Sekisui XenoTech

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Hepatocytes Demonstration Videos

Presenter: Dr. Brian Harvey, Emeritus Professor of Molecular Medicine at the Royal College of Surgeons in Ireland

Key concepts discussed in this webinar will include:
 - Background to the clinical use of dexamethasone in treating severe COVID-19
 - Novel molecular targets of dexamethasone in treating pulmonary edema in COVID-19
 - Molecular mechanisms of inhibitory effects of dexamethasone on ion channels
 - Gender disparity in inflammatory lung disease: COVID-19, Asthma and Cystic Fibrosis
 - Molecular mechanisms of sexual dimorphism in COVID-19 and CF
 - Sex hormone-related targets in COVID-19 and CF

Abstract:
In this webinar we will discuss novel molecular targets of the steroid dexamethasone and the steroid hormone estrogen in airway disease with a focus on Covid-19, asthma and cystic fibrosis.

Dexamethasone is a synthetic steroid commonly used in the treatment of inflammatory airway disease which has found a repurposed use in the clinical management of severe COVID-19 lung disease with great success in reducing mortality. The few clinical studies ascribe the therapeutic effects of dexamethasone to its anti-inflammatory actions, however, this does not explain the steroid action on reducing pulmonary edema per se and other targets may be involved. We have recently shown effects of dexamethasone to reduce secretion across human airway cell lines by inhibiting ion channels and these novel effects of the steroid will be discussed in detail.

A gender disparity has been observed since the first reports of COVID-19 appeared with more men than women suffering severe COVID19 disease and dying from it. The molecular mechanisms for this sexual dimorphism are still unknown although the evidence points to differences in estrogen hormone levels and estrogen receptor expression and their regulation of ACE2 receptor biology, after taking into account patients age and underlying comorbidities. We know that a ‘gender gap’ also exists in other lung diseases such as asthma and cystic fibrosis. Asthma has a higher prevalence in boys than in girls before puberty and a higher prevalence and severity in women than in men in adulthood. A similar trend is seen in cystic fibrosis with girls having an earlier onset of lung disease at puberty with more frequent pulmonary exacerbations and shorter life span than men in adulthood. Because of the complexity of these diseases, no single straightforward mechanism can explain the gender differences found in asthma and cystic fibrosis. In the latter half of the webinar we will focus on the influence of female sex hormones on CF pulmonary outcomes and summarise data from in vitro and in vivo experiments on how estrogen might modify airway clearance, immunity and bacterial infection in the CF airways. The potential for novel steroid hormone-related therapeutic interventions will also be discussed.

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2021/11/Ion-Channel-Targets-of-Dexamethasone-and-Sex-Steroid-Hormones-in-Airway-Disease.pdf
https://www.xenotech.com/about/events/webinar-role-of-udp-glucuronosyltransferases-in-drug-metabolism-and-drug-drug-interactions/
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More information on our research services and test systems: https://www.xenotech.com
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About the Presenter:
Dr. Brian Harvey is Emeritus Professor of Molecular Medicine at the Royal College of Surgeons in Ireland. He is also a Principal Investigator in the Ion Channel Group at the Centro di Estudios Cientificos, Chile, and Visiting Research Professor at the Sorbonne University, Paris. Brian holds a PhD in Physiology and Biophysics from the National University of Ireland and a DSc honoris causa from Michigan State University. His main research area is in cell and molecular endocrinology of rapid responses to steroid hormones and their regulation of ion channels on which he has published over 300 papers. He is a Chevalier of the French Order of Merit and Member of the Ordre des Palmes Academiques, and an elected fellow of the European Academy of Sciences and the Royal Irish Academy.

COVID-19 Drug Repurposing Webinar: Ion Channel Targets of Dexamethasone and Sex Steroid Hormones in Airway Disease

Presenter: Maciej Czerwinski, Ph.D., SEKISUI XenoTech Director of Scientific Consulting

Abstract:
The importance of glucuronidation for metabolism of xenobiotics in humans is illustrated by the abundance and broad tissue distribution of the enzymes, the diversity of substrates and reactions catalyzed, as well as a number of distinctive UGT enzymes and their genetic polymorphisms. The involvement of UGTs in metabolism of new drug candidates will be presented as it underscores the enzymes’ importance from regulatory and safety perspectives.

Basic biochemical characteristics of UGTs will be reviewed and examples of major forms of glucuronides formed in humans will be presented. Distinctive properties of acyl-glucuronides and their significance for drug-drug interactions will be highlighted. Factors contributing to underprediction of UGTs’ in vivo contributions to the metabolism of xenobiotics will also be covered. Laboratory approaches aimed at improving these predictions will be covered, as well.

Key concepts discussed in this webinar will include:
 - Significance of UGT-mediated metabolism in drug development process
 - Consequences of formation of acyl-glucuronides
 - Underprediction of in vivo UGT-mediated metabolism

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-role-of-udp-glucuronosyltransferases-in-drug-metabolism-and-drug-drug-interactions/
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. Maciej Czerwinski serves as a Director in the Scientific Consulting department at SEKISUI XenoTech. He received his Ph.D. from the University of Maryland at Baltimore Medical School in the Department of Pathology. Dr. Czerwinksi conducted his doctoral thesis research in the Laboratory of Dr. Frank Gonzalez at the National Cancer Institute in Bethesda, followed by a post-doc at the Department of Pharmaceutics, the 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. Dr. Czerwinski designed a patented method to analyze the in vitro cytokine-mediated drug-drug interactions between biologics and small molecule drugs, and he is also the inventor of SEKISUI XenoTech’s CryostaX single-freeze pooled hepatocytes.

The Important Role of UDP Glucuronosyltransferases in Drug Metabolism and Drug Drug Interactions

Presenter: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at SEKISUI XenoTech

This talk will discuss processes for the metabolism of a drug, referred to as ADME (Absorption, Distribution, Metabolism, Excretion), and the safety testing to provide requisite information to move a drug through IND and into clinical trials. Prior to marketing a new drug and actually prior to administering a candidate drug to humans in clinical trials, it is important to ensure that drug will not only be effective in the therapeutic manner prescribed, but also be safe and not bring any undo harm to patients. How a drug is metabolized is one of the most important aspects to understand. If you are involved in the development of potential new therapeutics, this discussion will help you gain necessary knowledge to inform your drug development decisions.

Key concepts discussed in this webinar will include:
 - The overarching aim of therapeutic drug development 
   - DMPK – Drug metabolism and pharmacokinetics
   - Based on ADME properties
 - Relationship to Drug-Drug Interactions (DDI)
 - ADME properties
 - Predominant types of in vitro ADME & Drug-Drug Interaction (DDI) studies
 - Why run these studies?
 - When to conduct these studies
 - Areas of concern: Proper design & interpretation

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2021/09/SEKISUI-XenoTech-Eliminating-Problems-in-Drug-Development-Understanding-the-Role-of-Drug-Metabolism.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/
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Request a webinar topic: https://www.xenotech.com/contact/webinar-seminar-request/

About the Presenter:
Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego, Scripps Institution of Oceanography. He joined SEKISUI XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies compliance with Good Laboratory in 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.

Eliminating Problems in Drug Development: Understanding the Role of Drug Metabolism

Presenter: Pallavi Limaye, Ph.D., DABT, SEKISUI XenoTech Director of Scientific Consulting

Abstract:
Aldehyde oxidase (AO) enzyme has gained increasing attention in drug development as one of the alternative approaches to reduce P450-mediated drug metabolism liability. However, clinical failure due to poor prediction of AO-mediated clearance is a major hurdle in development of drugs that are AO substrates. In vitro to in vivo extrapolation underpredicts AO-mediated drug clearance owing to several factors including lack of reliable representative animal models, marked species differences, significant inter-individual variability, substrate-specific activity, and discrepancy between absolute concentration and activity. To tackle these issues related to underprediction of AO-mediated drug clearance, in vitro tools to extrapolate in vivo clearance involving a yardstick approach are proposed. AO-metabolism is an attractive strategy to reduce P450-mediated drug metabolism liability but careful consideration of the unique challenges is essential.

Key concepts discussed in this webinar will include:
 - Wide range of AO substrates – Functional groups
 - AO substrate drugs that faced clinical failure unanticipated drug clearance
 - Underprediction and Factors affecting AO expression
   - Age, Disease state, Alcohol consumption, Pharmacogenomics
   - Species differences
   - Inter-individual variability
   - Sample handling, Freeze-thaw cycles, Fresh vs. Frozen tissue
 - In vitro AO inhibition and fm AO determination
 - In vitro yardstick approach

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-underprediction-of-drug-clearance-by-aldehyde-oxidase-ao-mediated-drug-metabolism-important-considerations-for-in-vitro-assessment/
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:
Pallavi Limaye is a Director in the Scientific Consulting department. Pallavi received her Ph.D. in Toxicology from The University of Louisiana. 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 2020, she 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 and has also contributed many book chapters in the field of toxicology and liver pathobiology. She is also actively involved in scientific societies and currently serves on the E-Learning Subcommittee of The American College of Toxicology and is the current President of the Central States regional chapter of The Society of Toxicology.

Underprediction of Drug Clearance by Aldehyde Oxidase (AO)–Mediated Drug Metabolism (Webinar)

Presenter: Zell Woodworth, Division Director of Products at SEKISUI XenoTech 

Abstract: 
Sometimes, standard products just don’t fit the objective of a unique assay. In this webinar, Products Director and custom test system expert, Zell Woodworth, will discuss some of the unique challenges his team have solved and the ways custom solutions are designed and executed to help researchers and drug developers meet goals outside the reach of standard in vitro products. He will be joined by Manager of Technical Support for Products, Dr. Chris Bohl, for a live Q&A with webinar registrants. 

The dedicated Custom Products team at SEKISUI XenoTech has impressive experience and specialized training in preparing test systems from notoriously difficult to work with tissue types. They have built an impressive collection of custom protocols for more than 40 different animal species (including insects!) and can design custom pools for improved representation of specific enzyme activity or patient characteristics. Tune in to hear about some of the custom solutions they have created to address challenges by researchers in drug metabolism, toxicology, cell biology, pathogen-host interactions, metabolomics, and more, as well as some background information on the team’s capabilities and technologies, the process of creating custom products, and several examples of applications for specialized in vitro test systems. 

Key concepts discussed in this webinar will include:
 - Past challenges addressed by SEKISUI XenoTech custom test systems
 - Species, tissue types, subcellular fractions, pooling, and other capabilities
 - Flexibility of existing or specially-created protocols for preparations
 - Areas of drug development and research our custom products may benefit 

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-addressing-unique-challenges-with-custom-in-vitro-test-systems/
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: 
Zell Woodworth serves as the Division Director of Products at SEKISUI XenoTech. Zell holds a Bachelor of Science in Biology and Chemistry from Olivet Nazarene University in Illinois. He began his career with XenoTech in 1996 and has over 25 years of experience in the development, production, and distribution of tissue-derived in vitro experimental models essential in drug candidate screening, drug-drug interaction investigations, and drug safety. Zell manages raw material procurement, development, production, and quality control of over 350 biological products utilized in pharmaceutical research in over 25 countries. He continues to provide technical support, product workshops, and in vitro test system support to researchers throughout the world. 

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.

Addressing Unique Challenges With Custom In Vitro Test Systems

Presenter: Steven McGreal, Ph.D, Study Director at SEKISUI XenoTech

Abstract:
Pharmacokinetic (PK) parameters of a new drug candidate are typically determined by measuring the drug’s concentration in plasma. However, many drugs have the potential to bind to or diffuse into red blood cells (RBCs), and because RBCs comprise at least 99% of cellular space in blood, this binding potential could significantly impact drug clearance and cause inaccuracies in PK calculations.

Usually, pharmacokinetic parameters are determined by measuring drug concentration in plasma at successive time points, as opposed to measuring the drug concentration in whole blood. However, failing to take into account the potential for a drug to sequester into red blood cells may lead to a misinterpretation of pharmacokinetic data and provide an overestimation of drug’s clearance. For example, certain compounds such as chloroquine are sequestered into red blood cells, thereby causing them to have a blood to plasma ratio that is greater than 1. This illustrates the importance of accounting for the amount of drug potentially sequestered into red blood cells, in addition to the extent of plasma protein binding, when trying to determine the true amount of free unbound drug available in the plasma (fu_plasma).

The assay is designed to determine the blood to plasma ratio of your drug at three concentrations, provide red blood cell distribution percentage, and measure stability. Between our SEKISUI partner laboratory in Japan and headquarters in Kansas City, we can work with whole blood from human donors and preclinical animal species including rat, mouse, dog, monkey, rabbit, and miniature pig.

In this webinar, SEKISUI XenoTech study director Dr. Steven McGreal will cover study design elements and other considerations like timing and characteristics of drugs with high RBC partitioning. He will discuss impacts on PK calculations and provide examples of how RBC partitioning rates can cause errors downstream if not properly investigated early in drug development. The webinar will conclude with a live Q&A session with webinar participants.

Both Red Blood Cell Partitioning and Plasma Protein Binding studies are available from our SEKISUI partners at the Drug Development Solutions Center in Tokai, Japan as well, for international customers who may be closer to Japan.

Key concepts discussed in this webinar will include:
 - Red Blood Cell Partitioning background & mechanism
 - Drug characteristics affected by RBC transfer, including intrinsic clearance (CLint) and exposure (AUC)
 - Standard study design
 - Supporting information sponsors could supply to improve results
 - Impact on PK calculations

Request a copy of the slides: https://www.xenotech.com/about/events/red-blood-cell-rbc-partitioning-webinar/
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. Steven McGreal received his Ph.D. in Toxicology from the University of Kansas Medical Center in 2017 and later that year joined SEKISUI XenoTech. Dr. McGreal is a Research Scientist in the Contract Services division, serving as Study Director for nonclinical studies including drug metabolism, enzyme induction, and enzyme inhibition. He is also responsible for review and interpretation of data, communicating results to sponsors, and responding to Quality Assurance audits. Dr. McGreal is a published author on six peer-reviewed studies and is trained to meet compliance standards of Good Laboratory Practices (GLP) Organization for Economic Co-operation and Development (OECD) Principles of GLP, and/or Japan Ministry of Health and Welfare (MOHW) Good Laboratory Practice Standards (Ordinance No. 21, March 26, 1997).

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