FDA regulatory strategy, frontier biotech investment thesis, and family office capital allocation. Three decades operating where the science is real and the agency record is the central question.
Four concentrations. Each one a place where regulatory rigor, capital discipline, and operator judgment converge.
Decide 351(a) versus 361. Frame the INTERACT or pre-IND meeting. Build the RMAT case. Stress-test the CMC narrative before the agency does.
Independent diligence on biologics, exosome programs, regenerative medicine, and targeted oncology. Regulatory pathway as the central variable, not an afterthought.
Quarterly portfolio review. Manufacturing-versus-product lock framework. Hiring-against-milestones discipline. Family office governance against operator drift.
Independent seat or observer for biologics, regenerative medicine, and FDA-regulated companies where regulatory strategy is the central narrative.
Strategy that survives a pre-IND meeting is strategy that survives the next investor call. The two failure modes look identical from the inside.
Most early-stage biotech failures are not science failures. They are pathway failures. Companies that pick the wrong section of 21 CFR 1271, the wrong development paradigm under 351(a), or the wrong RMAT timing will deplete capital long before they deplete optionality. The first conversation in every engagement is the pathway conversation.
FDA-regulated healthcare does not let you cut corners and survive. The category selects for operators who can absorb agency guidance at the cadence the science requires. Family offices that allocate against this category specifically are buying durability, not multiples. Manufacturing decisions follow product lock. Headcount follows revenue or paid clinical milestones. Regulatory strategy precedes site selection.
Money is not the renewable resource. Reputation is not the renewable resource until you have built one. Relationships are. Every advisory engagement is structured to leave the operator better equipped to retain the people, capital, and agency contacts they will need three years out, not just the next quarter.
Each engagement is sized to the operator and the question on the table. No standing retainer is the same as the last.
One-time, time-boxed. Two to four weeks. Output is a written pathway memo and a working session with the founding team or board.
Quarterly cadence. Pre-meeting prep, regulatory milestone tracking, capital allocation review. Most retainers are 12 to 24 months.
Independent seat for FDA-regulated companies. Observer seat for investors who need regulatory eyes in the room.
Independent regulatory diligence for venture, family office, and strategic investors evaluating biologics or regenerative medicine deals.
Curated highlights. Full operator history at andrew-hillman.com and the public record at andrewhillmanrecord.com.
Dallas family office investing in FDA-regulated healthcare since 1995. The last decade has concentrated in frontier biotech. Exosome biologics. Regenerative medicine. Targeted oncology. Cell and gene therapy programs where the manufacturing process is the product.
Substack publication on FDA regulatory strategy, biotech investment thesis, and capital discipline at family offices. Ships from Dallas. Short, direct, sourced. Subscribe at thehillmanletter.substack.com.
Founder-funded scholarship for early-stage entrepreneurs. Endowed grant for biotech research at Southern Methodist University. Permanent naming gift to the Lamplighter School in Dallas.
Federal and state matters where the regulatory record is the central question. Engagements limited to civil matters and limited to a small number of cases per year. Inquiries through andrewjhillman.com.
Short note, signal-to-noise. Tell me the question on the table, the timeline, and the audience for the work. Reply within two business days.