>

Dallas, Texas · Since 1995

Biotech insights from the inside of FDA-regulated medicine.

Long-form writing on regulatory strategy, frontier therapeutics, and capital decisions in healthcare. Operator notes from three decades inside the work, not commentary from the sideline.

Read The Hillman Letter Recent Essays

Featured Writing

Recent essays.

Published on The Hillman Letter at Substack. Subscribe to read full archives and receive new pieces by email.

FDA Regulatory

The 351 versus 361 question, answered honestly.

Why most exosome programs land on the wrong side of FDA jurisdiction and what the BLA pathway actually demands. CMC, manufacturing controls, and the cost of getting the classification wrong.

Read  → Frontier Therapeutics

Targeted Osmotic Lysis. How it works.

The mechanism behind TOL, the an academic medical foundation partnership, and why this approach to solid tumors differs from chemotherapy, radiation, and surgery. Written for clinicians and the curious.

Read  → Capital

Family office capital for regulated science.

Why patient capital fits biotech better than venture timelines. How Hillman Ventures structures investments around FDA milestones rather than fundraising rounds.

Read  → Operator Notes

What thirty years of operating taught me.

Patterns that show up in every FDA-regulated venture. Compliance failures that precede enforcement. The documentation gaps that drive liability. Field notes, not theory.

Read  →

What I Write About

Six subjects.

Narrow focus by design. Three decades of operator depth means I write what I know firsthand, not what I read on a deck.

FDA regulatory strategy.

351(a) BLA pathway, 361 HCT/P classification, IND mechanics, pre-IND meetings, RMAT designation, CMC documentation, INTERACT and Type B meetings.

Frontier therapeutics.

Mesenchymal exosome biologics, Targeted Osmotic Lysis for solid tumors, Discseel for spine, regenerative medicine the FDA respects.

Healthcare compliance.

Anti-Kickback Statute, Stark Law, OIG enforcement patterns, HIPAA, the compliance gaps that precede investigation.

Capital decisions.

Family office investing in regulated science. Milestone-based capital allocation. When to syndicate, when to write alone, when to walk.

Operator field notes.

Lessons from co-founding FDA-regulated device, pharmacy, surgical hospital, and pharmaceutical wholesale ventures. Multiple exits to strategic acquirers and PE.

Texas and Dallas context.

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

Andrew Hillman personal mark

About the writer

Andrew Hillman. Dallas, Texas.

Principal of Hillman Ventures, a private family office focused on frontier biotech in FDA-regulated healthcare. Three decades of operator experience across device, pharmacy, surgical hospital, intraoperative neuromonitoring, and pharmaceutical wholesale ventures. Co-founder, investor, expert witness, philanthropist.

Writing on this site captures the work as I see it from inside the regulatory process, not from the sideline. The Hillman Letter on Substack is the home for full essays. This page collects the published canon and the public-facing record.

The Principal Expert Witness Public Record LinkedIn
The Andrew Hillman cluster
andrew-hillman.com Principal · Hillman Ventures andrewjhillman.com Expert Witness andrewhillmanadvisor.com Strategic Advisory hillmanv.com Family Office andrewhillmanrecord.com Public Record andrewhillman.org Service · Community fixcancer.org Targeted Osmotic Lysis The Hillman Letter Substack · Long-form