In the latest edition of the Collaborator Spotlight, Daniel discusses his career journey, the progression of both EHDEN and DARWIN EU, how OHDSI can inform regulatory decision-making, and plenty more.

Can you discuss your background and career journey? What led you to your current role?

I trained clinically as a GP/family doctor. I always wanted to do some research, so when I completed my clinical training I was fortunate enough to be appointed to several fellowships, one of which allowed me to undertake doctoral research training at the University of Dundee where I obtained my PhD. It was during my PhD when I realised the potential for using real world data to help clinical decision making was huge!

After post-doctoral research I was offered a secondment as a national expert within the European Medicines Agency, whilst maintaining academic work. That was my first experience of medicines regulation and I supported initiatives aimed at integrating real world evidence to inform regulatory decision making.

I then returned to my full time academic post after I was appointed by the European Commission as an independent scientific expert to the EMA Pharmacovigilance Risk Assessment Committee, which I served on for over four years. I now have a role within the RWE team at the EMA working on DARWIN EU, and maintain an academic affiliation.  

How did you first connect with the OHDSI community, and what stood out to you about its impact on clinical research?

My first experience of OMOP was during a study-a-thon when the EHDEN project first began in Europe. The standardised approach to research, and working alongside colleagues who clearly understood the importance of generating RWE at scale using federated analytics really stood out. I became a fully-fledged member when the COVID-19 pandemic began and the OHDSI community all came together in response. Everyone was super helpful and welcoming as a community.

Since the launch of the EHDEN Initiative, how have you seen observational research evolve across Europe? Where do you see it heading in the future?

EHDEN has done a wonderful job in catalysing the adoption of OMOP infrastructure across Europe. It went further than just infrastructure however. It brought together collaborators across Europe to participate in studies, and has helped expand the OHDSI community.

As a member of the European Medicines Agency, how do you see OHDSI contributing to the regulatory decision-making process in Europe?

I think OHDSI can contribute in various ways, firstly by continuing its focus on generating reliable and robust RWE, and secondly by helping develop transferrable methods and tools for example.

DARWIN EU is now in its fourth year of using OMOP to generate real-world evidence for the EMA. What are some key updates on the initiative, and how do you assess its progress so far?

Speaking for myself, DARWIN EU it is exciting, rewarding, and a lot of work! I am impressed with the way everyone has come together to make it work. Now that thirty data partners have been onboarded it is starting to feel like its own community. It is currently focused on scaling up the number of studies it can perform.

From a clinical research perspective, what makes LEGEND such a powerful approach to observational studies?

Given the increasing number of treatment options available for chronic disease, along with differences in how they are used globally, you need an approach like LEGEND to systematically study potential treatment comparisons in a transparent, and robust way. It also leverages the knowledge of a wide range of experts that can help make findings more generalisable and relevant to decision making, which is a big plus.

Outside of your professional work, what are some of your hobbies? What’s one fun fact about you that the OHDSI community might not know?

If I can stay injury free, I am a fan of calisthenic exercise and I love travelling.