Dr. Lutz Mueller
I am a biologist with a Ph.D. in genetics as of 1986 and supplemental qualifications in EUDIPHARM and PharmaTrain in the EU.
I started my professional career in the German Federal Health Office in 1986 as a reviewer in the Department of Pharmacology and Toxicology at the Institute for Drugs in Berlin, Germany.
In 1989, I was appointed Head of the Section on Mutagenicity and Carcinogenicity in the German Federal Institute for Drugs and Medical Devices.
In leading this section, I translated the results of experimental research activities of the section on mechanisms of action in these areas into the risk/benefit assessment and approval process of new pharmaceuticals on the national and EU level.
The section included an active experimental safety research group that was supported by various German and EU research grants.
On the international level, I was appointed to serve as an expert toxicologist to the Safety Working Party of the EU CHMP and became ICH Rapporteur for the ICH guidelines on genotoxicity in 1992.
These guidelines were successfully finalized and came into operation in 1995 and 1997.
In June 2000, I joined the global Preclinical Safety Organization of Novartis Pharma AG in Basel, Switzerland.
At Novartis I supported the research and development process within Preclinical Safety (PCS) towards an optimized screening and selection strategy as global expert in Experimental and Molecular Toxicology and subsequently as Head of Investigational and in silico Safety & Metabolism. In addition, in my role as an international project team representative, I contributed to safety testing, evaluation and regulatory documentation for several projects in oncology. As globally responsible advisor for drug quality, I supported the Novartis technical organization for drug quality processes.
In November 2004, I joined the Pharmaceutical Sciences organization of F. Hoffmann-La Roche in Basel as Toxicology Project Leader. Since then, I have led the toxicology program for various projects in immunology, inflammation, virology, cardiovascular & metabolic, CNS and rare diseases involving small molecules and biologics.
Currently, I have responsibility for oversight on non-clinical safety for projects in early and advanced stages of pre-clinical, clinical development and selected marketed drugs. Projects with my contribution have passed successfully reviews by Health Authorities in all ICH regions (US, Europe and Japan) as well as in other countries such as China in all stages of preclinical, clinical development, approval for marketing and post-approval reviews.
Since 2006, I represent the European Pharmaceutical industry in the ICH process for ICH safety guidelines, including the revision of ICH S2 (genotoxicity testing) and ICH M7 (Mutagenic and Carcinogenic Impurities).
Within F. Hoffmann-La Roche, I serve on the Non-Clinical Drug Safety Governance body and chair the Carcinogenicity Strategy Advisory Board.
I am the liaison for the neuroscience, ophthalmology and rare diseases therapeutic areas in Roche Pharma Research and Early Development (pRED) and for the non-clinical/clinical translation into clinical development.
My contributions to research on and guidance for toxicity testing and assessment thereof for pharmaceuticals have resulted so far in more than 100 original publications, monographs and book chapters.
I have frequently organized and lectured on international conferences in toxicology and R&D in drug development.
