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!