Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
As a Director of Regulatory Sciences based in the ProPharma office in Leiden, The Netherlands, my role is to advise clients to the best of my ability on questions that arise during their drug development. I provide advice on all aspects pertaining to the development of a Marketing Authorization dossier with a main focus on the EU. These include advice on regulatory strategies, orphan drug designations, PIP applications, clinical gap analyses from US to EU or vice versa, scientific advices, PRIME eligibility requests, innovation incentives, feasibility assessments and addressing questions raised during applications or potential negative opinions by the different EU regulatory committees. I've worked as a principal regulator at the Medicines Evaluation Board in The Netherlands as well as the EMA, which provides me with an insight into the regulator's mindset and framework which is vital in translating regulator’s wishes and needs to clients. Together with a background in molecular biology I always try to combine my regulatory expertise with a sound understanding of the science behind any clients' development. Throughout my professional career my main motivation has always been helping patients’ wellbeing. If I have contributed to that even in the slightest, I am proud and happy.
I learned two main things. First, regulators' guidance and pharmaceutical regulations and laws may come across as intricate, complex and are sometimes even perceived as unnecessary burden. However, when you strip away the specific terminology and language, there is always logic behind rules and guidances. In fact, you don’t need to follow guidances to the letter or learn them by heart. The rule of thumb is: if it doesn't make sense, it is probably not the best way forward. The regulatory framework is science-based and science always follows the route of least resistance: that of logic.
The second thing I learned is that there is no us versus we. Regulators, sponsors, patients, health care professionals and all stakeholders involved in the lifecycle of a medicinal product have the patients’ wellbeing at heart. When you approach each other from this perspective, it brings an open, solution-driven interaction that contributes to a sound and robust developmental process.
Every client has their own unique development-based questions and requests for advice. What I enjoy most is to gain in-depth insight in the client’s development and wishes, seeing the energy and enthusiasm about their developments and meeting the people behind it. Every piece of advice is like a puzzle to be solved the best way I can. When clients are happy because their needs are met it always brings a buzz.
Clients' advice requests I handle always have one main focus: to help them address questions during their development program. The outcome of the questions raised should always lead to a sound and robust development program with a future Marketing Authorization as a dot on the horizon. A robust program automatically improves chances of getting more medicines to the patient by reducing attrition rates, but also improves the time to market approval. Both success and speed of approval have an impact on patients’ health and wellbeing. I set the highest possible goals for every client, aiming for the best possible and highest quality out there.
I am a proud father of two boys, but apart from that also a trumpet player. I’ve been playing for many years in all sorts of bands and toured quite a bit. It’s magical when you create music together and let people enjoy it as much as you do yourself.
Even though our organization is large, and our business evolves to meet global challenges, it feels and interacts like a small and thriving community of highly skilled experts. I love getting to know more and more people and the level of expertise is very high. Apart from professional expertise, I’ve been struck by the fun the team members have together. I feel we are a real team striving for the best for our clients and patients and have been touched by the warm welcome I’ve received from all.