Annual Meeting & ToxExpo Annual Meeting & ToxExpo Annual ...
Annual Meeting & ToxExpo Annual Meeting & ToxExpo Annual ... Annual Meeting & ToxExpo Annual Meeting & ToxExpo Annual ...
EXHIBITOR HOSTED SESSIONS 2:15 PM to 3:15 PM, Room 140A Machine Learning and Exposure to Modeling in the Prediction of In Vivo Toxicity from High Content Screening (HCS) Data Presented by: Cyprotex Discovery High content screening (HCS) is a powerful tool for generating insight into changes arising from exposure of cells to potentially toxic xenobiotics. Linking these changes to in vivo toxic responses enables the creation of predictive models for in vivo drug-mediated toxicity. In this presentation, novel developments in modeling of drug-induced hepatotoxicity from HCS data will be described. 2:15 PM to 3:15 PM, Room 140B Automated GLP Infusion Studies: Improved Process Quality and Labor Utilization Presented by: Instech Solomon GLP infusion studies, rife with high labor content and opportunities for quality improvement, present a classic automation opportunity. This session describes the costs (investment) and benefits (reduced labor and improved process data quality) of moving from manual to Part 11 compatible automated processes. 2:15 PM to 3:15 PM, Room 156 Predictive Analysis of Cell Viability, Apoptosis and ADME/Tox Properties Using Multiparametric In Vitro Assays and Human Induced Pluripotent Stem (iPS) Cell- Derived Cardiomyocytes and Hepatocytes Presented by: Promega Corporation This seminar will highlight the use of multiplexed bioluminescent and fluorescent cell-based assays with human iPS cell-derived cardiomyocytes and hepatocytes that offer a powerful new approach to predictive analysis of cell viability, apoptosis and ADME/Tox properties while enabling streamlined data collection, high data quality and robust interpretation with biologically relevant human cell model systems. 3:30 PM to 4:30 PM, Room 140A The Use of Minipigs in the Development of New Medicines Presented by: Ellegaard Göttingen Minipigs A/S This session provides an overview of marketed drug products where minipigs were used for safety and/or efficacy assessment. General trends of use are identified, furthermore its predictivity towards select clinical adverse reactions is evaluated. 3:30 PM to 4:30 PM, Room 140B Cryopreserved HepaRG: An Alternative In Vitro Screening Tool for Human Hepatic Drug Metabolism, and Safety Applications Presented by: Life Technologies The use of primary human hepatoxytes in screening applications is limited by tissue availability, donor variability, cost and a relative short lifespan in culture. The use of HepaRG cells solves these limitations without sacrificing many of the critical hepatocyte traits such as drug metabolizing enzyme expression, functional transport proteins, and expression of key nuclear receptor pathways. WEDNESDAY, MARCH 9 9:15 AM to 10:15 AM, Room 140A Reproductive and Developmental Toxicity Testing of Vaccines and Biologics Presented by: Charles River The regulatory-required testing of large molecules (vaccines and biologics) prior to marketing for effects on reproduction and development of the fetus presents unique problems in the selection of appropriate species, the timing of treatment, the evaluation of the response to treatment and the relevance of any findings to humans. 9:15 AM to 10:15 AM, Room 140B Key Six Sigma Methods Applied to Surgical Services for Operational Excellence Presented by: Harlan Laboratories, Inc. Harlan Laboratories removed non-value added steps and reduced sources of variation within our rodent surgical services processes using Lean Six Sigma methods. This was key to achieving operational excellence as toxicologists and others increased demand for our outsourced surgical services. 9:15 AM to 10:15 AM, Room 156 Developing Local and Systemic Biologics to Treat Inflammation of the Lung Presented by: Huntingdon Life Sciences Pharmaceutical companies have investigated the respiratory route as a potential to deliver large molecular weight drugs systemically. Many companies are continuing to explore the respiratory route for the treatment of local inflammation. Equally a number of companies are using systemically delivered drugs to treat inflammation of the lung. Session highlights issues and assess how the safety might be addressed. 10:30 AM to 11:30 AM, Room 140B Overview, Design, and Review of Transgenic Carcinogenicity Studies Presented by: BioReliance ® Corporation Experience and design of Transgenic Carcinogenicity studies; as well as, date, statistics and histopathology from the largest database of spontaneous tumors from these studies will be presented. Discussion will include an overview of the history of specific models, validations and the efficacy for use in regulatory submissions. EXHIBITOR HOSTED SESSIONS 17 Products and Services 365 days of the year—Visit ToxExpo.com
EXHIBITOR HOSTED SESSIONS WEDNESDAY, MARCH 9 10:30 AM to 11:30 AM, Room 140A Drug Testing Using 3D Microtissues Presented by: InSphero AG (Continued) More physiological in vitro cell models will foster the efficiency of the drug development process. InSphero provides an in-depth review of different 3D-cell-culture technologies used to create microtissue models. Applications in oncology and toxicology as well as examples of the successful use of 3D models up to the regulatory level for skin applications are presented. 10:30 AM to 11:30 AM, Room 156 Challenges of Assessing Biologics for Efficacy and Safety Presented by: MPI Research Biologics present an ongoing challenge to both PK/PD assessment and safety/immunotoxic effects. This session will discuss issues around assay development, impact of immunogenicity on PK/ efficacy, and risk-based approach to determine what, if any, additional safety immune-based endpoints should be assessed. 1:00 PM to 2:00 PM, Room 140A Electric Cell-Substrate Impedance Sensing: A Label Free, Non-Invasive Method of Cell Measurement Presented by: Applied BioPhysics, Inc. An overview of the use of impedance (both simple and complex) to detect cell morphological changes. Emphasis will be placed on the use of difference AC frequencies to distinguish cell parameters. Various ECIS applications will be discussed including proliferation, cell invasion, automated cell migration, barrier function, toxicology and signal transduction. 1:00 PM to 2:00 PM, Room 156 hESC Derived Cardiomyocytes for Drug Safety Testing Presented by: GE Healthcare Cardiomyocytes derived from human embryonic stem cells (hESC) on an industrial scale provide an advance towards more clinically predictive assays for assessing cardiotoxicity of new drugs. Data will be presented from high-content imaging and electrophysiological analysis of hESC derived cardiomyocytes illustrating a powerful complimentary and comprehensive approach to assessing cardiac drug liabilities. EXHIBITOR HOSTED SESSIONS 11:45 AM to 12:45 PM, Room 140A Toxicity Knowledge Bases and Pathway Analysis Tools for Systems Toxicology Presented by: GeneGo, Inc., a Thomson Reuters Business ToxHunter is a rich database and powerful suite of tools for analyzing high content molecular toxicology data. Capabilities of the system in a safety assessment will be demonstrated. Dr. Russell Thomas from The Hamner Institutes will follow with a presentation on Applications of Pathway Analysis to Chemical Risk Assessment. 11:45 AM to 12:45 PM, Room 140B Humanized Mouse Models for PK and Safety Profiling of Compounds Presented by: Taconic There are profound interspecies differences in levels and functions of proteins involved in absorption, distribution, metabolism, excretion and toxicology (ADMET). Thus, traditional mouse models can be poor predictors of ADMET in humans. Panels of transgenic mouse models with key murine ADMET genes knocked out or exchanged for their human counterparts are discussed. 11:45 AM to 12:45 PM, Room 156 Advances in Cell Based Assays for Toxicity and Genetoxicity Testing Presented by: Thermo Scientific We will discuss the advantages of cell imaging assays over traditional biochemical assays for toxicity risk assessment, as well as, new automated cell based tools for Genotoxicity testing. We will present several case studies in the drug discovery and consumer products testing areas. Products and Services 365 days of the year—Visit ToxExpo.com 18 1:00 PM to 2:00 PM, Room 140B Multiplex Biomarker Assays for Kidney and Liver Toxicity Presented by: MESO SCALE DISCOVERY Protein expression fingerprints of biological samples can be used for measuring drug efficacy and toxicity and for target selection. Multiplexing rapidly measures multiple analyte levels in limited sample volumes. MESO SCALE DISCOVERY ® develops and validates multiplex biomarker assays. We will discuss novel assays for specific kidney and liver biomarkers. 2:15 PM to 3:15 PM, Room 140B Accelerating Project Reviews and Improving Drug Safety Evaluation through Nonclinical Search and Data Exchange Presented by: PointCross, Inc. Toxicologists, pathologists and reviewers need new ways to identify safety and efficacy signals across nonclinical studies to improve drug selection decisions. Practical case studies that demonstrate the benefits of interactive and collaborative search, data visualization, and digital data exchange with regulatory agencies using standards such as SEND will be presented. 2:15 PM to 3:15 PM, Room 140A Function Genomics and High Content Screens— Getting the Best from Both Worlds Presented by: SimuGen With the maturation of high content imaging for screening, many are asking if genomic approaches are worth the cost and effort. We’ll have a look at the potential functional genomics and high content screens hold as modelling tools, and how we might combine both towards more comprehensive, useful toxicology practice.
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EXHIBITOR HOSTED SESSIONS<br />
WEDNESDAY, MARCH 9<br />
10:30 AM to 11:30 AM, Room 140A<br />
Drug Testing Using 3D Microtissues<br />
Presented by: InSphero AG<br />
(Continued)<br />
More physiological in vitro cell models will foster the efficiency<br />
of the drug development process. InSphero provides an in-depth<br />
review of different 3D-cell-culture technologies used to create<br />
microtissue models. Applications in oncology and toxicology as<br />
well as examples of the successful use of 3D models up to the<br />
regulatory level for skin applications are presented.<br />
10:30 AM to 11:30 AM, Room 156<br />
Challenges of Assessing Biologics for<br />
Efficacy and Safety<br />
Presented by: MPI Research<br />
Biologics present an ongoing challenge to both PK/PD assessment<br />
and safety/immunotoxic effects. This session will discuss issues<br />
around assay development, impact of immunogenicity on PK/<br />
efficacy, and risk-based approach to determine what, if any,<br />
additional safety immune-based endpoints should be assessed.<br />
1:00 PM to 2:00 PM, Room 140A<br />
Electric Cell-Substrate Impedance Sensing: A Label Free,<br />
Non-Invasive Method of Cell Measurement<br />
Presented by: Applied BioPhysics, Inc.<br />
An overview of the use of impedance (both simple and complex)<br />
to detect cell morphological changes. Emphasis will be placed on<br />
the use of difference AC frequencies to distinguish cell parameters.<br />
Various ECIS applications will be discussed including proliferation,<br />
cell invasion, automated cell migration, barrier function, toxicology<br />
and signal transduction.<br />
1:00 PM to 2:00 PM, Room 156<br />
hESC Derived Cardiomyocytes for Drug Safety Testing<br />
Presented by: GE Healthcare<br />
Cardiomyocytes derived from human embryonic stem cells<br />
(hESC) on an industrial scale provide an advance towards more<br />
clinically predictive assays for assessing cardiotoxicity of new<br />
drugs. Data will be presented from high-content imaging and<br />
electrophysiological analysis of hESC derived cardiomyocytes<br />
illustrating a powerful complimentary and comprehensive approach<br />
to assessing cardiac drug liabilities.<br />
EXHIBITOR HOSTED SESSIONS<br />
11:45 AM to 12:45 PM, Room 140A<br />
Toxicity Knowledge Bases and Pathway Analysis Tools for<br />
Systems Toxicology<br />
Presented by: GeneGo, Inc., a Thomson Reuters Business<br />
ToxHunter is a rich database and powerful suite of tools for<br />
analyzing high content molecular toxicology data. Capabilities of<br />
the system in a safety assessment will be demonstrated. Dr. Russell<br />
Thomas from The Hamner Institutes will follow with a presentation<br />
on Applications of Pathway Analysis to Chemical Risk Assessment.<br />
11:45 AM to 12:45 PM, Room 140B<br />
Humanized Mouse Models for PK and Safety Profiling of<br />
Compounds<br />
Presented by: Taconic<br />
There are profound interspecies differences in levels and functions<br />
of proteins involved in absorption, distribution, metabolism,<br />
excretion and toxicology (ADMET). Thus, traditional mouse models<br />
can be poor predictors of ADMET in humans. Panels of transgenic<br />
mouse models with key murine ADMET genes knocked out or<br />
exchanged for their human counterparts are discussed.<br />
11:45 AM to 12:45 PM, Room 156<br />
Advances in Cell Based Assays for Toxicity and<br />
Genetoxicity Testing<br />
Presented by: Thermo Scientific<br />
We will discuss the advantages of cell imaging assays over<br />
traditional biochemical assays for toxicity risk assessment, as well<br />
as, new automated cell based tools for Genotoxicity testing. We will<br />
present several case studies in the drug discovery and consumer<br />
products testing areas.<br />
Products and Services 365 days of the year—Visit <strong>ToxExpo</strong>.com<br />
18<br />
1:00 PM to 2:00 PM, Room 140B<br />
Multiplex Biomarker Assays for Kidney<br />
and Liver Toxicity<br />
Presented by: MESO SCALE DISCOVERY<br />
Protein expression fingerprints of biological samples can be used<br />
for measuring drug efficacy and toxicity and for target selection.<br />
Multiplexing rapidly measures multiple analyte levels in limited<br />
sample volumes. MESO SCALE DISCOVERY ® develops and<br />
validates multiplex biomarker assays. We will discuss novel assays<br />
for specific kidney and liver biomarkers.<br />
2:15 PM to 3:15 PM, Room 140B<br />
Accelerating Project Reviews and Improving Drug<br />
Safety Evaluation through Nonclinical Search and Data<br />
Exchange<br />
Presented by: PointCross, Inc.<br />
Toxicologists, pathologists and reviewers need new ways to identify<br />
safety and efficacy signals across nonclinical studies to improve<br />
drug selection decisions. Practical case studies that demonstrate the<br />
benefits of interactive and collaborative search, data visualization,<br />
and digital data exchange with regulatory agencies using standards<br />
such as SEND will be presented.<br />
2:15 PM to 3:15 PM, Room 140A<br />
Function Genomics and High Content Screens—<br />
Getting the Best from Both Worlds<br />
Presented by: SimuGen<br />
With the maturation of high content imaging for screening, many<br />
are asking if genomic approaches are worth the cost and effort.<br />
We’ll have a look at the potential functional genomics and high<br />
content screens hold as modelling tools, and how we might combine<br />
both towards more comprehensive, useful toxicology practice.
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