Hilke Zander
Clinical Assessor Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices
Hilke Zander (Ph.D., MDRA) is clinical assessor at the Paul-Ehrlich Institute (PEI) in the section of monoclonal and polyclonal antibodies. Hilke Zander studied human biology at Philipps-University Marburg and the Institut Curie, Paris. After receiving her Ph.D. in antibody engineering from the TU Munich, 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 authorization 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 Diagnostica Regulation 746/201. 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 CHMP/CAT CDx Expert Group , EMA SIA PGx (Leadership Team), and EU COMBINE Project and the scientific advice working party (SAWP).
Seminars
- How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
- Is there any strategy change in aligning with notified bodies and regulators?
- What are the most common bottlenecks companies encounter during co-development; from clinical trials to MAA and conformity assessment?
- News on the European regulatory framework for biomarker-guided medicines and CDx
- Current experiences and challenges to streamline co-development
- Updates from the EU COMBINE Project
