Advisory grounded in three decades co-founding, operating, and exiting FDA-regulated healthcare companies. The regulatory pathway, the capital plan, and the board come from the same operator.
Each engagement connects the science to the pathway to the capital, because the same person has been accountable for all three.
FDA pathway selection and sequencing, including the 351(a) BLA route, RMAT designation, 510(k) clearance, and pre-IND strategy for frontier biotech and devices. The pathway is decided first, then everything else is built on it.
Frontier biotech investment thesis, scientific and regulatory diligence, and clear risk framing for investors and family offices weighing a position or a transaction.
Capital deployment, burn discipline, and the operating cadence that turns a thesis into a company. Discipline with capital is treated as a competitive advantage, not a constraint.
Board director or board observer seats where regulatory, operating, and capital judgment are needed in the room at the same time.
The companies, exits, and clearances behind this advisory are documented in primary public sources, SEC filings, FDA records, and the CMS provider registry. The full record is at andrewhillmanrecord.com, consolidated on the credentials and verification index. Expert-witness work is at andrewjhillman.com.
A focused review of pathway options and sequencing for a specific program.
Ongoing strategic counsel across regulatory, capital, and operations.
A seat at the table for regulatory and operating judgment.
Independent diligence on a biotech thesis or transaction.
The pathway is decided first. Capital, hiring, and timeline are built on top of it, not wrapped around it later.
Discipline with capital is a competitive advantage. The companies that survive are the ones that respect the burn.
The science changes and the markets turn. Relationships built over three decades are what compound.
Tell me about the program or the thesis. I will tell you whether I am the right person to help.