The second Network Meeting and Consortium General Assembly (CGA) for the Methylomic Project took place in Amsterdam yesterday. Asphalion is the regulatory partner of the project and our expert Diego Sanoja carried out a presentation of the status of the project around the regulatory challenges, which include:
- Update on the in vitro Diagnostic Assay and Software development.
- Regulatory Strategy for Companion Diagnostic (CDx) Device.
- Support on Performance Study framework and pathway for authorization.
Partners from different Work Packages presented their advances so far, and conclusions for future actions were agreed upon by the whole METHYLOMIC Consortium. Among these activities we find: clinical study design, communication and dissemination of the project, scientific publications and activities, product development and product validation, as well as next assemblies.
The project METHYLOMIC is aiming to enhance the effectiveness of medication in chronic immune-mediate diseases such as Crohn’s Disease (CD), Rheumatoid Arthritis (RA), and Psoriasis (PsO). It aims specifically for the so-called biologicals, which are antibodies designed to target an inflammatory protein to reduce the inflammation.
For further information about the project please check: https://methylomic.eu/
Thank you very much to the Amsterdam Medical Center (AMC) for hosting such a great and productive meeting!
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