A Knight’s Tale

Did you always see yourself becoming a scientist?

My ambition in years gone by was actually to become an economist – my father was banker after all. But, ultimately, pharmacology chose me.

After completing my medical degree at St. Andrew’s in the UK, I took on a position at the Royal Postgraduate Medical School (RPMS) where I was offered a position in the new pharmacology department. The department’s approach to pharmacology meant that clinical pharmacology (which focused on the medical aspects of the field) and basic pharmacology (which looked towards physiology as its science) existed in two separate spheres. I was compelled to take the position because I felt it was imperative that these two branches of the same field be more closely tied together. It has always been my feeling that if these two areas are able to progress together, both industry and academia would be able to see greater advances.

What moments in your career stand out?

In 1974, as the Head of Pharmacology and Therapeutics at the University of Liverpool, I was able to take the reins and develop a department focused on combining basic and clinical pharmacology – a first for the UK. Though I have been knighted and received various accolades throughout my career for my services to medicine, the work of my colleagues and I changed the way an entire area of science was approached. And that is undoubtedly the highlight of my career – and a feat I am whole-heartedly proud of.  

More recently, I joined The Pistoia Alliance Advisory Board, a not-for-profit group which aims to lower barriers to collaboration within the life science and pharmaceutical sector. Working with The Alliance has really stood out in my career, as I get to use my experience to guide its strategy to help the industry increase innovation. This is something I feel is a real honour to be a part of.  

How did regulation become such an integral part of your career?

I’ve always had an interest in drug safety and the issues pertaining to it. My training at the RPMS was largely based on the subject, and there were safety concerns about some anti-hypertensive drugs and diuretics at the time. My work involved investigating these issues through the lens of clinical pharmacology and, as part of a natural progression, the draw of drug safety lead to a career in regulation.

In 1982, I accepted my first position in pharmaceutical regulation when I was appointed to the safety sub-committee of the Committee on Safety of Medicines, UK, and was made chair of the organization in 1999. When the Medicines and Healthcare products Regulatory Agency (MHRA) was formed in 2003, I was invited to chair the organization – and did so for 10 years.

Though the MHRA is now an unshakable institution in drug regulation, there was a great deal of headbutting when the MHRA was first formed. The agency was an amalgamation of the well-established Medicines Control Agency (MCA) and the Medical Devices Agency (MDA), which was the smaller of the two agencies and run by engineers. Coming from different disciplines, the agencies had different focuses, and many difficult conversations were needed to allow the MHRA to run smoothly; thankfully, both sides were able to discover a common language. The progression we’ve seen in the industry means that many of the products that are developed are a combination of medical devices and drugs. And the regulatory strategies that have been fostered over the past decade have allowed minds from both sides of the divide to work together cohesively.

Is regulation still a passion?

Much of my career has been defined by regulatory affairs, and though I’m no longer with the MHRA, I certainly haven’t left the field behind! In recent years, I’ve had the opportunity to explore the international regulatory sphere. I have been a partner in the US life sciences management consulting and contract development organization, NDA Partners, since 2013, and I also worked in Singapore at the Centre of Regulatory Excellence (CoRE) for several years. The South East Asian market is growing and it is essential that the quality, safety and efficacy of drugs used in the region be assured. CoRE was developed as part of a tripartite arrangement funded by the Singaporean government, the National University of Singapore and Duke University, and is the first center in South East Asia dedicated to regulatory affairs. The lack of uniformity in regulatory standards across the region means that, when a drug is approved for use in one country, it hasn’t necessarily met the regulatory standards of neighboring countries. Our aim is to streamline the regulatory process, improving the accessibility to drugs across the region. Collaboration is key to these efforts, and this is something I am working to further in another of my roles as a member of the Advisory Board for The Pistoia Alliance.

How will Brexit affect the pharma industry?

The collective consciousness of the UK is focused on Brexit and not without good reason. For those of us in the UK, it will affect almost every aspect of our lives moving forward, and with each passing day, the uncertainty about our future grows. Though the state of our fishing industry and bottlenecks at ports are conversation points for every concerned member of the public, the future of the pharma and healthcare industries are often neglected in public discussions about our departure from the EU. The ramifications of leaving the EU are still very much unclear. But a hard Brexit would spell disaster for the pharma industry and from a regulatory standpoint, the UK will have to tread a very careful path to prevent us becoming isolated. And without the structure of the EU’s regulatory system, it is more than likely that the UK will be left in the dust, forced to pay higher tariffs and exposed to delays in the introduction of new products to our market.

Even though Brexit has the potential to mark the start of dark period in the history of UK pharma and science, it could present the opportunity for positive change. The UK will have to build strong partnerships and increase collaboration with foreign regulatory bodies like the FDA and the Therapeutic Goods Administration in Australia to keep its head above water – this is something The Pistoia Alliance and I are helping the industry to understand. For regulators across the UK, a closer partnership between the MHRA, National Institute of Health and Care Excellence (NICE) and the Veterinary Medicines Directive would be advantageous due to the commonality of issues faced by these regulatory organizations. If these bodies were able to work in synergy with one another then the UK may be able to better weather the coming storms.