Drug Metabolism Letters

Dr. Hiroshi Yamazaki has been Professor of Laboratory of Drug Metabolism and Pharmacokinetics at Showa Pharmaceutical University, Tokyo, Japan since 2005. He received his PhD degree from Osaka University in Japan and was trained at Vanderbilt University, TN, USA in 1994. He was a scientist at Osaka Prefectural Institute of Public Health and an Associate Professor of Kanazawa (1998) and Hokkaido (2001) University. He has authored over 340 publications and has been the recipient of the Japanese Society for the Study of Xenobiotics (JSSX) Award and Fellow. He is a member of several editorial committees and the JSSX President-elect (2016-2017).

Dr. Li is currently President, CEO and co-founder of In Vitro ADMET Laboratories LLC, Columbia, MD and Malden, MA. He has devoted his scientific career to the development and advancement of scientific concepts and in vitro technologies to accurately predict human drug properties including metabolic fate, drug-drug interaction potential, and organ-specific toxicity. His research is focused on the development and application of human-based in vitro experimental models, especially primary cultured human hepatocytes and, most recently, enterocytes, in the accurate assessment of human drug properties including metabolic fate, drug-drug interactions and drug toxicity.

Prof ( Dr.) Alka Ahuja is currently serving as Chair of Pharmacy Program at the National University of Science and Technology, Muscat, Oman. She has been actively involved in teaching and Research activities for the last 36 years and has published more than 250 papers in peer reviewed journals of repute. She has authored books, chapters and has been an invited speaker at several international conferences. She has handled consultancy and funded projects and has been bestowed with awards for her Research and teaching accomplishments. Her Research interests are in the fields of Nanotechnology, drug delivery systems and Clinical Pharmacokinetics.

Upendra A. Argikar is a Senior Research Investigator at Novartis Institutes for Biomedical Research, Inc. in Cambridge, Massachusetts, USA. He received a Ph.D. in Medicinal Chemistry from University of Minnesota, USA. He has 15+ years of research experience in drug metabolism and pharmacokinetics. At Novartis he has been an active member of projects spanning many disease areas. Currently, he focuses on metabolite identification and structure elucidation of new chemical entities and clinical candidates. Upendra has continued to be interested in conjugative metabolism by uridine diphospho-glucuronosyl transferases, a topic on which he has co-authored research articles, reviews, and book chapters.

Dr Jae H. Chang received his PhD in the Department of Pharmaceutical Sciences under the mentorship of Dr Leslie Z. Benet at the University of California, San Francisco, where he investigated the impact of drug transporters in gut metabolism, specifically of glucuronidation. Currently, he is at Genentech where he has successfully progressed compounds in diverse therapeutically areas through the preclinical and clinical stages. His research interests consist of evaluating the impact of fundamental pharmacokinetic parameters on the absorption, distribution, metabolism and excretion of compounds, to drive discovery programs and applying this knowledge to enhance the profile of clinical candidates. Besides, his interests have expanded to explore the potential application of drug-metabolizing enzymes and drug transporters in better understanding toxicity. His research has resulted in many impactful publications and he is a frequent presenter at national and international conferences.

Dr. Chavan is a Toxicologist in the Developmental Sciences department at Sana Biotechnology in South San Francisco, CA. He received his Master’s in Pharmaceutical Sciences from the National Institute of Pharmaceutical Education and Research India in 2004. He finished his PhD in Toxicology from the University of Kansas Medical Center in 2013. From 2014-2017, he completed a postdoctoral fellowship at University of Kansas. He then moved to Charles River Laboratories where he worked for 3 years in conducting nonclinical studies in non-human primates. Dr. Chavan has published more than 22 publications and his research interests include preclinical pharmacokinetics, drug-drug interactions, and drug induced liver toxicities.

Dr. Li Di has over 20 years of experience in the pharmaceutical indus­try including Pfizer, Wyeth and Syntex. She is currently a research fellow at Pfizer, Groton, CT. Her research interests include the areas of drug metabo­lism, pharmacokinetics, drug-drug interactions, absorption, transporters, and blood–brain barrier. She has over 140publications including two books and presented over 80 invited lectures. She is a recipient of the Thomas Alva Edison Patent Award, the New Jersey Association for Biomedical Research Outstanding Woman in Science Award, the Wyeth President’s Award and Peer Award for Excellence.

Dr. He is currently a Research Advisor in Drug Disposition at Lilly Research Laboratories, with 20+ year’s pharmaceutical industry experience in discovery and development of drug candidates across different therapeutic areas. She received her Ph.D. degree in Medicinal Chemistry (Drug Metabolism) from University of Washington. Dr. He’s research interest includes drug metabolism and disposition, in vivo/vitro/in silico ADME, DMPK differences in disease models and ethnic populations. Her current research focuses on IVIVE and ADME translation including species scaling and extrapolations, mechanistic PBPK modeling and predictions of human clearance and drug-drug interactions.

Dr Mahmud Kajbaf holds a Ph.D. from the University of London, King’s College, Biopharmacy Department in the area of drug metabolism and MSc from Aston University, Birmingham. Currently Dr Kajbaf is Senior Scientist at Aptuit. He has received several awards and honors, such as: Aptuit CEO Excellence Award, GlaxoSmithKline the psychiatry CEDD Leadership Team Award. He is also on the editorial board for several journals. He has published over 33 research articles related to drug metabolism, in vivo-in vitro correlation, drug-drug interaction, HPLC, NMR and mass spectrometry.

Ethirajulu Kantharaj currently works at D3, A*STAR, Singapore as Head of Technical, R & D. He is a professional drug discovery & development leader with 21 years of experience in DMPK, CMC and Toxicology and early drug development across therapy areas in both small biotech and large pharmaceutical setting. In D3, he is responsible for all the preclinical development activities starting from preclinical development candidate to IND submissions. He was involved in the preclinical development of several NMEs leading to successful INDs in USA and regulatory submissions in Singapore and Australia enabling start of clinical studies. He also strategized successful regulatory meetings with both US (FDA) and EU (EMA) for seeking agreements on the non-clinical development plans and strategy from pre-IND stages to advanced clinical development stages. Previously, Dr Ethirajulu has worked with S*BIO Pte Ltd, Johnson & Johnson Pharmaceutical Research and Development as team leader, ADME/Tox department and AstraZeneca R&D as Head of DMPK and Bioanalytical Chemistry.

Dr. King earned a doctorate (Ph.D.) in Medicinal Chemistry from the University of Iowa, Iowa City. Her postdoctoral fellowship was in molecular toxicology at the National Center for Toxicological Research, followed immediately by earning a faculty position at the University of Rhode Island, College of Pharmacy in 1999. Dr. King is currently Professor of Biomedical and Pharmaceutical Sciences. Dr. King's research spans protein structural biology, receptor-based drug design, all aspects of drug-xenobiotic-hormone metabolism, and liver enzymology.

Hanlan Liu has more than 20 years of drug R&D experience at Ostuka, Wyeth-Ayerst Research, Genzyme, Sanofi, and Catabasis Pharmaceuticals. Currently, she serves as Vice President, Head of DMPK and Preformulation at KSQ Therapeutics. She contributed to 6 INDs and several product submissions and/or post market drug life cycle dossiers. Hanlan earned her PhD of Analytical Medicinal Chemistry and Molecular Pharmacology and conducted postdoctoral work at Purdue University prior to completing her MBA at New York University. Hanlan graduated with a BS in Biochemistry at Wuhan University. Hanlan is the co-inventor on 6 patents and co-author of 33 scientific publications.

Kexin Liu received his B.S. degree in Clinical Medicine and M.S. degree in Pharmacology from Dalian medical University in China and Ph. D. degree in Pharmacy in The University of Tokyo (Laboratory of Yuichi Sugiyama, Department of Pharmaceutics, Faculty of Pharmaceutical Sciences) in Japan. The focus of his research is on the molecular pharmacokinetics of transport in liver, intestine, kidney as well as transporter-mediated DDI and MDR. Prof. Kexin Liu is a co-author of more than 250 publications in international journals. He serves as a vice president of CSSX from 2005 and a dean in College of Pharmacy in Dalian Medical University from 2004.2-2015.1.

Dr. Lu is the director of drug metabolism at Sanofi. He received his B.S. degree in Chemistry from the Beijing University in 1982 and his Ph.D. in the Environmental Chemistry from the American University of Washington, DC in 1992. Dr. Lu did his postdoctoral training at the USDA from 1992 to 1996 with emphasis on the mutagenicity of pesticides and monoclonal antibody techniques. He then worked for the In Vitro Technologies, Inc. as a Principal Scientist where he focused his research on the hepatocyte cryopreservation and application of primary cells in drug metabolism. Dr. Lu served at the DMPK department at Takeda and Biogen as a Scientific Fellow from 2000 to 2016. His current research interests include drug metabolizing enzymes, drug-drug interaction, and in vitro – in vivo correlation including PBPK modeling.

Dr. Lum is a Principal Scientist at Genentech, Inc., where he has been employed for approximately 13 years in the Department of Clinical Pharmacology. He has served a leading role in the development and marketing approvals for a variety of small molecule and protein therapeutics, such as trastuzumab (Herceptin IV/SC), erlotinib (Tarceva), bevacizumab (Avastin), pertuzumab (Perjeta) vismodegib (Erivedge), and ado-trastuzumab (Kadcyla). Prior to moving to Genentech, Dr. Lum was a tenured Professor of Pharmacy at the University of the Pacific and Associate Director of the Clinical Trials Office in the Stanford University Medical Center. He has published over 100 manuscripts.

Sandhya Mandlekar is the Director of Pharmaceutical Candidate Optimization Department at the Biocon Bristol-Myers Squibb R&D Center (BBRC) in Bangalore, India. She also worked in the non-clinical DMPK field at BMS, NJ and DuPont Pharmaceuticals, DE for several years. She received her Ph.D. degree in Pharmaceutical Sciences from the College of Pharmacy at the University of Illinois, Chicago. Sandhya was responsible for setting up and equipping the laboratories, recruitment and staffing, and directing a group of scientists in drug metabolism, pharmacokinetics, bioanalytical sciences, and toxicology at the BBRC. She has published over 50 peer-reviewed articles and also serves as a reviewer for reputed journals.

Dr. Mehran F. Moghaddam obtained his PhD in medicinal chemistry at Oregon State University-School of Pharmacy and investigated novel lipid metabolism at University of California-Davis as a postdoctoral researcher. He also completed an executive MBA at University of Southern California. He started his industrial career by joining DuPont in 1995. Subsequently, he worked in Pfizer and Celgene. He is currently the head of Discovery Drug Metabolism and Pharmacokinetics (DMPK) at Celgene, a global biopharmaceutical company with marketed blockbuster drugs in oncology and anti-inflammatory spaces. Dr. Moghaddam has been a co-inventor on more than 5 patents. He has authored/co-authored more than 50 manuscripts on a variety of subject matters. He is on the editorial board of Drug Metabolism Letters and DARU. Additionally, he is a section editor for Current Medicinal Chemistry.

Promoted to Professorship position in 1999 at Obafemi Awolowo University, Ile- Ife, Nigeria, Prof Cyprian Onyeji occupied various posts including Deanship of his Faculty. Outside the University, he served as Governing Board member of different establishments. He was appointed Vice-Chancellor of Enugu State University of Science and Technology, and completed the tenure in 2015. He has made excellent contributions to the advancement of Science through his studies with focus on pharmacokinetic, metabolism and pharmacodynamic evaluations of anti-infective drugs, with the overall objective of generating information relevant for optimization of therapeutic utility of the drugs.

Professor Kevin Park is currently Professor of Pharmacology and Head of the Institute of Translational Medicine at the University of Liverpool. Professor Park is a Fellow of the Royal College of Physicians, a Fellow of the Academy of Medical Sciences and also a Commissioner on Human Medicines. The over-riding theme of his work is bringing “molecule–to-man” and back again, to enable the prediction of adverse drug reactions based on the chemical structure of the drug and the identification of susceptible individuals. This work has been expanded by using pharmacogenomics and toxicogenomics to link findings in patients to the chemical structure of the drug. The group are now in a position to provide solutions to adverse drug reactions through research in two areas: 1) improved drug design and 2) the delivery of individualised medicines.

Dr. Pusalkar obtained a doctorate degree (Ph.D.) in Medicinal Chemistry from Massachusetts College of Pharmacy and Health Sciences, Boston, MA. Dr. Pusalkar has more than 15 years of experience in drug metabolism and pharmacokinetics field and currently leads the Enzymology Group at Takeda Pharmaceuticals, Intl’ Co. in Cambridge, MA.

My research program seeks to understand how cells respond and adapt to stressful stimuli at the molecular and biochemical level. A primary focus has been on the carboxylesterase enzymes because of their important roles in xenobiotic and endobiotic metabolism, including their ability to catabolize drugs, toxicants, and lipids. Our research includes studies on carboxylesterase enzymology and gene regulation; how carboxylesterase activity influences macrophage cell physiology and phenotype; and inter-individual variations in its activity within human populations. Our group is also interested in macrophage reverse cholesterol transport, and investigating how lipid metabolism and inflammation intersect in these immune cells.

Dr Soars is a Senior Principal Scientist in the Metabolism and Pharmacokinetics department at Bristol-Myers Squibb in Wallingford CT. He received his Bachelors in biochemistry from the University of Warwick in 1998 and a Phd from the University of Dundee in 2002. From 2002-2003, he completed a postdoctoral fellowship at Eli Lilly where he worked on drug glucuronidation under the supervision of Steve Wrighton. He then moved to AstraZeneca where he worked for 8 years developing and implementing both drug metabolism assays and more recently transporter methodology. Since 2011 Dr. Soars has worked at Bristol –Myers Squibb where he helped develop the transporter strategy in Drug Discovery. Research interests include the prediction of pharmacokinetics and drug-drug interactions for new chemical entities and also the application of drug transporter methodology in early Drug Discovery. Dr Soars has published more than 30 scientific publications and is on the Editorial advisory board for a number of publications including Xenobiotica, Current Drug Metabolism and Drug Metabolism letters.

David Stresser is a Principal Research Scientist in the DMPK-Translational Modeling department at AbbVie. Prior to joining AbbVie in 2016, he held research, management and business development positions at Gentest Corporation, BD Biosciences and Corning Life Sciences in Woburn, MA. He received post-doctoral training in the laboratory of David Kupfer at the University of Massachusetts Medical School in Worcester, Massachusetts and graduate work in the laboratories of David E. Williams and George S. Bailey at Oregon State University in Corvallis, OR, receiving a Ph.D. in toxicology in 1994. Dr. Stresser has authored or co-authored > 40 articles or book chapters in the field of drug metabolism and has been an invited speaker at various national and international meetings, pharmaceutical companies and universities.

Prof. Dr. Mert Ulgen graduated from Marmara University, Faculty of Pharmacy, Istanbul, Turkey in 1981. He finished his MSc degree at the same department and in 1992, he obtained a PhD degree from University of London, King's College, Biopharmacy Department in the area of Drug Metabolism. He returned to Turkey and became an associated Professor in 1993 and a full professor in 1999 at the same department in the area of Pharmaceutical Chemistry. He has got a number of papers on drug synthesis and in vitro hepatic microsomal metabolism of xenobiotics. He directed a number of MSc and PhD thesis. He retired from Marmara University in June 2009 and he became a full time Professor at Acıbadem University, Vocational School of Health Services in the same year. He has a number of administrative duties. He is also a full time chemistry lecturer. He was Director of Enstitute of Health Sciences in Acıbadem University one term (2013-2016). He established Faculty of Pharmacy at the same University in early 2016 and he is currently dean of Pharmacy. He is also head of "Management in Drug Industry" MSc Program.

Bo Wen, Ph.D. is Research Fellow at GlaxoSmithKline Pharmaceutical Research and Development. Prior to GSK, Dr. Wen held multiple positions at Hoffmann-La Roche and Bristol- Myers Squibb. He received his B.Sc. in Pharmaceutical Sciences from China Pharmaceutical University and Ph.D. in Medicinal Chemistry from the University of Washington. He has authored over 30 peer-reviewed papers and book chapters in the fields of biotransformation, bioactivation of xenobiotics, and the molecular mechanisms of drug metabolism and chemical toxicology.

Upendra is Sr Scientist at Amgen Inc. His current role involves representing PKDM (pharmacokinetics and drug metabolism) in multi-disciplinary project teams in discovery to development stages, design in vitro and in vivo studies to understand PKDM properties of the project compounds, provide recommendation to the team to design better compounds with low metabolic and DDI liabilities. He spends time in interpretation of results from in vitro and in vivo studies and making conclusion based on the data and proposing further studies to understand PKDM related challenges and to mitigate the risks. He also involves in preparing the documents for regulatory filing. Prior to joining Amgen Upendra worked at Celgene and Pfizer. Upendra has diverse research interest and has demonstrated a good track record of peer reviewed publications in various areas

Mithat Gunduz is a Research Investigator at Novartis Institutes for Biomedical Research, Inc. in Cambridge, Massachusetts, USA. Mithat received his M.A. degree in Chemistry from Queens College, City University of New York, USA. He has more than 20 years of research and preclinical development experience in drug metabolism and pharmacokinetics. Currently, he is a member of PK Sciences group within Novartis Institutes for Biomedical Research with the emphasis on metabolite identification, structure elucidation, and potential bioactivation of new chemical entities. Mithat has continued to be interested in Drug Metabolism and Pharmacokinetics, especially the area of bioactivation.

Dr. Goutam Mondal is an emerging pharmaceutics and drug delivery scientist. He started his research journey in Dr. Arabinda Chaudhuri’s research group at CSIR-Indian Institute of Chemical Technology, Hyderabad in January 2006 with his own doctoral research fellowship from the Government of India. He contributed significantly in establishing Dr. Chaudhuri’s research on design & synthesis of integrin receptor selective novel lipopeptides for delivering anti-cancer drug/genes to tumor vasculature for antiangiogenic cancer therapy. He is an expert of design and synthesis of receptor targeted lipids and polymeric systems, the techniques of animal tissue culture, tumor growth inhibition studies, and pharmacokinetics studies of small molecules. He did his first postdoctoral research at the University of Nebraska Medical Center, USA. Presently, he is associated with Dr. Ikhlas A Khan’s research group at the National Center for Natural Products Research, University of Mississippi, USA. He has published 21 research articles in high impact peer-reviewed journals.

Dr. Utpal Nandi is currently working as a scientist at the PK Toxicology and Formulation Division of the Indian Institute of Integrative Medicine (CSIR), Jammu, India. His current research work is focused on preclinical pharmacokinetics of drug/drug phytotherapeutics for drug induced toxicities. He has published more than forty research papers in various reputed journals.

Dr. Guru R. Valicherla is a Postdoctoral Associate at the School of Pharmacy, University of Pittsburgh, USA. He received his Ph.D. in Drug Metabolism and Pharmacokinetics Division from CSIR-Central Drug Research Institute, Lucknow, India. He obtained his Masters (M.S. Pharm.) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Mohali, India and his Bachelors from St. Peters Institute of Pharmaceutical Sciences, Hanamkonda, India. He was awarded the Bright STAR fellowship in 2019-2020 by Magee-Womens Research Institute, Pittsburgh, USA. He has published more than 29 peer-reviewed papers and one patent.

Dr. Qinghua Wu got the doctor's degree from Huazhong Agricultural University, China in 2013. During 2010-2011, Dr. Wu has studied as a visiting scholar in Institute of Food Chemistry, University of Muenster, Germany. Since 2014, he is an invited professor in University of Hradec Kralove. Since 2015.07, he began to be an associate professor in Yangtze University. His research interest is metabolism, pharmacokinetics, toxicokinetics, immunotoxicity, and food safety. Dr Wu has published more than 40 peer-reviewed articles in the field of metabolism and toxicology.