EMA Seeks to Promote Collaboration with Academia

The European Medicines Agency (EMA) has developed a three-year plan to formalize, structure and develop interactions with the academic community.

“Academia plays an important role in helping the EU medicines regulatory network keep abreast of the opportunities and challenges brought by science, be it in the context of the development, assessment or safety monitoring of medicines,” noted EMA’s Executive Director Guido Rasi in a statement. “The framework will allow us to integrate cutting-edge scientific knowledge more tightly into our activities. It will also help academic start-ups benefit from advice from the EU regulatory network to translate their discoveries into patient-focused medicines.”

The framework’s objectives are to:

• Raise awareness of the mandate and work of the European medicines regulatory network to increase academia’s trust in and engagement with the regulatory system

• Foster the translation of academic research into novel methodologies and medicines which meet regulatory standards and address the needs of public and animal health

• Ensure the best scientific expertise and academic research are available on time to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes

• Work with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, such as for example, the use of novel endpoints or novel methodologies

The framework builds on EMA’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals and the pharmaceutical industry, continued the statement. The agency has also published a new web page for academia providing links to content that is likely to be of interest, and a section describing the way EMA interacts with academia, with more detail on the collaboration framework and action plan and useful resources for academics.

According to Prof. Piet H. van der Graaf, of the Leiden Academic Centre for Drug Research (LACDR) in The Netherlands, “This is an important step towards a strong alignment of the European excellence in regulatory and academic pharmaceutical sciences. In my discipline of systems pharmacology, I expect that this will act as a catalyst for new and better collaborations and cross-fertilisation in research, training and education. This should ultimately have a positive impact on the development of novel personalized medicines for patients.”

The dialogue between EMA and academia has already improved in time, but this is the perfect moment to structure this interaction and bring it to the next level, commented Dr. Rosa Giuliani, EU Policy Committee, European Society for Medical Oncology (ESMO).

“The framework of collaboration is a timely initiative, which is expected to fulfil specific tasks,” she said. “This is the platform needed to 1) promote regulatory awareness, 2) support academic research and 3) boost communication between the two parties. Now it is time to work!”

To view the full release, click herePhilip Ward is the European Editor for Applied Clinical Trials