2020

ADME 101 In Vitro DDI Drug Transporter Studies Webinar: Efflux and Uptake Transporters

Aired:  30 June 2020

Presenter: Andrew Taylor, Ph.D., Services Technical Support Manager

Drug transport can be thought of as the AD&E in ADME, as transporters are responsible for absorption, distribution, tissue-specific drug targeting, and elimination of drugs. Since they are involved in so much of the movement of a compound through the body, they can be involved in many drug-drug interactions (DDI). The clearance of transporter substrates can be impacted by transporter inhibitors or inducers which can lead to toxicity or loss of efficacy.This short, information-packed webinar features:


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.

ADME 101 Drug Metabolism Webinar: Reaction Phenotyping Studies

Aired:  15 June 2020

Presenter: Andrew Taylor, Ph.D., Services Technical Support Manager
 

It is important to identify the enzymes that significantly contribute to the metabolism of a drug candidate and to evaluate the potential of a drug candidate to be a victim or perpetrator. Knowing how a drug candidate is eliminated by the human body is important in understanding the potential for drug-drug interactions. Compounds with a single route of elimination have a high victim potential, which is why the FDA requires reaction phenotyping studies. This short, information-packed webinar features:

  • An overview of drug metabolism studies
  • 2020 FDA recommendations
  • Standard CYP reaction phenotyping study designs (recombinant enzyme, chemical inhibition or correlation analysis) and when to perform them
  • Test system selection and more...

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.

ADME 101 Drug Transporter Studies Webinar: Lysosomal Trapping

Aired:  29 May 2020

Presenter:  Andrew Taylor, Ph.D., Services Technical Support Manager
 

This ADME 101 video discusses how compounds can become trapped by lysosomes, which can lead to high organ-to-blood ratios and mistaken for active drug transport, how concomitant administration of lysosomotropics could lead to elevated drug exposure levels, and how accumulation of lipophilic amines can lead to drug-induced phospholipidosis due to decreased phospholipid catabolism. This short, information-packed webinar features:


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.

ADME 101 Guide to Subcellular Fractions and When to Use Which Test System

Aired:  13 May 2020

Presenter:  Chris Bohl, Ph.D., Global Technical Support Manager
 

This ADME 101 video provides an overview of different types of subcellular fractions, such as microsomes, S9, cytosol, lysosomes and homogenate, and their unique benefits for use in various types of vitro ADMET/DMPK & Drug-Drug Interaction studies. This short, information-packed webinar features:

  • The different types of subcellular fractions
  • How they are made
  • Who uses them, for which studies, and why
  • Advantages of the test systems
  • Different preparation options
  • Whether to use a NADPH regenerating system or 1mM NADPH
  • How tissue is procured and more...

About the presenter: 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.

In Vitro Inhibition Studies: Elements of Design and Important Considerations in Data Analysis

Aired:  06 May 2020

Presenter: Jennifer Horkman, Senior Scientist in Program Oversight at SEKISUI XenoTech
 
When evaluating drug-drug interaction (DDI) risk of an investigational drug, a battery of studies is needed to investigate victim/perpetrator potential. One of these comprises evaluation of the potential of a new therapy to inhibit drug-metabolizing enzymes, which can impact clearance of concomitantly administered drugs. The team at SEKISUI XenoTech has built a reputation of dedicating high-quality resources and specialists to conduct such studies with scientific rigor.

In this webinar, Jennifer will address frequently asked questions from sponsors seeking inhibition studies and elaborate on some recommendations we give to achieve successful regulatory submission. Points of discussions will include an overview of enzyme inhibition studies and critical considerations in design, from determination of supporting data to conclusive interpretation.

Key concepts discussed in this webinar will include:

  • Why is measuring CYP inhibition important?
  • Terminology for enzyme kinetics
  • FDA guidance requirements
  • CYP inhibition study design
  • Types of enzyme inhibition
  • Standard study considerations
  • CYP inhibition decision tree
  • IC50 determinations
 
About the presenter: Jennifer Horkman has more than 15 years of experience at SEKISUI XenoTech. First joining the company in a customer service role, Jenny moved into test system production, specializing in hepatocyte isolation and cryopreservation; and then into conducting enzyme inhibition studies. She is now a Senior Scientist in our Program Oversight department, serving as scientific reviewer and Study Director of multiple nonclinical, drug interaction-related contract studies across multiple disciplines in compliance with Good Laboratory Practices (GLP), The Organisation for Economic Co-operation and Development (OECD) Principles of GLP, and/or Japan Ministry of Health and Welfare (MOHW) GLP Standards.

Comparison Between the Final US FDA, Japan PMDA, and EMA In Vitro DDI Guidance Documents: Are We Finally Harmonized?

Aired:  21 April 2020

Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting
 
In January, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Ogilvie will offer his expert perspectives on major changes to the document, whether they will impact your drug development strategy, and with over 25 years of experience on the subject, what SEKISUI XenoTech’s strategy is to address potential development challenges presented by the final guidance. He will also compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three.

Key concepts discussed in this webinar will include:
  • An overview of the major changes
  • Are these recommendations or requirements?
  • Views of the worldwide DDI guidance landscape
  • A comparison of each agency’s guidance documents
  • A comparison of the equations and cutoff values
  • A comparison of experimental details
  • How to design studies to meet the expectations of each agency’s guidance documents
  • Impacts on in vitro DDI study design and interpretation
  • How SEKISUI XenoTech approaches developing effective strategies to ensure drug development programs are not delayed
  • Why good science is always a trump card
 

Approved registrants will receive a link to the recording, slides and comparison poster.

In Vitro ADME & Drug-Drug Interaction Considerations for Toxicologists

Aired:  17 April 2020

Presenter: Pallavi Limaye, Ph.D., DABT, SEKISUI XenoTech Director of Scientific Consulting with special Q&A guest, Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting
 
Originally scheduled to be presented at the canceled Society of Toxicology (SOT) 59th Annual Meeting & ToxExpo, our experts are bringing the tradeshow to you! Dr. Limaye will be discussing the intersection of ADME and toxicology in this webinar, followed by a live Q&A to address audience questions and comments.

In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. This ADME 101 webinar will provide insights at a high-level related to regulatory drivers, investigatory objectives, and practical concerns for such studies that are relevant to interested general toxicologists. Participants will gain insight as to the critical need and utility for in vitro ADME and DDI investigations as related to drug development. Regulatory expectations will be reviewed as will points of particular interest for enabling successful achievement of investigatory goals.

Key concepts discussed in this webinar will include:
  • Why run these studies?
  • Predominant types of in vitro ADME & Drug-Drug Interaction (DDI) studies
  • When to conduct these studies
  • Areas of concern: Proper design & interpretation
  • And other highlights and information...

Register to watch on-demand after the event

ADME 101: Considerations & Calculations When Sending In Vitro Test Articles

Aired:  06 April 2020

Presenter: Patrick McAnulty, SEKISUI XenoTech Scientist II, Program Design
 
This ADME 101 webinar discusses the #1 most frequently asked question that our Protocol Design team receives: “How much test article do I need to send for an in vitro drug metabolism or drug-drug interaction study?” The video outlines the important factors to consider when calculating the quantities of test article needed for top treatment concentrations that will meet regulatory guidance recommendations, including:

  • What are the properties of the test article?
  • What is the scope of the work?
  • What concentrations do the guidance documents say need to be tested?
  • What concentration of stock solution needs to be made?
  • What solvent percentage can we use in our incubation solutions?
  • Common concerns and more...

About the presenter: Patrick McAnulty has a Master of Science in Biomedical Sciences from the University of Missouri - Columbia. As a Scientist II in SEKISUI XenoTech's Program Design department, Patrick is responsible for preparing study protocols for disciplines such as enzyme inhibition, enzyme induction, drug metabolism, drug transport, and metabolic profiling.

The Basics of In Vitro Xenobiotic Metabolism and Drug-Drug Interaction Investigations: Applicability to All Xenobiotics

Aired:  03 April 2020

Since SOT's 59th Annual Meeting and ToxExpo has been canceled due to COVID-19 concerns, we are bringing the tradeshow to you! SOT is hosting this course virtually on April 3rd from 12-3:30pm EDT. Our VP of Consulting, Dr. Brian Ogilvie, will be conducting the workshop alongside our founder, Andrew Parkinson, and an excellent list of presenters including:


If you cannot attend, a recording of the virtual course will become available to registrants on SOT's website approximately 1 week after the event. The course number for the workshop is AM07.

FAQ: Tips & Tricks for Working with Plateable Hepatocytes

Aired:  24 February 2020

Presenter: Halee McElhaney, SEKISUI XenoTech Team Lead, Quality Control

In the latest installment of ADME 101, one of our hepatocyte experts answers frequently asked questions about plateable hepatocytes, discusses common reasons why hepatocyte plating fails and demonstrates helpful techniques that will improve the performance of your plated hepatocytes in your in vitro assays. Topics include:

  • What are plateable hepatocytes used for?
  • What do we consider to be an attaching lot?
  • How do I choose which species to use?
  • How do I know what concentration is best for seeding?
  • What’s the difference between CryostaX and traditional hepatocytes?
  • How crucial is accurate cell count?
  • How long can my cells sit before I plate them?
  • Why do I have to wait until the next day to overlay rat hepatocytes?
  • My 96 wells aren’t working; what am I doing wrong?

To learn more, please review our hepatocyte thawing and plating protocol and watch our demo videos.

About the presenter: Halee McElhaney joined SEKISUI XenoTech in 2013 and is now one of our primary hepatocyte experts (pun intended). She has been on both sides of hepatocyte production. She started performing animal perfusions and processing tissue. Now she cultures hepatocytes for both in-house characterization and customers, provides quality control for all hepatocyte lots, troubleshoots in-house and client issues, and processes and interprets data. She also performs R&D and provides training for our team of Product Specialists.

ADME 101: Metabolite ID & Characterization Studies FAQ

Aired:  17 February 2020

Presenter: Mark Horrigan, SEKISUI XenoTech Principal Scientist, Program Oversight

In this short, information-packed ADME 101 video, one of our study directors discusses the main frequently asked questions that we receive about metabolite identification and characterization studies. Major topics of the presentation include:


About the presenter: Mark Horrigan joined SEKISUI XenoTech in 2005 as a Senior Mass Spectrometry Specialist and Qualitative Analysis group leader. Since then he has served as a Principal Scientist in the Drug Metabolism and Program Oversight Departments.