WP4: Optimization of biomarker qualification procedures with regulatory agencies.
Work package 4
Dutch Medicine Evaluation Board
Peter Mol
Peter Mol
In Work Package 4 PRIME-CKD aims to initiate an EMA biomarker – companion diagnostic qualification program using the results of the analytical and clinical validation studies.
Objectives of this work package:
- To interact with regulatory agencies in Europe (EMA) and United States (FDA) to register validated pharmacodynamic biomarkers as companion diagnostics for the treatment of CKD.
- To discuss novel approaches of using pharmacodynamic biomarkers for drug development and registration.
- To identify regulatory standards and views of evidence required for using biomarkers to support drug development and registration.
- To develop clinical trial template protocols for biomarker guided trial designs and personalized medicine meeting regulatory standards.
To pave the way for a successful biomarker qualification procedure within PRIME-CKD and use of companion diagnostics in drug regulatory environment and clinical practice, the consortium will obtain stakeholder (industry, academia, regulators, health technology assessment, healthcare professional and patients) opinions throughout the research project to identify barriers and bottlenecks to implement personalized medicine and biomarker driven trial design.
Participants:
- CBG (Agentschap College ter Beoordeling van Geneesmiddelen)
- Renalytix AI Limited, Region Hovedstaden
- Steno Diabetes Center Copenhagen
- University Medical Center Groningen
- Lunds Universitet
- Universitaetsklinikum Hamburg -Eppendorf
- University of Campania “Luigi Vanvitelli”
- University of Leicester
- University Hospitals of Leicester NHS Trust
- Alma Mater Studiorum – Universita di Bologna
- IRCCS Azienda Ospedaliero – Universitaria di Bologna
- Hessels en Grob BV
- Fundacion para la Investigacion del Hospital Clinico de la Comunidad Valenciana – Fundacion INCLIVA.
