ADME & Predictive Toxicology Europe Keynote Speakers

Frank Gonzalez Chief, National Institutes of Health Frank Gonzalez received a Ph.D. in Oncology from the University of Wisconsin, Madison. Following postdoctoral study, he joined the National Cancer Institute where he is Chief of the Laboratory of Metabolism in the Center for Cancer Research. His research is focused on investigating the drug metabolism, mechanisms of chemical toxicity and carcinogenesis. Metabolomics and mouse models are a major focus of the laboratory.
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.
Robert Guttendorf Senior Consultant, DMPK, Aclairo Pharmaceutical Development Group Robert J. Guttendorf, R.Ph, Ph.D. is a Senior Consultant, DMPK, at Aclairo Pharmaceutical Development Group, Inc. in Vienna, VA. Dr. Guttendorf provides scientific, regulatory, strategic planning, and due diligence advice and support for drug discovery and development. He has held leadership positions in small biotech and large pharmaceutical companies, including Director of Discovery and Preclinical Development at Pfizer Global R&D and Parke-Davis Pharmaceutical Research, Scientific Strategy Advisor at Pfizer, Vice President of Pharmacology and Biopharmaceutics at Advancis (Middlebrook) Pharmaceutical Co., and Vice President of Pharmacology and Experimental Therapeutics at Sequoia Pharmaceuticals. He has directed ADME/PK support for discovery through NDA across a variety of therapeutic areas, overseeing numerous nonclinical pharm-tox and clinical pharmacology programs, and a host of regulatory submissions. At Parke-Davis/Pfizer, he helped pioneer the implementation of higher throughput ADME/PK screening approaches in drug discovery and was instrumental in defining best practices for DMPK in drug discovery and development. In addition, he led Pfizer’s Global PDM organization in evaluating and implementing new strategies to enhance the quality and R&D survival of exploratory development candidates. He has presented and published numerous papers on various topics in ADME/PK, including the strategic use of ADME data to improve drug discovery and development. He received a B.S. in Pharmacy from West Virginia University and a Ph.D. in Pharmaceutical Sciences from the University of Kentucky.
Magnus Ingelman Sundberg Professor/Head, Karolinska Institutet Magnus Ingelman-Sundberg is a PhD and BSc.Med. He is Chairman of the Editorial Board of Pharmacogenetics and Genomics and Chairman of the Microsomes and Drug Oxidation organisation. He has been working with pharmacogenomics at EMA (PGWP) since 2005. He has 350 original papers, 17 500 citations and an h-factor of 72. He is ranked as the 4th most highly impact researcher in the field of drug metabolism (www.cytochrome.net ) and one of the worlds most cited authors within the category Pharmacology http://isihighlycited.com/ . The current research is centered about genetic predictors for drug response and adverse drug reactions.
Roland Wolf Director, University of Dundee Roland Wolf graduated from the University of Surrey in 1972 with a BSc Honours in Chemistry followed by a PhD in Biochemistry finishing in 1975. He currently holds the position of Research Director at the University of Dundee Medical Research Institute and is also an Honorary Director at the Cancer Research UK Molecular Pharmacology Unit. Finally Roland is the Scientific Director at CXR Biosciences, based in Dundee, UK. Roland’s main research interests are understanding the pathways which determine the sensitivity of cells to drugs, environmental agents and chemical toxins, particularly molecular and genetic studies on how chemical agents interact with cells, how this influences their therapeutic and toxicological properties and how genetic polymorphisms in the genes involved relate to disease susceptibility, adverse drug pharmacology and toxicology. Specific current projects focus on preclinical drug development, pharmacogenetics, cancer therapy, the personalised treatment of cancer and chemoprevention. He has published over 460 papers in peer-reviewed scientific journals and is a member of numerous national and international committees and advisory panels. In 2001 Roland co-founded CXR Biosciences, which has a major focus on developing new models to accelerate the drug development process and reduce attrition when drugs enter man. Awarded an OBE in the 2010 New Year Honours List, Roland is a Fellow of the Royal Society of Edinburgh, the Academy of Medical Sciences, the Royal Society for the encouragement of Arts, Manufactures & Commerce and the British Toxicology Society. Roland is also recipient of the Gerhard Zbinden Award for contributions to the area of drug and chemical safety, the European Scientific Achievement Award 2005 from the International Society for the Study of Xenobiotics (ISSX) and Scottish Enterprise Award for Leading Individual Contribution to Life Sciences in Scotland in 2006.
Tsuyoshi Yokoi Professor, Kanazawa University Tsuyoshi Yokoi, Ph.D., Professor, Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University. After graduating from the Gifu Pharmaceutical University, he has obtained Ph.D. in Pharmacology from Tohoku University in 1985. He started his professional career as a research associate at Gifu University, Gifu, and as an assistant professor in Tohoku University, Sendai, and as an associate professor in Hokkaido University, Sapporo, then as a professor in Kanazawa University, Kanazawa from 1997.