Osteoarthritis is the most common joint disorder worldwide, but there is no efficient treatment so far. Over the next 4,5 years, #SINPAIN team will strive to develop an efficient therapy to improve the quality of life for those affected and reduce the high costs associated with this condition. The objective is to create a siRNA-combined advanced therapy, which will lead to more personalised treatment options for different stages of osteoarthritis. At Asphalion we are the regulatory partner throughout the project.
At Asphalion, we are the regulatory partner throughout the project, guiding all partners in ensuring the compliance of the regulatory requirements for the development of the nanotherapeutics, establishing a regulatory roadmap at the start of the project that will be validated with the Innovation Task Force (ITF) of the EMA. The clinical development of the nanotherapeutics and CMC aspects will also have to be considered from the regulatory perspective. Finally, an ATMP classification request will be envisaged to have a clear regulatory definition of the nanotherapeutic product.
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