Hilke Zander (Ph.D., MDRA) is clinical assessor at the Paul-Ehrlich Institute (PEI) in the section of monoclonal and polyclonal antibodies. After receiving her Ph.D. in antibody engineering from the TUMunich, she worked several years in cancer research at the University Clinic Hamburg-Eppendorf. Since 2013 she has been working on oncological antibody therapies at the PEI and in particular on the marketing authorisation of checkpoint-inhibitors.
With her involvement in the evaluation of targeted therapies, her focus has shifted to the co-development of companion diagnostics and medicinal products and the implementation of the In Vitro Diagnostic Regulation 746/2017. In addition to the implementation of a new official task, the evaluation of IVD performance studies, at the PEI, she is member in various European committees e.g. EMA SIA PGx, EMA ESEC Oncology, EMA CHMP/CAT CDx Expert Group, EU Combine Project, EMA MWP drafting group for a new guideline on predictive biomarker-assay development and the scientific advice working party (SAWP) of the EMA.
Events/Masterclasses Hilke Zander is currently speaking at
Pharma
Companion Diagnostics (CDx) - Navigating the Regulatory Challenges
11 – 12 June 2025
Vienna, Austria
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe.
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Hilke Zander (Ph.D., MDRA) is clinical assessor at the Paul-Ehrlich Institute (PEI) in the section of monoclonal and polyclonal antibodies. After receiving her Ph.D. in antibody engineering from the TUMunich, she worked several years in cancer research at the University Clinic Hamburg-Eppendorf. Since 2013 she has been working on oncological antibody therapies at the PEI and in particular on the marketing authorisation of checkpoint-inhibitors.
With her involvement in the evaluation of targeted therapies, her focus has shifted to the co-development of companion diagnostics and medicinal products and the implementation of the In Vitro Diagnostic Regulation 746/2017. In addition to the implementation of a new official task, the evaluation of IVD performance studies, at the PEI, she is member in various European committees e.g. EMA SIA PGx, EMA ESEC Oncology, EMA CHMP/CAT CDx Expert Group, EU Combine Project, EMA MWP drafting group for a new guideline on predictive biomarker-assay development and the scientific advice working party (SAWP) of the EMA.
