Speakers

Ryuta Asaumi initiated his career focusing on non-clinical pharmacokinetics research and subsequently expanded his scope to modeling and simulation, particularly in the field of physiologically based pharmacokinetic (PBPK) modeling. With over a decade of expertise in PBPK modeling, his efforts are primarily aimed at enhancing the predictive accuracy of drug-drug interaction (DDI) and deepening insights into the pharmacokinetics in special populations, especially in patients with hepatic impairment. In the area of DDI predictions, he has published papers utilizing a PBPK model of rifampicin, a typical perpetrator drug, to predict its induction effects on CYP isoforms, as well as its inductive and inhibitory effects on transporters such as OATP1B and P-gp. Leveraging this experience, he is currently focused on Model-Informed Drug Development (MIDD) for candidate compounds, acquiring a wide range of knowledge and skills from preclinical research through to clinical trials and the process of regulatory submission.

Ryuta Asaumi earned his B.S. in Pharmaceutical Sciences in 2005 and his M.S. in Pharmaceutical Sciences in 2007 at Tohoku University. He then received his Ph.D. in Pharmaceutical Sciences at the University of Tokyo in 2023.

Ryuta Asaumi started his career in the Pharmacokinetic Research Laboratories at Ono Pharmaceutical Co., Ltd. from 2007 - 2022. He then moved to the Clinical Pharmacology & Exploratory Development at Astellas Pharma Inc. from 2022-2023 and is now working in New Technologies in Early Development at Astellas Pharma Inc.

Jonathan Bauman is currently a Principal Scientist and biotransformation team leader in the Pharmacokinetics, Dynamics and Metabolism department at Pfizer, Groton, CT. He earned his B.S. in Pharmacology and Toxicology from the University of Wisconsin School of Pharmacy in 1991. Prior to Pfizer, Jon worked in DMPK groups at G. D. Searle & Co. & Parke-Davis. During his career, Jon has specialized in pharmacokinetics, enzyme kinetics and enzymology. Most recently his career focus has been on drug metabolism including biotransformation, structure elucidation, bioactivation of small molecules and championing the use AMS microtracer strategies for human ADME studies. Jon has contributed to 35+ external publication and presentations and has been a member of the International Society for the Study of Xenobiotics (ISSX) since 1993.

Dr. Bi is a tenure-tracked professor and the Dean of School of Pharmaceutical Sciences at Southern Medical University. She obtained her Ph.D. degree in Pharmacology at Sun Yat-sen University and did postdoctoral training with Dr. Frank J Gonzales in the National Cancer Institute of National Institutes of Health (NIH). Till now, she has attracted 20 grants as project PI, published over 150 papers and 12 book chapters, and has served as the primary mentor for almost 60 graduate students and postdoctoral fellows. Dr. Bi has been invited to serve as a board member of various pharmaceutical societies, on the editorial board of scientific journals, and as reviewer for scientific journals. Since 2013, she has been invited to present her research findings at about 100 national and international conferences or departmental seminars.

In 2018, the International Society for the Study of Xenobiotics (ISSX) awarded her the ISSX Asia Pacific New Investigator Award. At the 2021 ASPET Annual Meeting, Dr. Bi was awarded the Richard Okita Early Career Award in Drug Metabolism and Disposition in recognition of her research excellence and contributions to the DMPK field.

Dr. Jayaprakasam (Prakash) Bolleddula is a Clinical Pharmacology Expert Team Lead (CPET) at EMD Serono, Billerica, MA. Dr. Bolleddula is an experienced scientific leader with 20+ years of experience at the intersection of drug metabolism, drug-drug interactions, PBPK modeling, and clinical pharmacology. Before joining EMD Serono, Dr. Bolleddula led drug metabolism groups at Agios Pharmaceuticals, Takeda-Boston, and Theravance Biopharma. He has published over 50 peer-reviewed research articles and is also a co-inventor of numerous patents. Dr. Bolleddula obtained Ph.D. in organic chemistry from Sri Venkateswara University, Tirupati, India, and completed a postdoctoral fellowship at Michigan State University and held Junior faculty position at Mount Sinai School of Medicine.

Dr. Fabio Broccatelli received his PhD in computational chemistry from the University of Perugia. During his PhD and PostDoc at University of Perugia, UCSF and Institute of Cancer Research London, he focused on ML predictions of ADME properties, virtual screening and in vitro to in vivo PK correlations. Previously Dr. Broccatelli built the Computational ADME team within the DMPK department at Genentech, and supported the BMS Oncogenesis portfolio by leading the San Diego pre-clinical DMPK group. Dr. Broccatelli currently heads the DMPK and the Computational Chemistry groups at Altos Labs. His main areas of focus include ML/AI, PBPK, PKPD and IVIVc across multiple modalities. Dr. Broccatelli has published over 35 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.

Kim Brouwer, PharmD, PhD, is a Kenan Distinguished Professor in the School of Pharmacy and Curriculum in Toxicology at the University of North Carolina at Chapel Hill, and Associate Dean for Research and Graduate Education, UNC Eshelman School of Pharmacy. She received her BS in Pharmacy from Oregon State University, and completed a PharmD/Residency, PhD in Pharmaceutical Sciences/Pharmacokinetics, and postdoctoral fellowship in Pharmacology at the University of Kentucky prior to joining the UNC faculty. Her research program, supported by NIH since 1991, focuses on hepatobiliary drug disposition, hepatic transport proteins, and novel approaches to predict drug disposition, drug-transporter interactions, and hepatotoxicity. She has dedicated her career to fostering the development of future generations of clinical and translational pharmacologists. Dr. Brouwer was the founding Director of the UNC Pharmacokinetics/Pharmacodynamics Fellowship Program, and is Co-PI of NIH-funded Postdoctoral T32 Training Programs in Adult and Pediatric Clinical Pharmacology. She has served as major advisor for 35 PhD students, mentored more than 70 clinical pharmacology fellows and postdoctoral scholars, and authored more than 270 publications. Dr. Brouwer is co-inventor of B-CLEAR® technology and a company co-founder. She is a member of the International Transporter Consortium Steering Committee, and has served as a member of the ASCPT Board of Directors and the NIH Pharmacology Study Section. She is an AAPS Fellow and has received many prestigious awards for her outstanding contributions as a leading academic researcher including the PhRMA Foundation Award in Excellence in Pharmaceutics, the ASCPT-FDA Abrams Award, UNC Inventor of the Year, the AACP Volwiler Research Achievement Award, an honorary doctorate from the University of Eastern Finland, the ACCP Distinguished Investigator Award, and the 2024 ASCPT Rawls-Palmer Progress in Medicine Award.

Dr. Nadja B. Cech is Patricia A. Sullivan Professor of Chemistry at the University of North Carolina Greensboro. She supervises a dynamic research group engaged in developing novel mass spectrometry metabolomics approaches to solve challenging problems in natural products research. Dr. Cech is the recipient of the Jack L. Beal Award from the Journal of Natural Products and the Board of Governors Teaching Excellence Award from the University of North Carolina System. She is Principal Investigator for the NCCIH- and ODS funded Center for High Content Functional Annotation of Natural Products and Co-Director of the Analytical Core for the Center of Excellence for Natural Product Drug Interactions.

Dapeng is the Senior Director of DMPK at Kymera Therapeutics. In this position, Dapeng functions as a DMPK project representative in supporting lead optimization and advancing targeted protein degraders to safety studies, IND filing, and clinical development. Dapeng earned a Ph.D. from Lab for Cancer Research at School of Pharmacy, Rutgers University. He has 18 years industrial experience with discovery and development projects across multiple therapeutic areas including oncology, CNS, and inflammation and immunology. Dapeng’s core expertise includes human PK and dose predictions, DDI risk assessment, and PBPK modeling. He has held roles of increasing responsibilities at Merck Research Laboratories, KSQ Therapeutics, and now at Kymera.

Dr. Lei Ci is an associate scientific director at Moderna Therapeutics. She has 15 years of experience in drug discovery and development. She received her PhD from Dr. Sugiyama Yuichi’s lab at the University of Tokyo. After graduation, Dr. Ci worked at biotech companies leading the efforts in ADME and DMPK to support drug discovery. In her current role, she is leading DMPK and clinical pharmacology efforts for multiple high-impact projects in Moderna’s mRNA pipeline. She has actively participated in academic and regulatory consortia as well as professional societies. She recently published papers evaluating ADME, PK, and biodistribution of Lipid Nanoparticles (LNPs).

Xinxin Ding, Ph.D. currently serves at the University of Arizona’s R. Ken Coit School of Pharmacy as a Professor and Department Head of Pharmacology and Toxicology. He is also an Editor-in-Chief for the Dug Metabolism and Disposition and is engaged as a Fellow at the American Society for Pharmacology and Experimental Therapeutics.

Katherine Donovan holds the position of Lead Scientist and Managing Director at Fischer labs within the Dana-Farber Cancer Institute/Harvard Medical School. Her expertise lies in advancing the development of molecular glues and PROTAC molecules aimed at the targeted degradation of proteins. Her doctoral research was conducted under Prof. Renwick Dobson at the University of Canterbury, New Zealand, with a focus on protein biochemistry and structural biology. Katherine’s postdoctoral work began in 2016 in Prof. Eric Fischer’s lab, where she cultivated a keen interest in proteomics – a technique she uses to measure protein expression changes in response to various stimuli. She established and directed proteomics groups within both Fischer Lab and the Center for Protein Degradation, specializing in degrader screening and target identification. Her work has been pivotal in detecting the degradation targets of several molecules, notably uncovering SALL4 as the potential key to thalidomide’s teratogenic effects. Katherine has co-headed extensive projects to delineate the degradable kinome and HDACome, and has launched a public degradation proteomics initiative to offer complimentary degrader target mapping. Her notable contributions to targeted protein degradation (TPD) research were honored with the Arvinas TPD Early Career Researcher Award in 2022. Presently, she supervises and actively contributes to various projects in ligase biology and protein degradation while overseeing the TPD proteomics operations under the Chemical Biology Program.

Angela Doran, B.S., is a Senior Principal Scientist within Pharmacokinetics, Dynamics and Metabolism at Pfizer in Groton, Connecticut. She received her B.S. degree in Biology/Chemistry from Elmira College in Elmira, NY. She has over 30 years of experience with the Pfizer ADME group supporting early drug discovery and development programs in the Neuroscience, Oncology and Anti-infective portfolios. Over the years her research interests have evolved from early drug discovery experimental and laboratory support of in areas of small molecule drug metabolism, cytochrome P450 reaction phenotyping, enzyme kinetics, CNS tissue distribution, pharmacokinetics and drug disposition. More recently, she has transitioned to supporting late-stage ADME drug development for the Anti-infective Research Unit as a project representative for the development portfolio.

Muluneh Fashe, Ph., is a Research Assistant Professor at the Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina. Dr. Fashe completed his doctorate in Toxicology in 2016 at the University of Eastern Finland, where his research focused on the bioactivation of hepatotoxic pyrrolizidine alkaloids. After graduation, Dr. Fashe joined Dr. Negishi's Pharmacogenetics laboratory at the National Institute of Environmental Health Sciences, where he studied the regulation of drug-metabolizing enzymes. Since 2020, Dr Fashe has been studying mechanisms of altered drug metabolism and transport in pregnancy. Currently, his research focuses on understanding the extent and molecular mechanisms by which diabetes impacts (1) the functions of hepatic xenobiotic nuclear receptors that regulate transcription of maternal hepatic drug-metabolizing enzymes (DMEs) and (2) metabolism and clearance of pregnancy-relevant therapeutic drugs in obstetric patients.

In 2008, Tatsuki Fukami received his Ph.D. from Kanazawa University and later became and Assistant Professor with the Faculty of Pharmaceutical Sciences at Kanazawa University. Starting in 2015, he now serves as an Associate Professor with the Faculty of Pharmaceutical Sciences. In 2016, Tatsuki Fukami also volunteered his time at the National Cancer Institute, National Institute of Health.

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 is currently President of ISSX, in addition to her service on the ISSX Council. 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. Dr Galetin had her 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 (https://research.manchester.ac.uk/en/persons/aleksandra.galetin)

Speaker bio coming soon.

Dr. Kenta Haraya, a head of biologics DMPK in discovery biologics department in Chugai, has 15+ years of experience in biologics DMPK research with 30+ research article publications and 10+ patents. He joined in Chugai in 2008 and has been responsible for DMPK research of biologics project in discovery and preclinical development until now. From 2013 to 2017, He worked in Chugai Pharmabody Research in Singapore to promote several antibody projects utilizing antibody engineering technologies such as recycling antibody, sweeping antibody.

Niresh Hariparsad, PhD is a Senior Director and currently functions as the Site Head of Oncology DMPK at AstraZeneca, based in Boston, MA. Prior to joining AstraZeneca, Niresh has held various leadership roles at Merck and Vertex Pharmaceuticals where he was he was part of the team that discovered INAXAPLIN. Overall, Niresh has contributed to the discovery and development of compounds in several disease areas including oncology, multiple sclerosis, hepatitis-C, HIV and cystic fibrosis. Niresh has chaired and currently chairs various initiatives related to drug-drug interactions via Innovation and Quality (IQ) working groups and has been involved in several discussions with regulatory agencies on this topic. In addition, Niresh has also been part of various cross industry initiatives related to drug transporters and novel tools for ADME. Niresh is actively involved in speaking engagements at national and international scientific meetings and has published over 30 peer reviewed research articles. Niresh’s research interests include the use of novel approaches to enhance the prediction of human PK and drug-drug interaction risk for compounds advancing to the clinic.

Hideki Hirabayashi worked at Fujisawa Pharm. Co. Ltd./Astellas Pharma Inc. for 11 year to then join Takeda in 2006. He served as the Director of Global DMPK Res Lab with Takeda from 2017 - 2021 and then moved up to Senior Director and the Japan Site Head for the Global DMPK and Modeling Res Lab in Takeda Pharm Co.

Speaker bio coming soon.

Katsuhisa Inoue has been a Professor of Tokyo University of Pharmacy and Life Sciences since 2013. After receiving his Ph.D. degree in 1998 from Kumamoto University, he worked at Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Nagoya City University as a Research Assistant (-2001), an Assistant Professor (-2007), and an Associate Professor (-2013). During 2001 to 2003, he joined Dr. Vadivel Ganapathy’s research group at Medical College of Georgia as a postdoctoral fellow. His research is focused on the molecular mechanism of membrane transport of xenobiotics and endogenous compounds.

Seiichi Ishida has been Professor of Division of Applied Life Science, Graduate School of Engineering, Sojo University, and Guest Researcher of Biological Safety Research Centre at National Institute of Health Sciences since 2020. He received his PhD in Pharmaceutical Science from the University of Tokyo, Japan in 1993, and conducted postdoctoral studies at The Cancer Institute (Tokyo) and at Howard Hughes Medical Institute at Duke University Medical Centre. He used to be Senior Researcher (2000-2007) and Section Chief (2007-2020) of Division of Pharmacology at National Institute of Health Sciences. His research focuses primarily on the development of in vitro cell assay platform including MPS (microphysiological systems) for the evaluation of drug metabolism and drug induced liver injury and their application to the regulatory science field.

Dr. Akihiro Ishiguro, PhD is a Review Director of the Office of New Dru III, Pharmaceuticals and Medical Devices Agency (PMDA). His professional experience includes new drug review, review planning/management and post marketing drug safety. He had the opportunity to join projects to develop regulatory guidelines in the field of Clinical Pharmacology such as the MHLW guidelines (e.g., Drug Interaction, Population Pharmacokinetics, Exposure Response Analysis) and the ICH guidelines (e.g., Qualification of Genomic Biomarkers, Genomic Sampling). At the ICH M12 (Drug Interaction Studies) expert working group, he served as a regulatory chair. Currently he is also working as a leader in the field of Pharmacokinetics in Offices of Drug Review, PMDA; a leader of Omics working group, Project across multi-offices in PMDA.

Speaker bio and headshot coming soon.

Amit Kalgutkar is a Senior Research Fellow in the Medicine Design Group in Pfizer. He received his Ph.D. degree in Chemistry from Virginia Tech, and carried out postdoctoral research in Biochemistry, Vanderbilt University, before joining Pfizer. He has published over 190 peer-reviewed papers, reviews, and book chapters and holds multiple patents in the areas of medicinal chemistry and drug metabolism. He is currently on the editorial boards of Drug Metabolism and Disposition and Xenobiotica and has served two terms on the editorial board of Chemical Research in Toxicology.

Dr. Yukio Kato graduated from the University of Tokyo in 1990 and received a Ph.D. in 1998. He was appointed Research Associate at the University of Tokyo in 1993, Visiting Fellow at the National Institutes of Health, the USA in 2001, Associate Professor at Kanazawa University in 2002, and Full Professor at Kanazawa University in 2008 (Department of Molecular Pharmacotherapeutics). He has also been assigned as a Dean of the Faculty of Pharmacy, Kanazawa University in 2022 and President of JSSX (The Japanese Society for the Study of Xenobiotics) in 2023. His major research interests are pharmacokinetics and mathematical modeling of drug disposition, transporter-mediated drug efficacy/toxicity, and prophylactic pharmacology focusing on neurogenesis and brain cognitive function. He published 214 original research articles including 6 Nature journal series papers and 20 review articles.

Yuki Kishino is currently a Senior Director of DMPK research laboratories at Daiichi Sankyo (Tokyo, Japan). She has over 20 years of experience in the pharmaceutical industry, approximately 15 years dedicated to toxicological research for new drug candidates, and further focused on bioanalytical research involving various modalities for 5 years or more. She received her B.S. and M.S. in Graduate School of Pharmaceutical Sciences & Faculty of Pharmaceutical Science, Tohoku University (Miyagi, Japan), and Ph.D. in School of Pharmaceutical Science, University of Shizuoka.

Dr. Yichun Kuo (Carol) received her B.Sc. in Clinical Laboratory and Biotechnology (2008) at Chung Shan Medical University and preceded on to earn her M.Sc. in Biophotonics Engineering (2009) at the National Yang-Ming University. She then went on to earn her Ph.D. in Clinical medicine and Bioengineering in 2013 at the National Yang-Ming University and University of California.

Dr. Kuo developed novel methods for tracking drug distribution in the body, measuring volume of distribution, elucidating the mechanisms of drug accumulation in specific tissues and cells, identifying factors affecting drug targeting and clearance to help inform go/no go decision and de-risking. She currently works as a Senior Scientist at Takeda Pharmaceutical. She previously worked as an Antisense Drug Discovery researcher at Ionis pharmaceuticals where she developed a workflow to screen for the best receptor-mediate ligand conjugated antisense oligonucleotides which allow the ASO to go beyond the liver to the traditional undruggable tissues e.g. cardiovascular, etc. She investigated PK/PD relationship, biodistribution and cellular uptake of antisense oligonucleotides and conjugates in vitro and in vivo.

Dr. Kuo’s research focus includes oligonucleotides therapeutics and cell therapy, biodistribution of therapeutic agents, drug delivery systems and targeting strategies, pharmacokinetics and pharmacodynamics (PK/PD), and imaging techniques for drug distribution assessment (e.g., confocal microscopy, MALDI, light sheet microscopy for 3D imaging, Raman spectroscopy, SPR imaging).

Dr. Kuo also spends her time affiliated with American Heart Association and TIDES: oligonucleotide and peptide therapeutics.

Publications:

Kuo YC, Nikan M, Yeh ST, Chappell AE, Tanowitz M, Seth PP. Prakash TP*, Mullick AE*. 2022. Targeted Delivery of Antisense Oligonucleotides Via Angiotensin Type 1 Receptor. Nucleic Acid Therapeutics.

Kuo YC, Chang TH, Hsu WT, Zhou J, Lee HH, Ho JH*, Lee OK*, Chien S*. 2015 Feb. Oscillatory Shear Stress Mediates Directional Reorganization of Actin Cytoskeleton and Alters Differentiation Propensity of Mesenchymal Stem Cells. Stem Cells. 33(2):429-42.

Kuo YC, Ho JH, Yen TJ, Chen CF, Lee OK*. July 2011. Development of a Surface Plasmon Resonance Biosensor for Real-Time Detection of Osteogenic Differentiation in Live Mesenchymal Stem Cells. PLoS ONE 6(7): e22382.

Speaker bio coming soon.

Dr. Maeda is currently a professor in the Laboratory of Pharmaceutics in School of Pharmacy, Kitasato University (2021-). He received his B.S. in the University of Tokyo in 1999 and obtained M.S. degree from the Graduate School of Pharmaceutical Sciences, the Univ. of Tokyo in 2001. He was promoted to an assist. prof. in 2002 in the middle of the Ph.D. course (Lab. of Molecular Pharmacokinetics) and he continued to work in the same lab. as an assist. prof. (2002-2012) and assoc. prof. (2012-2021). He received Ph.D. degree from the Univ. of Tokyo in 2006. His research is mainly focused on the prediction of in vivo pharmacokinetics of drugs from in vitro data with the use of human-derived tissue samples and mathematical modeling approach.

John Miners holds BSc, MSc, PhD and DSc degrees. He is a Fellow of the Australian Academy of Science, a Fellow of the Australian Academy of Health and Medical Sciences, and an Honorary Fellow of the Royal Society of New Zealand. He is currently a Matthew Flinders Distinguished Emeritus Professor in the Flinders University College of Medicine and Public Health (Adelaide, Australia), having previously served as Professor and Head of the Department of Clinical Pharmacology of Flinders University and Flinders Medical Centre. John’s broad research interest is drug and chemical metabolism in humans, particularly sources of variability in drug elimination and its pharmacokinetic and therapeutic consequences. Specific interests include: (i) in vitro – in vivo extrapolation; (ii) drug-drug interactions; (iii) structure-function relationships of human UDP-glucuronosyltransferases and cytochromes P450; and (iv) computational modelling. He has published over 300 research papers, reviews and book chapters in these and related fields, and has an h-index (Google Scholar) of 87. He has been a member of the Editorial Boards of ten international journals that include Drug Metabolism and Disposition (Associate Editor), Drug Metabolism Reviews, Drug Metabolism and Pharmacokinetics (Associate Editor), and the British Journal of Clinical Pharmacology (Executive Editorial Board). John has been a member of ISSX for over 35 years and has served the Society in numerous positions and roles during this time, including: Councillor; Secretary; Convenor of the Scientific Affairs Committee; President-elect; and President. He was also Chair of the Organising Committee for the 5th International ISSX Meeting (Cairns, Australia - 1998). Additionally, John has held Officer positions in several other international and national organisations, including: President of the Asia Pacific Federation of Pharmacologists; President of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists; and member of the Executive Committee of the International Union of Basic and Clinical Pharmacology.

Speaker bio and headshot coming soon.

Tadahaya Mizuno specializes in bioinformatics and cheminformatics. Tadahaya, born in Kanagawa in 1987, graduated from The University of Tokyo in 2009, earned his Ph.D. in Pharmaceutical Sciences from the Graduate School of the University of Tokyo in 2014, and currently serves as an assistant professor in laboratory of molecular pharmacokinetics (Prof. Kusuhara’s Lab). His research theme is the recognition of unknown aspects of drugs by numerization and pattern recognition of all events related to drugs, armed with latent variable models and representation learning. Tadahaya likes beer, soccer, HR/HM music, and spends his free time with his wife to reinforce learning for their beloved son and daughter.

Speaker bio coming soon.

Dr. Sumio Ohtsuki is currently the Professor of Kumamoto University. He received B.S. degree in Pharmaceutical Sciences from University of Tokyo in 1991 and Ph.D. degree in Life Pharmaceutical Sciences from University of Tokyo in 1996. He completed a Postdoctoral training in Molecular Genetics and Developmental Biology research at University of California at San Diego and at Berkeley from 1996 to 1999. He was appointed Assistant Professor of Tohoku University in 2000, Associate Professor of Tohoku University in 2003, and Professor of Kumamoto University in 2012. Dr. Ohtsuki received three International Awards; New Investigator Award in Asian Pacific Region from International Society for the Study of Xenobiotics (ISSX) in 2008, Meritorious Manuscript Award from American Association of Pharmaceutical Scientists (AAPS) in 2010, and Ebert Prize from American Pharmacists Association (APhA) in 2020. His major research interests are patho-physiology and molecular biology of brain barrier and quantitative proteomics of membrane proteins. He published in journals with 198 original research articles and 21 review articles and contributed chapters to books.

Hiromi Okamoto is currently a Researcher of DMPK research laboratories at Daiichi Sankyo (Tokyo, Japan). She has over 10 years of experience in the pharmaceutical industry, focusing on bioanalytical research in ADME field through preclinical and clinical stages for diverse therapeutic areas including small and large molecules, and new modalities, especially antibody-drug conjugate. She received her B.S. and M.S. in the faculty of Science from Kobe University (Kobe, Japan).

Speaker bio and headshot coming soon.

Mary F. Paine, RPh, PhD is a professor in the Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University. She earned her BS in pharmacy at Oregon State University and PhD in pharmaceutics at the University of Washington, then completed a post-doctoral fellowship in clinical pharmacology at the University of Michigan. She has >25 years of experience using translational research approaches to evaluate the clinical relevance of pharmacokinetic xenobiotic-drug interactions, particularly those precipitated by natural products, which include botanical dietary supplements and everyday foods. Dr. Paine leads the Center of Excellence for Natural Product Drug Interaction Research, funded by the National Institutes of Health. This center is a multidisciplinary effort comprising clinical pharmacologists, natural products chemists, bioinformaticists, and health communications experts whose mission is to provide leadership and guidance on the study and dissemination of these complex, understudied, and underreported interactions. Dr. Paine has coauthored >125 publications as original research articles, reviews, editorials, and book chapters. She is currently serving as Co-Vice Chair for the ASCPT Membrane Transporter Community and as council member and treasurer for ISSX. She is a former associate editor for Clinical Pharmacology & Therapeutics and is currently serving her third five-year term as associate editor for Drug Metabolism and Disposition. She is the recipient of the 2021 ASCPT & FDA William B. Abrams Award and 2023 ASCPT Rawls-Palmer Progress in Medicine Award and is a member of the Scientific Advisory Board for Simcyp Certara.

Dr. Mitesh Patel is currently working as a Principal Scientist in the Drug Disposition Group at Novartis. He has received his Ph.D. in Pharmaceutical Sciences from University of Missouri-Kansas City, Missouri. He completed his Postdoctoral training at GlaxoSmithKline where he investigated transporter-mediated drug disposition to help understand the mechanistic basis for their unusual clinical PK. At present, as an ADME expert, he mainly focuses on designing, executing, interpreting, and contextualizing appropriate ADME/PK studies to explain uncharacteristic PK of small molecule drugs during discovery and development. He serves as a subject matter expert on drug absorption, distribution, excretion, clearance IVIVE and drug-drug interactions.

Dr. Sheila Annie Peters has a PhD in Chemistry. She started her career in Pharma R&D in 1999, working at Cyprotex, UK. Later, she joined AstraZeneca, Mölndal, where she developed and applied a generic whole-body PBPK model to support drug discovery and early development projects across different R&D sites. Here, she won the AstraZeneca Innovative Medicines Science Award for the “Design and Development of LungSim Simulation tool for Inhalation PK Modelling”. Sheila served as Head of Translational Quantitative Pharmacology group at Merck KGaA, Darmstadt for 6 years before taking her current position as Early Asset Lead at Boehringer Ingelheim. Sheila is the EFPIA Topic leader for the ICH M12 group focused on harmonizing drug-drug interaction (DDI) guidelines. She has published several papers on PK, PBPK, human dose predictions, gut metabolism and DDI in high impact journals and authored a book on PBPK.

Speaker bio coming soon.

Dr. Bhagwat Prasad’s primary research interest focuses on drug safety in populations that are underrepresented in clinical trials, such as children, pregnant women, and ethnic minorities. He leads several federal and industry-funded research programs on characterization of interindividual variability and in vitro to in vivo extrapolation (IVIVE) of drug transport and metabolism by utilizing quantitative proteomics and metabolomics. He serves as the director of proteomics-based research in non-cytochrome P450 enzymes (PRINCE), a consortium funded by multiple pharmaceutical companies. Prior to moving WSU, Dr. Prasad was an assistant professor at the University of Washington (UW), Seattle and was affiliated with the UW research affiliate program on transporters (UWRAPT). Dr. Prasad has published 110 peer-reviewed articles and delivered over 90 invited talks at various conferences, peer institutes, and FDA. Dr. Prasad is an elected member of Washington State Academy of Sciences and a recipient of ISSX North American New Investigator Award and ASPET Early Career Faculty Showcase award. Dr. Prasad has also served as the Secretary of Drug Metabolism and Disposition Division of ASPET. Dr. Prasad is a senior editor of Pharmacology Research and Perspectives and a member of the editorial boards of Drug Metabolism and Disposition, Clinical Pharmacology and Therapeutics, and Trends in Analytical Chemistry. Dr. Prasad obtained his MS and Ph.D. in Pharmaceutical Sciences from NIPER, Mohali, India (2010) and postdoc from UW, Seattle, WA (2012).

Kosuke Saito has been with the National Institute of Health Sciences for 16 years. He started as a Predoctoral and Postdoctoral Fellow with the Pharmacogenomics group, Reproductive and Developmental Biology Laboratory in the National Institute of Environmental Health Sciences in 2008 and moved to the Division of Medical Safety Science at the National Institute of Health as a researcher at the end of 2012. He is currently a Section Chief in the Division of Medical Safety Science, National Institute of Health Sciences, which he started in 2017. He specializes in Bioanalysis, Peptides, Biomarker, and Metabolomics/Lipidomics.

Laurent Salphati, Pharm.D., Ph.D., Genentech, Inc.

Laurent Salphati is currently a Senior Fellow in the Drug Metabolism and Pharmacokinetics department at Genentech, Inc, which he joined in 2004. He heads the Drug Transporters Group and has been supporting and leading oncology, immunology, neuroscience and neuro-oncology projects from preclinical discovery to late stage clinical development. He received his Pharm.D. from the University of Paris XI, France, and conducted his Ph.D. research at the University of California, San Francisco under the guidance of Dr. Leslie Z. Benet. His research interests include the pharmacokinetics and pharmacodynamics of drugs – PK/PD and PBPK modeling - and the role of transporters in drug absorption and disposition.

Dr. Hong Shen is currently a Scientific Director of the Drug Metabolism and Pharmacokinetics (DMPK) Department at Bristol Myers Squibb, where he researches drug transporter activities and provides preclinical DMPK support for multiple drug discovery and development programs. He received his Ph.D. in Pharmaceutical Sciences from the University of Michigan in Ann Arbor. Dr. Shen was a member of the organizing committee for the AAPS Drug Transporter Community from 2014 to 2018. He is currently a committee member of the International Transporter Consortium (ITC), ISSX Transporter Focus Group, and IQ Transporter Drug-Drug Interaction and IQ OATP1B Biomarker Working Groups. He received the James R. Gillette Drug Metabolism and Disposition Best Paper Awards of 2001, 2007, 2018, and 2023. He serves as a peer reviewer for multiple publications and an associate editor for the journal of Frontiers in Pharmacology. He has over 90 published journal articles and book chapters. His research is focused on applying mechanism-based approaches to the quantitative translation of preclinical in vitro and in vivo data to clinical findings in order to broadly impact drug discovery and development processes involving drug transporters.

Dr. Yoshiyuki Shirasaka is currently holding a position as an Associate Professor at the School of Pharmacy, Kanazawa University, and has been conducting research in the field of drug absorption and pharmacokinetics. After receiving a Ph.D. degree in 2007 at Setsunan University, Osaka, Japan supervised by Prof. Shinji Yamashita, he started his career as an Assistant Professor at Tokyo University of Science, then, he moved to Kanazawa University (2008). Since he was assigned as a JSPS Postdoctoral Fellow for Research Abroad from Japan Society for the Promotion of Science, he moved to the University of Washington in 2012 and worked as Visiting Scholar/Visiting Scientist under Prof. Kenneth E. Thummel, Prof. Joanne Wang and Prof. Nina Isoherranen. Then, he moved to Tokyo University of Pharmacy and Life Sciences in 2015 and worked as an Associate Professor, and then returned to Kanazawa University in 2020. His research interests include the gastrointestinal absorption, transport, delivery, interaction, and toxicity of oral drugs based on biopharmaceutics and pharmacokinetics. Through this work, he has developed various methodologies to quantitatively predict these kinetic properties of oral drugs. In recent years, his absorption research has focused on gastrointestinal physiology, and he has introduced various cutting-edge technologies such as quantum dot imaging, tissue transparency, and 3D organoid culture to analyze this complex physiology. He has over 80 internationally published original research papers to his credit. Furthermore, He has received brilliant awards from many academic organizations such as the PSJ, APSTJ, JSSX, and ISSX, and these awards are products of his research accomplishments.

Dr. Amala Soumyanath is a Professor in the Department of Neurology at Oregon Health & Science University (OHSU) in Portland, Oregon, USA. She received her Pharmacy degree and PhD from the University of London, UK. She is primarily a pharmacognosist, and her research investigates the chemistry and biological properties of traditionally used botanicals. Goals of this work are to promote evidence-based use of complex botanical products in healthcare, and identify novel phytochemical leads for drug development. Dr Soumyanath’s current research program examines botanicals with potential use in neurodegenerative diseases such as Alzheimer’s or Parkinson’s disease, or for resilience to neurological decline in aging. She has received multiple US federal grants for collaborative projects examining the botanical Centella asiatica through chemical analysis, preclinical models, translational studies and early clinical trials. Dr Soumyanath has published widely on her studies on biologically active botanicals, co-authoring the popular “Laboratory Handbook for the Fractionation of Natural Extracts” and editing a volume on “Anti-diabetic plants” for the series “Traditional Medicines for Modern Times”.

Dr Soumyanath currently directs the BENFRA Botanical Dietary Supplements Research Center at OHSU that is funded by the NIH Office of Dietary Supplements (ODS) and National Center for Complementary and Integrative Health (NCCIH). The BENFRA Center studies Botanicals Enhancing Neurological and Functional Resilience in Aging, with a focus on the popular dietary supplements gotu kola (Centella asiatica) and ashwagandha (Withania somnifera). She is also co-director of an NCCIH funded T32 grant for Complementary and Alternative Medicine Research Training in Neuroscience and Stress.

David Stresser is a Research Fellow in the Quantitative, Translation & ADME Sciences 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 and graduate work in the laboratories of David E. Williams and George S. Bailey at Oregon State University (Ph.D. in toxicology). He has co-authored > 50 articles or book chapters on drug metabolism and is an active participant in various pharmaceutical company consortia.

Hiroshi Suemizu is the Chair of the Research Division at the Central Institute for Experimental Medicine and Life Science (CIEM). He is an accomplished cellular and molecular biologist and laboratory animal scientist; he enjoys the contribution to human health and welfare of new research tools that he has developed using his skills to facilitate medical and drug discovery research. He received his Ph.D. degree in Health Sciences from Kitasato University in 1995. His research is specifically focused on developing human liver models consistent from in vitro to in vivo. He enjoys watching American comic movies and eating cheeseburgers from all over.

Yuichi Sugiyama started working as the Special Professor Emeritus in Josai International University as of April 1, 2021, and recently became Adjunct Professor at the iHuman Institute, Shanghai Tech University, China, as of Oct 1, 2022. Dr. Sugiyama was the Head of Sugiyama Laboratory, RIKEN, Yokohama between April 2012 until 2021, and Professor, Dept of Molecular Pharmacokinetics at the University of Tokyo from 1991 to 2012. Dr. Sugiyama is acknowledged as a world-leader in the fields of physiologically-based pharmacokinetic (PBPK) modeling and membrane transporters. His works on PBPK has been pivotal for quantitative in vitro – in vivo extrapolation, especially the development of models for the prediction of drug clearance and the magnitude of drug-drug interactions in humans. His studies on transporters, which encompass functional and kinetic characterization and the impact of genetic variation, have been fundamental to our understanding of the role of transporters in drug disposition. He was also the president of both “International Society for the Study of Xenobiotics (ISSX)” and JSSX in 2006-2007.

Dr. Tamai’s research has focused on membrane transporters for drugs and nutrients/endogenous compounds starting in 1980's. He has contributed to the research on the role of P-glycoprotein as the BBB firstly published in 1992, molecular cloning and physiological and pharmacological roles of OCTNs since 1997, and the roles of OATP transporters for intestinal absorption as well as hepatic disposition of drugs since 2000. Along with these studies, more recently he has been studying effect of food-derived micro-vesicles that contain microRNAs and proteins, which is expected to be applied to oral delivery of macromolecular drugs. Also, he is studying the roles of transporters in drug-induced liver and kidney toxicities by establishing new methods such as 3D-cultured renal proximal tubular epithelial cells and novel hepatocytes culture model, icHep that will be presented in this meeting. He served as a council member of ISSX and JSSX and Editor-in-Chief of Drug Metabolism and Pharmacokinetics (DMPK), and is currently an associate editor of Biopharmaceutics and Drug Disposition (BDD) and Pharmaceutical Research.

Speaker bio coming soon.

Kenneth Thummel received his Ph.D. in Pharmaceutical Science from the University of Washington in 1987 and completed a post-doctoral fellowship in Pharmacology at the University of Connecticut Health Science Center. In 1989, he was appointed to the University of Washington School of Pharmacy faculty, promoted to the rank of Professor in 2001 and was Chairman of the Department of Pharmaceutics between 2006 - 2019. He currently holds the title of Professor of Pharmaceutics. Dr. Thummel’s research interests include the elucidation of genetic, hormonal and environmental factors that contribute to interindividual differences in xenobiotic biotransformation, in particular, intestinal cytochrome P450 3A-mediated first-pass drug metabolism, natural product-drug interactions, as well as gene x diet modifiers of drug response in Alaska Native and American Indian people. Dr. Thummel is a Fellow of the American Association for the Advancement of Science (AAAS), the American Society for Pharmacology and Experimental Therapeutics (ASPET), and the American Association of Pharmaceutical Scientists (AAPS). He is the recipient of the Rawls-Palmer Progress in Medicine Award from the American Society for Clinical Pharmacology & Therapeutics and the Bernard B. Brodie Award from the ASPET Drug Metabolism and Disposition Division. He is a Past-President of ASPET.

Peter J. Turnbaugh, Ph.D., is a Professor in the Department of Microbiology & Immunology, the G.W. Hooper Research Foundation, and the Benioff Center for Microbiome Medicine at the University of California, San Francisco. He is also a CZ Biohub-San Francisco Investigator. For the past two decades, his research has focused on the metabolic activities performed by the trillions of microbes that colonize our adult bodies. Dr. Turnbaugh and his research group use interdisciplinary approaches in preclinical models and human cohorts to study the mechanisms through which the gut microbiome influences nutrition and pharmacology. He received a B.A. in Biochemistry, Biophysics, and Molecular Biology from Whitman College and a Ph.D. in Microbial Genetics and Genomics from Washington University in Saint Louis. From 2010-2014 he was a Bauer Fellow in the FAS Center for Systems Biology at Harvard University, where he established an independent research group prior to starting his faculty position at the University of California, San Francisco. Notable honors include the Kipnis Award in Biomedical Sciences, the Needleman Pharmacology Prize, the Damon Runyon-Rachleff Innovation Award, the Searle Scholars Award, the Burroughs Wellcome Fund Investigators in the Pathogenesis of Disease Award, and fellowship in the American Academy of Microbiology.

Dr. Vandrey is an experimental psychologist with degrees from the University of Delaware (BA) and University of Vermont (PhD). He is currently a Professor at the Johns Hopkins University Behavioral Pharmacology Research Unit (BPRU). Dr. Vandrey’s research focuses primarily on the impact of route of administration, dose, and chemical composition of cannabis products on resultant drug effects and pharmacokinetics. In addition, Dr. Vandrey has been involved with a broad range of studies related to the risks and benefits of medicinal cannabis use, cannabis-drug interactions, the effects of cannabis use on sleep, cannabis withdrawal and the treatment of Cannabis Use Disorder, cannabis product testing, and developing measures of cannabis use behavior.

Manoli Vourvahis is a Senior Director within the Pfizer Clinical Pharmacology group and serves as the Pfizer clinical pharmacology point of contact for drug-drug interaction (DDI) / ADME strategies and initiatives including work with endogenous biomarkers and extracellular vesicles/exosomes. He has more than 15 years of drug development experience and has published over 40 abstracts at scientific conferences and over 50 manuscripts in peer-reviewed scientific journals. Dr. Vourvahis serves on the Industry Liaison Board of the International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs, served on multiple DDI focused working groups sponsored by the International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development as well as serving as a reviewer for many peer-reviewed clinical pharmacology journals. He also serves on the steering committee and lectures on Drug Metabolism, DDIs, and Pharmacogenomics as part of the Pfizer Pharmaceutical Medicines Elective. Dr. Vourvahis received his Doctor of Pharmacy (PharmD) in 2004 from Northeastern University (Boston) and in 2007 completed a drug development/clinical pharmacology fellowship at the University of North Carolina at Chapel Hill.

Yanran Wang is a Principal Scientist in the DMPK Department at Genentech. Her research interests focus on mechanistic and ML models in predicting preclinical and clinical PK. Her work focuses on customizable in-house PBPK modeling and bridging ML and PBPK models in early drug discovery space for compound design and prioritization. Before joining Genentech, she graduated her PhD in Computational Biology from Rutgers University, USA, and Master’s in Clinical Pharmacy from Sichuan University, China.

Dr. Ying-Hong Wang is a senior reviewer in the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences (OTS)/CDER. Prior to joining the FDA, she worked for 14 years at Merck, where she was responsible for preclinical and clinical development of numerous compounds in multiple therapeutic areas. She chaired the Quantitative Prediction of Drug Interaction Working Group and developed the internal guidelines for DDI prediction. Her modeling work on predicting and characterizing enzyme and transporter-mediated DDI and hepatic impairment contributed to the NDA approvals of grazoprevir/elbasvir and letermovir. Dr. Wang earned her Ph.D. from the Oregon Health Science University and completed her Clinical Pharmacology Fellowship training at the Indiana University-Purdue University Indianapolis. Her current research focuses on applications of PBPK modeling in CYP induction, transporter-mediated DDI, and hepatic impairment.

Werner Weitschies is Professor of Biopharmaceutics at the University of Greifswald, Germany. He studied Pharmacy at the Free University of Berlin (1983-1987) and received his Ph.D. in Pharmaceutical Technology in 1990. From 1990 to 1995 he worked in contrast media research at Schering AG in Berlin. From 1996 to 1998 he was head of a research department in the field of medical applications of magnetic nanoparticles at the Free University of Berlin. In 1998 he was appointed Professor at the University of Greifswald. His main research areas are the investigation of the interplay between physiology and drug delivery systems with focus on the gastrointestinal tract. He is author or co-author of more than 300 scientific articles and 31 patents.

Hiroshi Yamazaki has been Professor of the Laboratory of Drug Metabolism and Pharmacokinetics at Showa Pharmaceutical University, Tokyo, Japan since 2005. He trained as a post-doctoral fellow at Vanderbilt University School of Medicine, Nashville, TN, USA in 1994. He was recruited as an Associate Professor at Kanazawa University from Osaka Prefectural Institute of Public Health in 1998 and then an Associate Professor at Hokkaido University Graduate School of Pharmaceutical Sciences in 2001. He is a recipient of the ISSX Asia Pacific Scientific Achievement Award.

I am the founder the CEO of Lead Molecular Design, S.L. a company dedicated to the development of software in the field of metabolism and structure elucidation. The company was incorporated in 2002 and now have 9 employees. We are small company heavily specialized in the field of Mass Spectrometry data interpretation. Over the years we have develop several software solutions in this area like: MetaSite (MetaSite – Mass Analytica (mass-analytica.com)), Mass, MetaSite (MassMetaSite – Mass Analytica (mass-analytica.com)), Oniro (WebMetabase, WebChembase, Compound Library and WebQuant) (ONIRO – Mass Analytica (mass-analytica.com)), Shop and MassChemSite (MassChemSite – Mass Analytica (mass-analytica.com)). These software solutions have become the standard of use in the pharma and biopharma Research & Development environment for the detection of metabolite. I like to work all these solutions in collaboration with a number of Pharmaceutical companies like Merck, Bristol Myers Squibb, Vertex, Genentech, etc… both in Europe and the USA.

My team and I have produced over 60 publications in peer review journals or book chapters and a numerous presentation in the international expert conferences (Ismael Zamora - Search Results - PubMed (nih.gov) and Resource Library – Mass Analytica (mass-analytica.com), . Also, I have work as external consultant in the field of Machine learning, metabolism and Artificial Intelligent for multiple Pharma companies, etc.. In addition since 2005 I am associated professor at the Pompeu Fabra University in Barcelona working in the Medicine and Biomedicine Faculty, teaching Bio statistics, Compound design and pharmacokinetics.

I am leading a team of 12 people across different countries in a customer driven approach to research, develop and implement solutions for the R&D Pharma section worldwide. The solutions are de developed in collaboration with a number of Pharma industry and Mass Spectrometry vendors that allow us to have the state of the art solution in the Mass Spectrometry data processing and analysis.

Zhu Zhou is a tenured Associate Professor at York College and Graduate Center, City University of New York. Her research utilizes pharmacokinetic (PK) and modeling approaches (PBPK, PK/PD) to assess drug disposition in special populations. She has served as a PI for external grants (federal, professional societies, and state) and internal grants focused on pharmacokinetic research. She is an editor-in-training for Clinical & Translational Science, a guest editor for Pharmaceutics, and a reviewer for various journals and NIH study sections. She is the recipient of the 2022 National Institute on Aging Butler-Williams Scholar Award and the 2023 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Darrell Abernethy Early Stage Investigator Award.