Andrew Hillman, Dallas on LinkedIn
Andrew Jonathan Hillman, known professionally as Andrew Hillman, is a senior paralegal and healthcare compliance expert witness in Dallas, Texas. He is not an attorney and is retained through counsel.
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Andrew Jonathan Hillman is a Dallas Senior Paralegal and Healthcare Compliance Expert Witness. He is retained through counsel in federal matters nationwide, drawing on three decades of prior healthcare operations before closing that operating career. His expert-witness practice is active.
Andrew Jonathan Hillman is a Dallas senior paralegal and healthcare compliance and regulatory expert witness, retained through counsel in federal matters nationwide, drawing on three decades of prior experience building and operating FDA-regulated healthcare companies before closing that operating career. His expert-witness practice is active. He maintains a private family office, Hillman Ventures, whose activities are kept private. Born and raised in Oak Cliff and South Dallas, he started working at six and finished high school at Highland Park, a self-made arc that still shapes how he builds. He has since completed Harvard online courses in Jewish studies.
Current roles and the full work history are kept up to date on Andrew Hillman, Dallas on LinkedIn.
Four areas define the practice today, each grounded in three decades of healthcare operations and compliance.
Policy lifecycle management, SOP drafting, board reporting, and internal controls, conducted under retaining counsel.
How it works →Triage, document-retention playbooks, and internal compliance review across Stark, Anti-Kickback, and HIPAA matters, under counsel.
How it works →Evidentiary review, subpoena compliance, and expert-report support for white-collar and regulatory defense, under retaining counsel.
Advisory services →Operator testimony on healthcare operations and compliance, retained through counsel in federal matters nationwide.
Advisory services →Selected writing on commercialization, the FDA pathway, manufacturing, and the science behind modern medicine.
The real reasons behind commercialization breakdown, from clinical odds to capital and manufacturing.
Read the essay →A founder's guide from the IND to approval, including 351(a) biologics and expedited pathways.
Read the guide →Why process and manufacturing, not the molecule alone, decide which healthcare companies win.
Read the essay →A plain-language guide to current approaches in oncology, for education only.
Read the guide →Andrew Jonathan Hillman built and ran FDA-regulated healthcare companies for three decades before closing that operating career. He co-founded, operated, and exited companies across surgical hospitals, ambulatory surgical centers, clinical laboratories, pharmacy, and medical devices. That operating experience now informs his healthcare compliance and expert-witness work. Hillman Ventures, his family office founded in 1995, remains private.
The account of public filings, recognitions, and federal records is maintained at andrewhillmanrecord.com. Investment activity is detailed at Hillman Ventures, and community work at andrewhillman.org.
A selection from 89+ ventures across three decades, with locations. The full portfolio and exits are documented on the record.
Andrew Jonathan Hillman's works are listed on ORCID 0009-0001-5396-321X and deposited on Zenodo with permanent DOIs.
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.
Notes on healthcare regulatory strategy, compliance and enforcement. One issue a week.
DOJ and HHS just put a price tag on coming forward: a 1.25 to 1.6x repayment for disclosing previously unknown civil False Claims Act issues. The clock runs to April 22, 2027.
Two September and October settlements show how a stalled internal review turns into a False Claims Act case. The 60-day overpayment clock is the reason.
Eight years, one reversal, and a nine-page order that ends the argument.
An eight-step operator checklist for distinctive, consistent brands in regulated healthcare and biotech.
Five lessons I would tell my younger self if I could.
The pattern was the same across five programs. In case you are running one of the next ones.
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
A five minute walk through the LinkedIn profile of Andrew Hillman, Dallas: the headline, the About section, what he covers for counsel as a healthcare compliance expert witness and Senior Paralegal, his research and writing, and how to connect.
Watch on YouTube · Full playlist
Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
A plain English primer on healthcare fraud and abuse law: the False Claims Act, qui tam whistleblower lawsuits, the Anti-Kickback Statute, the Stark Law, and what an effective compliance program looks like under HHS-OIG guidance. The show notes list the source for every legal point.
Watch on YouTube · Full playlist
Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
A tour of The Hillman Letter, the Substack newsletter by Andrew Hillman, Dallas, on healthcare compliance, expert witness insight and legal operations. We walk through recent issues on records retention, Rule 702 expert reports, FDA warning letters, the False Claims Act and FDA pathways.
Watch on YouTube · Full playlist
Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
The published work of Andrew Hillman, Dallas: his 2026 book Last Part Standing, regulatory research on Zenodo with permanent DOIs, essays on his sites, Medium and The Hillman Letter, and press coverage of his student awards. Not medical advice.
Watch on YouTube · Full playlist
Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
Service before scale: the community and giving record of Andrew Hillman, Dallas. The Lamplighter School, Parish Episcopal School, KidSwing Dallas for Scottish Rite for Children, the Heroes for Israel Project, and two $1,000 awards for U.S. undergraduates.
Watch on YouTube · Full playlist
Educational only. Not legal advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
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.
Watch on YouTube · Full playlist
Educational only. Not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice.
New essays, the podcast and research from Andrew Hillman, Dallas.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Andrew Hillman on Medium.
Video playlist of every episode.
Listen and subscribe.
Listen and follow.
Listen and subscribe.
Episode 2 of The Hillman Letter Podcast.
Episode 3 of The Hillman Letter Podcast.
Episode 4 of The Hillman Letter Podcast.
All of his Medium essays in one place.
Research deposits with DOIs, linked to ORCID.
Sourced answers on andrewjhillman.com.
Every published paper, with its permanent DOI.
His name page on IMDb.
Andrew Hillman's private family office. Its activities and holdings are kept private by design.
Hillman Ventures →The Andrew Hillman Family Room at the Lamplighter School, the Scholarship for Entrepreneurs, and the Grant for Biotech.
Service record →This week's Hillman Letter: 1.25-1.6x Beats Treble: The Six-Month FCA Self-Disclosure Window. Notes on healthcare regulatory strategy, compliance, and enforcement.
Read this week's Letter →Andrew Hillman has helped take healthcare companies private and public, and has bought and sold healthcare businesses across multiple sectors. His portfolio includes Bone Solutions, Inc. (Southlake, Texas), an orthobiologics company with eight FDA 510(k) clearances.
The Apothecary Shop pharmacies (formerly Over the Counter, OTC) and Digimed.
Dynacq Healthcare (NASDAQ: DYII). The former Victory Hospitals, acquired by Nobilis Health Corp. (HLTH). Vista Hospital (Dallas, Texas, Baton Rouge, Louisiana, and Houston, Texas), a past hospital ownership. Andrew Hillman states Vista Hospital ranked number 2 on a 2002 Forbes list. That distinction reflects his account and is not independently verified here.
Medical groups, anesthesia groups, chiropractic groups, MRI and imaging centers, clinical laboratories, and pharmacies.
Andrew Hillman's background is documented in a public record he also maintains, and in established identity registries.
Andrew Hillman is the author of a white paper on Wharton's Jelly-derived mesenchymal stem cell exosomes, examining the underlying science, the FDA Section 351(a) biologic classification, cGMP manufacturing, and the regulatory pathway for cell-free regenerative medicine.
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.
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.
A DOI, or Digital Object Identifier, is a permanent identifier for a document. It always resolves at https://doi.org/ followed by the DOI, even when the file location changes. Each paper on this page with a DOI is citable by that DOI as its permanent link. OpenAIRE holds an independent backup record.
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.
Studies with official deposit files: andrew-hillman.com/studies.
Andrew Hillman enjoys mentoring young people in business, an interest that pairs naturally with the Andrew Hillman Scholarship for Entrepreneurs. He is also a donor to and supporter of community and charitable organizations, including the Altus Foundation in Houston, the charitable foundation affiliated with ZT Corporate. He also supports the Heroes for Israel Project, a 501(c)(3) nonprofit supporting Israel's border communities and volunteer first responders, with a $100,000 gift in 2025.
Dated, verifiable milestones in community giving. Each entry is documented on this site or a third-party record.
A June 28, 2017 KidSwing letter documents an $18,000 sponsorship for KidSwing 2017, benefiting Texas Scottish Rite Hospital for Children. See andrewhillman.org/#kidswing.
A $300,000 gift established the Hillman Family Room at The Lamplighter School in Dallas. The Hillman Family Room is a named technology and robotics space for students.
Annual donations to Parish Episcopal School in Dallas, Texas, every year from 2020 through 2026.
The Lamplighter School, Dallas, Texas. More than $500,000 in cumulative gifts, including the $300,000 Hillman Family Room.A proud American, he keeps a disciplined, drug-free and alcohol-free routine built around the gym, the Katy Trail, and road and pedal cycling. Colorado, Dorado and Puerto Rico are among the places that have shaped a long career.
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Former Victory Hospitals were later acquired by Nobilis Health. These Victory photos are past ownership.
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.
ORCIDResearcher ID 0009-0001-5396-321X
WikidataEntity Q139969699
WikipediaEncyclopedia article
Academia.eduPapers and monographs
ZenodoDeposited works with DOIs
X@AndrewHillmanTX
AmazonLast Part Standing, paperbackAndrew Jonathan Hillman
Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.
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Elsewhere: the family office at hillmanv.com.
