Let's Talk Quality – Détails, épisodes et analyse

We are back for Season Two of Lets Talk Quality!

This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics.

Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra.

Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He started in a generics company which exposed him to a variety of product types. He worked his way up into leadership positions, across multiple different aspects of quality, to get to where he is now.

Takeaways

• The benefit of working in multiple aspects of quality in your early career
• Developing trust and building leadership capabilities
• Developing different generations of people
• Putting yourself out of your comfort zone in your career
• Key ingredients for moving from clinical to commercial operations in cell therapy
• Unlearning everything you've learnt when working in cell therapy
• Training for mindset and continuous development
• Managing stress, workload and your emotions
• Irving's values, views on legacy, inspiration, and advice for future leaders!

Chapters

• 00:00 Introduction and Overview of Irving Ford
• 03:00 Transitioning from Clinical to Commercial Operations
• 11:33 Building Strong Relationships and Creating a Positive Work Culture
• 19:24 Challenges and Real-Time Decision Making in Cell Therapy
• 25:30 Personal Values and Leaving a Legacy
• 32:18 Advice for Future Quality Leaders

Huge thank you to Irving for giving us his time!

Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding relationships with international quality colleagues and regulators. Joe highlights the need to attract and educate younger professionals about the field of quality assurance. He discusses the role of technology, including AI and blockchain, the challenges and opportunities they present, as well as offering advice for future quality assurance professionals.

• 01:25 - Election as President of SQA
• 05:09 - Vision for SQA and the Quality Assurance Industry
• 07:27 - Promoting Quality Assurance as a Career
• 10:09 - Challenges in Attracting Young Professionals to Quality Assurance
• 13:39 - The Role of Technology in Quality Assurance
• 27:26 - Advice for Future Quality Assurance Professionals
• 29:04 - Joe's Inspiration and Motivation
• 31:02 - Information about SQA and its Benefits

It was a privilege to be joined by Joe and hear him discuss his vision for the SQA, the wider industry, the role that technology will play, and what benefits the SQA can offer to future and existing members.

Thanks for listening, I hope you enjoy the show!

This week I spoke with Jacob Patterson, VP quality for a clinical stage biotech in Rhode Island.

Jacob, by his own admission, has had to continuously adapt, learn and be flexible in his approach to quality leadership. We had a great conversation about what skills the quality industry will demand in the next 10-20 years. We spoke about what Jacob thinks quality professionals should be doing now, from both a technical skills and a leadership perspective to help grow their career, develop succession, and become a great quality assurance leader in the future. We covered the below in detail:

• Working in a smaller biotech compared to larger organizations
• What makes a high performing quality function today?
• How times have changed and why quality isn't known as the police any more
• How speed, agility and data analysis are the skills quality professionals need to be learning now
• Data integrity and analysis, and it's significance
• How the industry can develop more quality leaders
• Managing people and how to deal with difficult employees
• Defining the ROI of quality and getting quality a better seat at the table
• What to look for in your people when building a team

Thank you to Jacob for giving us his insights into the world of quality assurance and it's future. Jacob is honest about his assessment of the current landscape of quality assurance and what he believes, the skills that QA professionals should be working on now, to build a successful career for the future.

Hope you enjoy the show!

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 people will be going through right now. We spoke about why lateral moves and working in different functions might sometimes not be a bad thing for your longer term career prospects. We also delved into what a great QC team looks like - the metrics that Brian holds his leaders accountable to and the key pillars to building a global QC function.

We cover the below in detail:

• How having different experiences in QC, regulatory, technical has shaped Brian's career
• How a lateral move can benefit you in the long term
• The importance of multiple mentors in the early and middle phases of your career
• How to build resilience in your career and advice on identifying your 'North-Star'
• The three key things which make a world-class QC team
• The metrics that Brian and his team monitor
• Brian's leadership style and how he develops his people
• What makes a great QC leader

Brian was a pleasure to speak with. His journey to now being part of an organisation that is developing vaccines that saves lives is inspiring. This is a must listen for anyone who is leading a QC team or an aspiring QC leader. In addition, for anyone who is feeling frustrated with their career progression, Brian provides some great advice for getting through the frustrating times, really understanding what you want to achieve and where you want to go.

Hope you enjoy the show!

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 challenges of overseeing quality at a CDMO in the CGT space
• How to develop a team that can operate in uncertain environments
• The importance of quality working 'on the floor' alongside manufacturing
• How to develop processes and procedures to upskill your team
• How to go about getting 'the right people in the room'
• Examples where things have gone wrong and how Peggy handled this
• The differences between working in a CDMO v sponsor side
• Advice for collaboration between CDMO's and the sponsor company

Peggy's attitude towards quality, the industry, and the patient is inspiring. One of the goals of this is show is to inspire future quality and biotech leaders. Peggy's purpose and motivation shines through in this episode, and she provides an excellent insight into how to develop and upskill quality professionals to help them operate in the grey area of cell therapy, particularly in the fast-paced CDMO world.

Thank you to Peggy for coming on the show and providing such great insights.

I hope you enjoy the show!

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 great quality assurance leader
• John's experience of being trained by Dr W. Edwards Deming
• The importance of senior leadership teams commitment to quality
• How John uses his sporting experience to help coach his team members
• The importance of team-work and collaboration across the business
• How to excel in global know-how through knowledge management
• John's advice for future quality assurance leaders

Thank you to John for giving us some key insights into some of the key factors that contribute to becoming a world-class quality leader. It's always a pleasure to speak with John. His positivity and energy is infectious and you can see how he's forged such a successful career in quality. He is a great mentor for anyone looking to develop their leadership career.

I hope you enjoy the show!

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 help bring this vision to life. We spoke about the following:

• How not many people set out to have a career in quality assurance, and why this is
• a benefit to the industry.
• As Greg grew in his career, why he began thinking about what he's leaving behind in the QA industry.
• How to relationships with regulatory bodies and health authorities have evolved over the years.
• Greg's advice for inexperienced QA professional in how to work well with the FDA.
• What makes a truly talented quality assurance leader in biotech.
• Embedding quality as a culture and mindset in the industry.
• Finding the balance when building quality functions.
• The legacy Greg wants to leave behind him.

Greg has a huge passion for the quality assurance industry and developing leaders that can help move the industry forward. He has achieved a lot in his career so far, and will continue to add value to the wider industry. I'm looking forward to seeing Greg and the team at Editas develop their gene therapies as they move closer to bringing them to commercial use.

Greg was an inspiration to speak with, and I'd urge any QA professional looking to develop their leadership career to listen and reach out to Greg!

I hope you enjoy the show!

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!