International Pharmaceutical Technology Symposium 2016
Sep 18 2016 to Sep 21 2016
Purdue University, United States
Purdue University, United States
Drug Delivery Technologies Making Real Differences
Kinam Park received his Ph.D. degree in pharmaceutics from University of Wisconsin in 1983. After postdoctoral training in the Department of Chemical Engineering of the same university, he joined the faculty of Purdue University in 1986. Since 1998, he had a joint appointment in the Department of Biomedical Engineering, and became Showalter Distinguished Professor of Biomedical Engineering in 2006. His research focuses on oral delivery, drug-device combination products, long-term microparticle formulations, and digital human simulation. He is the founder of Akina, Inc. specializing in polymers for drug delivery. He is currently the Editor-in-Chief of the Journal of Controlled Release.
Vladimir P. Torchilin is a University Distinguished Professor and Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University, Boston. He graduated from the Moscow University with MS in Chemistry, and obtained there his Ph.D. and D.Sc. in Polymer Chemistry and Chemistry of Physiologically Active Compounds in 1971 and 1980, respectively. In 1991, Dr. Torchilin joined MGH/Harvard Medical School as the Head of Chemistry Program, Center for Imaging and Pharmaceutical Research, and Associate Professor of Radiology. Since 1998 Dr. Torchilin is with Northeastern University. He was the Chair of the Department of Pharmaceutical Sciences in 1998-2008. His research interests include liposomes, lipid-core micelles, biomedical polymers, drug delivery and targeting, pharmaceutical nanocarriers, experimental cancer immunology. He has published more than 350 original papers (which received more than 30,000 citations), more than 150 reviews and book chapters, wrote and edited 10 books, including Immobilized Enzymes in Medicine, Targeted Delivery of Imaging Agents, Liposomes, Nanoparticulates as Pharmaceutical Carriers, Biomedical Aspects of Drug Targeting, and holds more than 40 patents. He is Editor-in-Chief of Current Drug Discovery Technologies, of Drug Delivery, and of OpenNano and on the Editorial Boards of many journals including Journal of Controlled Release (Review Editor), Bioconjugate Chemistry, Advanced Drug Delivery Reviews, Molecular Pharmaceutics. Among many awards, Professor Torchilin was the recipient of the 1982 Lenin Prize in Science and Technology (the highest award in the former USSR). He was elected as a Member of European Academy of Sciences. He is also a Fellow of American Institute of Medical and Biological Engineering, of American Association of Pharmaceutical Scientists (AAPS), and of the Controlled Release Society (CRS), and received the 2005 Research Achievements in Pharmaceutics and Drug Delivery Award from the AAPS, 2007 Research Achievements Award from the Pharmaceutical Sciences World Congress, 2009 AAPS Journal Award, 2009 International Journal of Nanomedicine Distinguished Scientist Award, 2010 CRS Founders Award, 2012 Alec Bangham Life Achievement Award, 2013 Journal of Drug Targeting Life Achievement Award, and 2013 Blaise Pascal Medal in Biomedicine from the European Academy of Sciences. In 2005-2006 he was a President of the Controlled Release Society. In 2011, Times Higher Education ranked him number 2 among top world scientists in pharmacology for the period of 2001-2010, and his H-index according to Google Scholar is 89 with more than 40,000 citations. His research was supported by more than $20 million he received as grants from the government and industry over the last 15 years.
Immunological Risks and Evaluation of Biotechnological Products
Importance of formulation for the success of biopharmaceuticals
Tudor Arvinte, Ph.D., received his academic training in physics at the University of Jassy, Romania, and his Ph.D. in biophysics from the University of Düsseldorf, Germany. He performed his doctoral work and postdoctoral stage at the Max-Planck-Institute West Germany and held numerous research positions in Europe and the USA: at C.N.R.S., Orléans, France, at Cornell University, New York, at Texas A&M University, and at the Biophor Corporation, College Station, Texas, USA. In 1989 he joined Ciba-Geigy Pharmaceuticals in Horsham, England, and in 1994 he moved to Ciba-Geigy in Basel, Switzerland (Novartis since 1997). Until 2002 he worked as Head of Exploratory Formulation, Novartis Biotechnology Development & Production, Basel. T. Arvinte worked on the characterization and formulation of more than 200 protein and peptide drugs and three of his protein formulations reached the market. T. Arvinte has over 80 publications and holds 14 patents on formulations of proteins. T Arvinte is Titular Professor at the School of Pharmacy, University of Geneva, Switzerland where he is teaching a post-graduate course on “Formulation and delivery of protein biopharmaceuticals”. In 2003 T. Arvinte co-founded Therapeomic, Inc., a biotech company focused on developing formulations for biopharmaceuticals in collaborations with pharmaceutical companies.
Solid Antisense Oligonucleotide-Loaded Nano -in-Nanoparticles for Potential Improvement of Duchenne Disease Treatment
Simon Benita is a Professor at The Hebrew University of Jerusalem, where he received his Ph.D. in Pharmacy in 1980. His research is focused on polymeric nano- and
microparticulate drug delivery systems aimed at improving the therapeutic performance of active ingredients.
As a result of his research activities, Prof. S. Benita formed and supervises a group of 37 M.Sc., 27 Ph.D. and 17 Post-Doctoral students in pharmaceutical sciences.
He has published 135 articles, 16 review articles, 20 book chapters, edited or co-edited 5 books and been issued 16 patents and 11 patent applications.
• Recipient of the Kaye Innovation Award: 2000, 2005 and 2014 at the Hebrew University of Jerusalem
• AAPS Fellow (2006)
• Founder of Novagali Pharma (website: novagali.com)
Novagali Pharma has been granted the 2004 Prize (Trophée) by the Chambre de Commerce France-Israel, Paris for its achievements and contribution to the successful economical exchanges between France and Israel. Novagali Pharma received in 2009 a “91 d’or:, a distinction from the French Business Confederation (MEDEF) and the Siemens “Health Award” Frost & Sullivan Recognizes Novagali Pharma for Innovation in Ophthalmic Therapies and grants the 2009 Best Practices Award. Listed in Euronext July 2010. Acquired by Santen Co. Japan, 2012.
• Chevalier dans l’Ordre National du Mérite (Knight in National Order of Merit), France, May 2012.
• Israel Controlled Release Society Chapter Prize for Outstanding Achievements in Controlled Release, September 2012.
Director of the Institute for Drug Research and Head of the School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem (October 2010-September
Controlled release of therapeutic protein drugs using layer-by-layer technology
Gerrit Borchard is a licensed pharmacist and obtained his Ph.D. in pharmaceutical technology from the University of Frankfurt (Germany) for his thesis on the interaction of colloidal drug carrier systems with the immune system. After holding several academic posts, including a lecturer position at Saarland University (Germany) and Assistant and Associate Professorships at Leiden University (The Netherlands), he joined Enzon Pharmaceuticals, Inc. (USA) as Vice President Research. In 2005, he was appointed Full Professor of Biopharmaceutics at the University of Geneva (Switzerland), and Scientific Director of the Centre Pharmapeptides in Archamps (France), an international center for biopharmaceutical research and training.
From 2008 to 2013, he served as Vice President of the School of Pharmaceutical Sciences Geneva-Lausanne (EPGL) and form 2013 to 2014 as acting president. In 2012 Prof. Borchard joined the Non Biological Complex Drugs (NBCD) working group hosted at Top Institute Pharma (TIP, Leiden, The Netherlands) and was nominated Chair of the NBCD working party at the European Directorate for the Quality of Medicines & Health Care (EDQM) by Swissmedic.
Prof. Borchard was nominated Fellow of the Swiss Society of Pharmaceutical Sciences (SSPhS) in 2010, and has been President of the Swiss Academy of Pharmaceutical Sciences since 2014. He also served as Vice President of the European Federation of Pharmaceutical Sciences (EUFEPS) from 2013 to 2015.
Due to his working in both academia and industry, and living in four countries, Prof. Borchard has acquired extensive experience in diverse working and cultural environments, and is fluent in the German, English, Dutch and French languages. Time allowing, he loves to roam the trails and by-roads of the Jura mountains on foot and bike.
Effect of Manufacturing Processes on Performance and IVIVC of Complex Parenterals
Dr. Diane J. Burgess, Board of Trustees Distinguished Professor of Pharmaceutics, University of Connecticut.
Dr. Burgess received her B.Sc. degree in Pharmacy from the University of Strathclyde, U.K. (1979) and her Ph.D. in Pharmaceutics from the University of London, U.K. (1984). She was a postdoctoral fellow at the Universities of Nottingham, U.K. (1984-1985) and North Carolina (1985). Dr. Burgess is an elected fellow of AAPS (American Association of Pharmaceutical Scientists), CRS (Controlled Release Society), Association of Pharmaceutical Science and Technology Japan, and of AIMBE (American Institute for Medical Biological Engineering). She served as President of AAPS in 2002 and CRS (Controlled Release Society) in 2009. Dr. Burgess is editor of the International Journal of Pharmaceutics (2009 – to date). She serves on the editorial boards of thirteen international journals. Among many awards and honors Dr. Burgess has recently received the 2014 AAPS Research Achievement Award in Formulation Design and Development; the 2014 AAPS Outstanding Educator Award; the 2014 CRS Distinguished Service Award; the 2013 AAPS IPEC Ralph Shangraw Memorial Award, for outstanding research in the area of pharmaceutical excipients; First recipient of the CRSI Fellowship, 2010 for outstanding contributions in the area of drug delivery; and the APSTJ Nagai International Woman Scientist Award 2011, from the Japanese Pharmaceutical Science Association. She has over 200 refereed publications, over 520 research presentations, over 260 invited presentations including 20 keynote and plenary addresses.
Therapeutic enzymes immobilized in micro- and nano-devices
MSc. and Ph.D. in Chemistry (Universidad de Buenos Aires, Argentina), Postdoc positions at Massachusetts Institute of Technology (1996-1998, Cambridge, US) and Tufts University (Boston, US), later Adjunct Professor in the Dept Biomedical Eng., Tufts University (2001-2006, US). Present positions: P.I. (Natl Res Council (CONICET, Argentina); Full Professor, Dept of Chemistry, School of Sciences, National University of La Plata (UNLP, Argentina). Director of Nanobiomaterials Laboratory and Institute of Applied Biotechnology (CINDEFI, La Plata, Argentina). Scientific production: 4 patents, more than 100 papers and book chapters. Areas of interest: biopolymers, biocatalysis, molecular controlled release, tissue engineering.
Università degli Studi di Parma, TEFARCO Innova, Italy
Università degli Studi di Parma, TEFARCO Innova, Italy
Inhalers or Drug Device Combination Products
Paolo Colombo, born in Italy, graduated in Pharmacy at the University of Pavia, Italy is Full Professor of Pharmaceutical Technology at the University of Parma, Italy. He is presently President of the Italian Interuniversity Consortium on Innovative Pharmaceutical Technology, TEFARCO Innova.
Paolo Colombo was acknowledged with the award for scientific production by University of Pavia in 1973, the Colorcon Award in 1991 and the AFI-Pharma Works 1992 Award. He was AAPS Fellow in 1996 and awarded with the 1999 Jorge Heller Journal of Controlled Release/CRS Outstanding Paper. In 2001 he has been Associated Professor at the Faculty of Pharmacy of the University of Paris Sud. In 2003 the Academy of Pharmacy of France nominated Prof. Colombo as foreign correspondent member. In 2004 he received the Maurice-Marie Janot Award as highly recognized drug research scientist and in 2007 the CRS Reiner Hofmann Award. He was Invited Professor at Universiti Sains Malaysia in Penang (MY) in 2009. In 2010 he received an Honorary Doctorate in Pharmacy for the University of Athens, Greece. In 2014 he received the CRS Founders Award and the IPEC Ralph Shangraw Award. In 2015 he University of Salerno assigned him the "Seal for Career Achievement Award". Dean of Faculty of Pharmacy from 2010 to 2012, he is presently retired.
Paolo Colombo has over 250 original papers and 40 patents on pharmaceutical technology and drug delivery systems. Since 1990 he delivered more than 130 invited lectures.
His research interests are devoted to oral matrices delivery, inhalation nasal and pulmonary powders and transdermal delivery. Many patents became products registered in various countries. The Geomatrix® technology, a hydrophilic matrix partially coated with impermeable films, allows the modulation of drug delivery kinetics. Dilacor XR, containing diltiazem and Xatral (Sanofi-Aventis) containing alfuzosin HCl are products made with this technology. Recently, he invented the “click technology” for the construction of module assembled delivery systems. Another marketed successful product has been the new physical form of the antiulcer drug sucralfate. This new form, named sucralfate gel, resulted more active than the regular sucralfate powder, allowing the reduction of the therapy schedule of sucralfate from four grams per day to two grams per day.
The role of drug transporters in inhalation biopharmaceutics
Dr. Carsten Ehrhardt is an Associate Professor in Biopharmaceutics at the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin. He was elected Fellow of Trinity College Dublin in 2013. Carsten has obtained his Ph.D. degree in Biopharmaceutics from Saarland University. His research is focused on transport mechanisms and cell physiology of lung epithelial barriers and the development of advanced drug delivery systems for pulmonary administration. He has authored 1 book, 77 peer-reviewed publications, 11 book chapters and more than 220 abstracts and conference proceedings. In addition, Carsten has given over 100 invited oral presentations. He actively serves on the Editorial Boards of the American Journal of Physiology - Lung Cellular and Molecular Physiology, Drug Delivery Letters, Journal of Aerosol Medicine and Pulmonary Drug Delivery and Journal of Pharmaceutical Sciences.
Gunes Esendagli received his BSc degree in Medical Biological Sciences from Cerrahpaşa Medical Faculty, Istanbul University in 2001. Following completion of MSc studies in basic immunology; in 2007, he received PhD in Tumor Biology and Immunology from Hacettepe University Cancer Institute, Ankara. Gunes worked as a guest researcher in Borstel Research Center (Germany), Department of Immunology and Cell Biology, Division of Immunotherapy; and, in Uppsala University Biomedical Center (Sweden), Department of Biochemistry and Organic Chemistry. Since 2011, he has been working as an associate professor of immunology in Hacettepe University. Dr. Esendagli’s research mainly focuses on the influence of cancer on myeloid cells and helper T lymphocytes and on the immune regulatory feedback mechanisms in inflammation. Moreover, he is interested in the determination of inter-cellular interactions that have been dysregulated in the tumor microenvironment. In his lab group, cell culture, experimental animal models, flow cytometry and cell sorting, molecular biology techniques are frequently and proficiently applied.
An introduction to microfluidic cell culture with applications to Parkinson's disease
Dr. Ronan Fleming studied veterinary medicine, computer science and mathematics before completing a PhD in systems biology. He is the Principal Investigator of the Systems Biochemistry Group, an interdisciplinary research group of mathematical, computational and experimental biologists, based at the Luxembourg Centre for Systems Biomedicine, University of Luxembourg. The fundamental interest of this group is to develop scalable mathematical and numerical analysis techniques that increase the predictive fidelity of biomolecular network models, by incorporating physico-chemical constraints, motivated by optimality principles. The applied interest of the group is in the aetiopathogenesis and amelioration of Parkinson’s disease. Computational model predictions are used for optimal experimental design and compared with quantitative experimental data, including that obtained from microfluidic cell cultures of dopaminergic neurons, derived from normal and Parkinsonian human subjects using stem cell biology techniques. Dr. Fleming is also an Adjunct Assistant Professor in the Division of Analytical Biosciences, Leiden Academic Centre for Drug Research at the University of Leiden, The Netherlands. Dr. Fleming is also the Technical and Quality Manager for the EU H2020 project, entitled "Systems Medicine of Mitochondrial Parkinson’s Disease". The overall objective of this project is to identify novel drug candidates capable of slowing down the progression of neurodegeneration in the subset of Parkinson’s disease patients with overt mitochondrial dysfunction.
Silk-elstinlike copolymers as liquid embolics and gene delivery systems
Hamid Ghandehari is a Professor at the Departments of Bioengineering and Pharmaceutics and Pharmaceutical Chemistry, Director of Utah Center for Nanomedicine and Co‐Founder and Co‐Director of the Nano Institute of Utah at the University of Utah. His research focuses on the design of new polymers for gene therapy of head and neck cancer, targeted delivery of polymer therapeutics to solid tumors, oral delivery of chemotherapeutics, and assessing the biocompatibility of silica and dendritic nanoconstructs. Dr. Ghandehari is Editor in Chief of Advanced Drug Delivery Reviews, Fellow of the American Institute for Medical and Biological Engineering, the American Association of Pharmaceutical Scientists and the Controlled Release Society. He serves on the scientific advisory board of several national and international drug delivery organizations such as the Controlled Release Society. He has published over 150 articles, and given over 200 invited talks. He received his BS in Pharmacy and PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah.
Dr. Xiaochen Gu is a Pharmacy Professor at Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada. His research programs focus on numerous aspects of novel drug delivery and evaluation, including transdermal drug delivery, sublingual drug delivery and use of nanotechnology in novel drug delivery. Dr. Gu is internationally known for his research work in transdermal permeation of insect repellents and sunscreen products, and development of sublingual epinephrine tablets for the treatment of anaphylaxis. He has established extensive research collaborations with universities and the pharmaceutical industry in the US, China and Brazil. Dr. Gu received his Ph. D. degree from China Pharmaceutical University in 1990; he joined the University of Manitoba as a professor in 1996. Dr. Gu is a member of Pharmacists Evaluating Examination Committee of the Pharmacy Examining Board of Canada (PEBC) and a member of the Editorial Advisory Committee of the Open Dermatology Journal.
1977-1981Faculty of Pharmaceutical Sciences, University of Tokyo.
Awarded the degree of BSc in Pharmaceutics.
1981-1983Faculty of Pharmaceutical Sciences, Graduate School, University of
1983-1985Faculty of Pharmaceutical Sciences, Graduate School, University of
Degree:June 1987. Ph. D from University of Tokyo.
" Kinetic analysis of the positive inotropic action of ouabain"
Research and Professional Experiences:
1985-1987Assistant Professor of Pharmacy, University of Tokyo.
1987-1989Postdoctoral fellowship at Department of Anesthesiology,
School of Medicine (Associate Professor Donald. R. Stanski)
1989-1999Associate Professor of Biopharmacy, Department of Biopharmacy,
Faculty of Pharmaceutical Sciences, The University of Tokushima
1999-Professor of Laboratory for Molecular Design of Pharmaceutics,
Graduate School of Pharmaceutical Sciences, Hokkaido University.
2007-Professor of Laboratory for Molecular Design of Pharmaceutics,
Faculty of Pharmaceutical Sciences, Hokkaido University.
2009- Professor of Laboratory of Innovative Nanomedicine, Faculty of
Pharmaceutical Sciences, Hokkaido University
1994Young Investigator Award from Japanese Society for the Study of
2007.3The Pharmaceutical Society of Japan Award for Divisional Scientific
2007.5The Japanese Society of Drug Delivery System: The Nagai Award
2010.8 FIP: Distinguished Science Award
2011.10 AAPS: AAPS Journal Manuscript Award.
2013.7 Fellow from Controlled Release Society
2015. 2 President’s Award from Hokkaido University
Membership:President of APSTJ (June 2012---May 2014), Director of APSTJ (2006---)
FIP (Co-chair of SIG until 2012, Delegate)
Director of Japanese Society of Drug Delivery System (July 2006---)
Director of Pharmaceutical Society of Japan (April 2014---)
Editorial Board:International Journal of Pharmaceutics.
Journal of Controlled Release.
Molecular Therapy (Jan.2008---)
Associate EditorJournal of Controlled Release (Apr. 2009---)
Cancer Science (Nov. 2009---)
Executive Editor Advanced Drug Delivery Reviews (Jan. 2012 ---)
1) Original Articles: 334 2) Invited Reviews: 87 3) Book Chapters: 50
4) Patents:118 5) Invited Lectures: 190
1.Kusumoto K, Akita H, Ishitsuka T, Matsumoto Y, Nomoto T, Furukawa R, El-Sayed A, Hatakeyama H, Kajimoto K, Yamada Y, Kataoka K, Harashima H. A Lipid Envelope-Type Nano Particle Incorporating a Multifunctional Peptide for the Systemic siRNA Delivery to the Pulmonary Endothelium. ACS Nano. 7: 7534-41 (2013)
2.Akita H, Fujiwara T, Santiwarangkool S, Hossen N, Kajimoto K, El-Sayed A, Tabata Y, Harashima H. Transcytosis-Targeting Peptide: A Conductor of Liposomal Nanoparticles through the Endothelial Cell Barrier. Small. (2015)
3.Furukawa R, Yamada Y, Kawamura E, Harashima H. Mitochondrial delivery of antisense RNA by MITO-Porter results in mitochondrial RNA knockdown, and has a functional impact on mitochondria. Biomaterials. 57:107-15 (in press).
4.Miura N, Shaheen SM, Akita H, Nakamura T, Harashima H. A KALA-modified lipid nanoparticle containing CpG-free plasmid DNA as a potential DNA vaccine carrier for antigen presentation and as an immune-stimulative adjuvant. Nucleic Acids Res. 43(3):1317-31 (in press)
5.Yamamoto N, Sato Y, Munakata T, Kakuni M, Tateno C, Sanada T, Hirata Y, Murakami S, Tanaka Y, Chayama K, Hatakeyama H, Hyodo M, Harashima H, Kohara M. Novel pH-sensitive multifunctional envelope-type nanodevice for siRNA-based treatments for chronic HBV infection. J Hepatol. (in press)
1.Nakamura T, Akita H, Yamada Y, Hatakeyama H, Harashima H. A Multifunctional Envelope-type Nanodevice for Use in Nanomedicine: Concept and Applications. Acc Chem Res. 45(7):1113-21 (2012)
2.Hayashi Y, Hatakeyama H, Kajimoto K, Hyodo M, Akita H, Harashima H. A multifunctional envelope-type nano device: Evolution from non-selective to active targeting system. Bioconjug Chem. 26(7):1266-76 (2015).
3.Sakurai Y, Kajimoto K, Harashima H. Anti-angiogenic nanotherapy via active targeting systems to tumors and adipose tissue vasculature. Biomater Sci. ;3(9):1253-65 (2015).
Targeting nanocarriers to the CD44 receptor: from hyaluronic acid to aptamers
Hervé Hillaireau is Assistant Professor in Pharmaceutical Technology at the School of Pharmacy of Université Paris-Sud. His research at Institut Galien Paris-Sud in Elias Fattal’s group relates to the design and the toxicological evaluation of biodegradable nanoparticles as nanocarriers in order to improve drug delivery in anticancer and antiviral treatments. In particular, his recent research focuses on:
-Nanocarrier functionalization using small molecules, polysaccharides and aptamers
-Design of nanogels for the delivery of nucleic acids, nucleotides and nucleotide analogues with anticancer or antiviral activity
-Toxicology of nanocarriers for drug delivery to the lungs.
He holds a chemical engineer degree from Chimie ParisTech with a PhD in Pharmaceutical Technology (2006) and was previously post-doc at Harvard University. He has published 35 papers in international peer-reviewed journals and book chapters.
Currently Professor of Pharmaceutical Technology at the School of Pharmacy of the University of Navarra
Dr. Juan M. Irache studied Pharmacy at the University of Navarra in Pamplona, where he also obtained a Ph.D. in 1990. He worked as a postdoc from 1992-1993 under the supervision of Professor Dominique Duchêne at the University of Paris South in Châtenay-Malabry, France. Previous to his appointment at the University of Navarra, he was Associate Professor (Maître de Conférences Universitaire) of Biopharmaceutics at the University of Rouen (France) from 1993-1996.
His research is focused on the design and evaluation of nanocarriers (e.g. polymer nanoparticles, SNEDDS, protein nanodevices) for (i) the delivery of drugs, actives and biomacromolecules through biological barriers, and (ii) the development of new mucosal adjuvants for vaccination and immunotherapy.
He served as President of the Spanish-Portuguese Local Chapter of the Controlled Release Society (2005-2006), member of the council of APGI (Association de Pharmacie Galénique Industrielle, International Society of Drug Delivery Sciences and Technology; 2000-2008), President of SEFIG (Spanish Society of Pharmaceutics and Pharmaceutical Technology), and as member of the “Board of Pharmaceutical Sciences” of the International Pharmaceutical Federation (FIP, 2008-2012). He is co-author of more than 160 peer reviewed articles, over 30 book chapters and 16 issued inventions covered by patents. In addition, he has supervised 26 Ph.D. dissertations.
Since November 2012 he is Foreign Corresponding member of the French National Academy of Pharmacy.
Prof. Dr. Claus Michael Lehr is co-founder and head of the department “Drug Delivery” of the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) and also professor at Saarland University. Additionally, Prof. Lehr is cofounder of Across Barriers GmbH and PharmBioTec GmbH. He studied pharmacy in Germany, PhD (1991) from Leiden University (The Netherlands), postdoctoral training at USC (Los Angeles, USA, 92), other appointments at Leiden University (93) and Marburg University (Germany, 94). The main focus of research of Prof. Lehr’s team over the past 15 years has been on the one hand exploring the biological barriers, in particular the gastro-intestinal tract, the skin and the lungs, and on the other hand developing the appropriate carriers capable of crossing these epithelial barriers and deliver the active molecule to the target.
Prof. Lehr is (co)author of more than 300 papers with >10.000 citations (h-index = 54). He was the recipient of the CRS Young Investigator Award (2001), the APV Research Award 2006 for outstanding achievements in the Pharmaceutical Sciences and the biannual International Price 2008 of the Belgian Society for Pharmaceutical Sciences. In 2011, his team was awarded the German national research award on alternatives to animal testing. Prof. Lehr is Fellow of the American Association of Pharmaceutical Scientists (AAPS, 2010) and of the international Controlled Release Society (CRS, 2013). He serves on different national and international scientific and editorial committees and is co-editor of the European Journal of Pharmaceutics and Biopharmaceutics. He is regularly involved in the organization of international conferences. In particular, he has been the initiator of an international workshop and conference on “Biological Barriers” at Saarland University, which will take place in 2016 for the 11th time with nearly 200 participants. In 2015, the British magazine “The Medicine Maker” rated him as one of the top 100 most influencing drug researchers in the world.
Jean-Christophe Leroux received his B.Pharm. from the University of Montreal, followed by a Ph.D. in Pharmaceutical Sciences from the University of Geneva. From 1996 to 1997 he completed a postdoctoral training at the University of California, San Francisco and then joined the University of Montreal as an assistant professor. He was promoted to the ranks of associate professor in 2002 and full professor in 2007. In 2001, he was awarded the Canada Research Chair in Drug Delivery. Prof. Leroux joined the Institute of Pharmaceutical Sciences at ETH Zurich as ordinary professor at the end of 2008, and became head of the institute in 2014. His research interests include the design of novel biomaterials and drug delivery systems, and the evaluation of colloidal antidotes for the treatment of toxicosis. He is the author or coauthor of more than 185 refereed articles (h-index: 65), 14 book chapters and 18 patents/patent applications. He is an associate editor of the Journal of Controlled Release, and serves in the editorial board of Molecular Pharmaceutics, Biomacromolecules, the Journal of Pharmaceutical Sciences, and the Journal of Drug Delivery Science and Technology. He has received several prestigious distinctions such as the CRS Young Investigator Award (2004), the Steacie Fellowship (2008), the Debiopharm Life Sciences Award (2010), the APV Research Award (2014) and the Phoenix award (2015) for innovative research in pharmaceutical technology. He is the co-founder of Versantis AG and Inositec AG.
Drug/cyclodextrin nanoparticles for topical drug delivery to the posterior segment of the eye
Thorsteinn Loftsson received a M.S. degree in Pharmacy from the University of Copenhagen, Faculty of Health and Medicinal Sciences (Denmark) and M.S. and Ph.D. degrees in Pharmaceutical Chemistry from the Department of Pharmaceutical Chemistry, University of Kansas (USA). He is a Professor of Physical Pharmacy at the University of Iceland, Faculty of Pharmaceutical Sciences. His main research interest is pharmaceutical applications of cyclodextrins. Other research interests include marine lipids, prodrugs and soft drugs. Thorsteinn has authored or co-authored over 250 papers in peer-reviewed journals, two books, 20 book chapters and 20+ patents and patent applications. Thorsteinn is on the Thomson Reuters’ lists of Highly Cited Researchers and World’s Most Influential Scientific Minds (2014 and 2015). He is on the editorial boards of five international peer-reviewed scientific journals.
Thorsteinn is an inventor and co-owner of two R&D companies: Oculis ehf., an ophthalmic drug delivery company with eye drops in Phase I and Phase II trials, and Lipid Pharmaceuticals ehf. that extracts biologically active compounds from marine lipids and has suppositories in Phase II trials and a dermal preparation going into Phase I trials.
Parenteral controlled release: how much do we control?
Karsten Mäder is the head of the Department of Pharmaceutics and Biopharmaceutics at the Institute of Pharmacy at the Martin-Luther-University Halle-Wittenberg in Germany. He studied Pharmacy at the Humboldt-University in Berlin from 1986-90. After completion of his Diploma and PhD at the same place he was a DAAD Postdoc scholar at the Dartmouth Medical School (NH, USA) in 1994/95. In 1996/97 Karsten returned to the Humboldt University Berlin and received a Habilitation scholarship from the German Research Foundation DFG. After his Habilitation he worked as a scientist at the Philipps-University Marburg (1997/98) and at the Free University Berlin (1998/2000). Karsten joined the Pharmaceutical Industry in Basle, Switzerland from 2000-2003. Since 2003 he is Full Professor of Pharmaceutics at the Martin-Luther-University Halle-Wittenberg.
His main research areas include polymer- and lipid based delivery systems, in vitro and in vivo characterization of DDS by non-invasive ESR- NMR- spectroscopy and Imaging and multispectral Optical Imaging, controlled release dosage forms, and stimulus-sensitive anticancer polymer conjugates. He published around 170 papers, several book chapters and patents. He works as an editor for the “European Journal of Pharmaceutics and Biopharmaceutics” and also as a member of the editorial board of the “Journal of Controlled Release”, the “Journal of Drug Delivery Science and Technology” and “Current Bionanotechnology”. He received several awards, including the Scheele-award of the German Pharmaceutical Society, the CRS - Capsugel award for innovative aspects in controlled drug release, the Young Investigator Award of the International EPR society, the 1. Prize “Pharma Technik”- award of the Bundesverband der Arzneimittelhersteller, the APV Research Award for Outstanding Achievements in the Pharmaceutical Sciences and the Phoenix Prize in Pharmaceutics.
Dr Mire-Sluis is currently Vice President, North America, Singapore, Abingdon, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee, an expert for the International Committee for Harmonization and on the board of the Journal of Immunological Methods.
A hitchhiker’s guide to bypassing infusion-related reactions to nanoparticles
Moein Moghimi is at Durham University (UK) where he serves as Professor and Chair in Pharmaceutics at the School of Medicine, Pharmacy and Health. He is also a Full Affiliate Member at the Department of Translational Imaging, Houston Methodist Research Institute, Houston Methodist Hospital Systems (Houston, Texas, USA) and Adjoint Professor at the Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Denver Medical Center (USA). In 2015, Moein was a Visiting Professor at Università Degli Studi Di Padova (Italy). Between 2008 and March 2016, he was based at the University of Copenhagen (Denmark) serving as Professor of Nanomedicine at the Department of Pharmacy, Professor of Pharmaceutical Nanotechology at the NanoScience Centre, and the Director of the multi-million Dollar Centre for Pharmaceutical Nanotechnology and Nanotoxiocology. His earlier appointments included a Senior Lectureship position in Biopharmacy and Molecular Pharmaceutics at the School of Pharmacy, University of Brighton (UK) and The Nottingham University Research Fellowship in Advanced Drug Delivery Systems at the Department of Pharmaceutical Sciences. Between 2008 and 2010, he further served as the Honorary Professor of Nanomedicine at the Multidisciplinary Research Center, Shantou University (China).
Moein’s research activities are focused on pharmaceutical nanoscience, nanomedicine and nanosafety. More specifically, Moein has made a major contribution to design and surface engineering of nanoparticles and functional nanosystems for parenteral site-specific targeting/drug delivery and imaging modalities (splenotropic entities, lymphotropic agents, ‘phagocyte-resistant’ nanoparticles, cerebral endothelial cell specific nanoplatforms and anti-cancer nanomedicine) as well as mechanistic understanding of nanomaterial/polymer-mediated infusion reactions and cell death processes. Moein has been the recipient of numerous awards as well as securing over €10 million in competitive research funds as principal investigator. Furthermore, he has partnered large-scale competitive European Commission FP-7 programmes in translational nanomedicine/drug delivery, addressing Alzheimer’s disease and atherosclerosis.
Moein has over 200 peer-reviewed publications/patents to his credit with more than 12000 citations (Google Scholar). He functions as the Editor-in-Chief of Current Bionanotechnology (Bentham), Associate Editor for Journal of Biomedical Nanotechnology (American Scientific Publishers) as well as Immunology Section Editor for Current Pharmaceutical Biotechnology. Moein also features on the editorial board of several high-impact peer-reviewed scientific international journals to include Advanced Drug Delivery Reviews, Nanomedicine-UK (Future Medicine), Journal of Controlled Release (Elsevier) and Molecular and Cellular Therapies (BioMed Central).
Following completion of secondary education at d’Overbroeck’s College Oxford (UK), Moein studied biochemistry at the University of Manchester (UK) and in 1989 earned his PhD in biochemistry (liposome immunobiology) from Charing Cross Hospital Medical School (Imperial College, University of London). He then completed a four-year SERC-funded post-doctoral training programme in Advanced Drug Delivery Research at the School of Pharmaceutical Sciences (University of Nottingham, UK)
Mr. Anthony Morandi is an Executive Director of Quality at Amgen and currently the Quality Head for Amgen Singapore Manufacturing operations. His previous leadership roles at Amgen have included Quality Assurance at the Rhode Island Manufacturing site and Corporate Quality Assurance. In his role as head of Corporate Quality Assurance he was responsible for Amgen’s global quality management system and processes.
Anthony has over 20 years of industry experience in protein and monoclonal antibody Drug Substance and Drug Product Manufacturing. Prior to joining Amgen, he was the Quality Site Head for a commercial parental drug product CMO site. He has held positions in manufacturing, quality and compliance at Biogen-Idec, Catalent Pharma Solutions, Cardinal Health, and Johnson & Johnson (Ortho Biotech). He holds a Bachelors Science in Microbiology from University of California, San Diego.
Senior Vice President, Science—Global Biologics, USP (USA)
USP Approaches to Standards for Biologics
Tina Morris, Ph.D., is Senior Vice President, Science—Global Biologics at USP. She coordinates USP’s standard-setting activities for biologics and biotechnology products. Her department is responsible for the USP Expert Committees charged with developing and revising documentary standards (monographs and chapters) to be included in the USP-NF compendia that are relevant to all biological product classes. The department also develops and maintains USP’s portfolio of biological reference materials and has laboratory resources at USP-U.S., USP-India, and USP-China.
Prior to joining USP, Dr. Morris held positions at a number of biotechnology companies in the areas of analytical development--particularly mass spectrometry and recombinant protein characterization. Dr. Morris holds several U.S. patents in the areas of virology and mass spectrometry assay development.
Dr. Morris completed her postdoctoral fellowship at the National Institutes of Health and earned a Ph.D. in Molecular Virology from the University of Lübeck, Germany. She is the author of many publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences.
The role of nanotechnology to fight against infectious diseases
Dr. Abdel Omri obtained his PhD from Université de Montréal in 1996. After completing postdoctoral fellowships at McGill University and the University of Toronto (1996-1998), he spent more than 2 years as Research associate at NRC (institute of biological sciences in Ottawa) from 1998 to 2000. Dr Omri is currently Full Professor in the Department of Chemistry and Biochemistry with a cross appointment to the Department of Biology, the Biomolecular Sciences PhD Programme, School of Rural and Northern Health PhD Programme. Dr. Omri’s research interests are focused on Lipid-based drug and vaccine delivery systems. His laboratory employs a multi-disciplinary approach to addressing the antimicrobial resistance to gram negative bacteria in cystic fibrosis patients and in medical devices implants. Dr. Omri is also involved in the education of undergraduate and graduate students through the coordination of several calendar courses in biochemistry, pharmacology and toxicology and pharmaceutical technology. In addition to research, Dr. Omri is actively involved in the research training of both undergraduate and graduate students. Dr. Omri has served in administrative capacities in several international scientific societies. He has published over 50 peer-reviewed research articles over his career on various aspects of drug delivery and targeting in addition to several published book chapters and books (2). He has served on a number of Editorial Boards and Granting Agencies in Canada and abroad. Dr. Omri has 2 patents.
siRNA Nanomedicine against Liver and Kidney Fibrosis
Dr. Hayat Onyuksel is currently Professor of Pharmaceutics and Bioengineering at the University of Illinois at Chicago (UIC), Department of Biopharmaceutical Sciences, College of Pharmacy. She received her B.S. degree in Pharmacy from Ankara University, Turkey, and Ph.D. degree from London University, England. After a brief post-doctoral experience at the University of Michigan, Dr. Onyuksel joined academia. Since1987 she is a faculty at UIC.
Dr. Onyuksel's research interest is in the area of targeted drug delivery. She uses lipid-based nano carriers to develop nanomedicines with improved drug solubility, stability and safety. Applying her innovative targeted approach she has prepared several nanomedicines and showed on animal models successful treatments of cancer, diabetes, and inflammatory diseases. Dr. Onyuksel has published 117 scientific journal papers, 35 conference proceedings, 192 abstracts, and 9 issued patents.
Dr. Onyuksel has been serving in several NIH grant/contract review panels since 1992. She was a regular member of newly formed NIH Nano study session during 2009-2011.
She was an associate editor of the Journal Nanomedicine: Nanotechnology, Biology, and Medicine between 2011-2013. She is currently on the Editorial Board of nine scientific journals related to nanotechnology and pharmaceutical sciences.
She has received several prestigious awards including New Investigator Award from American Association of Colleges of Pharmacy (1989), the UIC Inventor of the Year Award (2003), and the UIC Woman of the Year Award (2003), American Association of Pharmaceutical Scientist Fellow (2006), UIC Graduate Mentoring Award (2008), UIC University Scholar (2008), AAPS Lipid Based Drug Delivery Outstanding Researcher Award (2008). In December 2014 she received the most prestigious scientific award of Turkish Republic (TUBITAK) directly from the Turkish president.
Three-Dimensional Cell Cultures for Drug Screening and Cell-Based Therapy
Francesco Pampaloni is staff scientist with permanent position at the Buchmann Institute for Molecular Life Sciences (BMLS) in Frankfurt am Main (Germany). He leads the research on Three-Dimensional Cell Biology and he is coordinator and scientific manager of the EU Horizon 2020 project LSFM4LIFE.
Dr. Francesco Pampaloni graduated in Physical Chemistry at the University of Florence, Italy. Awarded with a Marie-Curie Fellowship of the “Transfer and Mobility of Researchers” (TMR) programme of the European Union, he moved to the University of Regensburg (Germany), where in 2002 obtained his Ph.D. with excellence with a work on Optical Force Microscopy. Following a postdoctoral position at the Research Center Juelich, Germany, in 2003 he joined the European Molecular Biology Laboratory (EMBL) in Heidelberg as a post-doctoral research associate in the group of Ernst Stelzer, one of the top advanced microscopy groups worldwide. In 2009 he was appointed staff scientist at EMBL. Since 2010 he is staff scientist with permanent position at the Buchmann Institute for Molecular Life Sciences (BMLS) of the Goethe University Frankfurt, Physical Biological Group, where he leads the research focus on three-dimensional cell biology. The main interests of Francesco Pampaloni are Three-Dimensional Cell Biology and physiologically relevant cellular models for drug screening and toxicology. He is interested in how the cellular microenvironment regulates cell behaviour and tissue development and pursues a cross-disciplinary approach comprising advanced microscopy (and particularly Light Sheet-based Fluorescence Microscopy -LSFM), 3D cell cultures, and proteomics to elucidate these processes. Francesco Pampaloni has authored and co-authored 30 publications in peer-reviewed journals. He has been reviewer of 30+ peer-review journals including Nature Communication, and grant reviewer for numerous international Funding Agencies. He holds three patents and he is main inventor and driving force of the High-Throughput LSFM (HT-LSFM) and the Tissue Culture LSFM (TC-LSFM).
Accreditation of professional pharmacy degree programs
Founding Dean, Texas A&M Rangel College of Pharmacy. A Fellow of the American Association of Pharmaceutical Scientists and the American Pharmacists Association, Dr. Reddy is Chair of the International Commission for the Accreditation Council for Pharmacy Education International Services Program.
Challenges with establishing a control strategy and specifications for biosimilar products
Dr. Rellahan holds a MS in Cell Biology, a PhD in Immunology and performed a post-doctoral fellowship in the Laboratory of Immune Cell Biology, National Cancer Institute, NIH. Dr. Rellahan joined the Division of Monoclonal Antibodies (DMA), Office of Biotechnology Products (OBP), FDA in 1995. She began her career with the FDA as a research scientist, was converted to a Staff Scientist in 1998, and a Principle Investigator in the Laboratory of Immunobiology in 2004. In 2008 she was promoted to a Product Quality Team Leader in DMA and supervised a team of regulator scientists with responsibility for review of CMC sections of regulatory filings including assessment of product comparability, manufacturing and testing. Dr. Rellahan was a member of the OBP QbD pilot working group and supervised review of the first successful QbD BLA submitted to DMA. In 2013 she joined Amgen as a Director of Product Quality and manages a group of Product Quality Leaders who have product quality oversight of Amgen's biosimilar products.
European Pharmacopoeia: Overview and current hot topics
Dr. Rose is pharmacist and has obtained his PhD in pharmaceutical chemistry at the Johannes Gutenberg University in Mainz, Germany. Following a 6-years period as assistant professor where he teached pharmaceutical analysis and physico-chemistry, he moved to the European Pharmacopoeia Secretariat (now EDQM) in Strasbourg in 1991.
He has a 20 years’ experience in the management of the European Pharmacopoeia reference standards programme , and also participated in the elaboration and revision of monographs from the laboratory perspective. Between 2011 and 2013 he was responsible for the management of the Mutual Joint Audit/Visit (MJA/MJV) – program of the EDQM, where he co-ordinated the audits of the European Official Medicines Control Laboratories (OMCLs) according to ISO/IEC 17025.
Currently he is head of division A of the European Pharmacopoeia Department where he is overlooking the monograph work on chemicals, excipients, herbals and general chapters of the Ph. Eur.
Dr. Rose is member of the “Analytical Quality Control Group” of ECA and author of more than 30 scientific papers.
Human factors engineering of geriatric drug delivery devices
Tom Sam retired in 2015 after 32 years of employment in the pharmaceutical industry from his position as Director CMC Regulatory Affairs, Late Stage Development, In-Line Products, Medical Devices & API Support, Merck Sharp & Dohme / Merck, the Netherlands. The first 12 years of his career he spent in the department of pharmaceutics, where he was responsible for development of a.o. the contraceptive systems NuvaRing and Implanon. His pharmaceutical research further focused on microencapsulation, bioadhesive systems, oral sustained delivery, and excipients. His regulatory activities in the following 20 years not only covered all new and existing (legacy) Organon portfolio products and medical devices, but also focused on Quality by Design, pediatric formulations and Quality Management.
Dr Sam holds a doctoral degree and a PhD in physical chemistry and biochemistry from Leiden University, and a master degree in business management from Twente School of Management. He holds several patents and published in the areas of biochemistry, drug delivery systems and regulatory science. Tom has held voluntary functions in the International Pharmaceutical Federation (FIP) and the American Association of Pharmaceutical Sciences (AAPS). Throughout Tom’s career he and his work were recognized with the Franchimont Award (1977) and the PhD bronze medal (1981) from the Department of Philosophy and Natural Sciences of the State University of Leiden, the Prix Innovation for Implanon (1993) from Elf Atochem, the Schering-Plough Shining Performance Award (2009) for the series of in-house RA-CMC Scientific Meetings, the Merck QMS Excellence Recognition (2011) for Tom’s valuable contribution to the Quality Management System, the AAiPS Distinguished Scientist Award (2012) for dedicated contribution to the development of pharmaceutical sciences and extraordinary leadership, and the Industrial Pharmacy Medal (2015) recognizing the international contribution to industrial pharmacy and to the pharmaceutical profession as a whole from FIP’s Industrial Pharmacy Section.
Tom Sam is active in advisory roles and in lecturing and giving courses in Pharmaceutical Development and CMC Regulatory Affairs.
Stability issues with formulations of antibodies and antibody drug conjugates: new aspects and assays
Dr. Schöneich is the Takeru Higuchi Distinguished Professor and Chair in the Department of Pharmaceutical Chemistry at The University of Kansas. He received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany. In 1991, he joined the Department of Pharmaceutical Chemistry at The University of Kansas, first as a post-doctoral researcher and subsequently as a faculty member. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, immunogenicity, biological aging and age-related pathologies. He has published > 200 papers in the field of peptide and protein oxidation reactions.
Innovative multifunctional zero order drug nano-delivery system for drug addiction and life span extension
Salomon A. Stavchansky, Ph.D., received his B.Sc. degree in Pharmacy from The National Autonomous University of Mexico (Suma cum laude) in 1969, and his Ph.D. in Pharmaceutical Sciences from the University of Kentucky at Lexington in 1974. Dr. Stavchansky’s research at Sloan-Kettering Institute for Cancer Research involved the synthesis of carbon-II phenytoin with the purpose of following the in vivo distribution of phenytoin and the identification of gliomas and neuroblastomas. Dr. Stavchansky worked as an analytical chemist at the National Medical Center in Mexico where he helped develop an immunofluorescence antibody diagnostic test for toxoplasmosis. In 1968, he joined the research and development group of Syntex Laboratories developing steroidal formulations. Dr. Stavchansky joined the University of Texas in 1974 where he was awarded the Teaching Excellence Award and has received the Alfred and Dorothy Mannino Fellowship in Pharmacy, the James T. Doluisio Centennial Fellowship, and is now holder of the Alcon Centennial Professorship.
Dr. Stavchansky recently served as an ad-hoc member in the Clinical Pharmacology and Pharmaceutical Sciences Advisory Committee of the Food and Drug Administration. Dr. Stavchansky was recognized as an Inaugural member of the Hall of Distinguished Alumni of the University Of Kentucky College Of Pharmacy. Dr Stavchansky is a fellow of the American Association of Pharmaceutical Scientists (AAPS), an expert member of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP). Corresponding Member of the National Academy of Pharmaceutical Sciences of Mexico, Corresponding Member of the National Academy of Pharmaceutical Sciences of Chile, Honorary member of the Mexican Pharmaceutical Association, Honorary Member of the United States Pharmacopeial Convention, and has served as advisor and external tutor of The Council of Science and Technology of Mexico. The jury presided by the President of the Commission of Honor and Justice of the Colegio Nacional de Químico Farmacéuticos Biólogos of Mexico, the oldest pharmacy guild in Mexico, recently awarded Dr. Stavchansky the Recognition to Pharmaceutical Excellence in the category of Professional Trajectory in Research and Education. Dr. Stavchansky presently served as Chair of the International Health Committee and served as a member of the Executive Committee of the Council of Experts of the United States Pharmacopeia (USP), Chair of the USP Expert Committee on Bioavailability and Nutrients Absorption and member of the Policy Committee of the USP. He recently served on the Advisory Committee to the Office of Generic Drugs and on the Pharmaceutical Science Advisory Committee of the Food & Drug Administration. Dr. Stavchansky was a member of the review committee on drug delivery systems for The National Institute of Child Human Development and The National Institute on Drug Abuse and served as an ad-hoc reviewer for the National Institute of Health and reviewer for NIH Small Business Grants. Dr. Stavchansky served in the expert panel of the World Health Organization and the Pan American Health Organization (PANHDRA) in the area of bioavailability and bioequivalence drugs and biologics. He served as a special advisor to the National Agency of Sanitary Vigilance in Brazil during the drafting of the regulation of generic drug products. Dr. Stavchansky was also a member of the Bioavailability Steering Committee of the American Pharmaceutical Association. He served as Chairman of the Translation Committee of the USP into Spanish.
Dr. Stavchansky presently serves in The University of Texas at Austin Policy Committee on Promoting Objectivity in Research Managing, Reducing or Eliminating Financial Conflict of Interest, and served in the Faculty Council, the Budget Committee, the Graduate Assembly, the Academic Committee of the Graduate Assembly, and the Committee for International Studies
Dr. Stavchansky has directed and participated in research concerning: 1) the development of analytical methodology for the measurement of drugs in biological fluids, the absorption, metabolism, distribution, and elimination of drugs from biological fluids in animals and man, and the evaluation and design of drug delivery systems, 2) the link of solubility, permeability, and drug transport through biological membranes, and 3) the conduct morphometric studies of the intestinal epithelium to elucidate the effect of formulation excipients.
Presently, Dr. Stavchansky’s research group is exploring cytoprotection from oxidative stress at the molecular level, 2) integration of system biology to pharmacodynamics and pharmacokinetics, and 3) targeted nano-delivery of drugs. Dr Stavchansky continues his research efforts in the area of generic drugs and biosimilars. This work has resulted in over 150 publications, more than 270 national and international presentations and two book chapters. Dr. Stavchansky has supervised and contributed to dissertations, theses, and reports for many Master and Ph.D. students
Development of biodegradable dendrimers for drug delivery
Peter W. Swaan received his Masters in Pharmacy and PhD in biopharmaceutics from the University of Utrecht, The Netherlands. He then completed a postdoctoral fellowship in pharmaceutical chemistry at the University of California, San Francisco. Swaan accepted a position as assistant professor of pharmaceutics at The Ohio State University after completing his training and was promoted to associate professor in 2002. He then joined the University of Maryland School of Pharmacy the following year where he is currently professor of pharmaceutical sciences and Associate Dean for Research and Graduate Studies. He has published nearly 200 articles focusing on all aspects of transporter proteins in drug targeting and delivery, pharmacokinetics and pharmacodynamics and has been funded by the National Institutes of Health(NIH), the Food and Drug Administration (FDA), and various other organizations. His major research contributions involve the application of transporters as targets for prodrugs; additionally, Dr. Swaan pioneered the application of computational techniques to determining structural requirements of membrane transporters, thereby paving the way for the rational discovery of novel substrates and inhibitors. Swaan has served on various peer review panels for NIH, including as a permanent member of the Xenobiotics and Nutrient Disposition and Action (XNDA) study section. He holds several US patents and serves as Editor-in-Chief for Pharmaceutical Research.
Design of carriers for antimicrobial photodynamic therapy
Controlled Drug Delivery-
nano and micro delivery systems for cancer therapy,
coating and matrix tablet/pellet,
bioadhesive thin film and patch
topical and systemic dosage forms for cancer/precancerous therapy and antimicrobial infection
formulation and in vitro/in vivo evaluation of functional skincare products,
brand and market development
Postdoc, Pharmacy, Taipei Medical University
Advisor: Professor Ming-Thau Sheu
Research topics: Solid dosage form manufacturing (powder, granule, pellet, tablet), novel excipient development
Ph.D., Pharmaceutical Technology, University of Kentucky, Lexington, Kentucky (USA).
Advisor: Professor Patrick P. DeLuca.
Dissertation: Peptide-polymer interaction and its implications in drug delivery.
Research Experience: Microsphere preparation, pharmaceutical analysis,
B.S., Pharmacy, Taipei Medical College (University), Taiwan.
Professor, Taipei Medical University
Executive Director, Taiwan Drug Relief Foundation & National ADR Reporting System
Director, Student Service Learning Center, Taipei Medical University
Visiting Professor, University of Kentucky
Visiting scholar, Academia Sinica, Taiwan
Associate professor, Taipei Medical University
Reviewer, Taiwan University Evaluation Society
General Secretary, Taiwan Controlled Release Society
Registrar, Taipei Medical University
2014 Best scholar award in biomedical engineering, Professor C-J Li’s Education Foundation
2008-2013 Outstanding teaching award of the year, Taipei Medical University
2010 Outstanding research scholar, National Education Development Center
2008-2010 Best mentor award of the year, Taipei Medical University
Controlled Release Society
American Association of Pharmaceutical Scientists
Biomaterials and Controlled Release Society (Taiwan)
Taiwan Pharmaceutical Association
IFSCC (Taiwan local chapter)
1.Peng PC, Hong RL, Tsai YJ, Li PT, Tsai T*, Chen CT*. Dual-Effect Liposomes Encapsulated With Doxorubicin and Chlorin e6 Augment the Therapeutic Effect of Tumor Treatment. Lasers in Surgery and Medicine. 2015; (47):77-87.
2.Li PT, Ke ES, Chiang PC, Tsai T*. ALA- or Ce6-PDT induced phenotypic change and suppressed migration in surviving cancer cells. Journal of Dental Sciences. 2015; (10):74-80.
3.Tsai YJ, Tsai T, Peng PC, Li PT, Chen CT*. Histone acetyltransferase p300 is induced by p38 MAPK after photodynamic therapy: the therapeutic response is increased by the p300 HAT inhibitor anacardic acid. Free Radical Biology and Medicine. 2015; (86):118-132.
4.Hsieh CM, Huang YH, Chen CP, Hsieh BC, Tsai T*. 5-Aminolevulinic acid induced photodynamic inactivation on Staphylococcus aureus and Pseudomonas aeruginosa. Journal of Food and Drug Analysis. 2014; (22):350-355.
5.Liu JJ, Nazzal S, Chang TS, Tsai T*. Preparation and characterization of cosmeceutical liposomes loaded with avobenzone and arbutin. Journal of Cosmetic Science. 2013; (64):9-17.
6.Yang YT, Chen CT, Tsai T*. Absorption and fluorescence spectral properties of hematoporphyrin in liposomes, micelles, and nanoparticles. Dyes and Pigments. 2013; (96):763-769.
7.Yang YT, Chien HF, Chang PH, Chen YC, Jay M, Tsai T*, Chen CT*. Photodynamic Inactivation of Chlorin e6-loaded CTAB-Liposomes Against Candida albicans. Lasers in Surgery and Medicine. 2013; (45):175-185.
8.Hsieh BC, Chen LC, Tsai T*. Quantification of 5-aminolevulinic acid by capillary electrophoresis using dynamic pH junction technique. Journal of Separation Science. 2013; 803-808.
9.Chen CP, Chen CT, Tsai T*. Chitosan Nanoparticles for Antimicrobial Photodynamic Inactivation: Characterization and In Vitro Investigation. Photochemistry and Photobiology. 2012; (88): 570-576.
10.Wu HD, Yang JC, Tsai T, Ji DY, Chang WJ, Chen CC, Lee SY*. Development of a chitosan–polyglutamate based injectable polyelectrolyte complex scaffold Carbohydrate Polymers. 2011; (85):318-324.
11.Yang YT, Chen CT, Chien HF*, Tsai T*. Cellular Photodynamic Toxicity of Hematoporphyrin in Various Nanocarrier Systems. Current Nanoscience. 2011; (7):850-855.
12.Nazzal S, Chen CP, Tsai T*. Nanotechnology in Antimicrobial Photodynamic Inactivation. Journal of Food and Drug Analysis. 2011; (19):383-395.
13.Tsai T, Chien HF, Wang TH, Huang CT, Ker YB, Chen CT*. Chitosan augments photodynamic inactivation of gram-positive and gram-negative bacteria. Antimicrobial Agents and Chemotherapy. 2011; (55):1883-1890.
14.Chang SF, Yang YT, Li WL, Lin CT, Tsai T*. Enhancement of 5-aminolevulinic acid-induced photodynamic therapy by a bioadhesive polymer. Journal of Dental Sciences. 2010; (5):30-35.
15.Yang YT, Chen CT, Yang JC, Tsai T*. Spray-Dried Microparticles Containing Polymeric Micelles Encapsulating Hematoporphyrin. AAPS J. 2010; (12):138-146.
16.Giovagnoli S, Tsai T, DeLuca PP. Formulation and Release Behavior of Doxycycline–Alginate Hydrogel Microparticles Embedded into Pluronic F127 Thermogels as a Potential New Vehicle for Doxycycline Intradermal Sustained Delivery. AAPS PharmSciTech. 2010; (11):212-220.
17.Chen KC, Chuang CM, Lin LY, Chiu WT, Wang HE, Hsieh CL, Tsai T, Peng RY. The polyphenolics in the aqueous extract of Psidium guajava kinetically reveal an inhibition model on LDL glycation. Pharmaceutical Biology, 2010; (48):23-31.
18.Tsai T, Ji HT, Chiang PC, Chou RH, Chang WS, Chen CT. ALA-PDT results in phenotypic changes and decreased cellular invasion in surviving cancer cells. Lasers in Surgery and Medicine. 2009; (41):305-315.
19.Tsai T, Yang YT, Wang TH, Chien HF, Chen CT. Improved photodynamic inactivation of gram-positive bacteria using hematoporphyrin encapsulated in liposomes and micelles. Lasers in Surgery and Medicine. 2009; (41):316-322.
20.Wang CY, Tsai T, Chiang CP, Chen CM, Chen CT. Improved diagnosis of oral premalignant lesions in submucous fibrosis patients with 5-aminolevulinic acid induced PpIX fluorescence. Journal of Biomedical Optics. 2009; (14):044026-.
21.Yu CH, Chen HM, Hung HY, Cheng SJ, Tsai T, Chiang CP. Photodynamic therapy outcome for oral verrucous hyperplasia depends on the clinical appearance, size, color, epithelial dysplasia, and surface keratin thickness of the lesion. Oral Oncology. 2008; (44):595-600.
22.Chang CC, Yang YT, Yang JC, Wu HD, Tsai T*. Absorption and emission spectral shifts of rose bengal associated with DMPC liposomes. Dyes and Pigments. 2008; (79):170-175.
23.Chen HM, Yu CH, Tsai T, Hsu YC, Kuo RC, Chiang CP. Topical 5-aminolevulinic acid-mediated photodynamic therapy for oral verrucous hyperplasia, oral leukoplakia and oral erythroleukoplakia. Photodiagnosis and Photodynamic Therapy. 2007; (4):44-52.
24.Chen HM, Yu CH, Chang JYF, Tsai T, Kuo RC, Chiang CP. Successful treatment of an extensive oral verrucous hyperplasia with topical 5-aminolevulinic acid-mediated photodynamic therapy. Journal of Dental Sciences. 2007; (2):216-220.
25.Chen HM, Yu CH, Tu PC, Yeh CY, Tsai T*, Chiang CP*. Successful treatment of oral verrucous hyperplasia and oral leukoplakia with topical 5-aminolevulinic acid-mediated photodynamic therapy. Lasers in Surgery and Medicine. 2005; (37):114-122.
26.Chen HM, Chen CT, Yang H, Lee MI, Kuo MYP, Kuo YS, Wang YP, Tsai T*, Chiang CP*. Successful treatment of an extensive verrucous carcinoma. J Oral Pathol Med. 2005; (34):253-256.
27.Tsai T, Hong RL, Tsai JC, Lou PJ, Ling IF, Chen CT. Effect of 5-aminolevulinic acid-mediated photodynamic therapy on MCF-7 and MCF-7/ADR cells. Lasers in Surgery and Medicine. 2004; (34):62-72.
28.Tsai JC, Chiang CP, Chen HM, Huang SB, Wang CW, Lee MI, Hsu YC, Chen CT*, Tsai T*. Photodynamic therapy of oral dysplasia with topical 5-aminolevulinic acid and light-emitting diode array. Lasers in Surgery and Medicine. 2004; (34):18-24.
29.Chen HM, Chen CT, Yang H, Kuo MYP, Kuo YS, Lan WH, Wang YP, Tsai T*, Chiang CP*. Successful treatment of oral verrucous hyperplasia with topical 5-aminolevulinic acid-mediated photodynamic therapy. Oral Oncology. 2004; (40):630-637.
30.Ho HO, Tsai T, Liu CM, Sheu MT. Influence of cosolvents and in situ forming hydroxyapatite on the mechanical characteristics of collagen films. J. Biomed. Mater. Res. 2003; (62):22-29.
31.Wang CY, Tsai T, Chen HC, Chen CT, Chiang CP. A PLS-ANN Based Classification Model for Oral Submucous Fibrosis and Oral Carcinogenesis. Lasers in Surgery and Medicine. 2003; (32):318-326.
32.Wang CY, Tsai T, Chen HM, Chang SC, Chen CT, Chiang CP. Autofluorescence spectroscopy for in vivo diagnosis of DMBA-induced hamster buccal pouch pre-cancers and cancers. J Oral Pathol. Med. 2003; (32):18-24.
33.Tsai T, Wang CY, Tsai RJ, Chiang CP, Chen CT. In vivo Autofluorescence Spectroscopy of Oral Premalignant and Malignant Lesions: Distortion of Fluorescence Intensity by Submucous Fibrosis. Laser in Surgery and Medicine. 2003; (33):40-47.
34.Ke WT, Ho HO, Tsai T and Sheu MT. Sustained-release effect of codried excipients of microcrystalline cellulose and Ganoderma fiber. European Journal of Pharmaceutics and Biopharmaceutics. 2001; (51):215-219.
35.Chen CT, Tsai T and Chiang CP. Photodynamic diagnosis and therapy in the management of oral neoplasia New Taipei Journal of Medicine. 2001; (3):1-5.
36.Wu JS, Huang CJ, Ku CC and Tsai T*. Preparation and in-vitro evaluation of a biodegradable carrier system for inducing spawning in fish. Chin. Pharm. J. 1999; (51):171-179.
37.Tsai T, Wu JS, Ho HO, Sheu MT. The modification of physical characteristics of microcrystalline cellulose by codrying with beta-cyclodextrins. J. Pharm. Sci. 1998; (87):117-122.
38.Tsai T, San YP, Ho HO, Wu JS and MT Sheu. Film-forming polymer-granulated excipients as the matrix materials for the controlled release dosage forms. Journal of Controlled Release. 1998; (51):289-299.
39.Tsai T, San YP, Ho HO, Kao CC and Sheu MT. Film-forming polymer granulated excipients as matrix material for the production of pellets by extrusion/spheronization. Chin. Pharm. J. 1997; (49):249-257.
40.Ho HO, Su HL, Tsai T and Sheu MT. The preparation and characterization of solid dispersions on pellets using a fluidized-bed system. Int. J. Pharm. 1996; (139):223-229.
41.Tsai T, Mehta RC and DeLuca PP. Adsorption of peptide to poly(D,L-lactide-co-glycolide): 1. Effect of physical factors on the adsorption. Int. J. Pharm. 1996; (127):31-42.
42.Tsai T, Mehta RC and DeLuca PP.Adsorption of peptide to poly-(D,L-lactide-co-glycolide): 2. Effect of solution properties on the adsorption. Int. J. Pharm. 1996; (127):43-52.
2016 Taiwan patent I 515023
2014 Taiwan patent I 442945
2013 Taiwan patent I 407965
2013 US patent (US 8,456,582 B2)：Process for producing inorganic 3D open cell bone substitutes
Tissue Engineering and Its Importance in Pharmaceutical Sciences
Prof. Dr. Kezban ULUBAYRAM graduated in Chemistry from Middle East Technical University in 1988. She got her PhD degree in Biotechnology from Middle East Technical University in 1997. Then, she trained with Prof.Langer as a post doctorate at Massachusetts Institute of Technology. During this period she did her research in the field of vascular tissue engineering. She followed her carrier at Hacettepe University, Department of Basic Pharmaceutical Sciences in 1999. Prof.Ulubayram is continuing her researches in the fields of; Biomaterials, Biomedical Engineering, Nanotechnology and Nanomedicine, and Tissue Engineering. She has great knowledge and experience in the field of tissue engineering and has fulfilled many projects. She patented a tissue engineering product which has been commercialized as wound dressing. She is the member of European Biomaterials Society, Tissue Engineering and Regenerative Medicine Society, Turkey’s Biomaterials and Tissue Engineering Society and Chemistry Society.
Architecturally controlled polyglutamate-based carriers to cross challenging biological barriers
Dr. María J. Vicent received her Ph.D. degree in 2001 in chemistry on solid supports from University Jaume I Castellón after several scientific stays in Prof. Fréchet’s lab. at University California, Berkeley (USA). Then, she moved to more biomedically oriented research, initially with a Spanish company Instituto Biomar SA., and subsequently at the Centre for Polymer Therapeutics with Prof. R. Duncan after the award of a Marie Curie Postdoctoral Fellowship in 2002. In 2004, María joined Centro de Investigación Príncipe Felipe (CIPF) as research associate through a Marie Curie Reintegration contract and was promoted to her current position, head of Polymer Therapeutics Laboratory at CIPF, in 2006. Currently she is also the responsible of the Screening Platform and the Advance Therapies Program Coordinator at CIPF.
Her research group focused on the development of novel nanopharmaceuticals, in particular Polymer Therapeutics, for different therapeutic applications and has been funded by national and European grants (several acting as coordinator including a recently awarded ERC Consolidator grant-MyNano). María co-authored 80 peer reviewed papers and 7 patents, 2 of them licensed to the pharmaceutical industry and a third one used as foundation of the spin off company ‘Polypeptide Therapeutic Solutions SL’ in 2012. She was the Spanish President of the Spanish-Portuguese Chapter of the Controlled Release Society up to end 2013 and the chair of key conferences on the nanomedicine field such as, the International Symposium on Polymer Therapeutics: From Laboratory to Clinical Practice.
Professor Gary Walsh is Chair of Industrial Biotechnology at the University of Limerick, Ireland.
Prior to joining the University he worked within the pharmaceutical and biotech industries. His research interests span various aspects of pharmaceutical and enzyme biotechnology and his 250 publications include 10 authored books, 2 edited books, 20 book chapters and 80 journal articles. He has presented his work at 70 international conferences, which include 38 guest/keynote presentations. He has served as (founding) editor, biotechnology section, of the European Journal of Pharmaceutics and Biopharmaceutics and as a member of the editorial boards of Biopharm. International, New Drugs and the Encyclopaedia of Industrial Biotechnology. He has also served as scientific secretary and as a member of the board of governors of the European Association of Pharmaceutical Biotechnology and is a former Fulbright research visiting professor at the University of Georgia, in the United States.
Biosimilar development: from cell culture to product
Irem Yenice graduated from Hacettepe University. She holds Ph.D. degree in 2007. After having worked as research assistant in Pharmaceutical Technology at Hacettepe University, she joined Sanovel, a Turkish Pharmaceutical Generic Company of TOKSOZ Group. She played leading roles in company’s biosimilar program. Over 7 years, she builts up biotechnology division for biosimilars comprising manufacturing and characterization experts. In 2014, Dr. Yenice and her team moved to ARVEN, a company of TOKSOZ Group, has a vision is to develop high-tech products committing to requested quality standarts toward global recognition. First biosimilar project of Turkey, was developed from cell line to product by Dr. Yenice and her team at Arven.