Roundtable Discussion

Thursday, November 14

Davenport Hotel, 8-10 Merrion Street Lower, Dublin 2

The way to move forward is to move together.

 ‘Breaking Barriers and Driving Collaborative Evidence Generation to Advance Access to Innovative Technologies’

The pace of innovation has accelerated dramatically in recent years and regulators are recognising the need to be ready to support the development of increasingly complex therapies. Since our last meeting in 2017, we have witnessed the approval by both the FDA and EMA for the first gene therapy to treat rare eye disease. The number of clinical trials taking place across a wide range of therapeutic approaches continues to rise, some of which are currently in Phase III. The European Reference Network dedicated to Rare Eye Disease (ERN-EYE) is well underway with the goals of concentrating knowledge and resources, and revolutionising patient clinical management. Just last month, the European Commission launched a call for new memberships. We are entering new territory and it is an exciting time for many. However, challenges still exist and solutions remain to be sought. With that we will review the current landscape, address known obstacles but also identify the steps we can now take to ensure we are meeting the needs for Irish patients living with retinal degenerations. Topics for discussion will include HTA models, knowledge gaps and evidence based generation, patient reported outcome measures, expectations management and ways with which stakeholders can collaborate and expedite the path to therapies.

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