Optimising the quality of cell-based immunotherapy products is critical to maximising safety and efficacy of novel cancer treatments. Employing the right manufacturing approach is necessary to ensure your product’s long term success.
Join us on 8th February to hear NDAs Dr Paula Salmikangas, Director of Biopharmaceuticals and ATMPs, discuss:
- How the CMC aspects impact safety and efficacy of cell-based cancer immunotherapy products
- The importance of early product characterization
- Cellular markers and correlation with responders
- Critical quality aspects to ensure safety
She will also provide an overview of recent updates in the EU regulatory system for ATMPs.
Dr Salmikangas will be available to answer questions at the end of the session.
Click here to book your place today.
Dr. Salmikangas is a clinical biochemist by original training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Dr. Salmikangas joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals.