In conversation with Alexis Cockroft: driving sustainable, globally accessible cell and gene therapies through regulation

What inspired your journey into CGT?

I became the CMC regulatory lead on the Strimvelis marketing authorisation application in mid-2011. From that point, I was hooked and have stayed in the CGT field ever since.

What has been the most pivotal development in the past decade?

I consider the CGT field as a hive; a colony of specialists and generalists building on collective progress. While it is tempting for individuals to believe their contribution was pivotal, most advances are the result of many minds working together. For me, the most significant development has been the spirit of collaboration, sharing, and learning.

That said, while COVID-19 was a deeply challenging period, it also served as a catalyst for extraordinary innovation. The accelerated development and global rollout of adenoviral vector and mRNA-based products provided invaluable lessons in manufacturing, regulation, logistics, and distribution.

What excites you most about the current landscape?

Decentralized manufacturing has enormous potential to improve patient access to advanced therapies, and I am encouraged by the close collaboration between experts across disciplines. I am also excited about approaches that increase precision and safety, such as in situ gene editing methods with minimal off-target effects, multifactorial strategies to reduce risks from T-cell therapies, and co-developed medical devices that protect products and standardize administration.

Equally inspiring is the expansion of regulatory approvals into more regions worldwide, which is critical for broadening patient access.

What is one piece of advice you would offer to researchers entering the field today?

Humility is essential. It helps us recognize what we do and do not know, how to identify who to consult, and how to focus on delivering therapies that are needed, reliable, and sustainable.

‘Needed’ refers to prioritizing unmet medical needs; ‘reliable’ ensures consistent efficacy and safety for every patient and batch; ‘sustainable’ considers the cost, resource use, and environmental impact.

What developments do you expect to shape CGT in the next 5–10 years?

Historically, many companies launched products in the US first, followed by other markets. Over the next 5–10 years, I anticipate a more comprehensive and balanced global regulatory strategy. I have seen remarkable dedication and collaboration from agencies such as the EMA, MHRA, FDA, and WHO. Widening regulatory pathways and working closely with these agencies will be key to positive progress.

Outside of work, what are your hobbies?

I enjoy horse riding, beekeeping, yoga, and walking my dog, and I have recently started breeding roses. Exploring new foods and drinks is another favorite pastime.

What do you enjoy listening to?

I particularly enjoy podcasts such as In Our Time and You’re Dead to Me, which offer both educational and entertaining content.

What is your favorite snack?

If I had to choose, I would say nuts, peanuts, and dried figs, so perhaps I was a squirrel in a past life!

Biography

Alexis Cockroft is an independent regulatory affairs consultant, specializing in CMC regulatory affairs (CMC RA) for cell and gene therapies (advanced therapy medicinal products). She has worked in CMC RA for more than 19 years and has focused solely on advanced therapies for the last 13 years. She has also worked in various science-based roles.

Affiliation

Alexis Cockroft PhD, Director and Regulatory Consultant, Lex Regulatory Ltd, Royston, Cambridgeshire, UK

Authorship & Conflict of Interest

Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The author has no conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.

Article & Copyright Information

Copyright: Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2025 Alexis Cockroft. Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Revised manuscript received: Sep 22, 2025.

Publication date: Oct 28, 2025.