RSNN interview series: Peter Mol
The RSNN interview series aims to give a better insight into the persons and organizations involved in the activities of RSNN. The series also provide an opportunity to highlight some of the current topics in the Regulatory Science field. For this fourth interview in the series, Peter Mol was interviewed.
Could you please introduce yourself?
My main role is within academia as a professor in the field of Drug Regulatory Science at University Medical Center Groningen (UMCG). I have a background as a pharmacist and I have worked at the department of clinical pharmacy and pharmacology at UMCG since my PhD research. At a certain point in my career my focus shifted from research on implementation-like aspects around clinical use of medicines and medicines safety, to regulatory science in line with my other roles at the Medicines Evaluation Board (MEB) and the European Medicines Agency (EMA).
At the MEB, I am an assessor involved in providing advice to the industry. Companies regularly consult us about their plans to develop drugs. They ask us for input at an early stage because drug development processes are very expensive and need to be aligned with regulatory expectations and public health needs.
At EMA I am involved in providing scientific advice at European level in the Scientific Advice Working Party (SAWP). I've been working at EMA for over ten years now and we discuss an increasing number of development programs there. We address approximately a hundred advisory procedures regarding drug development processes each month. I have been the vice-chair of the SAWP for 6 years, but now I am participating as a member.
Since May this year I have also been appointed as co-chair of the RSNN, together with Marjon Pasmooij (MEB) and Sjaak Bot (Janssen).
What activities are you currently focussing on?
The HORIZON programme application in which I am involved as a principal investigator, has recently been accepted. The project is about making better use of real-word data in the regulatory and Health Technology Assessment (HTA) fields. The topic is very much linked to the work I was already doing at the EMA on patient registries.
In addition to this, I will start a new role as work package lead in another recently granted HORIZON programme project focussing on Personalized Medicine in kidney diseases and biomarker development in regulatory context. The principle investigator of this project is Hiddo Lampers Heerspink from my department.
Furthermore, together with Marjon Pasmooij and Viktoriia Starokozhko I have been working on the Coordination and Support Action on Strengthening Training of Academia in Regulatory Science (CSA STARS)-project. Almost all registration authorities in Europe were involved. The project was concluded earlier this year and aimed to strengthen academic drug development. A number of recommendations from this project will be followed up upon in the new Accelerating Clinical Trials (ACT EU) in Europe project directed by the EMA and the Heads of Medicines Agencies. This latter project aims to provide more efficient advice on setting up clinical trials in collaboration with critical stakeholders. We aim to translate the knowledge gained during the CSA STARS project to achieve this goal.
What can you tell us about your role within RSNN?
RSNN is an organization that aligns perfectly with my other activities. Within my role as co-chair of the RSNN I represent the academic perspective, for example by monitoring the RSNN research agenda and determining how we can best share our acquired academic knowledge within the network. This is mainly driven by two academic groups, being Utrecht University and UMCG, but one of my goals is to extend this by actively involving other Dutch academic groups in the upcoming RSNN activities.
I am also involved in RSNN's collaboration with the Future Affordable and Sustainable Therapies program (FAST). From the beginning of this year, RSNN and FAST have initiated a effort to explore the possibilities to provide regulatory knowledge and support to academic and private innovators to ultimately stimulate drug development in the Netherlands. While doing this, we aim to design a multistakeholder dialogue model with a balanced representation and involvement of all stakeholder groups (academia, industry, regulators, and patients) to synergize their expertise. An important task is to map out what can be initiated by the RSNN in terms of cooperation with the FAST program and how to implement this within the RSNN.
I would also like to mention that it is a pleasure to co-chair the RSNN with Sjaak Bot and Marjon Pasmooij. They both contribute a lot of knowledge. They also have a alternative way of thinking and a different focus than I do so I think we complement each other well and I look forward to expanding the RSNN with them.
What is the importance of RSNN for you from your various roles?
As a regulator, the RSNN really gives me the advantage of being able to talk to the industry in a safe and neutral environment with an academic buffer added. This really helps in discussions.
As an academic, I am very pleased to learn about the framework of drug development. During RSNN expert meetings good insights are provided into the perspectives and reflections on a particular topic.
The RSNN forms a relevant network in the field, where open discussion is possible and where current issues are put forward and discussed
The importance of the RSNN is also increasingly recognized by other organizations. The organizations within our network include parties that are important for addressing urgent topics and they can be approached as a group through RSNN. I think that is a great advantage of the RSNN.
Which current topics should the RSNN address?
A number of current issues are prompted by the upcoming changes in pharmaceutical legislation, and partly also by what happened during the pandemic. We have to look very carefully at what possibilities new legislation offers for e.g. pandemic preparedness. The neutral platform for discussion that RSNN offers could be very helpful there.
Other topics such as personalized medicine and patient-centred drug development and evaluation may have faded into the background a bit due to the pandemic, but are just as important in my view. Regarding personalized medicine, a special interest group (SIG) has been created within the RSNN in the field of Advanced therapy medicinal products (ATMPs) as a result of RSNN expert meetings on this topic.
There are many points of interest regarding the patient perspective. For example, patient reported outcomes, which help to gain insight from the patient what the exact effects are of the medicines they use. The patient perspective is also the subject of the RSNN workshop on September 5, where we will look at the role of the patient perspective on drug development from different perspectives. The best methods to include the patient perspective will be highlighted by speakers representing the patient, regulators, academia, and the industry.
This year’s RSNN workshop a perfect way to gain insight into different perspectives on how best to incorporate patient input into drug development and regulation
In addition, an interactive session will be organized in which the audience will be challenged to make a cost-benefit assessment for the development of a medicine. Such cost-benefit considerations are made multiple times during a typical drug development process. As a participant, you will be made aware of what is important to you and how this relates to other interests and perspectives.