RSNN interview series: Wieteke Wouters

14 December 2021
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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 third interview in the series, Wieteke Wouters was interviewed. Wieteke is Program Director at HollandBIO. HollandBIO is the biotech industry association that connects and represents the interests of the sector.

Can you introduce HollandBIO and your position within this organization?
HollandBIO is the Dutch biotech association with over 250 members. These members are mainly companies, ranging from start-ups to multinationals. We have been around for eight years now and what drives us is that we are convinced that biotech makes life better.

Biotech innovations help people, animals, and the planet to move forward because they contribute to improving health, sustainability and our economy

We ensure that HollandBIO functions as a central point of contact and represents all biotech applications. We are in the midst of a biorevolution: the number of applications is rapidly increasing and ranges from medicines and vaccines, food and ingredients to biodegradable building materials and biofuels. The sector and the possible applications are growing fast.

In my role as Program Director, I am responsible for HollandBIO’s goal to strengthen the ecosystem for biotech innovations. I lead a team of project and program managers that are working on to improve the innovation climate, sustainability and personalized health.

What is the importance of the regulatory field for HollandBIO, and what are important regulatory challenges and themes for HollandBIO?
Our members develop biotech innovations, which are often truly ground-breaking. These technological pioneers are the first to test the limits of the existing system. These limits do not necessarily have to be regulatory in nature, but there are often also regulatory challenges.

One of our programs is called: faster and better from bench to bedside. In this program we focus on one shared ambition which is personalized health. Thanks to innovation, customization of health and healthcare is increasingly becoming a reality, and this makes it possible to meet the specific individual health needs of people. On the other hand, it also brings enormous challenges to the system, since the current system is much more built to facilitate “one size fits all” solutions. That is a very important point of attention for us in the regulatory field.

The adaptivity of the regulatory framework is also a major topic for us. It is not just about changing the system, but it is also about having a certain degree of adaptivity to enable continuous facilitation of new innovations. The RSNN could play an important role in helping to create a more adaptive regulatory system.

What do you consider the role of RSNN in regulatory innovation?
The RSNN has a key role in identifying developments, as well as in proposing solutions. How do technological developments relate to the regulatory field? What are the main bottlenecks and how can we use the network’s shared expertise to provide improvements?

The added value of RSNN for HollandBIO is primarily the collaboration within the network. Our members are mainly active in the business community, but we really need all stakeholders to improve the ecosystem.

For me, the RSNN really is the trusted platform that enables dialogue and expertise sharing

The Netherlands is known for being good at setting up public-private partnerships. In practice, there is quite a bit of cold feet and mistrust between the various stakeholders such as companies, the government, regulatory authorities, and patient organisations. This makes it important that there is an independent platform like RSNN to leverage this and work together towards a common goal.

When you talk about personalized health, it often seems as if this is still years away. However, a generation of such medicines and therapies is already being developed and finding its way to patients. Examples are orphan drugs as well as gene- and cell therapies. At the European level, ways are being found to do a proper benefit-risk evaluation for these medicines and therapies. The national procedures are lagging behind, they don’t always align with regulatory innovation at the European level. The RSNN could play a role in facilitating the dialogue between the European and national levels to bring European admission more in line with national routes to get a product to patients or onto the market. That is an urgent issue which cannot be postponed.

Another point is that within our field we easily assume that everyone knows everything. But if you bring parties together, it sometimes turns out that they are completely unaware of the issues and challenges of the other party, while these are often the same as they experience themselves. In that case you better make sure you put them on the agenda together and solve them. This is what the RSNN is about.

HollandBIO was involved in the ATMP (Advanced Therapeutic Medicinal Products) expert meeting, what can you say about the importance and outcomes of this meeting?
The subject is a good example demonstrating the added value of RSNN. In the development of ATMPs there are several routes, and it is not entirely clear which is the best for which purpose.

The subject was discussed a lot by several stakeholders separately before the RSNN managed to bring all important stakeholders together very quickly

During the meeting it became evident that the topic is very complex. One meeting turned out not to be sufficient to solve this issue. The conclusion was that a lot is still unclear and there is a need among various stakeholders for clarity and knowledge. I really see that as a prelude to start working on answering the open questions. A follow-up RSNN expert meeting is already being scheduled.

Do you have any suggestions on how the RSNN could increase its impact?
The RSNN should not do this by itself, but should instead make use of the organizations in its network. If we are able to jointly put a problem on the agenda within RSNN and explore it in depth, then I think, for example, that in consultations with the government such a shared opinion increases the chance of achieving an improvement or a solution.

In the past I noticed at RSNN meetings that we were often left with a lot of knowledge questions as the end product: we now know better what we don't know. Structured follow up to the knowledge questions identified in the meetings could increase the impact of the RSNN.

On the other hand, the RSNN already creates impact through the network function of the expert meetings. You get to know people who are working on the same problem and think about it in the same way. The RSNN expert meeting on pharmaceutical compounding, for example, brought me into contact with Marleen Kemper (Amsterdam UMC), which led to several follow-up discussions. When Marleen and colleagues started their “medicines for society” initiative, our support made perfect sense, and we are happy being able to contribute to this common goal. In that sense, the RSNN is a kind of launchpad to bring people together.