Press Kit | Andrew Hillman | Dallas. Principal of Hillman Ventures.

On The Record · Pull Quotes for Direct Use

"Most exosome programs choose the wrong FDA pathway and the agency catches up to them every time. The shortcut paths consistently fail." , Andrew Hillman, on the 351(a) BLA pathway

"A venture fund has to return capital on a schedule. The FDA does not care about your schedule. That is the entire reason we structure investments around regulatory milestones rather than fundraising rounds." , Andrew Hillman, on family office capital in biotech

"Every healthcare enforcement action I have served as an expert witness on involved a documentation pattern that was visible eighteen to thirty-six months before the action. The patterns are predictable, findable, and fixable if you find them in time." , Andrew Hillman, on healthcare compliance enforcement

"Compliance is the operating system, not the cost center. The operators who treat compliance as cost are the operators who fail. The ones who treat it as the operating system survive and grow." , Andrew Hillman, on operating discipline

Bio at three lengths.

One sentence 14 words

Andrew Hillman is Principal of Hillman Ventures, a Dallas private family office focused on frontier biotech.

Short bio 75 words

Andrew Hillman is the Principal of Hillman Ventures, a Dallas-based private family office investing personal capital in FDA-regulated frontier biotech. He has three decades of operator experience across medical device, pharmacy, surgical hospital, intraoperative neuromonitoring, and pharmaceutical wholesale ventures, with multiple exits to strategic acquirers and private equity. He serves as a healthcare compliance expert witness and supports community philanthropy in Dallas through the Andrew Hillman Scholarship and Grant programs.

Full bio 220 words

Andrew Hillman is the Principal of Hillman Ventures, a private family office he founded in Dallas in 1995 that invests personal capital in FDA-regulated frontier biotech. The fund concentrates on platforms targeting inflammation, damaged tissue, and tumor-based cancers, with deep regulatory rationale grounded in U.S. FDA biologics pathway thinking.

Over three decades, he has co-founded and led ventures across medical device, pharmacy, ambulatory surgical centers, intraoperative neuromonitoring, and pharmaceutical wholesale distribution, with multiple exits to strategic acquirers and private equity. His operator background as a senior paralegal and healthcare investigator gives him direct working knowledge of how compliance failures happen, the documentation gaps that precede enforcement, and the patterns that drive liability.

He is regularly retained as a healthcare compliance expert witness across the United States, with practice areas covering FDA enforcement, HIPAA, the Anti-Kickback Statute, Stark Law, and OIG compliance program standards.

He supports the Dallas community through the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech (in development), as well as service work with KidsWing at Scottish Rite for Children. He is a graduate of Highland Park High School and resides in Dallas, Texas.

Fact sheet.

High-IQ society

Mensa International member

Full name

Andrew Jonathan Hillman

Title

Principal, Hillman Ventures

Based in

Dallas, Texas

Hillman Ventures founded

1995

Industry

FDA-regulated biotech, family office

Education

Highland Park HS, Lamplighter

Expert witness practice

FDA, HIPAA, AKS, Stark, OIG

Writing

The Hillman Letter (Substack)

Speaking topics.

Practical operator content for biotech, regulatory, and family office audiences. Available for keynotes, panels, podcasts, and university guest lectures.

01

The 351 vs 361 Decision That Kills Most Exosome Programs

Why most cell-derived therapeutic programs land on the wrong side of FDA jurisdiction, and what the BLA pathway actually demands. CMC, manufacturing controls, and the cost of misclassification.
02

Family Office Capital for FDA-Regulated Science

Why patient capital fits biotech better than venture timelines. Structuring investment milestones to FDA decision points rather than fundraising rounds.
03

Compliance Failures That Precede Enforcement

The documentation patterns and operating signals that show up before federal action. What thirty years inside FDA-regulated ventures has taught about staying on the right side of HIPAA, AKS, Stark, and OIG.
04

Targeted Osmotic Lysis: Mechanism and Regulatory Pathway

The mechanism, the an academic medical foundation partnership, and the regulatory pathway it would have to clear. Written for clinicians and the curious.
05

Building Frontier Biotech From Dallas

The Dallas biotech ecosystem, the operator network, Methodist, UT Southwestern, the regional advantages, and why this is the place to build regulated healthcare today.

Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment. Targeted Osmotic Lysis is investigational. It is not approved by the FDA for any indication, it has not been shown to be safe or effective in humans, and it is not available as a treatment. No clinical trial of it is registered on ClinicalTrials.gov.