Associate Director, S-cubed Ltd
I have worked at S-cubed for nearly 8 years now and it has been an interesting journey. I finished a PhD in Pharmaceutics and knew that I did not want to stay in academia or become a formulation scientist. Regulatory Affairs seemed the obvious choice of career in the pharmaceutical industry, as I wanted to combine my writing skills and knowledge of pharmaceutics in an industry setting. I got a job working in the Regulatory Department in the generics company set up by Bayer.
After some time in the generics industry, I met Steve Smith and Tony Mitchell and heard they were setting up a CRO. I wanted to expand on my CMC experience to also include clinical and non-clinical aspects of drug development and thought that such a company would enable me to gain the broad experience I was looking for. That was certainly true and I worked on a wide range of projects, from a placement within a Pharmaceutical company maintaining Marketing Authorisations to writing regulatory strategies for drug development. I then took a career break to be at home with children while former colleagues set up S-cubed. As I had enjoyed working in a small CRO so much, joining S-cubed seemed logical and I have not looked back.
My Working Day
As long as I have my tea first, I am always ready for a busy day. I like the breadth of experience we gain at S-cubed, as no day is the same. I am not always completely sure what I will be working on when I turn on the computer, as urgent client requests may have come in overnight. My biggest challenge is making sure I fully understand all aspects of a project, especially when I might only be working on a small part with a limited budget.
There are many aspects of my work that I really enjoy, particularly orphan designations. The regulations are quite complex, especially regarding significant benefit, and you need to bring in many aspects of drug development. One of my biggest achievements has been demonstrating an orphan designation prevalence of 4.8 in 10,000 population (where 5 in 10,000 is the maximum limit). Other achievements include securing licences through MRP in 11 Member States with a non-harmonised Summary of Product Characteristics.
There are some challenges ahead for us, as there will be a lot of change due to Brexit particularly if there is no deal. It will be interesting to see how clinical research and registration of new medicines in the UK fares – will there be sufficient incentives to include the UK as a main player in global drug development or will the UK become a third market to Europe? There are technical developments such as IT that are always changing and may well affect the way we work. The IT set up at S-cubed has meant that flexible working has always been an option, which meant we were all well placed to carry on as usual during the restrictions imposed during the Covid-19 pandemic. I can see the frequency and quality of online client and regulatory meetings increasing in the future. The submission pathways used in Regulatory Affairs are always changing with technical developments in IT and I fully expect this to carry on in the future.
Life Outside the Office
I like hill walking and climbing mountains, but at the moment struggle to get to the hills as often as I would like due to lack of motivation to join me from the teenagers we have at home. In the meantime, I am mountain biking around the Chiltern Hills and trying to run a little. I had planned to complete another half marathon this year, but this was cancelled due to Covid-19 and meant that I did not have to quickly improve on my running time or distance. I also like reading, going to the theatre (when they reopen) and paddle boarding or swimming in the Thames with friends.
I am always busy, as I work until around 4pm then have to fit in looking after three children, walking the dog, exercising and socialising. I do not work on a Friday and relish the fact that I have all day to fit in the many things I want to do, even though invariably I only make it through half of my list. I appreciate that I have a good variety at work but also that I can balance it out with my time at home. I only have to occasionally work into the night, usually to meet set European deadlines, as we all help each other at S-cubed.
Where in the World?
If I ever won the Lottery, I would climb loads of mountains in some lovely new walking boots. But if I could be anywhere in the world, I would be on top of Great End in the Western Fells of the Lake District (along from Scafell Pike), as the view is beautiful and you can see many of the lakes and valleys in amongst the rocky hills. My greatest personal achievement is getting to the top of The Jungfrau in the Swiss Alps – it took me and my partner 9 hours to get up and down from the glacier, but the view was spectacular and well worth the effort. Having said that, 10 years from now, I still see myself at S-cubed doing the same, as I enjoy the fact that every day is different, we get to work on a wide variety of projects and have great colleagues of course!
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Bohua Li introduces an S-cubed extension for adding user comments in a Qlik Sense application, along with a guide for users to implement the extension themselves.
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...