Alex Avdeef, in-ADME Reserach, USA
Alex Avdeef, PhD, is an AAPS Fellow, a Visiting Senior Research Fellow at King’s College London, and the author of Absorption and Drug Development, Second Edition, Wiley, Hoboken, 2012. For over 40 years, he has been teaching, researching, & developing methods, instruments, & analysis software for measurement of ionization constants, solubility of practically-insoluble drugs, miniaturized dissolution, & permeability (PAMPA, cell-culture, & animal models). His accomplishments in the development of instrumentation include several well-known instruments currently manufactured by leading companies in the instrument market (e.g., ORION960 Autochemistry System - launched in 1984 and still being sold by ThermoFisher today). He has over 120 technical publications in primary scientific journals & chapters in books, 6 patents. He founded (2011) in-ADME Research (USA) and co-founded pION INC (USA) in 1996 & Sirius Analytical (UK) in 1989. His other positions were at Orion Research (USA), Syracuse University (USA), Univ. of Calif. - Berkeley (USA), & Caltech (Pasadena, USA).
Biserka Cetina-Čižmek, PLIVA, Croatia
Biserka has been working in GR&D PLIVA pharmaceutical company in Croatia, member of Teva group for last twelve years. Her current position is Senior Director and head of Preformulation Department. She is pharmacist by education. She finished Ph.D. in Pharmaceutical Sciencie and worked as Senior Lecturer in field Pharmaceutical Analysis and since 2007 she has become Professor in the field of Pharmaceutical sciences at Faculty of Pharmacy and Biochemistry University of Zagreb. Her scientific background is the field of preformulation studies in drug development of solid dosage forms, semisolid and liquid, development of in vitro methodology to predict in vivo drug behavior, IVIV correlation, characterization of drug molecules, and BCS classification. She is author and co-author of 30 scientific papers, 47 posters and 12 oral presentations, 3 patent applications and mentor of 22 graduated and 3 postgraduate students.
Aleksandar Danilovski, Xellia pharmaceuticals, Croatia
Dr. Danilovski is currently Chief Scientific Officer (CSO) and leads Global R&D and Global Regulatory affairs at Xellia Pharmaceuticals, a global specialty pharmaceutical company focused entirely on providing anti-infective treatments against serious and life-threatening infections. His previous work experiences include serving as Head of European R&D for Barr Pharmaceuticals (USA), Head of vertical integration and Head of improved chemical entities for PLIVA Pharmaceuticals (Croatia), as well as Member of the Management Board of PLIVA Pharmaceuticals. He was also actively involved in several anti-infective discovery projects (within beta-lactam and macrolide classes) with special focus on formulation improvement and life-cycle management of azithromycin (drug originally discovered in R&D laboratories of PLIVA Pharmaceuticals). Dr. Danilovski is Member of Scientific Selection Board of Novo Holdings REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund (Denmark), as well as Member of Board of Directors for a biotech company Pharmaero (Denmark) that is developing innovative inhalation based anti-infective therapies. Dr. Danilovski has participated in and led development and registration of several novel and patented specialty pharmaceutical products based on advanced formulation strategies that are providing innovative therapies tailored to patient needs. Just recently in February 2019 US FDA has granted approval for the novel, patented and innovative anti-infective therapy fully discovered and developed in Xellia’s Croatian R&D laboratories, that he also founded in 2011. In addition, he has led the development and registration of more than 100 different drug substances ranging from traditional synthetic API’s, semisynthetic and fermentation based API’s to rDNA technology based biologic API’s; and development and registration of more than 200 different drug products ranging from solid-oral dosage forms (IR/SR, tablets and capsules, ODTs), parenterals (lyophilized and liquid vials, infusion bags), oral solutions, suspensions, emulsions to semi-solids (ointments, creams and gels). He has authored more than 20 different patent families with granted patents and patent applications in various patent offices (USPTO, EPO, etc.) Dr. Danilovski obtained his Ph.D. in Chemistry and Biochemistry from University of Zagreb in Croatia and Cambridge University in the United Kingdom, and his B.Sc. in Chemistry from the University of Zagreb in Croatia.
Rolf Hilfiker, Solivias AG, Switzerland
Rolf Hilfiker is Head of the Department Solid-State Development at Solvias AG. Solvias AG is a scientific services company focused on leveraging expertise in various scientific disciplines to accelerate the drug discovery and development process. The department of some 20 people does contract research and development in the solid-state area, i.e. polymorphism studies, salt and co-crystal screening and selection, method development, crystallization optimization, etc. Rolf obtained his Ph.D in physical chemistry at the University of Basel, Switzerland. From 1987-89 he was Post Doc at SUNY, New York and from 1989-1992 Senior Research Fellow at the University of Basel. He has more than twenty years of experience in an industrial R&D environment at Ciba-Geigy, Novartis, and Solvias. Under his guidance, Solvias became one of the leading solid-state service providers in the world. He is author of more than 60 scientific publications as well as numerous patents in various areas of physical chemistry and editor of “Polymorphism – In the Pharmaceutical Industry”, Wiley-VCH, 2006.
Christos Reppas, University of Athens, Greece
Christos is Professor of Pharmaceutics, Faculty of Pharmacy, National and Kapodistrian (N&K) University of Athens, Greece. He received his B. Pharm degree in Pharmacy from the N&K University in Athens in 1982 and his Ph.D in 1986 from the same University. From 1988 to 1989 he completed a postdoctoral fellowship in Pharmaceutics at the University of Michigan (USA) and then he joined the N&K University of Athens in 1989 as a Lecturer. He has held research positions with the University of London (UK), the University of Michigan (USA), Glaxo R&D (UK) and the University of Frankfurt (Germany). Research interests focus on the effects of gastrointestinal physiology on intralumenal performance of xenobiotics and the development of in vitro tests that are predictive of the intralumenal dosage form and drug performance. He is coauthor of more than 95 peer reviewed papers in international journals, two books and one patent.
Abu Serajuddin, St. John's university, USA
Abu Serajuddin, Ph.D., is Professor of Industrial Pharmacy in the College of Pharmacy and Health Sciences at St. John’s University, Queens, New York, USA. He joined academia in 2008 after working for three decades in the pharmaceutical industry, where he formulated and developed numerous products, many with extremely difficult and challenging development issues. Several products that he developed or co-developed attained blockbuster status in the market. In his latest positions in the industry, Dr. Serajuddin served as the Director/Executive Director and the US Head of Drug Product Development (1999-2003) and Executive Director of Science, Technology and Outsourcing (2003-2008) for Novartis Pharmaceuticals Corporation. He authored over 90 research papers and book chapters and made over 100 invited presentations in scientific conferences. He is also a co-inventor in 12 patents. In recognition of his scientific and professional contributions, Dr. Serajuddin attained Fellow status in American Association of Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA), International Union of Pure and Applied Chemistry (IUPAC), and American Association of Indian Pharmaceutical Scientists (AAiPS). AAPS also honored him twice with its Research Achievement Award, first for Formulation Design and Development (FDD) in 2010 and the second for Manufacturing Sciences and Engineering (MSE) in 2014. In 2005, he received the Novartis Leading Scientist Award for extraordinary scientific achievement in research and development. He serves in the Editorial Advisory Boards of several journals, including Journal of Pharmaceutical Sciences. At St. John’s, Dr. Serajuddin established the Industrial Pharmacy Innovation Laboratory, where the primary focuses of his research are (1) the development of novel drug delivery systems, especially for poorly water-soluble drugs, and (2) the innovation in processing technologies for solid dosage forms.
Kin Tam, University of Macau, Macau
Kin Tam holds a DPhil in Physical Chemistry from the University of Oxford, UK. He is currently Associate Professor in Biomedical Sciences of the Faculty of Health Sciences, University of Macau, China. Before moving back to China in 2013, he worked for AstraZeneca, Alderley Park, UK, for 12 years, progressing from Senior Scientist, to Associate Principal Scientist, and working as a DMPK Design Leader from 2011. He contributed to a number of drug discovery projects in the areas of oncology and led the development of high-throughput physicochemical assays. Prior to joining AstraZeneca, he developed new instruments with Sirius Analytical Instruments, UK, for 5 years and commercialised UV-based devices for pKa determination. His current research interests include permeability and physiochemical studies of drug molecules, drug metabolism and pharmacokinetics as well as drug development. He has authored or co-authored over 70 articles in peer review journals. Dr. Tam is a Fellow of the Royal Society of Chemistry. He is currently the Editor-in-chief for ADMET & DMPK.
Klara Valko, Biomimetic chromatography Ltd. UK
Klara obtained her PhD at School of Pharmacy, Semmerlweis University in Budapest. Since 1995 Klara has been working with the Physico-chemical Characterization Group at GlaxoWellcome and now GSK. Leaving GSK after 22 years of service, now she is director of Bio-Mimetic Chromatography Consultancy providing data analysis, biomimetic HPLC method set up and measurements, in vivo drug distribution modelling and various courses to pharmaceutical companies and manufacturers of analytical equipment. She developed several bio-mimetic binding measurements of discovery compounds, such as Human Serum Albumin Binding, Immobilized Artificial Membrane binding and Chromatographic Hydrophobicity Index, etc. She developed in silico models for these and several other ADME properties using QSAR-WB general model building tool. Klara supported over 20 neuroscience and respiratory programs in the lead optimization by building general and local models between structure and properties. Klara is also a honorary professor at University College London, where she has been teaching the Physchem/ADME module for the Drug Discovery MSc students for 10 years. She has published over 100 papers that achieved over 3000 citations. She wrote a book on “Physicochemical and Biomimetic Properties in Drug Discovery; Chromatographic Techniques for lead optimization” published by Wiley in 2014. The book summarizes the methodology and applications of the measurements of physicochemical and biomimetic properties with examples for in vivo distribution models and applications in drug discovery.