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Andrew Jonathan Hillman is the Principal of Hillman Ventures, a Dallas-based private family office investing in FDA-regulated frontier biotech since 1995. He writes The Hillman Letter on FDA regulatory strategy and serves as an expert witness in healthcare compliance matters.
Andrew Jonathan Hillman is the Principal of Hillman Ventures, a Dallas-based private family office investing in FDA-regulated frontier biotech since 1995. Current concentrations include exosome biologics on the 351(a) BLA pathway, regenerative medicine for inflammation and damaged tissue, and targeted oncology mechanisms. He writes The Hillman Letter on Substack covering FDA regulatory strategy and family office capital discipline, sponsors the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech at Southern Methodist University, and is the donor of the Andrew Hillman Family Room at the Lamplighter School in Dallas. He serves as an expert witness in healthcare compliance matters.
Andrew Jonathan Hillman is the Principal of Hillman Ventures, a Dallas-based private family office investing in FDA-regulated frontier biotech since 1995. The original Hillman Ventures mandate, three decades old, is to invest in FDA-regulated healthcare ventures where the science is real, the regulatory pathway is defensible, and the operators can absorb agency guidance at the cadence the science requires.
Current portfolio concentrations include exosome biologics on the 351(a) Biologics License Application pathway, regenerative medicine for inflammation and damaged tissue, targeted oncology mechanisms that reach tumors small molecules and immunotherapies do not, and cell and gene therapy programs where the manufacturing process is the product.
Hillman writes The Hillman Letter on Substack covering FDA regulatory strategy, biotech investment thesis, and capital allocation discipline at family offices. Outside the portfolio, he sponsors the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech at Southern Methodist University, and is the donor of the Andrew Hillman Family Room at the Lamplighter School in Dallas. He serves as an expert witness in healthcare compliance matters where the regulatory record is the central question.
Hillman maintains a complete public record at andrewhillmanrecord.com. He is based in Dallas, Texas, and operates internationally through partner clinical and research sites in Mexico, Australia, and additional jurisdictions.
For your story. Attributable on the record.
Five lines, attributable to Andrew Hillman, Principal of Hillman Ventures. Use directly. No advance review required.
"In biologics the process is the product. Locking process before product is the most common capital destruction event I see in this category."Andrew Hillman, Principal, Hillman Ventures
"The single question that decides whether your biologic ever sees a BLA is 351(a) or 361. Three filters together. Miss one and you are 351(a). All three pass and you are 361. The cost delta is roughly a factor of one thousand."Andrew Hillman, Principal, Hillman Ventures
"Family offices that allocate against FDA-regulated healthcare are buying durability, not multiples. The category selects for operators who can absorb agency guidance at the cadence the science requires. That selection is the moat."Andrew Hillman, Principal, Hillman Ventures
"Manufacturing decisions follow product lock. Headcount follows revenue or paid clinical milestones. Regulatory strategy precedes site selection. These are not slogans. They are filters."Andrew Hillman, Principal, Hillman Ventures
"Everything is in the public record. Primary sources. The work since is the answer. Anyone deciding whether to work with me reads andrewhillmanrecord.com first. That has saved everyone time."Andrew Hillman, Principal, Hillman Ventures
Talks, panels, and podcast topics.
Six topics that fit any biotech, family office, or healthcare program lineup.
The Three Filters: 351(a) vs 361
Pathway determination under 21 CFR 1271. The free FDA paths to certainty. Why this question precedes every other regulatory decision.
Family Office Capital in Frontier Biotech
Why patient capital is structurally well-suited to biologics. Three filters that come up at every IC. Where venture capital and family office capital diverge.
The Pre-IND Meeting, Done Right
Four-corner preparation framework. The two-week post-meeting debrief that decides whether your IND submission is clean.
Exosome Biologics on the BLA Path
The current state of CBER pathway decisions for exosome programs. Pre-clinical sufficiency. CMC variability. Investor-side regulatory red flags.
Healthcare Compliance Expert Witness Practice
The role of an industry-experienced expert witness in healthcare compliance matters. Limits of expert testimony. What good cross-examination looks like.
Building After a Federal Matter
What seven years of rebuilding actually looks like in FDA-regulated healthcare. Transparency as operational discipline. The public-record framework.
About Hillman Ventures.
Hillman Ventures is a Dallas, Texas-based private family office investing in FDA-regulated frontier biotech since 1995. Current portfolio concentrations include exosome biologics on the 351(a) BLA pathway, regenerative medicine for inflammation and damaged tissue, targeted oncology mechanisms, and cell and gene therapy programs where the manufacturing process is the product. The firm operates under three filters: manufacturing follows product lock, headcount follows revenue or paid clinical milestones, and regulatory strategy precedes site selection.
Headshots, logo, and brand assets.
Headshot. High-resolution color headshot available at andrewjhillman.com/img/headshot-1600.jpg · 1600x1600 px · Credit: Andrew Hillman / Hillman Ventures
Logo. AH monogram on transparent background at andrew-hillman.com/img/ah-logo-1200.png · 1200x1200 px
License terms. Editorial use permitted with credit "Andrew Hillman / Hillman Ventures" and link to andrew-hillman.com. Commercial use requires written permission. Full terms at andrewhillmanrecord.com/license.
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