c4c Multi-Stakeholder Meeting on
Perinatal Asphyxia
18-19 September 2023
Ergife Palace Hotel, Rome & Zoom
conect4children is pleased to announce that the fourth c4c International Multi-Stakeholder Meeting (MSM) on perinatal asphyxia was successfully held on 18-19 September 2023 in Rome and virtually. The meeting was organised ahead of the 5th jENS (joint European Neonatal Societies) conference in Rome to maximise participation and interaction.
More than 120 participants from 39 countries worldwide attended the event, evenly split between on site and virtual. Participants included International academic experts in perinatal asphyxia, experts in neonatal preclinical and biomarker research, representatives from pharmaceutical companies developing relevant assets, representatives from regulators (EMA, FDA), parents and their advocates.
The overarching objective of the meeting was to define together the steps toward a strategy to improve the timely development and access to additional therapies to therapeutic hypothermia, properly addressing neonate unmet needs, introducing innovative development pathways in the regulatory environment, and increasing accessibility for all patients.
Specifically, the meeting focused on several important aspects of perinatal asphyxia:
- Update on science;
- Needs of neonates suffering of hypoxic ischemic encephalothy and their families;
- Discussion a preclinical path and strategy to a reach a consensus and provide a guideline for both the academic community and pharma development;
- To reach a consensus on which biomarkers to be used and consider a qualification process;
- To address the hurdles in feasibility of clinical development including maximising patient access and recruitment and propose solutions.
No regulatory decisions were made during the meeting, which focused on publicly available information only. However, the findings and conclusions of the meeting will pave the way for future development plans and concrete actions.
The next steps will include a joint scientific publication in a peer-reviewed Journal and an action plan according to the meeting’s conclusions.