Strategic Advisory, Dallas, Texas

Regulatory pathway as the foundation, not the wrap.

Strategic advisory for frontier biotech and FDA-regulated healthcare, grounded in three decades co-founding, operating, and exiting these companies. The regulatory pathway, the capital plan, and the board come from the same operator.

Where I help

Operator judgment across four areas.

Advisory that connects the science to the pathway to the capital, because the same person has run all three.

Regulatory strategy and pathway analysis

FDA pathway selection and sequencing, including 351(a) BLA, RMAT designation, 510(k), and pre-IND strategy for frontier biotech and devices.

Investment thesis and diligence support

Frontier biotech investment thesis, scientific and regulatory diligence, and risk framing for investors and family offices.

Capital allocation and operating discipline

Capital deployment, burn discipline, and the operating cadence that turns a thesis into a company.

Board director and observer engagements

Board director or board observer seats where regulatory, operating, and capital judgment are needed in the room.

How to engage

Four ways to work together.

Regulatory pathway review

A focused review of pathway options and sequencing for a specific program.

Standing advisory retainer

Ongoing strategic counsel across regulatory, capital, and operations.

Board director or observer

A seat at the table for regulatory and operating judgment.

Investor diligence support

Independent diligence on a biotech thesis or transaction.

How I think

Three convictions.

01

Regulatory pathway as the foundation.

The pathway is decided first. Everything else, capital, hiring, and timeline, is built on top of it, not wrapped around it later.

02

Capital discipline as the moat.

Discipline with capital is a competitive advantage. The companies that survive are the ones that respect the burn.

03

Relationships as the renewable resource.

The science changes and the markets turn. The relationships, built over three decades, are what compound.

Key facts

The essentials.

Advisor
Andrew Hillman (Andrew Jonathan Hillman), Dallas, Texas. Principal of Hillman Ventures.
Focus
FDA regulatory pathway strategy, frontier biotech investment diligence, capital allocation, and board engagements.
Regulatory scope
351(a) BLA, RMAT designation, 510(k), and pre-IND strategy.
Basis
Three decades co-founding and operating FDA-regulated healthcare companies, with more than 89 ventures and more than 85 strategic exits.
Related
Investing at Hillman Ventures; writing at The Hillman Letter; expert-witness work at andrewjhillman.com.

Inquire about an advisory engagement.

Tell me about the program or the thesis. I will tell you whether I am the right person to help.

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