystem, the operator network, and why this is the place to build regulated healthcare today.
