Let's Talk Quality

In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing.

Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory!

We talk about the following:

• Relocating from Miami to Michigan this year for a new VP role.
• Laurie's journey into science and quality.
• Working with different modalities, therapeutics and organizations.
• Laurie's love for quality and why she still has a passion for the industry.
• How the industry has evolved since she started.
• Communicating and leading cross-functionally.
• Moving from established organization to start-up.
• Laurie's hope for the future
• Advice for quality professionals
• The one person who inspired her the most.

Laurie's story should give inspiration to a lot of people in the early stages of their quality career that would like to progress into a Head of Quality one day.

She is kind, generous and incredibly passionate about leadership, quality and bringing safer medicines to patients. She's shown resilience throughout her career which has allowed her to widen her remit and grow her career. Her ambition to further her career shines throughout this conversation.

Thank you Laurie for sharing your incredible journey from washing glass-wear all of those years ago to where you are now!

Excited to see you continue to impact lives in your career.

Hope everyone enjoys the show!

In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.

I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional.

We discuss the following:

• Transitioning from GCP to GMP.
• Industry Trends.
• Gaining GMP Experience.
• Advancing to VP from director.
• Building a Team and Pilot Plant.
• Collaboration with Stakeholders.
• Gaining Organizational Buy-In.
• Importance of Listening.
• Strategic Thinking.

'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!

Thank you Jim for sharing your journey with us!

Hope everyone enjoys the show.

Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer.

Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders.

Takeaways

• Kelly's journey into quality began unexpectedly from a background in broadcast journalism.
• Mentorship played a crucial role in shaping her leadership philosophy.
• Building confidence in decision-making is essential for quality leaders.
• Quality should be defined in terms of efficiency and safety.
• User feedback is vital for successful quality system implementation.
• Quality management systems should be tailored to the organization's needs.
• Evolving perceptions of quality have led to greater appreciation from leadership.
• Inspiring passion for quality involves recognizing individual interests.
• Legacy is defined by the success of those you mentor and support.
• Future quality leaders should be confident yet flexible in their decision-making.

Chapters

• 00:00 Introduction to Quality and Career Journey
• 02:55 Transitioning from Science to Quality Leadership
• 06:03 Building Confidence in Quality Decisions
• 08:52 Defining and Articulating Quality
• 11:59 The Importance of Quality Management Systems
• 14:58 User Feedback and Quality System Implementation
• 17:59 Evolving Perceptions of Quality in Organizations
• 20:55 Inspiring Passion for Quality in Teams
• 23:50 Legacy and Mentorship in Quality Leadership
• 27:02 Final Thoughts and Advice for Future Leaders

This is a great conversation about the significance of defining and articulating quality to your organisation and the benefits this brings.

Thank you Kelly for joining us on the show!

In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.

Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus discusses the challenges faced by Autolus in their journey from a start-up to a commercial cell therapy company, the impact of COVID-19 and Brexit on their operations, as well a the transition from a paper-based QMS to an electronic QMS (EQMS) and the importance of having flexible systems.

• Transitioning into the cell and gene therapy field requires a steep learning curve
• The need for having the ability to work in a fast-paced, evolving environment.
• The importance of flexibility, adaptability, and collaboration
• The transition from a paper-based QMS to an EQMS
• The impact of COVID-19 and Brexit posed challenges for Autolus
• How patient impact is the driving force for Autolus
• How they strive to provide the best safety and efficacy data
• Essential qualities for quality leaders

Chapters

• 00:00: Introduction and Overview
• 05:04: Getting into Science and Quality Role
• 09:06: Differences in Quality Practices Between Countries
• 13:34: Transitioning into the Cell and Gene Therapy Field
• 19:25: Implementing Quality Systems at Autolus
• 23:26: Transitioning to an Electronic QMS
• 26:38: Challenges of COVID-19 and Brexit
• 30:43: Patient Impact in Cancer Treatment
• 34:35: Preparing for Pivotal Trials and Commercialization
• 37:28: Looking Ahead: Excitement for Commercialization
• 39:14: Values to Live and Die By
• 41:50: Leaving a Legacy
• 44:05: Advice for Future Quality Leaders

Thank you Markus for sharing your incredible journey and excited to see you and your teams work come to fruition.

I hope you enjoy the show!

Markus Gruell | LinkedIn

Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is really open about the failures she has had to overcome which have helped her develop her career and others.

Takeaways

• Finding your voice in leadership meetings
• Aligning quality objectives with business priorities are common challenges.
• The most rewarding aspects of working in quality.
• The value of listening more and speaking less for quality leader
• The importance of diverse perspectives and better decision-making.

Chapters

• 00:00 Introduction and Background
• 03:38 Building a Late Phase/Commercial Ready Quality Management System
• 06:32 Transitioning from Big Pharma to Start-ups
• 10:44 Key Challenges Faced in Career Development
• 15:26 Finding Your Voice and Building Confidence in Leadership
• 20:37 Aligning Quality Objectives with Business Priorities
• 23:06 Shaping Leadership Approach and Mentoring Others
• 24:55 Evolution of Quality as a Profession
• 26:52 Pride in Career Achievements and Future Excitement
• 32:36 Advice for Aspiring Quality Leaders

Huge thank you to Sonia for coming on the show and being very open about the challenges she faced in her early career and how she managed to overcome these.

Hope you enjoy the show!

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 is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006.

After a 12 year battle fighting follicular non-Hodgkin lymphoma, and six lines of therapy, Laurie received a call from her oncologist, informing her about a new therapy called CAR-T, that was being developed by Kite Pharma.

They were opening a clinical trial at UCLA with five patients. Laurie was to be patient number one. One month after her CAR-T treatment, Laurie was in complete remission.

Laurie is now focused on patient advocacy, volunteering and fundraising for cancer research, especially CAR-T immunotherapy.

I wanted to speak with Laurie, to talk about her fight against follicular non-Hodgkin lymphoma, how she learnt about a new game-changing therapy called CAR-T, and some key issues around access to patients, safety concerns raised by the FDA, bridging the gap between industry and patients, and what she is doing now to raise awareness of the benefits and potential of CAR-T. We discuss the following:

• [2:40] Laurie's Diagnosis, Initial Treatment and Challenges
• [5:00] 12 Year Cycle of Six Lines of Therapy and Relapse
• [10:55] Hearing the Story of Emily Whitehead and CAR-T in 2012
• [14:22] Starting Sixth Line of Therapy in 2016
• [14:57] Receiving a call about a CAR-T Trial in Spring, 2018
• [18:55] Going Through CAR-T Cell Therapy
• [21:32] Complete Remission
• [24:18] Becoming a Patient Advocate Volunteer
• [26:41] Patient Access and Challenges
• [35:41] Laurie's Response to the FDA Safety Advisory on CAR-T
• [41:30] Bridging the Gap Between Industry and Patients
• [46:16] The Potential and Future of CAR-T Therapy
• [51:34] Living Life to the Full
• [58:41] Meeting the People that Saved Her Life

I really hope people enjoy listening to Laurie's story and that it gives hope to anyone affected by Cancer, and raises awareness of the potential for CAR-T Cell Therapy to save more lives.

There are a number of challenges that Laurie is on a mission to tackle, and I would urge people to listen to this episode to learn more about how we can bridge the gap between the industry and patients, and get safter, faster and more affordable access of these therapies to more patients like Laurie.

Thank you Laurie for sharing your story with us!

In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in the contracting market, the types of projects she takes on, and the shift towards remote and on-site work. Kimberly also provides advice on building a network and finding contracts, including the importance of volunteering and referrals. She emphasizes the need for flexibility, problem-solving skills, and a strong support system when starting out in contracting.

• Kimberly's Background and Consulting Work
• Reasons for Getting into Contracting
• Changes in the Contracting World
• Types of Projects and Team Sizes
• Shifts in Remote and On-Site Work
• Building a Network and Finding Contracts
• Volunteering and Referrals
• Dealing with Slowdowns in the Market
• Skills Needed for Consulting
• Motivation and Enjoyment as a Consultant
• Advice for Starting Out in Contracting

This is a conversation which is worth listening for anyone considering become a contractor. The contracting market has seen changes, with more consultants entering the market and building a network and proactively finding contracts can be a challenge without the right support systems. Kimberly shares how flexibility, problem-solving skills, and the ability to adapt to different business models are important for success as a consultant.

Hope you enjoy the show!

This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation.

Stan provides practical advice for leaders to change perceptions and measure the strength of a quality culture. He also shares his leadership style and the importance of storytelling and analogies in articulating quality to the organisation, which can result in a function that is seen as truly valuable. We discuss the following:

• What is a 'Quality Culture' and why is it important?
• Evolution of the perception of quality
• How to measure the strength of a quality culture
• Practical steps for changing perceptions
• Utilizing management review to enhance your value
• How to facilitate team development
• Stan's leadership style and analogies he has used to communicate
• Advice for future quality leaders
• The 'one' soft-skill that Stan would advise leaders to develop

This is a fascinating insight into how quality leaders can ensure they are creating a function that puts people and the patient first, whilst enhancing the value and perception of the quality function within their organisation.

Stan is a true leader with an exceptional track record of quality leadership in enterprise and start-up organisations. A huge thank you for coming on the show.