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Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday


Drug Development and SEND: Evolving Current Practices Toward Future Opportunities

Room 340

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

Presented by: MPI Research

SEND represents a unifying platform with the potential to revolutionize the approach to, and context of, drug safety evaluation efforts. The session explores this potential by comparing and contrasting methodologies in the period before SEND with those anticipated in the period after SEND implementation.


US EPA’s Computational Toxicology Online Dashboard Demonstrations

Room 337

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

Presented by: US Environmental Protection Agency

EPA develops and uses new approaches to evaluate thousands of chemicals for potential toxicity and to estimate chemical exposure/dose. These methods produce large data sets that are publicly available through the “CompTox Dashboards”. This session provides hands-on demonstrations of the CompTox Dashboards. Learn more about CompTox research www.epa.gov/comptox


Immunology – Worth all the Hype? You bet it is.

Room 338

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

Presented by: Envigo

Non-clinical safety assessment studies with products designed to activate or suppress the immune system are increasingly complex.  But with the availability of reagents to quantitatively and qualitatively measure immunopharmacology and immunotoxicology increasing, this means the acquisition of high quality data on safety studies has entered a golden age.


An Overview of Pre-Clinical Microsampling Techniques and their Bioanalytical Challenges

Room 340

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

Presented by: Altasciences Clinical Research

This session will outline the pros and cons of various microsampling techniques such as DBS, capillary microsampling (CMS) and volumetric absorptive microsampling (VAMS). The bioanalytical challenges of each technique for use in regulated bioanalysis will be highlighted. Case studies using VAMS will be presented.


From Cells to Society and Beyond: Diversity and Scope of Neurotoxicology Testing at Battelle

Room 339

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

Presented by: Battelle

Explore the diverse applicability of neuroscience-based endpoints in toxicology studies. Highlights include neurobehavioral testing for pharmaceutical and chemical safety, novel applications like simultaneous cardiovascular measurements during real time performance in behavioral tests, in vitro and in vivo chemical weapon and nerve agent countermeasures, and pre-clinical support for clinical applications.


In Silico Strategies to Assess Potentially Mutagenic Impurities under ICH M7

Room 338

Monday, March 13, 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 on the different strategies that can be used to assess the risk of impurities under ICH M7, including the generation of purge based arguments and mutagenicity prediction methodologies.


Mechanistic Insights into Contractility and Electrophysiology Complemented by Optical stimulation of iPS Cardiomyocytes

Room 337

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

Presented by: Nanion Technologies and Axiogenesis

Here we present 1) a pioneering approach for simultaneous optogenetic stimulation and recording of electrophysiological and contractile parameters of iPS cardiomyocytes; 2) multiple high-throughput patch clamping platforms for assessment of acute/chronic drug effects; and 3) the application of these technologies for cardiac safety assessment in accordance with CiPA.


Begin with the SEND in Mind: Learnings, Challenges and Opportunities

Room 339

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

Presented by: Covance, Inc.

Leading up to the December 2016 deadline, SEND has been a highly anticipated and widely discussed  topic. Now that we’re “live,” what have we learned in implementing SEND 3.0 that can help the next evolution go more smoothly?
 


Developing an Implementation Strategy for Toxicity Testing in the 21st Century

Room 340

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

Presented by: National Institute of Environmental Health Sciences

A strategy for the safe, effective, and timely implementation of 21st century toxicity testing approaches in the U.S. is under development. This session will provide an update on ongoing efforts towards developing this strategy, and foster engagement in this process from stakeholders from the industrial, academic, animal welfare, and regulatory sectors.


Novel Pulmonary Exposure Studies Examine the Effects of Airborne Toxins

Room 338

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

Presented by: Data Sciences International

3D printer emissions and Firefighters have what in common? Join us to learn how researchers maximized their study designs to evaluate the effects of airborne toxins. Discussion will highlight inhalation technology for post-exposure studies and the use of implantable telemetry for respiratory breathing rate/amplitude experiments.


The Minipig as a Disease Model in Translational Medicine

Room 337

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

Presented by: Sinclair Research Center, LLC

The minipigs are becoming routinely used both in experimental pharmacology and as a therapeutic model for human diseases. Translational preclinical minipig data presented here support the current understanding that minipigs are the animal model of choice for the assessment of drugs targeting endocrine, dermal, and ocular disorders.


Generating Dry Powder Aerosols from Nanomaterials: A Precision Art

Room 339

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

Presented by: Inhalation Sciences Sweden AB

How do you generate dry powder aerosols from nanoparticles to enhance your research results? Aerosol authority Per Gerde explain why PreciseInhale dry powder aerosol technology is the system of choice for nanoparticle researchers at Dow Chemicals, Karolinska Institutet and more.


Optimized Testing of Nanomaterials: A Case Report

Room 337

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

Presented by: Fraunhofer ITEM

As an example of sophisticated nanomaterial testing, this session will present a tiered approach for different multi-walled carbon nanotubes. Information will include the generation of specific test atmospheres, results from different types of in vivo studies and innovative in vitro studies for elucidation of biological effects and their underlying mechanisms.


Beyond REACH

Room 340

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

Presented by: Charles River

Recent changes to REACH legislation and its guidance, the substance identity focus, etc., make it challenging to meet the 2018 deadline, and to register new substances. Companies should consider a global approach to testing of industrial chemicals, including regions such as China or USA with its updated TSCA requirements.


Replacement of Animal Testing for CLP/GHS Potency Classification of Skin Sensitizers is Now Possible using a Modified Genomic GARDskin [OECD TGP 4.106] Assay

Room 338

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

Presented by: SenzaGen AB

SenzaGen presents the latest development towards reliable potency classification of chemicals according to CLP 1A and 1B, taking both LLNA and Human potency data in consideration. The assay is based on GARDskin and utilizes a refined gene expression signature developed specifically for potency categorization with high predictability.


Global Initiatives for Replacement, Refinement and Reduction in Animal Use within Toxicology Programs

Room 337

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

Presented by: NC3Rs

This session will highlight opportunities for reductions or refinements in animal use, within (bio)pharmaceutical toxicology programs. Organised by the UK’s national centre for the 3Rs (NC3Rs), it brings together scientists and regulators from NC3Rs-led, international consortia to discuss initiatives investigating future efficiencies in study designs and promoting best practice.


African Green Monkeys: An Underutilized Alternative to the Macaque

Room 339

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

Presented by: Worldwide Primates, Inc.

African Green Monkeys are an underutilized primate model. Just as the Mauritian Cyno, they are naturally viral negative. Traditionally, there use has been restricted to the biodefense & vaccine industries. This session will discuss other uses of AGM’s and will provide previously unavailable historical data to the research community.


Discovery of Toxicity Mechanisms Using Phenotypic Profiling in Human Primary Cell-Based Models

Room 338

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

Presented by: DiscoverX Corporation

Falgun Shah (Merck) and Kevin French (GSK) will present case studies demonstrating the use of profiling using human primary cell-based assays to identify potential mechanisms of toxicity explaining (1) drug induced vascular injury in rodents, and (2) skin toxicity in non-human primates.



Tuesday


Challenges in Addressing Testicular Toxicity: A Pathologist’s Perspective

Room 340

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

Presented by: MPI Research

Testicular toxicity is a common finding in nonclinical toxicity testing. Histopathology of the tests is the most sensitive method for detection of effects on spermatogenesis, and the toxicologic pathologist plays a key role in hazard characterization and mitigation of risk when testicular toxicity is identified in nonclinical safety studies.


EU REACH Submissions; Learn the Lessons - Avoid the Mistakes

Room 338

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

Presented by: Envigo

REACH has changed the toxicological landscape - the demand for maximum information coupled with an obligation to minimize animal consumption, has meant the development of net new tests and the refinement of others.  Using a case study approach, these developments will be described with all-aspect data generation examples.


Integrated Approaches for Inhalation Toxicity Assessment

Room 337

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

Presented by: Fraunhofer ITEM

This session will focus on integrated approaches to testing and assessment (IATA) in inhalation toxicology combining the data from different alternative approaches such as human airway epithelial cells and fresh human lung material. A case study using these methods for a stepwise approach in risk assessment will be critically discussed.


Highly Relevant Proprietary Data and Predictive Models for Drug Development

Room 339

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

Presented by: Lhasa Limited and Molecular Networks

Lhasa Limited and Molecular Networks will provide an overview of a new resource to improve early drug candidate safety assessment. Resulting from the eTOX project, eTOXsys provides high quality proprietary toxicity data and predictive models integrated into an overall decision-making tool.


Quantitation of Biotherapeutics by LC/MS: Finding its Groove in Preclinical Toxicology

Room 340

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

Presented by: Charles River

LC/MS quantitation of biotherapeutics has evolved as a differentiated tool supporting investigative toxicology. Research demonstrates this methodology 1.) satisfies FDA criteria for TK assessments; 2.) addresses limitations of ligand binding assays techniques related to selectivity of endogenous analogs and metabolites; and 3.) mitigates reagent generation issues.


Detect Apoptosis in Real Time with a Plate Reader Using a Novel Homogeneous Luminescent Assay

Room 339

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

Presented by: Promega Corporation

We will describe novel homogeneous, multimode plate reader assays to detect apoptosis and necrosis in real time. Addition of annexin v–luciferase fragment fusion proteins generate light only when bound to apoptotic cells. Multiplexing with a DNA dye enables detection of necrotic cells from the same wells over multiple days.


Hepatocyte Spheroids for Toxicity Evaluation

Room 338

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

Presented by: In Vitro ADMET Laboratories Inc.

Hepatocyte spheroids maintain in vivo-like cell-cell contact with long-term maintenance of liver functions, including drug metabolic enzyme activities.  Properties of spheroids cultured from human and animal hepatocytes as hepatocyte monocultures and as hepatocyte/Kupffer cell co-cultures, and their application in the evaluation of drug metabolism and hepatotoxicity will be reviewed.


Neurotox and Cardiac Safety Assessment: Case Studies Employing iPS Cell Lines, MEA and Optogenetic Techniques

Room 337

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

Presented by: Axiogenesis AG and Axion Biosystems

Discover the predictive power of Axiogenesis iPS cardiomyocytes and neurons with Axion BioSystems’ Maestro multiwell MEA platform.  Experts in the field will present their case studies in neurotoxicology (HESI NeuTox) and cardiac safety (CiPA) in conjunction with innovative new products that control in vitro assays through optogenetic techniques.


A New Pathway and Related Assay Systems and Biomarkers for the Study and Prediction of Cholestasis Side Effects of Xenobiotics

Room 338

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

Presented by: Biopredic International

Our lecture will rely on two papers published that year and that explain that the bile canaliculi contraction and the RhoK and the MLCk enzymes regulating the level of phosphorylated light chain myosin are the targets of cholestatic compounds. 


Investigating Nrf2’s Protective Role in Kidney through Transcriptomics and Proteomics Data Interpretation using Ingenuity Pathway Analysis (IPA)

Room 340

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

Presented by: QIAGEN

IPA identifies Nrf2 as the key upstream regulator accompanying the activation of detoxification-related pathways and biological processes. Comparison analysis of transcriptomics and proteomics datasets shows enrichment of similar pathways and cellular processes, and highlights IPA as a powerful tool for multi-omics tox analysis.


DILIsym: A Computational Tool for Assessing the Risk of Drug-Induced Liver Injury

Room 339

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

Presented by: DILIsym Services Inc.

A quantitative systems toxicology (QST) model of drug-induced liver injury (DILI) has been developed through the DILI-sim Initiative over the past 7 years (DILIsym) to assist in the safety characterization of compounds in clinical development.  Case studies will be presented demonstrating how drug metabolism and disposition intersect with hepatotoxicity. Lunch will be provided to attendees while supplies last.


Novel In Vitro Models for the Study of Drug-Induced Hepatotoxicity

Room 337

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

Presented by: Corning Incorporated

Corning Life Sciences offers several novel in vitro model systems for drug-induced hepatotoxicity. This workshop will provide an applications overview using Corning® HepatoCells, which are single-use, cryopreserved cells, derived from primary human hepatocytes, and cellular fractions from mammalian cells expressing recombinant ABC transporters, which are important hepatotoxicity targets.


Functional Assays for Assessing Mitochondrial Toxicity and Metabolism of Live Cells

Room 337

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

Presented by: Agilent Technologies

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


Advantages with Genome Testing Opening up the Landscape for New Application Possibilities for Sensitization Testing using SenzaGen’s Genomic GARD Assay

Room 338

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

Presented by: SenzaGen AB

SenzaGen’s GARD assay is based on expression analysis of predictive genomic biomarker signatures. Prediction calls of test substances are generated by computational methods based on machine learning. SenzaGen presents their experience in skin and respiratory sensitization testing, working with challenging compounds and mixtures, active substances, potency classification and NOEL interpretation.


Comprehensive Solutions for Genotoxicity Evaluation of All Products (QSAR to Screening, to GLP Assays)

Room 340

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

Presented by: MilliporeSigma

Genotoxicity Experts from MilliporeSigma will outline and discuss the myriad of assays and paradigms for the hazard, safety assessment or preclinical evaluation of all types of products. BioReliance’s complete line of services includes: QSAR, HTP and predictive screening, GLP regulatory, and assays to follow up a Genetox positive result.


Neurotoxicology Investigations in the Minipig

Room 339

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

Presented by: Marshall BioResources, Ellegaard Göttingen Minipigs, CiToxLAB

Neurotoxicology is critical in various therapeutic indications such as anti-infectives, oncology, CNS and metabolic diseases. The limited translational value of rat FOB has raised interest for non-rodent neurotoxicology/neuropharmacology. A full battery of minipig neurological investigations to support drug development will be discussed in the context of this growing concern.


Obtaining Non-Invasive Readouts and Early Safety Signals from Rodent Models

Room 339

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

Presented by: Vium Inc.

This session will present the Digital Vivarium®, an in vivo animal model testing platform providing in-life physiological readouts enabling detection of early safety signals.  An overview of the technology with specific case studies will be presented.


Evaluating the Developmental Toxicity Potential of the ToxCast Chemical Library with devTOX quickPredict

Room 338

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

Presented by: Stemina Biomarker Discovery

devTOX quickPredict is a reliable, in vitro, human pluripotent stem cell-based assay used to assess chemicals for potential developmental toxicity affecting differing developmental lineages. We will discuss how the assay performs with the ToxCast chemical library and how the US EPA is using the data in support of Tox21. 


New Life for Natural Killer Cell Assays Using Non-Radioactive Approaches

Room 337

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

Presented by: Covance, Inc.

The Natural Killer cell is a key component of the innate immune system. Historically a chromium-release cytotoxicity assay has been used in preclinical drug development studies.  We will present data using nonradioactive plate- and flow- based methods and discuss the use of the NKc assay to complement standard toxicology studies.     


Trends, Trials and Triumphs in In Vitro Toxicology

Room 340

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

Presented by: Charles River and NIEHS

In vitro alternatives for toxicology screening and animal testing are increasing in variety. While validation against animal tests is costly and may result in false rejection, human clinical and/or mechanistic data is revolutionizing our acceptance and understanding of these tests. Such knowledge will serve to guide our future testing strategies.



Wednesday


IACUC 101: Balancing Requirements for Animal Welfare and Defining Test Article Safety

Room 337

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

Presented by: MPI Research

An attending veterinarian and a senior toxicologist, who are members of an IACUC, discuss common challenges institutions face for meeting the expectations of animal welfare regulations, while still ensuring the validity of data.  Although approaches can differ based on perspective, strategies for win-win solutions will be discussed.


Quantitative Measures Associated with DNA and RNA Therapeutics

Room 340

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

Presented by: Charles River

Increasing interest in the development of Oligonucleotide therapeutics among Biotech and Large Pharma companies has been recently fuelled by the approval of Mipomersen.  Sensitive and selective bioanalytical methodologies are key to the development process.  Chromatographic and hybridization ELISA approaches will be reviewed, compared and contrasted.


Genetic Toxicology – Is it Still Relevant or Even More Critical?

Room 338

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

Presented by: Envigo

Genetic toxicity remains one of the few areas that can stop the development of a material. Since its birth in the 1970s it is still regarded as an arcane branch of toxicology with often unruly assays and immeasurable interpretation; but things are changing.  Long standing traditions being called into question.


Minipigs in Translational Immunosafety Sciences

Room 337

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

Presented by: Ellegaard Göttingen Minipigs, Marshall BioResources, and Novartis Pharma

The increasing number of new drug targets to modulate immunological pathways has triggered interest to explore the porcine immune system. More systematic comparisons regarding the innate and adaptive immune system in pigs and minipigs are needed to assess the significance of immunological findings in minipigs to support translational safety sciences.


ICCVAM Tools for Validation and Regulatory Application of Alternative Methods

Room 337

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

Presented by: National Institute of Environmental Health Sciences and the National Toxicology Program

New technologies have enabled the development of complex cell-based and computational models to assess toxicity. Creating bridges between these technologies and regulatory applications requires access to computational tools and data. This session will detail existing tools available from ICCVAM member agencies as resources for stakeholders.