Every public video from the Andrew Jonathan Hillman YouTube channel, newest first. It covers The Hillman Letter Podcast episodes on healthcare compliance and fraud and abuse law, plus profile videos and shorts. Press play to watch here, or open any video on YouTube.
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Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Podcast episodes are narrated by an AI voice (synthetic narration).
Glass, Cold Chain and the Law: The 351(a) Classification of Wharton's Jelly Exosomes
Andrew Hillman's 2026 manuscript on why Wharton's jelly stem cell exosomes require BLA licensure under Section 351(a), and what that classification means for manufacturing. We cover the four-criteria test, cGMP and ISO and ICH quality systems, Type I glass, the minus 80 degree cold chain, and the labeling problems the paper sees in grey market products. Exosome products are not approved by the FDA for any indication.
The Biologics Paradigm: Why Exosomes Are a 351(a) Drug, Not a 361 Tissue Product
Andrew Hillman's 2026 paper on the line between Section 361 tissue products and Section 351(a) biologics, and why he argues Wharton's jelly exosomes belong on the 351(a) path. We cover the four criteria in 21 CFR 1271.10(a), the FDA's 2019 safety notification, the federal RMAT and Right to Try frameworks and their limits, and what manufacturing controls look like. Exosome products are not approved by the FDA for any indication.
What Compliant Should Mean for Wharton's Jelly Exosomes: Source, 351(a), Drug Master Files and the Cold Chain
Andrew Hillman's 2026 white paper on the regulatory and manufacturing standard for Wharton's jelly stem cell exosomes. We cover why the source tissue matters, why these products fall under Section 351(a), how a Type II Drug Master File works, and what donor testing, lot release, glass vials and cold chain shipping involve. FDA has not approved any exosome product.
Exosomes, Disc Repair and the Epidural Steroid Label: Research Questions from a 2026 Spine Paper
A 2026 review Andrew Hillman co-authored on Wharton's jelly stem cell exosomes and the spine. We cover the FDA's 2014 label warning on epidural corticosteroids, what lab and animal studies report about disc biology, and the three research questions the paper proposes for controlled trials. No exosome product is FDA-approved for any indication, and nothing here describes an available treatment.
Stem Cell Vesicles and Tissue Repair: 40 Studies Across Four Body Systems
A plain English tour of a 2026 narrative review Andrew Hillman co-authored on 40 peer-reviewed studies of stem cell extracellular vesicles in bone and joint, nerve, heart and skin repair. We cover the shared patterns the cited studies reported, the heart meta-analysis, manufacturing advances, and the review's stated limits. No MSC-EV product is FDA approved for any use.
What the Exosome Research Actually Shows: A Structured Review, Area by Area
Andrew Hillman's 2026 structured review of published studies on stem cell exosomes and extracellular vesicles across the spine, brain injury, lung disease, knee osteoarthritis and other areas. We cover how early the evidence still is, why dose is reported in units that cannot be compared, and what the field needs next. FDA has not approved any exosome or MSC-EV product, and human use requires an IND or BLA.
Compliance Expert Witness: A LinkedIn Walkthrough
A five minute walk through the LinkedIn profile of Andrew Hillman, Dallas: the headline, the About section, his healthcare compliance expert witness work for counsel, his research and writing, and how to connect.
False Claims Act, Qui Tam and Stark Law Explained
A plain English primer on healthcare fraud and abuse law: the False Claims Act, qui tam whistleblower cases, the Anti-Kickback Statute, the Stark Law and what an effective compliance program looks like under HHS-OIG guidance. Educational only, not legal advice.
The Hillman Letter: A Compliance Newsletter Tour
A tour of The Hillman Letter, the Substack newsletter by Andrew Hillman, Dallas, on healthcare compliance, expert witness insight and legal operations.
Published Work: Last Part Standing and Essays
The published work of Andrew Hillman, Dallas: his 2026 book Last Part Standing, regulatory research with permanent DOIs, essays and press coverage of his student awards.
Giving Back: Scholarships and Scottish Rite
Service before scale: the community and giving record of Andrew Hillman, Dallas, including The Lamplighter School, Parish Episcopal School, KidSwing Dallas for Scottish Rite for Children and two $1,000 awards for U.S. undergraduates.
Innovation Blueprint
The innovation blueprint of Andrew J. Hillman of Dallas, Texas.
Andrew Hillman: Blueprint
A blueprint video from Andrew J. Hillman of Dallas, Texas.
Andrew Hillman: A Profile
A video profile of Andrew Jonathan Hillman of Dallas, Texas.
The Andrew Hillman Explainer
An explainer on Andrew Hillman of Dallas, Texas.
Andrew Hillman's Record
An overview of the work of Andrew Hillman of Dallas, Texas.
Innovation Blueprint, Part 1
Part one of the innovation blueprint from Andrew J. Hillman of Dallas, Texas.
Andrew Hillman: Blueprint (June 2026)
The first blueprint video from Andrew J. Hillman of Dallas, Texas.
VIP Guest: Always Learning
A short clip of Andrew Hillman of Dallas, Texas as an invited VIP guest at a business event.