​Transporters in Drug Discovery and Development: Driving Knowledge from Laboratory to Label 2016

South Kingstown RI

Aug 1 - 3, 2016

Several factors led to the recent emphasis on the field of transporters and their impact on drug absorption and disposition. Pharmaceutical industry continues to have keen interest in optimizing the physicochemical space of NCEs and minimizing their Cytochrome P-450 (CYP)-mediated metabolic liability. This led to the increasing selection of compounds that are both hydrophilic and polar in nature. Such chemical space inherits low passive permeability and metabolic clearance characteristics, and more importantly have potential contribution of transporters to their disposition in man. This paradigm shift presents the research community with a more difficult chemical space for addressing drug absorption and predicting pharmacokinetics and tissue distribution. Appropriate understanding of transporters and in vitro and in silico tools that characterize their contribution to drug absorption, disposition and toxicity is key for the success of the pharmaceutical industry. Additionally, the US FDA, EMA and other regulatory agencies provided new guidance on approaches to assess the liabilities of transporter-mediated drug-drug interaction (DDI), efficacy and organ toxicity for new chemical entities (NCEs) with special emphasis on certain transporters with considerable knowledge in the clinic.

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Yurong Lai

Sr. Principal Scientist, Bristol-Myers Squibb

Bio: Dr. Lai is a Sr. Principal Scientist at BMS Pharmaceutical Candidate Optimization Department. His current role in BMS is to lead the transporter labs for the implementation of drug transporter strategies in drug discovery and development and in vitro/in vivo transporter investigations for regulatory filings. Dr Lai holds an Adjunct faculty position in the Department of Pharmacy of the University of Rhode Island. He received his M.D from Fujian Medical University in China and his Ph.D. (Toxicology) from Sapporo Medical University in Japan in 1998. From 1998 to 2001, he was a research fellow of Japanese Society for Promotion (JSPS) in Department of Physiopathology, Graduate School of Medicine of Hokkaido University, followed by a position as a Research Associate in Department of Pharmaceutics, University of Washington. In 2004, he Joined PDM, PGRD St. Louis and then moved to Groton R&D center in 2010, Pfizer Inc. and has been serving as a PDM representative (PI), postdoc supervisor and lab head for drug transporter research. In 2013, he joined BMS. He has had a significant role in translational researches in transporter associated ADME-PK-Tox. Current research interests include proteomics analysis for absolute differences of transporters across species, structure-activity relationship and the evaluation of in vitro/in vivo models to predict human PK and toxicity. He is a patent inventor and the author of a book, book chapters and over 110 original publications in peer-reviewed journals.

Manthena Varma

Associate Research Fellow, Pfizer

Bio: Dr. Manthena Varma, PhD is Associate Research Fellow, at Pfizer Inc. Dr. Varma received his B. Pharm. degree from the Kakatiya University, India, an M.S. degree in Pharmaceutics and PhD in Pharmaceutics in 2001 and 2005, respectively, from the National Institute of Pharmaceutical Education and research (NIPER), Punjab, India. From 2006 to 2008 Dr. Varma worked as a Post Doctoral Fellow at the Department of Pharmaceutics, University of Minnesota (Minneapolis). His research is focused in the fields of drug transporters in ADME, pharmacokinetics and DDI predictions/evaluation and prodrugs. He has over 80 original publications in the peer-reviewed journals and about 40 presentations in the scientific conferences.

Ayman El-Kattan, B. Pharm., Ph.D.

Associate Research Fellow, Pfizer Inc. Cambridge Laboratories

Bio: Dr. Ayman El-Kattan is Associate Research Fellow at the Pharmacokinetics, Dynamics, and Metabolism Department, Pfizer Inc. Cambridge Laboratories. He led Pfizer efforts in the emerging area of drug transporters with emphasis on developing in vitro and in silico tools to improve ability to predict transporter mediated clearance and DDI in man. Dr. El-Kattan earned his bachelor degree in pharmacy with distinction from University of Jordan and a Ph.D. in Basic Pharmaceutical Sciences at University of South Carolina in the US. His main research interests are focused on understanding the factors that affect drug disposition and oral bioavailability with emphasis on transporters. Also, it involves studying the utility of physiological based pharmacokinetic modeling (PBPK) tools e.g. SimCYP in projecting drug disposition and drug-drug interaction liabilities in man for new molecular entities (NME). Dr. El-Kattan is an Adjunct Associate Professor at College of Pharmacy-University of Rhode Island in Rhode Island, US, where he lectures in the graduate‐level pharmacokinetics and drug development courses and serves as external advisor on dissertation committees. He is active member of the American Association of Pharmaceutical Scientists (AAPS) and serves on the executive committee of the physical pharmacy and biopharmaceutics and Northeastern Regional Discussion Group (NERDG) sections of AAPS. He has been invited speaker over 30 times at national and international conferences and meetings and has published over 100 papers in peer-reviewed Journals, book chapters and proceedings.

Angela Slitt

Associate Professor, University of Rhode Island

Bio: Dr. Slitt is an Assistant Professor at the Department of Biomedical and Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island. Dr. Slitt received a B.S. in Molecular and Cellular Biology and Ph.D. in Pharmaceutical Sciences from University of Connecticut. From 2000-2004, she finished her postdoctoral fellowship at University of Kansas Medical Center with Dr. Curtis Klaassen, receiving an NIH Postdoctoral Fellowship to study induction of transporter expression in liver and altered acetaminophen excretion. Dr. Slitt research interests focus on how 1) expression of drug transporters affects chemical (i.e. drug and environmental chemical) disposition and toxicity, 2) nutrition and intake of dietary antioxidants affects the expression of drug transporters, 3) liver disease (i.e. diabetes, cholestasis, and alcoholic cirrhosis) affects transporter expression and chemical disposition, and 4) transporter expression affects cholesterol transport and susceptibility to gallstone formation. Dr. Slitt has 48 original publications in peer reviewed journals, 64 published abstracts and over 20 invited presentations at national/international conferences or as a guest speaker. So far, she has graduated 1 Ph.D., 4 Master Students, and trained 1 postdoctoral fellow.

Ping Zhao

Food and Drug Administration

Bio: Ping Zhao obtained his BS in Pharmacy from Beijing Medical University in China in 1994, and his PhD in Pharmaceutics from University of Washington in Seattle, WA, USA in 2002. Since then, Ping worked as a DMPK scientist at Pfizer in La Jolla (2002-2005), a pharmacokineticist at Sonus Pharmaceuticals in Seattle (2005-2007), a clinical pharmacologist at Amgen in Seattle (2008). In June 2008, Ping joined the Office of Clinical Pharmacology at FDA, and currently is the Scientific Lead of PBPK (physiologically-based pharmacokinetic modeling) Program and expert clinical pharmacologist responsible for assessing PBPK works in IND and NDA submissions.

Ayman El-Kattan

Associate Research Fellow, Pfizer Inc

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