Often, promising biomarkers, assays, technologies etc. are developed by academia, but do not reach the stage of maturity requried by regulatory authorities. Indeed, wihtin safety pharmacology standardized procedures and extensive scientific validation is a prerequisite. WP3 aims to bridge this translational gap. WP3 will build upon the expertise of Ncardia, TSE systems, NOTOCORD and Vivonics, which have demonstrated their ability to successfully translate innovative technology into products/services. Furthermore, the pharma partners (UCB Biopharma, Boehringer Ingelheim, AstraZeneca) will add their expertise in validating novel technologies and assays. In brief, WP3 has two major aims:
- Pushing the Technology Readiness Level (TRL) of prototypes and ensuring early regulatory-alignment.
- Scientific validation, interaction with regulatory agencies and eventual implementation of the newly developed SP solutions in drug development for safer medicines.
- Dr. Annie Delaunois
- Dr. Arie Reyerkerck