ANTHONY J. HICKEY, PHD, DSC
Professor of Molecular Pharmaceutics
School of Pharmacy
Biomedical Engineering of the School of Medicine
University of North Carolina at Chapel Hill
Dr. Hickey is Program Leader in Inhaled Therapeutics in the Center for Aerosol and Nanomaterials Engineering at the Research Triangle Institute, Emeritus Professor of Molecular Pharmaceutics of the Eshelman School of Pharmacy, and Adjunct Professor Biomedical Engineering of the School of Medicine, at the University of North Carolina at Chapel Hill (Professor, 1993-2010). He obtained Ph.D. (1984) and D.Sc. (2003) degrees in pharmaceutical sciences from Aston University, Birmingham, UK. Following postdoctoral positions, at the University of Kentucky (1984-1988) Dr. Hickey joined the faculty at the University of Illinois at Chicago (1988-1993). In 1990 he received the AAPS Young Investigator Award in Pharmaceutics and Pharmaceutical Technology. He is a Fellow of the UK Society of Biology (2000), the American Association of Pharmaceutical Scientists (2003) and the American Association for the Advancement of Science (2005). He has published numerous papers and chapters in the pharmaceutical and biomedical literature, one of which received the AAPS Meritorious Manuscript Award in 2001. He has edited five texts on pharmaceutical inhalation aerosols and co-authored others on Pharmaceutical Process Engineering, Particulate Science and Pharmaco-complexity. He is founder, President and CEO of Cirrus Pharmaceuticals, Inc. (since 1997), founder (2001, and formerly CSO, 2002-2007) of Oriel Therapeutics, Inc, which was acquired by Sandoz in 2010, member of the Pharmaceutical Dosage Forms Expert Committee of the United States Pharmacopeia (2010–2015) and formerly Chair of the Aerosols Expert Committee of the United States Pharmacopeia (2005-2010). Dr. Hickey conducts a multidisciplinary research program in the field of pulmonary drug and vaccine delivery.
COURTNEY V. FLETCHER, PHARMD
Dean and Professor
University of Nebraska
College of Pharmacy
Dr. Fletcher is presently Dean, College of Pharmacy and Professor, Departments of Pharmacy Practice and Division of Infectious Diseases, Department of Internal Medicine at the University of Nebraska Medical Center. He is the Director of the Antiviral Pharmacology Laboratory at University of Nebraska Medical Center. Dr. Fletcher received his Bachelor of Science degree in Pharmacy (with honors) from the University of Wyoming, and his Doctor of Pharmacy degree from the University of Minnesota. Dr. Fletcher has previously held faculty positions at the University of Colorado Health Sciences Center, University of Minnesota and Drake University. Dr. Fletcher has devoted his research and practice interests towards the clinical pharmacology of antiviral agents. Dr. Fletcher has 14.5 years of academic administrative experience including five years as Chair, Department of Clinical Pharmacy at the University of Colorado Health Sciences Center; three years as Director of Graduate Studies in Social, Administrative and Clinical Pharmacy at the University of Minnesota; three years as Assistant Head, Department of Pharmacy Practice at the University of Minnesota; and four years as Assistant Director of Pharmaceutical Services at the University of Minnesota Hospital and Clinic. Dr. Fletcher is a past member of the FDA Antiviral Drug Advisory Committee. He recently completed a four-year term as a member of the NIH AIDS Discovery and Development of Therapeutics Study Section. He is a member of the Department of Health and Human Services (DHHS) Panel on Clinical Practices for the Treatment of HIV Infection.
Dr. Elmquist is currently Professor and Chair at the Department of Pharmaceutics
and Director, Brain Barriers Research Center at the University of Minnesota. Dr. Elmquist's laboratory studies the biochemical and physiological determinants of drug absorption, distribution and elimination. Most of this work has involved the use of in vitro cell culture and in vivo animal models. Recent studies have focused on the role of drug transport proteins in drug disposition. Particular emphasis has been placed on determining the role of membrane-associated drug transport proteins in the distribution of drugs to target tissues. Current research examines the effect that various drug transport systems, such as p-glycoprotein (ABCB1), the multidrug resistance-associated proteins (ABCCx), and the breast cancer resistance protein (ABCG2) have on drug distribution to the central nervous system (CNS). The use of molecular biology, in vitro models, intracerebral microdialysis and gene knockout animals have been important tools in this research. Long-term objectives of Dr. Elmquist's research include examining expression and regulation of transport systems in key tissues that influence drug disposition, and how variability in expression, either genetically or environmentally controlled, may contribute to variability in drug response in the patient.
DARRELL J. IRVINE, PHD
Associate Professor of MSE and Biological Engineering
Investigator, Howard Hughes Medical Institute
Biological Engineering Division /Department of Materials Science & Engineering, MIT
Prof. Irvine received his bachelor’s degree in Engineering Physics from the University of Pittsburgh in 1995. He then moved to MIT for his graduate work with Profs. Anne Mayes and Linda G. Griffith in the development of surface modification strategies for the creation of protein adsorption-resistant, peptide-presenting surfaces. In this work, the nanoscale clustering of adhesion peptides from surfaces was controlled using novel amphiphilic comb copolymers of varying structure. He received his PhD in 2000 in Polymer Science. As a Damon Runyon-Walter Winchell Postdoctoral Fellow, Dr. Irvine moved from the physical sciences to the life sciences, studying fundamental aspects of T cell recognition in the laboratory of Mark M. Davis at Stanford University from 2000-2002. High resolution 3D fluorescence microscopy and a novel peptide-tagging approach was applied to quantify the number of antigenic peptides required to elicit T cell activation and formation of immunological synapses between T cells and antigen presenting cells, a long-standing question of basic interest for understanding the mechanisms of T cell priming. In 2002 he returned to MIT with a dual appointment in Materials Science & Engineering and Biological Engineering. He is also a member of the Koch Institute for Integrative Cancer Research at MIT. Prof. Irvine is the recipient of an Arnold and Mabel Beckman Foundation Young Investigator Award, an NSF CAREER award, and was selected to the Technology Review ‘TR100’ in 2004. In 2008 he was selected as a Howard Hughes Medical Institute Investigator. He is currently a member of the Steering Committee for the Ragon Institute of MGH, MIT, and Harvard.
Ted Randolph received his Ph.D. in Chemical Engineering at the University of California, Berkeley. He worked as a postdoctoral fellow at the Ecole Polytechnique Federale de Lausanne, and then joined the Department of Chemical Engineering at Yale University as an Assistant Professor. After promotion to Associate Professor, he was named to Yale’s first John J. Lee Junior Professorship Chair in Chemical Engineering. In 1993, Dr. Randolph accepted the Patton Associate Professorship Chair in the Department of Chemical Engineering at the University of Colorado. He currently serves as the Gillespie Professor of Bioengineering, co-Director of the University of Colorado’s Center for Pharmaceutical Biotechnology, and Director of the NIH Leadership Training in Pharmaceutical Biotechnology Program. Dr. Randolph is a National Science Foundation Presidential Young Investigator, and received the AIChE Professional Progress Award and the American Pharmacist’s Ebert Prize. His research interests include biopharmaceutical formulation, lyophilization of proteins, protein solvent interactions in non-aqueous environments, and protein refolding. His 134 publications have been cited 3167 times, a remarkable 23.6 times per publication.
JÜRGEN VENITZ, MD, PHD
Departments of Pharmaceutics, Medicinal Chemistry and Pharmacotherapy
Director of the Pharmacokinetic-Pharmacodynamic Laboratory
Virginia Commonwealth University
Dr. Jürgen Venitz is currently Associate Professor, Depts. of Pharmaceutics, Medicinal Chemistry, and Pharmacotherapy and Outcomes Sciences and Director of the Pharmacokinetic-Pharmacodynamic (PK/PD) Laboratory at the School of Pharmacy as well as Fellow at the Center for the Study of Complexity Sciences at Virginia Commonwealth University (VCU), Richmond, VA. Dr. Venitz received his M.D. in 1981 from the Universität des Saarlandes in Saarbrücken, Germany, where he also received his Ph.D. in physiology in 1986. From 1981 to 1985, he was Director of Clinical Research and Development at the Institut für Klinische Pharmakologie (IKP) Bobenheim in Grünstadt, Germany. He was in charge of a Phase I Clinical Pharmacology Unit and responsible for design, implementation and data analysis of phase I and PK/PD studies. From 1985 to 1987 he completed a postdoctoral research fellowship with Dr. E.R. Garrett at the Beehive, College of Pharmacy, University of Florida, Gainesville, FL.
In 1988, Dr. Venitz joined the faculty at the VCU School of Pharmacy where he has been teaching and mentoring numerous Pharm.D., Ph.D. and postdoctoral students. He has published and presented extensively to various scientific audiences in the area of PK/PD in early clinical drug development. He has served and continues to serve on multiple university, AAPS, ACCP, ASCPT, NASA, NIH, and FDA committees. For his research accomplishments, he was awarded ACCP and AAPS fellowship status. He serves as scientific expert consultant in clinical pharmacology with various pharmaceutical companies, as well as the FDA Office of Clinical Pharmacology; he is currently chair of the CDER Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee.
Dr. Venitz’s areas of expertise encompass clinical and quantitative pharmacology, interspecies PK/PD scaling as well as translational research from non-clinical to phase II. He is also involved in clinical risk management by using PK/PD modeling in identifying special populations at risk and optimal dose finding.