What 2026 holds for biotech and Quality - with Jon Voss and Ed Armstrong

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!