Post by Aude Clement

I am pleased to share the publication of our paper in Nature Scientific Reports: https://lnkd.in/eXAKP7-a "Navigating the EMA qualification of novel methodologies for digital endpoints: lessons from the DEEP project proof of concept." I had the opportunity to contribute to this initiative initially during my time at #Novartis and later through its progression at #Roche. The paper outlines a multi-stakeholder collaboration between #EFPIA, #DEEP, #EMA and eight pharmaceutical companies. Using nocturnal scratch in atopic dermatitis as a real-life case study, the project evaluated whether the DEEP platform and its Stack Model could facilitate and streamline the regulatory qualification and lifecycle management of digital endpoints. Key Findings 📏Standardization: The DEEP Stack Model helped establish common terminology and structured technical and analytical validation data across a multi-company applicant team. ♻️Evidence Reusability: The proof of concept demonstrated how components of validation evidence could potentially be reused or adapted for other contexts of use in the future. 🤝Regulatory Interactivity: The pilot utilized a "qualification-light" pathway via an EMA Innovation Task Force (ITF) procedure, providing insights into how early regulatory engagement and feedback curation can be optimized. Thank you to the co-authors Mireille Muller, Cathelijne de Gram, Bola Grace, PhD, MBA Rauha Tulkki-Wilke, Parla Işıl Yüksel, Igor Knezevic, Kai Langel, Claire Lansdall,Lada Leyens and Carrie Northcott, the #EMA and European Medicines Regulatory Network (#EMRN) reviewers who supported this collaborative effort. #DigitalHealth #DigitalEndpoints #RegulatoryScience #ClinicalTrials #EMAQoNM