Satellite Meeting: Meet the Hurdle - EV Therapeutics and Regulations

The chairs and members of the “ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics” will organize the satellite event titled “Meet the Hurdle - EV Therapeutics and Regulations”. We will invite a panel consisting of 3-4 regulatory experts and 2 teams (consisting of preclinical, clinical and manufacturing experts/scientists). The latter team should present a therapeutic approach with either naïve or modified EVs.
The panel of regulatory experts, acting as a “jury” for the “pitches” in which the scientists summarize the target product profiles (TPP) of their proposed EV therapeutic candidates, will provide feedback in the two slots of 45 minutes each. The research teams will receive sufficient guidance in advance to create a TPP of the EV-based drug candidates that will eventually be tested in clinical trials. Panel members will respond spontaneously with substantive questions and specific recommendations as grade of details and time permit.
With these two showcases, we are trying to simulate the situation before and the issues that will be discussed on the way to the application of EV therapeutics in clinical trials.