Guiding new medicines towards market approval
During his career Sipko Mülder has been working in various kinds of organisations. He worked as a PhD student at the university, he had a commercial position at a large pharmaceutical company and nowadays he is a coordinator at the Medicines Evaluation Board (MEB) agency, a governmental institution. Sipko Mülder describes the advantages and disadvantages of working at this organisation and his functions a coordinator.
His career developments
Sipko Mülder (38) did not get selected for the numerus fixus – study Medicine and started Biology at the Free University of Amsterdam. During this study he did a scientific internship at the Netherlands Cancer Institute and afterwards he became a PhD student in oncology at the Free University of Amsterdam. After obtaining his PhD Mülder decided to continue his career outside research. “I’m not a born scientist. I was more interested in the applications and the clinical relevance.” says Mülder.
In 1996 Mülder consequently applied for a job at Zeneca and he became Medical Information Officer for oncology products. After the company merged with Astra Mülder became Director Clinical Research Oncology. Mülder about this job: “In this function I had a lot of different responsibilities; for both clinical research and policy issues for oncology products. It was a very high demanding job with a lot of travelling. This was one of the reasons I decided to do something else after a while.”
So, he wrote a letter of inquiry to the Ministry of Health, Welfare and Sport. This leaded to the Medicines Evaluation Board (MEB) agency where Mülder began as a registration coordinator in January 2002. Soon after he was assigned, the MEB agency reorganised and in 2003 Mülder became coordinator for the pharmacotherapeutic group dealing with oncology, diabetes and blood products. In this current job he is leading a team of 12 registration coordinators who are responsible for the guidance of submitted dossier through the registration trajectory of marketing authorisation for these products.
The MEB
The MEB agency is an independent administrative body for scientific and procedural guidance of the medicine registration applications. The agency supports the 16 members of the evaluation board. This board has the authority to approve or reject medicinal products or to delete them from the Register acting on statutory criteria. Authorised medicinal products can be marketed in the
Due to standardised processes concerning medicine approval in the EU the MEB is also partly responsible for the approval of medicines in other countries. At the end of the procedure a marketing authorisation can be given for all member states of the EU. The MEB agency belongs to the European top-5 medicines agencies
The department of Mülder is guiding all applications in the therapeutic area of oncology, diabetes and bloodproducts. The agency consists of a operational staff, four pharmacotherapeutic groups, a pharmacovigilance group, a novel food group and a veterinary medicinal products unit.
Daily activities of a coordinator
Every pharmacotherapeutic group has a process manager and two coordinators. The process manager has the overall responsibility of the whole group. The two coordinators are responsible for daily management of all the applications that reach this department, from the submitted dossiers for assessment to the requests for scientific advice in the pharmacotherapeutic area.
“I am responsible for the overall planning, training programmes of new people and I interfere with policy developments,” says Mülder, “I discuss a lot with the policy makers about the daily practise of the execution of policy so they can reflect this in their policy. I also talk often to pharmaceutical organisations that have submitted a dossier. Mostly about the schedules and planning because it is very important for them to know how much time it takes. Thanks to my previous work experience in the pharmaceutical industry I know their side of the story well. This is an important advantage”. Various organisations also come to the MEB for scientific advice. “The scientific advice is given by our experts but the coordination of the advice in my pharmacotherapeutic group is my responsibility,” explains Mülder.
From time to time Mülder gives guidance to a registration application himself. “It is very important to do a registration process yourself now and then because you have to keep up with developments, and normally I also help the registration coordinators with difficulties that they come a cross”, says Mülder.
One of the most important characteristics of a coordinator is organisational skills. “You have to work very secure and keep an overview at all times. Because of the large supply of important documents there is a great risk in losing overview. The registration documents contain a lot of information and this demands discipline to read everything in a relative short time”, states Mülder. “Another important characteristics is to be diplomatic. When you are talking to EU member states about registration processes you have to respect each others methods of working, but you also have to speak up at times.”
The function of coordinator entails a lot of communicating with different people. Therefore it requires someone with good communication skills. Additionally a coordinator has to have in-depth knowledge about pharmaceuticals and clinical research. “Medical terms and large clinical dossiers shouldn’t scare you off. If you control these aspects then this function is great and very versatile.”
“We play an important role in the medical product of tomorrow”, says Mülder. “Our team has great responsibility and everyone is very much involved. This creates a great atmosphere of ‘together we will manage’. We have a very strong team spirit due to the heavy workload.”
Mülder can come up with only one little negative point about the job as coordinator. “You are not doing real scientific work anymore. You don’t have the time to go in depth; this is done by our experts and their opinion is paramount to us. Sometimes we disagree on something but it is not our job to judge their opinion.”
Seeking new colleagues!
About his future plans Mülder comments: “For now, I’m very content with this job. The MEB agency will expand so there are enough challenges and opportunities ahead. But I always keep an open eye of course!” Mülder states that the MEB agency is looking for new talents because of the expansion of the organisation. “For this function you should have knowledge of pharmaceutical products and biological processes. Experience in the pharmaceutical industry is a preference. Education in policy and legislation is provided by this institution.”
