EMA Scientific Advice for US-based somatic cell therapy

Added: 13th December 2015

CellData Services was asked to provide a detailed assessment of the data available on a US-based somatic cell therapy for neurological disorders. As this product was at a quite advanced stage in its development for the US market, it was important for the client to gain an understanding of how the data generated would be assessed in the EU, and to develop a sound strategy for initiating clinical trials in European countries. We were able to give a critical assessment of the development data and provide recommendations on next steps to optimise development in the EU. We prepared documentation for a Scientific Advice procedure with EMA and managed the procedure such that appropriate questions were asked and the client obtained clear and definitive responses from EMA concerning key elements of trial design for future EU studies.

"CellData Services is our default regulatory expert for cell-based therapies in Europe. They bring an uncommonly found knowledge of the science behind our products and they use this knowledge to ask extremely relevant questions that are essential in formulating our responses and approach to the EMA. CellData Services have consistently provided us with actionable guidance and support in a timely fashion. In short, they are an essential component of our European development strategy."

- Chief Medical Officer & Head of Research - SanBio Inc, USA