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.

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.

Andrew Hillman publications banner: close-up of curled blank paper edges in purple and royal blue light

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.

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 /coverage.

Direct contact

For media or interview requests: contact@andrewjhillman.com.

Book

Andrew J. 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 for entrepreneurs and family-business owners.

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

Authored studies

Published scientific literature by Andrew Jonathan Hillman, including the Biologics Paradigm paper (DOI 10.5281/zenodo.21142612) and the 351(a) CBER monograph (DOI pending). Investigational. Not FDA-approved treatments. Full list: andrew-hillman.com/studies. Last Part Standing remains a book, not a study.

Andrew Jonathan Hillman

Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.

Expert witness page · Publications · Q&A · Book a meeting

Profiles

Press

Sites

Paper pages

Each paper has one canonical page on andrew-hillman.com.