Lutz Mueller

Project Leader Non-Clinical Safety
F. Hoffmann-La Roche Ltd
Short Bio - Dr. Lutz Mueller Project Leader Non-Clinical Safety Distinguished Scientist F. Hoffmann-La Roche Ltd., Basel, Switzerland Education: Biologist with a Ph.D. in genetics. 1983-1989: Scientist in the Department of Toxicology of the German Federal Institute for Drugs and Medical Devices, Berlin, Germany. 1989-2000: German Federal Institute for Drugs and Medical Devices (BfArM), Berlin, Germany • Head of Section Mutagenicity and Carcinogenicity o Review process for marketing authorization of new pharmaceuticals o Generation of national, EU and international regulatory guidelines (ICH) o Experimental research into mechanisms of Genotoxicity and Carcinogenicity o Risk-benefit assessment for pharmaceuticals 2000-2004: Preclinical Safety Management, Novartis Pharma AG, Basel, Switzerland • Global expert in Experimental and Molecular Toxicology • Head of Investigational and in silico Safety & Metabolism • Project Team Representative, Oncology • Global Drug Quality Expert Since November 2004: Pharmaceutical Sciences, F. Hoffmann-La Roche, Basel, Switzerland • Toxicology Project Leader in R&D (Nervous System, Rare Diseases, Ophthalmology, Cardiovascular System, Inflammation, Metabolic Diseases) • Projects in early and late stage development with small molecules, biologicals, antisense modalities and vector-based gene therapy • Dedicated expertise in Genotoxicity, Carcinogenicity, Immunotoxicity, Impurities management, In vitro systems, safety risk assessment, regulatory toxicology • EFPIA representative to the ICH Guideline Expert Working Groups (currently Mutagenic Impurities – M7) • Member of various Roche Drug Development and Portfolio Committees • Non-Clinical Leader for IND and clinical trial submissions and submissions for drug approval processes (NDA, MAA, world-wide submissions) Scientific publication record: Over 100 original publications in peer reviewed journals and various book chapters. Organizer/lecturer of/on many international meetings and workshops

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