On 12 July, the PERMIT project held an online working session to discuss the regulatory gaps in the personalised medicine research pipeline. Gathering over 30 participants from within and beyond the PERMIT consortium, the session focused on the gaps and questions identified through the scoping reviews and consultation exercises. These items include the design, building and management of stratification and validation cohorts, the use of machine learning and artificial intelligence for patient stratification and the use of preclinical models for the development of personalised therapeutics and for the mimicking of patient clustering. The gaps that were presented and discussed by all attendees represented areas where the requirements and regulatory expectations are unclear or lack harmonization, where the methodological approaches do not seem to be covered by the regulatory texts and guidelines, or areas where regulatory requirements could dampen innovation. Representatives from HTAs, national competent authorities, the European Commission, the EMA, consulting companies specializing on regulatory aspects of medical devices and in-vitro diagnostics, and experts from the pharmaceutical industry shed light on the current regulatory framework in Europe, on pragmatic approaches for navigating the framework and on what can be expected from the regulations in the coming years.
A new publication about robust & reproducible preclinical research in #PersonalisedMedicine has been published in BMCMedicine. Among the authors are EATRIS staff & institutions members. Congrats to all involved. 👉Find out more hereatris.eu/news/new-publi…w#PERMITprojectect https://t.co/kp46SdWB9G
New #PERMITProject publication: Recommendations for robust & reproducible preclinical research in personalised medicine. 15 recommendations are presented aiming to improve the robustness of preclinical methods in translational research for PM. permit-eu.org/publications https://t.co/zAS8pYOlOm