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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.