ADDIA consists of five well designed work packages (WP) with an observational clinical validation study being the core of the project, as seen on the below image.
Amoneta Diagnostics will coordinate all project activities according to these work packages defined in the grant agreement that is signed with the European Commission, upon an excellent evaluation report by the independent experts.
You may find below a very brief summary of each of these WPs.
E.C. Grant # 674474
Duration: 36 months
Funding: ~5 Mio EUR
WP1: Project Management (Months 1-36)
Main objective: To ensure project's realization within pre-defined schedule and budget.
The work package 1 includes overall scientific, legal, financial, and administrative management of the project. This is a dedicated work package for a professional management in order to ensure that project’s main objectives are realized in a timely fashion and within defined budgets. Amoneta has extensive experience in managing national and international R&D projects, including academic, clinical and industrial partners. Planning and monitoring of the overall project, follow-up of all objectives, milestones and deliverables; also applying corrective measures when appropriate are among the main tasks of WP1.
WP2: Regulatory Affairs (Months 1-12)
Main objective: To prepare the observational clinical study.
Preparation of extensive documentation required for a smooth handling of clinical study, including the study handbok and informed patient consent forms, the development of a data management plan and a database design by preparing electronic Case Record Forms (eCRFs), training the clinical study teams are few among several tasks of the WP2. Preparation of a Briefing Book that shall cover all clinical, methodological and analytical aspects of the project is another very important task of the workpackage. The Briefing Book will be submitted to the European Medicines Agency (EMA) for scientific advise and is also required for interactions with other relevant health authorities in various markets (EMA, FDA, PMDA).
WP3: Multicenter clinical PoP study (Months 10-30)
Main objective: To validate the IVD method in an observational multi-centre Proof-of-Performance (PoP) clinical study.
For clinical validation of the IVD assay (ADDIA), the consortium will perform an observational multi-centre Proof of Performance (PoP) clinical study in well characterized AD patients at early and late stage of the disease, together with other dementia cases and healthy controls. Logistic preparation, production of the kit for research-use-only, a first chronobiological study for the characterization of intra-subject variabilities are the main tasks that will assist a spotless handling of the main clinical study.
WP4: CE-marking Registration (Months 30-36)
Main objective: To register the ADDIA IVD assay as an IVD medical device and obtain CE-marking.
In order to register the test as an IVD (in-vitro diagnostic) medical device, Amoneta will prepare and maintain the technical documentation, determine and justify what is appropriate and sufficient to assure product's IVD compliance with the 98/79/EC Directive. A notified body will assess the product documentation and validate that the product meets all required standards for CE-marking. Following all other steps required for conformity assessment, Amoneta will provide a written declaration that the IVD product meets the provisions of the 98/79/EC Directive and council notified bodies throughout the EU, such as the ANSM (Agence Nationale de Sécurité du Médicament).
WP5: Commercialization Plan (Months 1-36)
Main objectives: To ensure dissemination of the project results and to promote their further uptake and exploitation.
One vital task is to create a comprehensive Exploitation Plan, which shall include all regulatory approvals needed for the exploitation of the final IVD assay, a description of the business development model and legal affairs, management of IP, production and finally a complete description of the product with an instruction manual. WP5 involves all communication and dissemination tasks, as well as promotional activities to raise awareness, acceptance and support of the scientific and medical experts regarding the IVD assay for AD diagnosis. In this aspect, the WP5 will realize regular updates via all means on the preliminary results, present project outcomes at international and national conferences to industrial and regulatory institutions, as well as to AD patients and patient organizations via e-newsletters, websites, presentations and other means of communication. So, WP5 prepares and executes the marketing phase of the final IVD product and thus has a very critical role for project's commercial success.