Biotech Safety & Regulatory Strategist
Advisor to CEOs, boards, and investors at FDA-facing inflection points.
Physician, board-certified in Internal Medicine. MPH, Harvard. Twenty years of drug safety, pharmacovigilance, and regulatory leadership at GSK, Pfizer, Gilead, Zogenix, and Denovo Biopharma.
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.
I have practiced medicine since 1986 and have maintained a clinical panel throughout my career in pharmaceutical safety leadership. I hold a current California medical license and see patients weekly at a county hospital.
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 safety situations — not routine pharmacovigilance. My contributions have influenced regulatory outcomes, reduced approval risk, and informed board-level decisions in high-stakes programs.
Avandia (GSK)
Owned the myocardial infarction evidence stream following the 2007 New England Journal of Medicine publication, through two FDA Advisory Committee meetings and the Congressional scrutiny that followed.
Fintepla (Zogenix)
Led the cardiovascular safety strategy that enabled FDA approval of fenfluramine, a drug withdrawn worldwide in 1997, in a rare disease setting. No advisory committee was convened.