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Biomedical Sciences - Pharmacology & Toxicology | The AAPS Journal (Editorial Board)

The AAPS Journal

The AAPS Journal

An Official Journal of the American Association of Pharmaceutical Scientists

Editor-in-Chief: Ho-Leung Fung

ISSN: 1550-7416 (electronic version)

Journal no. 12248

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Editor-in-Chief:

Ho-Leung Fung, SUNY at Buffalo School of Pharmacy, Buffalo, New York, USA

Associate Editors:

Richard Bergstrom, Butler University, Indianapolis, Indiana, USA
Dexi Liu, University of Georgia College of Pharmacy, Athens, Georgia, USA
Marilyn Martinez, Rockville, Maryland, USA
Bernd Meibohm, University of Tennessee, Knoxville, Tennessee, USA
Marilyn Morris, University at Buffalo, SUNY, Buffalo, New York, USA
Aliasger Salem, The University of Iowa, Iowa City, Iowa, USA 
Jean-Michel Scherrmann, Hospital Fernand Widal, Paris, France
Craig Svensson, Purdue University, West Lafayette, Indiana, USA 
Lawrence X. Yu, Silver Spring, Maryland, USA

Editorial Advisory Board:

Bharat Aggarwal, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, USA
Bruce J. Aungst, QPS, Newark, New Jersey, USA
Joseph P. Balthasar, State University of New York at Buffalo, Buffalo, New York, USA
Leslie Benet, University of California, San Francisco, California, USA
Peter L. Bonate, Astellas Pharma Global Development, Illinois, USA
Gayle Brazeau, University of Buffalo, SUNY, Buffalo, New York, USA
Kim Brouwer, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Diane Burgess, University of Connecticut, Storrs, Connecticut, USA
Kenneth K. Chan, Ohio State University, Columbus, Ohio, USA
Saeho Chong, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
Daan Crommelin, Top Institute Pharma, Leiden, Netherlands
Johan Gabrielsson, Swedish University of Agricultural Sciences, Sweden
Michael Jay, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Vincent Hon-Leung Lee, The Chinese University of Hong Kong, Hong Kong, China
Wooin Lee, University of Kansas, Lawrence, Kansas, USA
Craig E. Lunte, University of Kansas, Lawrence, Kansas, USA
Ashim Mitra, University of Missouri-Kansas City, Kansas City, Missouri, USA
Sandy K. Pang, University of Toronto, Toronto, Canada 
Murali Ramanathan, University at Buffalo, SUNY, Buffalo, New York, USA
Mario L. Rocci Jr, Prevalere Life Sciences, Whitesboro, New York, USA
Wolfgang Sadee, Ohio State University, Columbus, Ohio, USA
Danny D. Shen, University of Washington, Seattle, Washington, USA
Steven J. Shire, Genentech, Inc, South San Francisco, California, USA
Duxin Sun, The University of Michigan, Ann Arbor, Michigan, USA
Jashvant Unadkat, University of Washington, Seattle, Washington, USA
M. Guill Wientjes, Ohio State University, Columbus, Ohio, USA
Xiang-Qun (Sean) Xie, University of Pittsburgh, Pittsburgh, Pennsylvania, USA 
Christos Reppas, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece

Meet the Editor-in-Chief and Associate Editors 

Meet the Editor-in-Chief and Associate Editors

Ho-Leung Fung, Ph.D. - EDITOR-IN-CHIEF 

Fung, Editor
DR. HO-LEUNG FUNG is a Professor of Pharmaceutical Sciences at UB. He received his undergraduate pharmacy training at the Victorian College of Pharmacy (now a faculty of Monash University, Australia), and his Ph.D. degree in Analytical Pharmaceutical Chemistry and Pharmaceutics in 1970 from the University of Kansas.
Awards include Research Achievement Awards from the American Association of Pharmaceutical Scientists (AAPS, in 1988), and the American Pharmaceutical Association in 1992, a MERIT grant award from the National Heart, Lung and Blood Institute in 1988, the Takeru and Aya Higuchi Award from the Academy of Pharmaceutical Sciences and Technology Japan in 1995. He has been a member of the NIH Pharmacology Study Section (1988-1992), member (1995-7) and Chairman (1996-8) of the NIGMS Pharmacological Sciences Review Committee.
He served as President of AAPS in 1997, and received the honorary Doctor of Laws (LL.D.) degree from Monash University of Australia in 2008. He is the Scientific Program Chair of the Pharmaceutical Sciences World Congress 2010. His research interests involve the bioanalysis, drug delivery, pharmacokinetics and pharmacodynamics of nitric oxide donors, and mechanisms of nitric oxide modulation.

Richard F. Bergstrom, Ph.D.- ASSOCIATE EDITOR  

Rich Bergstrom
Dr. Bergstrom is Professor of Pharmaceutical Sciences at Butler University College of Pharmacy and Health Sciences and Adjunct Professor of Medicine at the Indiana University School of Medicine, Division of Clinical Pharmacology, Indianapolis, IN. He received a B.S. in Pharmacy from the University of Pittsburgh, a M.S. in Pharmacology from Butler University, and a Ph.D. from The University of Michigan in Pharmacokinetics and Pharmaceutical Chemistry.
Dr. Bergstrom’s career includes 33 years at Eli Lilly and Company where his research focused on the pharmacokinetics and clinical pharmacology of a wide array of drugs notably including Axid® (nizatidine), Prozac® (fluoxetine), Zyprexa® (olanzapine), and Cymbalta® (duloxetine). Dr. Bergstrom is also a consultant providing strategic planning, study design, and analysis of pharmacokinetic and pharmacodynamic studies.
Dr. Bergstrom served a variety of leadership roles in the American Association of Pharmaceutical Scientists including AAPS President (2000) and was part of the executive leadership instrumental in launching the highly successful AAPS electronic journals. Dr. Bergstrom is an AAPS Fellow and the recipient of the AAPS Distinguished Service Award.
He is also a member of other professional associations including the American Pharmacists Association, American Society of Clinical Pharmacology and Therapeutics, American College of Clinical Pharmacology, and the International Society for the Study of Xenobiotics.

Dexi Liu Ph.D. - ASSOCIATE EDITOR 

Liu, Dexi, Editor
Dexi Liu received his PhD in Biochemistry from the University of Tennessee, Knoxville in 1990, and was a postdoctoral associate in the Department of Biochemistry and Molecular Biology at the University of California, Berkeley from 1991 to 1993.
Dr. Liu was on the faculty of School of Pharmacy University of Pittsburg from 1993 to 2011, and currently serves as a professor and Head of the Department of Pharmaceutical and Biomedical Sciences at the University of Georgia College of Pharmacy.
His research interests are in drug delivery, gene/protein drug discovery, cancer therapy and obesity. He has published ~100 papers in scientific journals and is a member of the American Society of Gene and Cell Therapy and the American Association of Pharmaceutical Scientists. He is on the editorial board of Molecular Therapy and on the editor’s advisory board of Pharmaceutical Research.

Marilyn N. Martinez, Ph.D. - ASSOCIATE EDITOR 

Martinez, Editor
Marilyn N. Martinez is an internationally recognized expert in the factors responsible for interspecies differences in drug pharmacokinetics (PK), spearheading numerous research initiatives and efforts to promote information exchange. She has published several book chapters, served as editor of journal themed issues, and has written numerous review articles on this topic.
Currently, Dr. Martinez serves as a Senior Biomedical Research Scientist with the US Food and Drug Administration Center for Veterinary Medicine where she is the point person for all questions pertaining to the use of PK in the US regulation of veterinary pharmaceutical products. As such, she is uniquely responsible for setting Agency policy, responding to external inquiries, and for overseeing all reviews pertaining to veterinary PK.
Her current research focus involves an exploration of the factors influencing oral and parenteral drug absorption, and how species differences may impact the applicability of product quality control specifications across animal species. Along these lines, she is the Principle Investigator for a Critical Path research project targeted to explore the differences in the critical quality attributes influencing oral drug absorption in humans versus dogs.
She is also is the Scientific Leader of the Ad Hoc Advisory Panel on Biopharmaceutics Classification System (BCS) Veterinary Medicine. This ad hoc panel reflects years of efforts to forward this concept within veterinary medicine and is USP initiative reflects the initial effort to develop BCS criteria for veterinary species. In addition to her scientific responsibilities at the FDA, Dr. Martinez is a scientific advisor to the Clinical Laboratory Standards Institute (CLSI) and she served as chair of the Breakpoint Task Force, which developed the CLSI guideline describing the development and role of pharmacokinetic-pharmacodynamic data in the establishment of veterinary susceptibility interpretive criteria.
Dr. Martinez previously served as Chair of the Distance Learning Committee and was the Chairperson of the 2007 AAPS Annual Meeting in San Diego.

Bernd Meibohm, Ph.D., FCP - ASSOCIATE EDITOR 

Meibohm, Editor
Dr. Bernd Meibohm is a Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN.
He received his B.S. in pharmacy and Ph.D. in pharmaceutics from the Technical University Carolo-Wilhelmina, Braunschweig, Germany. After completion of a clinical pharmacology research fellowship at the University of Florida in 1997, he joined the faculty of the University of South Carolina, and in 1999 the University of Tennessee.
Dr. Meibohm’s scientific interests include chronic inflammatory pulmonary diseases, pediatric pharmacotherapy and the application of quantitative modeling and simulation techniques in preclinical and clinical drug development, with specific focus on biotech drugs.
His research work has attracted more than $4 million in extramural funding as principal and co-investigator and has resulted in over 60 scientific papers and book chapters, two textbooks, and over 80 scientific presentations to national and international audiences.
Dr. Meibohm is a Fellow of the American College of Clinical Pharmacology (ACCP) and recipient of the 2000 ‘New Investigator Award in PK, PD and Drug Metabolism’ from the American Association of Pharmaceutical Scientists (AAPS).
He is currently serving as section editor for pharmacokinetics and pharmacodynamics for the Journal of Clinical Pharmacology, as associate editor for The AAPS Journal, and is a member of the editorial boards of the Journal of Pediatric Pharmacology and Therapeutics, Les Annales Pharmaceutiques Françaises and Die Pharmazie. He is also the 2008/2009 Past Chair of the ‘Modeling & Simulation’ focus group of AAPS and the 2008 Vice Chair/2009 Chair-Elect for the ‘Pharmacokinetics, Pharmacodynamics and Drug Metabolism’ (PPDM) section of AAPS.

Marilyn E. Morris, Ph.D. - ASSOCIATE EDITOR 

Morris, M, Editor
Dr. Morris is Professor of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences and Associate Dean in the Graduate School, University at Buffalo, State University of New York.
She received her B.Sc. (Pharmacy) from the University of Manitoba, Canada, M.Sc. (Pharmacology) from the University of Ottawa, Canada, and Ph.D. (Pharmaceutics) from the University at Buffalo. She was a Medical Research Council Fellow at the University of Toronto, before joining the University at Buffalo as an Assistant Professor.
Her research interests are in the areas of drug metabolism and membrane transport, with her most recent research focused on the pharmacokinetics and pharmacodynamics of the dietary components, flavonoids and organic isothiocyanates, with an emphasis on their potential for transport and metabolic drug interactions, and their role in cancer therapy and chemoprevention. Other current research projects involve evaluation of the kinetics and renal transport of monocarboxylic acids, including the drug of abuse, -hydroxybutyric acid. She is the author of over 110 scientific papers and co-editor of the book “Drug Transporters; Molecular Characterization and Role in Drug Disposition”.
Dr. Morris has served on numerous grant review committees, is an Associate Editor for AAPS Journal, is on the Editorial Boards of the Journal of Pharmaceutical Science, Pharmaceutical Research and Biopharmaceutics and Drug Disposition, recipient of the Chancellors’ Award for Excellence in Research and Creative Activity in the State University of New York, and is a fellow of the American Association of Pharmaceutical Scientists (AAPS). She currently serves as Chair of the PPDM section of AAPS.

Aliasger Salem, Ph.D. 

Aliasger_Salem
Aliasger Salem is the Bighley Professor and head of the Division of Pharmaceutics and Translational Therapeutics at The University of Iowa College of Pharmacy. He was educated in applied chemistry at Aston University of Science and Technology, Birmingham, UK (BSc 1998). He received his Ph.D. in pharmacy at the University of Nottingham, UK, in 2002. He then received postdoctoral training at Johns Hopkins School of Medicine until 2004.
His research interests are primarily focused on self-assembling systems, the rational design of novel drug and gene delivery systems, and on the development of vaccines that stimulate potent antigen-specific immune responses. His laboratory applies microfabrication techniques to develop novel drug and gene delivery devices and to optimize control over polymer-cell interactions. His research group is currently exploring the synergistic application of polymer particle technology, CpG oligonucleotides, adenoviruses, and heat shock protein therapy for generating sustained stronger immune responses against tumors.
He is the author of over 200 scholarly publications, patents, and abstracts and has published in journals that include Nature Materials, Advanced Materials, The AAPS Journal, Bioconjugate Chemistry, Biomaterials, the Proceedings of the National Academy of Sciences, the Journal of Pharmaceutical Sciences, Pharmaceutical Research, the Journal of Controlled Release, and the International Journal of Pharmaceutics. Salem is on a number of editorial advisory boards such as the International Journal of Pharmaceutics and regularly serves on international and national grant review panels for organizations that include the American Cancer Society, the National Institutes for Health, and the Department of Defense: Congressionally Directed Medical Research Programs.

Jean-Michel Scherrmann, Pharm. D., Ph. D. 

Portrait_Scherrmann_Jean_Michel_95x120px
Jean-Michel Scherrmann, Pharm.D., Ph.D.,is a professor in the department of Pharmacokinetics, Faculty of Pharmacy, the Paris Descartes University. He received his Pharm.D. and Ph.D.in analytical radiochemistry from the Paris Descartes University. He led the Neuropsychopharmacology Unit at the French Institute of Health and Medical Research (INSERM) and the National Center of Scientific Research (CNRS) from 2002 to 2013.
He was recently promoted to dean of the Faculty of Pharmacy at Paris Descartes University and nominated professor at the National Institute of Nuclear Sciences and Techniques. Scherrmann has made major contributions in the development of drug radioimmunoassay, drug detoxification by immunotherapy, and drug redistribution concepts in pharmacokinetics.He pioneered the first clinical application of colchicine immunotherapy in acute colchicine overdoses and is now focusing his research on the role of drug transporters in neuropharmacokinetics and on drug delivery strategies to the brain.
His work has resulted in two patents, 290 scientific articles, 35 books chapters, and more than 250 invited presentations. He has served on the editorial boards of several journals in the analytical and pharmaceutical sciences.He has mentored over 30 postgraduate and 44 doctoral students. Scherrmann has been a recipient of the 1992 Americal Academy of Clinical Toxicology Award and the 1999 French National Academy of Medicine Achievement Award. He is a Fellow of the American
Association of Pharmaceutical Scientists and a member of the French National Academy of Pharmacy. He was a visiting professor of Tohoku University (Japan) Graduate School of Pharmaceutical Sciences in 2008 and awarded as Honoured Member of the French Metabolism and Pharmacokinetics Group in 2014.

Craig Svensson, Ph.D. - ASSOCIATE EDITOR 

Svensson, Editor
Dr. Craig Svensson is Dean of the College of Pharmacy, Nursing, and Health Sciences, as well as Professor of Medicinal Chemistry & Molecular Pharmacology, at Purdue University. Born in Baltimore, Maryland, he pursued his pre-pharmacy and undergraduate training at the University of Maryland. He received his Pharm.D. degree from the University of Maryland in 1981 and his Ph.D. from the State University of New York at Buffalo in 1984. After a postdoctoral fellowship in pharmacokinetics at the University at Buffalo, he joined the faculty of the Wayne State University in Detroit, Michigan as an Assistant Professor, where he rose to the rank of Professor and Associate Chairman of the Department of Pharmaceutical Sciences. In August of 2003, he became the Lyle & Sharon Bighley Professor of Pharmaceutical Sciences and Head of the Division of Pharmaceutics in the College of Pharmacy, The University of Iowa. He assumed the position of Dean at Purdue University on October 1, 2006.
As chief academic for the College, Dr. Svensson has administrative responsibility for three schools (the School of Pharmacy and Pharmaceutical Sciences, School of Nursing, and School of Health Sciences) and the Purdue University Pharmacy. Comprised of over 2,700 students and 280 faculty and staff, the College is the primary unit on campus with a mission focused on human health. In addition to his appointment as Dean, Dr. Svensson is also the Chief Scientific Officer for McClure Park and a member of the Board of Directors for BioCrossroadsLINX. He is currently the Associate Editor for the AAPS Journal and is a Fellow of the American Association of Pharmaceutical Scientists.
Dr. Svensson has served as a member or Chair of numerous grant review panels for the National Institutes of Health and over the past year has served as an ad hoc member of several Study Sections. He is a regular reviewer for numerous scientific journals, including the Journal of Pharmacology & Experimental Therapeutics, Drug Metabolism and Disposition, and JAMA - the Journal of the American Medical Association. Dr. Svensson’s research interests have focused on the mechanism of unusual adverse drug reactions, with a particular emphasis on cutaneous drug reactions.
In addition to his experience as a faculty member, researcher, and administrator, Dr. Svensson has worked in community pharmacy, hospital pharmacy, and served as a hospital-based clinical pharmacokinetics consultant. He has also worked as a poison information specialist. He was inducted into the Rho Chi Honor Society in 1978. He is a recipient of the Meritorious Research Award from the American Federation for Clinical Research and the James A. Shannon Director’s Award from the National Institutes of Health. Dr. Svensson also received Teacher of the Year Awards at both Wayne State University and the University of Iowa.

Lawrence X. Yu, Ph.D. - ASSOCIATE EDITOR 

Yu, LX, Editor
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 associate 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’s research interests have centered on the prediction of oral drug delivery and the development of Pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM, which is being widely used in the pharmaceutical industry.
Dr. Yu is a fellow and the Physical Pharmacy and Biopharmaceutics Section Chair of the American Association of Pharmaceutical Scientists. 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 is the winner of numerous awards including the American Foundation for Pharmaceutical Education Fellowship, AAPS Excellent Graduate Research, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, Regulatory Science, and Team Excellence awards, Upjohn special recognition award, and Naigai Foundation Japan Tokyo Distinguished Lectureship.
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.

Meet the Editorial Advisory Board of The AAPS Journal: A-M 

Meet the Editorial Advisory Board of The AAPS Journal: A-M

Bharat Bhushan Aggarwal, Ph.D.  

Dr. Aggawal
Dr. Bharat Bhushan Aggarwal is the Ransom Home, Jr., Distinguished Professor of Cancer Research in The University of Texas M. D. Anderson Cancer Center Division of Cancer Medicine’s Department of Experimental Therapeutics, and Chief of the Cytokine Research Laboratory, in Houston, Texas, USA.
He obtained a Ph.D. degree in Biochemistry at the University of California in Berkeley, then underwent post-doctoral training at the University of California Medical Center in San Francisco, and thereafter worked for ten years at Genentech, Inc., where he isolated and determined the structure of TNF-α and TNF-β, before returning to a university-based academic position.
The primary focus of Dr. Aggarwal’s research has been the role of inflammatory pathways in tumorigenesis, and especially the impact of the transcription factor nuclear factor kappa B and STAT3 pathways in cancer. His group has also been interested in the use of natural products such as anti-inflammatory nutraceuticals from diet, spices and traditional medicine, to modulate both inflammatory pathways linked to survival, proliferation, invasion, angiogenesis and metastasis of tumors; cancer-induced bone loss. Several of these efforts have led to clinical trials targeting cancer patients using agents that are safe and affordable.
He has published more than 600 papers, granted more than dozen patents and has been invited for more than 300 national and international conferences to deliver lectures. Dr. Aggarwal’s research is currently funded by the National Institute of Health, and by various private organizations. Dr. Aggarwal also co-founded the International Society for Translational Cancer Research.
His work has been recognized by many awards, including the Ranbaxy Award, an Outstanding Scientist Award from the American Association of Indian Scientists in Cancer Research, a McCormick Science Institute Research Award from the American Society of Nutrition, Kosuna Distinguished Lecture Award from The University of California, Davis; and World Congress on Oxygen Club of California.

Bruce J. Aungst, Ph.D. 

Aungst, Author
Bruce J. Aungst is presently Director of Discovery and Preclinical Development at QPS in Newark, Delaware. He previously worked at DuPont Pharmaceuticals and Absorption Systems in the biopharmaceutics and drug delivery areas.
His expertise is in evaluating and optimizing the oral absorption potential of discovery compounds, determining the barriers to oral bioavailability and the mechanisms of intestinal permeation, preparing and testing formulations, and studying ways to maximize oral bioavailability.
He has worked on both discovery and development project teams that have identified new drug candidates and brought them to clinical use. He has contributed more than 75 papers, reviews, and book chapters to the literature, and has been awarded 5 issued U.S. patents.
Bruce is a Fellow of the American Association of Pharmaceutical Scientists (AAPS). He has been on the editorial advisory board of the Journal of Pharmaceutical Sciences since 1995. He also served on the contents advisory committee for the AAPS Newsmagazine, and as its chair for one year.
He received his B.S. (Biology) and M.S. (Pharmacology) degrees from Penn State University, and a Ph.D. (Pharmaceutics) from the State University of New York at Buffalo.

Diane J. Burgess, Ph.D. 

Burgess, Editor
Dr. Burgess is Professor of Pharmaceutics at the University of Connecticut, Storrs.
She was recipient of the Outstanding Teacher of the Year Award (2005 and 1992). She has over 100 refereed publications. She has given over 290 research presentations at major international scientific meetings; over 140 invited lectures and presentations, and 10 keynote addresses. Dr. Burgess has served as major advisor for four M.S. and fourteen Ph.D. graduates as well as fourteen post-doctoral fellows. She is currently major advisor for eight Ph.D. candidates and two post-doctoral fellows.
Research efforts focus on drug delivery systems: microspheres, emulsions, liposomes, hydrogels, as well as interfacial chemistry and span the following areas: development of novel technologies; preformulation; materials science, formulation; stability assessment and prediction; transport; sterility assessment; biophysical assessment; cell culture and in vitro and in vivo performance. She is currently developing a miniaturized, implantable biosensor for metabolic monitoring, investigating and controlling tissue response to the implant. She is also investigating intracellular trafficking of DNA therapeutics.
Dr. Burgess was the 2002 President of the AAPS and is an AAPS fellow. She is currently the President Elect of the Controlled Release Society. She is a member of the USP Biopharmaceutics Expert committee and the USP Advisory Panel on Injectables. Dr. Burgess was an editor for AAPSPharmSci (1999 - 2005) and is editor of the Journal of Drug Delivery Science and Technology (2003 - present) and serves on the editorial boards of seven international journals.
In 2001 she undertook a sabbatical at the Office of Testing and Research at CDER, FDA. She consults for pharmaceutical, food, cosmetic and other industries. Dr. Burgess received her B.Sc. degree in Pharmacy from the University of Strathclyde, U.K. (1979) and her Ph.D. in Pharmaceutics from the University of London, U.K. (1984).

Joseph P. Balthasar, Ph.D. 

Balthasar, Joe, Author
Dr. Balthasar is Professor of Pharmaceutical Sciences at the State University of New York at Buffalo. Dr. Balthasar received a B.S. in Pharmacy (1991) and a Ph.D. in Pharmaceutics (1996) from the University at Buffalo. Dr. Balthasar served as a Clinical Assistant Professor of Pharmaceutics at the University at Buffalo from 1996-1997 and, from 1997-1999, as an Assistant Professor of the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. He rejoined the University at Buffalo as an Assistant Professor in 1999, and was promoted to Associate Professor in 2003 and to Full Professor in 2008.
Dr. Balthasar serves as the Director of the Center for Protein Therapeutics. Dr. Balthasar’s research, which is funded by the National Institutes of Health, utilizes pharmacokinetic and pharmacodynamic analyses to guide the development of new therapies.
Current research focuses on the development of drug targeting strategies to improve the selectivity of cancer chemotherapy and on the development of new immunotherapies for the treatment of humoral autoimmune diseases.

Gayle A. Brazeau, Ph.D. 

Brazeau, Editor
Dr. Gayle A. Brazeau is currently an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences and the Associate Dean for Academic Affairs in the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo, State University of New York.
She received a B.S. in Pharmacy and a M.S. in Pharmaceutical Sciences from the University of Toledo in 1980 and 1983, respectively. She received a Ph.D. in Pharmaceutics from the University at Buffalo, State University of New York in 1989. Previously, she was a faculty member at the University of Houston and the University of Florida.
Dr. Brazeau is an Associate Editor for the American Journal of Pharmaceutical Education and serves on several editorial advisory boards for other scientific journals. She has served as an elected officer, committee member and committee chair for numerous scientific and professional organizations including the Chair of the Council of Faculties for AACP and the Chair of the Student and Post-Doc Outreach and Development Committee for AAPS.
She has been the recipient of teaching and student recognition awards at the University at Buffalo, University of Florida and the University of Houston. She served on FDA, USP and SBIR/STTR NIH panels and committees. She currently is the advisor to several organizations for pharmacy students including APhA-ASP, LKS and PLS. She served on the leadership team for the Middle States Accreditation at the University at Buffalo. Her pedagogical research interests focus on curricular assessment strategies, design and assessment of student learning.
Her laboratory research interests focus on investigating the biochemical and toxicological interactions of drugs or excipients with skeletal muscle following intramuscular or systemic administration and the role of myostatin in muscle wasting conditions. Other research interests include the development of intramuscular formulations with reduced muscle damage upon injection without altering drug bioavailability.
She is the author or co-author on over 45 peer-reviewed papers, chapters, books and other types of publications. She recently was selected to receive a State University of New York Chancellor’s Award for Excellence in Faculty Service.

Leslie Z. Benet, Ph.D. 

Benet, LZ, Editor
Dr. Benet, Professor and former Chairman (1978-1998), Department of Biopharmaceutical Sciences, University of California, San Francisco, received his A.B., B.S. and M.S. from the University of Michigan and Ph.D. from the University of California. He has received six honorary doctorates: Uppsala University, Sweden (Pharm.D., 1987), Leiden University, The Netherlands (Ph.D., 1995), University of Illinois at Chicago (D.Sc., 1997), Philadelphia College of Pharmacy and Science (D.Sc., 1997), Long Island University (D.Sc., 1999) and University of Athens (Ph.D., 2005).
His research interests, more than 480 publications, 7 books and 11 patents are in the areas of pharmacokinetics, biopharmaceutics, drug delivery and pharmacodynamics. Dr. Benet is listed by ISI as one of the most highly cited pharmacologists worldwide. His most recent work has addressed the interplay of metabolic enzymes and transport proteins as related to oral bioavailability and hepatic elimination.
Dr. Benet was a Founder/Editor of the JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS (1973-98) and Associate Editor of PHARMACOLOGY AND THERAPEUTICS (1995-2000). He presently serves as a member of 7 editorial boards including The AAPS JOURNAL. He is a Fellow of AAPS, AAAS and APSR. In 1982, Dr. Benet received the APhA Academy of Pharmaceutical Sciences (APS) Research Achievement Award in Pharmaceutics and the University of Michigan, College of Pharmacy, Distinguished Alumnus Award.
In 1985, he served as President of APS. During 1986, Dr. Benet was a Founder and first President of the AAPS. In 1987, Dr. Benet was elected to membership in the Institute of Medicine (IOM) of the National Academy of Sciences. In 1989, he was chosen to receive the first AAPS Distinguished Pharmaceutical Scientist Award. In 1991, he received the Volwiler Research Achievement Award of the American Association of Colleges of Pharmacy (AACP). In 1993-94, he served as AACP President. In 1995, he received the Rawls-Palmer Progress in Medicine Award of the American Society for Clinical Pharmacology.
In 1996, he received the AAPS Distinguished Service Award, and in 2000 the APhA Takeru Higuchi Research Prize and the AAPS Wurster Research Award in Pharmaceutics. In 2001 he was awarded the Høst-Madsen Medal of the International Pharmaceutical Federation (FIP) and the UCSF Outstanding Faculty Mentorship Award. In 2004, he was awarded the Pharmaceutical Sciences World Congress Research Achievement Award and the Controlled Release Society’s Career Achievement in Oral Drug Delivery Award. In 2007 he was selected as the UCSF Distinguished Clinical Research Lecturer.
Dr. Benet formerly served as Chair of the NIH Pharmacology Study Section, the FDA CBER Peer Review Committee, the FDA Expert Panel on Individual Bioequivalence, the Board of Pharmaceutical Sciences of the FIP, the Organizing Committee for the Millennial World Congress of Pharmaceutical Sciences and as a member of the FDA Generic Drugs Advisory Committee and the FDA Science Board. He presently serves on the IOM Forum on Drug Discovery, Development and Translation, the Biodefense Standing Committee of the National Research Council and on the Boards of Directors of the American Foundation for Pharmaceutical Education, Impax Laboratories and Institute for One World Health.
PHOTO CREDIT: Christine Krieg

Peter Bonate, Ph.D., FCP 

Bonate, Editor
Peter Bonate has 12 years industrial experience, 9 years as a clinical pharmacokineticist and 3 years in drug metabolism and bioanalysis. He is currently Senior Director of Pharmacokinetics at Genzyme Corporation. In his current role he is responsible for managing all clinical pharmacokinetic activities within Genzyme.
He has worked at Hoechst Marion Roussel, Eli Lilly, and Quintiles. He received his PhD in 1996 from Indiana University in Medical Neurobiology with an emphasis on the pharmacokinetics of drugs of abuse. He received an MS in statistics from the University of Idaho and an MS in Pharmacology from Washington State University both in 1990.
In 2003 he was elected a Fellow of the American College of Clinical Pharmacology and in 2007 he was elected a fellow of the American Association of Pharmceutical Scientists (AAPS). He was founder of the Modeling and Simulation focus group, has served as chair of the population pharmacokinetics focus group, and is currently the Clinical Pharmacology and Translational Research Section Vice-Chair within AAPS.
He has served or currently serves on the editorial boards for the Journal of Clinical Pharmacology, Pharmaceutical Research, and the AAPS Journal. He has more than 40 publications in the field of pharmacokinetics and clinical pharmacology, is the co-editor of the 2-volume series Pharmacokinetics in Drug Development published by AAPS Press in 2004, and is author of the leading textbook Pharmacokinetic-Pharmacodynamic Modeling and Simulation published by Springer in 2005.

Kenneth K. Chan, Ph.D. 

Chan, Editor
Dr. Chan is Professor of Pharmaceutics and Internal Medicine, Colleges of Pharmacy and Medicine, The Ohio State University, Columbus, Ohio.
He received his Ph.D. Pharmaceutical Chemistry at the University of California San Francisco.
His areas of interest include: Pharmacokinetics, metabolite and clinical pharmacokinetics; clinical studies; anti cancer drug development and drug formulation; drug metabolism, drug analytical method development, liquid chromatography mass spectrometry, cancer chemotherapy and modulation, antisense drug therapy.

Saeho Chong, Ph.D. 

Chong, Saeho, Editor
Dr. Chong is Associate Director, Department of Metabolism and Pharmacokinetics at Bristol-Myers Squibb Co., Princeton, NJ. He is also Adjunct Associate Professor, Department of Pharmaceutical Sciences, School of Pharmacy, SUNY at Buffalo.
Dr. Chong received his Ph.D. in Pharmaceutics from SUNY at Buffalo in 1988. Currently, Dr. Chong is responsible for the optimization of ADME/PK properties of novel drug candidates in coordination with Medicinal Chemistry, Biology and Toxicology. His current research interests include the development and implementation of new technologies to better support drug discovery and development processes, and the investigation of the role of drug transporters as a major determinant of drug disposition.
He is a member of the American Association of Pharmaceutical Scientists (AAPS) and the International Society for the Study of Xenobiotics (ISSX). He was a recipient of the AAPS Meritorious Manuscript Award in 2005. Dr. Chong has authored over 50 research publications including review articles and book chapters. He has been an invited speaker at numerous academic institutions and major scientific conferences in the US and internationally.

Daan J.A. Crommelin, Ph.D.  

Crommelin
Prof. Daan Crommmelin is presently scientific director of the Dutch Top Institute Pharma in Leiden. He is also professor at the Department of Pharmaceutics at Utrecht University. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah.
Crommelin is co-founder and chair of the scientific advisory board of OctoPlus, a Leiden based company specialized in the development of pharmaceutical product formulations and advanced drug delivery systems.
He published extensively and is on the editorial board of 10 peer reviewed journals in the pharmaceutical sciences. He presently chairs the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (F.I.P.) and was chair of the organizing committee of the Pharmaceutical Sciences World Conference 2007 in Amsterdam. He is president of the European Federation of Pharmaceutical Sciences (EUFEPS).

Johan Gabrielsson, Ph.D.  

Gabrielsson_Johan
Johan Gabrielsson has been Senior Principal Scientist at AstraZeneca R and D Mölndal. His responsibilities included kinetic/dynamic related project tasks in the CV and GI and CNS and Cancer and Biologics areas. He is author of the textbooks ‘Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications’ 4th ed. 2nd print (2010) and Quantitative Pharmacology: An Introduction to Integrative Pharmacokinetic-Pharmacodynamic Analysis (2012).
He is professor of Integrative Pharmacology at the Swedish Agricultural University in Uppsala, Sweden. He is also academically affiliated with Dept. of Pharmaceutics, Univ. Tennessee and University of Manchester. He has published extensively in the field of pharmacokinetic-pharmacodynamic modelling and reasoning, and has run numerous courses internally and externally in the area of biological data analysis since 1985 in Europe, the US and Asia (>4000 participants) at both the undergraduate and graduate level.
His research focuses on modelling different aspects of endogenous turnover, such as functional tolerance and rebound phenomena, physiological limits and target-mediated drug disposition in collaboration with Professor LA Peletier, Leiden University. He has been external examiner on several PhD Theses abroad.

Michael Jay, Ph.D. 

Jay, Michael, Author
Michael Jay, Ph.D., is an endowed professor in the Division of Molecular Pharmaceutics, Eshelman School of Pharmacy at the University of North Carolina - Chapel Hill. From 1981-2008, he was a professor in the Departments of Pharmaceutical Sciences at Diagnostic Radiology at the University of Kentucky where he also served as the Director of the Center for Pharmaceutical Science and Technology.
His research activities are at the interface between the pharmaceutical and nuclear sciences. They involve the development of radionuclide decorporation agents and the use of nanotemplate engineered nanoparticles for the tumor delivery of imaging and therapeutic agents.
Dr. Jay is a co-founder of NanoMed Pharmaceuticals Inc. and Cherry Orchard Products, LLC. He is a Fellow of American Association of Pharmaceutical Scientists and the recipient of the Mendell Award for Pharmaceutical Technology and the Berson-Yalow Award from the Society of Nuclear Medicine (1993)

Craig E. Lunte, Ph.D. 

Craig E. Lunte is Professor of Bioanalytical Chemistry and Adjunct Professor of Pharmaceutical Chemistry at the University of Kansas. He received his B.S. in Chemistry from the University of Missouri at Rolla in 1979 and the Ph.D. in Analytical Chemistry from Purdue University in 1984. From 1984 through 1985, he worked at the Procter & Gamble Company. He then did postdoctoral research at the University of Cincinnati from 1986 to 1987. Dr. Lunte joined the faculty at the University of Kansas in 1987 where he was promoted to Associate Professor in 1993 and to Professor in 1997. He is Chair of the Department of Chemistry.
Dr. Lunte’s research is focused on the development of new methods for the study of drug metabolism and disposition in vivo. He has taken a leadership role in applying microdialysis sampling to the study of drug development. His research group has provided both novel applications of microdialysis sampling and fundamental studies of the technique. Several novel microdialysis probes have been developed for sampling from peripheral tissue in awake animals. Studies of drug transport effects on the microdialysis process in vivo have led to greater insight into the use of this technique.
Dr. Lunte’s research also involves the development of microanalytical techniques based on separations. New approaches in both microbore liquid chromatography and capillary electrophoresis are being pursued. These new bioanalytical tools are being applied to several important problems. Some current projects include studying the transdermal delivery of several investigational drugs, studies of ischemia/reperfusion induced oxidative stress in the heart and brain, evaluating the pharmacokinetics of novel prodrugs, and evaluation of the neurochemical response to electrical stimulation related to epilepsy.
Dr. Lunte is a Fellow of the American Association of Pharmaceutical Scientists.

Wooin Lee, Ph.D. 

Wooin Lee, Ph.D.
Wooin Lee is an Assistant Professor of Pharmaceutical Sciences at University of Kentucky. She received her B.S. (Pharmacy) and M.S. (Pharmacology) from Seoul National University and Ph.D. (Pharmaceutics) from the University at Buffalo. After completing her postdoctoral training at Vanderbilt University, she stayed on as a research faculty of Vanderbilt-Ingram Cancer Center and as a Research Assistant Professor and pursued her research interest in incorporating pharmacogeomic and other correlative/translational studies into early clinical trials of anticancer drugs. She is currently an Assistant Professor of Pharmaceutical Sciences at the University of Kentucky.
Her current research focuses on investigating the genetic and molecular bases for interindividual variability associated with cancer therapy, with a particular emphasis on drug targets and transporter proteins. Other research interests include the role of alternative splicing and other disease-specific mechanisms in regulating the function and activity of transporter proteins and drug targets.

Ashim K. Mitra, Ph.D. 

Mitra, Ashim, Editor
for the 2007 ARVO/Pfizer Ophthalmics Translational Research Award.
He is the Vice Provost for Interdisciplinary Research for the University of Missouri-Kansas City (August 2004) and Director of Translational Research at UMKC School of Medicine. He is also the University of Missouri Curators’ Professor of Pharmacy and UMKC’s Chairman of Pharmaceutical Sciences, School of Pharmacy. He joined his current position after serving as an Associate Professor in the School of Pharmacy at Purdue University, West Lafayette, Indiana. He is the author and co-author over 200 research articles, book chapters, and review papers.
Dr. Mitra is the recipient of a numbers of research awards from the National Institutes of Health, the American Association of Pharmaceutical Scientists, the American Association of Colleges of Pharmacy, and numerous pharmaceutical organizations. He is the 1999 recipient of the University Trustee’s Faculty Research award from the University of Missouri and 1992 recipient of National Collegiate Inventor of the Year Award from the National Invention Center and the B.F. Goodrich Corporation.
He has served as the editor of a book titled “Ophthalmic Drug Delivery Systems” which is currently in its second edition, and co-editor of “Advanced Drug Delivery Reviews.”
He served as a regular member of Pharmacology Study Section at NIH. Currently, he is serving on the newly formed Gene and Drug Delivery Study Section at NIH. Dr. Mitra received the B.S. degree (1974) in pharmacy and the M.S. degree (1976) in pharmaceutics form Jadavpur University, Calcutta, India and the M.S. (1980) and Ph.D. (1983) degrees in pharmaceutical chemistry from the University of Kansas, Lawrence, Kansas.
Dr. Mitra has made significant contributions in the area of ocular drug delivery. His research group is developing a transporter/receptor based prodrug design for the targeted delivery of antiviral agents. His research interests also include nasal and pulmonary delivery of macromolecular drugs particularly peptides and proteins.
He has organized several symposia and round tables at various AAPS meetings on “Ocular Drug Delivery” and “Nose to Brain Delivery.” He served as Chair of the AAPS Nasal Drug Delivery focused group. Currently, he is serving as the Chair of Ocular Drug Disposition and Delivery focused group. He has been elected a Fellow of AAPS.

Meet the Editorial Advisory Board of The AAPS Journal: N-Z 

Meet the Editorial Advisory Board of The AAPS Journal: N-Z

Vincent Hon-Leung Lee 

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Vincent H.L. Lee is a research professor at the School of Pharmacy, Chinese University of Hong Kong. Prior to that, he was associate director at the Office of Pharmaceutical Science, Food and Drug Administration; vice president of Biological, Formulation, and Material Science at ALZA; and Gavin S. Herbert Professor of Pharmaceutical Sciences, professor of ophthalmology, chairman of the Department of Pharmaceutical Sciences and associate dean for Research and Graduate Affairs at the University of Southern California.
Lee is a world-renowned leader in drug delivery. His research was funded by the National Institutes of Health (NIH) in the United States for more than 20 years, a record that has placed him among the top five percent of all the NIH grant applicants. He has published more than 200 papers in three inter-related areas, including: (a) defining the biochemical barriers to peptide and protein drug delivery; (b) elucidating the structure-function of drug transporters; and (c) characterizing the pharmacokinetic barriers to drug delivery in treating retinal degenerative diseases. Over 30 graduate students, postdoctoral fellows, and visiting scientists from North America, Asia, and Europe have been trained by Lee.
Several international honors and awards, including the Young Investigator Award of the Controlled Release Society, Research Achievement Award in Pharmaceutics and Drug Delivery of the American Association of Pharmaceutical Scientists (AAPS), and Pharmaceutical Scientist of the Year award of the FIP Board of Pharmaceutical Sciences, have recognized Lee's research accomplishments. In 2002, he was awarded a Citation of Merit by the University of Wisconsin School of Pharmacy (only an honorary degree constitutes a higher honor than a citation). In 2003, he was awarded an Honorary Doctor of Science degree from the University of London, United Kingdom.
Lee was elected president of AAPS in 1996 and the Controlled Release Society in 1993. He is a member of several editorial advisory boards and scientific advisory boards and was editor-in-chief of Pharmaceutical Research and Advanced Drug Delivery Reviews.

K.Sandy Pang, Ph.D 

Pang, Editor
K.Sandy Pang, Ph.D., received her B.Sc. (Pharmacy) from the University of Toronto and Ph.D. (Pharm Chem) from USCF at San Francisco, and was a Fogarty fellow at the National Institutes of Health. She is presently Professor of Pharmacy and Pharmacology at the Faculties of Pharmacy and Medicine at the University of Toronto.
Dr. Pang is known for her contributions to the fields of pharmacokinetics, drug metabolism, and liver physiology. Her research is aimed towards a mechanistic-based understanding of the handling of drugs and their metabolites within eliminating organs, namely the liver, the intestine, and kidney. Her approach is via the development and formulation of physiologically relevant processes of organ clearances through theoretical treatises and the validation by experimental approaches in vitro [expression systems, cells and subcellular preparations] and in perfused organs.
The principles learnt on hepatic clearance have been extended to examine heterogeneity in intestinal absorption and clearance. Her work on metabolite kinetics emphasizes the need for consideration of heterogeneity and the order of sequential processing and led to the finding that differences exist in the kinetics of formed vs. preformed metabolites. This area sheds insight to metabolite-mediated toxicities. These important concepts developed by Dr. Pang on drug and metabolite clearances have provided a solid basis towards the understanding of metabolism, transport, and removal of drugs and metabolites in eliminating organs such as the liver, intestine, and kidney.
Her more recent interests include the role of the vitamin D receptor on regulation of transporter and enzymes and other nuclear receptors and on siRNA hepatic disposition.
She was the recipient of the NIH Research Career Development Award, Faculty Development award from the Medical Research Council of Canada, the McNeil Award from the Faculties of Pharmacies in Canada, and the Research Achievement Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism from the American Association of Pharmaceutical Scientists (AAPS).

Mario L. Rocci, Ph.D. 

Rocci, Author
Dr. Mario L. Rocci Jr. is the Executive Vice President of Prevalere Life Sciences, LLC, a Division of ICON Development Solutions. Dr. Rocci received his B.S. in Pharmacy and Ph.D. in Pharmaceutics from SUNY at Buffalo. He has held academic appointments in the Department of Medicine at Jefferson Medical College, and Pharmaceutics and Pharmacy Practice at the Philadelphia College of Pharmacy and Science. His research has focused on improving the therapeutic use of drugs, phenotypic probes of drug metabolizing enzyme activity and mass spectrometry to analyze drugs from biological matrices.
Dr. Rocci has authored over 125 scientific publications and is a Fellow of the American College of Clinical Pharmacology. Dr. Rocci is a Bureau Member of the International Pharmaceutical Federation, Chairman of the Board of the Pharmaceutical Quality Research Institute, and a Past-President of the American Association of Pharmaceutical Scientists. He also serves as Chair of the National Industrial Advisory Council in the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo. Dr. Rocci is the Congress Chair of the Pharmaceutical Sciences World Congress which will be held in New Orleans in 2010.
In these various capacities, Dr. Rocci has supported efforts to streamline the drug development process, raise the standard of practice of the pharmaceutical sciences and pharmacy in developing nations and provide financial support for students interested in the pharmaceutical sciences. Dr. Rocci has also worked to expand electronic journals devoted to research in biotechnology and the pharmaceutical sciences, to permit global access to the latest research.

Murali Ramanathan, Ph.D. 

Ramanathan, Editor
Dr. Murali Ramanathan is an Associate Professor of Pharmaceutical Sciences and Neurology at the State University of New York at Buffalo.
His research interest include the treatment of multiple sclerosis, pharmaceutical applications of genomics and pharmacogenomic modeling.
Dr. Ramanathan received his Ph.D. in Bioengineering from the University of California at San Francisco. He has a M.S. in Chemical Engineering from Iowa State University, Ames IA and a B.Tech (Honors) from the Indian Institute of Technology, Kharagpur, India.

Christos Reppas - Professor of Pharmaceutics 

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Christos Reppas is Professor of Pharmaceutics, Department of Pharmacy, National and Kapodistrian University of Athens (NKUA), Greece. He received his B. Pharm degree in Pharmacy from NKUA in 1982 and his Ph.D in 1986 from the same University. From 1988 to 1989 he completed a postdoctoral fellowship in Pharmaceutics at the University of Michigan (USA) and then he joined NKUA in 1989 as a Lecturer. He has held research positions with the University of London (UK), the University of Michigan (USA), Glaxo R and D (UK) and the University of Frankfurt (Germany). Research interests focus on the effects of gastrointestinal physiology on intraluminal performance of xenobiotics and the development of in vitro tests that are predictive of the intraluminal dosage form and drug performance. He is coauthor of more than 100 peer reviewed papers in international journals, two books and one patent.

Wolfgang Sadée, Dr.rer.nat. 

Sadee, Editor
Dr. Sadée is Felts Mercer Professor of Medicine and Pharmacology, Chair, Department of Pharmacology, and Director, Program in Pharmacogenomics, College of Medicine, The Ohio State University, Columbus OH. At OSU, he holds joint appointments in Pharmacy, Psychiatry, Medical Genetics, and is member of the Comprehensive Cancer Center and the Heart & Lung Research Institute.
He studied Pharmacy and received his doctorate in Pharmaceutical Chemistry at the FU Berlin in 1968. After two post-doctoral positions at UCSF and the FU Berlin, he joined USC in Los Angeles as Assistant Professor of Pharmacy and Medicine from 81-83, and subsequently, moved to UCSF, serving as Professor of Biopharmaceutical Sciences and Pharmaceutical Chemistry, University of California San Francisco until 2002.
Dr. Sadée’s research focuses the genetic basis of variable drug response in CNS and cardiovascular diseases, including addiction, and in cancer chemotherapy. He also pursues drug discovery in the treatment of addiction.
Dr. Sadée has published over 300 research papers and monographs. He has received the first AAPS Research Achievement Award in Biotechnology, the Paul Dawson Award in Biotechnology from AACP, and the 2001 Distinguished Pharmaceutical Scientist Award from AAPS.
He has served as founding editor of Pharmaceutical Research and the open access, on-line AAPS Journal. He teaches pharmacogenomics, pharmacology, and history of health sciences.

Danny D. Shen, Ph.D. 

Shen, DD, Editor
Danny Shen received his doctoral degree in pharmaceutics from the State University of New York at Buffalo in 1975. He is currently Professor and Chair of Pharmacy and Professor of Pharmaceutics at the University of Washington. He also holds a Member appointment in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Prior to his joining the faculty at the University of Washington in 1984, he held faculty appointments at the University of Kansas Medical Center (1975-1979) and State University of New York at Buffalo (1979-1984).
Dr. Shen is a Fellow of the AAPS, and a member of several other scientific societies, including the American Society of Pharmacology and Experimental Therapeutics (ASPET) and the American Society of Clinical Pharmacology and Therapeutics (ASCPT). He is a member of the editorial advisory board for AAPS Journal, Pharmaceutical Research, and Journal of Pharmaceutical Sciences. He has served as advisor or consultant to governmental agencies (e.g., National Institutes of Health, Food and Drug Administration) and drug companies.
Dr. Shen has a broad range of research interests involving drug metabolism, drug transport in the CNS, and pharmacokinetics-pharmacodynamics of opioid analgesics. He has published over 160 journal articles, reviews and book chapters.

Steven J. Shire, Ph.D. 

Shire, Editor
Dr. Shire received his Ph.D. from Indiana University Chemistry Department and, after Post Doctoral Training at the University of Connecticut, began his career at Genentech as Research Scientist in the Department of Protein Chemistry.
He was involved in the early work to isolate heterologous recombinant proteins expressed in bacterial systems. This work led to the granting of a patent and served as the basis for further product development of proteins expressed in bacterial systems. During his tenure in the Protein Chemistry Department he used numerous physicochemical techniques to characterize Genentech proteins at various stages of development.
Shortly after the creation of the Pharmaceutical Research and Development Department at Genentech, he joined the department where he made numerous contributions to development of protein formulation and delivery. In addition, he set up one of the first analytical ultracentrifugation laboratories in the Biotechnology industry.
Currently he is a Staff Scientist and Group Leader in the Late Stage Pharmaceutical and Device Development Department at Genentech, and an adjunct faculty member of the USC School of Pharmacy and University of Connecticut School of Pharmaceutical Sciences. He has been responsible for directing research and development of formulations for a variety of recombinant human proteins including Pulmozyme® and Xolair®.
Dr. Shire has served as the chair of the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section, and was elected as a Fellow of AAPS in 1998 and member at large to the AAPS Executive Council in 2001. He has published over 50 reviews and papers dealing with various aspects of formulation and pharmaceutical development of therapeutic proteins.

Duxin Sun, PhD.  

Duxin Sun
Duxin Sun, Ph.D., is a professor in the Department of Pharmaceutical Sciences and William I. Higuchi Collegiate Professor in the College of Pharmacy at the University of Michigan. Sun serves as the director of Pharmacokinetics (PK) Core. He also has joint appointment in the Chemical Biology program, the Interdisciplinary Medicinal Chemistry program, and University of Michigan’s Comprehensive Cancer Center.
Sun’s research interests focus on drug discovery to inhibit cancer stem cells and nanomedicine for cancer therapeutics and imaging. His research has made significant contributions to develop small molecules to inhibit novel cancer stem cell targets to prevent tumor formation and metastasis. He also developed a nanotheranostics, which incorporates therapeutic agent and imaging probe into one nanoparticle, for cancer therapy and tumor imaging. His group is also interested in direct measurement and computation modeling of drug dissolution in the human GI tract to ensure bioequivalence and product quality for modified release and locally acting drugs.
Sun has published more than 130 papers, 85 meeting abstracts, 9 book chapters, and holds 12 U.S. patents. He has supervised 27 Ph.D. students and 40 postdoctoral fellows and visiting scientists. Sun has served as chair of the PPB (Physical Pharmacy and Biopharmaceutics) section of AAPS (American Association of Pharmaceutical Scientists) and as vice president of the American Chinese Pharmaceutical Association (ACPA). Sun has served on study sections for the NIH, FDA, Cancer Research UK, French National Research Agency, and Italian Ministry of Health.

Jashvant (Jash) Unadkat, Ph.D 

Unadkat, Editor
Jashvant (Jash) Unadkat, Ph.D. is a Professor of Pharmaceutics in the School of Pharmacy at the University of Washington, Seattle.
He received his Bachelors degree in Pharmacy (B.Pharm.) from the University of London (1977), his Ph.D. from the University of Manchester (1982) and his postdoctoral training at the University of California at San Francisco (1982-85).
Dr. Unadkat’s research interests are focused on elucidating the mechanisms of transport and metabolism of anti-AIDS and anti-cancer drugs. In particular his laboratory has been interested in metabolism and transport of drugs during pregnancy, transport of drugs across the placental, intestinal and blood-brain barrier and in vitro to in vivo correlation of drug interactions.
Dr. Unadkat has published more than 100 research papers. Dr. Unadkat is a fellow of AAPS and the founding member and co-chair (1999-2001) of the focus group of AAPS on Drug Transport and Uptake. Dr. Unadkat has been an Associate Editor for the Journal of Pharmaceutical Sciences, an Editor of The AAPS Journal., and a member of the NIH Pharmacology study section (2000-3). Dr. Unadkat is currently on the editorial board of J. Pharm. Sci and The AAPS Journal.
Dr. Unadkat has organized or co-organized various national and international conferences including the 1st AAPS Workshop on Drug Transport, Georgia, 2003, the AAPS Workshop on Pharmacokinetics and Pharmacodynamics of Drugs in Pregnant and Lactating Women: Issues and Challenges, Crystal City, 2004, the EUFEPS conference on Drug Transporters: Integrative Approaches in ADME Research, Copenhagen, 2004 & 2006, and the AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside, Parsippany, 2005, and conferences on The Biomedical Transporters, Switzerland, 2005 & 2007.

M. Guillaume Wientjes 

Wientjes, Guill, Editor
M. Guillaume Wientjes received his training in pharmaceutics at the University of Leyden, UCSF and the University at Buffalo, where he received his Ph.D. with Dr. Gerhard Levy.
He then moved to Columbus, Ohio, where he did postdoctoral training and rose through the ranks to his current position of professor of pharmacy at The Ohio State University.
He is recognized for his use of computational modeling and simulation in cancer chemotherapy. He has demonstrated the value of this approach in a number of areas, including the pharmacokinetics/pharmacodynamics of regional therapy, mechanisms of chemoresistance, and development of mathematical models to guide therapy selection.
His studies with regional therapy have established that the kinetics of drug distribution on organ and sub-organ levels are determined by cell density, cell type, and tissue architecture. The new understanding of regional drug distribution was used to design an improved treatment schedule for the treatment of superficial bladder cancer, where his computer-based simulations suggested that treatment responses for the widely used drug mitomycin C could be increased from 20 to 40%. An international multi-center randomized trial confirmed his estimates and established the current standard treatment protocol for this drug. He is further interested in regional delivery to prostatic, pancreatic and intraperitoneal tumors.
Dr. Wientjes is a fellow of the AAPS and AAAS, and has served as member and chair of several advisory committees to the National Institutes of Health.

Xiang-Qun (Sean) Xie, M.D., Ph.D., EMBA 

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Xiang-Qun (Sean) Xie, Ph.D., is an associate dean for research innovation at the School of Pharmacy and professor of pharmaceutical sciences in the Drug Discovery Institute at the University of Pittsburgh. He serves as a member of the United States Food and Drug Administration’s (FDA) SCIENCE Board (the FDA’s highest advisory committee), and a charter member of the National Institutes of Health (NIH) BPNS Study Section. He is a recipient of 2014 AAPS Outstanding Research Achievement Award (the most prestigious award in pharmaceutical sciences). Sean Xie is principal investigator (PI) of an integrated research lab of CompuCore, BioCore, and ChemCore (www.CBLigand.org/XieLab), founding director of Computational Chemical Genomics Screening (CCGS) Center (www.CBLigand.org/CCGS), and director/PI of NIH-funded National Center of Excellence for Computational Chemogenomics Drug Abuse Research (www.CDARCenter.org). He also holds joint faculty positions at the Department of Computational Biology and Department of Structural Biology, and at the Pitt Cancer Institute MT/DD Program. He serves as an oversea expert for the Chinese Natural Science Foundation, ad hoc reviewer for Netherlands Organization for Scientific Research (NWO) Council for Chemical Sciences (CW), MCMB Foundation for MRC United Kingdom, and the Wellcome Trust Fund, Sir Henry Wellcome Fellowship, London, UK.
He is an invited guest editor for The AAPS Journal, an editorial board member of the American Journal of Molecular Biology, and an associate editor and editorial board member of BMC Pharmacology and Toxicology. He also holds/held an honorary professorship in top institutes and colleges of pharmacy in China, including the Chinese Academy of Medical Sciences & Peking Union Medical College; Stem Cell Medical Center, CAMS Tianjin Institute of Hematology; Fudan University; Shanghai Jiaotong University; and Zhejiang University. Xie was co-PI/core director of the NIH-funded Pittsburgh Center for Chemical Methodologies & Library Development (UPCMLD) and NCI/SAIC-funded University of Pittsburgh Center for Diversity Chemistry (UP-CDC). He was co-PI of the Pittsburgh Molecular Library Screening Center (PMLSC), which was funded by the NIH Roadmap Initiative.
Xie received his pharmacy M.D. degree in 1982 from the Second Military Medical University in Shanghai China; his Ph.D. in medicinal chemistry from the School of Pharmacy, University of Connecticut, 1993; and followed with biophysics postdoctoral training at MIT Francis Bitter National Magnet Laboratory/UCONN. In addition, he received an Executive M.B.A. degree in 2003. In 2011, he also received the Shared Leadership Cohort Development Experience Workshop Training by JPorcari & Associates, LLC.
Before he joined Pitt, he was a founding director of the Pharmacoinformatics Research Center at the College of Pharmacy at the University of Houston, Texas. He held several joint faculty positions at the Institute for Molecular Design (MDL), Texas Learning Computing Center (TLCC), and the Keck Center for Computational & Structural Biology, served as an advisory committee member for the NIH Pharmacoinformatics Training Program at Houston Gulf Coast Consortium (GCC), and was a director of the Chemistry Coordinating Unit for GCC-Chemical Genomics Screening Center. Prior to UH, Xie was a director of the IMS NMR Lab and a joint faculty of the School of Pharmacy at the University of Connecticut for over 10 years, where he received multiple NIH grants and pharma support, including Pfizer, Boston Scientific companies, etc. He was an invited International Assessment Panelist for Fudan University College of Pharmacy, a member of the board of directors of the Chinese Association of Professionals in Science and Technology (CAPST), and a chair of the CAPST-Biomedical & Pharmaceutical Society. He was keynote speaker and session chair/organizing committee for several international medicinal chemistry and drug design conferences/meetings.

Masato Yasuhara, Ph.D. 

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Dr. Yasuhara is a Professor of Pharmacokinetics and Pharmacodynamics at Tokyo Medical and Dental University. He received a B.S. in Pharmacy (1974) and a Ph.D. in Pharmaceutics (1979) from Kyoto University, Japan. He served as an Assistant Professor of Department of Pharmacy at Kyoto University Hospital, Faculty of Medicine, Kyoto University from 1979-1985. He was a postdoctoral research fellow at the State University of New York at Buffalo from 1985-1987. He rejoined the Department of Pharmacy at Kyoto University Hospital as an Assistant Professor in 1987, and promoted to Lecturer in 1988 and to Associate Professor in 1990. In 1995, Dr. Yasuhara joined the Faculty of Medicine, Tokyo Medical and Dental University, as a Full Professor. He served the Director of the Department of Pharmacy at the Medical University Hospital from 1995-2014.
His research focuses on the kinetics of drug action in disease states and on the therapeutic drug monitoring and clinical pharmacokinetics. He has published over 100 research papers. He is a recipient of The Japanese Society for the Study of Xenobiotics Award for Young Scientists (1992), The Academy of Pharmaceutical Science and Technology, Japan Award (2012) and The Japanese Society of Pharmaceutical Health Care and Sciences Achievement Award (2015).
He is a member of the American Association of Pharmaceutical Scientists (AAPS) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). He served as President of The Japanese Society of Pharmaceutical Health Care and Sciences from 2010-2014. Currently, he is a member of Science Council of Japan and serves as the Executive Director of Liaison Association of Medical Schools’ Ethics Committees in Japan.

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    The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including:

    ·         Drug Design and Discovery

    ·         Pharmaceutical Biotechnology

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    In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.  

     

    The AAPS Journal publishes six issues a year.

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