THE DELAWARE VALLEY DRUG METABOLISM DISCUSSION GROUP A Symposium on Mass Spectrometric Analysis of Protein Drugs (18April2012) Speaker Biographical Sketches Ian Blair Centers for Cancer Pharmacology and Excellence in Environmental Toxicology, University of Pennsylvania School of Medicine, Philadelphia, PA Dr. Blair received his Ph.D. in Organic Chemistry in 1971 from Imperial College of Science and Technology, London, where he worked under the direction of the Nobel Laureate Sir Derek H.R. Barton. He then taught organic chemistry at Makerere University, Uganda, under the auspices of the British Council’s aid scheme to Africa. He subsequently moved to Australia where he held research fellowships at the Australian National Univ. in Canberra and at Adelaide Univ.. Dr. Blair conducted some of the early ion cyclotron resonance mass spectrometry studies with Dr. John Bowie during his time at Adelaide Univ. In 1979, he was appointed to a lectureship and then senior lectureship in the Depart. of Clinical Pharmacology at the Royal Postgraduate Medical School (now part of Imperial College, London). In 1983 he moved to Vanderbilt University as a Professor of Pharmacology and Chemistry. Dr. Blair established a large Mass Spectrometry Center in the School of Medicine for the analysis of drugs and their metabolites, DNA-adducts, and proteins. In 1996, Dr. Blair was appointed to the Derek H.R. Barton Chair in Pharmacology. He was recruited to the University of Pennsylvania in 1997 as the A.N. Richards Professor of Pharmacology to establish a new Center for Cancer Pharmacology. In 2002, Dr. Blair was appointed as the Vice-Chair of the Depart. of Pharmacology and in 2003 he established a MS-based Proteomics and Systems Biology Facility at the Univ. of Pennsylvania. Dr. Blair is an internationally renowned expert in the use of MS- and NMR-based methods for the structural elucidation and quantification of endogenous biomolecules, DNA-adducts, protein-adducts, and drugs and their metabolites. He has published over 300-refereed manuscripts most of which have employed the use of mass spectrometry. A paper describing the application of electron capture atmospheric pressure chemical ionization to chiral lipid analysis was awarded the 2005 RCM Beynon Prize. In 2005, Dr. Blair became the 7th mass spectrometrist to be elected as a Fellow of the Amer. Association for the Advancement of Science. In 2006, he was awarded the prestigious Dean's award for graduate student training at the Univ. of Pennsylvania and was elected as a Fellow of the Amer. Assoc. of Pharmaceutical Scientists for his distinguished contribution to the pharmaceutical sciences. He received the Eastern Award for Outstanding Achievements in Mass Spectrometry at a symposium in his honor in November 2011. Dr. Blair is on the editorial boards of the Journal of Lipid Research, Chemical Research in Toxicology, Journal of Mass Spectrometry, Prostaglandins and Other Lipid Mediators, and Current Drug Metabolism, and he regularly serves on NIH study sections. Most recently he became a charter member of the Drug Discovery and Molecular Pharmacology (DMP) Study Section and is currently chair-elect of the Study Section. Daryl Davis Principal Research Scientist, Characterization Group, Large Molecule Method Development, PDMS Janssen R&D, Radnor, PA 19087 Dr. Davis holds a doctorate in Medicinal Chemistry from the Philadelphia College of Pharmacy and Science. His thesis focused on the use of MS in the characterization and quantitation of peptide phosphorylation. He started his career at J&J as a COSAT intern using MS to characterize the glycan linkages found on Remicade. Upon receiving his doctorate he accepted a full-time position within the Bioanalytical Characteriztion group at Centocor, a J&J company. Since joining J&J he has had a wide variety of responsibilities including starting and leading several sub-groups, analytical CMC lead, member of CDTs, member of technology development team for alternative production platforms and new technology and innovation lead within analytical. He has won several innovation awards within J&J for his work on automation and high-throughput analysis which continues to be his current focus. Steve Dueker Chief Scientific Officer, Vitalea Science, Davis, CA 95618 Dr. Dueker is a co-founder of Vitalea Science and currently serves as Chief Scientific Officer, having previously served as President until 2010. He received his Ph.D. in Analytical Chemistry from the University of California at Davis (UCD), and subsequently continued his career at UCD as a Faculty Research Professor in the Department of Human Nutrition. At the University he and his colleagues conducted the first human clinical trials to enlist the high sensitivity of 14C-Accelerator Mass Spectrometry for pharmacokinetic and metabolism research; these studies provided the background for the transference of AMS technology to pharmaceutical development in the forms of human microdosing and low radioactive ADME. In 2003 he left the University to form Vitalea Science. In 2008 he led the development and transfer of state-of-the-art AMS technology from the Swiss Federal Institute of Technology (ETH) to Vitalea. He continues to have an active role in the advancement of accelerator technology in collaboration with his scientific advisory board and ETH. As Chief Scientific Officer, he is keenly focused on development of new pharmaceutical applications for AMS while being an active participant in on-going focus groups related to regulated bioanalysis. He has >40 peer-reviewed publications, book chapters and review papers and is a frequently invited speaker on the application of AMS to human and non-clinical ADME/metabolism studies. Mohammed Jemal Senior Research Fellow in Bioanalytical and Discovery Analytical Sciences, Bristol-Myers Squibb, Plainsboro, NJ Mohammed Jemal, PhD, is a Senior Research Fellow in Bioanalytical and Discovery Analytical Sciences, Bristol-Myers Squibb. Over the years, Dr. Jemal has made notable contributions in bioanalytical/analytical sciences. He is the corresponding/first author of at least 75 scientific papers in peer-reviewed journals, with a total of 105 peer-reviewed publications. He is the author/co-author of more than 142 presentations at national meetings. Dr. Jemal’s contribution to bioanalytical sciences was featured as the cover story in the July 1999 issue of the Drug Discovery & Development magazine. He was elected AAPS Fellow in 2003 recognizing his professional competence reflected through scholarly and research contributions to the pharmaceutical sciences. He is the recipient of the 2006 AAPS Research Achievement Award for outstanding contributions to pharmaceutical sciences in the areas of biomedical and pharmaceutical analysis. Dr. Jemal is also the recipient of the 2007 North Jersey ACS Mass Spectrometry Discussion Group Award for achievements in mass spectrometry. His current interests include the use of LC-high resolution accurate mass spectrometry (LC-HRMS) for quantitative bioanalysis and the application of LC-mass spectrometry for the bioanalysis of therapeutic proteins in conjunction with ligand binding assay techniques. Hongyan Li Principal Scientist, PKDM Department, Amgen Inc, Thousand Oaks, CA Dr. Hongyan Li is a principal scientist at the PKDM department of Amgen Inc. He received his Ph.D. in analytical chemistry in 2003 at Purdue University and joined Amgen in the same year. He has been primarily responsible for mass spectrometry based bioanalytical method development and method validation for peptide/protein biomarkers, therapeutic peptides/peptide conjugates (PEG, FC and mAb), therapeutic proteins, mAbs and antibody-drug-conjugates. His research interest also includes peptide/protein biotransformation, ligand binding assay and analytical instrumentation. Rand Jenkins Scientific Director, Chromatographic Sciences Depart, PPD Bioanalytical Lab, Richmond, VA USA Rand G. Jenkins, B.S., is Scientific Director for the Chromatographic Sciences Department of the PPD Bioanalytical Laboratory in Richmond, VA USA. He received his undergraduate degree in Chemistry in 1972 from the University of Nevada and attended graduate school at the University of Washington, while conducting GC-MS-based bioanalysis research as a Senior Research Technologist in the Departments of Pathobiology and Psychiatry. He later served as an Applications Chemist at Finnigan Instruments and a Research Chemist at the National Marine Fisheries Service/NOAA, conducting environmental bioanalysis in marine organisms. Throughout the 1980’s, Mr. Jenkins was the Director of R&D at J&W Scientific (now part of Agilent), where he developed the first commercial bonded-phase fused silica capillary GC columns. Mr. Jenkins returned to pharmaceutical bioanalysis in 1994, joining Pharmaco, which later merged with PPD. In his current position, Mr. Jenkins directs a staff of 27 scientists in conducting bioanalytical methods research and development using LC-MS technologies, with a current major focus on macromolecule analytes. Kevin Meyer Research Scientist, Perfinity Biosciences, West Lafayette, IN Kevin Meyer graduated from Wabash College in 2006. As an original member of Perfinity Biosciences, Kevin was mentored by founder Fred Regnier and has focused his research on the areas of protein purification, column synthesis and automation.