The EMA Framework of Collaboration With Academic Stakeholders.

Abstract

The European Medicines Agency (EMA) recently published the minutes of a workshop organized by the Healthcare Professionals Working Party (HCPWP) called “Developing a Framework of Collaboration Between the European Medicines Agency (EMA) and Academia.”1European Medicines Agency Developing a framework of collaboration between the European Medicines Agency (EMA) and academia.http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/08/WC500211452.pdfGoogle Scholar The report summarizes the discussion between the members of the HCPWP and EMA staff and representatives of European academia.2European Medicines Agency List of participants—developing a framework of collaboration between EMA and academia.http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/07/WC500210075.pdfGoogle Scholar Similarly to the EMA, the US Food and Drug Administration (FDA) engages with stakeholders with a written policy to establish both a transparent process and accountability. The FDA's Professional Affairs and Stakeholder Engagement (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm385522.htm) office deals with stakeholders through Education, Engagement, and Safe Use teams. This framework does not deal with academia individually but with all relevant stakeholders from the private and public sectors. As the FDA employs in-house staff for the regulatory process, this is no doubt sufficient for outreach. However, the EMA is reliant upon national experts for the regulatory process, many of whom reside in academia, thereby placing an additional onus on the need for close and structured interaction. The aims of the workshop were to discuss and collect input for a new framework of collaboration between the EMA and academic stakeholders, which is currently in development. The introduction from Guido Rasi, EMA Executive Director, stressed the relevance of academia's contribution to the knowledge base underpinning drug innovation and how a more articulated and close relationship would benefit public health. The session content centered around an appraisal of the status quo, followed by presentations from key stakeholders of their perspectives, with a subsequent debate on the main pillars of the upcoming framework. The session participants enjoyed lively discussion in a very constructive atmosphere, underlining the timeliness of this initiative. We note that academics, regulators, and policymakers alike are actively seeking means by which to optimize Europe's innovation potential. The relevance of academia in this process cannot be underestimated, both as the originator of tomorrow's technologies, as well as a rich source of expertise to support the evaluation of those very innovations. Furthermore, we noted how a closer interaction between academia and the agency could lead to better training and education, allowing academia to understand the logic and methodology underpinning the risk–benefit evaluation and the procedures for the Marketing Authorization Application. Moreover, improved knowledge exchange and dialogue would potentially enable cutting-edge technologies developed in academia to be validated more quickly, supporting a faster and safer development pathway toward the patient. An interesting concept discussed was that of creating a framework whereby regulatory science questions emerging from the review process could be captured in a research agenda and subsequently executed within independent labs, through financing from third parties such as the European Commission. The multinational European biomedical research infrastructures such as EATRIS (the European Infrastructure for Translational Medicine) were vocal supporters of the concept. Currently, regulatory science, defined as the science validating findings and analytical tools required for the evaluation of efficacy and risk–benefit ratio, is lamentably underfunded. The development of research partnerships supported by funding mechanisms such as the Innovative Medicines Initiative only partially cover the needs, as the programs developed are still mainly focused on increasing innovation and basic research more than on answering specific questions. Moreover, the lack of nondilutive funding for academic confirmatory studies is a source of drag on the system, as the lack of robust validation for discovery efforts leads to wasted efforts by both academia and industry. The existence of Europe-wide research infrastructures created by the European Strategic Forum on Research Infrastructures roadmap and their importance for academic-sponsored drug development was acknowledged. Such consortia and networks, such as the learned societies, have an important role to play, particularly in informing the academic community, developing common training programs, and facilitating academic-sponsored translational medicine programs, all indicated as important goals of the framework. Overall, the participants agreed on a number of future actions as essential to improve the collaboration between academia and the EMA in terms of facilitating the development of better care for European citizens. All stakeholders present showed an enthusiasm and willingness to play their part in the future, toward the common goal of enhancing Europe's innovation capacity and patient safety.