WP08 - Exploitation and Scientific Direction
- To support the commercialization of nilvadipine in the European market
- To generate additional biomarker data of relevance to the mode of action of nilvadipine
- Building on the work of the NILVAD consortium, to explore the potential for future studies with second generation compounds within a European clinical trials framework
This work package will comprise the following tasks:
Task 1: Commercialisation of Nilvadipine
We will develop an Authorization Strategy to plan the appropriate steps, documentation and meetings required in order to obtain a Marketing Authorization for Nilvadipine. This strategy will include immediate discussions of the NILVAD trial with the EMA and/or National Competent Regulatory Authority to establish NILVAD as a pivotal clinical trial.
Task 2: Generation of additional biomarker data from NILVAD
Using blood/CSF samples from the NILVAD repository stored at the coordinating centre, Archer in collaboration with TCD, UGOT and UULM will explore the development of novel biomarkers that reflect the disease modifying and symptomatic mechanisms of action of Nilvadipine in AD, including novel markers of white matter integrity.
Task 3. Design of future European studies with second generation compounds
A NILVAD Conference will take place at the final end of the project and will be used to communicate the results of the project. The scientific findings for NILVAD (WP6) will determine the potential for nilvadipine and other
second generation compounds in this therapeutic area. The experience gained within NILVAD with this drug class with respect to patient recruitment, efficacy measures and safety will be invaluable in informing future studies with second generation compounds that are being developed by Archer. A Clinical Development Plan will be produced in this regard.
Archer Pharmaceuticals (Dr. Michael Mullan)