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