Dr. Bertil Abrahamsson, AstraZeneca
Bertil Abrahamsson has a broad experience of industrial drug development from more than 25 years of work with Astra and AstraZeneca. During this period, Dr. Ambrahamsson has had various line and project management positions. Presently Dr. Ambrahamsson is a Senior Principal Scientist with emphasis on biopharmaceutics. In this role, Dr. Abrahamsson is leading biopharmaceutics research and project support on a global basis. In addition, as one of the most senior scientists in AZ Pharmaceutical Development. He is also a member of the extended global leadership team. Dr. Ambrahamsson is active in the scientific area by means of publishing more than 70 papers and he is also presently an adjunct Professor in  Biopharmaceutics at Uppsala University, and he is also leading a major EU (IMI)/industry collaboration project in oral biopharmaceutics area (http://www.imi.europa.eu/content/orbito).

Dr. Gordon Amidon, University of Michigan
Dr. Gordon L. Amidon received his B.S. degree from the State University of New York, Buffalo (1967), an M.A. degree in Mathematics (1970) and Ph.D. in Pharmaceutical Chemistry (1971) from The University of Michigan.  From 1971 to 1981 Dr. Amidon was a member of the faculty at the University of Wisconsin. He was appointed Professor of Pharmaceutics at The University of Michigan in 1983 and was named the Charles R. Walgreen, Jr., Professor of Pharmacy in 1994. Dr. Amidon is internationally known for his research in the field of drug absorption, transport phenomena, solubility and dissolution, and prodrugs. He has published extensively in journals, with over 335 published papers and 370 abstracts, 18 US patents, contributed chapters to over 30 books and monographs and is co-editor of eight books.  Professor Amidon has mentored over 80 doctoral and postdoctoral students with more than 20 selecting academic careers. He has received numerous awards including; best paper awards in the Journal of Pharmaceutical Sciences (1975, 1981, 1984) and Pharmaceutical Research (2004); the Scheele Award of the Swedish Academy of Pharmaceutical Sciences for outstanding contributions to the field of oral drug delivery and biopharmaceutics (1996). He received an honorary Doctor of Pharmacy degree from the University of Uppsala, Sweden (2001); the Founders Award of the Controlled Release Society (2003); the Volwiler Award of the American Association of Colleges of Pharmacy (2004); the AAPS Distinguished Pharmaceutical Scientist Award (2005); the FIP Distinguished Pharmaceutical Scientist Award (2006); the Gerhard Levy Distinguished Lectureship (2006), the Alexander von Humboldt Research Award (2009) and the Japan Society for the Promotion of Science (JSPS) Fellowship Award (2011).  Dr. Amidon was the FDA/ASCPT Abrams Lecturer (2013) as part of an ongoing lecture series honoring William B. Abrams. He has organized and participated in many international symposia and workshops. Dr. Amidon developed a Biopharmaceutics Classification System (BCS), with the FDA, impacting bioequivalence standards worldwide. He is a Fellow of the AAPS, APhA/APS, and the AAAS. He is a member of the Controlled Release Society, serving as president in 1994, AACP, ACS and AAPS, serving as president in 1998. Dr. Amidon is the editor of the American Chemical Society Journal, Molecular Pharmaceutics

Dr. Gregory Amidon, University of Michigan
Gregory Amidon received his BS in medicinal chemistry and his PhD in pharmaceutical chemistry from the University of Michigan. After 28 years in the pharmaceutical industry, he returned to the College of Pharmacy in 2007 as a research professor of pharmaceutical sciences. He currently directs the Pharmaceutical Engineering program, jointly sponsored by the College of Engineering and the College of Pharmacy. He has held various research positions in R&D and is recognized for his expertise in the physical, chemical, and mechanical property characterization of active pharmaceutical ingredients, excipients, and products as well as the development of scientific strategies for oral solid dosage form development. Professor Amidon has served on the USP Council of Experts since 1990 and currently chairs the General Chapters – Physical Analysis Expert Committee. He is a member and Fellow of the American Association of Pharmaceutical Scientists and a past recipient of the Ebert Prize from the American Pharmaceutical Association.

Dr. Frank Ascione, University of Michigan
Frank J. Ascione is Dean and Professor of Clinical and Social and Administrative Sciences, University of Michigan College of Pharmacy and has been a faculty member there since 1977. He was appointed Dean of the College of Pharmacy in September 2004 and is a graduate of the University, where he received his BS, PharmD (College of Pharmacy) MPH and PhD (School of Public Health) degrees. He presently teaches a course on issues in regulatory science. Dr. Ascione was Director of the APhA Program (1973 to 1976) that produced the second edition of Evaluation of Drug Interactions and is the author of the publication, Principles of Drug Information and Scientific Literature Evaluation: Critiquing Clinical Drug Trials. Dr. Ascione’s past research has included evaluation of various models of medication therapy management, consumer medication taking behavior, and the use of technology in pharmacy practice. His current research focuses on drug policy, specifically the FDA regulatory process and health care institutional decision making. Specific projects include examining the decision making ability of Pharmacy and Therapeutics Committee and the impact of Direct-to-Consumer Advertising.

Christel Bergström, Uppsala University, Monash University
Christel Bergström is Associate Professor in Pharmaceutics at the Department of Pharmacy, Uppsala University, Sweden and Adjunct Associate Professor at Monash University, Australia. She earned her PhD from Uppsala University in 2003 and was immediately thereafter employed to establish a pharmaceutical profiling laboratory at Uppsala University. In parallel she continued to perform fundamental research within the drug solubility/absorption/distribution area. In 2010 she secured a highly competitive Marie Curie Fellowship for international qualification and the research program has since then been performed partly in collaboration with Monash University, Australia. Her research is now focused on in silico and in vitro models to allow identification of key molecular features driving poor aqueous solubility and to which extent enabling formulation strategies for such compounds can be predicted from molecular structure alone. Current funding come from highly competitive sources e.g. the Swedish research council, IMI (EU FP7; OrBiTo), NIH, The Swedish Agency for Innovation Systems and NordForsk. She has published 41 papers and book chapters and given more than 40 invited talks.

Dr. Marival Bermejo, University Miguel Hernández of Elche-Alicante
Marival Bermejo is currently Full Professor at the University Miguel Hernández of Elche-Alicante (Spain). She earned her B.Pharm and Ph.D degrees at the University of Valencia under the supervision of Prof. Plá-Delfina with a grant from Spanish Government. She got a position at the University of Valencia as Assistant Professor in 1993 and was promoted to Associate Professor in 1998. In 2008 she was appointed at University Miguel Hernández to coordinate the Area of Pharmacy and Pharmaceutical Technology in the Department of Engineering. She performed two post-doctoral research stages at the Institute of Topology and System Dynamics in Paris VII University, collaborating with Prof. Christiane Mercier and at the University of Michigan, working with Prof. Gordon Amidon. Dr. Bermejo research was centered on intestinal absorption. Her last research projects have been focused on the validation of in situ and in vitro models for oral permeability predictions and blood-brain-barrier permeation and their application to the biopharmaceutical development of new drugs.  Marival Bermejo is member of the “BIOSIM Network of Excellence” and she is the coordinator of the Alpha III project “Red Biofarma”, both funded by the European Commission and devoted to the improvement of in vitro methods for drug absorption predictions and the use of modeling and simulation as tools in drug development. She has been co-author of 50 papers,  9 books chapters and is co-author along with Gordon Amidon of the English and Spanish versions of Modern Biopharmaceutics, a CD-Rom teaching tool. In 2001 her team was awarded with the Research Prize of “Liconsa-Chemo Ibérica” for their work on fluoroquinolones absorption. She is member of the Board of Directors of the Drug Delivery Foundation (www.ddfint.org) and external assessor of the Spanish Agency of Medicines (AGEMED) and EMEA (European Medicines Agency). Dr Bermejo has been recently nominated as a foreign member of the Chilean Academy of Sciences.

Dr. James Brasseur, Pennsylvania State University
James (Jim) Brasseur is Professor of Mechanical Engineering, Biomedical Engineering and Mathematics at the Pennsylvania State University. He did his graduate work in fundamental fluid dynamics at Stanford University followed by postdoctoral appointments at NASA-Ames Research Center (CFD), the University of Southampton England (aerodynamics), and The Johns Hopkins University (turbulence and biomechanics). He has been at Penn State since 1989. Jim pursues two research tracts: (1) the study of turbulence physics, direct and large-eddy simulation, atmospheric boundary layer dynamics and wind turbines, and (2) physiology, mechanics and medicine of the gastrointestinal tract and related pharmaceutical issues in drug delivery. Jim is Fellow of the American Physical Society (APS), is recent Chair of the APS Topical Group on the Physics of Climate (GPC) and is a member of the permanent scientific advisory committee for the World Organization for Specialized Studies on Diseases of the Esophagus (OESO). Currently, Jim leads a research team developing a HPC "Cyber Wind Facility" for wind turbine research and is part of an international effort to improve prediction of drug dissolution in vivo vs. in vitro.

Dr. Cindy Buhse, U.S. Food & Drug Administration
Dr. Buhse joined DPA in 2001 as Deputy Director of the Division of Pharmaceutical Analysis for Center for Drug Evaluation and Research in the FDA. She was promoted to Division Director in June, 2004 and has been acting director for Office of Testing and Research since June 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley under the direction of John H. Clark and George C. Pimentel. Before joining FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. She leads a laboratory based office in the Center for Drug Evaluation and Research (CDER) responsible for supporting FDA review, investigation and enforcement actions and for conducting research programs to advance the science needed to regulate the quality of human drugs. 

Dr. Jack Cook, Pfizer Inc. 
Jack Cook is Vice President, Clinical Pharmacology in the Global Innovative Pharma Business Unit at Pfizer, Inc., Groton, CT.   Dr. Cook is also an Adjunct Professor in the Colleges of Pharmacy at the University of Michigan and the University of Florida. He currently serves as an industrial representative on the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, United States Food and Drug Administration.  He received the A.A.S degree in Industrial Chemistry Technology (1978), and B.S. degrees in Applied Mathematics (1981) and Pharmacy (1981) from Ferris State College; and the Ph.D. degree in Pharmaceutics from the University of Michigan (1987).  Dt. Cook started is career with Sterling Drug Inc. in Albany, NY in 1981. In 1987 he joined Parke-Davis which later became Pfizer, Inc. Dr. Cook’s areas of technical expertise are in biopharmaceutics, pharmacokinetics, pharmacodynamics, modeling and statistics. He is a member and fellow of the American Association of Pharmaceutical Scientists and serves as steering committee member for the Quality by Design and Product Performance Focus Group.  He is on the Board of Directors for the Drug Delivery Foundation.  His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs. He has published over 50 original research articles and 3 book chapters.

Dr. John Crison, Bristol-Myers Squibb Company
John Crison is a Research Fellow at Bristol-Myers Squibb with twenty five years experience in small and large molecule formulation research and development.  Prior to joining BMS, John has held positions in biopharmaceutics and drug delivery for large Pharma and Biotech, as well as product development in the software industry.  While his experience includes development of immediate and modified release dosage forms for oral, parenteral and ocular delivery, John’s focus has been in developing mathematical models for predicting and understanding drug absorption, dissolution and process unit operations.  John contributed to the FDA Guidance of a Biopharmaceutical Classification System (BCS) for establishing in vitro tests to waive in vivo bioequivalence tests and has shared this expertise on industrial applications and as a speaker at professional meetings.   John received his B.S., M.S. and Ph.D. degrees in Pharmacy and Pharmaceutics from the University of Michigan and has held adjunct faculty position at Michigan and the University of the Pacific and Albany Colleges of Pharmacy.  He is active in the American Association of Pharmaceutical Scientists and has held leadership positions in several focus groups.  

Dr. Arik Dahan, University of the Negev
Arik Dahan is an Assistant Professor of Pharmaceutics and Biopharmaceutics at the Department of Clinical Pharmacology and the School of Pharmacy, Ben-Gurion University of the Negev in Beer-Sheva, Israel. He is also an Adjunct Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Michigan. Dr. Dahan received his Ph.D. (2007) from the Hebrew University of Jerusalem. He was a Post-Doctoral Research Fellow at the University of Michigan (2007-2010) with Professor Gordon L. Amidon. Dr. Dahan's research interest is the integration of up-to-date molecular/cellular mechanistic investigations of drug disposition in the context of the human body. In implementing this molecular biopharmaceutical approach to ADME research, Dr. Dahan is seeking to enable mechanistic-based successful solutions to drug delivery/therapy, in challenging scenarios e.g. low-solubility, low-permeability, extensive metabolism, poor site targeting, various pathophysiological conditions, and pediatrics. He has published over 50 top-notch Journal papers, and contributed chapters to 6 books.

Dr. Dwayne Friesen, Bend Research Capsugel
Dr. Friesen has been employed since 1980 at Bend Research, a contract research and development company that has focused on drug development and delivery from compound selection through GMP manufacture of clinical supplies. Dr. Friesen served as Senior Vice President of Research for over 10 years and with the acquisition of Bend Research by Capsugel in September of 2013, now holds the position of Senior Advisor to Bend Research and Dosage Forms Solutions, a division of Capsugel. Dr. Friesen received his Ph.D. in physical chemistry from Oregon State University, Corvallis Oregon in 1980. He holds 45 U.S. patents and has 17 scientific publications. Dr. Friesen directs the research and development of novel drug-delivery platform technologies and pharmaceutical formulations for advancement of specific compounds. He has been instrumental in the development of novel drug forms and dosage forms for the delivery of compounds with challenging properties – including those with extremely low water solubility. Current work includes the development of novel oral formulations for delivery of small molecules with challenging properties as well as the development of in vitro and in silico methods for selecting technologies and formulations that will deliver target in vivo PK performance.

Dr. Ping Gao, AbbVie Inc.
Ping Gao, Ph.D., currently holds Center Director position, NCE-Formulation Sciences, Global Pharmaceutical and Analytical Sciences, GPRD, Abbvie, Inc. and was elected as Fellow of American Association of Pharmaceutical Scientists (AAPS) in 2009. He obtained his Ph.D. degree in Analytical Chemistry, Purdue University. He has over 24+ years working experiences in pharmaceutical industry. He developed his scientific and technical expertise in the areas including the early discovery support and preformulation, material characterizations, formulation sciences and drug delivery technologies, and commercial scale manufacturing. His long-standing interest and scientific investigation have been focusing on physicochemical/biopharmaceutical properties of drugs, design and development of controlled/extended release dosage forms, enabling drug delivery technologies including SEDDS and superssaturatable formulations for poorly soluble drugs, and in vitro dissolution methods and in vitro-in vivo relationship. He has 57 publications including research articles in peer-reviewed journals and book chapters, over 50 podium presentations at the national and international conferences, workshops and short courses, universities, and US-FDA. He has 20 US and European patents and 18 patent applications pending.

Dr. Michael Hawley, Boehringer-Ingelheim Pharmaceuticals Inc. 
Michael received his BS in Chemistry from Binghamton University and PhD in Physical Chemistry from the University of Arizona.  After some experience in other industries, in 1994, he moved to the pharmaceutical industry, starting with The Upjohn Company.  His experience with Upjohn, Pharmacia, Pfizer and BI has covered several cross functional areas of analytical, formulation and chemical development.  A unifying goal through these experiences has been to successfully integrate API properties with drug product design in order to create more robust formulations, while using significantly less resource and time.  Within this area, one of his long-term research interests has been developing experimental methods to assess the in-vivo performance of formulations.  Michael is currently leading the Solid Formulation Development group within the Pharmaceutical Development organization at Boehringer-Ingelheim in Ridgefield, CT and has co-authored over 40 publications and patents with various collaborators.

Dr. Ajaz Hussain, Insight Advice and Solutions, LLC
Dr. Ajaz Hussain is now a management consultant for lifesience sector and his practice is focused on mitigating risks of development failure and regulatory noncompliance.  His practice is based on about three decades of experiences distributed in the industry, US FDA and academic research and teaching.  During his industrial career (of about 9 years) he has built teams to develop and launch several fist-in class  complex generic and biosimilar products, contributed to advancing plant based vaccines and development of evidence necessary to demonstrate tobacco harm reduction.  In his corporate role he held high position of responsibility - President Biotechnology (Wockhardt), Chief Scientific Officer (Philip Morris International) and Vice President Biopharmaceutical Development (Sandoz). His career at US FDA spanned 10 years; form 2000-2005 he served as  the Deputy Director of the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER), FDA and held a "peer reviewed" Senior Biomedical Research position in the US Government Service. Dr. Hussain has published widely in the area of biopharmaceutics and product development. In particular his research focus has been on prediction of quality and performance attributes of pharmaceutical dosage forms, computer-aided formulation design, application of artificial neural networks to complex pharmaceutical problems, and application of modern process analytical technologies in pharmaceutical manufacturing. 


Dr. Johannes Krämer, PHAST GmbH
Dr. Krämer is the founder and managing director of  the “PHAST group” with sites in Germany, France, and Switzerland. Since 1987, he is working in the field of dosage form performance testing. He obtained his degree in pharmacy from Frankfurt University. After specializing in pharmaceutical analysis, he obtained his Ph.D. in pharmaceutical technology and biopharmacy from Heidelberg University.  Dr. Krämer is an elected member of the USP Dosage Forms Expert Committee and chairman of USP’s Subcommittee K (medicated gums) . With the International Pharmaceutical Federation (FIP) he is member of the Focus Group on Dissolution/In Vitro Release Performance Testing. He is a member of the American Association of Pharmaceutical Scientists, the Biopharmaceutics Group within APV (International Association for Pharmaceutical Technology), and the Deutsche Pharmazeutische Gesellschaft (DPhG). His scientific interest is focused on IVIVC-based (in vitro in vivo correlations) in vitro performance testing method-development for pharmaceutical dosage forms, with special regard to stability problems. He is the author of several publications and several book chapters as well as coeditor of a book on dissolution testing. 

Professor Peter Langguth, Johannes Gutenberg University
Peter Langguth is Pharmaceutical scientist by training and Professor of Pharmaceutical Technology and Biopharmaceutics at the School of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Germany. He did undergraduate studies in Pharmacy at the Johann Wolfgang Goethe University in Frankfurt, where he also received a Ph.D. in 1985 with Prof. Ernst Mutschler on the improvement of transdermal and intestinal permeability of furosemide prodrugs. Until 1988 he was Post-doctoral Research Fellow in Pharmacokinetics in the group of Prof. Edward R. Garrett at the University of Florida in Gainesville and from 1989 until 1995 he was Senior Research Fellow at the Department of Pharmaceutical Technology, Swiss Federal Institute of Technology (ETH) in Zürich, Switzerland with Prof. Hans P. Merkle. In 1995 he received the Venia legendi (Habilitation) in Pharmaceutical Technology and Biopharmaceutics from the ETH. In 1996 Prof. Langguth joined Astra Hässle AB in Mölndal, Sweden, as Group Leader in Drug Absorption Research. Since 1998 Dr. Langguth is Head of the Department of Pharmaceutical Technology and Biopharmaceutics at the Johannes Gutenberg University in Mainz. From 2003 to 2005 he was Associate Dean of the Faculty of Chemistry and Pharmacy and from 2005 to 2008 he served as Dean for the Faculty of Chemistry, Pharmacy and Earth Sciences at that University. Dr. Langguth has published more than 200 articles in the areas of Biopharmaceutics and Pharmaceutical Technology and Drug Delivery. He has co-editored the book “Biopharmazie” (Wiley-VCH, 2004), and he is Co-editor of the Scientific Commentary to the European Pharmacopoeia. His research interests include membrane transport of drugs when relevant for bioavailability, pharmacokinetics and drug targeting, in vitro / in vivo correlations and biowaivers, dosage form design and pharmaceutical quality.

Professor Hans Lennernäs, Uppsala University
Dr. Hans Lennernäs is a professor of Biopharmaceutics at Uppsala University since 1 July 2000, Sweden and he has been an adjunct professor of Biopharmaceutics at Copenhagen University, Denmark between 2000-2012. His research aims to develop novel strategies of tissue drug targeting and delivery that aims to improve the clinical use and efficacy of drugs in various disease states, such as metabolic and cancer diseases. He has been the Principal Investigator in an extensive collaboration with Food Drug & Administration, USA, University of Michigan, USA, and Medical Product Agency, Sweden during several years to develop a new guideline for the Biopharmaceutics Classification System. He has established an extensive human permeability database (45 compounds) that today is widely used in academia and pharmaceutical industry. Dr. Lennernäs has been the chairman for numerous international conferences. He serves as reviewer for several scientific journals in clinical pharmacology and pharmaceutical science. His work had led to more 180 publications, 200 invited lectures and more than 300 submitted presentations at scientific meetings. He is well-cited author with more than 8000 citations and a H-index of 45. He has supervised 24 doctorial theses and acted as co-supervisor for two neurologists. He has obtained several national and international research grants. Dr. Lennernäs has received Glaxo Wellcome Achievement Award 1997 and Annual Award from the Industrial Pharmacy Section 1998, Fédération Internationale Pharmaceutique (FIP), and a Honourable Mentions at EURAND AWARD 2000, been elected the AAPS Fellow 2004 and received the AAPS Meritorious Manuscript Award 2004 and New Safe Medicine Faster Award 2008. He is the managing entity for an EU-grant from IMI (Innovative Medicine Initiative) of 24.5 MEuro during 5 years (starting 1 October 2012). He received the highest research rank after an external international evaluation at UU during 2011 (Quality and Renewal 2011). This research group has during more than 10 years been active in developing a local drug delivery strategy for treatment of localized prostate cancer and primary liver cancer. Prototypes emerging from this research are currently evaluated in phase II clinical trials. Novel treatments would be especially important in the group of patients with slightly elevated PSA and low-grade localized PC. He is the inventor of more than 15 drug delivery patents. He is one of the innovators and developers of a novel sublingual drug delivery system currently used for the treatment of various acute pain conditions.(Rapinyl®). He has also together with co-inventors initiated two other start-up companies. One company has developed a novel oral replacement therapy (Plenadren®) for Addison disease and the second company is developing of unique local drug treatment of localised prostate cancer (www.liddspharma.com). The oral modified release product, Plenadren®, was approved by EMA in July 2011. He is on the board at LIDDS AB, Empros Pharma AB and Recipharm Pharmaceutical Development AB, Sweden. Based on this strong focus on research and development of novel drug delivery principles with the aim to treat unmet medical need I consider my participation on this meeting as very important for future successful work.

Dr. Robert Lionberger, U.S. Food & Drug Administration 
Robert Lionberger, Ph.D. serves as Acting Deputy Director for Science in the Office of Generic Drugs.  In this role, Dr. Lionberger leads OGD’s implementation of the GDUFA regulatory science commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products.   In his 10 years as member of the OGD Science Staff, his accomplishments include the development of bioequivalence methods for complex and locally acting drugs, mathematical modeling of drug dissolution and absorption, and incorporation of pharmaceutical development information into the ANDA review process. He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering, working on modeling the rheology of colloidal suspensions. After his Ph.D., he spent two years of post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA, he was an Assistant Professor of Chemical Engineering at the University of Michigan. 

Dr. Raimar Löbenberg, University of Alberta
Dr. Löbernberg holds a BS in pharmacy from the Joahnnes Gutenberg-University in Mainz, Germany. He received his PhD in pharamceutics from the Johann Wolgang Goethe-University in Frankfruit in 1996. He joined the University of Alberta in 2000. His research interests are in Biopharmaceutics to predict the oral performance of drugs and botanicals and inhalalble nonparticles to treat lung cancer. He is founder and director of the Drug Develope and Innovation Centre at the University of Albert, president of the Canadian Society for Pharmaceutical Sciences, member of the United States Pharmacopeia Dietary Supplement Expert Committee, Vice Chair of the Specialty Committee of Traditional Chinese Medicine in Pharmaceutics of the World Foundation of Chinese Medicine Science and member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clincial Pharmacology. 


Dr. Luca Marciani, University of Nottingham
Dr. Marciani is non-clinical Lecturer in Gastrointestinal MRI at the Nottingham Digestive Diseases Centre, School of Medicine, The University of Nottingham, Nottingham, U.K. He received his Laurea in Physics from the University of Genoa in 1993. He then worked as a research intern in the NMR Research Lab, IRCCS San Raffaele Hospital, Milan and as a EU Human Capital & Mobility Visiting Research Fellow at the Department of Chemistry, Birkbeck College, London, before joining the Sir Peter Mansfield Magnetic Resonance Centre, School of Physics and Astronomy, University of Nottingham in 1996. He was awarded his Ph.D. there in 2001. From 2003 he was awarded two personal Research Fellowships to translate to the Nottingham Digestive Diseases Centre where he joined the faculty in 2010. His personal expertise is in imaging the human gastrointestinal tract using magnetic resonance imaging (MRI). His research focuses on imaging gastrointestinal function in health and disease using MRI methods in combination with other physiological and behavioral techniques. Current interests include in-body imaging of foods, intestinal fluid fluxes, the gastrocolonic response to feeding, the development of MRI tests of gastrointestinal function (e.g. transit), physical factors in food as mechanisms of symptoms such as satiety and bloating, the search for biomarkers of subtypes of Irritable Bowel Syndrome, the mode of action of gastrointestinal agents including secretagogue and osmotic laxative formulations. He has published 49 research papers and 11 book chapters. 


Dr. Deanna Mudie, University of Michigan
Deanna Mudie is a post-doctoral research fellow in the department of Pharmaceutical Sciences at the University of Michigan in Ann Arbor. The goal of her research is to pursue the development of predictive in vitro dissolution methodologies that more closely reflect in vivo conditions, with a current focus on the impact of fluid hydrodynamics, buffer species and concentration on the dissolution rate of oral dosage forms. Dr. Mudie’s graduate research helped to define a basis for the determination of key, rate-determining factors that influence in vivo oral drug product bioperformance and the selection of appropriate in vitro predictive dissolution methodologies. Deanna earned her Ph.D. in Pharmaceutical Sciences (2014) and B.S.E. in Chemical Engineering (2000) from the University of Michigan. She has seven years of industry experience at Merck Research Laboratories and Pfizer Global R&D, in the areas of solid oral dosage form characterization, development and manufacturing.


Dr. Anette Müllertz, University of Copenhagen
Dr. Anette Müllertz is Associate Professor and head of Bioneer: FARMA, Danish Drug Development Center, at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. After receiving her PhD degree in lipid nutrition at the Technical University of Denmark, she went to work for Novo Nordisk A/S, on development of structured lipids, digestive lipases and digestion models, among other projects. In 1998, she joined the Faculty of Pharmaceutical Sciences, University of Copenhagen, as an associate professor. She is heading the Rational Oral Drug Delivery Research Group, focusing on developing predictive biopharmaceutics tool for oral drug delivery and lipid based drug delivery systems. She has >100 publications in international, peer--‐refereed journals, as well as 6 book chapters and >200 presentation at international meetings, including many as invited speaker. She is/has been supervising 23 PhD students and numerous master students. She is a driving force in the IMI OrBITo Consortium, as co--‐leader of the API characterization workpackage. She was the winner of the 2005 AAPS Lipid Based Drug Delivery Award and is in the steering committee of 2 AAPS Focus Groups (FGs); The Lipid--‐based Drug Delivery FG and the QbD and Product Performance FG. She has been involved in the organization of several international meetings, both in Denmark and abroad. 


Dr. Fernando J. Muzzio, Rutgers University
Fernando Muzzio is a Distinguished Professor of Chemical Engineering at Rutgers University. For the last 22 years, pharmaceutical product and process design has been Professor Muzzio’s main research and educational focus. His research interests comprise continuous manufacturing, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. In the last ten years, his main research focus has been the development of continuous systems for solid dose manufacturing. He is the author of over 250 peer-reviewed scientific articles, book chapters and patents, and several hundred lectures at technical conferences, companies, and universities in areas relevant to the pharmaceutical industry. He is a frequent advisor and lecturer at FDA events, and in 2010 he was appointed a voting member of the FDA committee on Pharmaceutical Sciences and clinical pharmacology. Professor Fernando Muzzio is also the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems. The center, which has a life span of 10 years and a total budget in excess of $8 million per year, focuses on pharmaceutical product and process design, with special emphasis on continuous manufacturing, particle engineering, and personalized medicine.  FDA and 45 companies are currently members of the center, including 10 of the top 15 pharmaceutical companies in the world, and many world class technology suppliers in the equipment, instrumentation, software, and control industries. Professor Muzzio is a consultant to 50+ companies, including most of the large pharmaceutical companies, as well as many other industries, including chemical, petroleum, polymers, food, consumer products, catalysts, manufacturing equipment, software, and construction materials. His consulting practice includes product and process design, use of statistical methodology for product and process optimization, materials characterization methods, and strategic research and development planning. He has also organized numerous training courses at companies, including Pfizer, Merck, BMS, J&J, Sepracor, Allergan, Eli Lilly, Mallincrodt, Haldor Topsoe, USB, and ILC Dover. Professor Muzzio is also the president of Mixing Consultants Inc, a specialty consulting company focused on providing scientific and technical support in the general applications of mixing science and technology



Dr. James Polli, University of Maryland
Dr. Marciani is non-clinical Lecturer in Gastrointestinal MRI at the Nottingham Digestive Diseases Centre, School of Medicine, The University of Nottingham, Nottingham, U.K. He received his Laurea in Physics from the University of Genoa in 1993. He then worked as a research intern in the NMR Research Lab, IRCCS San Raffaele Hospital, Milan and as a EU Human Capital & Mobility Visiting Research Fellow at the Department of Chemistry, Birkbeck College, London, before joining the Sir Peter Mansfield Magnetic Resonance Centre, School of Physics and Astronomy, University of Nottingham in 1996. He was awarded his Ph.D. there in 2001. From 2003 he was awarded two personal Research Fellowships to translate to the Nottingham Digestive Diseases Centre where he joined the faculty in 2010. His personal expertise is in imaging the human gastrointestinal tract using magnetic resonance imaging (MRI). His research focuses on imaging gastrointestinal function in health and disease using MRI methods in combination with other physiological and behavioral techniques. Current interests include in-body imaging of foods, intestinal fluid fluxes, the gastrocolonic response to feeding, the development of MRI tests of gastrointestinal function (e.g. transit), physical factors in food as mechanisms of symptoms such as satiety and bloating, the search for biomarkers of subtypes of Irritable Bowel Syndrome, the mode of action of gastrointestinal agents including secretagogue and osmotic laxative formulations. He has published 49 research papers and 11 book chapters.

Dr. Nair Rodriguez-Hornedo, University of Michigan 
Naír Rodríguez-Hornedo is Associate Professor of Pharmaceutical Sciences at the University of Michigan. Professor Rodríguez’s research program is based on molecular-mechanistic approaches, founded on the premise that the concepts of supramolecular chemistry and crystal engineering can be applied to: (i) design novel pharmaceutical materials with desirable composition, structure and properties, and (ii) understand crystallization pathways and phase transformations that are important in controlling pharmaceutical processes and bioperformance.  Two main areas of research involve solid-state and crystal-solution interactions, which together address the fundamental principles of enhancing solubility and dissolution of water insoluble drugs. Pharmaceutical cocrystal engineering is an emerging interdisciplinary field of research that deals with applying the concepts of supramolecular chemistry to design multiple-component crystals via non-covalent interactions. This field is rapidly developing and Professor Rodríguez is one of the pioneers and internationally recognized leaders.   Her work illustrates that applying design elements is critical to generating supramolecular assemblies and cocrystals of drugs or active pharmaceutical ingredients (APIs), and more importantly that cocrystals can be used to fine-tune solid and solution properties of a drug, with huge implications for improving solubility, processability, stability, and bioperformance. Professor Rodriguez’s contributions to pharmaceutical cocrystal engineering began in 2003 and at the present have received over 1,000 citations.  She has chaired or co-chaired numerous conferences and workhops in Japan, Mexico, Brazil, The Netherlands, Italy, India, England, Spain, Portugal, Canada, Puerto Rico, and the United States. Dr. Rodríguez was awarded the Ebert Prize for the best article published in the Journal of Pharmaceutical Sciences (2005). She was the recipient of an Indo-US Science Technology Grant  (2009) and co-chaired the First Indo-US Science Technology Forum on Pharmaceutical Cocrystals and Polymorphs, in Mysore, India.  Professor Rodríguez has also served as a Member of the U.S. Food and Drug Administration Advisory Committee for Pharmaceutical Sciences, (2000-2003) as well as in editorial boards of Crystal Growth and Design, Molecular Pharmaceutics, Journal of Pharmaceutical Sciences and Guest-Editor, Molecular Pharmaceutics, Special Issue on Cocrystals

Dr. David Sperry, Eli Lilly & Company
Dr. Sperry is a Research Advisor in Small Molecule Drug Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules.  In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance.  In 2013, Dr. Sperry joined a computational modeling group at Lilly.  He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.

Dr. Erika Stippler, USP
Erika Stippler, Ph.D. is the Director of the Dosage Form Performance Laboratory at the U.S. Pharmacopeia in Rockville, MD. She has more than 20 years of experience in the pharmaceutical industry having been at various contract research organizations in Germany and Switzerland and now currently working at USP. In 1992, her career began as an analyst in Zentrallaboratorium Deutscher Apotheker, Eschborn. In 1996 she proceeded to attend the W. J. Goethe University Frankfurt Institute of Pharmaceutical Technology as an external Ph.D. student. With the thesis title “Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products” she received her Ph.D. in 2004, under the guidance of Prof. Dr. Jennifer B. Dressman. Between 1998 and 2002, she was head of Biopharmacy/Stability Testing of Laboratory and Quality Services in Eschborn, Germany. Dr. Stippler has also been Technical Director of PHAST laboratories and Project Manager at Solvias, Switzerland before coming to USP. Her scientific interest is focused on IVIVC-based dissolution method development for various dosage forms and on the characterization and standardization of dissolution apparati and dissolution methods for performance evaluation of pharmaceutical products. Currently she is involved in PQRI activities, where she chairs the Biopharmaceutics Technical Committee. She is also a member of American Association of Pharmaceutical Scientists (AAPS).

Dr. Kiyohiko Sugano, Toho University
Kiyohiko Sugano, PhD, is currently Associate Professor of Pharmaceutical Sciences in the Department of Pharmaceutics at Toho University. Dr. Sugano graduated with his MS in 1995 from Waseda University, and with his PhD in 2002 from Toho University. Dr. Sugano has previously worked with Chugai Pharmaceuticals 1995-2004, Pfizer Japan 2004-2007, Pfizer UK 2007-2011, and AsahiKasei Pharma 2012-2013. Dr. Sugano's major publications include: Sugano, K. et.a., Coexistence of passive and carrier-mediated processes in drug transport. Nature Review: Drug Discovery 2010, 9, (8), 597-614 and K. Sugano, Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications, Wiley (Single author).

Dr. Duxin Sun, University of Michigan
Duxin Sun is a professor in the Department of Pharmaceutical Sciences. He has joint appointment in the Chemical Biology program, and the Interdisciplinary Medicinal Chemistry program. Dr. Sun also serves as the director of Pharmacokinetics (PK) Core and is a member of University of Michigan’s Comprehensive Cancer Center. He received his PhD degree in pharmaceutical sciences from the University of Michigan. Professor Sun’s research is supported by the NIH, FDA, and other grant agencies. He has published more than 120 papers in peer-reviewed journals and has 73 meeting abstracts, 8 book chapters, and 8 U.S. patents. Dr. Sun has supervised 25 PhD students and 29 postdoctoral fellows and visiting scientists. Dr. Sun has served as chair of the PPB (Physical Pharmacy and Biopharmaceutics) section in AAPS (American Association of Pharmaceutical Scientists); vice president of the American Chinese Pharmaceutical Association (ACPA); and a study section member for many grant agencies, such as the NIH, FDA, Cancer Research UK, French National Research Agency, and Italian Ministry of Health.

Dr. Werner Weitschies, Ernst Moritz Arndt University of Greifswald 
Werner Weitschies is Professor of Biopharmaceutics at the University of Greifswald, Germany. He studied Pharmacy at the Free University of Berlin (1983-1987) and received his Ph.D. in Pharmaceutical Technology in 1990 (summa cum laude). From 1990 to 1995 he worked as a scientist in the research laboratories of Schering AG in Berlin in the field of injectable microparticulate contrast agents for ultrasound. From 1996 to 1998 he was head of a research department in the field of medical applications of magnetic nanoparticles at the Institute for Diagnostic Research of the Free University of Berlin. In 1999 he was appointed Professor of Pharmaceutical Technology at the Institute of Pharmacy in Greifswald, Germany. His main research areas are the investigation of the interplay between physiology and drug delivery systems with focus on the gastrointestinal tract, and the development of nanoparticle based techniques for molecular imaging and physical therapy. He has supervised over 20 Ph.D. students. Werner Weitschies is author or co-author of more than 170 scientific articles and 25 patents.


Professor Shinji Yamashita, Setsunan University
Dr. Shinji Yamashita is a Professor of Faculty of Pharmaceutical Sciences at Setsunan University, Japan. After receiving Master degree of Pharmaceutical Science in 1982 at Kyoto University, he started his carrier as an academic scientist in Jyosai University, then, he moved to Setsunan University and was promoted to Assistant Professor (1989), Associate Professor (1995) and full Professor (2001). He received his Ph.D. degree in 1987 from the Kyoto University supervised by Prof. Hitoshi Sezaki. From 1992 until 1993 he worked at the University of Michigan, college of pharmacy, as a post-doctoral research fellow under Prof. Gordon L. Amidon. His research interests include drug absorption, drug delivery and PK/PD analysis. Especially, he has been focusing on the prediction and improvement of intestinal drug absorption and has developed various methodologies to evaluate oral drug absorption. In 2002, he started to organize "Consortium of Oral Drug Absorption Screening" with 25 pharmaceutical companies in Japan. He has published over 130 original research articles and book chapters. He is a fellow of AAPS (2008), JSSX (2010) and a chair of bioavailability/bioequivalence focus group in Board of Science, FIP. He has received the JSSX Award at 2011 and the Minister Prize of Economic, Trade and Industry at 2013.

Dr. Lawrence Yu, U.S. Food & Drug Administration
Dr. Lawrence X. Yu is the Director (acting), Office of Pharmaceutical Science, Food and Drug Administration, overseeing Office of New Drug Quality Assessment, Office of Generic Drug Quality Assessment, Office of Biotechnology Products, and Office of Testing and Research. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. 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, Division Director, and Deputy Office 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 and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 120 papers, and presented over 100 abstracts, and given over 180 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. 

Listing Row

Tuesday, April 1, 2014
Tuesday, April 1, 2014