Experience at Moments That Matter
My perspective has been shaped by direct involvement in high-stakes safety situations tested under regulatory, public, and investor scrutiny—not routine pharmacovigilance operations. My contributions have influenced regulatory outcomes, reduced approval risk, and informed board-level decisions in high-stakes programs.
The following roles reflect long-standing trust in my judgment at moments of scientific, regulatory, and governance risk.
Avandia (GSK)
Participated in the executive safety response following the 2007 New England Journal of Medicine publication, including two FDA Advisory Committee meetings and a Congressional testimony.
Fintepla (Zogenix)
Led cardiovascular safety strategy enabling FDA approval of a reformulated version of fenfluramine, a previously withdrawn drug, in a rare disease setting.
FDA-accepted real-world evidence analyses
Designed and executed post-marketing safety studies requested by the FDA, using large claims databases to confirm or refute emerging signals under time pressure.
Internal cardiology safety panels
Served on senior cardiology safety panels at large biopharma organizations, advising across therapeutic areas on cardiovascular risk and regulatory strategy.
These experiences inform how I help teams distinguish manageable uncertainty from approval-limiting risk.