Exhibitor Hosted Sessions

Monday

In Vivo Ecotoxicity Tests: Responding to U.S. EPA Endocrine Disruptor Screening Program
Monday, March 8, 9:15 AM–10:15 AM, Room 155 F
Presented by: Analytical Bio-Chemistry Labs, Inc.

The U.S. EPA recently initiated a program to screen chemicals that may disrupt an animal’s endocrine system. This session will focus on two in vivo ecotoxicity tests, one with fish and a second with amphibians. It will include background information, and an overview of the testing and data analysis methods.

Biological Test Center Capabilities Overview
Monday, March 8, 9:15 AM–10:15 AM, Room 155 C
Presented by: Biological Test Center

The Biological Test Center has been providing pharmaceutical, biotechnology, and medical device industries with preclinical contract laboratory services since 1980. Our GLP, AAALAC-accredited facility is located in Irvine, CA. The Center performs a wide range of biocompatibility, toxicology, pharmacology, pharmacokinetics, ocular, and surgical studies, including innovative ophthalmological and surgical models.

Digital Pathology in the 21st Century
Monday, March 8, 9:15 AM–10:15 AM, Room 155 B
Presented by: Charles River

Digital pathology is an emerging technology that affords many benefits to pathologists. While pathologists in the clinical area have made good use of this technology, pathologists in the preclinical area have not moved forward as rapidly. The use of digital pathology today and in the future in support of preclinical studies will be reviewed and discussed.

Choose the Diet Wisely: Purified Diets Vs. Chow in Lab Animal Research
Monday, March 8, 10:30 AM–11:30 AM, Room 155 C
Presented by: Research Diets, Inc.

Grain-based laboratory animal ‘chow’ diets contain measurable and variable levels of toxic heavy metals and bioactive compounds such as phytoestrogens. These can affect the animal’s phenotype. Purified ingredient diets are free of these compounds and can be used to reduce data variability and influence outcome.

Demonstration of a Cigarette Smoke Generator in Combination with a Novel Cell Culture Exposure System
Monday, March 8, 10:30 AM–11:30 AM, Room 155 F
Presented by: TSE Systems Inc.

Classic submerged cultures (covered by medium) do not mimic the in-vivo situation. Lung cells for example are directly exposed to the air. Therefore, dry-wet cultures in combination with cigarette smoke have been chosen to validate our cell culture exposure system.

Analyzing Cells in Real Time: xCELLigence Technology Use in Pharma Research
Monday, March 8, 11:45 AM–12:45 PM, Room 155 C
Presented by: Roche Applied Science

The xCELLigence Real-Time Cell Analyzer (RTCA) System allows the label-free, noninvasive dynamic monitoring of cell proliferation and viability in real time by utilizing an impedance read-out. Several cell-based applications have been developed for the system so far. Among them are cellular quality controls, detection of cell proliferation or cytoxicity.

Genetically Engineered Rats: A New Paradigm for ADME/Tox Assessment
Monday, March 8, 11:45 AM–12:45 PM, Room 155 B
Presented by: Sigma Advanced Genetic Engineering (SAGE) Labs

With the recent advent of ZFN-induced gene targeting, it is now possible to make rat models with very specific gene deletions or insertions. These next-generation models have the potential to serve as more predictive indicators of drug effects than currently available murine models. In this session, you will learn about the creation of such models and potential applications.

Cytokines and Lineage Choice in Stem Cell Differentiation
Monday, March 8, 11:45 AM–12:45 PM, Room 155 F
Presented by: STEMCELL Technologies Inc.

A key feature of hematopoietic stem cells and their progeny is that their proliferation and differentiation is regulated by, and dependent on, external stimulation from cytokines. This session will discuss various assays that offer more biologically relevant screening to determine the mechanism of action on target cells of various pharmaceuticals.

Predictive In Vitro Model for Determining Additive or Synergistic Toxicity of Combinations of New Small Molecule Compounds and Standard Treatments
Monday, March 8, 1:00 PM–2:00 PM, Room 155 F
Presented by: ReachBio LLC

Although certain compounds alone may not exhibit myelotoxicity, they may cause unexpected neutropenia when given to specific patient populations in combination with other drugs. The talk will focus on in vitro CFC model for predicting clinical neutropenia of intentional or coincidental combination therapies.

Interests and Limitations of New In Vivo Methodologies to Assess the Potential Cardiovascular Effects of NCEs and Biologics in Large Animal Models
Monday, March 8, 1:00 PM–2:00 PM, Room 155 B
Presented by: SNBL U.S.A., Ltd.

In NHPs, stress induced by manual restrain, complications of anesthesia, and limited data collections can confound Arterial blood pressure and ECG data and interpretation in Safety Pharmacology/Toxicology studies. The physiological and pharmacological validation of the new Jacketed External Telemetry (JET™-BP System) will reveal the advantages and limitations of such methodology.

DNA Damage, PARP, and the CometAssay®
Monday, March 8, 1:00 PM–2:00 PM, Room 155 C
Presented by: Trevigen, Inc.

The CometAssay® is a valuable tool for monitoring strand breaks in DNA that result from exposure to genotoxic agents. Such exposure may initiate PARP 1 mediated DNA repair and mask DNA strand breaks. Conditions for optimal detection of both double and single strand breaks will be discussed.

The Scientific Quest for a New Millennium of Drug Discovery and Development
Monday, March 8, 2:15 PM–3:15 PM, Room 155 C
Presented by: Covance

Ten years after starting the Drug Development “New Millennium”, researchers are feeling the impact of new guidelines, an increased emphasis on safety, challenges in the development of biologics, globalization, strategically integrated approaches, and CROs as scientific partners. We invite you to participate in this interactive scientific review of the challenges that have been overcome, those that still exist, and what might lie ahead.

Therapeutic Monoclonal Antibodies—Predicting Antibody-Mediated Cytokine Release
Monday, March 8, 2:15 PM–3:15 PM, Room 155 B
Presented by: Huntingdon Life Sciences

Acute cytokine release after clinical dosing has been seen with a small number of therapeutic monoclonal antibodies. The ability to understand this potential in human and toxicity species is essential prior to clinical studies. Understand the mechanisms of cytokine release and the design of in vitro and in vivo studies.

The Usefulness of the Minipig in Regulatory Toxicology
Monday, March 8, 2:15 PM–3:15 PM, 155 F
Presented by: LAB Research Inc.

The seminar will highlight the minipig as the non-rodent species in regulatory studies and how in some cases is preferable over dogs and primates. In particular, their use in general toxicology testing employing the continuous intravenous infusion and dermal route will be discussed.

Utilizing Data Services to Increase Productivity and Throughput
Monday, March 8, 3:30 PM–4:30 PM, Room 155 B
Presented by: Noesys Data

Noesys Data details its integrated data services offerings, providing a range of services from raw data reduction to final report generation. Raw data reduction includes data review, parsing data into defined protocols, and grouping experiments into studies. Statistical analysis and full independent third party report generation services extend the range of services offered. Reports can be used for internal or external verification, independent documentation of milestones, or due diligence assessments.

New Preclinical Assays for Predicting Cardiotoxicity
Monday, March 8, 3:30 PM–4:30 PM, Room 155 C
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.

Early Safety Assessments Through Semantically Relevant Search & Data Exchange
Monday, March 8, 3:30 PM–4:30 PM, 155 F
Presented by: Pointcross

PointCross’s Semantic Search & Data Exchange Solutions integrate disparate types of non-clinical data and documents into a dynamic repository for cross-study meta-analysis and to discover patters and correlations. Real world cases, approaches to find relevant information fast, and practical implications for safety assessments and data standards compliance will be discussed.

Tuesday

ECIS Applications—Label Free, Non-Invasive Cell Measurement
Tuesday, March 9, 8:30 AM–9:30 AM, 155 C
Presented by: Applied BioPhysics

This session will provide an overview of the use of impedance (both simple and complex) to detect cell morphological changes. Emphasis will be placed on the use of different AC frequencies to distinguish cell parameters. Various ECIS applications will be discussed including cell invasion, automated cell migration, barrier function, toxicology and signal transduction.

Enabling Integrated Data Analysis using Genedata Analyst
Tuesday, March 9, 8:30 AM–9:30 AM, 155 F
Presented by: Genedata AG

Genedata Analyst is the premier platform for the integration and interpretation of experimental data in life science R&D. It puts rigorous statistical tools and flexible interactive data mining into the hands of researchers and biostatisticians alike. Built on scalable cline-server architecture with a rich set of application programming interfaces (APIs), Analyst provides a centrally managed, secure and scalable data mining platform that can be tightly integrated into existing research IT ecosystems.

Obese Animal Models of Metabolic Disease
Tuesday, March 9, 8:30 AM–9:30 AM, Room 155 B
Presented by: Charles River

Animal models for the assessment of metabolic changes associated with the onset and development of obesity and diabetes are important tools for studying the safety and efficacy of novel therapeutics. This session will focus on how two widely used models (ZDF rat and large animals fed on a high-fat diet) can aide in the development of new drugs to treat insulin resistance, insulin resistance-associated chronic diseases and obesity.

Preclinical Anticancer Drug Development: Shifting Challenges
Tuesday, March 9, 9:45 AM–10:45 AM, Room 155 C
Presented by: Accelera Srl

Development of oncology treatments involves a unique set of challenges. Learn from the people behind the preclinical development of marketed treatments (Adriamycin, Ellence, Sutent) how to advance your anticancer program smoothly, from screening/lead selection to the development of tailor-made IND packages, and how ICHS9 may impact the future landscape.

Functional Biomarkers of Renal Injury—Optimizing Interpretive Value in Renal Pharmacology Studies
Tuesday, March 9, 9:45 AM–10:45 AM, Room 155 F
Presented by: Huntingdon Life Sciences

Recognition of adverse renal pharmacodynamic effects requires sophisticated experimental designs and appropriate quantitative evaluations. Biochemistry and histopathology evaluations routinely used have limitations in adequately characterizing drug effects. This session proposes appropriate designs for renal safety pharmacology studies incorporating the use of functional biomarkers for identification and characterization of drug effects.

Introduction to the Development and Validation Study of the New Technology “Cell able” for New Drug Discovery
Tuesday, March 9, 9:45 AM–10:45 AM, Room 155 B
Presented by: Transparent Inc.

Introduction to the development of and validation study of the new technology “Cell able” for new drug discovery. It is possible to culture human hepatocytes and maintain their functions for a long period using “Cell able.” It could be used for prediction of the toxicity of a large number of drug candidates at one time.

A System’s Toxicology Approach for Drug Discovery and Development
Tuesday, March 9, 11:00 AM–12:00 NOON, Room 155 F
Presented by: Ingenuity Systems

Learn how IPA-Tox™ can help you with your research and provide the following:

• An understanding of drug toxicity and mechanism of action
• Identify specific molecular toxicity components
• Industry relevant case study will demonstrate the functionality of the toxicity module

Predictive Multiparametric In Vitro Assay Combinations for Cytotoxicity, Viability, Apoptosis and ADME Applications with Hepatocytes and Human Stem-Cell Derived Cardiomyocytes
Tuesday, March 9, 11:00 AM–12:00 NOON, Room 155 B
Presented by: Promega Corporation

Combining bioluminescent and fluorescent cell-based assays allows multiparametric measurements from single samples, simplifying mechanistic studies. Multiplex approaches, using human-cell model systems, streamlines data collection, improves data quality, strengthens interpretation, and removes ambiguity. This seminar reviews multiplex applications of viability, cytotoxicity, apoptosis, cytochrome P450 induction/inhibition, and genetic reporter assays.

SkinEthic Laboratories—Providing You Available, Predictive, User-Friendly, and Sustainable In Vitro Solutions
Tuesday, March 9, 11:00 AM–12:00 NOON, Room 155 C
Presented by: SkinEthic Laboratories

SkinEthic models are predictive in vitro tools for efficacy and safety screening tests. The usefulness of Episkin and RHE will be discussed within the frame of the GHS classification as well the on-going validation of the HCE—human corneal model .The reproducibility of our production processes for these validated or under validation models will be presented. This updated information will create a forum of information for all scientists and toxicologists on reliable and relevant tools for decision making during preclinical safety phases.

Higher Throughput In Vitro Screening Assays for Drug-Drug Interactions and Organ-Specific Toxicity Using Human Hepatocytes and IdMOC
Tuesday, March 9, 12:15 PM–1:15 PM, Room 155 C
Presented by: ADMET Group

Screening of new chemical entities for adverse drug properties would aid the selection of drug candidates without such liabilities. Higher throughput human hepatocyte P450 inhibition, P450 induction, and cytotoxicity assays and the Integrated Discrete Multiple Organ Co-culture (IdMOC) assay for the evaluation of multiple organ toxicity, will be described.

Systems Toxicology Data Analysis with GeneGo
Tuesday, March 9, 12:15 PM–1:15 PM, Room 155 F
Presented by: GeneGo, Inc.

GeneGo provides a rich database and powerful suite of tools for analyzing high content molecular toxicology data. Current capabilities of the system and upcoming enhancements for safety assessment will be presented. A guest speaker from industry will present a case study investigating sex and strain differences in toxic response.

How to Screen for Arrhythmias in Safety Pharmacology When More Than 86,400 Beats are Recorded in One Dog Over 24 Hours
Tuesday, 12:15 PM–1:15 PM, Room 155 B
Presented by: LAB Research Inc.

Telemetry is essential for continuous monitoring of ECG in safety pharmacology. On the flip side, the amount of data generated presents a challenge during analysis and interpretation, particularly for identification of cardiac arrhythmias. ECG analysis strategies and arrhythmia detection beyond QT interval measurements will be presented and discussed.

Noninvasive Blood Pressure and Respiration Measurements on Large Animals
Tuesday, March 9, 1:30 PM–2:30 PM, Room 155 F
Presented by: emka TECHNOLOGIES

This presentation will explain how recent improvements in hardware and in a software algorithm enabled higher efficiency and reliability in the noninvasive study of blood pressure and respiration, as well as the computation of new parameters. Studies done to compare these measurements with those obtained using traditional methods will be presented. Fixed and recurring costs of doing such measurements will also be discussed.

Tips and Tricks to Maximize Your Literature Search Results
Tuesday, March 9, 1:30 PM–2:30 PM, Room 155 C
Presented by: Quertle, LLC

The workshop will cover the following: 1. Understanding the difference between relationships versus simple occurrence of keywords, 2. Using Power Terms™ such as $AdverseEffects to enhance results, 3. Constructing efficient queries, including use of capitalization, 4. Searching full-text documents and MEDLINE simultaneously, and 5. Effective filtering to refine results.

Making New Connections: Networking Strategically
Tuesday, March 9, 1:30 PM–2:30 PM, Room 155 B
Presented by: Science/AAAS

Find ways to make networking work for you. By being strategic about how you meet people, you can increase your number of contacts with ease. We’ll discuss myths and realities surrounding networking and different strategies for networking in various arenas. Learn about informational interviews, business cards, elevator pitches, and more.

Quantitative Tissue Analysis: How to Get the Most from Your Pathologist
Tuesday, March 9, 2:45 PM–3:45 PM, Room 155 B
Presented by: Aperio

Toxicologists will learn what to expect in new imaging techniques from their pathologists. Computer-assisted measurements across an entire tissue section lead to a truly quantitative pathology evaluation. The expert use of whole slide imaging by the pathologist allows many improvements in workflow and communication of study results.

Lead Optimization—What Does the Future Look Like?
Tuesday, 2:45 PM–3:45 PM, Room 155 C
Presented by: Covance

Now, more than ever, it is crucial to make the right decisions early in the development process. Lead Optimization advancements in the last 10 years have led to the ability to make faster, more concrete decisions, increasing the probability of bringing a successful drug candidate forward. In this session, explore what advancements have been made, why they are important, and what we expect to happen in the next 10 years.

The Minipig—A Non-Rodent Species in Regulatory Toxicity Testing
Tuesday, March 9, 2:45 PM–3:45 PM, Room 155 F
Presented by: Ellegaard Gottingen Minipigs A/S

This session highlights the relevance of the minipig as a non-rodent model in regulatory toxicity testing, and, in this context, discusses species selection in non-clinical safety studies. The session also provides an overview of marketed drug products (case studies) where minipigs have been used as the non-rodent species.

Wednesday

Innovative Safety Studies and Successful Strategies for an Efficient IND-Enabling Program
Wednesday, March 10, 8:30 AM–9:30 AM, Room 155 B
Presented by: Charles River

Early stage developers need a clear view of the path forward to human trials. Most failures to win FIH trial approval stem from underestimating timelines and the complexity of toxicology programs. Effective planning of toxicology programs and cost-effective innovative approaches to preclinical study design for IND-enabling programs are critical to generating data that will add value to a novel drug or biologic and increase regulatory success.

Inhalation Study Test Article Consumption—Ensuring Preclinical Inhalation Toxicology Programs Don’t Break the Bank
Wednesday, March 10, 9:45 AM–10:45 AM, Room 155 B
Presented by: Huntingdon Life Sciences

Aerosol generation and exposure techniques employed historically for Inhalation preclinical programs did not consider test article costs. Increasing sensitivity within the Pharmaceutical Industry to spiralling preclinical program costs together with extreme manufacturing costs for many large molecule therapeutics has required refinement of existing systems and engineered solutions to minimise consumption.

Cell Based Assays for In Vitro Toxicology—Are We There Yet?
Wednesday, March 10, 11:00 AM–12:00 NOON, Room 155 B
Presented by: Thermo Scientific

We will discuss the advantages of cell imaging assays over traditional biochemical assays for toxicology risk assessment and review recent literature. We will show that the Thermo Scientific ToxInsight IVT Platform, provides new tools for assessing toxicity risk in multiple organ models.

Multiplex Analysis of Toxicity: A Two-Part Seminar
Wednesday, March 10, 11:00 AM–12:00 NOON, Room 155 C
Presented by: EMD Chemicals

Determining the safety profile of compounds earlier in the drug development process is becoming more common as the benefits of dropping potentially hazardous candidates sooner are realized. Here we discuss the development and application of two suites of multiplex biomarker assays for the evaluation of compound nephrotoxicity and mitotoxicity.

New Applications of the Latest Telemetry Technology in Toxicology and Safety Pharmacology
Wednesday, March 10, 12:15 PM–1:15 PM, Room 155 C
Presented by: Data Sciences International

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

Mechanisms of Toxicity and Prediction of Whole—Organ Toxicity: In Vitro Assays and Their Validation—What Can We Predict Early On to Avoid Costly Mistakes Later?
Wednesday, March 10, 12:15 PM–1:15 PM, Room 155 B
Presented by: Gentronix Limited and Apredica LLC

The session will review predictive toxicology strategies for genotoxicity and other early attrition rate toxicities. New approaches for HT profiling and HCA will be presented. Delegates will also have opportunity for input through an interactive open forum session to discuss current issues and future directions in this important field.

hESC Derived Cardiomyocytes for Drug Safety Testing
Wednesday, March 10, 12:15 PM–1:15 PM, Room 155 F
Presented by: GE Healthcare

Cardiomyocytes derived from human embryonic stem cells (hESC) provide an advance towards more clinically predictive assays for assessing cardiotoxicity of new drugs. We are developing methods for industrialization of provision of hESC derived drug safety testing models. Data from phenotypic and electrophysiological analysis of hESC derived cardiomyocytes will be presented.

Determining Mechanisms of Action in Toxicology Using Metabolomics
Wednesday, March 10, 1:30 PM–2:30 PM, Room 155 B
Presented by: Metabolon, Inc.

Metabolomics is defined as “the non-biased quantification and identification of all metabolites present in a biological system,” but in practice the term metabolomics is used in a rather broad sense and covers many different analytical methodologies. To address the challenges associated with metabolomics, a comprehensive, integrated analytical and data handling platform was developed that provides a chemo-centric global metabolomics analyses of biological systems.

In Vitro Assays for the High Throughput Detection of Mitochondrial-Mediated Drug Toxicity
Wednesday, March 10, 1:30 AM–2:30 PM, Room 155 C
Presented by: Luxcel BioSciences

Luxcel Biosciences provides a simple high-throughput approach to the detection of drug-induced mitochondrial dysfunction. This session will focus on the use of Luxcel technology for the detection of such dysfunction by measuring the metabolic activity of both isolated mitochondria and whole cells using standard fluorescence plate readers.