The European drugs gatekeeper
Bringing new drugs to market in Europe keeps pharmacist Marion Westwood on her toes.
Marion Westwood is a pharmaceutical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA). She explains why she was drawn to the world of pharmaceutical regulations.
What made you want to be a pharmacist?
I was always intrigued by science and thought being a pharmacist would be an interesting way to learn about the science of medicine with the added bonus of being able to help patients. Also, I thought it would be a relatively straightforward career path because the degree was a clear route to working as a community pharmacist — the only pharmacy career I was aware of at 18 years old. I had little idea at the time of the career path I was actually embarking on.
What is your current role and how did you get there?
As I progressed with my undergraduate degree, I became more interested in the technical laboratory-based aspects of the degree rather than the clinical side. I was sure I wanted to have a role in the pharmaceutical industry after I completed a summer placement with AstraZeneca, where I got a sense of the work that goes into the development of new medicines and the possible roles that a pharmacist could have in the industry. I was determined to complete a PhD and try to work in a research or scientific role.
My PhD, at Queens University in Belfast, was a great period in my life. I researched biomaterials, trying to develop materials for urinary catheters to reduce device-related infection. After I finished my PhD I undertook a post-doctoral position in a similar field. I then spent an unplanned year working as a community pharmacist. However, I was actively looking for work in the pharmaceutical industry throughout this time.
I became aware of the work of pharmaceutical assessors at the MHRA and thought it sounded interesting and challenging. I did not get the position the first time round but, thankfully, the agency gave me a second chance.
What are your responsibilities in your current role?
I work in the licensing division of the MHRA — the division is responsible for assessing the quality, safety and efficacy of drug products before they are granted a marketing authorisation, which is required for all products before they are placed on the market for patients.
As a pharmaceutical assessor, most of my work involves the assessment of the quality aspects of marketing authorisation applications. This involves a wide range of scientific and technical issues which need to be assessed, for example: synthesis, purity and stability of drug substance; manufacture of drug product; packaging; stability; analytical techniques for analysis of drug product; and suitability of drug product labelling. The assessments are varied depending upon the type of drug product (e.g. complex liposome or standard immediate release tablet) and whether or not the drug substance has been previously authorised (generic) or if it is a new active in Europe. I work in a team with other pharmaceutical assessors, with doctors who assess the clinical efficacy and safety of the product and also with non-clinical assessors who assess the safety of the product. My team handles the oncology and rheumatology products.
I am currently assessing applications for three new active drug substances which, if approved, would be available in Europe for the first time, and I also have several ongoing procedures for generic medicines.
What do you enjoy most about your work and of which achievement are you most proud?
I enjoy that I am constantly updating my knowledge in all areas relating to the development and manufacture of medicines. The knowledge I gained through my degree and PhD provides the necessary background for this learning, so nothing from my past training has gone to waste. There are many areas of the pharmacy degree that come into play, from assessing a radiopharmaceutical to determining the acceptability of a sterilisation cycle for a drug product.
What I am most proud of is my contribution to public health. It is the ethos of the MHRA that public health is critical to everything it does, and knowing I have been involved in making safe and effective new medicines available to the public is satisfying.
What do you find most difficult about your current role?
Meeting deadlines. The work is deadline driven based upon agreed timetables in Europe for the assessment process. It can be challenging at times to meet the non-negotiable targets but it keeps me on my toes. Being able to organise and prioritise workloads is vital to the success and smooth running of the team.
I also need to be able to respond quickly if any urgent work is required. For example, if a critically important drug product is in short supply due to manufacturing problems, I must assess proposed resolutions to those manufacturing issues at short notice in order to maintain supply of the drug product.
What might another pharmacist find surprising about your role?
The MHRA hosts the largest collection of pharmacists in a single building in the UK. In my division alone, there are 63 pharmaceutical assessors and 10 of the managers are pharmacists, including the deputy director and director. Pharmacists are not used to working en masse but it is a great collaborative working environment. The training I received from the more experienced assessors was excellent and I am now able to help new assessors in their new roles.
What would you like to achieve professionally in the next five years?
I have recently been appointed as a senior pharmaceutical assessor, which was a big achievement. As my career develops, I would like to have a bigger role in the groups at the European Medicines Agency (EMA) to help shape discussions at a European level — for example, being involved in the development of guidelines or in the scientific working groups at the EMA.
I hope to work towards the position of deputy manager of an assessment team, which is a route that many assessors take into management. In the next year I plan to make use of the in-house management training to ensure this would be a good role for me to pursue.
The MHRA is hosting a Twitter Q&A about becoming a pharmaceutical assessor on 10 March 2016 from 1–2pm — interested parties can tweet questions to @mhragovuk using the #askpharm.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200705
Recommended from Pharmaceutical Press