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The main objective of J-AGE II is the implementation of the Strategic Research Agenda (SRA) of the JPI More Years Better Lives (JPI MYBL) which includes the alignment of national, European and international policies and programs and issuing calls and other joint activities in the field of demographic change as well as updating the SRA and SRA implementation strategies on the basis of experience with joint programming.
J-AGE II will essentially continue the work of J-AGE as a Coordinated Support Action for JPI MYBL. This implies continuity between the objectives, tasks and Work Packages of J-AGE and J-AGE II. However, as described by the Council Conclusions on Joint Programming (ESF December 2008, p.13), J-AGE II will support JPI MYBL in the next phase of the Joint Programming Cycle. Phase 1 (Identifying challenges) and Phase 2 (Identifying themes and priorities; developing a vision; setting up the governance; developing SRA) have been accomplished within J-AGE at the point of this application. The JPI MYBL has moved to the first phase of implementation, still supported by J-AGE , and is collecting first experiences by issuing the first pilot call, initiating new fast tracks, and entering the process of alignment of national programs with initiatives taken by the Research Policy Group (RPG).
The support for JAGE-II will be highly relevant for the European Commission. Some specific tasks are directly related to network JPI activities with EU-bodies (EC, ESFRI, GPC, SFIC, etc.), H2020 or EC-driven initiatives (e.g. EIP-AHA). The international networking (integration of further countries from Eastern Europe and outside the EU) is also in frame with the mission of H2020. In addition, the fact that some countries suffer at present under a strict austerity policy makes the continuing support of the EC important. Although some MS suffer under these current restrictions they are willing to participate in J-AGE II which is focused on implementation of joint activities.
In JAGE II, EU Open will act as Third Party to the Catholic University of Rome, providing substantial expertise for the implementation of innovative relationship management strategies.
Innovative Medicine Initiative Project "SprintT -Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies"
EU Open Consulting is co-leader with Sanofi RD of Workpackage 3 "Regulatory Consensus over operational definitions". The objectives of this work-package are:
Enabling regulatory tools for addressing the prevention of mobility disability in frail sarcopenic older persons, an unmet medical need in our aging EU population. More specifically:
- Agree an operational definition of Physical Frailty & Sarcopenia - in order to assess the effectiveness of a multi-component treatment (centered on physical activity) in a randomized clinical trial.
- Qualify a panel of biomarkers related to PF&S for future use in the same context;
- Discuss with regulators novel methodologies for physical activity measurements and fall detection;
- Refine the population definition based on the data generated by the RCT.
In order to realize these key objectives this WP will initiate and follow-up two Scientific Advice Procedures at the European Medicines Agency and put in place a Dialogue Platform with Stakeholders: Patients and Carers, General Practitioners and Health Care Professionals, Bioethics experts, ICT and Data experts.
The extended Dialogue Platform will include Regulatory Experts from the EU; non-EU Regulatory Authorities could be also invited as observers, bringing their region approach into the overall debate.
Early regulatory dialogue and the final outcome of the formal SA procedures embedded in the project will pave the way for future therapeutic development in the field of geriatric indications, an area of medical and societal unmet needs.