Exhibitor Hosted Sessions

Monday

Logistic and Technical Challenges of Conducting Developmental Toxicity Studies in Nonhuman Primates

Monday, March 7, 9:15 AM–10:15 AM

Presented by: MPI Research

The preclinical safety testing of biotherapeutics poses a particular challenge in selecting a relevant animal species for use in toxicology studies. The nonhuman primates are most frequently used for developmental and reproductive toxicity testing when commonly used rodents and/or rabbits are not pharmacologically relevant species. In this presentation, the logistical and technical challenges when conducting developmental toxicity testing in nonhuman primates will be presented and discussed.

Phototoxicology: Current Practices and Regulatory Status

Monday, March 7, 9:15 AM–10:15 AM

Presented by: Charles River

Phototoxic risk can be assessed during drug development from candidate screening through Phase IV. When and how to evaluate for phototoxic potential is not always clear and the changing regulatory status adds additional uncertainty. The tools for phototoxicity testing and how current/upcoming regulations may affect these approaches will be presented.

The Impact of Intravital Microscopy Imaging and 3D Image Reconstruction on Early Discovery Analysis

Monday, March 7, 9:15 AM–10:15 AM

Presented by: Covance

Intravital microscopy is a technique that provides quantitative, in vivo molecular imaging at subcellular resolution, resulting in a cost-effective approach to accelerate preclinical drug development. State-of-the-art multiphoton microscopy combined with novel surgical techniques and multiple fluorophores allow in vivo imaging at subcellular resolution. The impact of this technology to facilitate an understanding of efficacy and safety will be discussed.

First in Human Monoclonal Antibody Development Strategies for the Treatment of Cancer Patients

Monday, March 7, 10:30 AM–11:30 AM

Presented by: Huntingdon Life Sciences

Monoclonal antibodies have demonstrated to provide huge healthcare benefits in treatment of cancer. Designing and performing the optimal IND enabling non-clinical safety package is very important. Some non-standard approaches are discussed which highlight the need for focus upon the pathophysiology of disease, the biology of the drug target and the risks that need to be considered with drug intervention.

From Guidelines to Protocol: Lessons from EDSP Validation

Monday, March 7, 10:30 AM–11:30 AM

Presented by: Harlan

This session will discuss the challenges faced in developing laboratory test protocols from the original OPPTS guidelines that were issued, as well as the final resolution of those challenges. A summary of validation data will be presented along with a perspective on interpreting results obtained from the assays.

HepaRG, Novel Human Hepatic Cells for In Vitro Tox

Monday, March 7, 10:30 AM–11:30 AM

Presented by: Biopredic Inc

Biopredic will present exciting new study information about the varied applications of HepaRG cells to assess various mechanisms of toxicity, and to screen candidate compounds for risk of toxicity in metabolically-compatent cells which can be reliably and reproducibly used even in 384 well applications.

Knockout Rats as More Effective Pre-Clinical Models

Monday, March 7, 11:45 AM–12:45 PM

Presented by: Sigma Life Science

Knockout models for disease have been limited mostly to mice, which may not accurately reflect the physiology in humans. Advances in genetic engineering have extended the species available, enabling the creation of targeted knock-outs in rats, rabbits, zebrafish and swine. An expert panel will discuss genetic engineering technologies used to develop more relevant translational animal models, including the newly developed Tp53, Mdr1a, Mrp1, Mrp2, and Bcrp knockout rat models.

Non-Clinical Evaluation of Drug-Abuse Liability

Monday, March 7, 11:45 AM–12:45 PM

Presented by: Porsolt

Evaluation of abuse liability is currently a major topic in drug safety. Recent documents from European and U.S. authorities provide guidance as to how to address this issue but many issues remain. This session will explore this topic from the point of view of pharma companies, regulatory agencies, and CROs.

Urine and Blood Based Biomarkers for Detecting Nephrotoxicity

Monday, March 7, 11:45 AM–12:45 PM

Presented by: Rules-Based Medicine

Hear the pertinent facts from a recent set of publications by the Predictive Safety Testing Consortium (PSTC) Nephrotoxicity Working Group on qualifying a panel of seven biomarkers for preclinical studies of nephrotoxicity. Data demonstrating the utility of the biomarkers for human kidney injury will also be presented.

How to Comply with the U.S. EPA’s Endocrine Disruption Screening Program

Monday, March 7, 2:15 PM–3:15 PM

Presented by: WIL Research Laboratories

The U.S. EPA’s Endocrine Disruption Screening Program (EDSP) was established in response to growing concern that humans and animals may exhibit adverse endocrine effects due to environmental chemicals. The first tier in the U.S. EPA’s EDSP includes a suite of specific assays designed to look at endocrine effects at the molecular, receptor, and functional levels. These assay will be reviewed in this session.

Nonhuman Primate (NHP) Infant Age and Relevance of Postnatal and Juvenile Assessments: Principles for Understanding Specific Endpoints in Study Designs Supporting Biologics Regulatory Submissions

Monday, March 7, 2:15 PM–3:15 PM

Presented by: SNBL USA

In regulatory-mandated NHP pre-/post-natal and juvenile studies, infant development milestones and test compound pharmacology dictate the types of parameters to monitor. The pertinent question is how to identify critical parameters from the numerous possibilities that exist. This presentation will highlight approaches to take and provide examples of background data and interpretation.

Utility of Hematopoietic Colony Forming Cell (CFC) Assays in Drug Development

Monday, March 7, 2:15 PM–3:15 PM

Presented by: STEMCELL

A potential side effect of anticancer and some antiviral/antimicrobial drugs is damage to the hematopoietic (blood) system. Compounds that impair cell proliferation and differentiation can result in neutropenia, anemia or thrombocytopenia. This talk outlines the value of hematopoietic in vitro clonogenic assays for prediction of hematotoxicity.

Announcing U.S. EPA’s Clean Air Research Centers: Science to Protect Health in a Multipollutant Atmosphere

Monday, March 7, 3:30 PM–4:30 PM

Presented by: U.S. Environmental Protection Agency, Office of Research and Development

The U.S. Environmental Protection Agency is investing $32 million in new Clean Air Research Centers (CLARCs). The CLARCs will investigate exposures to air pollution mixtures, atmospheric transformation products, and associated health outcomes to determine impacts across life stages, amongst vulnerable populations, and within high-risk communities.

New Pre-Clinical Assays for Predicting Cardiotoxicity

Monday, March 7, 3:30 PM–4:30 PM

Presented by: ChanTest Corporation

Sudden Cardiac death from non-cardiac drugs is the cardiotoxicity issue for regulatory agencies. Greater predictivity will be achieved by using Stem Cell-derived Human Cardiomyocytes and cardiac ion channel screens, and by considering rate-dependent effects on telemetered QT. Case reports that resolve discordances with the traditional S7B approach will be presented.

Screening of Drug Candidates with Idiosyncratic Hepatoxic Potential: Concepts and Approaches

Monday, March 7, 3:30 PM–4:30 PM

Presented by: In Vitro ADMET Laboratories LLC (IVAL)

Experimental assessment of idiosyncratic drug toxicity is elusive due to the rarity of the events and the lack of appropriate animal models. The multiple parameter hypothesis of idiosyncratic drug toxicity and promising experimental approaches based on the hypothesis will be described.

Tuesday

LiverPool: Pooled Human Cryopreserved Hepatocytes and Their Advantages Across Diverse ADME-Tox Applications

Tuesday, March 8, 9:15 AM–10:15 AM

Presented by: Celsis In Vitro Technologies

The patented LiverPoolTM pooled hepatocyte product, provides an average response that is optimal for ADME-Tox studies. Advances in pre-pooling have further increased the usefulness of pooled human hepatocytes including their ability to meet targeted activity profiles. Applications like transporter and inhibition will be discussed.

Preclinical Cellular Therapeutic Safety Testing

Tuesday, March 8, 9:15 AM–10:15 AM

Presented by: Charles River

Cell-based therapies present unique challenges for the evaluation of safety, cell survival, differentiation and distribution, and the potential for tumor formation in the appropriate animal model. These specifically designed preclinical studies with different approaches provide valuable information for assessment of potential clinical and regulatory risks of these promising therapies.

Predicting the Human Clinical Dose

Tuesday, March 8, 9:15 AM–10:15 AM

Presented by: MPI Research

Allometric scaling has been the primary technique for human dose prediction. The development of humanized ADME reagents has led to techniques where the metabolic characteristics of a drug are taken into account to improve the accuracy of predicting human clinical doses and potential drug /drug interaction issues.

Developing a Novel Vaccine/Adjuvant Combination for the Prophylaxis and Treatment of Infectious Disease

Tuesday, March 8, 10:30 AM–11:30 AM

Presented by: Huntingdon Life Sciences

Novel vaccine/adjuvant combinations introduce new risks that need to be assessed during safety assessment. Standard paradigms do not exist and approaches must be designed on a case by case basis with a good understanding of the predicted clinical immunogenicity of the vaccine candidate. Case studies will be discussed which highlight varying approaches for both prophylactic and therapeutic vaccines.

Diets for GLP Studies, Including Those for REACH

Tuesday, March 8, 10:30 AM–11:30 AM

Presented by: Harlan

In vivo testing as part of REACH programs further challenges the toxicologist to make scientifically-sound decisions on what is appropriate diet in terms of nutrient levels and ingredients for GLP work, in light of the well-established evidence that diet can adversely impact on endocrine disruptor studies.

National Toxicology Program Chemical Effects in Biological Systems

Tuesday, March 8, 10:30 AM–11:30 AM

Presented by: National Toxicology Program

NTPCEBS (National Toxicology Program Chemical Effects in Biological Systems), the NTP public database, now contains data from legacy NTP studies, making this data available in cross-study queries. Recently the NTP also made DrugMatrix (Entelos) available in NTPCEBS. This session will introduce NTPCEBS and how to use it.

A Battery of Toxicity Screening Assays for Selection of Dermal Drug Candidates

Tuesday, March 8, 11:45 AM–12:45 PM

Presented by: LAB Research

This session will describe a battery of in silico, in vitro, and in vivo toxicity screening assays that—prior to selecting the final drug candidate for clinical development—are useful to screen out candidate molecules for their potential to cause local irritancy, contact sensitization or photototoxicity reactions.

Biological Network Analysis Software: The Value Of A Technology Is A Function Of The Knowledge And Skill Of The User

Tuesday, March 8, 11:45 AM–12:45 PM

Presented by: Ingenuity Systems
Presenters: Kevin T. Morgan, Ph.D., and Ke Xu, Ph.D.

The interpretation of Toxicogenomics studies may be compromised if researchers involved have insufficient time and/or inadequate training in a broad range of biological disciplines. This issue will be discussed in relation to Bioenergetics and Dynamics through the application of Array Studio™ and IPA® software.

New Applications of Latest Telemetry Technology in Toxicology and Safety Pharmacology

Tuesday, March 8, 11:45 AM–12:45 PM

Presented by: Data Sciences International

Advances in wireless technology have enabled new non invasive and plantable telemetric physiological monitoring to provide additional new parameters. Leading researchers will present their latest validation data from recent work with new innovative combined applications in toxicology and safety pharmacology. Data from rodent, canine, and NHP model studies will be presented.

Latest Advances in Arrhythmia Detection and in Non-Invasive Blood Pressure Monitoring from Ambulatory Animals

Tuesday, March 8, 1:00 PM–2:00 PM

Presented by: emka TECHNOLOGIES

An alternative to implantable telemetry for measuring blood pressure (BP) in ambulatory animals, will be presented. We will explain how improvements in hardware and in software algorithms enabled higher efficiency and reliability in the noninvasive study of BP. Finally we will describe computerized methods that optimize efficiency and minimize resources in the detection of arrhythmia.

The Marmoset As an Experimental Model for the Development of Biopharmaceuticals

Tuesday, March 8, 1:00 PM–2:00 PM

Presented by: RTC Research Toxicology Centre

Pharmaceuticals are now often represented by biotechnology-derived products. For biopharmaceuticals NHP are usually the only relevant model. Marmosets with their small size and early sexual maturation represent an interesting alternative to macaque for toxicity testing and could speed up development, requiring a limited amount of product to start safety evaluation.

Uses for Stereology in Toxicologic Pathology

Tuesday, March 8, 1:00 PM–2:00 PM

Presented by: WIL Research Laboratories

Unbiased stereological analysis is required for documentation of shifts in neuronal and other cell populations as well as changes in lung parameters such as aleveolar counts and size estimations. This session will introduce the specialized terminology and basic mathematical and technical concepts involved in stereological sampling and analysis.

Automated GLP Infusion Studies: Improved Process Quality and Labor Utilization

Tuesday, March 8, 2:15 PM–3:15 PM

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.

Machine Learning and Exposure to Modeling in the Prediction of In Vivo Toxicity from High Content Screening (HCS) Data

Tuesday, March 8, 2:15 PM–3:15 PM

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.

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

Tuesday, March 8, 2:15 PM–3:15 PM

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.

Cryopreserved HepaRG: An Alternative In Vitro Screening Tool for Human Hepatic Drug Metabolism, and Safety Applications

Tuesday, March 8, 3:30 PM–4:30 PM

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.

The Use of Minipigs in the Development of New Medicines

Tuesday, March 8, 3:30 PM–4:30 PM

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 evaluate.

Wednesday

Developing Local and Systemic Biologics to Treat Inflammation of the Lung

Wednesday, March 9, 9:15 AM–10:15 AM

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.

Key Six Sigma Methods Applied to Outsourced Surgical Services for Operational Excellence

Wednesday, March 9, 9:15 AM–10:15 AM

Presented by: Harlan 3

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.

Reproductive and Developmental Toxicity Testing of Vaccines and Biologics

Wednesday, March 9, 9:15 AM–10:15 AM

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.

Challenges of Assessing Biologics for Efficacy and Safety

Wednesday, March 9, 10:30 AM–11:30 PM

Presented by: MPI Research 3

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.

Drug Testing Using 3D Microtissues

Wednesday, March 9, 10:30 AM–11:30 AM

Presented by: InSphero AG

More physiological in vitro cell models will foster the efficiency of the drug development process. InSphero provides an in-depth review of different 3D-call-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.

Overview, Design, and Review of Transgenic Carcinogenicity Studies

Wednesday, March 9, 10:30 AM–11:30AM

Presented by: BioReliance

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.

Advances in Cell Based Assays for Toxicity and Genetoxicity Testing

Wednesday, March 9, 11:45 AM–12:45 PM

Presented by: Thermo Fisher 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.

Humanized Mouse Models for PK and Safety Profiling of Compounds

Wednesday, March 9, 11:45 AM–12:45 PM

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.

Toxicity Knowledgebases and Pathway Analysis Tools for Systems Toxicology

Wednesday, March 9, 11:45 AM–12:45 PM

Presented by: GeneGo, Inc

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.

Electric Cell-Substrate Impedance Sensing: A Label Free, Non-Invasive Method of Cell Measurement

Wednesday, March 9, 1:00 PM–2:00 PM

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.

hESC Derived Cardiomyocytes for Drug Safety Testing

Wednesday, March 9, 1:00 PM–2:00 PM

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.

Multiplex Biomarker Assays for Kidney and Liver Toxicity

Wednesday, March 9, 1:00 PM–2:00 PM

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.

Accelerating Project Reviews and Improving Drug Safety Evaluation Through Nonclinical Search and Data Exchange

Wednesday, March 9, 2:15 PM–3:15 PM

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.

Function Genomics and High Content Screens. Getting the Best from Both Worlds

Wednesday, March 9, 2:15 PM–3:15 PM

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.