Speakers

Armina Abbasi received her Ph.D. in the field of chemistry of biological systems from the Washington State University in 2020 and her graduate work was focused on the numerical modeling of the atypical pharmacokinetics of aldehyde oxidase as well as the time-depended inhibition (TDI) of cytochrome P450 family of enzymes. She has a strong background in the ADME characterization of small molecule therapeutics and since joining Amgen, she has expanded her expertise to siRNA therapeutics and PROTACs. Dr. Abbasi joined the pharmacokinetics and drug metabolism (PKDM) department at Amgen Inc. as a scientist in 2021 where she serves as the associate project team representative and the ADME and drug-drug interactions expert on various programs. She is currently spearheading the incorporation of a more routine use of TDI modeling, machine learning and data consolidation and analysis tools across programs within the PKDM department.

Matt is currently a Scientist in the Drug Metabolism and Pharmacokinetics (DMPK) department at Takeda, San Diego. Matt received his PhD in biochemistry from Vanderbilt University where he focused mainly on cytochrome P450 inhibition. He has a wide range of analytical expertise including chromatography, mass spectrometry, and qPCR specializing in method development and implementation. Matt currently leads the oligonucleotide and cell therapy bioanalytical team at Takeda, San Diego and serves as DMPK project representative.

Eurofins Discovery accelerates the critical drug discovery endeavor for our global clients through decades of experience and flexible solutions. We provide comprehensive services from assay-ready development to DiscoveryOne™ integrated programs; chemistry, in vitro safety and efficacy phenotypic assays, ADME-tox and pre-clinical pharmacology. Whether you require outsourcing needs or perform research in-house, Eurofins Discovery Services and Eurofins DiscoverX product solutions empowers R&D through IND. Eurofins Discovery

Chris received his BS in Pharmaceutical Sciences and BA in Italian from Ohio State University in 2018. Chris is currently a 4th year PhD student at the University of Washington in the department of Pharmaceutics with an expected graduation of December 2023. Chris' research focuses on developing novel model systems of the human intestine in order to better characterize oral drug disposition.

Per Artursson is a professor in Dosage Form Design at the Department of Pharmacy, Uppsala University, Sweden, where he heads the Drug Delivery research team. He is also Director of the Uppsala University drug optimization and pharmaceutical profiling platform within Science for Life Laboratories. His research aims at understanding drug absorption, distribution, metabolism and elimination (ADME) at the molecular and cellular level in order to deliver drugs more effectively via the oral route. He also investigates the influence of drug transporting proteins, drug metabolizing enzymes and cellular and sub-cellular drug uptake, distribution and elimination. For this purpose, both 2D and 3D cell cultures are used in combination with state-of-the-art omics and bioinformatics. Both traditional small drug molecules and biopharmaceuticals such as peptide and antisense oligonucleotides are investigated. He has published more than 200 research articles and 50 reviews and book chapters, is highly cited and has received several international awards for his research.

Dr. Backes received his Ph.D. in Biochemistry from West Virginia University, and postdoctoral training under Dr. John B. Schenkman at the University of Connecticut Health Center prior to joining the faculty in the Department of Pharmacology at LSU Health Sciences Center. Dr. Backes’ primary research interests involve the function of the cytochrome P450 system and other microsomal electron transfer proteins. His studies focus on the protein-protein interactions that are necessary for electron transfer to P450s, and how protein interactions, not immediately related to electron transfer, can affect P450 function. These studies also extend to examining how P450 system proteins interact with specific membrane microdomains, and how these interactions can influence whether

Dr. Benet, Professor and former Chairman (1978-1998) of Bioengineering and Therapeutic Sciences, University of California San Francisco (UCSF), received his AB, BS and MS from the University of Michigan, and PhD from UCSF. He has received nine honorary doctorates, five from Europe and four from the US, most recently the University of Lisbon in 2016. Dr. Benet served as President of the Academy of Pharmaceutical Sciences (1985) and as first President of the American Association of Pharmaceutical Scientists (1986). In 1987 he was elected to membership in the National Academy of Medicine of the US National Academy of Sciences. He previously served as the Treasurer of ISSX, Chair of the Drug Metabolism Gordon Conference in 2006, and in 2015 received the ISSX North American Achievement Award. Dr. Benet has published over 610 scientific articles and book chapters, holds 12 patents and served as editor of 7 books. He has been listed continuously by Clarivate Analytics among the most highly cited pharmacologists worldwide, with his peer reviewed publications being referenced in the peer reviewed literature on more than 31,000 occasions.

Dr. Fabio Broccatelli received his PhD in computational chemistry from the University of Perugia. During his PhD, focusing on machine learning based predictions of ADME properties, he was a visiting scientist at UCSF. He went on to a PostDoc at the Institute of Cancer Research London and then joined Genentech, where he worked for 8 years building an in silico ADME group within the DMPK department. Dr. Broccatelli currently woks as Associate Director leading the DMPK group at the BMS San Diego site. He's main areas of focus include ML/AI, PBPK, IVIVc and ADME informed chemical design. Dr. Broccatelli was awarded with the 2013 AAPS Manuscript Award, has published 25 peer reviewed articles, patents and book chapters and serves as a reviewer for over 15 scientific journals. Dr. Broccatelli initiated and co-led the in silico ADME IQ group.

Sarah Burris-Hiday received her B.S. in Chemistry at Indiana University Purdue University at Indianapolis where she received the Chancellor’s Scholar Award for being the top student in the School of Science. While pursuing her bachelor’s degree, she worked in the lab of Dr. Martin O’Donnell studying unnatural amino acids for orphan diseases, published in ACS Chemical Biology. Additionally, Sarah worked as an intern at Heritage Research Group as an analytical chemist primarily using gas chromatography and mass spectrometry. Sarah is a senior graduate student pursuing a Ph.D. in Medicinal Chemistry at the University of Michigan. She earned an NIH institutional training grant fellowship in the Pharmacological Sciences. She works in Dr. Emily Scott’s lab investigating the protein-protein interaction between various human cytochrome P450 enzymes and their redox partner protein cytochrome P450 reductase. Sarah has presented this work at both regional and national conferences, and she has published a review article in Molecular and Cellular Endocrinology on Cytochrome P450 17A1.

Tom received his Ph.D. from the University of Toronto, in the Department of Pharmaceutical Sciences studying mechanistic toxicology under the late Peter J. O’Brien. Following this, he spent several years as a postdoctoral fellow studying changes in liver metabolism during ischemic liver injury at the Centre Hospitalier de l’Universite de Montreal under Dr. Marc Bilodeau. Tom is currently employed at Boehringer Ingelheim Pharmaceuticals as a Senior Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics with general interests in novel approaches and methodologies to develop drugs from an ADME perspective. He is an active representative of BI in the IQ MPS Affiliate and the New England Drug Metabolism and Discussion Group. Tom has co-authored 31 peer reviewed articles and 6 book chapters in the fields of toxicology, DMPK and Drug Development.

Dr. Katrina Claw is an Assistant Professor at the University of Colorado Anschutz Medical Campus in the Division of Biomedical Informatics and Personalized Medicine. Broadly, her research program focuses on personalizing medicine, pharmacogenomics, and the ethical, legal, social, and cultural implications of genomic research with American Indian/Alaska Native and other Indigenous communities. Dr. Claw’s current research focuses on pharmacogenetic variation, tobacco cessation and nicotine metabolism, evolutionary medicine, and examining the perspectives of genomic research in tribal communities. Dr. Claw grew up on the Navajo Nation, and she obtained her BS in biology and BA in anthropology at Arizona State University; her PhD in genome sciences at the University of Washington in Seattle, WA in 2013.

Marie Croft has over 17 years of experience in bioanalytical applications of accelerator mass spectrometry (AMS). Following her graduation from De Montfort University in 2004, Marie started her career with Xceleron Ltd, obtaining hands on laboratory experience in AMS and LC+AMS analysis. During this time, she conducted research into AMS microdosing, specifically cassette dosing in DDI studies, and combined use of AMS and PET after microdose administration. She received her PhD in ‘Applications of human microdosing with accelerator mass spectrometry’ from the University of York in 2013. Marie has a keen interest in the utilization of AMS in clinical and pre-clinical development and as Scientific Director, Radiolabeled Sciences at Pharmaron, plays a key role in the design, review and execution of studies utilizing AMS.

Deepak Dalvie is currently a Vice President of drug metabolism and pharmacokinetics at Crinetics Pharmaceuticals. Prior to this he was a Scientific Executive Director of Drug Metabolism and Pharmacokinetics at Bristol Myers Squibb in San Diego and a Research Fellow at Pfizer Global Research and Development in the Department of Pharmacokinetics, Dynamics, and Metabolism in La Jolla, CA. Dr. Dalvie received his B.Sc. (Honors) in Chemistry at the University of Bombay (now Mumbai), B.Sc. (Tech) and M.Sc. (Tech) in Technology of Pharmaceutical and Fine Chemicals at UDCT (now ICT) at University of Bombay, India and his Ph.D. in Medicinal Chemistry at State University of New York at Buffalo, New York. After a postdoctoral fellowship in the areas of organic chemistry and drug metabolism under the supervision of Professors Richard Sundberg at the University of Virginia and Professor Neal Castagnoli at Virginia Tech, he joined Pfizer as a research scientist in 1992. Dr Dalvie serves on the editorial board of drug metabolism journals, including Drug Metabolism Reviews and Xenobiotica and he is an Associate Editor of Drug Metabolism and Disposition. He is reviewer for several ACS journals, including Journal of Medicinal Chemistry, ACS Medicinal Chemistry letters and Chemical Research in Toxicology and is also a member of the scientific advisory board for Xenotech and Wisconsin Alumini Research Foundation (WARF Therapeutics) and is also an affiliate faculty member at Skaggs School of Pharmaceutical Sciences University of California at San Diego.

Dmitri R. Davydov is an enzymologist, biophysicist, and biochemist with over 40 years of experience in molecular enzymology of cytochromes P450. He obtained his Master's degree in 1978 from Moscow State University and Ph.D. in biochemistry in 1982 from Russian State Medical University (Moscow, Russia). In 1979, when working under Prof. Boris Kurganov's mentorship, Dr. Davydov began his studies in P450 enzymology, which became the primary area of his research interests for his entire career. Since then, Dr. Davydov has worked in several leading research institutions in Russia, France, and the United States. His research has always been directed towards understanding the mechanisms of protein-protein and enzyme-substrate interactions in cytochromes P450 and exploring protein conformational dynamics related to the mechanisms of their function and regulation. In his current research, Dr. Davydov focuses on the systems biochemistry of drug metabolism and the mechanisms of functional integration in the human cytochrome P450 ensemble.

De: Prashant Desai is currently a senior director in the ADME (DMPK) function of Eli Lilly and Company, responsible for in silico and in vitro modeling groups namely, Computational ADME, Mechanistic PK and Investigational Drug Disposition. He received BS in Pharmacy, MS in medicinal chemistry and PhD in Biophysics and Computational Chemistry from University of Bombay (India). Prashant has been working with the DMPK function in Eli Lilly for the past 15+ years. He started his career at Lilly as a computational ADME scientist in 2007 and has been instrumental in building the infrastructure for machine learning models for predicting ADME properties, among other cheminformatics tools. He has also served as ADME project leader across various therapeutic areas during his career at Lilly. As a scientific leader in the preclinical ADME research, Prashant’s primary focus has been on effective integration of in silico, in vitro, and in vivo ADME models during the early phase of drug discovery in line with the mechanistic pharmacokinetics principles. He has contributed to more than 50 papers in peer reviewed journals and book chapters.

Dr. Li Di has over 25 years of experience in the pharmaceutical industry including Pfizer, Wyeth and Syntex. She is currently a research fellow at Pfizer Worldwide Research and Development, Groton, CT. Her research interests include the areas of drug metabolism, pharmacokinetics, drug-drug interactions, absorption, transporters, and blood–brain barrier. She has over 170 publications including two books and presented over 100 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.

Sally joined Genentech as a Research Scientist in 2000. She moved to Development Sciences department in 2003 and is currently a Senior Director & Senior Fellow in the Assay Development and Technology (ADT) group within the Bioanalytical Sciences (BAS) department. Through the past 19 years, Sally has led a team that develops bioanalytical strategies to measure drug levels, assess immunogenicity and evaluate biomarkers using novel technologies. Her group provides essential data to enable IND, BLA, NDA and related filings to support Genentech development pipeline in the areas of immunology, neuroscience and metabolism. Another area of focus for Sally and her team has been evaluation and implementation of innovative patient centric healthcare solutions to improve patient care and clinical trials.

Dr Galetin is a Professor of Translational Pharmacokinetics in the School of Health Sciences, University of Manchester, UK and Deputy Director of the Centre for Applied Pharmacokinetic Research. She has served on the ISSX Council (2017-2021) and has started her term of office as ISSX President-Elect in January 2022. Dr Galetin holds long-standing leadership position in the International Transporter Consortium (ITC) where she led multiple white papers, defining best practices for the application of endogenous biomarkers and PBPK modelling of transporter-mediated drug-drug interactions among others topics. In 2016, Prof. Galetin completed a sabbatical in the US FDA Office of Clinical Pharmacology where she provided expert advice on the PBPK modelling of drug-drug interactions and specific populations in new drug applications. She has published extensively and supervised/mentored over 40 graduate students and postdoctoral research associates.

Dr. Stephen Greene is a clinical pharmacologist and pharmacometrician and Moderna Therapeutics. Dr. Greene has experience in model-informed drug development (MIDD) across multiple therapeutic areas and drug formulations including small molecule and biologics. Dr. Greene enjoys communicating the benefit of MIDD to help interdisciplinary teams effectively develop drug therapeutics.

Meghna Gupta is a postdoc in the Stroud lab at University of California San Francisco (UCSF). She is using biochemistry and structural biology tools to determine mechanism of fatty-acid transport and metabolism in peroxisomes. She will be presenting part of this work here. In addition to that, through her expertise, Meghna has contributed to many projects at UCSF pertaining to autoimmune diseases, SARS-CoV2, membrane proteins.

Mei is currently a Principal Scientist in the Pharmacokinetics & Drug Metabolism (PKDM) department at Amgen South San Francisco. She has 20+ years’ of biopharma experience in drug discovery and development specialized in analytical sciences, biologics optimization, pharmacokinetics and drug metabolism. As a subject matter expert of protein therapeutics purification and characterization, in vitro (pre-dose) and in vivo (post-dose), her expertise ranging from chromatographic, electrophoresis and mass spectrometry analytical method development, inter- and intra- departmental method transfer, method qualification per ICH guidelines and experience with regulatory filings. Currently, she leads the large molecule ADME team within PKDM and serve as a PKDM project team representative in project team for multiple projects. She also serves as a CE Pharm Committee member and Associate Director for CASSS.

Oliver Hatley is a Principal Scientist who has been working at Certara UK Limited’s Simcyp Division since 2013. He received his MSc in Drug Discovery Skills at the Kings College London in 2009. He went on to study in vitro to in vivo (IVIVE) extrapolation of Intestinal Metabolism with the University of Manchester (CAPKR) and AstraZeneca, focusing on IVIVE scaling factors, receiving his PhD in 2014. Oliver is part of the translational sciences in DMPK group within the Simcyp Division. He has lead development of the esterase organ and blood IVIVE scaling strategies and the development of special adult populations within the Simcyp Population-based Simulator. Oliver also serves on the ISSX Modeling & Simulation Focus Group Steering Committee.

Finished the University of Tokyo, Graduate school of Pharmaceutical Sciences (M.S. Pharmaceutical Science in 2004, Ph.D. Pharmaceutical Science in 2007) after graduating from the University of Tokyo, School of Pharmacy (B.S. Pharmacy) in 2002. Joined Daiichi Sankyo Co. Ltd., Drug Metabolism and Pharmacokinetics Research Laboratories in 2007. Visiting Scientist in the Laboratory of Dr. Edward J. Kelly (University of Washington) from 2018 to 2020. Daiichi Sankyo Co. Ltd., Drug Metabolism and Pharmacokinetics Research Laboratories from 2020.

Magnus Ingelman-Sundberg, PhD; BSc.Med is a Professor of Molecular Toxicology and research group leader in Pharmacogenetics at the Department of Physiology and Pharmacology, Karolinska Institutet. He has more than 500 original papers and a h-factor of 94 (ISI) or 121 (Google Scholar). Assigned “Highly Cited Researcher” for 2014, 2015, 2016, 2017 and 2021 by Thomson & Reuters/Clarivate. He was a member of The Nobel Assembly at Karolinska Institutet 2008-2018 and a member of Editorial Advisory Boards of e.g. Trends in Pharmacological Sciences (Edit Board), Pharmacogenetics and Genomics, Pharmacogenomics, Drug Metabolism Reviews, Drug Metabolism and Disposition, Human Genomics. He has received numerous Awards, most recently the 2018 BCPT Nordic Prize in Basic and Clinical Pharmacology and Toxicology and an honorary doctorship at SydDansk University. His research focuses on genetics, polymorphism, regulation, function and toxicology of the hepatic ADME system with aims at understanding interindividual differences in drug response. Furthermore, he develops novel hepatic in vitro systems for studying liver function, liver diseases, and validation of hepatic drug targets.

Associate professor, Division of Pharmaceutical Cell Biology, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan. BSc 1988 Pharmaceuti Sci. Fukuoka University, Japan. Master 1990 Pharmaceuti Sci. Grad Sch Pharmaceuti Sci, Kyushu University.Ph.D. 1995 Pharmaceuti Sci, Grad Sch Pharmaceuti Sci, Kyushu University. 1993-1999 Instructor, Fac Pharmaceuti Sci, Kyushu University, Fukuoka, Japan.1997-1998 Visiting Post Doctoral Fellow, Dep Clin Pharmacol, Flinders Medical Centre, Bedford Park, South Australia, Australia. 1999-2001 Instructor, Grad Sch Pharmaceuti Sci, Kyushu University. 2001-2003 Lecturer, Inst Commun Med, University of Tsukuba, Ibaraki, Japan. 2003- Associate professor, Grad Sch Pharmaceuti Sci, Kyushu University.
Summary of Awards, Honors: The JSSX Young Investigator Award from the JSSX in 2008. The 6th Japanese Research Foundation for Clinical Pharmacology Research Award in 2013 . Tanabe Award, the Japanese Society of Toxicology in 2011 and 2017 . The Scientific Award, the Division of Pharmaceutical Health Science and Environmental Toxicology, the Pharmaceutical Society of Japan, 2018.

Dr. Klarissa Jackson is an assistant professor at the University of North Carolina at Chapel Hill (UNC) Eshelman School of Pharmacy in the Division of Pharmacotherapy and Experimental Therapeutics. She received her Ph.D. in pharmacology from Vanderbilt University, and she completed her postdoctoral training at the University of Washington School of Pharmacy in the Department of Medicinal Chemistry under the mentorship of Drs. Allan Rettie and Sidney Nelson. Jackson began her faculty career as an assistant professor in the Department of Pharmaceutical Sciences at Lipscomb University College of Pharmacy, and in July 2019, she joined the faculty at UNC. Jackson’s research interests focus on understanding the mechanisms of interindividual variability in drug metabolism and toxicity in ethnically diverse populations. Her laboratory is currently investigating the roles of cytochrome P450 and non-P450 enzymes in the metabolism and hepatotoxicity of tyrosine kinase inhibitors used in targeted cancer therapy.

Dr. Jusko is SUNY Distinguished Professor & former Chair of Pharmaceutical Sciences at the University of Buffalo. He received his BS in Pharmacy (1965) and PhD (1970) degrees from Buffalo. He then served as Clinical Pharmacologist at the Boston VA Hospital and Assistant Professor of Pharmacology at Boston University. He returned to Buffalo in 1972 as Director of the Clinical Pharmacokinetics Laboratory and Assistant Professor. He received the Doctor Honoris Causae from the Jagiellonian University in Poland (1987) and from the University of Paris Descartes (2015) and has many other awards including the 2018 Oscar B Hunter Career Award from ASCPT and the 2020 Distinguished Pharmaceutical Scientist Award from AAPS. He serves on the Editorial Boards of 7 journals and is former Editor-in-Chief of JPKPD. His research covers clinical, basic, and theoretical PK/PD of diverse drugs, particularly immunosuppressants, anti-diabetics, anti-cancer drugs, and antibodies with over 650 publications.

Chris Keefer is a Research Fellow and leads the Computational ADME (cADME) group at Pfizer. Before joining Pfizer, he was the head of the Cheminformatics Group at GlaxoSmithKline in RTP, NC. The cADME group is responsible for maximizing the value of the data collected by project teams and ensuring it is used to facilitate decision making. This includes the building and maintenance of a suite of Global ADME/T in silico models and Matched Molecular Pair/Series (MMP/MMS) tools. Chris’ background and interests lie in the generation of high-performance algorithms for the analysis of large data sets, machine learning, confidence metrics, and the development and application of MMP based methodologies for drug discovery.

Dr. Kelly earned his PhD in Biochemistry from the University of Washington in the laboratory of Dr. Richard Palmiter, developing transgenic and knockout mouse models to study the function of the metal-binding protein metallothionein. Following a postdoctoral fellowship in molecular toxicology with Dr. David Eaton, he ventured into Seattle Biotech, managing the Preclinical Bioanalytics group at Targeted Genetics Corporation, evaluating the safety and efficacy of gene therapeutics.

Upon his return to academia, his research interests have stayed within the realm of preclinical biology. The focus of the Kelly lab is ex vivo modeling of human organ function and drug/toxin-induced injury. This research utilizes 3D-microfluidic “organs on chips” or microphysiological systems (MPS) as an alternative to animal testing. Recent work includes using MPS technologies to model how the kidney responds to the extreme environment of microgravity on the International Space Station.

Dr. Kelly holds the position of Associate Professor in the Department of Pharmaceutics, Adjunct Associate Professor in the Department of Environmental and Occupational Health Sciences and serves as Co-Director of the Pharmaceutical Bioengineering Extension Program.

I previously received Ph.D. degree at Texas A&M University under mentoring of Dr. Stephen Safe and studied about role of estrogen receptor-Sp1 transcription factor interactions in breast cancer. Currently, I am an assistant Professor in Department of Environmental and Public Health Sciences in College of Medicine at University of Cincinnati. My research has focused on the role of nuclear receptors and noncoding RNAs in liver injury, metabolism, and cancer.

Dr. Korzekwa is Professor of Pharmaceutical Sciences at Temple University School of Pharmacy. He received his Ph.D. in Medicinal Chemistry from the University of Washington and was a PRAT fellow, Staff Fellow, and Senior Staff Fellow at the NIH. Prior to joining Temple University, he has been an Associate Professor at the University of Pittsburgh, was involved in two startup companies, and was Director and Distinguished Senior Investigator at Merck. His research interests are developing predictive models for drug metabolism and pharmacokinetics.

Deanna Kroetz is Professor and Chair of Bioengineering and Therapeutic Sciences and the Jere E. Goyan Presidential Chair for the Advancement of Pharmacy in the School of Pharmacy at the University of California San Francisco. She received her B.S. degree in Pharmacy from Ohio State University and her Ph.D. in Pharmaceutics from the University of Washington, under the mentorship of Dr. René Levy. Dr. Kroetz was a PRAT Fellow in the Laboratory of Molecular Carcinogenesis at the National Cancer Institute under the mentorship of Dr. Frank Gonzalez before joining the faculty at the University of California San Francisco. She has received numerous awards, including the AAPS New Investigator Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism, the Josephine Failer Award from the Ohio State University Alumni Association, the Leon Goldberg Young Investigator Award from the American Society for Clinical Pharmacology and Therapeutics, fellow of the American Association of Pharmaceutical Scientists and the American Association for the Advancement of Science, and the Distinguished Alumna Award for Excellence in Pharmaceutical Sciences and Research from the University of Washington School of Pharmacy. Her research interests are focused on understanding the mechanisms underlying interindividual variation in drug response and toxicity. Current research efforts include clinical and functional genomics studies of chemotherapy-induced toxicity and structure-function studies of ABC transporters. Teaching responsibilities include pharmacokinetics to professional pharmacy students and drug metabolism and transport to graduate students in the Pharmaceutical Sciences and Pharmacogenomics graduate program. Dr. Kroetz served as the Director of the Pharmaceutical Sciences and Pharmacogenomics Graduate Program from 2010 – 2019. She is currently the Deputy Editor-in-Chief of Clinical and Translational Science.

Dr. Marina Li is an Associate Principal Scientist in the Global Bioanalytical group within the Preclinical Development department at Merck & Co. In this role, Marina focuses on the development of pharmacokinetic and immunogenicity assays for the quantitation of biotherapeutic drug candidates to support preclinical and clinical studies. Prior to joining Merck & Co in 2020, Dr. Li was a research investigator at Bristol Myers Squibb responsible for bioanalytical method development and validation. She received her PhD from the University of The Sciences in Philadelphia and completed her doctoral training at The Wistar Institute in the laboratory of Dr. Yulia Nefedova.

Dr. Lukacova is Chief Scientist at Simulations Plus, Inc. Over the last decade she has been contributing to the research in the area of mechanistic absorption and PBPK modeling and the development of GastroPlus®, DDDPlus™, and MembranePlus™ software packages widely used throughout the pharmaceutical industry in early drug development, formulation, pre-clinical, and clinical research. She also contributes to modeling studies helping companies with their drug development programs in the early discovery stage, formulation development, clinical pharmacology applications and interactions with regulatory agencies.

John has 25 years of clinical pharmacology and pharmacometrics experience in a variety of roles and leadership positions. He is currently the Vice President of PKPD, Quantitative Sciences at Metrum Research Group, an industry leader in pharmacometric analysis services. He has extensive experience applying pharmacometric methods to pharmacokinetic, pharmacodynamic, and outcome analyses, leading multidisciplinary drug development project teams, and interacting with regulatory agencies. His research has largely been focused in pediatric rare disease therapeutic areas. drug development, and finally to regulatory review, focusing on biologics and biosimilars currently.

Dr. Bridget Morse is currently a Director/Principal Research Scientist in the Drug Disposition department at Lilly Research Laboratories, which she joined in 2016. She received her Pharm.D. from Butler University in Indianapolis and her Ph.D. from the University at Buffalo, followed by a postdoctoral fellowship at the University of Western Ontario. At Lilly, she serves as a subject matter expert in pharmacokinetics, transporters, and drug-drug interactions, particularly in the use physiologically-based pharmacokinetic (PBPK) modeling for transporter substrates. She is actively involved in many committees in the transporter field, has published over 25 journal articles and a co-authors a recurring chapter on Membrane Drug Transporters in Foye’s Principles of Medicinal Chemistry.

Sibylle Neuhoff, PhD, Certara UK (Simcyp division) works in the translational science team as Senior Principal Scientist in the field of PBPK/PD modelling, oral drug absorption, transport, metabolism, and toxicity. After qualifying as a chemist (Frankfurt am Main, Germany), she received her PhD from the department of pharmacy at the Uppsala University (Sweden).

Sibylle is: supervising a team of scientists at Simcyp who extrapolate in vitro data to predict in vivo pharmacokinetics in humans and animals; helping to develop and implement models within the Simcyp Simulator, which link the processes of drug discovery and development using simulations in virtual patient populations; helping to develop and implement models within the SIVA tool kit for the transport module, which allows modelling of in vitro transport assay data to obtain for instance transporter kinetic data; involved in consultancy projects related to application of the Simcyp Simulator within the pharmaceutical industry. Sibylle has taught at more than 50 PBPK workshops on the Simcyp Simulator and SIVA (MIDD, Transporter, FIH, DDI, and Best Practice) and published more than 50 peer-reviewed journal articles.

K. Sandy Pang Ph.D. is Professor of Pharmacy and Pharmacology, Faculties of Pharmacy and Medicine at the University of Toronto. Dr. Pang received her Ph.D. (Pharmaceutical Chemistry) from UCSF and post-doctoral training as Fogarty International Fellow at the National Institutes of Health. Dr. Pang’s work spans the fields of pharmacokinetics, drug metabolism and transporters and their regulation. Her research involves both experimentation and theory. She uses mechanistic-based approaches to explain the handling of drugs and their metabolites within eliminating organs, namely the liver, the intestine, kidney and brain, upon examination of the relevant transport and metabolic processes and their integration into physiologically-based pharmacokinetic models (PBPK). Dr. Pang is noted for her work in hepatic drug clearance, metabolite kinetics, the intestinal segregated flow model and PBPK-PD modeling. Recent work focuses on the regulation of transporters and enzymes by the vitamin D receptor. Dr. Pang has published over 260 original articles, reviews, and chapters. She has served on various committees for NIH ASPET, AAPS, ISSX, and AAAS. She is the editor-in-chief of Biopharmaceutics and Drug Disposition and is a member of the editorial review boards of Drug Metabolism and Disposition, and Xenobiotica. She was the recipient of the NIH Research Career Development Award, the Faculty Development awards from the Medical Research Council of Canada, Nagai Foundation, the McNeil Award and the Pfizer Research Career Award from the Faculties of Pharmacies in Canada, the Research Achievement Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism from the American Association of Pharmaceutical Scientists (AAPS), the Gary Levy Lectureship, and the ISSX North American Scientific Life Achievement Award.

Kiran studied Chemical Engineering at the Indian Institute of Technology (Mumbai, India). He moved to the Technical University of Denmark (DTU) to work with Prof. Jens Nielsen and obtained his PhD in Systems Biology. Kiran was then appointed as Assistant Professor at DTU where he worked on transcriptional regulation and metabolic engineering. In 2010, Kiran joined the Structural and Computational Biology Unit at the European Molecular Biology Laboratory (EMBL-Heidelberg, Germany). He was appointed Director of Research at the MRC Toxicology Unit (University of Cambridge) in 2019.

Dr. Arthur Roberts is currently an associate professor within the College of Pharmacy (COP) at the University of Georgia (UGA). He graduated with a Bachelor of Science (B.S.) in Biochemistry at the University of New Mexico (UNM) in 1996, where he did undergraduate research developing inhibitors for aldose reductase, which plays a major role in diabetic complications. He did his Ph.D. graduate work at the Institute of Biological Chemistry, Washington State University in Pullman, WA. There he worked to unravel the bioenergetic mechanism of photosynthesis, and learned how to build and design instruments. In 2002, he graduated from WSU with a Ph.D. in Biochemistry. His research interests changed to the drug metabolism field in 2003 as a postdoctoral researcher at the University of Washington, Seattle with Dr. William M. Atkins. His background in photosynthesis provided him with a unique perspective of the drug metabolism field. During 2003-2008, he advanced NMR and computational approaches to study drug-cytochrome P450 interactions. Following his tenure at the University of Washington, he worked with Dr. Jim Halpert at the University of California San Diego (UCSD), who is now dean of the COP at the University of Connecticut. At UCSD, he continued to develop the NMR and the computer technology. After two and half very productive years, he joined the faculty of the University of Georgia as an assistant professor in 2011 and promoted to associate professor in 2017. His research is focused on a drug transporter that plays a major role in several major diseases including cancer, Alzheimer’s disease, and AIDS. His laboratory uses cutting-edge microscopy, computer technology, and nuclear magnetic resonance to study these transporters. Since his tenure at UGA, he has been recipient of both National Institute of Health (NIH) and American Heart Association grants totaling more than $2 million. In his career, he has published over 40 manuscripts in journals such as Biochemistry and the Journal of Biological Chemistry.

Dr. Sallam is an Associate Professor of Medicine and Physiology at the David Geffen School of Medicine at UCLA and a clinical cardiologist at Ronald Reagan UCLA Medical Center. He is a member of the Atherosclerosis Research Unit and Cardiovascular Theme Initiative at UCLA. Dr. Sallam graduated from the University of California, Irvine School of Medicine. He completed residency and chief residency training in Internal Medicine at Yale, followed by Cardiology fellowship training at UCLA. Dr. Sallam graduated from the STAR program at UCLA earning a PhD in Molecular, Cellular and Integrative Physiology. The Sallam Lab investigates the role of regulatory RNAs in cardiometabolic disease with a focus on the contributions of lncRNAs and epigentic/epitranscriptomic mechanisms in gene phenotype relationships. In 2015, Dr. Sallam was named the Lauren B. Leichtman and Arthur E. Levine Cardiovascular Discovery Fund Investigator at UCLA. Dr. Sallam is the recipient of an NIH K Award, American College of Cardiology Presidential Career Development Award, American Heart Association Early Career Investigator recognition, and American Society for Clinical Investigation Young Investigator Award. Dr. Sallam currently serves as co-director of the UCLA center for Cholesterol Management and Associate Director of the UCLA Specialty Training and Advanced Research (STAR) Program. The Sallam Lab is currently funded by multiple NIH R01 grants and American Heart Association Transformational Project Award.

Hiroyuki Sayama Ph.D

Systems Pharmacology, Non-Clinical Biomedical Science, Astellas Pharma Inc. 2003 B.S., School of Agriculture and Animal Science, Obihiro University of Agriculture and Veterinary Medicine. 2003-2015 Drug Metabolism & Pharmacokinetics Research Labs., JAPAN TOBACCO INC. 2015-2017 Translational Science Research Labs., Astellas Pharma Inc. 2017-2022 Analysis & Pharmacokinetics Research Labs., Astellas Pharma Inc. 2022-present Non-Clinical Biomedical Science, Astellas Pharma Inc. 2014 Ph.D., Faculty of Pharmaceutical Sciences, Kindai University.

Dr. Emily Scott became fascinated with heme proteins scuba diving for undergraduate field research on brittle star hemoglobin. This led to studies of myoglobin structure and function for a Ph.D. from Rice University and cytochrome P450 enzymes as a postdoctoral fellow at the University of Texas Medical Branch. Previously at the University of Kansas and now at the University of Michigan, Dr. Scott’s research focus has been the structure/function relationships of human cytochrome P450 enzymes. The Scott lab uses structural biology and biochemical techniques to understand drug metabolism and how to target specific P450 enzymes in disease pathways. Her laboratory is perhaps best known for X-ray structures of human P450 enzymes involved in xenobiotic metabolism and steroidogenesis, most of which were the first known. Dr. Scott’s research has been continuously funded by the National Institutes of Health since 2004 and received a MERIT award in 2015. Notable awards include the ISSX North American New Investigator Award and the Early Career Achievement Award from the Drug Metabolism Division of The American Society of Pharmacology and Experimental Therapeutics. She is a Fellow of the American Associate for the Advancement of Science and the F. F. Blicke Collegiate Professor of Pharmacy.

Dr. Jasleen K. Sodhi received her undergraduate degree from the University of California Berkeley, then spent 9 years in the pharmaceutical industry, primarily at Genentech in the Drug Metabolism and Pharmacokinetics (DMPK) department where she ran the suite of in vitro ADME assays and experimentally investigated in vitro to in vivo extrapolation (IVIVE) disconnects. Jasleen then received her Ph.D. from the University of California San Francisco under the mentorship of Dr. Leslie Benet, where she focused on identifying transporter involvement in complex drug-drug interactions, and on improving the IVIVE of hepatic clearance from a theoretical perspective. She has published more than 30 peer-reviewed articles or book chapters spanning topics such as IVIVE, methodologies to interpret complex drug-drug interactions, and the novel finding that aldehyde oxidase can mediate amide-hydrolysis reactions. After leading the DMPK and Nonclinical Formulations groups at Plexxikon, Jasleen has very recently joined Septerna where she now leads the DMPK efforts.

Douglas K. Spracklin is the Director of the Biotransformation & Environmental Sciences group within Medicine Design PDM at Pfizer. He received his Ph.D. degree in Chemistry from the University of British Columbia and carried out postdoctoral research at the University of Washington. He spent two years at Abbott Laboratories before joining the Neuroscience Drug Metabolism group at Pfizer. In that role, he supported programs spanning early discovery through clinical development for almost 10 years before assuming his current position.

Tore B. Stage (born 1987) is an Associate Professor at Clinical Pharmacology and Pharmacy, University of Southern Denmark. He received his PhD in clinical pharmacology at University of Southern Denmark in 2015 and did his postdoc at University of California, San Francisco in Deanna L. Kroetz’ laboratory. He leads a group in translational pharmacology that combines mechanistic in vitro studies with clinical studies and register-based studies to ensure patient-relevant translation. The main research areas of the group are chemotherapy-induced peripheral neuropathy, drug-drug interactions and type 2 diabetes pharmacology.

Dr. Sun is the Therapeutic Biologics Program (TBP) biologics lead in the Office of Clinical Pharmacology (OCP), CDER, FDA. Her key job functions include guide and support reviews and policy development for new molecular entity (NME) biologics or biosimilar products. In addition, Qin is PI or co-PI for biologics related research projects. Qin joined FDA in 2016. Before that, she worked at Pharmaceutical Product Development (PPD) from 2015 to 2016, and at Bristol-Myers Squibb from 2008 to 2014. Qin received her PhD from University of Virginia. Her work experience extends from drug discovery to drug development, and finally to regulatory review, focusing on biologics and biosimilars currently.

Nessy Tania is a Principal Quantitative Systems Pharmacologist at Pfizer. Prior to transitioning to industry and joining Pfizer, she was an Associate Professor in the Department of Mathematics and Statistics at Smith College. She was trained as a math biologist: she obtained her Ph.D. in Mathematics at the University of Utah followed by a postdoctoral fellowship at the University of British Columbia. Since joining Pfizer in 2019, she has developed and utilized QSP models to support clinical development of programs in the Rare Disease Research Unit.

Dr. van Groen is a DMPK/PD project leader at Roche Pharmaceutical Research and Early Development in Basel, Switzerland. She conducted her Ph.D. at the Erasmus MC – Sophia Children’s Hospital, where she was the coordinating scientist for a pediatric microtracer study on the intensive care unit. With this experience and her current position at Roche, she is interested in the application of microdosing/microtracing studies for drug development in vulnerable populations.

Manthena Varma, PhD is Research Fellow, at Pfizer Inc. Dr. Varma received his B. Pharm. degree from the Kakatiya University, Warangal, India; and an M.S. degree and PhD in Pharmaceutics, from the National Institute of Pharmaceutical Education and research (NIPER), Mohali, India. Later, Dr. Varma worked as a Post Doctoral Fellow at the Department of Pharmaceutics, University of Minnesota (Minneapolis). In 2008, he joined Worldwide R&D, Pfizer, Groton, CT. Dr. Dr. Varma’s research is focused in the fields of ADME/PK technologies and strategies in drug design and development, role of drug transporters and transporter-enzyme interplay (extended clearance) in ADME/PK, clinical pharmacokinetics and DDI predictions/evaluation via mechanistic (PBPK) modeling. Varma supported preclinical and clinical development of several Pfizer compounds in the oncology, metabolic diseases, and more recently in NASH/NAFLD therapeutic areas. He published about 135 original articles/reviews and presented over 75 presentations at the scientific conferences in these areas.

Dr. Wang obtained her BS in Biochemistry from Peking University and PhD in Pharmaceutical Chemistry from the University of California, San Francisco. She is currently Professor of Pharmaceutics in the School of Pharmacy, University Washington and an affiliate member of the Fred Hutchinson Cancer Research Center. Dr. Wang’s research has been focused on understanding membrane transporters and their roles in drug disposition, response and drug-drug interactions, with a special focus on organic cation and monoamine transporters. Dr. Wang is on the editorial advisory boards of Molecular Pharmacology, Drug Metabolism and Disposition, and Biopharmaceutics and Drug Disposition. She is currently the Chair for the Drug Metabolism and Disposition Division and also serves on the program committee at the American Society of Pharmacology and Experimental Therapeutics (ASPET).

Dr. David Waxman is Professor of Biology, Medicine and Biomedical Engineering at Boston University. He received his PhD in Biochemistry and Molecular Biology from Harvard University and postdoctoral training in enzymology in the Department of Chemistry at MIT. He is an active member of many journal editorial boards, and is a frequent speaker at major symposia in the fields of drug metabolism, molecular endocrinology, and cancer pharmacology. He has made seminal contributions to our understanding of hepatic cytochrome P450 enzymes, their role in drug metabolism and cancer therapeutics, nuclear receptor-based mechanisms of responsiveness to environmental chemicals, and to the role of growth hormone in regulating sex differences in liver genomics and epigenetics. Dr. Waxman has been recognized as a 20 Year Highly Cited Researcher in Pharmacology and Toxicology by Thomson-Institute for Scientific Information, and in 2018 was awarded the Bernard B. Brodie Award in Drug Metabolism, a Scientific Achievement Award by the American Society for Pharmacology & Experimental Therapeutics (ASPET).

Aaron Wright is the James R. Schofield Endowed Chair in Biomedical Sciences in the Department of Biology at Baylor University. Dr. Wright’s research program focuses on interdisciplinary studies on the biomolecular functions of microbiomes and integrates microbiology, systems biology, chemical biology, and functional omics. His research group is active in the following areas: (1) identifying and validating the mechanisms driving microbial functions, interactions and spatial dynamics, and response to perturbation in microbiomes; (2) revealing the biochemical mechanisms for xenobiotic and drug metabolism in microbiomes; and (3) developing novel chemical biology, systems biology and omics methodologies to enable discoveries in biology at the molecular scale and with functional resolution.

Dr. Graeme Young has been employed in departments of Drug Metabolism in GSK for over 30 years. Graeme has acted as a "champion" of Accelerator Mass Spectrometry (AMS) for many years, with responsibility for bringing the AMS in-house to GSK and applying it to clinical and non-clinical projects at all stages of development. Graeme has been lead author or contributing author to many groundbreaking papers published on the subject of AMS and its application to Drug Metabolism and Bioanalysis. He was Chair of the Global Bioanalysis Consortium team on AMS, bringing together leaders in the field to help establish harmonized approaches to clinical study support using this enabling technology and continues to have broader interests in accelerating translational drug development through application of novel strategies.

Dr. Haoming Zhang is Associate Professor in Department of Pharmacology at the University of Michigan Medical School. He received his PhD in Biophysical Chemistry from the Australian National University under the mentorship of Drs. Thomas Wydrzynski and Barry Osmond. He completed his postdoctoral training on a fellowship from the National Science and Engineering Research Council of Canada (NSERC) in the laboratory of Dr. Grant Mauk at the University of British Columbia, Canada. He then joined the faculty at the University of Michigan and worked on drug metabolism by cytochrome P450 enzymes. He has published over 60 peer-reviewed articles on the structure, function, and dynamics of cytochrome P450 enzymes including use of electron microscopy to study P450 enzymes.

Prof. Lirong Zhang present executive Vice-Dean of the Academy of Medical Sciences of Zhengzhou University, board member of Chinese Pharmacological Society, Vice Chairman of Pharmacological Society of Henan Province. Prof. Zhang earned her Ph.D in Pharmacology at Fudan University. She was a Visiting Scholar in Pharmacology Department of the Medical Centre in University of Kansas. Her research involves drug metabolism, pharmacogenetics and epigenetic pharmacology, and has made pioneering achievements in the fields of precision medicine, in particularly. She recently revealed the mechanism of individual differences in drug response at the molecular and genetic level by using a “pharmacogenomics” principle, which represents the current “hot-spot” in this scientific field internationally. Now she is among the leading scientists exploring the innovative ideas and methods for individualized drug therapy and precision medicine.

Xinyuan (Susie) Zhang, Ph.D., is a Director of Quantitative Clinical Pharmacology at Daiichi Sankyo, Inc. (DSI). Prior to joining DSI, she was a PBPK co-lead in the Division of Pharmacometrics (DPM)/ Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences (OTS) / Center for Drug Evaluation and Research (CDER)/FDA where she provided scientific oversight for PBPK review and research activities in OCP. Dr. Zhang conducted clinical pharmacology reviews for numerous INDs and NDAs and participated in several clinical pharmacology related guidance development during her tenure in OCP. Prior to joining OCP, Dr. Zhang was a scientific lead for absorption modeling in the Office of Generic Drugs (OGD) / CDER where she focused on applying PBPK absorption modeling and simulation to address scientific issues in generic drug product review and guidance development. She received her Ph.D. from the University of Michigan, Ann Arbor.