Let's Talk Quality

This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma.

"Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help harmonize processes, engage the global network, and create a 'one team' quality approach.

Vaishali talks us through her journey in quality and some of the challenges of leading a global quality operation of 500+ people, and the key aspects which have helped her to get to where she is now. We discuss the below points:

• The challenges of managing a global quality operation.
• Navigating the pandemic and transitioning into a remote world.
• Managing people in time-zones across the US, Europe, and Asia.
• Staying relevant with guidelines across different jurisdictions.
• Balancing compliance and innovation in the cell therapy industry.
• How to manage M&A and the complex transition that takes place.
• The evolution of guidelines and technology over the past two decades.
• How to stay relevant in a constantly evolving landscape.
• The skills Vaishali has developed to progress to where she is now.
• Vaishali's outlook on leadership, and within the ATMP space.

Whether you want to work in a global operation or small biotech, this is a must listen for any current or aspiring quality leader. So many great insights into the mindset of a highly successful quality leader and some key traits to help accelerate your own leadership career.

I hope you enjoy the show!

As a biotech professional, how do you know that the questions you ask 'experts' are accurate?

Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by historical organisational practise?

In this episode, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses his mission to raise awareness around the importance of industry 'experts' providing accurate and evidence-based information, rather than relying solely on personal experience or company practice.

As a recognised 'expert' himself, Greg talks about organisations and individuals giving disclaimers about their opinions. He encourages both experts and learners to prioritize understanding compliance and to seek the facts rather than blindly trusting opinions. We discuss the following:

• The Importance of Understanding Compliance
• The Risk of Mistakes and Misinformation
• Clear Regulations in the Biotech Industry
• Answering Compliance Questions in ATMP's
• The Goal of Understanding Compliance
• Obligations of Leaders in Answering Questions
• Advice for Future Quality Assurance Professionals
• What Inspires Greg in his Career.

Huge thanks to Greg for sharing his views and raising awareness around this important matter. Greg is on a mission to move away from giving subjective personal opinions based on organisational practises - towards a compliance framework anchored in explicit regulations and guidance documents.

Enjoy the show!

This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer.

Jason 'Jake' Treese, played a critical role in the development, approval and commercialization of Abecma and Breyanzi; two cell therapies which have now treated 4,700 patients in clinical and commercial settings - patients that are often on their last line of treatment, and last hope of a successful treatment.

We discuss leading the quality function in CAR-T cell therapy, the challenges faced in gaining approval for these therapies, the background of CAR-T cell therapy, the importance of building a strong team, the setbacks encountered during the approval process, and the motivation and inspiration behind the work.

• Understanding CAR-T Cell Therapy
• Leading the Quality Function in CAR-T Cell Therapy
• Building the Team and Planning for Success
• Challenges and Setbacks in the Approval Process
• Maintaining Motivation and Mission
• The Approval and Reflections
• Advice for Quality Leaders in Cell Therapy
• Considerations for the Industry
• Reflections on the Impact of Cell Therapy

It's an incredible, emotional, and highly insightful story. For anyone that is leading an organisation through clinical development, particularly within cell therapy, this is a must listen!

This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics.

Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit the wide range of patients with cancer, autoimmune diseases, and respiratory diseases. We discussed RNA cell therapy and how Cartesian are bringing forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail:

• The work Cartesian are doing in RNA cell therapy and why it is exciting for patients.
• How early data suggests that Cartesian's lead programme can provide durable therapeutic benefit to patients with autoimmune diseases.
• Why Cartesian brought manufacturing in-house, the implications and the benefits of internal manufacturing.
• The transition in thinking and managing for risk and potential downtimes in the future versus planning for success.
• The challenges of bringing autologous cell therapies to patients at scale.
• Creating scalable processes for commercialisation, ensuring sustainability, and streamlining quality processes.
• At which stage in clinical development should organisations be thinking about creating scalable processes.
• How Cartesian are changing the way traditional cell therapies are developed and the implications of these changes.
• Emily’s values, her outlook on leadership, and what inspires her.

It was a pleasure to speak with Emily. It’s hugely exciting to see the incredibly innovative work that her and the team at Cartesian are doing to help patients suffering from autoimmune diseases. I’m looking forward to seeing the progress that Emily and her team make in bringing these therapies closer to the patients as they scale in a commercial setting.

We will definitely have another conversation in 12 months time to see how things are progressing at Cartesian!

I hope you enjoy the show!

The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade.

Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development.

In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics.

Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:

• The importance of data integrity in pharma and biotech.
• What does good data integrity look like?
• How Brian drives a culture of data integrity in his current role.
• Data integrity gone wrong - real life examples.
• The consequences of poor data integrity practises.
• When biotech's should be thinking about developing more robust quality systems.
• How to start building better data integrity practises into your business.
• The challenges of overseeing multiple functions in a start-up biotech.

Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success.

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!