Long-form writing.
The Hillman Letter
Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions in healthcare. Latest: The Spreadsheet Knew (October 19, 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.
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, 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.
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.
Episode 4 of The Hillman Letter Podcast walks through Andrew Hillman's published work, including a book, research papers, essays and press. Apple Podcasts · YouTube · Episode notes
Direct contact
For media or interview requests: contact@andrew-hillman.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).
Studies and permanent DOIs.
Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. References here describe published scientific literature. They do not describe an available treatment.
Find these papers on: ORCID · Google Scholar · Zenodo · Academia · ResearchGate.
- 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 (paper page) , 2026. Structured review, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.21209815. OpenAIRE. Listen: The Hillman Letter Podcast, Episode 6: Apple Podcasts · YouTube · Episode notes
- Wharton's Jelly Mesenchymal Stem Cell-Derived Exosomes: Dosing Protocols, Manufacturing Quality Systems, Drug Master File Requirements, cGMP Compliance, and the Complete Federal and State Regulatory Framework Under the FDA 351(a) CBER Pathway , 2026. Regulatory monograph, Academia.edu. Author Andrew J. Hillman (ORCID 0009-0001-5396-321X). Zenodo DOI pending (not found / not yet issued).
- Mesenchymal Stem Cell-Derived Extracellular Vesicles for Tissue Repair Across Multiple Body Systems: A Narrative Review (paper page) , 2026. Narrative review, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.21047847 (all versions). This version: 10.5281/zenodo.23574345. Listen: The Hillman Letter Podcast, Episode 7: Apple Podcasts · YouTube · Episode notes
- Wharton's Jelly-Derived MSC Exosomes (short version). No DOI yet.
- Wharton's Jelly MSC-Derived Exosomes in Spinal Disc Repair. Permanent DOI 10.5281/zenodo.20978822 (paper page). OpenAIRE backup. Listen: The Hillman Letter Podcast, Episode 8: Apple Podcasts · YouTube · Episode notes
- Mesenchymal Stem Cell-Derived Exosomes from Wharton's Jelly: The Gold Standard for Safe, Compliant Regenerative Medicine (paper page) , 2026. Repository deposit, Zenodo. DOI: 10.5281/zenodo.20974697. Listen: The Hillman Letter Podcast, Episode 9: Apple Podcasts · YouTube · Episode notes
- From our Research, The Biologics Paradigm: Wharton's Jelly Mesenchymal Exosomes as a Section 351(a) Drug vs. the Section 361 HCT/P pathway (paper page) , 2026. Repository deposit, Zenodo. DOI: 10.5281/zenodo.21142612. Listen: The Hillman Letter Podcast, Episode 10: Apple Podcasts · YouTube · Episode notes
- Mesenchymal Stem Cell-Derived Exosomes from Wharton's Jelly Umbilical Cord: Regulatory Classification Under FDA CBER Section 351(a) (paper page) , 2026. Zenodo DOI 10.5281/zenodo.21169929. Listen: The Hillman Letter Podcast, Episode 11: Apple Podcasts · YouTube · Episode notes
Essays with DOIs: paper pages
Each Hillman Letter essay below has a permanent Zenodo DOI and is indexed in OpenAlex. Every item links to its paper page on this site.
- The Spreadsheet Knew , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23476169.
- The Shred Bin Is Evidence , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352302.
- How to Write a Healthcare Compliance Expert Report That Survives Rule 702 , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352300.
- Pathway Diligence Before the Check Clears , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352298.
- The R3 Medical Warning Letter Is a Pattern, Not a Mood , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352296.
- What Retaining Counsel Actually Needs from an Operator Expert , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352292.
- The Permission Gap , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352290.
- Sponsor kills ExoFlo perianal fistula trial after enrolling five patients , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352288.
- The False Claims Act Is the Biggest Compliance Risk in Healthcare. Most Programs Are Not Built for It. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352282.
- The CMC chasm. Why most biotech IND submissions fail at chemistry, not biology. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352278.
- What "non-toxic cancer treatment" actually means , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352276.
- When RMAT designation actually helps you. And when it is a marketing pin. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352274.
- Voltage-gated sodium channels in cancer. The biology, explained for non-scientists. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352272.
- Your stage-4 second opinion checklist (no fluff) , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352270.
- The Pre-IND Meeting. What CBER Reviewers Actually Want to See. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352268.
- The NextMed Settlement Is a Roadmap. Read It Before You Build the Next Telehealth Brand. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352264.
- RMAT or BLA. When to chase Regenerative Medicine Advanced Therapy designation, and when to wait. , 2026. Essay, CC BY 4.0, Zenodo. DOI: 10.5281/zenodo.23352261.
Latest Hillman Letter issue with a DOI: The Spreadsheet Knew , 2026. Essay, Zenodo. DOI: 10.5281/zenodo.23476169.