Thinking ahead on how the future iPSpine product can eventually be authorised, we support the project with regulatory advice and organize early interactions with relevant health authorities. In our conducted and planned scientific advice meetings, we clarify questions such as: Into which ATMP category will the iPSpine product be classified? Which role do the cell and the biomaterial components play for the intended therapeutic activity? What parameters will need to be tested for each product batch before it can be released?
We also support the design of experiments testing the safety and efficacy of the future product or its components taking into account that the results can later be suitable for implementation into the required dossier for marketing authorisation.
Another role of our team is also to enable researchers to make first contact with the regulatory way of thinking and help understanding what results will be expected by a regulatory body.
And of course, we are extremely nosey and curious and love sticking our noses into everything and discussing with other group members on their newest results!
To learn more about PharmaLex and our support on ATMPs click here: https://www.biopharma-excellence.com/
Dr. Zaklina Buljovcic
Principal Consultant Innovative Therapies
We are all former scientists, so it is exciting to be back at the roots of science. The challenge is to keep up with all these brilliant researchers and to identify the regulatory topics that are relevant at this stage.
We have the unique opportunity to support the researchers’ team and to provide insight how understanding of regulatory thinking can support research to get a step closer towards a biologic cure for Spine degeneration!
Dr. Angela Vogt-Eisele
It is great to work in this consortium, and after almost 4 years, it almost feels like a huge family! Sitting at the interface of the various disciplines, we have an excellent position to see the accomplishments within the individual groups as well as across the different areas and how they join efforts to reach our common goal.
ATMPs are always exciting products to develop, as every single one is unique – and so is its regulatory journey. For us, it is a great chance to be involved at such an early stage in development, and to assist finding an efficient development pathway.
Dr. Pavan Beleyur
Senior Manager Regulatory CMC
Working with a large consortium brings in the challenge of collaboration and getting updated on the progress from the various groups. Within the IPSpine team, co-ordination and knowledge sharing is actively promoted to keep up with the pace of work.
Development of manufacturing and Quality control of ATMPs is complex, due to the complicated biology involved in their production. Supporting early development of such cutting-edge technologies and working so close with the science involved in this research is a fantastic opportunity.
Senior Manager for Medical Devices / IVD
Is very exciting to work in an international project with so many experts in their field. We feel happy to participate from so early stages, providing our regulatory perspective and experience to help the team to design the documents and experiments with the final goal of the registration.
Participating in this project is a wonderful opportunity to be part of the development of the medical innovations.
Senior Manager, Regulatory Affairs
It is a great experience to be part of a large consortium composed of universities, research institutes and specialised companies from different EU countries.
From a regulatory point of view, it is very exciting being part of the iPSpine project as it covers different regulatory frameworks such as stem cells, ATMPs and medical device regulations, and we can help to the researcher’s team to understand the requirements applicable to iPSpine product.