As one of the speakers invited to present at this year’s Probiota, Cordaillat-Simmons used the microbiome field as an example on the importance of introducing regulatory science consideration early on to de-risk innovative product development.
When asked about a possible scenario in which regulation could stifle this innovation, Dr Cordaillat Simmons agreed with this notion adding, “even if most of the industry (microbiome-based drug products) wished for more guidelines and regulation, it was not a bad situation we are experiencing now.
“In absence of such regulatory framework, it is still possible for pioneers to develop their products thanks to dialogue with regulators based on scientific advice or other procedures.
“It makes sense for regulators to see what it is out there and how is evolving to ensure regulations and regulatory frameworks will not slow down innovation.
Improving assessment and robustness
Dr Cordaillat Simmons explained that this was where regulatory science activities were fundamental as they addressed ways to improve assessment and robustness of developments based on most recent scientific and technological evolutions.
“It is sad to see the lack of involvement of EU regulators in microbiome regulatory science and the difficulty to have them on board in European projects as well,” she added.
“Our wish for the near future is to obtain more feedback from regulators along the activities in microbiome regulatory science in which we are involved (internally or through EU R&I projects).”