Christiane Niederlaender

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. At the same time Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline, and she was a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector.
Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to get advanced therapies into the clinic and to market. Since joining Parexel, Christiane has done substantial amount of work within the US system and and has knowledge about EU, UK and US CMC regulatory requirements.

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Thu. February 24 | 2.30pm – Comparability for genetically modified cells: challenges for vectors and cells

• Case studies on key changes that developers may want to make to vectors and cells and how comparability can be demonstrated in those scenarios. Considerations when developing a comparability plan and devising the study as well as common pitfalls when introducing changes during development of genetically modified cells.
• Ensuring that the right studies are conducted from the beginning of the development process and adapted as new information becomes available, which then continues into the post-approval phase. comparability studies under these circumstances.
• Taking regulatory experience into account, the talk tries to outline the most pragmatic ways of implementing comparability studies . The use of model systems, key requirements for vector changes and cell-product manufacturing changes are discussed.