DIA Europe 2021 RSNN Session: Regulatory Science Dialogue

During the virtual DIA Europe 2021 conference from the 15^th till the 19^th of March, the RSNN organised the session titled “Regulatory Science Dialogue”. More than 60 attendees joined the session.

The chair, Hugo Hurts (Executive Director, Medicines Evaluation Board), highlighted the fundamental role of regulatory science dialogue to promote collaboration between the various stakeholders in the regulatory landscape. Three presenters, Pieter Stolk (RSNN/Lygature), Sini Eskola (Director Regulatory Affairs, EFPIA), and Peter Mol (Principal Clinical Assessor, University of Medical Center Groningen, Vice-Chair SAWP EMA) shared their views on the need for regulatory science dialogue to maintain regulatory equilibrium. This was followed by a panel discussion with panellists Gerrit Borchard (University of Geneva, President of the Swiss Academy of Pharmaceutical Sciences) and Carla Torre (Faculty of Pharmacy of the University of Lisbon).

First, Pieter Stolk presented on the past decade and a half in regulatory science collaboration. He proposed three distinct phases in public-private collaborations in the field of regulatory science. These consecutive phases include 1) collaboration on regulatory science/dialogue on new methods that improve standards and tools, 2) collaboration on regulatory evidence models, and 3) collaboration on therapeutic strategies. Each of the phases was illustrated with initiatives from the national and the EU level.

Sini Eskola followed with her presentation entitled “Informed Dialogue and Stakeholder Interests in Regulatory Science“. Sini focussed on recent examples of how stakeholders can jointly shape regulatory science and strategy. The presentation described EFPIA’s strong supportive role to contribute to the EMA Regulatory Science Strategy to 2025 by providing recommendations and supporting its implementation. EFPIA used the priorities of the EMA regulatory science strategy to inform its own regulatory strategy plan entitled “4e for 2023”. Evidence was gathered regarding chosen priority areas, such as the use of real-world data and complex clinical trial designs, as a basis for recommendations on regulatory-driven regulatory science. Furthermore, various IMI-projects were highlighted to emphasize the essential role of public-private partnerships in multi stakeholder research to translate into regulatory guidance and evolve regulatory innovation.

Peter Mol continued the session by depicting a ‘triangle of regulatory dialogue’, connecting the regulator, industry, and academia around the patient. Peter explained the major role of early interaction between medicine developers and regulators through scientific advice to ensure that novel products meet their regulatory requirements. This early interaction could be in the form of ‘consensus meetings’ to define obstacles and solutions of different stakeholders and strategize a way forward to implement precision medicine. Peter described the RSNN platform as an example on the national level to bring different people together as equals at the same table to define new regulatory research questions. On a European level, the Horizon 2020 STARS-initiative plays a crucial role in strengthening regulatory science in academia by bridging this translational gap. Peter reflected on the future challenges of multi-stakeholder interaction and the need for neutral platforms (e.g., IMI, Horizon Europe, RSNN) to ensure transparency and trust.

The session ended with reflections from the panellists. Carla Torre emphasized the challenge of (too) moderate effects of novel drugs, urging to complement randomised control trials with new methods and sources of evidence (such as real-world evidence). In line with Peter, Carla addressed the regulatory knowledge gap between industry and academia and stressed the crucial role of the EU STARS project in this. According to Carla, it is time to bridge and connect, citing Bert Leufkens – chair of the RSNN – “regulation is too important to leave to regulators only”.

Gerrit Borchard continued the discussion with three remarks. First, regulatory interaction can only take place at a neutral platform where challenges and potential solutions can be discussed as equals. Second, interaction is the only way to establish a regulatory equilibrium to balance between overregulation and regulatory risk. Finally, all involved stakeholders need to keep the ‘real outside world’ in mind and reach out to the general public.