Sekisui XenoTech

Hepatocytes Demonstration Videos

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Presented by SEKISUI XenoTech Technical Support Managers, Drs. Andrew G. Taylor and Chris Bohl Metabolic stability influences the oral bioavailability and plasma half-life of a compound. Metabolic stability assays measure intrinsic clearance and determine the extent to which a drug will be metabolized. This study can be conducted in a variety of test systems, which is why it may also be referred to as a hepatocyte stability study, microsomal stability study, etc. This quick overview video discusses: - Test systems for stability assays - Stability study endpoints - Example data in different species - Considerations for those wanting to conduct stability studies Download slides: https://www.xenotech.com/wp-content/uploads/2020/11/SEKISUI-XenoTech_Metabolic-Stability-ADME-101.pdf Questions, comments and requests: https://www.xenotech.com/contact/ More information on our research services and test systems: https://www.xenotech.com Other previously aired webinars: https://www.xenotech.com/access-adme-research-resources/resource-type/webinar/ Upcoming webinar notifications: https://www.xenotech.com/contact/newsletter-sign-up/ Request a webinar topic: https://www.xenotech.com/contact/webinar-seminar-request/ About the Presenters: Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego. He joined SEKISUI XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies in compliance with Good Laboratory Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met. Dr. Chris Bohl received his PhD from the School of Biological Sciences from the University of Nebraska – Lincoln and has been with SEKISUI XenoTech since 2014, first operating as a research scientist before becoming the Senior Manager of Technical Support for Products. Chris provides valuable guidance to scientists seeking to choose the correct test system, troubleshoot difficulties and much more.

ADME 101: Drug Metabolism Studies – Metabolic Stability

Presenter: Pallavi Limaye, Ph.D., DABT, SEKISUI XenoTech Director of Scientific Consulting This informative ADME 101 discusses In Vitro to In Vivo Extrapolation (IVIVE) and how a model-based approach following routine perpetrator potential studies (i.e. CYP inhibition, CYP induction, and transporter inhibition) assessing clinical potential may eliminate the need of conducting clinical studies. Listen in as Dr. Limaye outlines a step–wise approach for bringing robustness to the prediction, including: - Regulatory guidance - ADME & DDI study types for in vitro to in vivo prediction - Models for DDI prediction - Decision tree for whether modeling is needed - Model equations by study type Download slides: https://www.xenotech.com/wp-content/uploads/2020/10/SEKISUI-XenoTech_DDI-Modeling-ADME-101.pdf Questions, comments and requests: https://www.xenotech.com/contact/ More information on our research services and test systems: https://www.xenotech.com Other previously aired webinars: https://www.xenotech.com/access-adme-research-resources/resource-type/webinar/ Upcoming webinar notifications: https://www.xenotech.com/contact/newsletter-sign-up/ Request a webinar topic: https://www.xenotech.com/contact/webinar-seminar-request/ About the presenter: Dr. Pallavi Limaye is a Director in the Scientific Consulting department. Pallavi completed her Ph.D. in Toxicology from The University of Louisiana and her postdoctoral research in the Department of Pathology at University of Pittsburgh Michalopoulos and subsequently at the Department of Pharmacology, Toxicology, and Therapeutics at University of Kansas Medical Center. Dr. Limaye originally joined SEKISUI XenoTech in 2011 as a Research Scientist and served as a study director for in vitro drug metabolism studies. In 2013, she joined Xenometrics LLC, as a Senior Scientist and served as a study director for regulated nonclinical IND- and NDA-enabling toxicology studies. From 2018 to 2020 Dr. Limaye worked at MRIGlobal as a Principal Scientist and oversaw nonclinical toxicology and animal health studies, as well as contributed to containment research with select chemical agents. Recently Dr. Limaye joined SEKISUI XenoTech’s consulting team and provides input on drug-drug interaction study needs for sponsors. Dr. Limaye has published several original research articles in various journals (Hepatology, Toxicological Sciences among others) and has also contributed many book chapters in the field of toxicology and liver pathobiology. Dr. Limaye is also actively involved in scientific societies and currently serves on the Program Committee of The American College of Toxicology and is the Vice President of the Central States regional chapter of The Society of Toxicology.

Model-Based Approaches to DDI Risk Prediction-Transitioning from In Vitro Data to In Silico Modeling

Hyaluronan (HA) Synthesis Inhibition Normalizes Hepatic Fibrogenic Features by Reducing Hepatic Stellate Cell Activation in Alcohol-Associated Liver Disease Models Presenters: Michele Pritchard, Ph.D., Associate Professor, University of Kansas Medical Center and Maciej Czerwinski, Ph.D., Director of Consulting, SEKISUI XenoTech In 2018, Dr. Pritchard published an abstract suggesting ethanol exposure sensitizes hepatic stellate cells (HSC) to activation stimuli resulting in enhanced pathogenic hyaluronan (HA) production. Targeting HSC hyaluronan production may therefore attenuate liver disease progression in alcohol-associated liver disease (ALD) patients. Alcohol-associated liver disease (ALD) remains a pharmacologically incurable disease. Hyaluronan (HA), an extracellular matrix glycosaminoglycan, is increased in livers and blood of advanced liver disease patients who are actively drinking compared to those who do not drink. In the liver, hepatic stellate cells (HSCs) are responsible for most HA production, and HA synthesis is a prerequisite for fibroblast to myofibroblast transition. Further, increased HA content and fragmentation drive inflammation and fibrosis in many tissues. In this keynote, Dr. Pritchard will discuss how she and her colleagues tested the hypothesis that ethanol facilitates HSC activation through hyaluronan production in early ALD. As a complementary presentation to Dr. Pritchard’s keynote, our in-house Director of Scientific Consulting, Dr. Maciej Czerwinski, will provide insight into pertinent test systems. SEKISUI XenoTech’s Research Biobank provides researchers with access to tissue microarrays (TMA) and liver tissue samples in various formats suitable for liver disease research. As a contributing author to Dr. Pritchard’s published abstract, and upcoming peer-reviewed publication, and resident expert for disease-state test systems, Dr. Czerwinski will provide details of the materials used and present an overview to the offerings and applications of Research Biobank tissue. Key concepts discussed in the webinar: - Hyaluronan (HA) role in alcohol-associated liver disease (ALD) - Ethanol facilitation of hepatic stellate cell (HSC) activation through HA production early in ALD - Inhibiting HA synthesis in ALD mouse models - Tissue microarrays (TMAs) to evaluate HA and collagen content in steatotic livers - Research Biobank tissue applicability Download slides: https://www.xenotech.com/wp-content/uploads/2020/09/SEKISUI-XenoTech_Hyaluronan-Synthesis-Inhibition-Normalizes-Hepatic-Fibrogenic-Features.pdf Questions, comments and requests: https://www.xenotech.com/contact/ More information on our research services and test systems: https://www.xenotech.com Other previously aired webinars: https://www.xenotech.com/access-adme-research-resources/resource-type/webinar/ Upcoming webinar notifications: https://www.xenotech.com/contact/newsletter-sign-up/ Request a webinar topic: https://www.xenotech.com/contact/webinar-seminar-request/ About the Keynote Presenter: Dr. Michele Pritchard is an Associate Professor with tenure at the University of Kansas Medical Center in the Department of Pharmacology, Toxicology, and Therapeutics, and is also Associate Director of the Interdisciplinary Graduate Program in Biomedical Sciences. She received her Ph.D. in Immunology from the University at Buffalo in 2003. She has authored or co-authored more than 40 peer-reviewed publications in scientific journals including International Journal of Toxicology, Journal of Histochemistry & Cytochemistry, American Journal of Physiology. Gastrointestinal and Liver Physiology, and Hepatology. Her current research involves exploring hyaluronan biology in regenerative wound repair and fibrosis after tissue injury and during physiologic aging. The aim of Dr. Pritchard’s research is to identify ways to prevent organ fibrosis and to improve wound repair by targeting hyaluronan.

Hyaluronan Synthesis Inhibition Normalizes Hepatic Fibrogenic Features...

Webinar Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting with special guest for Q&A, Lois Haupt, SEKISUI XenoTech Principal Scientist in Program Oversight Many drug candidates are screened out in discovery due to a time-dependent cytochrome P450 (CYP) enzyme inhibition signal in an in vitro IC50 shift assay because time-dependent inhibition (TDI) is often of greater clinical concern than direct inhibition. Depending on the drug target or intended indications, this approach may be akin to throwing the baby out with the bathwater. Numerous successful drugs cause TDI of CYP enzymes such as fluoxetine, gemfibrozil, esomeprazole, clopidogrel, etc. TDI may be reversible if it is caused by a metabolite that is simply a more potent inhibitor than the parent is, or irreversible. Irreversible time-dependent inhibition may be the result of mechanism-based inactivation, sometimes known as “suicide inhibition.” There are also several types of apparently irreversible inhibition-- an experimental approach that distinguishes these types from true mechanism-based inhibition can be important. Even in cases where the TDI is due to mechanism-based inhibition, the extent of inactivation may not be sufficient to cause clinically relevant drug-drug interactions (DDIs), or if they do, the risk can be managed through labelling or dosage adjustments. Key concepts discussed in the webinar: - In vitro approaches to evaluate time-dependent inhibition, including determination of IC50 shifts, KI and kinact values - Methods to distinguish reversible from irreversible TDI - Approaches to predicting clinical DDIs resulting from reversible or irreversible TDI - Case examples Download slides: https://www.xenotech.com/access-adme-research-resources/resources/suicide-by-binding-putting-time-dependent-inhibition-of-cyp-enzymes-into-perspective/?emat=1020LT Questions, comments and requests: https://www.xenotech.com/contact/?emat=1020LT More information on our research services and test systems: https://www.xenotech.com/?emat=1020LT Other previously aired webinars: https://www.xenotech.com/access-adme-research-resources/resource-type/webinar/?emat=1020LT Upcoming webinar notifications: https://www.xenotech.com/contact/newsletter-sign-up/?emat=1020LT Request a webinar topic: https://www.xenotech.com/contact/webinar-seminar-request/?emat=1020LT About the presenters Dr. Brian Ogilvie currently serves as Vice President of Scientific Consulting at SEKISUI XenoTech. Brian joined XenoTech in 1997, and obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. Brian is an author or coauthor on over 50 scientific posters, peer-reviewed publications and book chapters on the topics of drug metabolism, transport and drug-drug interactions, and has represented the company as an invited speaker at various drug metabolism conferences. As VP of the Consulting Department, he leads drug-drug interaction-related R&D projects, authors various publications, writes expert opinions for consulting clients, and oversees all consultancy services. Lois Haupt will join Dr. Ogilvie for the live Q&A following the presentation. Lois celebrates her 20th year with SEKISUI XenoTech this summer, beginning as a Scientist I in the Enzyme Inhibition service group and working her way up to Principal Scientist in Program Oversight. Her expertise spans drug metabolism research and regulatory compliance, and her specific area of expertise encompasses CYP and UGT inhibition assays along with data interpretation and follow-up to these studies.

Suicide by Binding: Putting Time-Dependent Inhibition of CYP Enzymes into Perspective

Presenter: Maciej Czerwinski, Ph.D., SEKISUI XenoTech Director of Consulting This ADME 101 discusses biobank tissue and its research applications. The Research Biobank was established to preserve, characterize histologically, and distribute a diverse selection of samples from normal and diseased organs. This 20-minute mini-webinar features: - Research Biobank tissue preparations and characterization - Featuring stages of steatosis and steatohepatitis with history of alcohol use or not, fibrosis, diabetes, pediatric, etc. - Attributes of fatty liver disease tissue - Microarrays for fatty liver disease research - Benefits of tissue over hepatocytes or subcellular fractions - Applications for microarrays You may also be interested in viewing Drs. Pritchard & Czerwinski's biobank application webinar: "Hyaluronan (HA) synthesis inhibition normalizes hepatic fibrogenic features by reducing heaptic stellate cell activation in alcohol-associated liver disease models." https://www.xenotech.com/access-adme-research-resources/resources/hyaluronan-ha-synthesis-inhibition-normalizes-hepatic-fibrogenic-features-by-reducing-hepatic-stellate-cell-activation-in-alcohol-associated-liver-disease-models/ Download slides: https://www.xenotech.com/webinar-slides/sekisui-xenotech_biobank-adme-101.pdf Questions, comments and requests: https://www.xenotech.com/contact-us More information on our research services and test systems: https://www.xenotech.com Other previously aired webinars: https://www.xenotech.com/scientific-resources/webinar-series Upcoming webinar notifications: https://www.xenotech.com/newsletter-signup Request a webinar topic: https://www.xenotech.com/scientific-resources/upcoming-webinars About the presenter Dr. Maciej Czerwinski currently serves as Director of Consulting at Sekisui XenoTech. Maciej received his PhD from the University of Maryland at Baltimore Medical School in the Department of Pathology. He conducted his doctoral thesis research in the Laboratory of Dr. Frank Gonzalez at National Cancer Institute in Bethesda, followed by a post-doc at the Department of Pharmaceutics, University of Washington in Seattle. He has been with Sekisui XenoTech since 1999 and guides the development of products and services for the in vitro analysis of drug safety. Maciej designed a patented method to analyze the in vitro cytokine-mediated drug-drug interactions between biologics and small molecule drugs. Dr. Czerwinski is also the inventor of XenoTech’s CryostaX single-freeze pooled hepatocytes.

Biobank Fatty Liver Disease Tissues and Their Exploration in Microarrays

Presenter: Andrew Taylor, Ph.D., Services Technical Support Manager The clearance of a drug can be increased and its effectiveness or safety compromised if it is co-administered with a second drug that induces the enzyme responsible for its metabolism, which is why regulatory agencies highlight the importance of studies to evaluate this potential cause of drug-drug interactions. This 20 minute overview features: - An overview of enzyme induction - Why is measuring CYP (or other enzyme) induction important? - Regulatory guidance & expectations - Types of induction studies - Typical study design (definitive vs. screening) - Considerations & questions to ask upfront - Test systems for induction studies and more... You may also want to view the more in-depth webinar: In Vitro Induction Studies: Elements of Design and Important Considerations in Data Analysis, presented by Joanna Barbara, Ph.D., Vice President of Scientific Operations at SEKISUI XenoTech. Download slides: https://www.xenotech.com/webinar-slides/sekisui-xenotech_enzyme-induction-adme-101.pdf Questions, comments and requests: https://www.xenotech.com/contact-us More information on our research services and test systems: https://www.xenotech.com Other previously aired webinars: https://www.xenotech.com/scientific-resources/webinar-series Upcoming webinar notifications: https://www.xenotech.com/newsletter-signup Request a webinar topic: https://www.xenotech.com/scientific-resources/upcoming-webinars About the presenter: Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego. He joined SEKISUI XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies in compliance with Good Laboratory Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.

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