Essays · The Hillman Letter · Long-form

Writing. Operator notes, in public.

Long-form essays on FDA, frontier therapeutics, and capital. Operator notes from inside the work.

Targeted Osmotic Lysis (TOL) is investigational. It has not been approved by the FDA for any indication. It is not available as a treatment. Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. Content on this page is educational and describes published scientific literature. It does not describe an available treatment, it does not report results in patients, and it does not offer access to any therapy.

Long-form writing.

What Retaining Counsel Actually Needs from an Operator Expert

2026-08-31
The designation is wasted if the role is fuzzy, the file is a theory, and the opinion is asked to outrun the operating record. Read on Substack.

The Permission Gap

2026-08-16
Twelve states rewrote regenerative medicine law in eighteen months. Federal law did not move. Here is what that costs you. Read on Substack.

After the Tissue Grey Market Warning Letters, What Clinics Should Pressure-Test Before a CID Arrives

2026-08-24
The Paradigm Peptides sentencing was not a peptide story. Read on Substack.

The Hillman Letter

Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions in healthcare. Publication home: 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, an academic medical foundation partnership, and what it means for chemotherapy-free oncology.

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

LinkedIn

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].

Studies

Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. Targeted Osmotic Lysis is investigational and is not FDA-approved. The work referenced here describes published scientific literature. It does not describe an available treatment.

Authored studies with published titles and DOIs where issued. Last Part Standing is a book, listed separately. Issuu community PDFs stay on the studies page under Issuu, not here.

Open the full Studies page · Issuu profile

Book

Andrew Hillman. Last Part Standing book cover

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). Wikidata Q140403984. ISBN 979-8184773162.