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Manufacture Advanced Medicine

Reinforcing Regulations

With Karen Nichols, VP Regulatory and Quality at Magenta Therapeutics, and Chief Regulatory Officer at ISCT.

What has led you to your role at ISCT?

I am a patent attorney by training, and my background is in biology. I started with ISCT in the mid-2000s on the legal Regulatory Affairs Committee – work has simply expanded since then. 

In 2016, I took on the new position of Chief Regulatory Officer. We created this role within the organization to demonstrate our commitment to the regulatory component of cell and gene therapies – you can’t get a drug to market without having a regulatory pathway that guides it to that end. The regulatory space is one of my passions, so I get a little enthusiastic.

What is your take on ISCT’s education and training initiative?

We give a high degree of visibility to the care of those just entering the cell and gene therapy workforce. They have mentors – giants in this industry – to guide them, and in turn they will pass their own skills back to future generations. 

The Cell Therapy Training Course is really important to ISCT. Of course, the core reason for the program is that it provides technical skills. But it also provides the participants with an understanding of the larger environment of which they are a part; they need to develop skills not only in manufacturing, but also a regulatory knowledge base, and an understanding of everything from supply chain to commercialization.

As the industry advances, we will develop this training further to meet the key needs of our members. We also have a rich offering of annual meetings and conferences. People come to see and hear what’s advancing within this rapidly changing field. Again, these don’t just present a technical perspective, but also offer insights into what the regulators might be thinking.

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About the Author

James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.

From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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