Sharing knowledge has been a core tenet of XenoTech's ideology for the past 25+ years to help the industry understand, prepare for and address ADME/PK & Drug-Drug Interaction concerns. XenoTech is a global Contract Research Organization that provides unparalleled in vitro ADME/DDI experience utilized by 98% of top pharma companies and countless other organizations. For more than 25 years, the company has offered proven drug development expertise in evaluating drug candidates in compliance with regulatory requirements and guidance prior to entrance to market. The company offers a variety of in vitro safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism and pharmacokinetic research.

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Hepatocytes Demonstration Videos

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

In June 2022, the ICH released the first draft of its harmonized Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024.

Hear expert Dr. Brian Ogilvie discuss the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-highlights-of-the-in-vitro-sections-of-the-draft-ich-drug-interaction-studies-guideline-and-comparison-with-current-guidance/
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:
As Vice President of Scientific Consulting at XenoTech, Dr. Brian Ogilvie is responsible for operational activities within the Scientific Consulting and Quality Assurance departments, as well as strategic planning for the company in scientifically relevant areas. Dr. Ogilvie obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. Brian joined XenoTech in 1997 as a Scientist I and progressed into leadership as the head of the CYP Inhibition Department in 1999, with increasing levels of responsibility, ultimately to the current Vice President role. Dr. Ogilvie also serves as a Volunteer Assistant Professor of Pharmacology, Toxicology and Therapeutics for the University of Kansas Medical Center. He 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 XenoTech as an invited speaker at various drug metabolism conferences.

Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies Guideline and Comparison with Current Guidance

Learn about what CTD Section 2.6.4 consists of, the studies that are expected and how you develop the section over time from discovery to registering the compound. Key topics include:
 - Generation of ADME data for an NCE throughout development
 - Contents of final filing package
 - What ADME data should be contained at the time of IND
 - Types of ADME data typically found in IND
 - Interdependencies with other non-clinical sections
 - Additional detail on human dose projection and DILI liability prediction

This presentation was one of the keynote presentations from XenoTech's XenoTalks™ Seminar Series on the importance of ADME and Drug-Drug Interactions in drug development. You can register for or request a seminar here: https://www.xenotech.com/about/events/2022-seminar-series-the-importance-of-adme-and-ddi-in-drug-development/ or register to receive notifications of future events here: https://www.xenotech.com/contact/newsletter-sign-up/. These fully interactive events provide in-depth presentations from industry experts along with free food and drinks and good conversations. They cover various topics around pharmaceutical non/preclinical testing with specifics on how to effectively move compounds through the development pipeline.

About the presenter:
Griff Humphreys, Ph.D., is on XenoTech's team of external consultants. Prior to consulting, he spent 26 years at Bristol-Myers Squibb Pharmaceutical Company, with the last 12 years leading the Biotransformation Department. He received his graduate training at the University of Virginia in chemistry and completed a postdoctoral fellowship at Vanderbilt University in the Center in Molecular Toxicology. His research interests include the consequences of reactive metabolite formation, development of new analytical methodologies for metabolite detection, reaction phenotyping of CYP- and UGT-catalyzed biotransformations, predictive metabolism and toxicology models, in vitro–in vivo correlations, and strategies for candidate optimization. He has co-authored over 120 refereed manuscripts and numerous reviews and book chapters. Dr. Humphreys is a member of the ISSX and the ACS Chemical Toxicology Division (TOXI). He is on the Editorial Advisory Boards of Drug Metabolism and Disposition and serves as reviewer for multiple additional journals. He has served on the Executive Committee of TOXI since 2008 and most recently as Program Chair for the 2013-2014 National meetings. He is currently a member of the ISSX Council and was a member of the Meeting Organizing Committee for the 22nd NA ISSX Meeting.

Filing an IND and Beyond: Development of CTD Section 2.6.4, Pharmacokinetics Written Summary

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.

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