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.

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 would have to clear.

Building Frontier From Dallas

The Dallas biotech ecosystem, the operator network, and why this is the place to build regulated healthcare today.

Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment. Targeted Osmotic Lysis is investigational. It is not approved by the FDA for any indication, it has not been shown to be safe or effective in humans, and it is not available as a treatment. No clinical trial of it is registered on ClinicalTrials.gov.

Where to find it.

Substack

The Hillman Letter weekly essays. thehillmanletter.substack.com

Long-form LinkedIn articles. linkedin.com/in/andrew-hillman-dallas

Press & podcasts

Coverage and podcast appearances logged at andrew-hillman.com/coverage.

Direct contact

For media or interview requests: [email protected].

Book

Last Part Standing

by Andrew Hillman, with Beverly Levine · Business & Entrepreneurship · Published July 2026

Last Part Standing is the account of three generations inside Midway Auto Supply, a Dallas family business founded in 1959 and closed in 2020. Part family history, part business post-mortem, it draws ten lessons on adapting to industry change, family conflict, financial discipline, and succession that entrepreneurs and family-business owners can use.

Available as Kindle eBook ($9.99) and Paperback ($12.99, 58 pages).