Cell and Gene: Article Series on CGT’s Key Drivers

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:  

Article Series On CGT's Key Drivers

Delivering On Our Promise To Patients: Why Funding Challenges, Risk Sensitivity Stymie The CGT Space

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.  

Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing

Crystal Mersh
May 24, 2023

Pharmaceutical Quality is NOT a Spectator Sport

Mike Levitt
May 22, 2023

The Six Keys for Effective Deviation Investigators

Mike Levitt
May 18, 2023

There Has to be a Better Way to Train

Tyler DeWitt, Ph.D.
May 15, 2023

Cell and Gene: Article Series on CGT’s Key Drivers

Mark Roache
May 8, 2023

Bacterial Endotoxin Testing is on the Move

Christine Feaster
May 5, 2023

Top 20 Pharma Company Chooses QxP Virtuosi® Platform

Vanessa Figueroa
May 3, 2023

Crystal Clear: Controls are not enough

Crystal Mersh
April 22, 2023

Myth #1: Complying with Regulations and Product Specifications

Brian Duncan
April 20, 2023

Myth #2: Proactively Remediating Bad Inspection Outcomes: What’s the benefit?

Brian Duncan
April 20, 2023

Is it Time to Outsource Internal Auditing?

Mike Levitt
April 18, 2023

Quality is Number One, Even When Trying to Address Supply Chain Issues

Christine Feaster
April 14, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 2

Bob Ferer
April 10, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 1

Bob Ferer
April 10, 2023