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 where men and woman come together to break down the barriers and challenges for woman in the...

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 originatedHow the FDA guidance has evolved, and how it startedAmon's role in liaising with the FDA to develop a 'graded approach' to qualityHow this approach evolved into the term...

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 onboarding new team members. We cover the following in detail: Ann's customizable onboarding...

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 worldHow has quality evolved in the past decade The significance of what the team at Mustang Bio are...

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 therapyThe global potential of CGT, its impact on healthcare, and why it is exciting?The hurdles we will face which could slow down...