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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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  • Contains 3 Component(s) Includes a Live Web Event on 09/28/2026 at 5:00 PM (EDT)

    In patients with renal impairment, tubular secretion of drugs via drug transporters is reduced. As a possible mechanism, the chronic inflammatory state associated with renal injury may affect the expression and activity of drug transporters. However, the relationship between inflammatory status and drug transporter expression have not been clarified using patient samples. In this study, we analyzed the expression levels of drug transporters in human kidney specimens and examined the effects of inflammatory cytokines on the expression and activity of renal drug transporters, organic anion transporter (OAT) 1 and 3, using three-dimensionally cultured human proximal tubular epithelial cells (3D-RPTEC) [1,2]. Proteomic analysis of non-tumor portion specimens of kidneys removed from patients with renal tumors revealed 93 transporters including OAT1. Enrichment analysis of proteins negatively correlated with OAT1 and OAT3 expression in human kidney using Metascape revealed GO terms related to inflammation. To characterize the direct effects of inflammatory cytokines on RPTECs, IL-1β and TNFα were exposed to 3D-RPTECs. As a result, mRNA expression of OAT1 and OAT3 was decreased and the uptake activity of the OAT1 substrate [3H] PAH was reduced. The decrease in mRNA expression due to inflammatory cytokine exposure was suppressed by the addition of the NF-κB inhibitor benzoxathiole. In conclusion, our studies revealed that inflammatory cytokines negatively regulate the expression of renal drug transporters OAT1 and OAT3.

    Abstract: In patients with renal impairment, tubular secretion of drugs via drug transporters is reduced. As a possible mechanism, the chronic inflammatory state associated with renal injury may affect the expression and activity of drug transporters. However, the relationship between inflammatory status and drug transporter expression have not been clarified using patient samples. In this study, we analyzed the expression levels of drug transporters in human kidney specimens and examined the effects of inflammatory cytokines on the expression and activity of renal drug transporters, organic anion transporter (OAT) 1 and 3, using three-dimensionally cultured human proximal tubular epithelial cells (3D-RPTEC) [1,2]. Proteomic analysis of non-tumor portion specimens of kidneys removed from patients with renal tumors revealed 93 transporters including OAT1. Enrichment analysis of proteins negatively correlated with OAT1 and OAT3 expression in human kidney using Metascape revealed GO terms related to inflammation. To characterize the direct effects of inflammatory cytokines on RPTECs, IL-1β and TNFα were exposed to 3D-RPTECs. As a result, mRNA expression of OAT1 and OAT3 was decreased and the uptake activity of the OAT1 substrate [3H] PAH was reduced. The decrease in mRNA expression due to inflammatory cytokine exposure was suppressed by the addition of the NF-κB inhibitor benzoxathiole. In conclusion, our studies revealed that inflammatory cytokines negatively regulate the expression of renal drug transporters OAT1 and OAT3.

    Learning Objectives:

    - What is the role of renal drug transporters?
    - How does renal impairment and/or inflammation affect renal function (especially transporter function)
    - Familiarization with methods and tools that can be used to study renal drug handling

    Target Audience: DMPK scientists with particular interest in renal drug transport and the effect of disease / inflammation on kidney function.

    Educational Needs Statement: Knowledge gaps continue to exist regarding the impact of renal disease on drug transport in proximal tubular cells

    Hiroshi Arakawa, PhD

    Hiroshi Arakawa, PhD

    Professor

    Nagoya City University

    Academic Career 2013 Kanazawa University, Japan Ph.D. in Pharmacokinetics
    2009 Tokyo University of Science, Japan M.S. in Pharmacokinetics
    2007 Tokyo University of Science B.S. in Pharmacokinetics

    Professional Experience 2025–present Full Professor Graduate School of Pharmaceutical Sciences, Nagoya City University
    2021–2025 Associate Professor Faculty of Pharmacy, Kanazawa University, Japan
    2016–2021 Assistant Professor Faculty of Pharmacy, Kanazawa University, Japan
    2013–2016 Assistant Professor Faculty of Pharmacy, Takasaki University of Health and Welfare, Japan

    Kunal Taskar

    Kunal Taskar (Moderator)

    Director, Global Head of PBPK Modelling

    GSK

    Kunal Taskar, Ph.D., is currently working as Director, Global Head of PBPK Modelling at GSK. Kunal completed his doctorate more than a decade ago and postdoctoral research at Texas Tech University Health Sciences department, USA, in Quentin Smith’s lab with research focused on Neuropharmacokinetics and role of transporters in drug delivery across the blood-brain barrier (BBB).

    Kunal’s experience and research focus include: PBPK modeling of small/large molecules and new modalities for PK and dose predictions, drug-drug interaction predictions and mechanistic understanding of the clinically occurring drug–drug interactions; and application of PBPK modeling in special populations including pediatrics, pregnancy, and organ impairment. His expertise also includes transporter mediated drug delivery and intracellular drug concentrations, especially the role of uptake and efflux transporters in drug pharmacokinetics-pharmacodynamics in disease and toxicology; novel transporters and role in drug disposition and use of endogenous probes and modeling for drug mediated transporter modulations.

    Kunal is a member of American Society of Clinical Pharmacology and Therapeutics (ASCPT), International Society for the Study of Xenobiotics (ISSX) and the International Brain Barriers Society. Kunal is a member of several IQ consortiums including MIDD Pilot Program WG, Transporters, Induction PBPK and Pediatric PBPK. He is the founder member and Chair of the ASCPT QP PBPK Community. He received the 2014 AAPS Pharmaceutical Research Meritorious Manuscript Award for a manuscript that was published in the same journal in 2012. He has actively published and given invited talks and conducted workshops at international conferences.

  • Contains 3 Component(s)

    This webinar is intended to enable ADME and DMPK scientists to understand how emerging machine learning and high-throughput PBPK approaches can enable earlier, more scalable prediction of pharmacokinetics and support decision-making for complex drug candidates.

    This webinar is designed to provide an overview of emerging strategies transforming pharmacokinetic (PK) prediction in modern drug discovery. It will explore how high-throughput physiologically based pharmacokinetic (HT-PBPK) modelling, combined with machine learning, enables rapid, structure-driven prediction of PK properties, reducing reliance on experimental data in early discovery.
    This session will highlight the application of HT-PBPK workflows for large-scale compound prioritisation, alongside advances in modelling beyond Rule-of-Five (bRo5) compounds such as PROTACs and cyclic peptides. Through case studies, speakers will demonstrate how novel physicochemical descriptors improve the prediction of key ADME and in vivo PK endpoints, including permeability, solubility, and systemic exposure. Together, these approaches offer new opportunities to enhance decision-making and accelerate the design of developable drug candidates.

    By the end of this webinar, participants will be able to:

    1. Describe how in silico inputs can replace in vitro data to enable scalable pharmacokinetics prediction. 2. Assess the value of novel physicochemical descriptors in improving ADME and pharmacokinetics predictions
    3. Interpret prediction accuracy (e.g., fold-error ranges) and identify key success factors (e.g., clearance pathway classification, ML confidence).
    4. Understand the drug development challenges posed by PROTACs and cyclic peptides
    5. Describe emerging strategies for modelling beyond Rule-of-Five (bRo5) compounds

    Davide Bassani

    Davide Bassani

    Computational DMPK and Translational PK/PD Leader

    Hoffmann-La Roche

    Computational DMPK Leader and Translational PK/PD Project Leader at Roche in Basel, specializing in the application of advanced computational methods, in silico DMPK/PD, and translational pharmacology to accelerate small-molecule drug discovery. With a Ph.D. in Computer-Aided Drug Design, I leverage machine learning, in silico PK prediction, and medicinal chemistry expertise to guide portfolio projects and strengthen scientific decision-making. My work focuses on optimizing screening strategies, improving cycle times, and integrating ADME, DMPK, and pharmacodynamic insights to advance promising candidates toward the clinic.

    Jeremy Jones

    Jeremy Jones

    Principal Scientist

    Simulations Plus

    Dr. Jones received his PhD from Stanford University and completed his postdoctoral fellowship at UC San Francisco, before becoming an Assistant Professor in Molecular Pharmacology at City of Hope. There he focused on drug development and translational research in urologic oncology, developing and licensing a lead series for prostate cancer. He also spent a year at Terray Therapeutics before moving to New Zealand, and now has been working at Simulations Plus on the early drug discovery team for over three years.

    Daniel Scotcher

    Daniel Scotcher (Moderator)

    Lecturer

    The University of Manchester

    Dr. Dan Scotcher is a Lecturer in Applied Pharmacokinetics at the University of Manchester, where his research focuses on mechanistic modelling and simulation to understand drug disposition and optimise drug dosing. He has extensive experience in physiologically based pharmacokinetic (PBPK) modelling and its application across drug development and clinical pharmacology. Dan currently serves as Chair of the ISSX Modelling & Simulation (M&S) Focus Group.

    William Weigel

    William Weigel (Moderator)

    Scientist, Molecular Design

    Terray Therapeutics

    At Terray Therapeutics, my role involves the design and analysis of small-molecule combinatorial libraries used to drive hit finding around protein targets of interest. My academic background was focused on synthetic organic chemistry during my PhD and work with DNA Encoded Libraries (DELs) during my postdoc.

  • Contains 3 Component(s)

    ATP binding cassette (ABC) and solute carrier (SLC) placental transport proteins (i.e., transporters) regulate the transfer of nutrients, endogenous compounds, drugs and metabolites between mother and fetus, impacting fetal development and pregnancy outcomes. Identification and accurate quantification of these transporters is critical for predicting nutrient and drug disposition and assessing drug safety throughout pregnancy. Proteomic approaches—both targeted and untargeted—offer complementary strategies for identifying and quantifying transporter abundance in placental tissue of varying gestational age. This webinar will feature work conducted at the University of Washington Transporter Elucidation Center (UWTEC) and the Integrated Transporter Elucidation Center (InTEC) to elucidate which transporters are present in the placenta at different gestational ages and at what levels. The aims of the presentation are to emphasize the pharmacological importance of accurately identifying and quantifying placental transporters at different gestational ages, to predict human fetal drug and nutrient exposure using physiologically based pharmacokinetic (PBPK) modeling, to illustrate how experimental methodology influences data variability, and to highlight novel associations between maternal and infant factors, including environmental chemical exposures, and ABC and SLC transporter enrichment in the placenta.

    Placental ATP binding cassette (ABC) and solute carrier (SLC) transporters regulate the transfer of nutrients, endogenous compounds, drugs and metabolites between mother and fetus, impacting fetal development and pregnancy outcomes. Identification and accurate quantification of these transporters is critical for predicting nutrient and drug disposition and assessing drug safety throughout pregnancy. Proteomics and transcriptomics offer complementary strategies for identifying and quantifying transporter abundance in placental tissue of varying gestational age. 

    The key focus of the NIH‑funded Transporter Elucidation Network (TEN) aims to identify, quantify, and characterize SLC and ABC transporters in the human placenta, the lactating mammary gland, developing gut, and blood-brain barrier.  This webinar will focus on the placenta and feature investigators from the University of Washington Transporter Elucidation Center (UWTEC) and the Integrated Transporter Elucidation Center (InTEC), two of the four Centers that comprise the NIH TEN.

    The webinar will begin with proteomic approaches, both targeted and untargeted, and how they offer complementary strategies for identifying and quantifying transporter abundance in placental tissue.  The webinar will then describe newly identified gestational age associated changes in nutrient transporter expression, novel associations between maternal and infant factors, including environmental chemical exposures, and ABC and SLC transporter enrichment in over 250 placentas from the US-based Understanding Pregnancy Signals and Infant Development (UPSIDE) cohort.  Finally, transcriptomic analyses defining the spatial and temporal landscapes of SLC and ABC mRNA expression in human placentas will be presented and discussed. 

    Together, this webinar aims to advance understanding of SLC and ABC transporters in fetal nutrient and xenobiotic exposure and highlight emerging technologies that are transforming our ability to characterize placental transporters and their implications for fetal exposure to nutrients and medications.

    Learning Objectives:
    - Profile high and low abundance ABC and SLC transporter proteins in human placentas
    - Compare placental membrane enrichment methods on measured ABC and SLC transporter protein abundance
    - Differentiate the roles of targeted versus global proteomics in identifying and quantifying transporters
    - Identify potential maternal and infant factors that may impact enrichment of ABC and SLC proteins in human placentas
    - Compare nutrient and xenobiotic transporter expression across gestational development

    Jaqueline Tiley

    Jaqueline Tiley

    Assistant Professor

    University of North Carolina at Chapel Hill

    Jacqueline B. Tiley, PhD, is an Assistant Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. She obtained her MSc in Pharmacy and PhD from the University of Basel in Switzerland. Dr. Tiley completed her postdoctoral training at the University of North Carolina at Chapel Hill. Her research program focuses on disease- and drug-mediated alterations in hepatic and placental transport proteins and its impact on drug disposition and toxicity.

    Joanne Wang

    Joanne Wang

    Professor

    University of Washington

    Dr. Joanne Wang is a Professor of Pharmaceutics at the University of Washington School of Pharmacy in Seattle. She earned her PhD in Pharmaceutical Chemistry and completed postdoctoral training at the University of California, San Francisco. Her research focuses on membrane transporters and their roles in xenobiotic and nutrient disposition, pharmacokinetics, and drug-induced toxicity. Her current work examines placental transporters in fetal nutrient uptake and drug exposure and applies systems pharmacology and PBPK modeling to predict transporter-mediated drug exposure during pregnancy and lactation.

    Samuel Arnold

    Samuel Arnold

    Assistant Professor

    University of Washington

    Dr. Samuel Arnold joined the Department of Pharmaceutics at the University of Washington as an Assistant Professor in 2023, and his research predominantly focuses on characterizing exposure-response relationships for therapeutic treatment of infectious diarrhea. This work includes the development of novel in vitro and in vivo models for enteric pathogens such as Shigella and clinical pharmacology support for clinical trials investigating novel treatments for enteric infections. In addition to his work on enteric infections, Dr. Arnold is the director of the Bioanalysis and Pharmacokinetics Lab at the University of Washington. This lab supports a variety of internal and external projects using mass spectrometry to quantify small molecules and proteins in complex tissue samples.

  • Contains 3 Component(s)

    This award recognizes an ISSX member who has made groundbreaking and continued scientific accomplishments in the field of Drug Discovery and Development. It represents the peak of scientific recognition within ISSX and celebrates vision, dedication, and achievement.

    The International Society for the Study of Xenobiotics (ISSX) is proud to announce that Dr. Donglu Zhang has been named the 2025 recipient of The 2025 ISSX Distinguished Accomplishments in Drug Discovery and Development Award, one of the most prestigious recognitions within the Society. Donglu Zhang's career exemplifies innovation, impact, and leadership in drug metabolism and pharmacokinetics. 

    As part of this distinguished recognition, Dr. Zhang delivered his award lecture at the 2025 ISSX International Meeting in Chicago. This webinar offers the broader ISSX community the opportunity to hear his presentation, highlighting the scientific achievements and insights that have shaped his career and contributed meaningfully to the advancement of xenobiotic research worldwide.

    Donglu Zhang

    Donglu Zhang

    Senior Fellow, Drug Metabolism and Pharmacokinetics, Drug Discovery

    Genentech

    Donglu earned his Ph.D. in Organic Chemistry under Professor C. Dale Poulter at the University of Utah in 1990, studying the biosynthesis of archaebacterial membrane lipids. He continued his postdoctoral work at Utah, refining his skills in cloning and purification techniques, and then joined the FDA, where he first explored drug metabolism in microbial systems. Throughout his career, Donglu has combined scientific rigor with creativity, co-inventing mass defect filtering, a tool that revolutionized metabolite identification and has been widely adopted across mass spectrometry platforms.

    Donglu’s achievements span decades and have had global impact. He was a key scientific lead in the development of Eliquis (apixaban), one of the top-selling drugs in the U.S., and contributed to the development of Polivy, an antibody-drug conjugate. His work on gemfibrozil glucuronide and atazanavir led the FDA to adopt these compounds as standard probes in clinical drug-drug interaction studies, directly shaping regulatory guidance. He has published more than 136 papers, authored numerous book chapters, and holds patents that have advanced the science of drug metabolism.

    At both Bristol-Myers Squibb and Genentech, Donglu has been recognized for his ability to bridge discovery and development. He is known internationally for his expertise, invited as a keynote speaker at the Gordon Research Conference on Drug Metabolism, and has inspired countless colleagues with his commitment to “Science without Borders.”

    Cyrus Khojasteh

    Cyrus Khojasteh (Moderator)

    Senior Director and Distinguished Scientist (Technology), Drug Metabolism and Pharmacokinetics, Drug Discovery

    Genentech

    S. Cyrus Khojasteh heads the Biotransformation Function at Genentech (South San Francisco). His research focuses on the mechanisms of biotransformation in drug discovery and development, from small molecules, antibody-drug conjugates, and macrocyclic peptides. Cyrus received his Ph.D. in Medicinal Chemistry from the University of Washington under the direction of Dr. Sidney D. Nelson.

  • Contains 3 Component(s)

    Named in honor of R.T. Williams, this award recognizes an ISSX member who has made seminal and sustained scientific contributions to the field. It represents the pinnacle of scientific recognition within ISSX and celebrates vision, dedication, and achievement at the highest international level.

    The International Society for the Study of Xenobiotics (ISSX) is proud to announce that Dr. Scott Obach has been named the 2025 recipient of the R.T. Williams Distinguished Scientific Achievement Award, one of the most prestigious recognitions within the Society. This award, generously sponsored by Charles Crespi and his family, honors ISSX members who have made substantial and lasting contributions to the field of xenobiotic research.

    As part of this distinguished recognition, Dr. Obach delivered his award lecture at the 2025 ISSX International Meeting in Chicago. This webinar offers the broader ISSX community the opportunity to hear his presentation, highlighting the scientific achievements and insights that have shaped his career and contributed meaningfully to the advancement of xenobiotic research worldwide.

    About the R.T. Williams Distinguished Scientific Achievement Award Named in honor of R.T. Williams, this award recognizes an ISSX member who has made seminal and sustained scientific contributions to the field. It represents the pinnacle of scientific recognition within ISSX and celebrates vision, dedication, and achievement at the highest international level.

    R. Scott Obach, PhD

    R. Scott Obach, PhD

    Vice President of Scientific Research

    Pfizer

    Dr. Obach’s distinguished career at Pfizer Global Research and Development exemplifies the award’s spirit. Rising from Research Scientist to Vice President of Scientific Research, he has advanced global understanding of drug metabolism, enzyme kinetics, bioactivation, and drug-drug interactions. His work has profoundly influenced drug discovery and development, improving the prediction of human pharmacokinetics across therapeutic areas.

    A prolific scientist, Dr. Obach has authored more than 240 publications, achieved an H-Index of 76, and garnered over 12,000 citations. His groundbreaking research and mentorship have earned him a global reputation as the “godfather of applied ADME sciences.

    Dr. Obach’s contributions extend beyond research. A committed leader within ISSX, he has served as President (2022–2023), President-Elect (2020–2021), and Chairman of the Scientific Advisory Board (2016–2020), as well as a journal editor for Drug Metabolism and Disposition and Xenobiotica.

    This year’s award marks a historic milestone, as Dr. Obach becomes the first industry scientist to receive the R.T. Williams Distinguished Scientific Achievement Award. His career stands as a testament to the excellence, innovation, and dedication that define the ISSX community.

    Upendra Dahal

    Upendra Dahal (Moderator)

    Upendra Dahal is currently a Scientific Director in Pharmacokinetic and Drug Metabolism (PKDM) Department at Amgen. He represents PKDM in multi-disciplinary teams from discovery to development, oversees small molecule projects and outsourcing of ADME studies, and supervises scientists and PTRs. Proficient in designing in vitro and in vivo studies to characterize/understand PKDM properties of the drug candidates, provides recommendations to the teams to design better compounds with minimal metabolic and DDI liabilities. Leading the biotransformation group for small molecule drugs, Upendra reviews data, monitors studies, and addresses PKDM challenges to mitigate risks. His role involves preparing as well as reviewing regulatory documents for IND and NDA submissions. Previously worked at Celgene and Pfizer, Upendra boasts diverse research interests, evidenced by a strong track record of peer-reviewed publications across various domains. Upendra received his PhD focusing on enzyme kinetics and drug metabolism from Washington State University under supervision of Prof. Jeff Jones.

     

  • Contains 5 Component(s)

    This short course introduces key considerations and data requirements for PBPK and PK/PD modeling of challenging drug modalities, emphasizing how computational approaches support decision making in drug discovery and development.

    Co-chairs: Daniel Scotcher, University of Manchester, UK and Jaydeep Yadav, Merck, USA

    • FiH dose predictions for protein degraders with PKPD modelling
      Jaydeep Yadav, Merck & Co, USA
    • Translational strategies for multi-specific antibodies (t-cell engagers) in oncology/ immunology
      Fei Hua, Certara, USA
    • Modelling of oligonucleotides and RNAi therapeutics
      Vivaswath Ayyar, GSK, USA
    • Applications and considerations of mechanistic modeling in regulatory decision process
      Yuching Yang, Cary, NC, USA
  • Contains 6 Component(s)

    This short course delves into the emerging issue of "missed metabolites" in drug development, highlighting challenges, case studies, and advanced techniques to enhance metabolite detection and characterization.

    Co chairs: Kevin Johnson, Inotiv, USA and Shuai Wang, Genentech, USA

    • Missing metabolites: what’s the big deal?
      Shuai Wang, Genentech, USA
    • Metabolic Outliers: When Drug Metabolism Goes Off Script
      Valerie Kramlinger, Amgen, USA
    • From Inception to Detection: Tracking Thiol Drug Metabolites
      Simone Schadt, Roche, Switzerland
    • Avoiding Missed Metabolites for Confidence at IND Submission
      Matthew Hutzler, Inotiv, USA
    • Mass Balance Study Design and Strategies For Addressing Unexpected Metabolites
      Raman Sharma, Pfizer, USA
  • Contains 5 Component(s)

    This short course covers the design, purpose, and regulatory expectations of human radiolabeled mass balance studies, emphasizing their role in understanding drug disposition, informing drug development decisions, and supporting DDI assessments and PBPK modeling.

    Co-Chairs: Bhagwat Prasad, Cincinnati Children’s Hospital, USA and Eva Berglund, Certara, USA

    • Strengths and weaknesses of biomarker PBPK models to assess transporter-mediated DDIs
      Hiroyuki Kusuhara, The University of Tokyo, Japan
    • Endogenous Probes in Practice: Why, When, and How?
      Ryota Kikuchi, AbbVie, USA
    • Clinical transporter probes: Selectivity and sensitivity
      Xiaoyan Chu, Merck, USA
    • Endogenous transporter probes from a regulatory perspective
      Xinning Yang, Ellicott City, MD, USA
  • Contains 5 Component(s)

    This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.

    Co-Chairs: Lei Zhang, Silver Springs, MD, USA and Dennis Heller, Certara, USA

    • Mass balance study and metabolite profiling: Design, data analysis, and interpretation
      Chandra Prakash, Agios Pharmaceuticals, USA
    • Industry application and case examples
      Ellen Cannady, Eli Lilly, USA
    • FDA guidance on human radiolabeled mass balance studies
      Zhixia Yan Danielsen, US Food and Drug Administration, USA
    • EMA’s perspectives on human mass balance studies
      Karin Fawkner, Medical Products Agency, Sweden
  • Contains 3 Component(s)

    This webinar is designed to provide an updated understanding of intestinal secretion, biliary elimination, and their roles in drug clearance, while addressing existing knowledge gaps in predicting direct intestinal excretion as a primary clearance pathway. Although often overlooked due to the challenges of distinguishing it from biliary excretion or unabsorbed drug, intestinal excretion represents an important and underrecognized route of elimination. This session will highlight current insights and introduce predictive frameworks and tools to help researchers better identify, assess, and modulate these pathways across the drug-like chemical space.

    This two-part webinar features the presentations “Intestinal Secretion: An Underappreciated Clearance Mechanism” and “Unveiling Intestinal Excretion as a Hidden Pathway for Drug and Metabolite Clearance.” Together, these sessions provide a comprehensive overview of intestinal pathways in drug elimination, highlighting both established but underrecognized mechanisms and emerging insights into intestinal excretion as a key contributor to drug and metabolite clearance. 

    The learning objectives for the two presentations are:

    1. Identify the specific physicochemical drivers, primarily hydrophobicity and acidity, that favor intestinal excretion over renal or biliary pathways.
    2. Describe the mechanistic roles of passive permeability and efflux transporters in driving the transport of metabolically stable drugs into the intestinal lumen.
    3. Apply structure-clearance relationship principles to modulate clearance routes in drug design, such as using acidic functional group modifications to shift excretion between intestinal and biliary pathways. 
    4. To provide an update on our current understanding of intestinal secretion, biliary elimination and their importance to drug clearance and tools to assess the same 

    Chen Chen, PhD

    Chen Chen, PhD

    Postdoctoral Fellow

    Genentech

    Chen Chen is a postdoctoral fellow in the Department of Drug Metabolism and Pharmacokinetics at Genentech, Inc. He earned his Ph.D. from the Tri-Institutional Chemical Biology program, a joint offering from Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, and The Rockefeller University. His research focuses on the mechanistic understanding of drug clearance pathways, as well as nanoparticle drug assembly and tumor-targeted delivery.

    Murali Subramanian, PhD

    Murali Subramanian, PhD

    Director

    Gilead Sciences

    Murali Subramanian is a director of research in DMPK at Gilead Sciences where he is a project leader and DMPK representative for multiple programs in discovery and development across several therapeutic areas. Prior to this, he worked in Janssen Pharmaceutica and Biocon Bristol Myers Squibb Research Center. He obtained his PhD in Chemical and Biological Engineering from Iowa State University and was a postdoctoral and research fellow under Professor Timothy S Tracy and Professor Rory Remmel at the University of Minnesota. His interests lie in the mechanistic understanding and translation of DMPK and ADME principles.

    Xinning Yang

    Xinning Yang (Moderator)

    Policy Lead

    FDA

    Xinning Yang is a Policy Lead in Guidance & Policy team (GPT) under the Office of Clinical Pharmacology (OCP), CDER of FDA. He received his Ph.D. in Pharmaceutical Science from University at Buffalo, mentored by Dr. Marilyn Morris. In the past, as a clinical pharmacology reviewer, he reviewed a number of IND/NDA submissions contributing to the benefit/risk assessment of neurology drug products. His current primary focus is guidance and policy development and implementation in various areas, focusing on drug metabolism, pharmacokinetics, and drug-drug interactions related Clinical Pharmacology issues. He is active in research and led or co-led multiple research projects funded internally. He served as the Chair of Transporter Scientific Interest Group of OCP from 2014 to 2015. He has received a number of individual and team awards from CDER which recognized his contribution to regulatory science and research. He is the Co-Chair of Transporter Focus Group of ISSX and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance working group. He has been an invited speaker for multiple conferences and workshops and organized symposia at several meetings.