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AAPS Honors Nanoresearchers as 2013 Fellows

The American Association of Pharmaceutical Scientists (AAPS) is pleased to announce its 2013 AAPS Fellows. AAPS Fellows are granted the honor each year for making sustained remarkable scholarly and research contributions to the pharmaceutical sciences such as original articles, scientific presentations at AAPS Annual Meetings, and/or patents.

Sathy Balu-Iyer, Ph.D, State University of New York at Buffalo
Dr. Sathy Balu-Iyer’s contributions are focused on understanding the mechanism of immune response against biotherapeutics and rationally developed strategies to mitigate immunogenicity. Based on antigen processing and pharmacokinetics, he has developed a mechanistic model to understand immunogenicity of subcutaneously administered biotherapeutics. His mechanistic studies have shown that phosphatidylserine mediated reduction in immunogenicity is due to induction of tolerance. Pre-exposure of therapeutic proteins in the presence of phosphatidylserine led to antigen specific hypo-responsiveness. Based on this observation, he has proposed a novel clinical intervention-reverse vaccination-to mitigate immunogenicity. Unlike conventional vaccination strategies, this approach desensitizes patients towards biotherapeutics.

Guru Betageri, Ph.D., Western University of Health Sciences
Dr. Guru Betageri obtained his Ph.D. in Pharmaceutical Sciences from the University of Alberta, Canada. He is currently professor of Pharmaceutical Sciences and associate dean, Graduate College of Biomedical Sciences at Western University of Health Sciences. His research expertise includes liposome, proliposome and lipid based drug delivery systems. Dr. Betageri is an inventor of the “Proliposomal” technology and has been awarded four U.S. patents to date. He has co-authored a book entitled “Liposome Drug Delivery” and contributed to several book chapters. He serves as a member of several professional societies and is a charter member of AAPS. Dr. Betageri served as an advisor/co-advisor to 20 M.S./Ph.D. students, and as a thesis committee member for more than 30 students. Additionally, he has supervised nine post-doctoral fellows in his laboratory. Dr. Betageri has published more than 70 peer reviewed publications and has over 130 podium and poster presentations to his credit. He has been invited to speak at various national and international conferences and pharmaceutical companies. Dr. Betageri served in various organizations, including AAPS. He is a member of the Lipid-Based Drug Delivery Systems Focus Group. He is currently serving on six editorial boards and is a manuscript reviewer for more than a dozen journals.

Robin Bogner, Ph.D., University of Connecticut
Dr. Robin Bogner’s research focuses on the mechanisms of drug and excipient dissolution from oral dosage forms, with the goal of achieving enhanced release of poorly soluble drugs. Her work has involved the characterization of the microenvironment near the surface of dissolving excipients, demonstrating that the microenvironment differs significantly from the bulk fluid, not only in its pH but also its dielectric constant and viscosity, which have significant impact on the dissolution of all compounds in that microenvironment. Her patented dissolution flow-cell is currently in use at four pharmaceutical companies. Dr. Bogner and her group have explored mesoporous silicates for improving the dissolved concentration of poorly soluble drugs. She and her students have provided a fundamental understanding of the drug form, stability, and mechanism of enhancement from the nanopores in pharmaceutical silicates. Her collaborative research with Dr. Michael Pikal improved the prediction of the enhancement of drug concentration available from amorphous forms relative to crystalline forms. Dr. Bogner’s team continues to study the time course of solution-mediated phase transformation on the bioavailability of drugs from supersaturating drug dosage forms. She has recently extended her dissolution expertise to address the unacceptably long reconstitution times of highly concentrated lyophilized protein therapeutics.

Jack Cook, Ph.D., Pfizer Inc.
Dr. Jack Cook’s work in clinical pharmacology has impacted current practices in drug development in a number of different areas. His work in biopharmaceutics involving the strategic use of the biopharmaceutics classification system and the correlation of in vitro dissolution with in vivo product performance has facilitated optimization of formulation development. Additionally he has championed the use of modeling and simulation to make rational decisions in the development of drugs. Applications in this area have included correlation of in vitro data to clinical results in order to assess the likelihood of a clinically relevant drug interaction for a new chemical entity, the use of clinical trial simulation to support dose selection, and a proposal for a staged regulatory approval pathway that would allow patients with rare diseases earlier access to new therapies.

Weiguo Dai, Ph.D., Janssen Research and Development
Dr. Weiguo Dai is a Scientific Director and Janssen Fellow at Johnson and Johnson. He has been recognized for his innovative and outstanding contributions that have had a significant impact on the areas of patient-centered drug delivery technology and delivery-enhanced drug product development. He has a proven track record of driving products from concept to development and commercialization. Dr. Dai’s research and innovation have primarily focused on improving the drug efficacy, safety, and patient compliance through the design and development of novel formulations, and delivery technologies and processes. His technology innovations have directly led to the launch of delivery-enhanced commercial products. As a well-recognized industrial expert, Dr. Dai has made influential and sustained contributions in the areas of developing new oral controlled delivery technologies, novel delivery technologies for sustained release of biologics, enhanced delivery systems for biologics product differentiation and life cycle management, and applying enabling delivery technologies for drug products in the development pipeline.

Elizabeth de Lange, Ph.D., Leiden Academic Centre for Drug Research
Dr. Elizabeth de Lange’s research focuses on interspecies extrapolation and prediction of human (CNS) drug effects on the basis of preclinical data. To that end she develops translational pharmacokinetic (PK) – pharmacodynamic (PD) models combinaing advanced preclinical experiments, to obtain multiple level data, and advanced mathematical modeling. Dr. de Lange is an internationally recognized expert on blood-brain barrier (BBB) transport and intra-brain distribution. Special emphasis is put on measuring unbound concentrations of drugs by microdialysis. This had led to successful predictions of human cerebrospinal fluid (CSF) concentrations and human CNS drug effects.

Divyakant Desai, Ph.D., Bristol-Myers Squibb
Dr. Divyakant Desai is a Research Fellow at the Bristol-Myers Squibb (BMS). He has been working in the area of oral dosage form for the last 25 years. He was the lead formulator for nine commercial products. He has more than 30 research articles in peer-reviewed journals and many formulation and technology related patents. He has won many prestigious awards at BMS for the formulation design of some key commercial products. He was presented the Ondetti and Cushman Innovation Award for developing Abilify Discmelt™ tablet formulation in 2006. The orally disintegrated tablet formulation was designed to disintegrate rapidly upon coming in contact with saliva to increase patient compliance. He was awarded the James Palmer Product Development Award for Onglyza™ tablet formulation in 2009. This novel approach was needed because the traditional formulation approaches could not be used. He was declared as the winner for the 2012 Edison Patent Award in the pharmaceutical category. The award was given for the formulation patent of saxagliptin and its fixed dose formulations with metformin for the treatment of type 2 diabetes by the Research and Development Council of New Jersey for the innovative work with high impact on the society.

Nicholas Holford, MB, ChB, MSc, MRCP (UK), FRACP, University of Auckland, New Zealand
Professor Nicholas Holford’s research and contributions have detailed the importance and significance of understanding the effects of dose and time on drug effects. His 1981 publication on “Understanding the time course of drug effect” has served as a foundation in the area of pharmacodynamics. Professor Holford was the main proponent of analyzing drug effect data longitudinally and he developed most of the methodology used today. Today, these concepts and analyses are routinely carried out for virtually all new therapeutic agents in the pharmaceutical industry and regulatory agencies, e.g., U.S. FDA Guidance for Industry on Exposure response relationships. Building on this work, his research and knowledge about the pharmacotherapy of existing drugs in the area of neurodegenerative disorders has led to new insights in therapy by assessing whether a drug’s effect on a disease is disease modifying or merely symptomatic. Regulatory agencies use such concepts and tools to contemplate and discuss criteria for claims for disease modifying drug effects. He has served as a Special Government Employee as an expert for the Center for Drug Evaluation and Research, U.S. FDA. His work in the areas of pediatrics and on the effect of pharmacokinetic variability in dose individualization remain cornerstones in clinical pharmacology.

Holly Kimko, Ph.D., Janssen Research and Development
Dr. Holly Kimko is a Scientific Director and Janssen Fellow in the Department of Model Based Drug Development at Janssen R&D of Johnson & Johnson in New Jersey. Before joining the company, she was a faculty member at the Center for Drug Development Science in Georgetown University Medical School. She received her Ph.D. in Pharmaceutical Sciences from the State University of New York at Buffalo. She applies modeling & simulation tools in drug development by designing cost-effective studies and solving compound-specific regulatory challenges. She has published frequently cited key papers and has edited two books.

Lee Kirsch, Ph.D., The University of Iowa
Professor Lee Kirsch has had distinguished careers as an academician at The University of Iowa and as an industrial scientist at Lilly Research Laboratories. His main areas of research focus have been the kinetics and mechanisms of drug stability, e.g., hydrolytic degradation of daptomycin, glucagon, growth hormone, biguanides, gabapentin, substituted formanilides, and kynurenine, and scientifically-based pharmaceutical package integrity technology. As an industrial scientist he contributed to the development and commercialization of various peptides and peptide hormones including daptomycin, glucagon, insulin growth hormone. He has mentored over 20 graduate students and post-doctoral scholars and has taught courses in drug stability, product development, pharmacokinetics, and physical pharmacy at Iowa, Virginia Commonwealth University, West Virginia University, and Chulalongkorn, Thailand. Professor Kirsch has been an active member and leader in AAPS, PDA and NIPTE, and has served on various USP, PQRI, grant review committees, task forces and editorial advisory boards. He was the editor for the PDA Journal of Pharmaceutical Science and Technology from 2000 to 2008 and is currently the editor-in-chief of the AAPS PharmSciTech journal.

Ping Lee, Ph.D., University of Toronto
Dr. Ping Lee is professor and GlaxoSmithKline chair in Pharmaceutics and Drug Delivery in the Leslie Dan Faculty of Pharmacy, University of Toronto. Prior to joining the academia, he spent many years heading R&D functions in the pharmaceutical industry. He has made significant contributions to the field of controlled-release drug delivery particularly relating to hydrogels and matrix systems. His research has had a major impact on the fundamental understanding of the complex drug release mechanisms from polymers and on the rational design of controlled-release products. He was the first to demonstrate the novel concept of constructing a non-uniform drug distribution in hydrogels to modulate the drug release, which provided a viable new option for overcoming a major design challenge facing controlled-release researchers. His current research focuses on the understanding of release mechanisms from solid molecular dispersions in hydrogels intended for applications in enhancing the delivery of poorly soluble drugs.

Tonglei Li, Ph.D., Purdue University
Dr. Tonglei Li and his laboratory study pharmaceutical solid-state materials. His research program largely revolves around organic crystals with a keen interest in molecular packing, intermolecular interactions, and phase transition mechanisms. He has made contributions in utilizing electronic calculations to unravel how molecules interact in the solid state. In particular, much of his efforts have been focused on developing new concepts and methods within the framework of conceptual density functional theory for understanding the locality of intermolecular interactions. Other related work includes crystal engineering of structurally similar compounds and characterization of crystallization kinetics and mechanism. In addition, his research team has recently developed nanocrystals of poorly soluble drugs for cancer therapy. One unique contribution was achieving concurrent bioimaging and chemotherapy with hybrid nanocrystals. The long-term goal of Dr. Li’s research program is to predict physicochemical properties as well as drug action kinetics in vivo based on the molecular structure of a drug compound.

Hanns-Christian Mahler, Ph.D., F. Hoffmann-LaRoche Ltd.
Dr. Hanns-Christian Mahler has been researching protein aggregation and more specifically protein particulates in biotech formulations. His studies include exploring and advancing methods to measure and chacterize protein particulates, studying mechanisms of the generation of particles, and ways to formulate and protect protein from theses stress, e.g., via the use of surfactants. These surfactants, especially polysorbate 20 and 80, have been studied by Dr. Hanns-Christian Mahler from multiple perspectives such as performance during membrane separation processes, adsorption to filters, degradation in raw material, and under typical aqueous formulation conditions and for potential interaction with dendritic cells. Polysorbates are key stabilizers and widely used and a more thorough understanding of their functionality, performance, stability and interaction with surfaces will most probably help to further improve the quality of both formulations and the excipient itself.

Murali Ramanathan, Ph.D., State University of New York at Buffalo
Dr. Murali Ramanathan is professor of Pharmaceutical Sciences and Neurology at the State University of New York at Buffalo and co-director of its Data-Intensive Discovery Initiative. Dr. Ramanathan received his Ph.D. in Bioengineering from the University of California, San Franscisco. Dr. Ramanathan has made fundamental contributions in the applications of pharmacogenetics and pharmacogenomics in the pharmaceutical sciences. The twin foci of Dr. Ramanathan’s research are multiple sclerosis (MS) therapeutics and pharmacogenomic modeling. MS is a neurological disease that causes physical and cognitive disability, whose etiology and pathogenesis remains poorly understood. The goals of his research are to identify gene environmental interactions and molecular mechanisms by which the autoimmunity of MS results in neurological damage in the central nervous system. His group is actively involved in multi-disciplinary research spanning genomics, proteomics, molecular and computational pharmacology, imaging and clinical research in MS to enable drug discovery and development for MS. Dr. Ramanathan’s pharmacogenomics research interests focus on developing innovative methods to leverage genomewide and next-generation sequencing data for drug discovery, and therapy optimization. Current research includes projects in gene-environment interaction analysis, systems pharmacology and integrating pharmacogenomics modeling in population pharmacokinetics and pharmacodynamics.

Amin Rostami-Hodjegan, Pharm.D., Ph.D., FCP, University of Manchester, United Kingdom
Dr. Amin Rostami was the first professor of systems pharmacology (2007, University of Sheffield) to receive recognition of his broad contribution to the field of pharmacokinetics and pharmacology. His specific achievements are widely recognised in the sub-specialities of ‘Population Pharmacokinetics and Pharmacokinetics-Pharmacodynamics modelling of Metabolites’ and ‘In Vitro In Vivo Extrapolation (IVIVE) within the Physiologically-Based Pharmacokinetic (PBPK) framework’. The PBPK-IVIVE models developed by his research and adopted across the pharmaceutical industry have reduced animal testing, accelerated discovery, led to faster development of better and safer drugs and informed the evolution of best practices as recommended by the regulators. He has championed the movement away from traditional, essentially empirical, approaches towards a more mechanism-based modelling strategy to increase the efficiency of clinical trials. In addition to leading an active research group at the University of Manchester, Professor Rostami is the Vice President of Research & Development at Simcyp (Certara) and he has directed the research activities of the Simcyp Consortium (involving over 25 of international pharmaceutical companies) for over a decade. The common thread in all scientific achievements by Professor Rostami is his concerted effort towards “Finding Better Applications for Pharmacokinetics” and his ability to “Communicate these with Scientists outside the PK Community."

David Volkin, Ph.D., University of Kansas
Dr. David Volkin has contributed to advances in the characterization, stabilization, and formulation of therapeutic proteins and macromolecular vaccines. During his 20- year R&D career at Merck and J&J, Dr. Volkin led formulation and analytical groups that developed dosage forms and test methods for dozens of therapeutic proteins, monoclonal antibodies (mAbs), and vaccines used in clinical trials, including five vaccines and two mAbs approved for human use. He is now a Distinguished Professor of Pharmaceutical Chemistry and directs the Macromolecule and Vaccine Stabilization Center at The University of Kansas. Dr. Volkin is co-author of over 90 scientific publications and co-inventor on 14 U.S. patents. His contributions to vaccine development include papers describing the biophysical characterization of complex vaccine antigens, formulation challenges with novel adjuvants, and correlations of physicochemical properties of vaccine formulations with their ability to elicit protective immune responses. He co-authored one of the first papers applying novel analytical techniques to describe mAb instability due to subvisible particle formation during long-term storage. Along with colleagues from several laboratories, Dr. Volkin’s group recently described effects of different excipients on a mAb’s local flexibility, conformational stability, and aggregation propensity.

APS Larry Wienkers, Ph.D., Amgen Inc.
Dr. Larry Wienkers’ career has been focused towards understanding how drugs interact with biologic systems with an emphasis on the elucidation of the mechanisms of cytochrome P450 oxidation reactions and the application of novel in vitro metabolism techniques to understand the enzymatic basis for P450 mediated drug-drug interactions. His current research interests are focused on small molecule mechanism based inhibition of P450 enzymes with particular focus on the identification of active site amino acid(s) and peptide(s) of the P450 enzymes modified during inactivation and determination of the mechanism(s) by which the inactivation reaction occurs at a molecular level.

Lei Zhang, Ph.D., U.S. Food and Drug Administration
Dr. Lei Zhang has been a key player in regulatory science research, guidance, and policy development in the Office of Clinical Pharmacology at the U.S. FDA for the past 11 years, apart from regulatory review responsibilities. She has played important roles in the development of various clinical pharmacology guidances including drug interactions, studies in renal impairment patients, clinical pharmacogenomics, and clinical pharmacology labeling. She is well known in the field of drug interactions involving transporters and enzymes. Understanding critical factors that affect a drug’s exposure and response and defining regulatory strategies have been the focus of her research. Findings from her research have formed the scientific basis for recommendations made in various guidances and are applied by scientists throughout the industry. Dr. Zhang brings a tremendous regulatory perspective to collaborative projects with academia and industry. She is a member of the International Transporter Consortium that published transporter whitepapers in 2010 and 2013. She is active in service to professional societies (e.g., AAPS, ASCPT, and ISSX), journals, and universities. She is an Adjunct Associate Professor at the University of California, San Francisco. She co-authored several impactful papers on transporter-mediated drug interactions. Dr. Zhang received her Ph.D. from UCSF and worked at Bristol-Meyers Squibb prior to joining the FDA.

Honghui Zhou, Ph.D., FCP, Janssen Research and Development
Dr. Honghui Zhou has demonstrated both a depth and breadth of achievement relevant to clinical pharmacology of biotherapeutic drug development, and a commitment to scientific excellence and innovation. Dr. Zhou manages to contribute new basic knowledge in the context of the demands of an industrial position. The result has been his substantial contributions to the fields of therapeutic proteindrug interaction, pediatric development of therapeutic proteins and clinical pharmacology strategy in biotherapeutic development, and clear impact on the drug development process across the pharmaceutical industry. His numerous publications in those areas have been widely read and cited in both academia and industry. One of his recent research interests focuses on mechanistic understanding of distribution of antibody-based biotherapeutics to the target tissues and their ability to neutralize targets at the sites of action.


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