Experience Shaped by Scrutiny

GSK — Avandia

Part of the executive safety response following the 2007 NEJM publication suggesting increased myocardial infarction risk. Participated in Congressional testimony and two FDA Advisory Committee meetings. The committee ultimately voted 20–1 to keep Avandia on the market.

Pfizer & GSK — Internal Cardiology Safety Panels

Served on internal cardiology safety panels advising across therapeutic areas, contributing to cardiovascular risk assessment and regulatory strategy.

Gilead — FDA-Facing Real-World Evidence Analyses

Partnered with epidemiology to design FDA-requested post-marketing safety analyses using the Pharmetrics database, including time-sensitive reviews for Letairis and Ranexa. In each case, FDA accepted the analyses and conclusions.

Zogenix — Fintepla

Led cardiovascular safety strategy for a reformulation of fenfluramine, a previously withdrawn drug. Developed a conservative, defensible safety approach that contributed to FDA approval.