Scientific publication record: More than 100 original publications in peer reviewed journals and various book chapters. Lutz Müller supports the overall strategy of the company in developing new medicines in these areas. As disease therapeutic area liaison for NORD (Neuroscience, Rare Diseases, Ophthalmology) in pharma research and early development (Roche pRED), Dr. Müller has been involved in the ICH guideline process since its inception in the early nineties of the last century. In terms of scientific expertise, genotoxicity, impurities, carcinogenicity, immunotoxicity, in vitro systems, risk assessment, regulatory toxicology are his primary reference areas.ĭr. These span small molecules, peptides, antisense molecules, and biologicals. The focus of his work is on projects in R&D in therapeutic areas such as nervous system, cardiovascular, inflammation, immunology, oncology, and rare diseases. Lutz Müller is a project leader in toxicology with F.
He also published a book addressing genotoxic impurities, 'Genotoxic Impurities Strategies for Identification and Control' (Wiley and Son), and is soon to publish as editor a book focussed on the practical implementation of ICH Quality Guidelines.ĭr. Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He has also led a number of industry expert groups these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences.
In his current role, he chairs AstraZeneca's Impurity Advisory Group.
Andrew has over 20 years' experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles.
It is an honour and privilege to invite you to participate in this Summit. The Summit will shed light on the practice of the implementation of recent updates in ICH M7 and Q3D, and novel strategies for efficient mutagenic and elemental impurity identification and control.
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