Why did you decide to specialise in life sciences?
I have a science background – a PhD in organic chemistry – and worked for a short time as a medicinal chemist for Glaxo. I also had an interest in the humanities at school, so law had always seemed to be an option, and life sciences law made sense. I had assumed that I would go into IP/patents, but was lucky enough to meet a life sciences regulatory lawyer from Covington and spent some time there before my training contract. I came back to Covington on qualification and I am still here 25 years later. I clearly made the right choice.
What were the key challenges facing the sector when you started out, and what do you think they are now?
This is going to date me, but the biggest challenge facing the sector when I joined Covington was the pharmaceutical industry’s shift from small molecule drugs to biotechnology-derived medicines. While the core concepts of pharmaceutical regulation remained, the shift had significant practical implications for pretty much every aspect of drug development, approval, manufacture, supply and post-market safety monitoring and support. High-profile safety issues in early stage clinical trials and in the post-marketing context meant that regulators, companies and their advisers had to rethink the value of non-clinical research and refine the way they assessed the safety of medicines. They also had to find new ways of assessing the effect that even minor changes in the way biotech products are manufactured and formulated could have on product safety and efficacy.
What’s been the biggest change in the sector/in the role of a life sciences lawyer since you started out?
The increasing sophistication and personalisation of medicines is transforming the industry. Gone are the days when a pharmaceutical company would release one medicine to the market and return to focusing on developing new ones. New medicines now usually require the approval companion or complementary diagnostic tests, and companies are increasingly offering patient support services, including digital health solutions. That means that they are engaging much more closely with doctors, patients and health service providers. It is no longer enough for firms to be experts in pharmaceuticals; they also need to be experts in medical device and in vitro diagnostic medical device regulation; healthcare regulation; data protection and health data regulation; tech and AI regulation, as well as being sophisticated transactional and competition lawyers, etc. Not only do you need a strong team of lawyers to serve our clients’ needs, but you also need collaborative culture. Thankfully, we have that.
Would you recommend specialising in life sciences to junior lawyers, and why?
Absolutely. There have been times in my career where I have wondered what we will be doing once the world has moved on from the big issues of the time. I should never have worried because there have always been interesting challenges around the corner. You are never bored!
Grant Castle is a partner in Covington’s London, Brussels, and Dublin offices, practising in the areas of EU, UK, and Irish life sciences regulatory law.