A welcome to Marjon Pasmooij
It’s good to welcome Marjon Pasmooij as the latest member of the RSNN Steering Committee. We asked her to discuss how she sees the role of RSNN, and what challenges come next for regulatory science.
Marjon Pasmooij has a formidable track record in engaging with and helping to shape the research and regulatory process. As a longstanding employee of the Medicines Evaluation Board (MEB), she started last year as Science Programme Manager. Pasmooij is a strong advocate of meaningful collaboration across all stakeholders in the area of regulatory science.
Pasmooij said that the RSNN is particularly significant because of its role in providing a genuinely neutral platform where new ideas can be shaped: “RSNN makes a big contribution to hearing different views, helping academics, regulators, industry players and patient groups to arrive at new, mutual insights. It’s a unique platform, and it gives us the kind of interactions that foster creative ways to move forward.”
Changing the summary of product characteristics (SPC)
A recent example of an RSNN achievement is a workshop held last year that focused on the SPC. One of the key questions that was discussed was the responsibility of keeping the SPC up-to-date. Currently, proposals for adaptations are applicant driven, but what happens if an academic group has interesting findings: can they also submit this information for a change in the label? RSNN was able to arrange a workshop for all of those interested, followed by a small drafting group that wrote a manuscript based on the discussion in the workshop. This manuscript will soon be submitted to a peer-reviewed journal.
Challenges ahead
Pasmooij said that maintaining an optimal regulatory framework is key in years to come: “With major challenges such as big data and personalised medicine, we need to think very carefully about how regulation should operate. Medicine is becoming more focused, and so we need to establish what is needed to perform clinical studies in a way that yields good data. We want good medicines to reach the market without unnecessary obstacles, but we also need to maintain quality and safety. That means finding the right balance – finding new ways to perform clinical trials while retaining academic rigour and taking all relevant perspectives into account.”
The EMA Regulatory Science agenda
The fact that the EMA has now published its Regulatory Science Strategy to 2025, which is now open for public consultation, is seen as a positive step by Pasmooij: “This is a very interesting piece of work – an excellent starting point for further consultation. Our latest Regulatory Science e-magazine of the MEB (www.regulatoryscience.nl) includes an interview with Tony Humphreys, who is leading the Regulatory Science Strategy to 2025. This agenda impacts on many topics and it will be thought-provoking to see how priorities end up being set.”
Beyond RSNN
The MEB is currently involved in 19 different PhD projects, along with several Horizon 2020 and IMI projects. One of these Horizon 2020 projects is STARS (Strengthening regulatory sciences and supporting regulatory scientific advice), which started in January 2019. One of the aims of this project is to strengthen regulatory knowledge by reaching clinical scientists during professional training and qualification.
Pasmooij was project leader, patient-oriented evaluation, from 2014-2018 for the Strategic Business Plan. In this role she also initiated collaborations with several registries. Since 2014 she has been working on big data, and how to use disparate registries in the Netherlands to optimise assessment reports. Pasmooij is part of the joint Big Data Task Force for Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), seeking to know what data are available and how they can be used by applicants and the regulatory agencies.
Working together
RSNN extends a very warm welcome to Marjon Pasmooij, and we look forward with some anticipation to the positive changes we can make together.