Advisory Focus

I advise biotech leaders at moments when safety and regulatory judgment, not additional data, determine outcomes.

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.