As VP, Cell and Gene Practice with QxP, I spend a lot of time talking to people involved in this new sector of drug development and manufacture. I really enjoy this aspect of my work since it connects me to sponsor companies, both big and small, investors, regulators, academicians, and a wide range of service providers and partners, such as CDMOs and CROs. These discussions allow me to see common trends, be they successful strategies, challenges, or the emergence of good practices.
Even with all these different perspectives, one thing is clear: Everyone is here to help the patient and to deliver on the promise of novel therapeutics. With that shared goal in mind, I thought it would be helpful and interesting to share some of the issues that we see emerging in the Cell and Gene space for the near- and mid-term future and share some thoughts on how they might be avoided, or at least managed when they occur.
So, we have partnered with the folks at Cell & Gene to create a series of articles, with each one covering a key theme. The introduction to this series provides an overview of what is to come. The first detailed article covers how the management of risk can facilitate or inhibit investment relationships. The links to these articles in Cell & Gene are here:
We hope you find these discussions interesting, thought-provoking, and ultimately helpful. When you’re ready to implement and execute on some of these ideas, let’s talk! Click here to learn more about the QxP Cell and Gene Therapies Practice.
Mark Roache, QxP VP of Cell and Gene Therapies, has spent his 30-plus year career in GXP. Mark was the Chief Quality Officer for AveXis (now Novartis Gene Therapies) at the time of Zolgensma launch. He was previously Senior VP of Quality for KBI (a CDMO with cell-therapy capabilities) and has held other senior Quality roles at Novartis, Merck and Bayer.