Dr. Christoph Kneip

Responsible for establishment and technical validation of biomarker assays used in clinical drug programs. Expert on molecular technologies and required validation parameters. Provision of technical expertise and guidance on new technologies, transfer of molecular assays from early programs to analysis labs. Networking with academic institutions, diagnostic companies, industry associations and health authorities and ethics committees. Ensure compliance of biomarker assays and companion diagnostic products.

Maintain oversight of regulatory strategies for all projects with IVD/CDx component. Build and maintain relationships with regulatory colleagues from external Dx partners. Support development of CDx related documents for submissions to Health Authorities or Ethics Committees. Monitor key changes in the regulatory environment in the area of personalized medicine, with special focus on IVDs. Provide technical expertise surrounding biomarker technologies to support CDx development programs.

Development and validation of biomarker assays to support clinical trials, including assays for drug-response analysis, efficacy/safety prediction, prospective patient stratification. Support of external companion diagnostic projects. Expert for medical devices and biomarker technologies. Internal and/or external development of assays of all levels of qualification: RUO, LDT, CAP/CLIA, CE-IVD, 510k, PMA. Management of collaborations with external CROs and analytical labs around the world.

Assay- and product development of cancer molecular diagnostics. Development, validation and verification of biomarker assays. Technical lead design, development and verification of the CE-IVD products RNXtract and Mammatyper. In the context of cancer molecular diagnostics, Mammatyper is the first CE-IVD kit using RTqPCR based gene expression (RNA) analysis for subtyping/classification.

Technischer Leiter Entwicklung eines CE in-vitro Diagnostik Produkts zur Krebsfüherkennung, Assay-/Produktenwicklung, vom Assaydesign bis zur Markteinführung. Labororganisation, Dokumentation, Durchführung klinischer Studien.

Forschung an epigenetischen (methlylierungsspezifischen) Biomarkern zur Krebsfrüherkennung. Entwicklung eines CE in-vitro Diagnostik Produkts zur Krebsdiagnose, vom initialen Design bis zur Markteinführung. Assay-/Produktenwicklung, techn. Dokumentation, Durchführung klinischer Studien.

Molekulare Zellbiologie, Molekularbiologie, Nukleinsäureanalytik, Genomsequenzierung und-analyse

Zellbiologie, Parasitologie, Med. Mikrobiologie, Immunologie