12 Questions with Andrea Manfrin

Professor Andrea Manfrin joined the MHRA in June 2023 as Deputy Director of Clinical Investigations and Trials, to spearhead the regulator’s overhaul of the clinical trial regulations. His ambition is to facilitate regulatory change that will make the UK one of the best places in the world to conduct clinical research for both sponsors and patients. With over 30 years’ international experience in the healthcare sector as an academic, consultant, and entrepreneur, he is in the perfect position to do this.

What are the main responsibilities of your current role? The MHRA’s response to the COVID-19 pandemic demonstrated what an agile, flexible regulator can accomplish. My new role is to apply what we learned from the pandemic to our clinical trials work in a way that puts patients first and supports research and development.

My team will be delivering one of the biggest overhauls of UK clinical trial regulations in 20 years, as announced by the MHRA earlier this year. We’ve already started this work by launching a new notification scheme for the lowest-risk clinical trials, which will see the time we take to process initial applications reduced by over 50%. This is exciting, as it benefits sponsors, the healthcare system, and - of course - UK patients.

What is your background prior to this role and how did it prepare you for the work you do now? Prior to working at the MHRA, I worked at University of Central Lancashire (UCLan) as the Faculty Director of Research and Innovation in the Faculty of Clinical and Biomedical Sciences and Chair Professor of Pharmacy Practice, where I led the conceptualisation and development of clinical trials in medicine, dentistry, pharmacy, and health services research. I still hold a visiting professor position at UCLan.

What is your proudest professional accomplishment to date? Launching the streamlined notification scheme for clinical trials earlier this month for the lowest risk clinical trials. Clinical trials regulation should be flexible and risk-proportionate, so that the regulatory requirements match the risk that a trial presents. For so long there has been a “one size fits all” approach. Moving to a more agile, risk-proportionate system will mean that around 20% of trials in the UK could be up and running more quickly. This will give UK patients quicker access to the potentially life-saving medicines being studied.

What are some of the biggest ongoing challenges in your work? An ongoing challenge is ensuring we have a regulatory system in place for UK clinical trials that is as resilient as possible to external influences. The COVID-19 pandemic is a good example of an external influence that increased the demands on the agency in a number of ways, but one that we could provide a world-leading response to because of our ability to be flexible and agile.

Our overhaul of the clinical trials regulations aims to achieve this resilience, and flexibility and adaptability will be the bedrock of this.

What motivates you about working in pharmaceutical regulation? Knowing that the work I do can have a truly meaningful impact on people’s lives. I learned this quickly early on in my career when I developed and led a national research project for a novel cost-effective intervention for asthma patients that changed policy and practice, leading to the Italian government allocating 36 million euros to fund these types of services.

Also working with a community of inspiring experts who are all driven by this same motivation.

What are your biggest short-term goals for this year and next year? To restore and enhance the reputation of the UK as one of the best places in the world to conduct clinical research for both patients and researchers. For me, this means transforming clinical trials regulation in the UK and bringing fresh new talent and expertise into my team.

What are the most important professional skills in your work and how do you hone them? Obviously, having technical skills for your area of expertise, but also critical thinking, adaptability, and flexibility. I have also found that approaching everything in a patient-centred way always leads to better outcomes for everyone involved – improving patient health is the ultimate goal, after all.

What excites you most about current industry trends? There’s a lot to be excited about – AI, developments in personalised medicine, and significant steps forward in our understanding of complex diseases mean that the possibility of solving big healthcare problems like cancer and dementia feel within our reach.

How do you promote patient-centricity in your workplace? Patient-centricity is one of the biggest priorities for the MHRA as an agency. We fully recognise the value that patients and the public can add to our decision making and want to make sure that we listen to their concerns and views at every opportunity.

Evidence suggests that the involvement of participants in the planning and execution of clinical trials is critical not only to their success, but also so that the participating communities can benefit from them. The quality of clinical research is improved if a variety of voices are involved in the design and conduct of trials, because researchers can draw on patients’ experience and knowledge, and make sure their work is relevant to those their study is aiming to benefit. Diversity of participants is also crucial to ensure results of research are widely applicable and meet the needs of the whole population. That’s why we’re working with the Health Research Authority to develop new guidance on how to include patients meaningfully into the design and conduct of trials, and how to achieve diversity in trials in a way that is proportionate and achieves the best results.

What advice would you give to a young person starting out in your field? Get experience working in different environments – in small, medium, and large organisations. Develop skills you know are transferable, but be flexible and adaptable. Be a life-long learner.

What are your hobbies? What do you do in your free time? I love being outdoors and when I can, I will go skiing or mountain biking. Years ago, I was a ski racer and used to ski for 120 days a year. Now, I’m lucky if I get 7 days, but, in some ways, it means I enjoy it even more. The feeling of freedom while on the mountain, combined with the silence, is unique.

If you could have any job other than the one you have now, what would you choose? It would probably be something directly involving research, but still within clinical trials. I can’t imagine a life where I’m not working in clinical trials. I’ve seen first-hand how they can change lives and it is the most amazing feeling seeing this happen. What you’re doing is truly making a difference.

Connect with Andrea Manfrin on LinkedIn.