Dr Michael Rothe

Lead scientist · Hannover Medical School · company speakers →

Michael Rothe is a lead scientist at the Hannover Medical School’s Institute of Experimental Hematology in Hannover, Germany. He is a biologist by training and focuses on the safety assessment of retroviral vectors that are used in gene therapy. Many inherited diseases can be treated with gene modification of hematopoietic stem cells, but in early clinical trials, several patients suffered from retroviral vector-induced leukemia. The risk for malignant mutagenesis due to gene insertion can be addressed by viral integration site analysis in animal models, but the predictive value of these studies is limited and the burden to the animal is not justified when an alternative exists. The In Vitro IMmortalization assay (IVIM), developed at the Hannover Medical School (MHH) in 2006, is a powerful in vitro test and has become a de facto gold standard assay for retroviral vector safety analysis and is considered a crucial element of an investigational new drug or clinical trial application by regulatory agencies (EMA, FDA, TGA, Health Canada). IVIM still has limitations associated with the use of myeloid cytokines and sensitivity. To overcome these limitations, Dr. Rothe and his team has developed the Surrogate Assay for Genotoxicity Assessment (SAGA). SAGA determines the risk of vector mutagenicity based on machine learning techniques applied to gene expression data. Currently, Dr. Rothe is working on an all-in-one safety test that detects insertional mutants, also from the lymphoid lineage. This work is conducted within the framework of the R2N (https://r2n.eu/ – Replace and Reduce in Lower Saxony, Germany), a consortium devoted to developing alternative methods to replace and reduce animal models in biomedical research.

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