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Hepatocytes Demonstration Videos

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).

Webinar: Red Blood Cell Partitioning Studies to Improve Accuracy in Pharmacokinetics (PK) Calculations

Presenters: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at SEKISUI XenoTech and Scott Boley, Ph.D., DABT, Senior Vice President of Research at Sinclair Research

Abstract:
Choosing the most relevant species for your toxicity studies is critical to ensure your IND provides the relevant data regulators need to advance your program to clinical trials. But selecting the right species for your nonclinical program must be based on scientific rationale and begins with understanding the potential species-dependent variability in the metabolism of your drug.  The decision of which animal model to utilize may not always be obvious. Comparing animal species to human data helps identify human or animal-specific metabolites and can help you identify the most appropriate species to generate the nonclinical safety data needed to progress your program into Phase 1.

This  webinar will dive into the scientific rationale driving species selection for your nonclinical program with an emphasis on how in vitro species comparison studies can help to determine the right species for your in vivo program.

Key concepts discussed in this webinar will include:
 - Drivers of species selection for nonclinical programs
 - Considerations for rodent and non-rodent species selection
 - Characteristics and structural assignment of metabolites in different preclinical species
 - In vitro species comparison screening studies

Download a copy of the slides: https://www.xenotech.com/wp-content/uploads/2021/07/Selecting-The-Right-Species-For-My-Small-Molecule-Program-The-Role-Of-In-Vitro-Assays.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:
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.

Scott E. Boley, PhD, DABT, has advised sponsors on their nonclinical needs for the last 15 years and managed toxicology programs for over 19 years. He has extensive expertise in drug development as well as the regulatory expectations for a variety of test article types and indications. In his role as Senior Vice President of Research, Scott oversees the Research, Report Services, and SEND groups at Sinclair Research that supports each Sponsor’s nonclinical safety programs. Scott is a diplomate of the American Board of Toxicology and holds a B.Sc. in Biochemistry and a Ph.D. in Biochemistry/Environmental Toxicology from Michigan State University.

Webinar: Selecting The Right Species For My Small Molecule Program-The Role Of In Vitro Assays

Presenter: Brian Ogilvie, Ph.D, Vice President of Scientific Consulting at SEKISUI XenoTech

Abstract:
Although cytochrome P450 (CYP)-mediated metabolism continues to be of major importance for a large proportion of small molecule new drug candidates, various methods in recent decades have accelerated the development of drug candidates with significant non CYP-mediated metabolism. Increased interest in these molecules stems from the efforts to develop drug candidates possibly lacking CYP metabolism liability from the drug interactions and toxicity standpoints. Regulatory agencies still have a safety interest in understanding the biochemical pathways involved in the metabolism of these drugs.

In general, uridine diphosphate glucuronosyltransferases (UGTs) are the most common enzymes involved in metabolism after CYP enzymes, followed by numerous hydrolases, carbonyl reductases, aldehyde oxidase and other enzymes. Reaction phenotyping of many of these enzymes is not as straightforward as with CYPs due to their inherent diversity and limited research tools available. With UGTs, commercially available recombinant human preparations are available for the most relevant enzymes, although selective inhibitors may be lacking. In the case of aldehyde oxidase, a recombinant human enzyme and relatively selective inhibitors are available. For hydrolases, carbonyl reductases and other enzymes such as FMO, strategies may rely on the use of various subcellular fractions, plasma, and inhibitors to elucidate a plurality of the enzymes that may contribute to drug metabolism. The complexity of elucidation of non CYP-mediated metabolism is reflected in regulatory safety requirements.

In this webinar, Dr. Brian Ogilvie will discuss strategies to address non-CYP related metabolism questions in your drug’s safety assessment and following the presentation, he will answer follow up questions from the audience.

Key concepts discussed in this webinar will include:
 - In vitro approaches to evaluate non-CYP enzyme contribution to new drug candidates
 - Case examples

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-an-overview-of-non-cyp-mediated-metabolism-pathways-and-in-vitro-evaluation-strategies/
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 Ogilvie currently serves as Vice President of Scientific Consulting at SEKISUI XenoTech. Brian obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. He joined XenoTech in 1997. From 1999 to 2006 Dr. Ogilvie was the head of the CYP Inhibition Department at SEKISUI XenoTech. 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. In April 2006, Brian became a member of the SEKISUI XenoTech Consulting Department, in which he participates in drug-drug interaction-related R&D projects and authoring various publications, and also writes expert opinions for consulting clients. As Vice President of Scientific Consulting, Dr. Ogilvie is additionally involved in quality management and strategic planning for the company in scientifically relevant areas.

An Overview of Non CYP Mediated Metabolism Pathways and In Vitro Evaluation Strategies

Webinar Presenters: Becky Campbell, Principal Scientist in Program Oversight, and Andrew G. Taylor, Ph.D., Technical Support Manager for Services

Abstract
As a part of IND-enabling preclinical drug development studies companies are required to meet regulatory expectations to evaluate the induction potential of their compound for the cytochrome P450 CYP enzymes CYP1A2, 2B6, 2C8, 2C19 and 3A4. While only CYP1A2, 2B6 and 3A4 must be assessed in the initial induction panel, any observed induction of CYP3A4 requires further investigation of induction potential for enzymes in the CYP2C family due to shared activation by the PXR nuclear receptor pathway. This webinar will focus on CYP2C induction and will emphasize when to include CYP2C induction in a study, how to design the study to generate meaningful data and meet the regulatory requirements, what endpoints to measure, and how to interpret results.

Keypoints covered in this webinar include:
- Enzyme Induction studies in DDI risk prediction
- Crosstalk and other mechanistic considerations
- Conditions that warrant 2C investigation
- Regulatory expectations for induction data
- Standard CYP2C induction assay design
  - Positive controls
  - Appropriate test systems
  - Endpoints (mRNA versus activity)
- Efficient planning to anticipate CYP2C inclusion
- Possibility of metabolites masking induction when looking at activity as an endpoint
- How to interpret results

Receive a copy of the slides: https://www.xenotech.com/about/events/2c-or-not-2c-cyp2c-induction-studies-for-successful-preclinical-risk-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 Presenters:
Becky Campbell, B.S. Principal Scientist in Program Oversight
Rebecca Campbell joined SEKISUI XenoTech in 2001. Prior to joining SEKISUI XenoTech, she obtained her Bachelor of Science in Biology from the University of Central Missouri and studied toxicology and pharmaceutical sciences at the University of Missouri-Kansas City School of Pharmacy. Rebecca has extensive experience in in vitro CYP induction studies, regulatory compliance, and project management. As a Principal Scientist in Scientific Operations, she is responsible for the conduct and oversight of the nonclinical, drug interaction-related contract studies in the Program Oversight Department of SEKISUI XenoTech’s Scientific Division.

Andrew G. Taylor, Ph.D. Manager, Technical Support for Services
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.

2C or Not 2C: CYP2C Induction Studies for Successful Preclinical Risk Assessment (Webinar)

This webinar was presented on Jan. 26, 2021 by Miki Fujishima, a manager in the Business Development Department at the Drug Development Solutions Center.

Synopsis:
Hepatotoxicity studies in preclinical development provide key data to de-risking a compound early or screening compounds out that would not meet regulatory scrutiny. Drug-Induced Liver Injury (DILI) incidents account for more than 10% of all cases of acute liver failure, posing a major clinical and regulatory challenge. While the cause of DILI is multifactorial and difficult to predict, there are known mechanisms that can be screened for in preclinical development using in vitro methods.

Two of these mechanisms are cholestasis and mitochondrial toxicity.

In cholestasis, bile acid accumulation leads to hepatocyte cytotoxicity, reducing the liver’s ability to function and causing tissue damage. Mitochondrial toxicity impacts cells’ energy source and can further inhibit function. Our cholestatic DILI assessments, including a functional assay and an ROC analysis, and mitochondrial toxicity assay can help you evaluate your compound’s risk of hepatotoxicity.

Key concepts discussed in this webinar will include:
 - DILI risk assessment planning and considerations
 - Overviews of following studies, including study design and test systems:
   - Bile Acid-Dependent Hepatotoxicity, an in vitro functional assay
   - Receiver Operating Characteristics (ROC) analysis to estimate clinical risk
   - Mitochondrial Toxicity assay, long- and short-term exposure experiments
 - Using functional assay data and ROC analysis together to better predict risk
 - Long versus short term assessment in mitochondrial toxicity assay design

Receive a copy of the slides and transcript: https://www.xenotech.com/access-adme-research-resources/resources/in-vitro-cholestatic-dili-mitochondrial-toxicity-studies-to-assess-hepatotoxicity/
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.

Sekisui XenoTech

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