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SELECTBIO Conferences ADME & Predictive Toxicology Europe

Gerhard Gross's Biography

Gerhard Gross, Head, Lundbeck Pharma

Gerhard has a B.Sc. degree in Physics and Chemistry, and received his M.Sc. in Physics and Chemistry (1980) and Ph.D. in Organic Chemistry (1983) from the University of Marburg where he studied the generation of reactive molecules through flash vacuum pyrolysis. As a postdoc he worked with Prof. Michl in Utah, USA on multiple silicon bonds. In the past years Gerhard was holding several senior positions in the pharmaceutical industry, among them Department Head of ADME at Novartis, head DvDMPK AP at AstraZeneca as well as Section Director ADME at AstraZeneca UK, Alderly Park and Global Discipline Leader in ADME. Currently he is Head of Drug Metabolism department at Lundbeck A/S in Copenhagen. He is also a member of the scientific advisory board of Entomopharm and a guest lecturer at the university of Copenhagen. Gerhard has extensive experience in the area of drug metabolism and drug development. He was setting up ADMET screening and profiling at Novartis and Aventis. He has been a key player in the development and registration of numerous drugs during his work for Novartis, e.g. Glivec, Everolimus, Exjade, Myfortic, Rasilez, Zelmac and Zoledronate. He holds several patents for Glivec, Exjade and Rasilez. In AstraZeneca he was establishing a transporter group, an outsourcing group and a biomarker group at Alderly Park in 2006. In 2008 he was leading a cross functional team within AstraZeneca to elaborate an internal strategy for the new FDA MIST guideline. At Lundbeck, he was establishing the companies strategy for transporter and reactive metabolites, as well as strategically aligning the interface between discovery DMPK and development. There he was also responsible for the DMPK part of filing Nalmefene and also involved in the filing of Clobazam. He is the author of 29 publications and gave more than 21 lectures at scientific congresses. He also gave lectures on the subject of metabolites and toxicity, as well as on pharmacokinetics and enzyme kinetics at the Universities of Bern, Switzerland and Copenhagen, Denmark.

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Metabolites and Safety, the MIST and ICH-M3 Guidance and their Impact on ADME

Wednesday, 14 March 2012 at 11:45

Add to Calendar ▼2012-03-14 11:45:002012-03-14 12:45:00Europe/LondonMetabolites and Safety, the MIST and ICH-M3 Guidance and their Impact on ADMEADME and Predictive Toxicology Europe in Munich, GermanyMunich,

Content of FDA MIST guidance and the ICH-M3 guidance is presented. Industrial strategies, including the Lundbeck approach, regarding these guidances are outlined and exemplified through recent studies. New models in this area and their application are discussed as well.

Add to Calendar ▼2012-03-13 00:00:002012-03-14 00:00:00Europe/LondonADME and Predictive Toxicology EuropeADME and Predictive Toxicology Europe in Munich, GermanyMunich,