Advisory Focus

I advise biotech leaders at moments when safety and regulatory judgment — not additional data — determines the outcome.

My work centers on situations where evidence is incomplete, narratives are contested, and decisions carry asymmetric downside—FDA interactions, late-stage development pivots, financing risk, or board-level escalation.

In these moments, internal teams often struggle with three questions:

• What truly matters?
• What can be safely ignored?
• And how will regulators interpret the decision after the fact?

I help founders, boards, and investors navigate those questions by applying pattern recognition from prior high-stakes precedents, upstream trial design thinking, and an explicit focus on preserving regulatory credibility.

I do not provide routine pharmacovigilance outsourcing or CRO execution. I work selectively, confidentially, and most often before safety or regulatory issues become public, adversarial, or value-destructive.