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Collaboration key to advancing regulatory science


The core message from the meeting participants was on the added value of collaboration. ‘Collaboration is key,’ the report states. ‘The ability to succeed in step-changing medicines innovation is contingent on partnerships in vibrant ecosystems.’ The report also highlights the need for both intra-sector as well as inter-sector collaboration, and notes that this requires safe harbours such as IMI to facilitate collaboration, build trust and pilot new ideas.

The need for greater collaboration was also underlined on gaps to be addressed. Here, the participants flagged up the need for cross-disciplinary research involving diagnostics, devices, and areas like food, for example. At the same time, the participants encourage a shift in focus from disease management to health management, from treating to preventing and intercepting diseases.

The participants were also clear that they wanted more and earlier dialogue with projects. ‘Early engagement with regulators is critical for them to know what is in early development as well as to enable early dialogue regarding innovative medicine development to help enable mutual expectation setting,’ the report notes. This will also help projects to deliver impactful outputs, for example through the qualification of methods.

One major goal of these meetings is to obtain regulators’ insights into the activities of IMI, and IMI Executive Director Pierre Meulien welcomed the participants’ contributions to the discussions.

 ‘This was a fantastic meeting,’ he said. ‘The level of engagement of both EMA and FDA representatives in IMI since the beginning is truly impressive. Their support and input help us to ensure that our projects have a real impact on patients’ lives and global health.’

Both Guido Rasi, Executive Director of the EMA, and Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA, gave keynote speeches at the meeting on their vision for future innovation in drug development and patients’ access. You can watch the videos here: