Advisory Focus
What I advise on
I advise leadership teams and investors on safety and regulatory decisions that materially affect approval probability, capital risk, and organizational credibility.
My work is focused on judgment at inflection points—situations where available data are incomplete, scrutiny is high, and the cost of misinterpretation is asymmetric.
Core areas of focus include:
Safety and regulatory diligence for venture and private equity investors
Pre-milestone readiness for INDs, NDAs, and FDA Advisory Committees
Board-level framing of approval-limiting risk versus manageable uncertainty
Interpretation of emerging safety signals under regulatory and time pressure
Integration of clinical, epidemiologic, and regulatory perspectives into a single defensible narrative
This work is advisory by design. I do not function as an operational safety department or a routine pharmacovigilance service.
How I Work With Teams
I am typically engaged when leadership teams recognize that standard processes are no longer sufficient, and that independent judgment is required.
Engagements most often begin with a focused diagnostic, designed to:
distinguish signal from noise
identify risks that are regulatory-fatal versus addressable
clarify how regulators are likely to interpret the totality of evidence
inform next decisions at the board or investor level
From there, my role is to help teams decide what to do—and what not to do—before positions harden or external scrutiny begins.
What This Is — and Is Not
This work is not about producing reports, building safety infrastructure, or substituting for internal teams.
It is about:
clarity under uncertainty
restraint where overreaction is costly
credibility where trust is fragile
I work with a limited number of organizations each year, often during periods when decisions must withstand regulatory, investor, and public scrutiny simultaneously.
All engagements are confidential.