In today’s episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who’ve both worked across early-stage, clinical, and complex biotech environments.

Ed and Jon share what they’re seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence.

They talk about the following:

1. The current state of pharma and biotech, and whether the market has really bottomed out
2. Which modalities and parts of the market feel resilient, and which are still struggling
3. How FDA leadership changes are (and aren’t) showing up in day-to-day work
4. The shift toward written-only FDA interactions and what that means for sponsor–agency relationships
5. Whether regulators are prioritising speed or risk, and how that tension plays out
6. Where AI and digital tools are genuinely adding value today, versus where there’s still a lot of noise
7. How Quality has evolved from “policing” to partnership over the last 20 years
8. Why pragmatic, phase-appropriate Quality systems matter more than perfection
9. Burnout in senior Quality leaders and the risk of doing too much with too few people
10. What separates Quality leaders who are listened to from those who are merely tolerated
11. What the strongest Quality teams will be doing differently by the end of 2026

Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability.

Hope everyone enjoys the show!