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Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday


A Typical Timeline for Your Biologics Toxicology Program

Room 217B

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: WuXi AppTec

This session will address what a standard program for a biologic will look like. Preclinical studies for biologics are customized for each product and designed to generate meaningful results through the performance of a thorough scientific and regulatory-compliant program. 


Implementing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States

Room 217C

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP)

In 2017, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) coordinated the development of a strategic roadmap to establish new approaches for toxicity testing in the United States. This session will detail implementation plans and associated activities directed towards the reduction and replacement of animal use for the “six-pack” of acute toxicity studies.


Primary Human Hepatocyte 3D Spheroid Model for Predicting Drug-Induced Liver Injury

Room 217D

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: Corning Life Sciences

Emerging 3D technologies may fill the need for more physiologically relevant in vitro models to improve liver toxicity prediction accuracy. This presentation wil review work with cryopreserved PHH lots and spheroids using Corning Ultra Low Attachment spherid microplates to demonstrate a superior model to predict DILI in high-throughput capacities.


Releasing the Immune System Brakes: The Importance of Modeling Effects in Nonclinical Safety Studies

Room 217A

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: Envigo

Checkpoint inhibitors release the immune system’s biological control mechanisms, increasing anti-tumor activity.  As these products enter the clinic, increasingly in combination with other drugs, it is essential to understand potential risks.  Design of appropriate nonclinical studies, interpretation of results, and translation to the clinic are critical to understanding potential impact.


A New Telemetry-Based System for Assessing Cardiovascular Function in Large Animals-Part II, Pharmacological Validation by M.Markert, Boehringer Ingelheim

Room 217A

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: TSE Systems

A first pharmacological evaluation of a newly-developed total implant telemetry system for cardiovascular, electrophysiological, and body temperature measurement. It is intended to be used for drug candidate safety pharmacological evaluations.


Implementation of Liquid Chromatography-Mass Spectrometric Workflows for the Quantitation of Large Molecule Biotherapeutics

Room 217C

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Altasciences Clinical Research

This session will outline workflows implemented using immunocapture-liquid chromatography mass spectrometry assays, high-resolution mass spectrometry, nano and micro flow chromatographic separation, and microsampling to expedite bioanalysis of large molecule biotherapeutics, including monoclonal antibodies, fusion proteins and peptides. Case studies highlighting scientific considerations and regulatory challenges will be presented. 


New Regulatory Drivers for Agrochemical Testing

Room 217B

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Charles River

New data requirements have been set for European agrochemical Regulations 283/2013 and 284/2013. Affecting such studies as in vitro metabolism, toxicokinetics, phototoxicity, immunotoxicity, and others, the requirements have shifted the agrochemical framework toward a more pharma-based development process.


Skin Sensitization: What Place Does In Silico Have within a Defined Approach?

Room 217D

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Lhasa Limited

Testing strategies incorporating in silico predictions can provide additional value by considering factors such as metabolism, lipophilicity, and chemical reactivity. Lhasa Limited will describe a defined approach integrating Derek Nexus with non-animal assays to reliably predict skin sensitization and will compare its performance to both human and animal data.


Evolution of 3D Tissue Models for Toxicology and Disease Modeling

Room 217D

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

Presented by: Bio-Techne

This session will present the history of in vitro models for toxicology, drug screening, and disease modeling. It will emphasize culture methods, advantages, and disadvantages of current 3D models. It will introduce MimEX™ Tissue Model Systems, a platform to generate sustainable, accessible, and physiologically-relevant 3D organ tissue on a 2D surface.

 


Leveraging Genetic Diversity to Reduce Clinical Attrition: A Novel Approach to In Vitro Safety and Toxicity Testing

Room 217C

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

Presented by: Coyne Scientific, LLC

Coyne Scientific, a biotech services company, invites you to discover how using hiPSC-derived cardiomyocytes obtained from a cohort of genetically-diversified individuals (rather than a single individual) can significantly improve the assessment of cardiac toxicity of pharmaceuticals within a target population and potentially reduce attrition of compounds in clinical development.


Neurotox and Cardiac Safety Assessment: Case Studies Employing iPS Cell Lines and Next-Generation MEA Technology

Room 217A

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

Presented by: Axion BioSystems and Cellular Dynamics International, a FUJIFILM company

Discover the predictive power of iCell Cardiomyocytes2 and iCell GlutaNeurons with the Maestro Pro multiwell MEA platform.  Experts in the field will present case studies on optimization of neuronal/astrocyte co-culture for neurotoxicology (HESI NeuTox) and incorporation of the local extracellular action potential (LEAP) signal for cardiac safety (CiPA).


Tools for Streamlining QSAR/PBPK/QST Modeling and Simulation

Room 217B

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

Presented by: Simulations Plus, Inc.

Simulations Plus and DILIsym Services have partnered to combine top-ranked, easy-to-use software (GastroPlus™, ADMET Predictor™, and DILIsym®) to streamline QSAR/PBPK/QST modeling and simulation in animals and humans, following administration around the body, and predict exposure/safety characterization of compounds in preclinical and clinical development. In this session, case studies will be presented demonstrating the integrated workflow to support research activities and regulatory submissions. Lunch will be provided.


Can Pharmacokinetic Modeling Keep Up with Risk Assessment in the 21st Century?

Room 217C

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: ScitoVation

This session will explore current issues and future challenges associated with the increased requirement for rapid pharmacokinetic modeling associated with Tox21, the Lautenberg Chemical Safety Act, and animal welfare concerns.  It will feature panel discussions with audience participation to discuss issues such as modeling platforms, model evaluation, and modeler training.


Immunopharmacology and Immunotoxicology in Minipigs in Support of Nonclinical Drug Development

Room 217B

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: Sinclair Research Center

This session will describe how to develop, validate, and implement the different assays needed to support immunotoxicoloy investigations in minipigs. The design of special immunotoxicity studies for different breed of minipigs (Yucatan, Hanford, Sinclair, and Göttingen) and the collection and interpretation of immunotoxicology data in minipigs will be discussed.


Novel MetMax Hepatocytes and Enterocytes for the Evaluation Drug Metabolism, Drug-Drug Interactions, and Metabolism-Dependent Toxicity

Room 217A

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: In Vitro ADMET Laboratories

MetMax™ hepatocytes and enterocytes are permeabilized cells supplemented with metabolic cofactors that have complete metabolizing enzyme pathways but can be stored and used like cell free fractions.  Applications include metabolism, drug-drug interactions, and as exogenous metabolic activating systems for in vitro toxicity assays involving target cells incompetent in xenobiotic metabolism.


Validation of 3D Human Liver Microtissues for Enhanced DILI Prediction and Investigation of Mechanisms of Hepatotoxicity

Room 217D

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: InSphero Inc.

3D microtissues have emerged as promising tools to assess mechanisms of hepatotoxicity, as they demonstrate enhanced liver phenotype and function. This session will present the most comprehensive evaluation by pharma to date, demonstrating their utility for enhanced DILI prediction, as well as application examples for studying mechanistic aspects of hepatotoxicity.


Cytotoxicity Assessments for Cancer Prevention and Optogenetics: the Future of Toxicology?

Room 217A

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: Nanion Technologies and Ncardia

This session presents an assay methodology for in vitro investigations of adjuvant chemotherapy related to tumour recurrence prevention. We will discuss cardiotoxicity investigations of iPS-derived cells using optogenetic stimulation. State of the art transfection and optogenetic technology allow simultaneous recordings of voltage and contractility, for efficient risk evaluation.


Strategies for Successful PreIND and IND Submissions for the Toxicologist

Room 217D

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: ToxStrategies, Inc.

Preparing PreINDs and INDs can be challenging. ToxStrategies consultants will provide strategic scientific and regulatory advice on preparing PreIND and subsequent IND submissions. Insights on the PreIND/IND process, addressing what nonclinical data to include, how to prepare concise nonclinical summaries, and how to avoid submission delays will be presented.


What Can In Vitro Toxicology Learn from Genetic Toxicology for Regulatory Acceptance?

Room 217C

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: Charles River and Toxys

Acceptance of in vitro toxicology models has been slower or difficult to adopt, despite formal validation and OECD test guidelines. What can in vitro toxicology learn from the genetic toxicology experience for the acceptance of these models and replacement of their, usually, acute tests?  


Agilent Seahorse XF Technology: Real-Time Functional Cell-Based Assays for Assessing Cytotoxicity and Mitochondrial Liability

Room 217B

Monday, March 12, 4:30 PM to 5:30 PM

Presented by: Agilent Technologies

Discover how Agilent Seahorse XF technology can be used for understanding and screening toxic compound effects on cellular functions such as proliferation, activation, and differentiation, as well as specific liabilities in metabolic pathways, cellular energy generation and mitochondrial toxicity.


Integrating Adult Human Primary Cardiomyocytes into Early Cardiac Safety Assessment

Room 217C

Monday, March 12, 4:30 PM to 5:30 PM

Presented by: AnaBios

Early identification of safety margins can greatly enhance drug development program success. This session introduces an innovative preclinical platform for simultaneous assessment of pro-arrhythmia and inotropic risks based on brightfield imaging of adult human primary cardiomyocytes. Strategies for integrating this approach in the early discovery pipeline will be discussed.


iPSC-Based Neurotoxicity Screens

Room 217D

Monday, March 12, 4:30 PM to 5:30 PM

Presented by: Applied StemCell, Inc.

This session will present the utility of human iPSC for neurotoxicity assays, including assays to determine the specificity of different neural cell types derived from iPSC for a small range of chemicals and drugs from the Tox21 library, and for MEA-based functional assays with neurons and astrocytes and their co-culture.


Risk Assessment of Cosmetics: New Approaches and Science behind the Data

Room 217A

Monday, March 12, 4:30 PM to 5:30 PM

Presented by: Fraunhofer ITEM

Cosmetics are designed for direct application to the human body. Thus assessment of their safe use is required. Fraunhofer ITEM is focusing on a tailored risk assessment using its scientific competences to assess inhalation exposure: aerosol characterization and exposure to relevant test atmospheres for in vitro testing, including in silico approaches and read-across.



Tuesday


A Novel 3D Microtissue-Based Platform for Studying Liver Fibrosis

Room 217D

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: InSphero Inc.

This session will share the characterization of a 3D Human Liver Fibrosis Model as a novel tool to study liver fibrosis, suitable for high-throughput efficacy testing of anti-fibrotic drugs. The disease model consists of only primary cell material for more physiologically-relevant screening hits.


Advanced Therapy Medicinal Products -The Good, the Bad, and the Unknown

Room 217C

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: Envigo

The nonclinical safety assessment of advanced therapies (cell and gene therapies) requires additional investigations beyond what is expected for traditional therapeutics. Frequently, the use of non-standard toxicology models, such immunodeficient rodent strains, is required to obtain crucial information on potential toxicities and inform clinical study design. 


Are Your Regulatory Submission Timelines at Risk?

Room 217B

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: PDS Life Sciences

The SEND (Standard for Exchange of Nonclinical Data) requirements have begun to roll out.  The data standardization schema presents both challenges and opportunities for the toxicology community.  This session will present the latest updates to the SEND requirements and the current best practices to comply with them for toxicologists.


TSCA Reform: Use of New Tools and Technology for Prioritization and Chemical Risk Evaluation

Room 217A

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: ToxStrategies, Inc.

This session will provide an overview of chemical prioritization and risk evaluations under TSCA as amended by the Lautenberg Chemical Safety Act. It will focus on new analytical tools, technologies, and databases that can be used for prioritization and testing of new chemicals and for risk evaluation of existing chemicals. 


Achieve Higher-Quality Data and Enable Multiplexing Options by Adopting Real-Time In Vitro Cytotoxicity Assays in 2D/3D Cultures

Room 217A

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Promega Corporation

Real-time assay methods have been developed enabling kinetic measurement of live, dead, and apoptotic cells repeatedly from the same sample using a plate reader. The methods simplify and reveal how time and dose affect cytotoxicity in 2D or 3D models and enable downstream applications with the same samples.


Quantitation of Oligonucleotides Using a Hybridization Method in Various Tissues and Species for Accurate Pharmacology and Toxicology Evaluations

Room 217D

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Altasciences Clinical Research

Antisense oligonucleotides (ASOs) are widely used for silencing gene expression leading to promising treatment of rare diseases. This session will be an introduction to concepts and techniques in support of ASOs quantitation in blood and various tissue samples. Case studies highlighting scientific considerations and regulatory challenges will be presented.


Quantitative Methods for Monitoring Thyroid Hormones in Late-Fetal and Early-Neonatal Rat Specimens

Room 217C

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Charles River

During thyroid development in the late stages of gestation, serum concentrations of T3 and T4 can be well below the limits of detection using conventional assays. An HPLC/MS/MS method has been validated to secure accurate data during early development to meet EPA and OECD guidelines expectations. 


Three-Dimensional (3D) Cultures of HepaRG Cell Models Physiologically-Relevant Drug Metabolism, Drug-Induced Liver Injury, and Hepatic Signaling Pathways

Room 217B

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Lonza

Prediction of liver injury and toxicological mechanisms remain focal points to pharmacological and environmental toxicology research. In this presentation, the development and application of organotypic in vitro liver models (e.g., 3D) will be described, including their utility to predict liver injury and characterize physiologically-relevant transcriptomic perturbations reflective of human outcomes.


Development of Real-Time Cardiotoxicity and Hepatotoxicity Assays Using Human iPSC-Derived Cells

Room 217B

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: ACEA Biosciences

Human iPSC-derived cells provide a relevant model system for screening and assessment of potential toxicities associated with pharmaceutical and environmental compounds. In this session the utility of real-time cell-based assay using matured iPSC-cardiomyocytes and iPSC-hepatocytes for risk assessment of pharmaceutical and environmental hazardous compounds will be discussed.


Let the Machine Do the Work: Using Automation for High-Throughput In Vitro Toxicity Assays

Room 217C

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: Miltenyi Biotec Inc.

Fast and standardized flow cytometry workflows overcome the limitations of microscopic analysis, providing both reproducible and reliable high content toxicology information. This session will present Litron Laboratories multiplexed DNA damage assay for MOA detection and the Institute for In Vitro Sciences efforts with flow cytometry and the human Cell Line Activation Test (h-CLAT).


Solving Target Safety Assessment Challenges

Room 217D

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: Instem

Companies are under enormous pressure to quickly produce high-quality target risk assessments to make drug development decisions. KnowledgeScan (KS) Target Safety Assessment (TSA) is revolutionizing this area. Hear how Instem clients are improving quality, reducing costs, getting faster results and gaining value by engaging in TSA projects with Instem.

 


Ames Test Strain Profile: Implications for Mutagenicity Predictions and ICH M7

Room 217D

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Lhasa Limited

Recent discussions around the bacterial strains used for the Ames test may impact both the development of in silico models (e.g. training sets) and the interpretation of predictions. These topics will be discussed and new features in Sarah Nexus to assist with expert review will be demonstrated.


Bioanalysis and Toxicology Challenges with Antibody Drug Conjugates (ADC)

Room 217C

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Intertek

Avoid preclinical testing failure by understanding the complex bioanalytical and toxicology challenges associated with Antibody Drug Conjugates (ADC) drug development and unique ways to overcome them. ADCs are new compounds compared to others, but they also face challenges in the immunogenicity assays requirements and increasing bioanalysis assay complexity.


Cardio quickPredict: A New Way to Evaluate the Cardiotoxicity Potential of Compounds

Room 217A

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Stemina Biomarker Discovery, Inc.

Stemina has developed a new cardiotoxicity assay, Cardio quickPredict, which predicts the cardiotoxicity potential of a compound based on changes in human iPSC-derived cardiomyocyte metabolism and viability and indicates whether the cardiotoxicity profile is consistent with functional or structural toxicity.  This session will cover assay development, performance, and application.


Standard for Exchange of Nonclinical Data (SEND): What Is It and Why Is It Mandated by the US FDA?

Room 217B

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: WuXi AppTec

During this session, we will be discussing what SEND is and why it is mandated by the US FDA. 

 


Avoid Oxidative Stress Artifact Oxygen: The Neglected Variable

Room 217C

Tuesday, March 13, 3:00 PM to 4:00 PM

Presented by: BioSpherix

Toxicologists need biologically relevant in vitro assays for accurate prediction. Routine laboratory practices disregard oxidative stress artifact caused by incubating, handling, and analyzing samples under ambient oxygen conditions. We will present new evidence that challenges old paradigms and offer practical strategies for control of physiological oxygen in cellular toxicology assays.


CometChip® —A New Platform for DNA Repair Pathway Analysis, Genotoxin Screening, and Translational Science

Room 217B

Tuesday, March 13, 3:00 PM to 4:00 PM

Presented by: Trevigen, Inc.

We will describe the CometChip® Platform, an advanced 96-well single cell gel electrophoresis assay coupled with high-throughput data processing software.  The accuracy and quantitative capacity of the CometChip® Platform is demonstrated by the analysis of environmental genotoxins, patient samples and a detailed analysis of chemotherapeutics to discover mechanism of action.


Pathology Peer Review Principles and Practices

Room 217D

Tuesday, March 13, 3:00 PM to 4:00 PM

Presented by: Vet Path Services, Inc.

Pathology peer review is an important part of the toxicologic pathology assessment of drugs and chemicals.  The basis of pathology raw data, how peer review is normally structured, and current controversies will be discussed.  The aim of this presentation is to demystify for toxicologists what happens in a peer review.


The CONFIRM Initiative: Immunological Safety Evaluation in Minipigs

Room 217A

Tuesday, March 13, 3:00 PM to 4:00 PM

Presented by: Ellegaard Göttingen Minipigs and Marshall BioResources

The CONFIRM Initiative is a COllaborative Network For Immunological safety Research in Minipigs. Its aim is to trigger and bring together fundamental, translational and regulatory efforts from researchers and academic/private organizations to bridge gaps in our understanding of immune responses and the practice of immunological safety evaluation in minipigs.


In Vitro Alternative Assays and the 3Rs

Room 217C

Tuesday, March 13, 4:30 PM to 5:30 PM

Presented by: MilliporeSigma

BioReliance will discuss its numerous in vitro options that avoid animal testing, yet provide valuable mechanistic information for regulatory approval. New assays such as the 3D Skin Comet Assay will be introduced as well as other assay paradigms that follow up and can resolve positive in vitro genotoxicity results.


ProxTox-HTS: Rapid and Accurate In Vitro High-Throughput Prediction of Nephrotoxicity in Humans

Room 217D

Tuesday, March 13, 4:30 PM to 5:30 PM

Presented by: SOLVO Biotechnology

ProxTox-HTS is the first high throughput in vitro screening method developed to predict nephrotoxicity in humans with high accuracy. Run in 384-well format with high content imaging analysis and a machine learning approach, we will present data from a pre-validation set of 44 chemically diverse compounds with known clinical effects.


Read-Across, Risk, and Safety Assessment with ChemTunes-ToxGPS

Room 217A

Tuesday, March 13, 4:30 PM to 5:30 PM

Presented by: Molecular Networks GmbH

Molecular Networks and Altamira (MN-AM.com) will present their unique ChemTunes-ToxGPS platform, a comprehensive knowledgebase of high-quality in vitro and in vivo toxicological information including an MoA-based prediction system and versatile workflows to support read-across for human health and regulatory relevant toxicity endpoints in the risk and safety assessment of chemicals.


Sensitization Testing in the 21st Century: GARD Updates on OECD Validation, Progress Towards Potency Assessment, and R&D Pipeline

Room 217B

Tuesday, March 13, 4:30 PM to 5:30 PM

Presented by: SenzaGen AB

Sensitization testing is rapidly changing and the need for improved in vitro assays remains urgent. We will report the results from the ring trial leading to a formal Organisation for Economic Co-operation and Development/European Centre for the Validation of Alternative Methods (OECD/ECVAM) validation of SenzaGen´s GARDskin assay. We provide updates on the progress towards potency assessment and the GARD platform R&D pipeline.



Wednesday


From Nose to Tail: Nonclinical Safety Assessment Success Factors in Rats

Room 217A

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

Presented by: Envigo

The rat has been used extensively in nonclinical safety assessment for many years.  Rat strain and diet selection for long-term studies are important in mitigating age-related pathologies. Managing body weight, maintaining proper organ function, and avoiding non-nutrient confounders can impact animal welfare and should be considered when designing studies. 


Maximizing Your Experience and Relationship With Your CRO—A 40-Year Perspective of a CRO Veteran

Room 217B

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

Presented by: WuXi AppTec

This session will present advice on how to have a productive relationship with your CRO.


Optimized In Vitro Models for the Prediction of Drug-Induced Liver Injury

Room 217C

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

Presented by: Fraunhofer ITEM

Human precision-cut liver slices (PCLiS) as well as cell-based in vitro models will be introduced. By co-culturing hepatocytes with cells of the immune system or by adding pro-inflammatory stimuli, enhanced sensitivity of these models to detect the rare but particularly severe idiosyncratic form of liver injury is achieved.


US EPA and Unilever Research Collaboration: Accomplishments and Next Steps

Room 217D

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

Presented by: US Environmental Protection Agency (EPA) Office of Research and Development (ORD)

US EPA's National Center for Computational Toxicology and Unilever are collaborating to use new tools and approaches to build a risk assessment to enable decisions to be made without using animal tests. This session will highlight the accomplishments of the collaboration to date and describe next steps. 


Advanced In Vitro Solute Carrier Transporter Models for Renal Toxicity Studies and Screening

Room 217D

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

Presented by: ATCC

The lack of truly predictive in vitro models of trans-tubule transport hinders the reliable testing of renal clearance. This session will introduce transporter cell models using hTERT-immortalized RPTECs that stably overexpress the OAT1, OCT2, or OAT3 gene that provide tissue-relevant results, improved consistency over time, and predictability for clinical trials.


Anticancer Drug Development—Comparison of Toxicity in Minipig and Mouse

Room 217A

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

Presented by: Sequani Ltd.; Ellegaard Göttingen Minipigs; and Marshall BioResources

The presentation provides a comparison of the toxic response of the mouse and minipig to a novel anticancer drug. Included are comparisons of toxicokinetics data, clinical signs, haematology, and pathology of the gastrointestinal and immune systems.


Classic, Modern, and Innovative Uses of Electron Microscopy in a GLP Environment

Room 217C

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

Presented by: Charles River

Electron Microscopy (EM) has evolved as generations of scientists have pushed the boundaries of its classical application to answer novel scientific questions. Experience demonstrates that electron microscopy can be successfully utilized in a GLP regulatory environment for a variety of important applications in discovery, safety assessment, and manufacturing.


Designed-For-Purpose: Complex Liver Cell Cultures for Improving In Vitro Hepatotoxicity Testing

Room 217B

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

Presented by: Lonza

Lonza, in collaboration with ScitoVation, will present 2D and 3D hepatotoxicity models that can recapitulate in vivo liver phenotypes. These models combine primary hepatocytes and liver non-parenchymal cells to improve hepatocyte viability, phenotype, and response to chemicals.  Maximizing improvements to phenotypic relevance while minimizing culture complexity will be discussed.


Application of Truly Sensitive Microelectrode Arrays for High-Throughput Neurotox Screening Assays

Room 217A

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

Presented by: Alpha MED Scientific Inc.

Discover the power that truly sensitive microelectrode arrays (MEAs) provide for neurtox assays. Experts in the field will present studies on the predictive power of the MED64 family of truly sensitive MEAs for high-throughput screening using stem cell derived neurons and acute brain slices. 


Challenges and Solutions to Receptor Occupancy Studies by Flow Cytometry

Room 217B

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

Presented by: Covance

The key themes that will be discussed during this session include challenges and solutions of identifying appropriate critical reagents for running receptor occupancy (RO)  assays; validation of RO assay, including thoughts about key parameters for successful validation activity; and lessons learnt for assay transfer of RO assays.


Error-Corrected Next-Generation Sequencing: Nonclinical Applications of Duplex Sequencing

Room 217C

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

Presented by: MilliporeSigma

Next-generation sequencing (NGS) has transformed medicine and biotechnology, but safety assessment applications were always limited by an extremely high error rate, preventing detection of ultra-rare de novo mutations. A new technology, duplex sequencing, lowers the sequencing error rate, allowing for applications in nonclinical safety assessment. 


US EPA's Toxic Substance Control Act—Strategy for Alternative Test Methods to Reduce Animal Testing

Room 217D

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

Presented by: US EPA

The updated Toxic Substances Control Act (TSCA) requires the US EPA to develop a strategic plan by June 22, 2018 to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing. This session will provide an overview of the progress that has been made to develop this strategic plan.  


Effective Structural Analog Search for Performing Expert Review Relating to REACH and ICH M7

Room 217C

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

Presented by: MultiCASE Inc.

This session summarizes a new analog search technique that effectively identifies relevant structural analogs for an alerting chemical. This methodology may be applied to perform read-across to satisfy REACH requirements or to perform expert review in accordance with the ICH M7 guideline.


PhysioTel M-Series Telemetry versus Jacketed External Telemetry (JET) for Continuous Cardiovascular Data Collection on Toxicology Studies

Room 217B

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

Presented by: Covance

This session will compare/contrast a new technology (PhysioTel M-series) with an established technology, focusing on:

1. Characteristics of PhysioTel M-series, and potential advantages vs. JET 

2. Review of validation data support the transition to the new technology


Principles of Preclinical Ocular Safety Studies: A Primer for the Non-Ophthalmologist

Room 217D

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

Presented by: MPI Research

Three of four leading causes of blindness (glaucoma, diabetic retinopathy, and age-related macular degeneration) persist without cures. There are urgent needs for new therapeutics to address these debilitating conditions. The prospect of tackling an ocular safety study may scare you. Don’t worry, this session will include specific ocular study needs.


Translational Platforms for Metabolic Syndrome Drug Discovery: A Discussion on Hunger, Obesity, and NASH

Room 217A

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

Presented by: GVK Biosciences

Excess fat and carbohydrate in diets have been associated with the development of obesity, metabolic syndrome, and NASH. This session will present novel translational platforms that mimic multiple aspects of metabolic syndrome, including ghrelin mediated obesity, fatty liver, NASH, and HCC, and their utility in drug discovery programs.


A New Generation of Multichannel Continuous Glucose Telemetry for Group-Housed Nonhuman Primates

Room 217A

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

Presented by: Data Sciences International (DSI)

How would the ability to collect continuous glucose data change the way you do research? Attend this session to see what you've been missing and hear a first-hand account from Crown Bioscience Inc. on its experience with second-by-second glucose monitoring in nonhuman primates. Refreshments provided.


High-Throughput Transcriptomics: Addressing the Human Risk Assessment Challenges of Chemical Coverage, Metabolism, and Population Variation

Room 217C

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

Presented by: BioSpyder Technologies

In vitro approaches to chemical risk assessment are being more widely used for evaluating mechanisms of action and estimating effect doses. Several challenges remain before wide acceptance in regulatory settings. This session will cover topics such as coverage in chemical and biological space, lack of metabolic capacity, and understanding of population variability.


How to Understand the Key Challenges and Issues of a Compound, and Develop a Plan to Eliminate Them

Room 217B

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

Presented by: Evotec

We know that developing drugs is expensive; failure is always a possibility and a compound’s problems are not mitigated by time. What if you were able to understand the key challenges and issues of a particular compound at an early stage, and develop a clear plan to eliminate them?


The Complexity of Immune System Safety Assessment: Pathology, Immunotoxicology, and Integration for Understanding

Room 217D

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

Presented by: MPI Research

There is an ever-increasing array of immunomodulatory therapies being developed that have complex effects on the immune system.  Subtle changes rather than overt toxicity makes safety assessment a daunting task.  This seminar will present approaches used to evaluate the pathology and immunotoxicity of these immunomodulatory therapies on the immune system.


Approaches to Handling Out-of-Domain and Indeterminate (Q)SAR Results to Support ICH M7 Regulatory Submissions

Room 217B

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

Presented by: Leadscope, Inc.

Computational or (Q)SAR analysis is used to support the ICH M7 guideline. Computational results are combined to generate an overall assessment of many compounds while avoiding false negative predictions. This process can be especially challenging if the results are “out-of-domain” or “indeterminate.”


Ensuring SEND Success Beyond Regulatory Compliance

Room 217A

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

Presented by: Instem

SEND - is it simply a standard, or are there more commercial factors that organizations are overlooking? Join us for this informative session where we will be discussing how to exploit the standard beyond simply being compliant. During this time attendees will also receive the latest SEND updates.


Evaluation of Estimated Maximum Tolerated Dose (EMTD) in Tg.rasH2 Studies

Room 217D

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

Presented by: MPI Research

BioReliance’s experienced team (over 50 rasH2 studies) will report on its understanding of the rasH2 transgenic carcinogenicity model. Specific focus will be given to study design and findings from recent papers.