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Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday


Endocrine Disruption: Research, Analysis, Regulation, and Communication

Room 213

Monday, March 14, 9:00 AM to 10:00 AM

Presented by: TERA Center, University of Cincinnati

The purpose of the workshop is toengage stakeholders in endocrine disruption research, analysis, assessment, regulation and communication so that potential public health risks are better understood and public health safety is achieved.


In Vitro Proximal Tubule Cell Monolayers As a Predictive Tool for Nephrotoxicity: Investigating Time- and Dose-Dependent Renal Toxicity using Clinically Relevant Biomarkers

Room 211

Monday, March 14, 9:00 AM to 10:00 AM

Presented by: SOLVO Biotechnology

Available using human or rodent primary proximal tubule cells, viable in culture for up to 14 days, we will describe an in vitro kidney model retaining uptake and efflux transporter, and drug metabolizing enzyme activity; expression of megalin and cubilin; and modulation of clinically relevant biomarkers in response to toxicants.


Key Considerations for the Development of Oligonucleotide-Based Therapeutics

Room 212

Monday, March 14, 9:00 AM to 10:00 AM

Presented by: Covance

Oligonucleotide-based therapeutics have the potential to be a major drug class, with a variety of molecules in development for the treatment of multiple indications. This session will call upon the experience gained in the Covance laboratories to address issues of how to assess the bio-distribution and safety of these molecules.


US EPA and Unilever Present New Research Collaboration to Advance Nonanimal Approaches for Chemical Risk Assessment

Room 205

Monday, March 14, 9:00 AM to 10:00 AM

Presented by: US Environmental Protection Agency

US EPA and Unilever will present progress on a research collaboration to develop ground-breaking scientific approaches to better assess the safety of chemicals found in some consumer products without using animal data. US EPA and Unilever are developing a series of case studies based on chemicals of mutual interest.


Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert Review

Room 212

Monday, March 14, 10:30 AM to 11:30 AM

Presented by: Lhasa Limited

Lhasa Limited, the world leader for knowledge and data sharing in chemistry and the life sciences, will present their views on the benefits of utilizing an integrated in silico solution to comply with the ICH M7 guidelines.


Continuing Advancements for In Vitro and In Vivo Medical Device Hemocompatiblity Testing

Room 205

Monday, March 14, 10:30 AM to 11:30 AM

Presented by: American Preclinical Services

The in vivo thrombogenicity test is a method for screening blood contacting medical devices for thrombogenicity. The results are used to aid in the generation of safety data. The in vivo test is a screening designed to determine the thrombogenicity in comparison to a predicate device already on the market.


Essential Elements and Considerations for Neurotoxicity Study Designs: Excerpts from the presentation given to the US FDA on September 16, 2015

Room 211

Monday, March 14, 10:30 AM to 11:30 AM

Presented by: NeuroScience Associates, Inc.

As the session title suggests, the focus of this presentation and discussion will be essential elements for thorough assessment of neurotoxic effects of any insult to the brain. The presentation given here summarizes the presentation given by Dr. Switzer, at the US FDA on September 16, 2015.


Key Considerations in the Safety Evaluation of Drugs Targeting Immune Checkpoints

Room 213

Monday, March 14, 10:30 AM to 11:30 AM

Presented by: Envigo

Checkpoint inhibitors are a new and exciting class of therapeutics. As with any drug that targets the immune system, careful consideration in the design and execution of study programms are required. The session is aimed at safety assessment professionals keen to learn more about the subject matter.


Are Industry Blood Pressure Standards about to Change? A Discussion of New Clinical Findings and Potential Impact to Preclinical Assessment

Room 205

Monday, March 14, 12:00 PM to 1:00 PM

Presented by: Data Sciences International

Compelling results from the latest research on blood pressure question current industry standards on systolic blood pressure measurement. Join us for a panel discussion from preclinical and clinical experts on the importance of accurate blood pressure measurements; and the impact beyond the laboratory.


Stakeholder Session: US EPA Endocrine Disruptor Screening Program (EDSP) and the Use of High Throughput Assays and Predictive Models to Screen for Endocrine Activity

Room 212

Monday, March 14, 12:00 PM to 1:00 PM

Presented by: US Environmental Protection Agency

The US EPA’s Endocrine Disruptor Screening Program (EDSP) is incorporating high throughput and predictive model approaches for screening chemicals for endocrine activity. These sessions concern the benefits of this transition as well as progress, next steps, and opportunities to participate. This approach will accelerate the pace of screening, decrease costs, and reduce animal testing.


Why Basolateral Transporters Matter—Their Importance in Predicting Biliary Clearance and Hepatotoxicity

Room 213

Monday, March 14, 12:00 PM to 1:00 PM

Presented by: Qualyst Transporter Solutions, LLC

Hepatic basolateral efflux transporters are an under-recognized class of transporters and are responsible for the efflux of endogenous compounds, drugs and metabolites into the systemic circulation. The impact of basolateral efflux transporters on hepatotoxicity, cholestasis, and drug interactions will be discussed. In addition, we will review various methodologies for determination of basolateral efflux, protein binding effects, and the impact of transporter induction on basolateral efflux.


XposeALI—Setting a New Standard for ALI Cell Exposures

Room 211

Monday, March 14, 12:00 PM to 1:00 PM

Presented by: Inhalation Sciences Sweden AB

Combining PreciseInhale and its module for ALI cell exposures, XposeALI, provides new possibilities for researchers to study inflammatory and toxic effects of cells exposed to airborne particles. Listen to Dr. Per Gerde describe his ground breaking technology and Dr. Lena Palmberg (Karolinska Institute) explain its possibilities when studying nano particles.


Biomarker Immunoassays: To Validate, or Not to Validate, That Is the Question

Room 212

Monday, March 14, 1:30 PM to 2:30 PM

Presented by: Charles River

The increased reliance on biomarkers to evaluate the toxicity and/or efficacy of new drugs during preclinical toxicology studies has driven routine validation of new analysis methods. Use of commercial immunoassay kits offers advantages, as the methods are usually functional. Some, however, require optimization of the methodology to suit regulatory compliance.


Do You See What Eye See? Ocular Distribution for Exposure Assessment

Room 211

Monday, March 14, 1:30 PM to 2:30 PM

Presented by: MPI Research

We use our eyes to understand the world around us, which is why diseases that distort or destroy our vision can be so devastating. This seminar will discuss a variety of in vivo and ex vivo biodistribution modalities to help you “see” your compound in the ocular space.


ICH M7—Dealing with Genotoxic Impurities

Room 205

Monday, March 14, 1:30 PM to 2:30 PM

Presented by: BioReliance

BioReliance will provide an overview of this legislation and go into detail on what are genotoxic impurities and why be concerned. We will then elucidate on what approaches and specific assays are acceptable per the guideline and BioReliance’s experience and recommendations on the proper assay designs.


New Way of Evaluating Drug Toxicity—Label-Free Live-Cell Kinetic Imaging Cytometry

Room 213

Monday, March 14, 1:30 PM to 2:30 PM

Presented by: Phase Holographic Imaging

Cell-based assays are indispensable in the assessment of drug toxicity. The majority of traditional assays require toxic stains. Holographic imaging cytometry offers label-free, quantitative real-time monitoring of drug effects on multiple cellular generations with more physiological relevancy and less experimental complexity. Seeing is believing, but quantitative seeing is knowing.


CASE Ultra: Combining Statistical and Rule Based Methodologies

Room 211

Monday, March 14, 3:00 PM to 4:00 PM

Presented by: MultiCASE Inc

MultiCASE Inc, the leading provider of in silico toxicology solutions for chemical and pharmaceutical industries, will share its experience in implementing and combining statistical and expert rule-based methodologies for better performance and regulatory acceptance. Highlights, interpretation scenarios, and case studies will be presented.


Cryopreserved Human Enterocytes and Hepatocytes for the Evaluation of Adverse Drug Properties

Room 205

Monday, March 14, 3:00 PM to 4:00 PM

Presented by: In Vitro ADMET Laboratories LLC

Orally administered xenobiotics are subjected in intestinal metabolism/absorption and hepatic metabolism/systemic circulation. The isolation and characterization of human and animal enterocytes, and the application of enterocytes in conjunction with hepatocytes to define adverse drug properties including metabolism, drug-drug interactions, and toxicity will be described.


Multiplexed Assays for Flow Cytometry: Case Example of Mode of Action Determination for Genotoxic Agents


Room 213

Monday, March 14, 3:00 PM to 4:00 PM

Presented by: Litron Laboratories

The MultiFlow™ family of kits enables fast, reliable, high-throughput, high-content flow cytometry-based analyses. The MultiFlow DNA Damage kit—p53, γH2AX, phospho-histone H3 is a multiplexed, add-and-read assay that provides classification of compounds based on genotoxic mode of action. Information on related kits will also be provided.


The Miniature Swine As a Model in Translational Medicine: Clinical and Pathology Evaluations

Room 212

Monday, March 14, 3:00 PM to 4:00 PM

Presented by: Sinclair Research Center

The use of miniature swine as a nonrodent species in safety assessments has continued to expand, and they are becoming routinely used as a model for human diseases. The specific features of the miniature swine, their impact on pharmacotoxicology, and clinical and anatomic pathology data will be presented.


Functional Assays for Assessing Mitochondrial Toxicants and Other Energy Metabolism Disruptors in Live Cells

Room 211

Monday, March 14, 4:30 PM to 5:30 PM

Presented by: Seahorse Bioscience, a part of Agilent Technologies

As toxicology testing moves more toward in vitro methods, robust cell-based assays for assessment of mitochondrial toxicity of drug candidates are required. The Seahorse XF Cell Mito Stress Test has been successfully used to screen for mitochondrial toxicants and can distinguish mitochondrial toxicity from overall loss of viability.


How to Make SEND Business As Usual

Room 212

Monday, March 14, 4:30 PM to 5:30 PM

Presented by: Instem

The goal of SEND is to improve the quality, efficiency and speed of getting new drugs to market. All industry stakeholders will hear from a panel of experts about accelerating the production and management of high quality eStudy data packages that are easy to review and more efficient to submit.


Pharmacological Assessment of CIPA Reference Compound Effects using Simultaneous Impedance and Extracellular Field Potential Recordings from iPSC-derived Cardiomyocytes

Room 213

Monday, March 14, 4:30 PM to 5:30 PM

Presented by: Nanion Technologies Inc.

The CardioExcyte 96 is a screening instrument that combines impedance with MEA-like extracellular field potential recordings. The session presents the workflow of utilizing the CardioExcyte96 for the assessment of acute /chronic cardiotoxicity in cultured iPSC cardiomyocytes. Results from reference compounds tested on iPS-derived cardiomyocytes in accordance with CiPA guidelines are presented.


Use of 3D InSight™ Human Liver Microtissues As a Tool for Prediction of Drug-Induced Liver Injury

Room 205

Monday, March 14, 4:30 PM to 5:30 PM

Presented by: InSphero Inc.

Prediction of DILI is an important task in drug developmment. InSphero will present the results from recent evaluation studies by the pharmaceutical industry using 3D InSight Human Liver Microtissues for prediction of DILI, performed with more than 100 clinically known test compounds.



Tuesday


Advances in the Use of Bioprinted 3D Human Liver Tissues for the Assessment of Drug Induced Liver Toxicity

Room 212

Tuesday, March 15, 9:00 AM to 10:00 AM

Presented by: Organovo

3D bioprinted tissues exhibit architectural and functional features that mimic key aspects of a natural tissue environment, allowing for generation of clinically translatable toxicity data from biochemical, genomic, metabolic and histologic endponts. Several case studies using bioprinted liver tissues for toxicity testing will be presented.


Dealing with Uncertainty: Science-Based Solutions to the Challenges of Worldwide Agrochemical Registration

Room 213

Tuesday, March 15, 9:00 AM to 10:00 AM

Presented by: Envigo

The session will discuss the roadmap for successful registration and registration of agrochemical products. Case studies will be discussed which highlight the relevant human and environmental safety studies conducted in support of regulatory submissions, the submission process itself in different jurisdictions and how to plan for a successful registration.


Efficiently Generating Reliable Toxicological Data on Protein Therapeutics

Room 205

Tuesday, March 15, 9:00 AM to 10:00 AM

Presented by: Altasciences

The complex nature of protein/peptide therapeutics can affect the integrity of toxicokinetic data and how it should be interpreted. Through case studies, this session will demonstrate how concerns directly relevant to the generation of toxico/pharmacokinetic and pharmacodynamic data can be addressed by innovative and proactive bioanalytical method development.


Ocular Gene and Cell Therapy Safety Studies: Critical Ophthalmology Endpoints to Consider

Room 211

Tuesday, March 15, 9:00 AM to 10:00 AM

Presented by: MPI Research

Gene and cell therapies are making significant advances in preclinical and clinical development for management of various diseases in ophthalmology. Familiarization with current ocular therapeutic strategies, common intraocular dosing routes, and eye-specific safety endpoint assessments will help you successfully develop your IND-enabling study designs.


Combining Real-Time Measurement of Cell Viability and Extraction of RNA from the Same 3D Spheroids

Room 205

Tuesday, March 15, 10:30 AM to 11:30 AM

Presented by: Promega Corporation

Promega developed a new luminescent assay technology to measure viable cell number in real time. We'll describe an efficient experimental approach to use the same 3D spheroids for measuring the real-time onset of cytotoxicity and extracting RNA to detect changes in gene expression associated with events leading to cytotoxicity.


Conducting Aerosol and Vapor Inhalation Studies Using Highly Hazardous Chemical Agents: A Case Study of Sulfur Mustard (HD) Vapor Inhalation to Swine

Room 213

Tuesday, March 15, 10:30 AM to 11:30 AM

Presented by: Battelle

In animal models it's critical to have stable aerosol or vapor concentration control for inhalation testing of highly hazardous compounds delivered inhalation in order to evaluate potential treatments. The considerations taken to meet these requirements and a case example system to deliver HD vapor to swine will be discussed.


Corning HepatoCells and 3D Organotypic Spheroid Culture Systems for Predicting Drug Induced Liver Toxicity

Room 211

Tuesday, March 15, 10:30 AM to 11:30 AM

Presented by: Corning Life Sciences

The session will introduce Corning HepatoCells, a renewable human hepatocyte-like cell for ADME/Tox studies. Data will be presented demonstrating HepatoCells ability to detect a wider range of known toxins compared to other liver cell models such as HepG2, as well as the improvement in sensitivity with 3D organotypic spheroid cultures.


Inflammation—Discovery to Toxicology

Room 212

Tuesday, March 15, 10:30 AM to 11:30 AM

Presented by: Charles River

Recent advances in immunology and knowledge of mechanisms involved in inflammation raise hope for developing more effective treatments of autoimmune diseases, including arthritis. This session will briefly explore recent advances in inflammation, and highlight the importance of selecting appropriate in vitro and in vivo models for research.


Combining xCELLigence® CardioECR Technology and iPSC Cardiomyocytes for Relevant Frontline and Mechanistic Cardiotoxicity Screening

Room 213

Tuesday, March 15, 12:00 PM to 1:00 PM

Presented by: ACEA Biosciences and Cellular Dynamics International, a FUJIFILM Company

The CardioECR Instrument combines impedance and multi-electrode array technology to simultaneously assess cardiomyocyte contractility, viability, and electrophysiology. This workshop covers (1) priniciple/workflow of utilizing CardioECR and iPSC Cardiomyocytes to assess acute and chronic cardiotoxicity; (2) mechanistic insights from combining CardioECR and disease-model iPSC-cardiomyocytes; (3) results from US FDA's CiPA studies.


easyTEL-Digital, New Implanted Telemetry for Large Animals

Room 211

Tuesday, March 15, 12:00 PM to 1:00 PM

Presented by: emka TECHNOLOGIES INC

The presentation describes key features of the newly released emka TECHNOLOGIES’ easyTEL-Digital implanted telemetry for large animals. This powerful state of the art product is cost effective, easy to use, and specifically designed for cardiovascular, cardiorespiratory, neurological studies. QTest labs researchers will present results from trials made at their facility. QTest labs and Lovelace Respiratory Research Institute researchers will present results from trials made at their facility.


Stakeholder Session: US EPA Endocrine Disruptor Screening Program (EDSP) and the Use of High Throughput Assays and Predictive Models to Screen for Endocrine Activity

Room 212

Tuesday, March 15, 12:00 PM to 1:00 PM

Presented by: US Environmental Protection Agency

The US EPA’s Endocrine Disruptor Screening Program (EDSP) is incorporating high throughput and predictive model approaches for screening chemicals for endocrine activity. These sessions concern the benefits of this transition as well as progress, next steps, and opportunities to participate. This approach will accelerate the pace of screening, decrease costs, and reduce animal testing.


The Next Generation of Cardiomyocyte Contractility, Cell Migration, and Cell Viability Assays using the Sony SI8000 Live Cell Imaging Platform

Room 205

Tuesday, March 15, 12:00 PM to 1:00 PM

Presented by: Sony Biotechnology Inc.

The Sony SI8000 Cell Motion Imaging System combines high-speed video microscopy with a motion vector algorithm to quantify cell motion. This new platform provides high resolution cardiomyocyte contractility analysis making it ideal for toxicology screening. Easily adapt the platform to assays such as cell migration, cell death, and viability assays.


Can We Learn More from Our Göttingen Minipig Toxicology Studies?

Room 205

Tuesday, March 15, 1:30 PM to 2:30 PM

Presented by: Ellegaard Göttingen Minipigs, Marshall Bioresources and CitoxLab Scantox

The Göttingen minipig is widely used for regulatory toxicology, and safety pharmacology endpoints can be added to the same studies or taken as stand-alone studies. Strategies to evaluate cardiovascular, respiratory and central nervous system pharmacology using the minipig will be presented. The seminar will allow time for discussions and questions.


Complete CV Assessment, In Vitro through In Vivo

Room 212

Tuesday, March 15, 1:30 PM to 2:30 PM

Presented by: ChanTest and Charles River

This presentation will describe complete preclinical cardiovascular assessment, including in vitro, in silico, and in vivo assessments, and introduce arrhythmia detection. We will discuss both prospective and retrospective cases, highlighting the added sensitivity of PK/PD modeling. The forum will also showcase the latest approaches in socialized telemetry.


Evolution of the Spheroid: Advanced 3D Microtissue Models As a Versatile Tool for More Physiologically Relevant Efficacy and Safety Assessment

Room 213

Tuesday, March 15, 1:30 PM to 2:30 PM

Presented by: InSphero Inc.

3D Microtissues reflect organ physiology more closely than conventional 2D cultures, but are still amenable to automation. Here the recent developments in 3D microtissue technology are presented which allow for high throughput efficacy and safety testing. In addition, incorporation of spheroids into microphysiological systems will be discussed.


Genomics—The Future of Sensitization Testing and Safety Assessment

Room 211

Tuesday, March 15, 1:30 PM to 2:30 PM

Presented by: SenzaGen

In vitro testing in human cellines usinggenomic technologyis the future insafety testing of chemicals and proteins. SenzaGen is presenting their use of genomics for sensitization testing with GARD assays for skin and respiratory sensitization. Using +200 biomarkersenables better predictions, including potency information.


Evaluation of the Human Renal Proximal Tubule Epithelial Cell Line, SA7K, in a Multiplexed qHTS Platform for Investigating Nephrotoxicity and a 3D Organ-on-a-Chip OrganoPlate™ Platform for Measuring Renal Clearance

Room 213

Tuesday, March 15, 3:00 PM to 4:00 PM

Presented by: BioReliance

The pseudo-immortalized proximal tubule cell line, SA7K, from human primary renal proximal tubule epithelial cells has been utilized for investigating nephrotoxicity and transporter studies. Data will be presented demonstrating the utility of SA7K cells in a multiplexed qHTS platform for nephrotoxicity and a 3D organ-on-a-chip OrganoPlateTM platform for renal clearance.


Performing Toxicological Risk Assessment of Leachables in Combination Products

Room 205

Tuesday, March 15, 3:00 PM to 4:00 PM

Presented by: NSF International / Health Sciences

Leachables in Combination Products are a potential safety concern.Often, rather than only one, multiple leachables are found in products.This session will describe the risk assessment process using reviews of existent public literature and, along with regulatory guidelines, the determination of a safe level of exposure for each leachable.


Practical Application of a Human Stem Cell Assay for Developmental Toxicity Testing

Room 211

Tuesday, March 15, 3:00 PM to 4:00 PM

Presented by: Stemina Biomarker Discovery

devTOX qickPredict is a reliable, human stem cell screen for developmental toxicity. Using two structurally related compound series, we will demonstrate practical application of our assay for series ranking and enhancing read across and weight of evidence approaches for toxicity assessment. Additionally, ongoing collaborations and validation efforts will be discussed.


The Use of iPSC-Derived Cells As In Vitro Models for Toxicity Screening

Room 212

Tuesday, March 15, 3:00 PM to 4:00 PM

Presented by: Axol Bioscience

Toxicologists have access to a range of iPSC-derived cell types, including cardiomyocytes, hepatocytes, and renal cells, used in toxicity screening. We discuss how these models are accurate and representative cell models, and how they can phase out inconsistencies in primary cell assays and reduce the use of in vivo models.


Implementation of ICH M7 Recommended (Q)SAR Analyses

Room 205

Tuesday, March 15, 4:30 PM to 5:30 PM

Presented by: Leadscope, Inc., Lhasa Limited and MultiCASE Inc.

This session outlines principles to consider when generating a (Q)SAR assessment consistent with the ICH M7 guideline. Presentations will cover when an expert opinion might be beneficial, what it may contain, and how the prediction results and accompanying opinions may be documented.


KnowledgeScan™, a New Approach to Target Safety Assessment

Room 213

Tuesday, March 15, 4:30 PM to 5:30 PM

Presented by: Instem

This session will introduce KnowledgeScan™ Target Safety Assessment, which utilizes a combination of manual and automatic data-mining approaches to help users assess the potential safety consequences of targeting specific biological pathways. This assessment is rapid, comprehensive, reproducible and cost-effective and will appeal to Discovery Toxicologists working in pre-clinical safety.


Protecting Life’s Circuitry-In Vitro, Functional Evaluation of Neurotoxicity and Cardiotoxicity using the Maestro Multiwell Microelectrode Array (MEA) Platform

Room 211

Tuesday, March 15, 4:30 PM to 5:30 PM

Presented by: Axion BioSystems

The Maestro MEA platform assesses the activity of cultured primary or iPSC-derived neurons and cardiomyocytes on the benchtop. This session will discuss the application of MEA technology to (1) high-throughput environmental neurotoxicology screening, (2) acute cardiac safety studies under the CiPA initiative, and (3) advanced pre-clinical assessment of drug-drug interactions.


Stem-Cell Derived Cardiomyocyte Preparations in Single Cell, 2D and 3D Tissue Systems: Their Role in Cardiotoxicology and Novel Lead Investigation

Room 212

Tuesday, March 15, 4:30 PM to 5:30 PM

Presented by: Clyde Biosciences

This session will highlight the electrical and mechanical properties of iPS-derived cardiomyocytes in a series of formats (3D micro-structures, 2D cultures to single cells). The process of excitation-contraction coupling will be discussed including the intracellular Ca signal and the differences in the adult phenotype discussed.



Wednesday


The rasH2 Transgenic Model in Carcinogenic Risk Assessment: A Story of Quality, Data, and Increasing Utilization in Regulatory Studies

Room 213

Wednesday, March 16, 9:00 AM to 10:00 AM

Presented by: Taconic Biosciences

75% of mouse carcinogenicity studies are conducted using the rasH2 model. Join Taconic Biosciences, CIEA, & BioReliance presentations on the continuing trend of rasH2 utilization. We will cover the phenotypic stability of rasH2 and its use in Weight of Evidence for carcinogenicity evaluation.


Your SEND Datasets have Passed Validator Checks, but are you Really Submission Ready to Meet US FDA Expectations? An Evidence-based Discussion of Data Quality Issues that will Impact your Regulatory Submissions

Room 211

Wednesday, March 16, 9:00 AM to 10:00 AM

Presented by: PointCross Life Sciences

Being SEND ready means much more than passing technical conformance checks. This session will present real examples of SEND data quality, consistency, and sufficiency issues that can impact US FDA reviewability.  Approaches to solve data issues, automate SEND workflows, and plan for evolving standards changes will be discussed by leading experts.


In Vitro Toxicology and Integrated Toxicology—What Are These?

Room 212

Wednesday, March 16, 9:00 AM to 10:00 AM

Presented by: Charles River

In vitro toxicology tests utilize mammalian tissues. Acceptance and regulatory demand for these is increasing with validation testing leading to OECD guidelines. AOPs provide mechanistic approaches that can lead to test banks. These are part of integrated testing strategies allowing products to be brought to market more rapidly and safely.


Use of Long-Term Micropatterned Primary Human Hepatocyte Cultures (HepatoPac) to Assess Efficacy and Tolerability of Antisense Oligonucleotides

Room 205

Wednesday, March 16, 9:00 AM to 10:00 AM

Presented by: Hepregen Corporation

Micropatterned primary hepatocyte co-cultures have many advantages compared to standard 2D primary hepatocyte cultures including physiologically relevant protein expression and culture longevity. We sought to assess whether those properties could improve our ability to screen for well-tolerated and pharmacologically antisense oligonucleotides in a more relevant human cellular system.


Preclinical Ototoxicity Screening for the New US FDA Guidance

Room Rivergate Room

Wednesday, March 16, 10:30 AM to 11:30 AM

Presented by: OtoScience Labs

US FDA Releases First Guidance Including Preclinical Ototoxicity Testing.  Ototoxicity is damage to the cochlea or auditory nerve that results in hearing loss and/or tinnitus. 
 


Key Considerations in the Safety Evaluation of Novel Therapeutic Modalities for Oncology

Room 213

Wednesday, March 16, 10:30 AM to 11:30 AM

Presented by: Envigo

The session will address the development of novel cancer drugs, how the drug development landscape is changing. This educational, interactive forum will highlight recent advances in novel cancer therapies including ADCs. Preclinical and regulatory considerations will be discussed, and case studies shared highlighting developments in the field.


Software Considerations When Expanding Your Tox Lab to Include PGx Testing

Room 205

Wednesday, March 16, 10:30 AM to 11:30 AM

Presented by: UNIConnect

An overview of the differences between Toxicology and Pharmacogenomics software systems. Can one system handle both types of tests?


The Minipig as a Model for Preclinical Cardiac Safety Testing

Room 211

Wednesday, March 16, 10:30 AM to 11:30 AM

Presented by: Ellegaard Göttingen Minipigs and Marshall Bioresources

Preclinical safety testing requires both rodents and non-rodents. Dogs are most commonly used but may not always be suitable. Lately, pharmaceutical companies and CRO’s have characterized the Göttingen Minipig for both in vitro and in vivo safety testing. Preliminary data from reference compounds will be presented.


Utilizing Long-Enduring Primary Hepatic Co-Culture Models to Gain Improved, Mechanism-Specific Insights on Cholestasis and Reactive Metabolites

Room 212

Wednesday, March 16, 10:30 AM to 11:30 AM

Presented by: Hurel Corporation

This session will present data demonstrating the potential of signals generated by a metabolically competent test system that affords repeat-dosing of fully functioning primary hepatocytes over 14 days to better assess the involvement of reactive metabolites or cholestasis in a chemical’s hepatotoxic mechanism of action.


DRAGON ONLINE: A Web-Based Tool for Systematic Literature Review

Room 212

Wednesday, March 16, 12:00 PM to 1:00 PM

Presented by: ICF International

ICF's DRAGON enables scientists to work collaboratively on literature screening, study quality evaluations, and data extraction for systematic literature reviews. Documenting the data and decisions supporting the review increases transparency and preserves institutional knowledge. ICF's team will demonstrate how the original prototype has grown into DRAGON ONLINE with expanded capabilities.


High-Throughput Imaging and Kinetic Endpoints for Toxicity Testing in iPSC-Derived (iCell) Cardiomyocytes and Hepatocytes in 2D and 3D Spheroid Cultures

Room 213

Wednesday, March 16, 12:00 PM to 1:00 PM

Presented by: Cellular Dynamics Intl, a FUJIFILM Company & Molecular Devices

iCell Hepatocyte and Cardiomyocytes spheroids in 3D provide a more organotypic culture environment . The physiological and morphological impact of a panel of toxicants on iCells in 2D and 3D will be reported as measured using calcium flux, morphology and viability read-outs by FLIPR (fast kinetic) and confocal imaging technologies.


Implantation Studies for Medical Devices According to ISO 10993-6 – Pitfalls, Diagnostic Problems, Misinterpretations

Room 211

Wednesday, March 16, 12:00 PM to 1:00 PM

Presented by: Eurofins BioPharma Product Testing and Anapath

Implantation studies evaluating the local tolerance of medical devices and materials are carried out according to ISO 10993-6. The session will focus on pitfalls in implantation studies (case studies) based on diagnostic problems and misinterpretations and new diagnostic tools to overcome such problems will be introduced.


Testing Approaches Towards Safe Nanoproducts

Room 205

Wednesday, March 16, 12:00 PM to 1:00 PM

Presented by: Fraunhofer ITEM

The session will discuss current strategies for testing and risk assessment of nanomaterials. Emphasis will be placed on specific testing requirements for different types of nanoproducts, e.g. particles, tubes and nanotherapeutics. Finally, an overview of the current regulatory policy for different product groups will be given.


How ICH M7 Regulatory Guidance is used to Support Toxicological Risk Assessment of Impurities in Drugs and Combination Products

Room 212

Wednesday, March 16, 1:30 PM to 2:30 PM

Presented by: Intertek

The recent ICH M7 guidance provides a framework for a step-wise approach for analysis of drug products, and the risk assessment of impurities, the scientific principles of which can be extrapolated to other drug-related evaluations.  Potential applications and limitations of ICH M7 are discussed from an analytical and toxicological prospective.


Human iPS Cell-Derived Hepatocytes with Drug Metabolizing Function and High Specificity to Hepatotoxins for Utilization in Toxicity Screening Applications

Room 211

Wednesday, March 16, 1:30 PM to 2:30 PM

Presented by: Clontech Laboratories, Inc., a Takara Bio Company

The Cellartis® Hepatocyte portfolio provides homogeneous populations of human iPSC-derived hepatocytes. Available as fully-differentiated hepatocytes, do-it-yourself kits to generate patient-specific hepatocytes using a universal protocol or custom services for directed differentiation from any iPS line, our hepatocytes express major drug-metabolizing enzymes and transporters and show high specificity to hepatotoxic compounds.


US FDA - Chinese FDA - OECD: Similarities and Differences You Need to Know for Your IND

Room 205

Wednesday, March 16, 1:30 PM to 2:30 PM

Presented by: Pharmaron

Each regulatory body has at its core, a government mandated regulatory framework that influences the implementation of requirements and the expectations for regulatory compliance.  While harmonization is the goal, clear differences in expectations must be anticipated and understood for successful acceptance of INDs in different parts of the world.  


Specimen Logistics Best Practices: Improve Lab KPIs like Turn Around Time, Specimen Stability and Total Cost Per Accession through Quality and Optimization

Room 213

Wednesday, March 16, 1:30 PM to 2:30 PM

Presented by: UPS

It is a common belief within the industry that 80% of errors occur before a specimen gets to the lab.  Front-end errors and common pain points in laboratory logistics from patient specimen collection to lab delivery.  Learn tips for impacting TAT, quality and cost through solutions leveraged by top firms.


Behavioral and Neurological Assessments in the Miniature Swine

Room 212

Wednesday, March 16, 4:30 PM to 5:30 PM

Presented by: Sinclair Research Center

The miniature swine are becoming routinely used in toxicology as a nonrodent species for neurobehavioral and neurotoxicology assessments, as well as a model for human neurological and neurodegenerative diseases. The important behavioral and neurological features of the miniature swine will be presented in the perspective of drug safety evaluations.