Long-form writing.
The Hillman Letter
Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions in healthcare. Latest: Zero Was True. The Claim Was Still False. (November 2, 2026). Also new: 1.25-1.6x Beats Treble: The Six-Month FCA Self-Disclosure Window (October 26, 2026). Also from the Letter: 351(a) or 361. The pathway question that determines whether your biologic ever sees a BLA (June 3, 2026). 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. Also on Issuu.
TOL Mechanism
Targeted Osmotic Lysis explainer. The mechanism behind TOL, 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.
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: contact@hillmanv.com.
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 for entrepreneurs and family-business owners.
Available as Kindle eBook ($9.99) and Paperback ($12.99, 58 pages).
Paper pages
Each paper has one canonical page on andrew-hillman.com.
- Mesenchymal Stromal Cell-Derived Exosomes and Extracellular Vesicles Across Therapeutic Indications: A Structured Review of Published Preclinical and Early-Phase Clinical Study Designs, Administration Parameters, and Reported Outcomes (DOI 10.5281/zenodo.21209815)
- Mesenchymal Stem Cell-Derived Extracellular Vesicles for Tissue Repair Across Multiple Body Systems: A Narrative Review (DOI 10.5281/zenodo.23574345)
- Mesenchymal Stem Cell-Derived Exosomes from Wharton's Jelly: The Gold Standard for Safe, Compliant Regenerative Medicine (DOI 10.5281/zenodo.20974697)
- The Biologics Paradigm: Wharton's Jelly Mesenchymal Exosomes as a Section 351(a) Drug vs. the Section 361 HCT/P pathway (DOI 10.5281/zenodo.21142612) (also on Issuu)
- Mesenchymal Stem Cell-Derived Exosomes from Wharton's Jelly Umbilical Cord: Regulatory Classification Under FDA CBER Section 351(a) (DOI 10.5281/zenodo.21169929)
- Wharton's Jelly Mesenchymal Stem Cell-Derived Exosomes as an Adjunctive and Alternative Therapeutic Strategy in Spinal Disc Repair, Post-Surgical Recovery, and as a Replacement for FDA-Unindicated Epidural Corticosteroid Injections (DOI 10.5281/zenodo.20978822)