Important DDI Considerations for Repurposing Drugs to Treat COVID-19

Author: Madison Knapp Posted: 08 June 2020

In the battle against a global pandemic, time is of the essence. In some cases, drug developers can circumvent the years of development it takes to make a new therapy by turning to compounds which have already gone through the gamut of preclinical and clinical testing to vet as potential treatments for patients suffering from acute respiratory distress caused by COVID-19. However, urgency must not come at the sacrifice of due diligence since the risk of drug-drug interactions can be increased...

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Missing Out on Annual ‘Comforting of the Soul’

Author: Deja Coffin, Madison Knapp, Jolanta Golec Posted: 29 May 2020

Every year, Japanese laboratories pay homage to animals sacrificed in experiments in a national memorial ceremony known as ireisai. Though the event has been canceled this year out of deference to social distancing practices, our partners at the Drug Development Solutions Center would like to share with our international community a moment to honor the lives given to improve our understanding of therapeutics and advance safe drugs to patients who need them...

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What is DMPK and how does it fit into drug development?

Author: Madison Knapp Posted: 11 May 2020

Drug metabolism and pharmacokinetics (DMPK) is a core discipline in drug development that considers the biotransformation of a drug compound and other pharmacokinetic properties to assess drug safety. DMPK studies allow drug developers to experimentally evaluate intrinsic properties of a drug candidate to validate that it can and will be cleared from the body, when administered to a patient, without producing harmful byproducts (metabolites), reaching dangerous exposure levels (toxicity), or causing adverse side effects. This class of in vitro and in vivo studies can also help drug developers to predict potentential risks, early in drug development, as well as provide nonclinical evidence to justify decisions or explain clinical observations...

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ADME and Drug-Drug Interactions for the Toxicologist

Author: Madison Knapp Posted: 28 April 2020

In her recent webinar (now available for free access to registrants), Dr. Pallavi Limaye discusses in vitro absorption, distribution, metabolism, and excretion (ADME) and drug-drug interaction (DDI) studies and their utility in preclinical safety evaluation as well as early decision making for Investigational New Drug (IND)-enabling preclinical studies and overall drug development...

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Meet the Scientist: Pallavi Limaye

Author: Madison Knapp Posted: 28 April 2020

We have welcomed a new consultant to the team! Dr. Pallavi Limaye now serves as a Director in the Scientific Consulting Department where she is available to support clients with expert advice. Our consulting team provides gap analyses, mechanistic static modeling for drug-drug interactions, response to regulatory questions, and more...

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New TMPRSS2-Expressing Cell Line for COVID-19 Research

Author: Madison Knapp Posted: 23 April 2020

We are offering a brand new cell line to assist researchers in the fight against COVID-19.
The cell line (JCRB1819), developed by Dr. Takeda at the National Institute of Infectious Diseases in Japan, is cited in two peer-reviewed publications...

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What is ADME and how does it fit into drug development?

Author: Madison Knapp, Dr. Brian Ogilvie Posted: 10 April 2020

The main aim of drug development is to get a compound that has a therapeutic effect into the form of a medicine we can dose to patients. A drug must reach the site of action, exert its pharmacological effects, and be eliminated in a reasonable timeframe – preferably to allow once-per-day dosing. Characterization of absorption, distribution, metabolism, and excretion (ADME) properties help to explore and explain how pharmacokinetic processes happen, so as to provide safety considerations of a new drug on which risk-based assessments can be made...

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COVID-19 Updates

Author: SEKISUI XenoTech Posted: 25 March 2020

Although somewhat affected, our services, test systems and customer support have not stopped and additional presentations will be made available online...

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In Vitro Evaluation of Drug-Drug Interaction (DDI) Potential

Author: Madison Knapp, Zach Mitts, Dr. Joanna Barbara Posted: 24 March 2020

In its most recent in vitro drug interaction guidance update, the FDA emphasized harmony with the EMA and PMDA on the importance of a risk-based approach to mitigating adverse drug reactions with new compounds by evaluating drug interactions prior to first-in-human studies. In our newest blog post, we explore the core in vitro DDI studies and the interconnection of ADME, PK, and DDI...

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Four ways to optimize preclinical in vitro data to mitigate risk of late-stage clinical failure

Author: Madison Knapp Posted: 09 March 2020

Pharmacokinetics and defensible risk assessment can make or break a drug’s chances of success in the clinic. Here are 4 tips for avoiding technical and translational pitfalls by strategically using preclinical results to identify possible safety concerns, such as drug-drug interactions or toxicity...

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How can in vitro and in vivo studies help me understand my drug’s clearance?

Author: Madison Knapp, Dr. Joanna Barbara Posted: 05 March 2020

Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical importance to a drug candidate’s pharmacokinetic profile. Tools such as the Extended Clearance Classification System (ECCS) and in vitro-in vivo extrapolation (IVIVE) can help drug developers predict the rate at which a drug compound is eliminated. Information gleaned from these applications support a risk-based approach to pharmacokinetic evaluation of a drug candidate and may inform dosing considerations and clinical study design...

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KC Business Journal: KCK company helps Big Pharma save money at the molecular level

Author: Lily Lieberman Posted: 27 February 2020

The Kansas City Business Journal recently interviewed representatives from SEKISUI XenoTech's leadership to profile our company...

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Meet the Scientist: Andrea Wolff

Author: Michael Millhollen Posted: 20 February 2020

This month's featured scientist is Andrea Wolff, Director of Service Logistics, who has been with SEKISUI XenoTech since 1999. Andrea shares her perspective on how SEKISUI's 3S Principles are put into practice...

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Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success

Author: Madison Knapp Posted: 13 February 2020

When do you need to do ADME/DMPK/DDI studies? What are regulators expecting in terms of DMPK studies during drug development to make sure an investigational new drug will be safe to give to clinical trial volunteers?

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Meet the Scientist: Mark Horrigan

Author: Michael Millhollen Posted: 27 January 2020

Continuing our effort to put faces to the names of some of the scientists you interact with at SEKISUI XenoTech, we interviewed one of our study directors, Mark Horrigan, who has been part of the company since 2005...

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SEKISUI CHEMICAL selected as one of the 2020 Global 100 Most Sustainable Corporations in the World for the third year running

Author: Michael Millhollen Posted: 24 January 2020

We are delighted to share that our parent company, SEKISUI CHEMICAL, has been ranked 12th overall in the "2020 Global 100 Most Sustainable Corporations in the World index (2020 Global 100)". Not only is this our highest ranking to date, but the highest ranked Japanese company this year. SEKISUI CHEMICAL has also been placed on the Climate Change A List for the 2nd year in a row...

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How Can I Make Sure My Data Meets Regulatory Expectations?

Author: Madison Knapp, Greg Loewen Posted: 10 January 2020

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to know exactly how to plan assays to get acceptable data. Luckily, our scientists have made a career of piecing it all together...

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What You Need to Know About Micro-Autoradiography (mARG) Distribution Studies

Author: Jolanta Golec, Madison Knapp Posted: 19 December 2019

In vivo determination of drug localization in tissue can be uniquely informative to drug developers investigating distribution within the context of the ADME/pharmacokinetic profile of their drug compounds. Micro-autoradiography can demonstrate sites of accumulation of a drug and drug-related material, which can be used as supplemental data for evaluation of parameters such as toxicity, efficacy, drug penetration, or differential metabolite distribution...

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What In Vitro Metabolism and DDI Studies Do I Actually Need?

Author: Madison Knapp, Greg Loewen Posted: 25 November 2019

While there may not be a set ‘roadmap’ spelling out the studies required to achieve regulatory approval of every drug candidate, recent documents published by FDA, EMA, and PMDA highlight several in vitro studies evaluating metabolism and potential for drug-drug interaction...

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In Vivo ADME Expertise Providing Cost Savings

Author: Scott Hickman Posted: 19 November 2019

Over 10 years ago, SEKISUI and the expertise of the Tokai Drug Development Solutions Center in Japan merged with XenoTech in Kansas City, KS. This adjoining was a marriage made from similar values and the shared importance of quality, experience and expertise. If you haven’t worked with our Tokai laboratory, we don’t want you to miss out on the incredible value of this famous laboratory. So we have lowered pricing on many of our in vivo services so you can experience the same quality studies they have always offered but at a reduced price...

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Mass Balance Studies: What You Need and Why You Need It

Author: Jolanta Golec, Madison Knapp Posted: 15 November 2019

In vivo mass balance studies are an important element of nonclinical drug development, to inform first in-human (FIH) studies and to understand the pharmacokinetic (PK) profile of a drug. Not only do you need it for dosimetry calculations to determine appropriate radiolabeled dose in human absorption, metabolism, and excretion (hAME) studies, but lucidating PK properties can help bridge activity and toxicity data to paint a full picture of a drug’s behavior in patient populations...

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Meet the Scientist: Rachel Murphy, PhD

Author: Michael Millhollen Posted: 06 November 2019

We thought it might be nice to put faces to the names of some of the scientists you interact with at SEKISUI XenoTech, so we're recording video interviews with various team members about what it's like working here and what motivates them to do what they do. In this interview, Dr. Murphy discusses how our foundational 3S principles influence her daily work life...

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I have my data… Now what?

Author: Madison Knapp Posted: 16 October 2019

In planning the steps to gather crucial nonclinical data components for an IND submission, developers can perform studies in house or work with a specialty CRO. Read about considerations that should impact your choices and the benefits of partnering with experts in our most recent blog post...

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The FDA has requested follow-up data... how do I fill in the gaps?

Author: Madison Knapp Posted: 09 October 2019

The best way to evaluate risk and important safety considerations for the patient is going beyond a ‘box-checking’ approach. ADME and DDI are two often overlooked areas of investigation for a new drug because they are often not directly prescribed, but the information you can glean from those data are crucial for painting a complete picture of a drug’s disposition and can help drug developers gather necessary components for a comprehensive data package...

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Why You Need QWBA for Human Radiolabeled ADME Studies

Author: Madison Knapp, Satoshi Ito Posted: 04 October 2019

Quantitative whole body autoradiography (QWBA) is an in vivo study in which a rat (or in some cases mouse) is dosed with radiolabeled test article and at successive time points radioactivity is measured in cross-sectioned slides of the whole animal to show distribution over time. Dosimetry data from QWBA is required for planning hAME radiolabeled mass balance studies in the clinic and can be useful to inform pharmacokinetics (PK) considerations such as distribution. This post describes standard study design and why you should be planning your QWBA studies in advance to make the most of your time and resource investment...

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Sekisui XenoTech Named Best In Vitro Drug CRO 2019

Author: Michael Millhollen Posted: 19 September 2019

SEKISUI XenoTech has been named the Best In Vitro Drug CRO in the 2019 Healthcare & Pharmaceutical Awards...

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How to Choose the Right Test Systems for Your DMPK Studies

Author: Madison Knapp, Dr. Chris Bohl Posted: 12 September 2019

There are so many options available to DMPK scientists for test systems, and different considerations to keep in mind for matching the right products to fit your application. Not everyone has the time to comb through methods sections of journal articles to figure out whether to use microsomes or S9 for a certain assay, so our new blog post gives you the broad strokes of how to choose the right test system for your DMPK studies...

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SEKISUI XenoTech Named a 2019 Top-Performing Provider on Science Exchange

Author: Michael Millhollen Posted: 04 September 2019

Science Exchange surveyed scientists on the challenges they face and compiled a list of top providers in the most requested service categories based on responsiveness, productivity, and requester endorsements. SEKISUI XenoTech ranked in the top 5 providers...

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Cypex Adds Recombinant UGTs

Author: Madison Knapp Posted: 03 September 2019

Cypex has just announced the rollout for out a new line of recombinant UGTs...

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Can CYP3A4 Induction Predict P-glycoprotein Induction in DDI Studies?

Author: Shanté Jackson, Madison Knapp Posted: 20 August 2019

Earlier this summer, one of our Research Scientists attended the international conference on Drug-Drug Interactions in Seattle, WA. Read her takeaways from one of the presentations discussing how CYP3A4 induction data can be predictive of P-gp, OATP, and CYP2C9 activity in DDI studies. The digest covers experimental design and conclusions, clinical implications, and forward direction in key drug development program considerations...

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Reduced Pricing for In Vitro Transporter Studies

Author: Madison Knapp Posted: 20 August 2019

Our scientists’ ongoing dedication to enhancing our processes and discovering new efficiencies without sacrificing quality has allowed us to offer our customers reduced pricing on transporter studies...

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Consultancy Expansion

Author: Madison Knapp Posted: 20 August 2019

We're expanding our pool of consultants who can help you plan your drugs’ path to market, find answers to unexpected challenges, and consider your options to move forward wisely...

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Sekisui XenoTech Named Best for Drug Candidate Evaluations 2019, Leading Providers of Pharmaceuticals Safety Testing

Author: Michael Millhollen Posted: 12 August 2019

SEKISUI XenoTech has been named the Best for Drug Candidate Evaluations and was recognized for leadership in Pharmaceutical Safety Testing in the 2019 International Lifesciences Awards...

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In Vivo ADME: What You Need and Why You Need It

Author: Madison Knapp, Satoshi Ito Posted: 22 July 2019

Are you in need of in vivo studies to support your IND application but unsure where to start? This blog post out outlines foundational in vivo ADME steps to make your submission package more compelling; cover all your bases with staple absorption, distribution, metabolism, and excretion studies performed by the experts and learn more about timing supplemental studies earlier to avoid late-stage failure and the high expense of conducting critical ADME studies late in development...

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The Story of Us

Author: Madison Knapp, Satoshi Ito Posted: 01 July 2019

This year at SEKISUI XenoTech we celebrate our 25th birthday, and our Japan branch turns 64! Read about our journey from a small academic research lab to the trusted global Contract Research Organization we are today, as well as our sister lab's path to becoming the top ADME CRO in Japan...

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Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents

Author: Madison Knapp, Dr. Brian Ogilvie Posted: 25 June 2019

In May, Dr. Brian Ogilvie gave a webinar presentation titled “Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents.” Read about key takeaways from the presentation: transporters discussed in most recent FDA and ITC publications, a case study examining effects of OCT1 polymorphisms on sumatriptan AUC, the Extended Clearance Classification System, and consideration of transporters involved in atypical routes of administration...

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Make the Most of Your Media

Author: Madison Knapp, Dr. Chris Bohl Posted: 19 June 2019

Getting reliable, reproducible results from studies using hepatocytes as a model system for drug metabolism is in part dependent on how well you store and handle the cells. Hepatocytes require more finesse than other cell types, and some considerations and precautions in handling might not be obvious to scientists that are new to performing studies using cryopreserved, primary hepatocytes, but have experience with cell lines. Additionally, making the right choices with respect to media is key to seeing the best results in viability, attachment, and culture life of your cells. Here we discuss some tips for handling hepatocytes and making the most of your media...

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

Author: Madison Knapp, Rebecca Campbell, Dr. Joanna Barbara Posted: 13 May 2019

Enzyme Induction studies provide insight to a compound’s potential for DDI (drug-drug interaction) and is a required component for an IND submission. Induction potential is informed by testing a compound’s effects on cytochrome P450 (CYP) enzymes representative of three major receptor pathways involved in expression of drug metabolizing enzymes and transporters. In a webinar in April of 2019, Dr. Joanna Barbara addressed frequently asked questions, important study design considerations, and interpretation of study results, discussed here...

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Official PMDA English Translation

Author: Dr. Brian Ogilvie, Madison Knapp Posted: 07 May 2019

The Japanese regulatory agent PMDA (Pharmaceuticals and Medical Devices Agency) recently published an official English translation of their final Drug Interaction Guideline document which describes recommended approaches by which new drug entities should be evaluated for drug-drug interaction potential prior to (or concurrently with) clinical trials and market entry in Japan. The PMDA made a correction to one legend in the final guideline. Read more about the differences from the translation of the draft document...

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Quality Control is What Makes the Comprehensive Collection of Cell Lines from JCRB Among the Highest Regarded and Most Widely Distributed in the World

Author: Dr. Arihiro Kohara, Kimiho Yamada, Madison Knapp Posted: 23 April 2019

We are proud to be the exclusive distributor in North America and Europe for the Japanese Collection of Research Bioresources, a cell bank with over a thousand unique cell lines used in research labs worldwide. Of utmost importance to JCRB is quality assurance, from acquisition through storage and distribution. Read more about the methods JCRB employs to maintain high standards in quality and care for their cell lines…

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Minding Your Binding: Plasma Protein Binding Potential Study Now Available at Our US and Japan Labs

Author: Madison Knapp, Andrea Wolff, Dr. Joanna Barbara Posted: 15 April 2019

Plasma Brotein Binding potential is an important part of safety considerations for a drug candidate, and data can affect dosing considerations in clinical trials. PPB studies, now available on our KC campus, use Rapid Equilibrium Dialysis to determine fraction unbound so you can reliably measure free drug concentration for therapeutic effect. Read more about the features and benefits of this updated service...

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Studies in Japan: Easier & More Beneficial than You Might Think

Author: Madison Knapp Posted: 08 April 2019

The idea of sending compounds to labs outside the country may be daunting, but partnering with SEKISUI XenoTech makes it easy. Our US lab is well-known for unparalleled experience in quality in vitro ADME/DMPK/DDI studies and complementary products, but did you know that our Tokai campus is the number one market share holder in ADME studies in Japan?

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Can Interactions Between Therapeutic Proteins and Small Molecule Drugs Be Evaluated In Vitro?

Author: Greg Loewen, Dr. Maciej Czerwinski Posted: 04 April 2019

Even with the rise of biologics, small molecules make up most of prescribed drugs around the world — how do they interact with large molecule therapies like therapeutic proteins?

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New Liver Tissue Microarrays Available – What Would Benefit Your Research?

Author: Madison Knapp, Dr. Maciej Czerwinski Posted: 02 April 2019

Liver disease research is expanding, and researchers need the best available materials with which to expand knowledge in this area. SEKISUI XenoTech offers a variety of tissue microarrays for use in applied and academic research, and has conducted studies utilizing a newly available pediatric array to advance understanding in hyaluronan deposition and CYP activity in children affected by liver dysfunction...

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Disease-State Test Systems

Author: Dr. Chris Bohl, Michael Millhollen Posted: 13 January 2019

Sekisui XenoTech has been working with and supplying reagents for the pre-clinical ADME field for well over two decades. Years of acquiring and banking human liver tissues for the production of hepatic subcellular fractions and hepatocytes has allowed us to be able to identify and produce interesting and novel hepatic disease state test systems for research groups. These test systems form the basis for our Research Biobank. We also partnered with the National Institute of Biomedical Innovation to distribute the Japanese Collection of Research Bioresources (JCRB) Cell Bank’s extensive selection of cell lines to North America and Europe...

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Important Considerations for the Conduct of In Vitro Drug Transporter Assays

Author: Greg Loewen, Andrea Wolff, Michael Millhollen Posted: 11 January 2019

Not only can drug transporters affect the absorption and excretion of drugs, they can be involved in pharmacokinetic-based drug-drug interactions (DDI), impacting distribution into tissues as well as the overall exposure of the drug. As a result, regulatory bodies such as the FDA, EMA and PMDA recommend studying the potential of NCEs to be inhibitors or substrates of drug transporters in vitro in order to better understand the ADME and DDI potential of drugs and help determine if clinical studies should be performed. The design and scope of in vitro transporter studies can vary depending on the physicochemical properties and major route(s) of excretion of the drug and should be considered when designing and performing in vitro studies that will support a new drug application (NDA) or decisions to run clinical DDI studies...

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5 Keys to Set Your Contract Research Organization (CRO) Collaboration Up for Success

Author: Kelsey Pigg, Michael Millhollen Posted: 07 January 2019

Over the past 25 years of performing ADME/DMPK/DDI contract research, we’ve learned some key strategies to maximize the efficiency and effectiveness of our clients’ studies. Here are a few critical considerations that will help you ensure that your studies are completed on time and deliver the most accurate, relevant data...

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Holiday CSR Activities

Author: Michael Millhollen, Deja Coffin Posted: 26 December 2018

Sekisui understands that a better future starts with our actions today, and encourages its global family to remain focused on contributing to society through our business activities. This includes a commitment to environmental stewardship, our customers, diversity in human resources and giving back to our communities. This holiday season, Sekisui XenoTech employees participated in numerous efforts, including a Harvesters Food Drive, Angel Tree and volunteer work...

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2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies

Author: Dr. Brian Ogilvie, Andrea Wolff Posted: 06 December 2018

While the 2017 FDA DDI guidance contains many important changes, the earlier timing of drug-drug interaction studies is perhaps the most daunting. This is especially true for developers with drugs in the later clinical stages. Does this guidance mean sponsors are required to backtrack, and if so, how far? This article outlines the implications of these new timing requirements and best practices for negotiating them efficiently and effectively moving forward...

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SEKISUI Continues Environmental Awareness and Sustainability Efforts

Author: Michael Millhollen Posted: 03 December 2018

SEKISUI participated in the Natural Capital Week in Paris and “Forum on Decarbonizing the Economy” panel while Sekisui XenoTech made progress towards our sustainability goal of zero emissions and zero landfill...

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Coverage from the October 2018 PBSS DDI Workshop

Author: Greg Loewen, Michael Millhollen Posted: 05 November 2018

The Pharmaceutical and BioScience Society (PBSS) hosted the workshop “Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation and Regulatory Requirements” on October 16 at the Crowne Plaza Hotel in Foster City, CA. The workshop was well attended and provided a great update on DDI potential...

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October Presentations on In Vitro Effects of Biologics on CYP Enzymes and Regulatory DDI Guidances

Author: Michael Millhollen Posted: 26 October 2018

Dr. Brian Ogilvie presented on In vitro Direct and Cytokine-Mediated Effects of Therapeutic Peptides and other Biologics on CYP Enzymes at the Peptide ADME Discussion Group Workshop and a Comparison Between the US FDA, EMA and Japan PMDA In Vitro DDI Guidances: Are we Closer to Harmonization? at the DMDG-SPS Joint Meeting in Gothenburg, Sweden...

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To GLP, or Not To GLP?

Author: Scott Hickman, Dr. Brian Ogilvie, Tim Patterson Posted: 05 October 2018

In vitro drug interaction studies do not necessarily need to be performed under GLP conditions. To learn more — and probably save time and considerable money — read this article...

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New Recommendation: Evaluate NMEs for OCT1 Transporter-Mediated DDI Potential

Author: Andrea Wolff, Brian Ogilvie Posted: 01 October 2018

Patient-to-patient variability in the activity of liver transporter OCT1 turns out to be a huge factor in the therapeutic activity and clearance of several commonly prescribed drugs. Dr. Brian Ogilvie presented a case for in vitro OCT1 transporter studies in 2017 based on the effects of polymorphisms on sumatriptan, and now the International Transporter Consortium (ITC) is weighing in. Learn some of the highlights of their August 2018 recommendations (like why OCT1 studies matter)...

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Cypex Expands Portfolio of Recombinant Enzymes

Author: Scott Hickman Posted: 18 September 2018

Cypex offers an extensive portfolio of Cytochrome P450 (CYP) enzymes (Bactosomes) prepared using their patented technique involving expression in E. coli, rather than in insect cells. In addition to humanmouse, monkey and rat enzymes, Cypex has introduced several dog, insect and pig CYPs. These recombinant enzymes, available as preparations with activity levels similar to those found in vivo, or as preparations with a high activity, are ideal test systems for preclinical reaction phenotyping and inhibition studies...

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New Rodent, Monkey CryostaX Hepatocytes Featured in Industry News

Author: Michael Millhollen Posted: 13 September 2018

Following Sekisui XenoTech's announcement Sekisui XenoTech Adds Monkey, Rodent Hepatocytes to Patented CryostaX Product Line, Anticipates the End of Traditionally Cryopreserved Hepatocytes, various industry publications have posted coverage...

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Challenges & Solutions in Today’s In Vitro Transporter Research

Author: Dr. Joanna Barbara, Michael Millhollen Posted: 30 August 2018

In vitro drug transport assays are performed throughout drug development and range from simple permeability screens to kinetic assessments in complex assay formats. Sometimes interpreting transporter assay results is straightforward, and sometimes applying the data to make smart decisions is challenging...

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Sekisui XenoTech Named Best Global CRO 2018; Recognised Leaders in Pharmaceutical Safety Testing 2018

Author: Michael Millhollen Posted: 24 August 2018

Sekisui XenoTech has been named the Best Global CRO and was recognized for leadership in Pharmaceutical Safety Testing in the 2018 International Lifesciences Awards...

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Response to FDA Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins RFI and Comments

Author: Michael Millhollen Posted: 06 August 2018

In July, Drs. Maciej Czerwinski, Director of Consulting, and Brian Ogilvie, Vice President of Scientific Consulting, submitted Sekisui XenoTech’s comments in response to the Food and Drug Administration (FDA) public docket to assist with its development of a policy/guidance document on the assessment of drug-drug interactions (DDIs) for therapeutic proteins (TPs)...

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IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction - Focus on CYP3A4 mRNA

Author: Scott Hickman, Dr. Brian Ogilvie Posted: 13 July 2018

Sekisui XenoTech made contributions to the June 29th paper entitled, “Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA in vitro response thresholds, variability, and clinical relevance.” This paper, prepared by the IQ Induction Working Group of The International Consortium for Innovation & Quality in Pharmaceutical Development (IQ) and found in the journal Drug Metabolism and Disposition, provides recommendations that do not supersede any regulatory guidance at this time, but do guide pharmaceutical companies on how to conduct CYP induction studies...

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New Guidance on Bioanalytical Services

Author: Seema Muranjan, Scott Hickman Posted: 06 July 2018

On May 24, 2018, the US Food and Drug Administration (FDA) released new Bioanalytical Method Validation Guidance for Industry. Sekisui XenoTech’s approach to method validation is based on this bioanalytical guidance document, along with the most recent European Medicines Agency (EMA) 2011 Guideline on bioanalytical method validation...

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No-Cost, On-Demand Primary Human Hepatocyte Pooling Using CryostaX Pellets

Author: Dr. Chris Bohl, Michael Millhollen Posted: 15 June 2018

CryostaX® hepatocytes are created using a patented process that produces unique single-donor cell pellets, allowing unprecedented ease and versatility for custom pooling...

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AAPS-FDA Drug Transporters in ADME Workshop Recap

Author: Greg Loewen, Michael Millhollen Posted: 30 May 2018

The AAPS and FDA co-sponsored the workshop “Drug Transporters in ADME: From the Bench to the Bedside.” There were 26 presentations covering numerous aspects of transporter science as well as poster sessions...

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NADPH RapidStart regeneration system for extended metabolism

Author: Isabelle Nobiron, tebu-bio Posted: 30 May 2018

A post from our EU partner, tebu-bio, on NADPH regeneration for ADME-Tox studies using recombinant CYPs (incl. bactosomes) or cellular fractions (Microsomes, S9)...

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In Vitro DDI Regulatory Guidance Reference Poster

Author: Michael Millhollen Posted: 29 May 2018

Download Sekisui XenoTech’s poster outlining the current FDA, EMA & PMDA guidance experimental details, equations, cut-off values, etc. for in vitro drug-drug interaction studies...

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Maximize Metabolic Activities by Limiting Hepatocyte Cryoinjury

Author: Dr. Chris Bohl, Michael Millhollen Posted: 01 May 2018

Cryopreservation and thawing of primary hepatocytes causes inherent damage to the cells. However, utilizing a single-freeze method for pooling donors is shown to preserve higher metabolic activity...

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Assess catabolic stability of biologics & ADCs with Lysosomes – Characterized test systems

Author: Isabelle Nobiron, tebu-bio Posted: 30 April 2018

A post from our EU partner, tebu-bio, on the characterization of isolated human liver lysosomes, and validating them as test systems for in vitro assessment of catabolic stability of biologics drugs entering the cell by the endosomal–lysosomal pathway...

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No More Water Baths! Simplify Hepatocyte Thaws and Eliminate Contamination

Author: Dr. Chris Bohl, Michael Millhollen Posted: 03 April 2018

By eliminating the need for water baths, a significant source of tissue culture contamination can be removed, efficiency is increased and performance variability is decreased...

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Sekisui XenoTech Adds US and Japanese Support for MATE1 and MATE2-K Drug Transporter Studies

Author: Michael Millhollen Posted: 02 April 2018

Sekisui XenoTech now offers MATE1 and MATE2-K drug transporter evaluation services at our research labs in the USA as well as Japan!

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Sekisui Medical Celebrates its 10th Anniversary

Author: Michael Millhollen Posted: 01 April 2018

It's been 10 years since Sekisui Medical Co., Ltd. was established, the same year XenoTech, LLC was acquired...

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Sekisui XenoTech Named Best In Vitro Drug Metabolism Studies Provider 2018

Author: Michael Millhollen Posted: 27 March 2018

Sekisui XenoTech has been named the Best In Vitro Drug Metabolism Studies Provider in the 2018 Biotechnology Awards. “This awards programme recognises the hard work and dedication of the firms, and the individuals behind them, that are driving innovation in this vital market. It has been my honour to recognise these dedicated professionals and I would like to wish them the very best of fortunes for the future...”

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Choosing a Relevant Small Animal Model for Pharmacokinetic or Toxicity Studies

Author: Dr. Chris Bohl Posted: 01 March 2018

Choosing the most suitable small animal model is crucial for pharmacokinetic and/or toxicology studies in order to get usable, relevant data. Due to potential species-dependent variability in candidate drug metabolism, the decision of which small animal model to utilize may not always be obvious...

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Recombinant CYP Bactosomes: versatile formats for many ADME applications

Author: Isabelle Nobiron, tebu-bio Posted: 25 February 2018

A post from our EU partner, tebu-bio, on Recombinant CYPs, which are commonly used in ADME-Tox studies as in vitro tools, mostly for reaction phenotyping, enzyme inhibition screening, clearance and metabolite ID...

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Insects and Cattle and Sheep, Oh My!

Author: Aaron Hilgedick, Michael Millhollen Posted: 15 February 2018

Over the past two decades, we’ve received a lot of interesting requests for custom tissue preparations here at Sekisui XenoTech. Read about some of the unique species, tissues and cellular preparations as well as characterization assays that we’ve performed...

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Sekisui Named in the 2018 Global 100 World’s Most Sustainable Corporations

Author: Michael Millhollen Posted: 26 January 2018

Our parent company has been selected as one of the 2018 Global 100 Most Sustainable Corporations in the World index (2018 Global 100)!

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Sekisui XenoTech Hiring and Growing to Meet Customer Demand

Author: Michael Millhollen Posted: 08 January 2018

We hired a record number of new staff over the past year in order to meet current demand for our products and services…

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What to Do with Microsome Stable, Low-Turnover Compounds

Author: Dr. Chris Bohl Posted: 07 December 2017

Compounds that exhibit high metabolic stability in hepatocytes and subcellular fractions can be a challenge for ADME scientists. These in vitro drug metabolism test systems are easy to source and use at the bench, and the methods for xenobiotic metabolism in these matrices are largely standardized and accepted by the scientific community, but they are limited to a 4-6 hour window of time when they are metabolically active and can generate quality data. There have been many interesting advances in the field to address these constraints, though...

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Sekisui XenoTech Featured in the Fall Issue of NewsWave

Author: Michael Millhollen Posted: 15 November 2017

Read about our academic roots, how our path led us to being a global contract research organization, and where our path is taking us...

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Initial Impressions of the new Draft FDA DDI Guidance Documents from Sekisui XenoTech

Author: Dr. Brian Ogilvie, Michael Millhollen Posted: 26 October 2017

The FDA has released its new draft guidance for DDI studies. View the documents and learn more about this important release...

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Hepatosure Hepatocytes: the largest donor pool for your DMPK applications

Author: Isabelle Nobiron, tebu-bio Posted: 18 October 2017

HepatoSure® is a pool of human hepatocytes designed to facilitate your DMPK applications. HepatoSure® is best suited for both discovery and development of ADME-Tox study assays where generation and comparison of data is required. Let’s take a closer look...

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Further Research on the Drug-Drug Interaction Between Gemfibrozil and Repaglinide Presented

Author: Michael Millhollen Posted: 27 September 2017

Sekisui XenoTech scientists previously established a gemfibrozil/repaglinide DDI resulting in increased repaglinide and metabolite plasma exposure and a vectoral shift in elimination pathways from biliary to urinary excretion following administration of gemfibrozil in male Sprague-Dawley rats. In that study, negligible effects on liver enzyme activity were observed following gemfibrozil treatment, suggesting that the DDI in rats was unlikely to be caused by P450 or UGT inhibition. In the present study, the potential role of uptake transporter proteins in the interaction was explored in vitro...

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Cold Storage Solution Linked to Lower AO, XO Activity

Author: Michael Millhollen Posted: 22 August 2017

Allopurinol, UW cold storage solution has been shown to reduce aldehyde oxidase and xanthine oxidase activity in common human liver test systems for in vitro drug metabolism studies…

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Considerations in Response to Drug-Drug Interaction Guidances

Author: Michael Millhollen Posted: 17 August 2017

Sekisui XenoTech scientists contributed to the published considerations from the IQ Induction Working Group in response to drug-drug interaction guidances from regulatory agencies...

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URI Drug Transporters Workshop Presentations

Author: Michael Millhollen Posted: 11 August 2017

If you couldn't make it to The University of Rhode Island College of Pharmacy's 5th Annual Transporters in Drug Discovery and Development: Driving Knowledge from Laboratory to Label (TDDD 2017), you can still view our presentations...

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New Division Directors for Core Services and Services Logistics Appointed

Author: Michael Millhollen Posted: 01 August 2017

Following the promotion of Dr. Joanna Barbara, Ph.D., to Vice President of Scientific Operations, Dr. Etsuko Usuki, Ph.D., has been promoted to the position of Division Director for Sekisui XenoTech's Core Services. Andrea Wolff has also been appointed to the newly created position of Division Director for Sekisui XenoTech's Services Logistics...

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Sekisui XenoTech's Analytical Services Department Adds New Instrumentation

Author: Michael Millhollen Posted: 17 July 2017

Sekisui XenoTech's Analytical Services lab provides researchers with custom method development and method validation, dose solution analysis, in vitro and in vivo metabolite profiling studies, small-molecule non-GLP bioanalysis and more utilizing specialized equipment, including a Waters Xevo TQ-S mass spectrometer and Xevo G2-XS quadrupole time-of-flight (QTof) mass spectrometer...

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Considerations When Studying Esterase Activities in the Intestine

Author: Dr. Chris Bohl, Michael Millhollen Posted: 11 July 2017

First-pass metabolism in the gut is commonly associated with CYP450 and UGT enzymes, however, it may be important for you to consider the impact of intestinal esterases on your compound. Utilizing a PMSF-free preparation for your test system maintains high levels of esterase activity to ensure reliable experimental results, but is less useful for CYP450 metabolism studies due to low activities...

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UGT activities, concomitant drugs, and DDI

Author: Michael Millhollen Posted: 20 June 2017

Do you have questions or concerns about how your compound may affect UGT induction and/or inhibition when combined with other therapeutic regiments? We can help address those concerns...

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New range of Pig P450s Bactosomes

Author: Isabelle Nobiron, tebu-bio Posted: 19 June 2017

If you are looking for enzymatic in vitro tools for drug metabolismreaction phenotyping or metabolite generation using a pig model, you may find these newly released Pig Bactosomes from Cypex of interest...

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Metabolite production made fast and easy – BMO Kits

Author: Isabelle Nobiron, tebu-bio Posted: 14 June 2017

Metabolite characterization can be a lengthy process making your in vitro drug testing time consuming and expensive. Whether you are working on phase I or phase II metabolic enzymatic reactions, take a look at these BMO kits which can help you speed up this characterization process...

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New Liver Disease Resource & Other Research Biobank News

Author: Dr. Maciej Czerwinski, Michael Millhollen Posted: 26 May 2017

Download the new FLD progression infographic: Characteristics of Normal and Fatty Liver Disease Tissues, or read about the new gallbladder tissue as well as liver tissue samples from donors diagnosed with steatosis and steatohepatitis along with additional details on NASH and Diabetic donors...

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Big Hepatocytes News!

Author: Michael Millhollen Posted: 10 May 2017

Sekisui XenoTech was issued U.S. Patent No. 9,642,355 for the “CRYOPRESERVATION OF CELLS AND SUBCELLULAR FRACTIONS” and enhanced its catalog of hepatocyte offerings...

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New VP of Scientific Operations and VP of Scientific Consulting Appointed

Author: Michael Millhollen Posted: 04 May 2017

Sekisui XenoTech has appointed Dr. Joanna Barbara as Vice President of Scientific Operations and Dr. Brian Ogilvie as Vice President of Scientific Consulting...

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New Lysosome Catabolism Protocol and Tech Tips

Author: Dr. Chris Bohl, Michael Millhollen Posted: 17 April 2017

New guide available: IgG Catabolism Protocol & Lysosome / Tritosome Technical Tips… 

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Sekisui XenoTech Adds New Drug Transporters to Portfolio

Author: Michael Millhollen Posted: 01 April 2017

Sekisui XenoTech features the most extensive selection of drug transporters and assays available in the world, and now we have added 6 more to the list...

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Sekisui Turns 70 This Month!

Author: Michael Millhollen Posted: 03 March 2017

From a single plastics manufacturing plant in Japan to a diverse, multi-billion-dollar, global family which includes Sekisui XenoTech in Kansas City, Sekisui Chemical Group has positioned itself as a corporate leader in key industries and a strong advocate for environmental issues. XenoTech joined the Sekisui team in 2008 to bring focused expertise on biotransformation and preclinical development consulting to the broad range of pharmaceutical development services offered by Sekisui.

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Sekisui XenoTech Named Best for Pharmaceutical Safety Testing 2017

Author: Michael Millhollen Posted: 02 March 2017

Sekisui XenoTech has been named the Best for Pharmaceutical Safety Testing in the 2017 Biotechnology Awards. “This awards programme recognises the hard work and dedication of the firms, and the individuals behind them, that are driving innovation in this vital market. It has been my honour to recognise these dedicated professionals and I would like to wish them the very best of fortunes for the future...”

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Sekisui XenoTech Adds New Dermal Subcellular Fraction Test Systems

Author: Michael Millhollen Posted: 01 February 2017

Sekisui XenoTech now offers human, minipig, mouse and rat dermal microsomes or S9 fractions as in stock standard test systems for the development of safer new products delivered to or through the skin. Subcellular fractions are widely used in drug discovery and preclinical drug development to evaluate the in vitro metabolism of new therapeutics.

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Pharmaceutical Outsourcing Magazine Interview Nov-Dec 2016

Author: Michael Millhollen Posted: 29 November 2016

Pharmaceutical Outsourcing Magazine interviewed Chris Bohl, PhD, Global Technical Support Manager for Sekisui XenoTech’s Products Division, on the company and what's new...

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Sekisui XenoTech Standardizes Lysosomal Test Systems for Biopharmaceutical Development

Author: Dr. Chris Bohl, Michael Millhollen Posted: 05 October 2016

Sekisui XenoTech now offers hepatic human lysosomes and rat tritosomes as standard test systems. These products contain high concentrations of lysosomal degradative enzymes and constitute advantageous test systems for analysis of catabolism and/or activation for targeted biopharmaceuticals that enter cells through the endosomal-lysosomal pathway...

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Sekisui XenoTech Joins Fight Against Liver Disease

Author: Dr. Maciej Czerwinski, Michael Millhollen Posted: 16 September 2016

Currently, there are no approved therapies for NASH, yet nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) affects 1-in-4 people worldwide. Research BioBank provides disease-defined liver tissue samples and hepatocytes as a convenient human model for hepatic disease research...

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Sekisui XenoTech Featured on Labiotech.EU

Author: Michael Millhollen Posted: 05 July 2016

In the article, titled "Understand which transporters are involved in a drug’s absorption, distribution & excretion," Labiotech.EU's editors collaborated with our team to discuss: "How can you build the best case for a new drug application to the regulatory agencies? Preclinical studies are a crucial part in determining the pharmacokinetics of a drug – and more specifically how it is going to interact with drug transporters. So reaching out to the leading provider and consultant in this area (with strong academic roots) is the logical step at this stage of development..."

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XenoTech Scientists Publish Paper, Present Research Evaluating Ketoconazole and its Alternative Clinical CYP3A4-5 Inhibitors as Inhibitors of Drug Transporters

Author: Michael Millhollen Posted: 25 April 2016

Sekisui XenoTech scientists published a paper in Drug Metabolism and Disposition evaluating Ketoconazole and its alternative clinical CYP3A4-5 inhibitors as inhibitors of drug transporters, and presented their research at a meeting of the Delaware Valley Drug Metabolism Discussion Group (DVDMDG), during a webinar earlier this month, and with a poster at the AAPS/ITC Workshop on Drug Transporters.

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Sekisui XenoTech Fulfills Largest Order To Date

Author: Michael Millhollen Posted: 01 February 2016

Sekisui XenoTech recently fulfilled its largest order of human liver subcellular fractions to date. A large pharmaceutical customer ordered over 30,000 vials of microsomes, 5000 vials of S9 fractions and 5000 vials of cytosol.

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XenoTech Hosts Bring Your Kids to Work Day

Author: Matt Beck Posted: 04 May 2015

XenoTech hosted "Bring your kids to work" day on April 23rd.

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XenoTech Executives Take the Ice Bucket Challenge to Benefit ALS

Author: Matt Beck Posted: 22 August 2014

XenoTech employees raised over $1,400 in a single day to benefit the ALS Association. Watch the video of the Ice Bucket Challenge by clicking on the link to read more!

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XenoTech Promotes Environmental Responsibility

Author: Christian Darabant Posted: 14 August 2014

XenoTech employees embrace Sekisui Environmental Week

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XenoTech Company Halloween

Author: Matt Beck, Marketing Manager Posted: 01 November 2013

Happy Halloween, XenoTech style! Enjoy some pictures from this year's festivities.

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Navigating the Transporter Wave of 2013: A Review of the Seven ITC Publications on Drug Transporters

Author: Greg Loewen, Principal Scientist - Drug Transport Posted: 28 August 2013

The International Transporter Consortium (ITC) issued seven papers in the July 2013 issue of Clinical Pharmacology & Therapeutics. These seven papers summarize the current understanding of transporters as related to possible drug-drug interactions (DDI). Although there is a mountain of research focusing on many aspects of drug transport such as the transport of endogenous compounds, transport regulation, characterizing transporter function, targeting transporters for disease treatment, etc. these papers outline the information most drug development companies need to know to investigate possible DDIs and properly label their compounds to prevent transporter based DDIs. Since the FDA issued the 2006 “Guidance for Industry, Drug Interaction Studies…” which described the in vitro assays suggested to predict possible P-gp related DDIs, the ITC published a white paper in 2010, the EMA issued the draft “Guideline on the Investigation of Drug Interactions” in 2010 and both the FDA and EMA published updated guidelines in 2012. The most recent guidelines described seven transporters that should be studied for possible DDIs, the in vitro assays used to study those transporters and decision trees to help decide if clinical studies were warranted to further elucidate possible DDIs. The seven papers published in July discuss the clinical importance of the MATE transporters, the clinical importance of OATP1B1 and BCRP polymorphisms, the applicability of the decision trees with some examples of compounds approved since the decision trees were published, in vitro methods used to study transporters, intercellular drug concentrations, kinetic parameters in conjunction with translational modeling, and why DDIs at the blood brain barrier are unlikely. A summary of the focus and main points of each of the seven papers can be found by clicking "Read More" below. To view our webinar on the seven papers click here

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