Let's Talk Quality
“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the im...
10
The Big Pharma Habits You Have to Unlearn in a Startup, with Dawn Lundin
<p>Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.</p><p>Dawn Lundin on the big pharma habits you have to unlearn in a startup.</p><p>In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big pharma and climb one ladder. She spent twenty years...
How Quality Stopped Being Black and White, with Tim Mitchell
<p>Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today.</p><p>Tim Mitchell on how quality stopped being black and white</p><p>In today's episode I was joined by Tim Mitchell, Vice President of Quality at Aktis Oncology, a radiopharmaceutical company in Boston developing treatments across several types of cancer. I really wanted to speak to Tim because very few people have watched quality evolve the way he has. He started in 1980, when the GMP regulations were barely a year and a half old and a...
Swetha Krishnan on her journey from Individual Contributor to Inspiring People Leader
<p>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 bringing back.</p><p></p><p>Swetha Krishnan on Building a Quality Mindset from the Ground Up</p><p></p><p>This is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely unplanned...
Building Quality That Scales, with Laura Singer
<p>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.</p><p></p><p>In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how...
From Virologist to CTO: Leading Quality Through Crisis, with Kimberly Garko
<p>From the lab bench to the C-Suite - and every crisis in between.</p><p></p><p>In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.</p><p></p><p>I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the...
Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese
<p></p><p>Three BLAs. Three companies. One industry-defining challenge.</p><p></p><h2>Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene Therapy</h2><p></p><p>In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product.</p><p>Jake Trees spent five years at Bristol Myers Squibb leading the quality function...
The Non-Linear Path to Quality Leadership, with Cinta Burgos
<p>The non-linear path is often the most powerful one.</p><p></p><p>Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.</p><p></p><p>In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma.</p><p></p><p>I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence...
From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane
<p>From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.</p><p>In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb.</p><p>I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has...
Laurie Adami on Life After CAR-T, and the Reality Patients Still Face
<p>CAR-T Saved Her Life. Why Can’t Most Patients Access It?</p><p></p><p>In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast.</p><p></p><p>I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had.</p><p></p><p>Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her...
How to Drive KPI's the Right Way in Global Quality, with Burak Begen
<p>Perseverance, perspective and people-first leadership in a global quality role.</p><p>In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers.</p><p>I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level.</p><p>Burak’s career hasn’t been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuil...
