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