The American Association of Pharmaceutical Scientists (AAPS) has announced its 2007 AAPS Fellows, cited for making "remarkable scholarly and research contributions to the pharmaceutical sciences." They will be recognized at the group's annual meeting this week in San Diego, which Bill Swichtenberg will be attending. Congratulations to each and every one of them. (If PhRMA would like to launch a new P.R. campaign to improve the public image of the pharma industry, perhaps its marketing types could describe some of these individuals' work in its public affairs material. It's definitely a nice counterpoint to all the sales and marketing news). And, for those who remain skeptical about process analytical technologies (PAT), or who think Quality by Design is the FDA's latest "flavor of the month," consider that at least two of these Fellows are very closely involved in both these areas. More on each of the fellows below: Kenneth R. Morris, Ph.D is currently a Professor and the Associate Head of the Industrial and Physical Pharmacy Department at Purdue University . He has worked in the academic, industrial, and governmental sectors in both the pharmaceutical and environmental disciplines. His main research contributions have been in the area of pharmaceutical materials science and engineering. These pursuits led Dr. Morris to develop advanced techniques to monitor processing stress-induced changes for use in developing predictive models, and he emerged as the academic thought leader in the areas of quality by design, PAT and other important pharmaceutical product development initiatives. Moheb M. Nasr, Ph.D is the Director of the Office of New Drug Quality Assessment, Center for Drug Evaluation and Research , U.S. Food and Drug Administration. He is responsible for providing executive leadership, scientific expertise, and overall technical direction to 150 multidisciplinary pharmaceutical scientists, chemists, engineers, and medical professionals engaged in the regulatory and scientific evaluation of Chemistry, Manufacturing and Controls (CMC) for all Investigational new drugs, and new drug applications intended for human use. Throughout his distinguished career at the FDA, Dr. Nasr has exemplified the spirit of distinguished public service through outstanding scientific and scholarly contributions to improving human health. Mansoor M. Amiji, Ph.D is a Professor and Associate Chairman of the Pharmaceutical Sciences Department at Northeastern University , and Co-Director of the Nanomedicine Education and Research Consortium (NERC). Over the past 15 years, Dr. Amiji has contributed to the development of novel approaches for surface modification of polymeric biomaterials to improve biocompatibility, micro- and nanotechnologies for target-specific drug and gene delivery, and newer generations of multifunctional nanostructures for biomedical and pharmaceutical applications. Steven Baertschi, Ph.D is a Research Fellow in Analytical Sciences R&D at Eli Lilly and Company, Indianapolis , Indiana . Over the last 18 years he has made significant contributions to the pharmaceutical sciences in the areas of drug stability, stress testing/degradation chemistry, photostability testing, and the development of analytical methodologies. Dr. Baertschi's work in delineating degradation pathways has demonstrated the importance of using a "chemistry-guided approach" to solving complex stability problems and to the development of stability-indicating methods. Ajay K. Banga, Ph.D is Professor and Chair in the Department of Pharmaceutical Sciences at the College of Pharmacy and Health Sciences, Mercer University , Atlanta , Georgia . His research expertise is in non-traditional approaches for transdermal drug delivery. Dr. Banga has investigated transdermal iontophoretic delivery of water soluble drugs for several years and more recently is also using microneedles and other approaches for transdermal delivery of macromolecules. He has just published a theme section on transdermal delivery of proteins in Pharmaceutical Research as a guest editor. Peter L. Bonate, Ph.D.is currently Senior Director of Pharmacokinetics at Genzyme. His research has involved the exploration of new modeling and simulation methodologies and their application to drug development. He was one of the pioneers in using linear and nonlinear mixed effects modeling of exposure-QTc interval data. Dr. Bonate has been or is currently on the editorial advisory boards of the Journal of Clinical Pharmacology , the AAPS Journal , and Pharmaceutical Research , and he has more than 40 publications in the field of pharmacokinetics and clinical pharmacology Piet Herdewijn, Ph.D. is one of the founders of the International Society for Nucleosides, Nucleotides and Nucleic Acids and is a member of the Belgian Academy of Medicine. He has taught the course of medicinal chemistry for 20 years at the Katholieke Universiteit Leuven in Belgium and is the head of the laboratory of medicinal chemistry in the Rega Institute for Medical Research, Belgium . Dr. Herdewijn contributed to the medicinal chemistry of nucleosides, oligonucleotides and peptides with applications in the anti-infection and antitumoral field. He has published 500 articles in international journals on these topics and, more recently, he discovered nucleoside triphosphate mimics that are accepted as substrate by HIV reverse transcriptase. Donhgho (Robert) Lu, Ph.D. joined the U.S. Food and Drug Administration/ONDQA in 2005. Prior to his FDA career, he was a full professor in pharmaceutics at School of Pharmacy , Temple University , and an associate/assistant professor at College of Pharmacy , University of Georgia . Dr. Lu's academic research interests have included the development of gene delivery and controlled-release systems, and the syntheses of pharmaceutical compounds with enhanced targeting properties Tobias Massa, Ph.D. has supervised the regulatory strategy and authoring of chemistry, manufacturing and control sections of 20 globally approved pharmaceutical products and over 150 investigational drug applications. He is currently responsible for managing the CMC regulatory strategy for a portfolio of over 50 products in development and 300 approved products globally for Bristol-Myers Squibb Company. In addition to his corporate responsibilities, Dr. Massa has had a leadership role in efforts to refine regulatory policy for the manufacture and control of synthetic and biological products. He has chaired numerous industry committees on topics such as submission content, change control, specifications, biologics regulations and utilization of biologics manufacturing facilities. Carlo Rossi, Ph.D.started his research career in the chemistry of natural products field. In particular, he studied the holothurinogenins, toxic saponin principles produced by the Actinopyga agassizi , a marine animal that is very active against its predators. More recently, Professor Rossi turned his scientific interests on the pharmaceutics and drug delivery areas, where he continues to be active. Noteworthy is the research line by which he developed, in a close collaboration with a group of MDs, multifunctional composite microcapsules as potential artificial bio-hybrid organs as a final cure for the type I diabetes mellitus. Mandip S. Sachdeva, Ph.D.is a professor and section leader for the pharmaceutics activity at Florida A&M, College of Pharmacy . He has made significant contributions to the knowledge and understanding in the area of drug delivery with special emphasis in inhalation/aerosol delivery as applied to lung cancer and topical delivery of neuropeptides. He has used a multidisciplinary approach of not only delivering novel anticancer agents by inhalation drug delivery but also looking into their mechanism of action to look for newer targets. During the last 20 years, besides developing new approaches for improved drug delivery to the lungs and through the skin, Dr. Sachdeva has identified new molecular pathways and mechanisms for therapeutic agents intended for the treatment of lung cancer and skin inflammation. Robert M. Straubinger, Ph.D
Dr. Straubinger's research in the field of biopharmaceutics focuses primarily upon drug carriers, drug targeting, and drug delivery. His sustained research on the taxane anticancer agents represents a comprehensive exploration of biophysical factors that determine formulation stability, as well as the pharmacological consequences of formulation properties. This work is described in approximately 14 publications and several patents, and resulted in the development of improved, liposome-based formulations of taxol (paclitaxel) having reduced toxicity.
Shinji Yamashita, Ph.D.has conducted continuous research on oral drug absorption and has published many important articles in this field. He is best known for his pioneering work on the development of in vitro and in situSumie Yoshioka, Ph.D. has been involved in fundamental studies with particular emphasis on the difficult and complex area of solidstate stability for more than 25 years. Dr. Yoshioka has published over 100 papers in peer-review journals and provided important leadership in the application of such science to regulatory and health policy issues world-wide. Achievements in her research include: elucidation of the importance of the role played by the physical properties of molecules in the solid state in determining the tendencies for such systems to undergo both physical and chemical instability, and work on solid-state stability using nuclear magnetic resonance to quantitate various types of molecular motions and to demonstrate their role in promoting instability.