Biotech Safety & Regulatory Strategist
Advisor to CEOs, boards, and investors at FDA-facing inflection points.
I work with biotech CEOs, boards, and investors when safety and regulatory decisions carry disproportionate consequences for approval, valuation, and credibility.
My focus is on programs under heightened scrutiny—those with prior safety history, class effects, or emerging signals—where early judgment determines whether risk is contained or compounds.
When I’m Typically Brought In
I am typically engaged when organizations face decisions that cannot be delegated or deferred:
- • Assets with prior safety history or class effects
- • Programs approaching INDs, NDAs, or FDA Advisory Committees
- • Board or investor concern about approval risk or valuation exposure
- • Situations requiring an independent, credible safety voice
Experience at Moments That Matter
My perspective is shaped by direct involvement in public, high-stakes safety situations—not routine pharmacovigilance. My contributions have influenced regulatory outcomes, reduced approval risk, and informed board-level decisions in high-stakes programs.