Let's Talk Quality

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 workplace and what both men and woman can do to help overcome these challenges.

• Why Christy is such a strong advocate for females in quality assurance
• Some of the key obstacles female leaders typically face in biotech
• The role that mentors can play in personal and career development
• Importance of finding a great mentor who is in line with your values
• Specific aspects females can struggle with in negotiating
• Building credibility and being seen as a valued business partner
• The benefit of really getting to know people in your company and network
• The 'Circle Philosophy' - what this is and how it can influence your life
• How being self-aware in minimising unconscious bias in the work-place
• How to find a good work-life integration
• The importance of aligning your company with the culture that you want to create
• The advice Christy would give to her younger self
• Christy's vision for woman in quality assurance

This is a conversation that should consistently be happening. For the industry to continue to develop and grow, we need more female leaders, and we need more people like Christy helping those who may be facing the same challenges she has faced in her career.

Christy gives some really practical advice to females at any level who are looking to build their personal and career development. Whether you’re a male or female, this episode will give anyone in the work-place some great insights into the challenges females face, and what everyone can be doing to on how to help create a better culture, improve employee retention and progress the industry forward.

I hope you enjoy the show!

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 FDA to develop a 'graded approach' to quality
• How this approach evolved into the term 'phase-appropriate'
• What factors to consider when implementing quality that is 'phase-appropriate'
• Real-life examples where this impacted the commercialisation of therapies
• Managing upwards with C-suite to promote quality within an organization
• The importance of understanding the science and technology
• What inspires Amnon to progress and contribute to society

This is a fascinating discussion about such a widely used phrase in quality assurance and the wider pharma and biotech industry.

Amnon's knowledge on this subject matter dates back to before the term was coined and it's fascinating to speak to someone who played a significant role in identifying the importance of implementing quality at the right time and to the right extent.

Hope you enjoy the show!

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 process for new QA team members
• Why understanding the history of quality assurance improves employee engagement
• How she makes it engaging and fun for new team members
• The timelines of regulations put in place and the tragedies that have occurred
• How she customizes her approach to different personalities or seniorities
• The importance of bringing in quality early in a company journey
• Measuring return on investment of quality assurance
• How to define the ROI to upper management
• Ann's advice to future quality leaders

Anne offers some great practical guidance for any level of quality professional, particularly when it comes to having a customizable process to onboard new colleagues through making quality relatable.

Hope you enjoy the show!

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 quality evolved in the past decade
• The significance of what the team at Mustang Bio are doing
• Autologous cell therapy and Car-T and the impact it has on patients
• How cell therapy has evolved over the past decade
• How the regulatory agencies and manufacturers are collaborating better
• Challenges faced in autologous cell therapy
• Scaling up manufacturing of autologous cell therapy
• Phase appropriate quality in clinical development
• Preparing for quality management maturity regulations
• Ed's leadership style and the values and principles he holds
• Which attributes Ed looks for in future quality leaders
• Why quality is not the office of product prevention!
• Why you have to be a good learner for a career in quality assurance
• Ed's life outside of his work!

I really enjoyed the conversation with Ed. He comes across as an exceptional leader and clearly leads from the front, with purpose, and 'shoulder to shoulder' with his people. He's passionate about the industry he works in and the therapies his team are developing for patients. The energy he brings is infectious and this shows in the incredibly successful career he's had to date.

Ed presents on a range of different courses for the SQA and he's also presenting at the 8th Car-TCR summit in Boston later this month. If anyone would like to know further information on these events, please check the links in the comments.

Hope you enjoy the show!

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 impact on healthcare, and why it is exciting?
• The hurdles we will face which could slow down progression
• What companies can do to navigate the talent shortage
• Inspiring your people to create a patient centric culture
• Jas' experience of leading quality functions through BLA's
• Developing robust quality processes as companies scale up manufacturing

In addition to all of the above, we talk about Jas' outlook on leadership, advice for up and coming quality leaders, and what inspires her.

Jas' journey is inspirational and her authenticity and patient centric mindset shines through throughout the episode.

Hope you enjoy the show!