AAPS Announces 2005 Fellows

ePT--the Electronic Newsletter of Pharmaceutical Technology

AAPThe American Association of Pharmaceutical Scientists (AAPS), Sunday named 18 scientists as AAPS Fellows for their contributions to the pharmaceutical sciences through articles and presentations at AAPS annual meetings and patents. Fellowship recipients in the field of pharmaceutical technology, quality control, formulation, regulation, and development include Mansoor A. Khan, RPh, PhD; Anthony C. Moffat, PhD; Lian Yu, PhD; Jean P. Remon, PhD; Glenn A. Van Buskirk, PhD; Chang-Koo Shim, PhD; and Masaki Otagiri, PhD.

The American Association of Pharmaceutical Scientists (AAPS), Sunday named 18 scientists as AAPS Fellows for their contributions to the pharmaceutical sciences through articles and presentations at AAPS annual meetings and patents. Fellowship recipients in the field of pharmaceutical technology, quality control, formulation, regulation, and development include Mansoor A. Khan, RPh, PhD; Anthony C. Moffat, PhD; Lian Yu, PhD; Jean P. Remon, PhD; Glenn A. Van Buskirk, PhD; Chang-Koo Shim, PhD; and Masaki Otagiri, PhD.

The 18 AAPS Fellowship recipients for 2005 are:

Mansoor A. Khan, RPh, PhD, is the director of product quality research in the Office of Testing and Research at the US Food and Drug Administration. Khan's research concentrates on the area of controlled drug delivery of challenging molecules, specifically in creating solid oral dosage forms. He serves on the editorial boards of Pharmaceutical Technology, Critical Reviews in Therapeutic Drugs Carrier Systems, and the Journal of Clinical Research and Regulatory Affairs. He has published more than 100 peer-reviewed manuscripts, four texts including Pharmaceutical and Clinical Calculations, three book chapters, and more than 100 presentations in various meetings.

Anthony C. Moffat, PhD, has made research contributions to further the understanding of the practical use of near-infrared analysis of pharmaceutical materials in the industrial setting. His work with gas chromatography, thin-layer chromatography, and high-performance liquid chromatography has paved the way for systematic toxicological analysis. He has also initiated the use of mass spectrometry in forensic science.

Lian Yu, PhD, has worked at Eli Lilly and Company for 14 years and has emerged as an expert in the study of solid-state properties of pharmaceutical materials. His research and collaboration with formulation and process scientists have contributed toward the development of many of Lilly's products. Yu has served as an adjunct faculty member in the Department of Pharmaceutics at the University of Minnesota and recently joined the Pharmaceutical Sciences Division at the University of Wisconsin School of Pharmacy. Yu's current research focuses on polymorphs of molecular crystals and stabilization of amorphous drugs.

Jean P. Remon, PhD, conducts research primarily on the formulation of solid oral dosage forms, with an emphasis on granulation and pelletization, bioadhesive dosage forms, and oral controlled drug delivery systems. His work explores both the technological approach and the process of drug delivery. Remon's research team has also been involved with the development of oral drug delivery systems of genetically modified Lactococcus lactis, bacteria found in lactic acid, for the treatment of inflammatory intestinal diseases. Professor Remon's laboratory has been granted several innovative patents, which have been licensed to pharmaceutical companies in Europe and the United States.

Glenn A. Van Buskirk, PhD, is internationally recognized as a leader in the advancement of regulatory research. He has contributed to the formulation, scale-up, launch, and post-approval product development improvements of many different classes of drug products. Buskirk played a pivotal role in developing brand brand-name drugs such as Imodium capsules; Eprex injections to treat anemia in cancer patients; and Floxin tablets, an antibiotic used to treat a variety of ailments ranging from ear infections to pelvic inflammatory disease. He has influenced the current concept for the federal pharmaceutical regulatory process regarding scale-up and post-approval changes and helped organize those principles into a common working format suitable for use by the US FDA. His leadership in creating the "Scale-Up and Post-Approval Changes (SUPAC) Guidance" documents can be seen as the forerunner to today's process analytical technology initiative.

Chang-Koo Shim, PhD, is the former commissioner of the Korean Food and Drug Administration. He established the Korean Society of Pharmaceutical Regulatory Sciences last year, and played a key role in establishing regular joint symposia to share knowledge and research on pharmaceutics between Korea and Japan. His research focuses on molecular weight-dependent transport of organic cations to bile, and the characteristics of xenobiotics during disease states. Recently, Shim has been interested in altering the functional activity for transporters on the canalicular membranes to demonstrate its effect on the liver.

Masaki Otagiri, PhD, is a professor and Dean of the Graduate School of Pharmaceutical Sciences of Kumamoto University, Kumamoto, Japan. He has concentrated his research on the analysis of pharmacokinetics and the development of new drug delivery systems. Otagiri has studied the interactions of plasma proteins and drugs, and used natural polymers to improve a drug's pharmaceutical characteristics. He has published more than 350 peer-reviewed articles and has won awards from the Academy of Pharmaceutical Science and Technology, Japan; the Japanese Society of Study for Xenobiotics; and the Molecular Chirality Research Organization.

Non-manufacturing

Sandra R.B. Allerheiligen, PhD, researching drug development at the University of Texas and at Eli Lilly and Company, has expanded her interest from designing appropriate studies, to validating population pharmacokinetic and pharmacodynamic modeling and trial simulation, to studying in the arena of quantitative pharmacology. Allerheiligen has contributed to more than 10 investigational new drugs, several development programs, and the new drug application (NDA) studies for gemcitabine, a cancer-fighting drug, and raloxifene, which combats osteoporosis. She currently serves as treasurer on the AAPS Executive Council. as treasurer.

Margareta Hammarlund-Udenaes, PhD, a professor of pharmacokinetics and pharmacodynamics at Uppsala University in Sweden, has been a member of AAPS for almost 20 years. Her research focuses on the central drug action of opioids and also on the development of microdialysis as a tool in blood-brain barrier studies. Hammarlund-Udenaes has most notably contributed to the significant development of in vivo microdialysis as a quantitative technique to study blood-brain barrier transport and the equilibration of drugs, which carries enormous implications for in vivo microdialysis as a reference technique for drug transporter studies.

Richard B. Kim, MD, is a professor of medicine and pharmacology at Vanderbilt University School of Medicine. His research focuses on patients' varied reactions to similar drug dosage levels, specifically in reference to proteins known as drug transporters, which shuttle the drug in and out of the body. His contributions have greatly enhanced the understanding of genetic and environmental factors that affect drug transporters, and may allow for better identification of patient risk for toxicity or of the ineffectiveness of drugs for therapeutic reasons.

Rodney J.Y. Ho, PhD, is a professor of pharmaceutics and director of the DNA Sequencing and Gene Analysis Center at the University of Washington in Seattle, WA. He has made outstanding contributions to science and health by improving anti-HIV and cancer drug efficacy and safety and elucidating physio- and biological processes involved in virus and drug disposition. His most recent accomplishment was the development of a novel drug delivery strategy to improve drug exposure to lymphoid tissue for HIV patients who showed deficiencies in treatment drug levels in their lymph nodes. In addition to his ground-breaking research, Ho has also published the book "Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs," co-authored with Milo Gibaldi.

Richard A. Kenley, PhD, has worked in the pharmaceutical sciences for more than 25 years in areas such as drug discovery and development, biotechnology, and drug regulation and control. He currently works as the chief operating officer of Anaborex, Inc., a new company researching ways to combat tissue wasting disease. Kenley has contributed to numerous NDA studies including those for butoconazole (Femstat), a vaginal anti-fungal treatment; rh-IL11 (Neumega), a drug used to prevent low platelet counts (blood clotting cells) that are a result of chemotherapy; and pramlinitide (Symlin), a secondary treatment to improve glucose levels in patients with Type 1 and 2 diabetes. He has three patents and 60 research publications in peer-reviewed scientific journals.

Uday B. Kompella, PhD, has focused his research on ocular and respiratory drug delivery. He has developed new approaches for drug delivery for neovascular disorders such as diabetic retinopathy, age-related macular degeneration, and lung cancer. His research supports a growing hypothesis that these disorders have a significant inflammatory component. Kompella's research shows that there is a pharmacokinetic advantage to using trans-scleral drug delivery methods for diabetic retinopathy. His research on respiratory drug delivery has demonstrated differences between known systems such as nasal delivery and receptor-mediated hormone agonist delivery, and has shown the merit of new techniques such as supercritical fluid technology.

Frans G.M. Russel, PhD, is a professor of molecular pharmacology and toxicology, and the scientific director of the bachelor's and master's degree programs in Biomedical Sciences at Radboud University Nijmegen Medical Centre, Nijmegen, Holland. Russel has developed novel theoretical concepts and experimental techniques to study drug transport and distribution in the kidneys. By combining molecular, cellular, whole organ, and in vivo techniques, he has been able to develop an in-depth understanding of the role of transporters in drug distribution and excretion.

Christian Schneich, Ph.D, is internationally recognized as an expert in the area of post-translational protein modification, both in vivo and in vitro. In his research, Dr. Schneich has identified oxidation pathways that modify proteins during pathological conditions and biological aging. By examining these pathways in vivo, novel therapies can be developed to protect or express these proteins. Dr. Schneich and his research team have also developed a novel mechanism that inhibits apoptosis (cell death) in muscle cells by using protein Bcl-2 to inactivate the sarco/endoplasmic reticulum Ca-ATPase (SERCA) in the endoplasmic-sarcoplasmic reticulum.

Gary A. Thompson, PhD, is currently a research fellow in clinical pharmacology and pharmacokinetics at Procter and Gamble. He specializes in the practical implementation of theoretical pharmacokinetic principles and mathematical modeling to drug development in order to improve the reliability of critical decisions and ultimately, the efficiency of the overall drug development process. During his career, Thompson has served as a mentor to more than 25 academic and industrial scientists and physicians. He has served as a reviewer for more than 10 scientific journals, primarily in the area of clinical pharmacology, and has published more than 50 book chapters and journal articles.

Kenneth E. Thummel, PhD, is a professor in the Department of Pharmaceutics and is also the associate dean for research and new initiatives at the University of Washington in Seattle, WA. His research focuses on drug metabolism, specifically on investigating the genetic, hormonal, and environmental factors that contribute to metabolism differences. He placed special emphasis on studying the drug metabolism of intestinal cytochrome P450. Thummel is a Fellow of the American Association for the Advancement of Science and an Associate Editor for Drug Metabolism and Disposition.

M. Guillaume Wientjes, PhD, a professor of pharmacy at Ohio State University, is recognized for his use of computational modeling and simulation in chemotherapy. Wientjes has demonstrated the value of this approach in a number of areas, including the development of prostate cancer treatment, mechanisms of chemoresistance, and the development of mathematical models to guide therapy selection. His research has helped improve understanding of regional drug distribution at organ and sub-organ levels, which allowed for improved treatment of superficial bladder cancer.