RSNN interview series: Peter Bertens
The RSNN interview series aims to give a better insight into the persons and organizations involved in the activities of RSNN. It also provides an opportunity to highlight some of the current topics in the Regulatory Science field.
For this second interview in the series Dr Peter Bertens was interviewed. Peter is a senior policy advisor and project leader at Vereniging Innovatieve Geneesmiddelen/Association Innovative Medicines (VIG/AIM). The VIG is the industry association for the Dutch branches of innovative pharmaceutical companies and represents the interests of its members towards third parties such as governments, regulatory bodies, and others.
In your current position one of your main responsibilities is the Innovation Climate pillar of VIG. What is the scope of this Innovation Climate Pillar?
We are trying to create the best conditions possible for the industry to do its job, now and in the future. Our aims are to enable research and to get medicines to patients. We are looking ahead a couple of years to get clear what we need to prepare our members for, nationally and internationally. The Netherlands is a small player but one that has many ideas and is looked at with interest from the large companies. Our country is accessible and open to partnerships which creates opportunities to take new paths and to explore those together with other stakeholders.
What are the benefits of being a part of RSNN for VIG?
For the VIG, the RSNN is a great place where you can see that regulatory science is constantly providing us with lots of new knowledge. Within RSNN insights are shared that enable us to revise the regulations regarding drug registration together. In the dynamic regulatory field, the RSNN plays an important role and could do even more.
It is important to be able to respond to new developments rapidly in order to keep the regulatory system up to date. There are several innovations that show us that the regulatory system can become even better than it is now. It is also important to realize that there is no single party that has all knowledge. We should all work together and share knowledge. This is done well within the RSNN.
Collaboration is essential to get better medicines to patients.
I have been a member of the RSNN advisory group since the beginning of this year. Many relevant stakeholders are part of this group, bringing many different perspectives to the table. There is also an enormous drive to jointly take regulatory science to the next level, which is wonderful to see. Sometimes people say that regulations are rigid, but that is simply not true. There is a lot happening to keep the rules up to date and to allow them to evolve with the available knowledge.
A good example of what collaborations in the regulatory field such as RSNN can lead to comes from when NEFARMA (previous name of VIG) financed a number of PhD positions, including the position of Peter van Meer (currently MEB/vice-chair of RSNN). His research examined the necessity and usefulness of animal testing for registration studies for biological medicines.
Peter then demonstrated with a colleague that animal tests in a number of cases were redundant. Subsequently, the regulations on this have been amended. This is where you see what can be achieved by working together. If you bring academy, regulators, and the industry together and they are collaborating at a scientific level, the shared goal is to make the system better.
You have been part of the organizing committee for the first RSNN ATMP Expert Session and are also part of the organizing committee for the upcoming second RSNN ATMP Expert Session. What can you tell about your experience and expectations regarding this topic?
ATMPs (Advanced therapy medicinal products) are a typical example where you can expect that new scientific insights can lead to changes in regulation. We know that it is currently very difficult for companies to develop and market ATMPs, that was also illustrated during the first ATMP expert meeting by the MEB (Medicines Evaluation Board). The MEB is asking for a lot of information from applicants in different rounds of questions. It shows that there is a huge knowledge need on all sides and for me it was interesting to see that come together during the session.
The question is: how can you draw up the rules in such a way and keep flexibility in them so that they can quickly be adapted to new scientific insights?
ATMPs have enormous technological possibilities and there is an enormous increase in knowledge in the field, which will lead to many more possibilities for therapy development. It is great that the regulations go along with this development without losing sight of the basic principles of safety and effectiveness.
The development of COVID vaccines and COVID medicines have also shown us that a different way of working can speed up the development and admission processes. That is really something we can learn from, and we should ask ourselves: what does this mean for the future, for all therapies?
What other current topics or questions in the field do you think the RSNN should address?
Three topics spring to mind. Firstly, the human genome. Now that we have mapped the genome well and a lot of new knowledge is being generated there are quite a number of open questions: what do we do with all this knowledge? Is it already being used optimally?
The second topic is Artificial Intelligence (AI). AI is playing an increasingly important role in the field. Vaccine designs have been developed recently in a day based on AI. What does the use of AI mean for regulatory purposes? Is that something a regulator should do something about or not?
Lastly, connecting the discussions around registration and reimbursement as we have done before within the RSNN is still an important topic where we could follow up upon. What we now notice is that there is often a lot of uncertainty around reimbursement. It would be optimal for patients if the process is streamlined so that they can access resources as quickly as possible.
What role could the RSNN have in the regulatory field in 5 years’ time?
For the coming years, the RSNN has the ambition to build on the results of the workshop/expert meeting phase set up research. In my opinion, the focus of the RSNN should be to follow up on this ambition in order to make more impact.
Secondly, I think the RSNN should aim its focus more to a European level. Medicine registration is a European process, the entire regulatory playing field is European. Especially with the EMA in Amsterdam it is very interesting to see if RSNN can collaborate with the EMA more. It is important for the industry that RSNN sets objectives at a European level because most -if not all- companies affiliated with VIG work on a European scale.
If you want to have impact you have to ensure that your activities take place on the right scale and the right level.
If you have any questions about the interview series or would like to participate in them, please contact the RSNN program office through info@rsnn.nl.