Biotech Safety & Regulatory Strategist

Advisor to CEOs, boards, and investors at FDA-facing inflection points

I work with biotech leadership teams 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 decisions can no longer be handled through routine processes or delegated to standard functions.

Common situations include:

  • Assets with prior safety history or known class effects

  • Programs approaching INDs, NDAs, or FDA Advisory Committees

  • Board or investor concern about approval risk or valuation exposure

  • Emerging safety signals requiring defensible interpretation

  • Situations where an independent, credible safety voice is required

I work with a limited number of organizations each year, often at moments when clarity and restraint matter more than speed.

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.

  • Avandia (GSK): Participated in the executive safety response following the 2007 New England Journal of Medicine publication, including two FDA Advisory Committee meetings and 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Led cardiovascular safety strategy enabling FDA approval of a reformulated version of fenfluramine, a previously withdrawn drug, in a rare disease setting.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 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.

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