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Hepatocytes Demonstration Videos

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

Abstract:
Continuing our series on non-CYP-mediated metabolism pathways, we will be discussing another of the most requested enzymes: Sulfotransferases (SULTs). SULTs participate in Phase 2 metabolism of xenobiotics in humans and are characterized by the abundance and broad tissue distribution of the enzymes. Gene regulation and genetic polymorphism of SULTs also contribute to our understanding of the significance of these enzymes in the process of drug development. Basic biochemical characteristics of SULTs will be reviewed and examples of major forms of sulfonates formed in humans will be presented. Some properties of SULTs-mediated metabolism will be compared to other major Phase 2 enzymes, particularly UDP-glucuronosyltransferases (UGTs).

Key concepts discussed in this webinar will include:
 - Significance of SULT-mediated metabolism in the drug development process
 - Tissue distribution of human SULTs
 - Gene regulation of SULT enzymes

Download a copy of the slides: https://www.xenotech.com/about/events/role-of-sulfotransferases-in-drug-metabolism-and-potential-for-drug-drug-interactions/
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 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.

Role of Sulfotransferases in Drug Metabolism and Potential for Drug Drug Interactions

Presenters: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at SEKISUI XenoTech and Heather Heading, Director of LCMS at Agilex Biolabs

Abstract:
Profiling, characterising, and identifying metabolites are key steps in supporting drug discovery and development of novel compounds. Metabolite identification (Met ID) studies help you to understand presence of potential active or reactive metabolites and observe the unique metabolites in your compound to better understand your molecule’s biotransformation capabilities. SEKISUI XenoTech and Agilex Biolabs’ combination of in-depth scientific knowledge in drug metabolism and mass spectrometry, extensive pharmaceutical industry experiences, and advanced software, can quickly identify metabolites in both in vivo and in vitro samples and help accelerate sponsors’ drug development programs through FIH clinical trials.

Key concepts discussed in this webinar include:
 - How to improve bioanalytical clinical outcomes by performing MetID characterisation.
 - How metabolite characterisation helps troubleshoot problems earlier in the drug program.
 - Test system selection for in vitro MetID.
 - The use of MetID for tox species selection.
 - Integrating MetID with your bioanalytical program and how the two corelate.
 - Why metabolite characterization studies are not quantitative.
 - Regulatory expectations for MetID.

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2022/03/Bridging-In-Vitro-Data-to-Clinical-Outcomes-with-MetID.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 Presenters:
Andrew G. Taylor, PhD, received his PhD 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.

Heather Heading is currently the Director of LCMS at Agilex Biolabs. She obtained her Bachelor of Science with Honours and a Bachelor of Technology from the world-renowned Flinders University in South Australia where she then joined Agilex Biolabs in 2009. Now Heather is responsible for the management and oversight of the Agilex Biolabs LC-MSMS division and works closely across the various departments to ensure her clients are provided with an exceptional customer experience. She is passionate about bringing new medicine to market for a healthier world and sees the crucial role that her work with Agilex Biolabs does as a vital part of this process.

Bridging In Vitro Data to Clinical Outcomes with MetID

Presenter: Kusum Parikh, MBBS, PhD, SEKISUI XenoTech Senior Scientist in Program Oversight

Abstract:
Regulatory guidance states that drug developers should correct for nonspecific binding in microsomes if it is expected to influence the analysis of kinetic data. Evaluating microsomal protein binding provides a better understanding of the relationship between in vitro metabolism and in vivo pharmacokinetics. Since this data provides insight into how the drug may be distributed throughout and cleared by the body, it is important for developing the DMPK profile as well as assessing the drug-drug interaction potential of a drug candidate.

Key concepts discussed in this webinar will include:
 - What is microsomal protein binding (MPB)?
 - Why is measuring MPB important?
 - Methods to measure MPB
 - MPB study design
 - Sample data

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2022/02/SEKISUI-XenoTech_Microsomal-Protein-Binding-of-Drugs.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. Kusum Parikh is a Senior Scientist in the Program Oversight division serving as a Study Director for enzyme inhibition, enzyme induction, plasma protein binding and microsomal protein binding studies. Kusum earned her MBBS degree from Seth Gordhandas Sunderdas Medical College and the King Edward Memorial (KEM) Hospital, Mumbai, India. She subsequently obtained her Ph.D. in Human Genetics at University of Pittsburgh which was followed by her postdoctoral training in the Department of Medicine at University of Pittsburgh. During the course of her training, Kusum has published several original research articles, contributed to book chapters and was an invited speaker in scientific conferences.

Microsomal Protein Binding of Drugs

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

Continuing our ADME 101 presentation series assisting researchers and industry professionals with navigating ADME, DMPK, and DDI within the complex landscape of drug development, Dr. Taylor presented on whether in-vitro metabolism and drug-drug interaction (DDI) studies are critical for an IND to the American Association of Pharmaceutical Scientists (AAPS) in January 2022.

Drug metabolism and drug-drug interaction (DDI) studies often take a back seat to toxicity studies when preparing for an IND. Cross-species metabolite identification and plasma protein binding are typically considered sufficient for an IND. However, benefits to drug development efficiency and expense along with modern regulatory expectations are causing many to look deeper earlier.

Metabolism studies can help bridge in vivo data to clinical outcomes. Furthermore, guidance documents from regulatory bodies indicate that DDI studies should be done before clinical studies. So when is the appropriate time to conduct ADME (Absorption, Distribution, Metabolism, Excretion) studies in pre-clinical species?

This talk will discuss processes for the metabolism of a drug, referred to as ADME, 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.

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2022/02/SEKISUI-XenoTech_Are-in-vitro-metabolism-and-DDI-studies-critical-for-an-IND.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, 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.

Are in vitro metabolism and DDI studies critical for an IND?

Presenter: Miki Fujishima, Manager in Business Development at the Drug Development Solutions Center in Tokai, Japan.

Abstract:
Drug-induced liver injury (DILI) is caused by various mechanisms, so conducting a variety of experiments to form a comprehensive score leads to more accurate risk assessment. Including covalent binding for reactive metabolite detection in this approach greatly improves selectivity and specificity, however, that requires a radioisotope-labeled test article, making it unsuitable for early stage development. Glutathione (GSH) trapping is often conducted in its place, but that can be costly with lower throughput or less quantitativity, depending on the trapping agent.

The cysteine trapping study developed by our sister SEKISUI lab, the Drug Development Solutions Center (DDSC), is more quantitative with higher throughput and lower cost. Listen to a DDSC expert discuss:

 - The relation between DILI and reactive metabolites
 - Evaluating reactive metabolites
 - A relevant case study
 - A comparison of different GSH and cysteine trapping evaluation methods
 - Their cysteine trapping study design and assay procedure
 - Comparative data

Download a copy of the slides (including transcript in the comments): https://www.xenotech.com/wp-content/uploads/2022/01/ADME101-Reactive-Metabolite-Detection-Study-Cysteine-Trapping.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:
Miki Fujishima is an Assistant Manager in the Business Development department at the Drug Development Solutions Center in Tokai, Japan. In this role, she facilitates ADME solutions for clients and works closely with research & development scientists to develop and improve assays relating to liver toxicity. Miki received her master’s degree in Drug Metabolism and Molecular Toxicology from Tokyo University of Pharmacy and Life Sciences in 2007. She joined the Drug Development Solutions Center in 2007, helping to establish Drug Transporter study offerings performed at both the Tokai facility and SEKISUI XenoTech. She moved on to specialize in DMPK test systems, including hepatocytes and subcellular fractions, and finally to her current position assisting clients in their assessment of Hepatotoxicity.

ADME 101 Reactive Metabolite Detection Study: Cysteine Trapping

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/
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. 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.

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