Work Plan

WP1 on "Overall Sustainability & Business Development (Exploitation) of the PHOENIX-OITB association" will establish an easy access SEP operational structure to sustainably coordinate the value chain that will merge all services necessary to develop solutions for customers.

WP2 on "Quality Management" will develop and generate a PQMS providing a strategic life cycle approach, based on GAMP 5, SbD and QbD supported by a Process Analytical Technology (PAT) strategy, where computational, technical, manufacturing, testing and stability aspects are proactively implemented and monitored, controlled and optimised by way of a feed-back system (=control strategy). QM will be responsible for ensuring the development of all the required procedures in accordance with relevant GMP standards.

WP3 on "Research and Development" will be mainly responsible for identification, evaluation, and verification of the quality, efficacy and safety (QES) methods to ensure their suitability for the intended purpose. The methodologies for the physico-chemical characterisation, advanced in vitro and in vivo characterisation will be implemented into a framework that will ensure that the properties and features of the nano-pharmaceuticals are maintained throughout the transition from the lab to the production. WP3 will strive to implement GLP-compliant facilities for conducting preclinical and safety pharmacological studies (absorption, distribution, metabolism and excretion (ADME), PK/PD, and toxicology testing) of nano-pharmaceuticals adhering to international regulatory requirements and submission requirements for clinical trials or marketing authorisation. Accordingly, WP3 will demonstrate the cost-effectiveness, clarity, and viability of guidance documents and decision-making tools provided by PHOENIX-OITB R&D Strategy in relevance to demo cases.

WP4 on "Production (Chemistry, Manufacturing, Control – CMC)" will represent the gateway that links lab processes to the clinics, by providing the necessary knowledge and support for the production of nano-pharmaceuticals under GMP conditions. To do so, WP4 will combine process knowledge with regulatory knowledge based on regulatory requirements for the QES of the nano-pharmaceutical products, intermediates, and formulations (technical transfer from Non-GMP to GMP). WP4 comprises quality control testing under GMP conditions, on site acceptance tests (SAT) for demo-case related KETs and the production of demo case batches to show that the established production systems can be properly implemented and interfaces properly with the new peripherals and working environment. Thus, WP4 will work on method and tech transfer, establishment of Process Analytical Technologies (PAT), process optimizations during scale-up and GMP production. During the PHOENIX project, scale-up will be demonstrated by bringing five demo cases to batch sizes that are representative of real industrial production.

WP5 will offer regulatory support to end-users to eliminate “non-necessary” testing as well as to ensure “certainty” about regulatory compliance of nano-pharmaceuticals under development. The regulatory team will analyse the guidelines and legislation to develop PHOENIX Regulatory Roadmap that will help in determining any additional testing, studies or documents that might be required for target products prior to initiating clinical trials. Therefore, all relevant QES issues with regard to user product vs. gold standard and the overall regulatory acceptance of the nano-pharmaceuticals will be addressed, elaborated and evaluated. WP5 will provide the Investigational Medicinal Product Dossier (IMPD) for all the PHOENIX demo cases at the end of the project.

WP6 on "Marketing (Dissemination & Communication)" will establish effective communication and dissemination via web, conferences & workshops, social and business networking and scientific publishing channels. WP6 aims to identify and establish the link to stakeholders, and to create access to PHOENIX data and facilities by conducting marketing activities interacting closely with WP7 to ensure adequate protection of IP before public disclosure, and with WP1 for supporting sustainability by establishing a link between service partners.

WP7 on "Project Management and Coordination" will cover project coordination of the PHOENIX project, organisation of overall administrative management (capture, annual work plans); organisation of project-related meetings; reporting to the European Commission; effective dialogue and coordination with project partners to monitor the project progress for early detection of any potential deviation or delay; to review and ensure quality and compliance of the time and budget.