Experience at Moments That Matter
My perspective has been shaped by direct involvement in 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)
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Led the cardiovascular safety strategy that enabled FDA approval of fenfluramine, a drug withdrawn worldwide in 1997, in a rare disease setting.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 — an outcome with few precedents for a drug with that history. Approved by the FDA in 2020 and by the EMA the same year, with a second indication approved in 2022.
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.
Cardiovascular adverse event reporting standard (GSK)
Originated and developed the cardiovascular adverse event case report form standard for non-cardiovascular trials. Presented to the GSK Global Safety Board and implemented across all therapeutic areas. The approach was subsequently taken up by the Cardiac Safety Research Consortium and published in Therapeutic Innovation & Regulatory Science in 2015.
Internal cardiology safety panels
Served on senior cardiology safety panels at large biopharma organizations, advising across therapeutic areas on cardiovascular risk and regulatory strategy.
Current Governance Roles
Data Safety Monitoring Board Chair
Chair of the Data Safety Monitoring Board for Rapport Therapeutics, providing independent oversight of participant safety and trial integrity.
These experiences inform how I help teams distinguish manageable uncertainty from approval-limiting risk.
Earlier cardiovascular training, research, and affiliations
Cardiology fellowship completed in India. Research on the Myocardial Infarction Triage and Intervention (MITI) registry at the University of Washington (1992–1993). Associate Director, Angiographic Core Laboratory, TIMI Study Group, Brigham and Women’s Hospital (2004–2005).
Invited member of the Cardiac Safety Research Consortium (2015–2024), the public–private partnership formalized in 2006 under a memorandum of understanding between the FDA and Duke University.