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!

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(78)

My Thoughts on Quality Leadership, Halfway Through Season Four

Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often.The quality leader whose main functio...

30 Jul 16min

Speaking the Language of the Business, with Jamey Lindholm

Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide.Speaking the Language of the Business, with Jamey Lindholm...

21 Jul 38min

The Big Pharma Habits You Have to Unlearn in a Startup, with Dawn Lundin

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.Dawn Lundin on the big pharma habits you have to unlearn in a sta...

14 Jul 29min

How Quality Stopped Being Black and White, with Tim Mitchell

Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today.Tim Mitchell on how quality stopped being black and whiteIn today's episode I was joined by...

7 Jul 33min

Swetha Krishnan on her journey from Individual Contributor to Inspiring People Leader

She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bri...

26 Mai 41min

Building Quality That Scales, with Laura Singer

What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales.In today's episode I w...

19 Mai 35min

From Virologist to CTO: Leading Quality Through Crisis, with Kimberly Garko

From the lab bench to the C-Suite - and every crisis in between.In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.I rea...

12 Mai 37min

Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese

Three BLAs. Three companies. One industry-defining challenge.Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene TherapyIn this special comp...

7 Mai 34min