March 14, 2014
Barcelona, Spain, March 14, 2014 – Seeking innovative approaches to combat the devastating effects of frailty and muscle loss in the older person, the Innovative Medicines Initiative Joint Undertaking (IMI-JU) will soon announce the project finally selected to share some 50 million € in research funding. At today’s International Conference on Frailty and Sarcopenia Research (ICFSR), Susanna Del Signore, M.D., Associate Vice-President of Global Regulatory Policy at Sanofi provided an update on the IMI project call, which was published in July, 2013.
Physical Frailty & Sarcopenia (the age related loss of muscle mass and strength) is a common condition of older age and increases the risk of falls, disability, and death. However, lack of consensus on how the condition is defined has slowed progress in developing interventions. According to Dr. Del Signore, addressing the gaps in drug development and reaching consensus can only be achieved through a collaborative approach that brings together in a public private partnership the expertise of pharma, the scientific experience of academia, and the innovation found in small and medium enterprises.
IMI, a Joint Undertaking between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), is Europe’s large public-private partnership aiming to improve the efficiency of drug discovery and development through collaborations between industry, academia, regulatory agencies, health care providers, and patient organizations. The IMI identified interventions for frailty and sarcopenia as unmet medical needs of an increasingly ageing population in the EU and worldwide.
The IMI Frailty and Sarcopenia project plan is centered on a large randomized clinical trial that will enroll 1600 older persons representative of the diverse European population and at risk of developing frailty and mobility disability. The trial will test the ability of physical activity and adequate food intake to modulate the development of sarcopenia and frailty, incorporating evaluation of a panel of biomarkers for sarcopenia. As well, the project plan will include working with regulatory authorities to qualify a panel of biomarkers and develop regulatory guidance on methodologies for sarcopenia and frailty data collection in clinical trials. Partners in the project will be required to share generated data as a means of expediting further research and increasing understanding of frailty and sarcopenia.
“Most importantly, we will put patients at the center of this initiative and give them a voice in our work,” said Dr. Del Signore. Patients will participate not only as consultants for the research projects but also will contribute essential data in the form of patient reported outcomes and real time activity data collected with biometric sensors and other new technologies.