ODD09 – Speaker Profiles
March 8-13, 2009 • Garmisch Germany
Bertil Abrahamsson, Ph.D.
AstraZeneca, Phoenix, Arizona
Bertil Abrahamsson has a broad experience of drug development after more than 20 years with Astra and AstraZeneca (AZ) in various management and expert positions. He presently holds a position as Senior Principle Scientist in AZ and is leading the global biopharmaceutics skill area within the company. He is also an adjunct Professor in Biopharmaceutics at Uppsala University. Bertil’s present research interests includes in vivo predictive dissolution testing, oral drug delivery, in vivo imaging and animal models for pharmaceutical testing. He has published more than 40 papers and book chapters in the biopharmaceutics area and is frequently an invited speaker to international scientific meetings.
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Gordon Amidon, Ph.D.
University of Michigan, Ann Arbor, Michigan
Gordon Amidon is internationally recognized for his research in the field of solubility, transport phenomena, prodrugs, and drug absorption. He is actively involved in developing the Biopharmaceutics Classification System (BCS) with the FDA, which will serve as a basis for international drug regulation.
Gordon received his B.S. degree from the State University of New York, Buffalo (1967), his M.A. degree in mathematics (1970), and his Ph.D. in pharmaceutical chemistry (1971) from the University of Michigan. From 1971 to 1981 he was a member of the faculty at the University of Wisconsin. In 1981 he became director of Pharmaceutical Research at Merck/INTERx, in Lawrence, Kansas. He was appointed Professor of Pharmaceutics at the University of Michigan in 1983 and was named the Charles R. Walgreen, Jr., Professor of Pharmacy in 1994.
Gordon has published extensively in journals, with over 170 published papers and 250 abstracts. He has contributed chapters to over 30 books and monographs. He is co-editor of three books, The Chemical Stability of Pharmaceutics, Peptide-based Drug Design: Controlling Transport, and Metabolism and Pharmacokinetic Analysis, A Practical Approach.
Gordon received the Ebert Prize of APhA in 1974 and 1981, and was co-recipient in 1984. In 1996 he received the Scheele Award of Swedish Academy of Pharmaceutical Sciences for outstanding contributions to the field of oral drug delivery and biopharmaceutics. He is a fellow of AAPS (and served as president in 1998), APhA/APS, and AAAS. He is also a member of the Controlled Release Society (and served as president in 1994), AACP, ACS, and the American Peptide Society.
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Stefan Balbach, Ph.D.
Frankfurt, Germany
Stefan Balbach is pharmacist by training and currently Head of the Analytical Sciences Department at sanofi-aventis in Frankfurt/M., Germany.
He received his Ph.D. in Pharmaceutical Chemistry (1991) from the Johannes-Gutenberg University in Mainz. From 1991 until 1992 he was Post-doctoral Research Fellow in Pharmacokinetics in the group of Prof. Derendorf at the University of Florida, Gainesville. Thereafter, he joined Hoechst AG (now sanofi-aventis) in Frankfurt/M. In 1993, he started at the Medical Sciences and Sales Department as Medical Advisor, and from 1996 until 1999 he was appointed Project Leader for various R&D projects in the cardiovascular field. In 1999, he joined the Analytical Sciences Department as Group Leader "New Projects & Technology", and became Head of the Analytical Sciences Department in 2005.
One major focus of his analytical development activities, has been the characterization and evaluation of early development compounds, which has been published as the so-called "100 mg-approach" in 2004.
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Marival Bermejo
Universidad de Valencia, Spain
mbermejo@uv.es
www.uv.es/~mbermejo/
Marival Bermejo is currently Associate Professor of Pharmaceutics at the University of Valencia (Spain). She earned her B.Pharm and Ph.D degrees at the same University under the supervision of Prof. Plá-Delfina with a grant from Spanish Government. She got a position as Assistant Professor in 1993 and was promoted to her actual position in 1998. She performed two research stages at the Institut of Topology and System Dynamics in Paris VII University, collaborating with Prof. Christiane Mercier and at the University of Michigan, working with Prof. Gordon Amidon. Dr. Bermejo research was centered on biophysical absorption models and their use in the study of the influence of surfactants on intestinal absorption. Her last research projects have been focused on the validation of in situ and in vitro models for oral permeability predictions and their application to the biopharmaceutical development of new fluoroquinolones. Marival Bermejo is member of the “BIOSIM Network of Excellence” and she is the coordinator of the project “MEMTRANS”, both projects funded by the European Commission and devoted to the improvement of in vitro methods for drug absorption predictions and the use of modeling and simulation as tools in drug development. She has been co-author of thirty papers, five of them in Spanish journals, four books chapters and is co-author along with Gordon Amidon of the English and Spanish versions of Modern Biopharmaceutics, a CD-Rom teaching tool. She has co-advised seven PhD. thesis and seven PhD. dissertations since 1998. Dr Bermejo was member of the team of translators of European Pharmacopoeia into Spanish. In 2001 her team was awarded with the Research Prize of “Liconsa-Chemo Ibérica” for their work on fluoroquinolones absorption. She is member of the Board of Directors of the Drug Delivery Foundation (www.ddfint.org). Dr. Bermejo is member of SEFIG and EUFEPS and external assessor of the Spanish Agency of Medicines (AGEMED) and EMEA.
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Mike Bolger, Ph.D.
Simulations Plus, Inc., Lancaster, California
Dr. Bolger is Chief Scientist at Simulations Plus, Inc., Lancaster, California. He obtained a B.A. in Biology and Chemistry from UC San Diego in 1973 and his Ph.D. in Pharmaceutical Chemistry from UC San Francisco in 1978. From 1978-1980 he was an NIH Postdoctoral Fellow in pharmacology at the UC San Diego School of Medicine.
For the next 23 years, he was a professor of Pharmaceutical Sciences at USC School of Pharmacy, Los Angeles, California and he retired from USC in the spring of 2004. During this period he developed an interest in the computational aspects of drug design and drug development. As a faculty member at USC School of Pharmacy, his research was supported by several NIH basic science research grants and he published over 50 peer-reviewed publications. From 1989-1991 he served as a US Food and Drug Administration National Science Advisor. He is Chair of the AAPS Data Mining Focus Group, a member of the editorial board of Pharmaceutical Research and AAPS PharmSci, and has served as a reviewer for numerous scientific publications. He is currently Adjunct Associate Professor of Pharmaceutical Sciences at USC.
From 1987-1993, simultaneous with his academic duties, he was a founder and Director of Medicinal Chemistry at CoCensys Inc. There, he studied the chemistry and use of novel neuroactive steroids for treatment of anxiety, epilepsy, and sleep disorders. Drug candidates emanating from seven of Dr. Bolger’s patents have been tested in Phase I and II clinical trials for petite mal epilepsy, sleep disorders, and migraine.
Currently, he oversees a team of scientist / programmers at Simulations Plus, Inc. (Lancaster, CA) in the development of software programs (ADMET Predictor, GastroPlus, ADMET Modeler, DDDPlus, and MembranePlus) for estimation of biopharmaceutical properties, simulations of absorption and bioavailability, automated generation QSP/AR model building, in vitro dissolution, and cell culture permeability simulation. He was elected to the rank of Fellow of the American Association for the Advancement of Science in 1996.
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Jack A. Cook, Ph.D.
Pfizer Global Research and Development, New London, CT
Jack Cook is a Senior Director of a Clinical Pharmacology group at Pfizer, Inc. Prior to joining Pfizer in 1990, he was a group leader at Sterling Drug, Inc. and served as an adjunct faculty member at Albany College of Pharmacy. He also currently serves as an Adjunct Associate Professor at the University of Michigan. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs.
Jack received an A.A.S. degree in industrial chemistry in 1978 and B.S. degrees in Pharmacy and in Applied Mathematics in 1981 from Ferris State College. He received his Ph.D. from the University of Michigan in 1990.
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John Hilfinger, Ph.D.
TSRL Inc. in Ann Arbor, MI
John Hilfinger is the Executive Vice President of TSRL Inc. He joined the organization in 1994 and has been responsible for implementing and managing a strong, extramurally-funded research and development program directed at drug formulations, drug delivery, prodrugs, and gene delivery. His work includes development of freeze-dried recombinant adenovirus as a potential oral dosage form, microencapsulated oral vaccine formulations, controlled release formulation of recombinant adenoviral vectors, and development of improved drug permeability screens for prodrugs and transporters.
John received his B.S. degree in chemistry from the State University of New York at Syracuse in 1977, and his Ph.D. in biochemistry at the University of Michigan Medical School in 1984. During his postdoctoral work at the University of Michigan, John acquired extensive expertise in molecular biology, protein chemistry, tissue culture techniques, and virology. He has worked on gene regulation in widely diverse biological systems, from ribonucleotide reductase regulation in bacteriophage T4 to HIV-2 and adenoviral expression in human cultured cells. Several papers, review articles, and book chapters have resulted from this work. John is a member of AAPS, CRS, and AAAS.
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Peter Langguth, Ph.D.
Johannes-Gutenberg University, Mainz, Germany
Peter Langguth is pharmacist by training and currently Professor of Biopharmaceutics and Pharmaceutical Technology at the School of Pharmacy, Johannes Gutenberg-University in Mainz, Germany. He received a Ph.D. in Pharmacology (1985) from the Johann Wolfgang Goethe-University in Frankfurt with Prof. Ernst Mutschler. From 1986 until 1988 he was Post-doctoral Research Fellow in Pharmacokinetics in the group of Prof. Edward R. Garrett at the University of Florida in Gainesville and from 1989 until 1995 he was Senior Research Fellow at the Department of Pharmaceutical Technology, Swiss Federal Institute of Technology (ETH) in Zürich, Switzerland. In 1995 he received the Venia legendi (Habilitation) in Pharmaceutical Technology and Biopharmaceutics from the ETH. From 1985 until 1995 he was also Visiting Scientist in various institutions including Alza Corporation, Palo Alto, STADA AG Dortelweil, and the University of Michigan (Prof. Gordon Amidon). In 1996 Prof. Langguth joined the Department of Pharmacokinetics and Drug Metabolism at Astra Hässle AB in Mölndal, Sweden, as Group Leader in Drug Absorption Research. In 1998 Dr. Langguth accepted a call to the University of Mainz as Head of the Department of Biopharmaceutics and Pharmaceutical Technology. His research interests include formulation and absorption of pharmaceuticals including bioavailability, pharmacokinetic and drug targeting aspects.
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Kyung-Dall Lee, Ph.D.
University of Michigan, Ann Arbor, MI
Prof. Kyung-Dall Lee received a BS in Physics (Seoul National Univ) and a Ph.D. in Biophysics from the University of California, Berkeley. Dr Lee was an American Heart Association postdoctoral fellow in membrane biophysics and drug delivery in the lab of Prof. Demetrios Papahadjopoulos at UCSF. He then moved to Boston and served as instructor in the Dept. of Cell Biology at Harvard Medical School.
In 1996, Dr Lee took the current position in the department of Pharmaceutical Science at the Univ. of Michigan, Ann Arbor, where he is currently an Associate Professor of Pharmaceutics. Since 2003, he has served as associate editor of the American chemical society journal, “Molecular Pharmaceutics”. Most recently he served as vice-chair for Gordon Research Conference “Drug Carriers in medicine and biology”, and will be a chair for the conference in 2008. Dr Lee’s main research area is the cellular/subcellular targeting and delivery of drugs, primarily large molecular therapeutic molecules including gene and vaccine delivery. His research is also on the drug targeting using prodrugs and prodrug-activating enzymes that are differentially expressed in target cells.
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Hans Lennernäs, Ph.D.
Uppsala University, Uppsala, Sweden
Dr. Hans Lennernäs is a full professor of Biopharmaceutics at Uppsala University since 1 July 2000, Sweden and he also holds an adjunct professor of Biopharmaceutics at Royal Danish School of Pharmacy in Copenhagen, Denmark since 2000. His research interest is focused on clinical significance of mechanisms and regulation of membrane transport and metabolism of drugs/metabolites in the gastrointestinal tract, hepatobiliary system and cancer tissues. This work is performed in vivo with clinical models in humans and in various tissue and cell culture models. His research aims to develop novel strategies of tissue drug targeting and delivery that aims to improve the clinical use and efficacy of drugs in various disease states, such as metabolic and cancer diseases. Hans Lennernäs has together with gastroenterologists developed and validated two new clinical intestinal perfusion techniques for investigations of intestinal transport and metabolism of drugs and nutrients. He has been the Principal Investigator in an extensive collaboration with Food Drug & Administration, USA, University of Michigan, USA, and Medical Product Agency, Sweden during several years to develop a new guideline for the Biopharmaceutics Classification System. He has established an extensive human permeability database (45 compounds) that today is widely used in academia and pharmaceutical industry. Dr. Lennernäs has been the chairman for numerous international conferences. He serves as reviewer for several scientific journals in clinical pharmacology and pharmaceutical science. His work had led to more 140 publications, 190 invited lectures and more than 300 submitted presentations at scientific meetings. He has supervised 16 doctorial theses and acted as co-supervisor for two neurologists. He has obtained several national and international research grants. Dr. Lennernäs has received Glaxo Wellcome Achievement Award 1997 and Annual Award from the Industrial Pharmacy Section 1998, Fédération Internationale Pharmaceutique (FIP), and a Honourable Mentions at EURAND AWARD 2000, been elected the AAPS Fellow 2004 and received the AAPS Meritorious Manuscript Award 2004. He is on the board of the non-profit Drug Delivery Foundation, which promotes research and education in this area all around the world. He is also one of the innovators to a novel sublingual drug delivery system for the treatment of various acute pain conditions (Abstral, Rapinyl). He has invented seven patent/patent applications, which have resulted in drug products in pre-clinical phase and in preparation for phase I, II and III clinical trials. Abstral (Rapinyl) has been approved in Europe. He is also working with pharmaceutical development of novel strategies for replacement therapy of oral hydrocortisone in adrenal insufficiency and focal hormonal treatment of prostate cancer and BPH. His research team is currently composed of 7 Ph.D. students, and has an extensive national and international interdisciplinary collaboration with both universities and national and international pharmaceutical companies.
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Lennart Lindfors, Ph.D.
AstraZeneca R&D Mölndal and Göteborg University, Sweden
Lennart Lindfors is currently a Principal Scientist at Pharmaceutical and Analytical R&D at AstraZeneca and an adjunct Professor at the Department of Chemistry at Göteborg University since 2007. In 1988 he finished his undergraduate studies in Chemical Engineering at Chalmers University of Technology, Göteborg, after which he started his PhD studies at AstraHässle AB. Although he was employed by Chalmers University of Technology, the research was conducted at the company within the department of Drug Delivery Research. His dissertation was in 1993 with the thesis title “Diffusion and Interaction in Gels and Solutions”. Thereafter he got married and changed his name from Lennart Johansson to Lennart Lindfors (since his wife refused to being Mrs. Johansson!) and went on a post doc to University of California in San Francisco. There he studied swelling kinetics of chemically cross-linked gels together with Professor Ronald Siegel. In 1994 he was finally employed at AstraHässle AB. Since then he has been working within what has now become AstraZeneca R&D Mölndal on gastrointestinal absorption, oral vaccines, and more recently, on molecular simulations and nanoparticle systems of poorly soluble drugs.
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James Polli, Ph.D.
University of Maryland, Baltimore, MD
Dr. James E. Polli is Professor and Vice-Chair of Pharmaceutical Sciences at the University of Maryland School of Pharmacy. He received a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science and a Ph.D. (pharmaceutics) from the University of Michigan. Dr. Polli’s research interest evolves around the performance and pharmaceutical quality of orally administered medicines. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. He has published in the areas of dissolution, drug intestinal permeability, prodrug design, oral bioavailability, in vitro - in vivo correlation, and bioequivalence. He is an Editorial Board member of several journals and is Vice-Chair of the USP Expert Committee on Biopharmaceutics. He is a licensed pharmacist and teaches professional pharmacy students and graduate students.
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Ikumi Tamai, Ph.D.
Kanazawa University, Kanazawa, Japan
Dr. Tamai is Professor of Department of Membrane Transport and Pharmacokinetics, Faculty of Pharmacy, Institute of Medical, Pharmaceutical, and Health Sciences, Kanazawa University since April 2008. He received his B.S. from Kanazawa University in 1982, and Ph.D. in Pharmaceutical Sciences from University of Tokyo in 1988. He studied the carrier-mediated transports of drugs with Prof. Akira Tsuji at Kanazawa University. From 1989, he studied P-glycoprotein with Prof. Ahmad Safa at University of Chicago and intestinal transporters at University of Michigan with Prof. Amidon. In 1991, he joined Prof. Tsuji’s laboratory in Kanazawa University as assistant and associate professor till 2002 and contributed to the researches on the role of P-glycoprotein as the BBB, characterization of PEPT1, molecular cloning and functional characterization of OCTNs and OATPs transporters. In 2002, he was promoted as Professor in Tokyo University of Science, Faculty of Pharmaceutical Sciences, Tokyo, Japan and continued researches on the roles of membrane transporters in drug absorption and disposition. Then, he moved to Kanazawa University in 2008. He has published over 190 original articles related to transporters.
He is studying relevance of transporters to the efficacy and toxicity of drugs as well as to pharmacokinetics of drugs and application to drug delivery by mainly focusing on tissues such as small intestine, liver, kidney and lung. He is also studying physiological transporters such as uric acid, vitamins and amino acids to clarify the roles of transporters for the regulation of nutrients and physiological compounds for the purpose of finding novel pharmacological targets and biomarkers of any diseases. The targeted transporters are OATPs, OCTs, OATs, PEPTs, URAT, PGT, SGLTs, OCTNs, P-gp, MRPs, and others.
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Geoffrey T. Tucker, Ph.D.
University of Sheffield, United Kingdom
Geoff Tucker is Emeritus Professor of Clinical Pharmacology at the University of Sheffield, UK. He graduated in pharmacy (1964) with a Ph.D (1967) from the University of London. He was at the Virginia Mason Research Center (Seattle) and the Anesthesia Research Center, University of Washington (1968-72) before returning to the UK in 1972. He has published widely in the areas of pharmacokinetics, drug metabolism, pharmacogenetics and the pharmacology of drugs used in anaesthesia (‘Highly Cited Author – Pharmacology: Institute of Scientific Information (ISI)). Chairman of the Editorial Board of the British Journal of Clinical Pharmacology (1995-2002), Member of the Council of the British Pharmacological Society (1995-2002), Expert Advisor to the Committee on Safety of Medicines (CSM) (UK) (2000-), Council Member of the Clinical Division of IUPHAR (1995-2005), Member of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)(1995-98; 2005-), Vice-President of FIP (2008-), Councillor – International Society for the Study of Xenobiotics (ISSX)(1988-91; 2004-), Founding Member and Elder of the African Society for Drug Metabolism and Development (2007-), Visiting Professor at the Universities of Harvard, Cincinnati and Otago and the US FDA, Fellow of the Royal College of Anaesthetists (FRCA), of the Royal College of Physicians of Edinburgh (FRCP(E) of the Faculty of Pharmaceutical Medicine (FFPM), Royal College of Physicians UK of the British Pharmacological Society (FBPS) and of the British Toxicological Society (FBTS) and of the American College of Clinical Pharmacology (FCCP), and Chairman of Simcyp Ltd, a University of Sheffield spin-out company (www.simcyp.com.)
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Walter S. Woltosz
Chairman, President and CEO of Simulations Plus, Inc.
Walter S. Woltosz has been Chairman, President and CEO of Simulations Plus, Inc. since its incorporation in 1996, and of its wholly owned subsidiary, Words+, Inc., since its incorporation in 1981.
After serving five years in the U.S. Air Force Strategic Air Command as an Air Launch Missile Systems Analyst, Walt earned a Master of Science in Aerospace Engineering from Auburn University, and a Master of Administrative Science from the University of Alabama in Huntsville. While at Auburn, he was awarded a National Science Foundation Graduate Fellowship and was elected to the Tau Beta Pi national engineering honorary society and the Sigma Gamma Tau national aerospace engineering honorary society.
Walt's multidisciplinary background encompasses three careers. He spent 13 years in the aerospace industry where he pioneered and managed the development of software for the simulation and design optimization of a wide range of solid propellant rocket motors and missile systems, including the Space Shuttle, Advanced Medium Range Air-to-air Missile (AMRAAM), MidgetMan ballistic missile, and Pegasus air launched satellite booster. Prior to founding Simulations Plus, he spent 15 years managing the Company’s Words+ subsidiary, developing augmentative communication systems for persons with severe disabilities, including the system used by Professor Sir Stephen Hawking. Since 1996, he has been involved in developing simulation software for pharmaceutical research, including simulation of gastrointestinal absorption, pharmacokinetics, and pharmacodynamics, and software for predicting the properties of molecules from just their structure. He has authored or co-authored a number of scientific publications and poster presentations relating to oral drug absorption, and has been an invited speaker at numerous scientific meetings in the U.S., Europe, and Japan over the past seven years.
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Shinji Yamashita, Ph.D.
Setsunan University, Osaka, Japan
Dr. Shinji Yamashita is a Professor of Faculty of Pharmaceutical Sciences at Setsunan University, Japan. After receiving Master degree of Pharmaceutical Science in 1982 at Kyoto University, he was employed by Jyosai University as Associate Researcher of Pharmaceutical Sciences. In 1985, he moved to Setsunan University and promoted to Assistant Professor (1989), Associate Professor (1995) and full Professor (2001). He received his Ph.D. degree in 1987 from the Kyoto University under Prof. Hitoshi Sezaki. From 1992 until 1993 he did post-doctoral research work in college of pharmacy, the University of Michigan under Prof. Gordon L. Amidon.
His research interests include pharmacokinetics, drug absorption, drug metabolism and drug delivery systems. Especially, he has been focusing on the screening of intestinal drug absorption by in vitro method using Caco-2 cultured cells. He has published over 50 original research articles and book chapters.
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Lawrence X. Yu, Ph.D.
Director for Science, Office of Generic Drugs, Food and Drug Administration
Dr. Lawrence X. Yu is the Director for Science at the Office of Generic Drugs, Food and Drug Administration. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan and adjunct Professor of Pharmaceutical Sciences at the University of Maryland. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, and Division Director. Dr. Yu is a fellow and the Physical Pharmacy and Biopharmaceutics Section Chair of the American Association of Pharmaceutical Scientists (AAPS) and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers, book chapters, and abstracts, and given over 120 invited presentations. He is a co-editor of the book entitled "Biopharmaceutics Applications in Drug Development". Dr. Yu received his B. S. in Chemical Engineering from Zhejiang Institute of Technology, his M. S. in Chemical Engineering from Zhejiang University, his M. S. in Pharmaceutics from the University of Cincinnati, and his Ph.D. in Pharmaceutics from the University of Michigan.
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