Did you always envision a career as a regulator? Not at all. I’ve got a PhD in pharmaceutical chemistry and I’m a pharmacist by training. I’ve worked in both retail and hospital pharmacies, and for a while I was a research and teaching fellow at King’s College London. I was looking around for new opportunities and I saw a job advertisement at the Medicines Control Agency (MCA, the former Medicines and Healthcare products Regulatory Agency (MHRA)). I liked the idea of being an assessor, and I had research and academic skills that I could bring to the role. Perhaps most importantly, I felt it was an opportunity to really make a difference to public health. I joined the MCA in 1989 and I’ve been here ever since.
How would you define a regulator’s role? The role of a regulator is very different to what some people think – we are not just there to stop you! Everything we do is for the protection and benefit of public health. Of course, we have to make sure that medicines are high quality, safe and efficacious – but we also want them to be developed and manufactured in the most efficient manner and we want patients to get them as quickly as possible. To that end, we have a very open door policy when it comes to offering regulatory and scientific advice to support organizations to make the best possible products. And that’s what the MHRA’s Innovation Office is all about? In 2011, the Prime Minister’s strategy in Growth in Life Sciences highlighted the challenges facing the UK’s life sciences sector and the development of healthcare innovation, including new medicines. The establishment of the Innovation Office is one of the MHRA’s ways of responding to those challenges. The office was set up in March 2013 and it aims to help organizations that are developing medicines, medical devices or using novel manufacturing processes navigate the regulatory system. The benefits are two-fold; the innovator clearly gains from our expertise, but it also helps us to get closer to what’s happening on the ground – and that means we can more easily identify gaps that could be addressed. It’s in our interest to work closely with developers and we see early dialogue between innovative organizations and the MHRA as an important step in the process. What kind of projects does the Innovation Office support? Essentially, anyone with a novel concept, product, technology, manufacturing process or even just some new ideas can come to us for advice. We try to explain what the regulatory issues for the innovation in question might be at different stages – and what advice we can give to help them. For example, in the case studies that we have published, we’ve worked with AstraZeneca on plans for a new facility for supplying cancer medicine, and we’ve been involved with the Jenner Institute at the University of Oxford, who asked for advice with the development of a malaria vaccine that uses viral vectors from chimpanzee virus DNA. We will be publishing more case studies where we have helped organizations, with their agreement. What has the Innovation Office achieved so far? The innovative sector has reacted very well; we’ve had over 230 enquiries since launch – and we’ve received lots of very interesting and exciting ideas, which make me feel positive about the future of the medicine pipeline. However, given that pharmaceutical development takes many years, we haven’t actually seen any of the products we’ve been involved with make it to market yet, but some of the projects have progressed to clinical trials, which is extremely satisfying. Something else I’m very proud of is the fact that we’ve extended the Innovation Office to be a one-stop-shop for advanced therapy medicinal products (ATMP) or regenerative medicines to hopefully ease the development process for these important therapies. Such medicines can be somewhat tricky because you may have to work with different regulators (HTA, HFEA, HRA and MHRA) depending on the stage of development. The Innovation Office acts as a portal and we can pass queries from companies on to the right authority at the right time. How do you think regulatory processes are perceived? There are many trends and challenges in the industry, but I think that, from the point of view of the innovator, regulatory processes are probably seen as the biggest challenge. Innovators know how to generate ideas and may have a good understanding of how to turn that idea into a reality, but when they look at our area – the regulations – they see huge complexity. Big pharma companies tend to have large regulatory affairs departments, but for small companies or academic institutions there is often a lack of regulatory knowledge, and the processes can seem daunting. We are very much aware of that perception and we want to ease the process for everyone as much as possible. What are your hopes for the future? We need to continue reaching out to innovators, academics and other drug developers to get our message across: regulators are here to help and guide. We are scientists and we all want to bring safe and effective medicines, as early as possible, to patients. I encourage the industry to make use of the scientific knowledge and advice that regulators offer. There is no need to see us as the barrier to successful innovation.
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