Let's Talk Quality

This week, we spoke with Brian Nunnally, and discussed some of the challenges that Brian faced throughout his journey to where he is now, Global Head of QC at CSL. Brian is hugely passionate and is driven by being a part of and leading the best quality control function in the world. What I liked about this conversation was Brian's honest assessment of his struggles and frustrations that many peopl...

This week I was joined by Peggy Owens, Head of Quality at Kincell Bio, a CDMO operating in early phase cell therapy. Peggy has an extensive background in cell therapy, having worked on both the CDMO and sponsor side. We had a great discussion about the challenges of building and leading a quality function in an area of medicine which is constantly evolving. We discussed the following: The challeng...

On this weeks show, I speak with John McKay, a well respected, well loved and highly seasoned quality assurance leader in pharma and biotech across clinical development and commercial manufacturing. John breaks down four key pillars that he believes are critical for achieving quality assurance excellence and developing world-class quality functions. We discuss the following: What it takes to be a...

Welcome to episode 6 of Let's Talk Quality. I was joined by Greg Whitehead. Greg is Head of Quality at Editas Medicine and has been working in biotech for 30 years, with a particular focus on cell and gene therapy. Greg has a vision to leave the quality assurance industry in a better place than when he started in the industry. We spoke about why this is important to him and what he is doing to hel...

There are 6 female CEO's of biotech companies with a market cap of over $5bn. In this episode, I was lucky to speak with Christy, who is an incredible advocate for females in quality and the wider biotech industry. Christy has an incredible passion for helping other females leaders overcome some of the struggles that she has faced in her career. Christy chairs a women in quality group for ASQ wher...

What exactly is 'phase-appropriate' quality? In episode 4 of Let's Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, 'phase-appropriate' quality. Amnon and I discuss the following: What exactly is 'phase-appropriate' quality? The history of GxP and how the term originated How the FDA guidance has evolved, and how it started Amon's role in liaising with the F...

Welcome to Episode 3 of Season 1, of Let's Talk Quality: The Podcast. Hemish was joined by Ann Farnsworth. Ann is the VP of Quality Assurance for C4 Therapeutics, a clinical phase biotechnology organisation, headquartered in Massachusetts. Ann explains why understanding the history of quality assurance is a key part of her leadership philosophy and details the practical measures she takes when onb...

Welcome to Episode 2 of Let's Talk Quality! Today's guest is Edward Armstrong. Ed is the VP of Quality at Mustang Bio. What stood out about the conversation with Ed was his passion for continuous learning in quality and why all QA professionals should always be looking to adapt, overcome and improvise in quality and compliance. What makes a great quality assurance leader in today's world How has q...

Welcome to Episode 1 of Season 1, of Let's Talk Quality: The Podcast . Hemish was joined by Jaspreet Gill , Chief Quality Officer at Sangamo Therapeutics. We discussed the incredible potential of cell and gene therapies and the role that quality leaders play in helping the industry reach its full potential. Transitioning from small molecule to cell and gene therapy The global potential of CGT, its...