What 2026 holds for biotech and Quality - with Jon Voss and Ed Armstrong
Let's Talk Quality10 Feb

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!

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