One Phase 3 readout can add years to a company’s future or erase it in a morning and that swing is exactly where D&O insurance, securities litigation and leadership decisions collide.

Patricia Ramos, Director, North America Commercial D&O at Howden, sits down with life science D&O underwriters, Millie Refalo, Senior D&O Underwriter at Indigo, and Marshall Burns, Senior Underwriter, Management Liability at Berkshire Hathaway Specialty Insurance, to unpack what truly raises concern when a biotech is public, pre-revenue, and living milestone to milestone.

We walk through the underwriting basics that set the tone quickly: market capitalisation, where the lead programme sits in the clinical trial journey, and how long the company has been trading publicly (including IPOs and reverse mergers). From there, we get specific about concentration and catalyst risk, why a single asset story can be so fragile, and how “priced for perfection” valuations make even small delays or slightly weaker data feel like a breach of trust to investors.

The FDA and the shifting regulatory landscape come up repeatedly, but not as a simple “approval risk” narrative. The sharper point is disclosure: how management builds flexibility into timelines and funding, what gets said on earnings calls, and when a hypothetical risk becomes a real one that needs updating. We also dig into the funding reality for clinical-stage life sciences after the post-2021 market tightening, including cash runway assumptions, access to follow-on capital, and why debt can look like a trap.

Finally, we tackle AI-driven drug discovery and the growing fear of AI washing, plus practical renewal advice: be prepared to explain the downside with the same clarity as the upside and aim for wording and carrier continuity through pivotal development stages. If you found this useful, subscribe, share it with your team, and leave a review with the risk question you want us to tackle next.