Exhibitor Hosted Sessions

Monday

Evaluating and Choosing the Right CRO
Monday, March 16, 9:45 AM–10:45 AM
Presented by: CANTEST Ltd.

The selection of a CRO can be difficult to evaluate. This session provides guidance for securing the optimal outsourcing options. New techniques, instrumentation, regulations, method development/R&D applications, communications, and study management will be discussed. CANTEST provides GLP Bioanalytical, Physical/Chemical, Environmental Fate and Ecotoxicology testing solutions for industry worldwide.

Methodology for Using External Cardio-Respiratory Telemetry Approach in Toxicology Studies
Monday, March 16, 9:45 AM–10:45 AM
Presented by: MDS Pharma Services

Capturing the electrocardiogram in regulatory toxicology studies faces constraints involving recording and analysis of data. Invasive telemetry approaches are impractical. MDS Pharma Services has introduced a new external telemetry system in response. This session will present the system and will discuss the methodology for using external telemetry in regulatory studies.

Sysmex XT-V Hematology Workshop
Monday, March 16, 9:45 AM–10:45 AM
Presented by: Sysmex America, Inc.

This workshop provides an overview of the fluorescent flow cytometry technology and multi-species profile creation capability of the XT-V Hematology analyzer from Sysmex America. Applications specific to the toxicology market are highlighted via case examples of various animal species for whole blood, bone marrow and BALF specimens.

Cell-Based Assays for Predictive Toxicity
Monday, March 16, 11:00 AM–12:00 NOON
Presented by: Thermo Fisher Scientific

Panels of cell-based assays, measured using a quantitative imaging approach have been shown to be predictive of toxicity in humans. In this session we will review the cellular targets of toxicity, demonstrate the multi-parameter imaging approach and show cross-validation data with existing biochemical assays. The benefits of this approach for reducing potential toxicity risks in drug development will be outlined.

The Cardiovascular System and Drug Development
Monday, March 16, 11:00 AM–12:00 NOON
Presented by: Charles River

The cardiovascular system is an important therapeutic target for novel drug discovery and development. Development and utilization of appropriate models are essential to demonstrate the efficacy and safety of these drugs. Additionally, non-cardiac drugs can result in cardiovascular abnormalities which require further study and/ or additional monitoring in clinical trials. Experiences from developing cardiac drugs and non-cardiac drugs with cardiac liabilities will be presented.

Why You Should Conduct Your Next Preclinical Study in China
Monday, March 16, 11:00 AM–12:00 NOON
Presented by: Bridge Laboratories

Bridge Laboratories will share insights into the current status and trends of the China preclinical safety sector and how companies can leverage conducting work in Asia. Bridge is a preclinical CRO that provides US-level regulatory compliant drug development services globally and is among the leading and most established “western standard” CROs in China. The presentation will be based on an evaluation of preclinical CROs in China and Bridge’s experience in providing GLP toxicology services through their Beijing lab.

A Systems Toxicology Approach for Drug Discovery and Development
Monday, March 16, 12:15 PM–1:15 PM
Presented by: Ingenuity Systems

Within this session an overview of Ingenuity’s pathway and networks analysis software (IPA) will be presented with its specific molecular toxicity components specifically developed to understand drug toxicity and action. Following this overview, an industry relevant case study will demonstrate the functionality and richness of the toxicity module.

Cultures of Primary Hepatocytes As Predictive Models of the Liver
Monday, March 16, 12:15 PM–1:15 PM
Presented by: CellzDirect, Invitrogen

Liver function can be modeled in vitro using cultures of primary hepatocytes (high-throughput) monitoring metabolism, induction/ cell-signaling, transport, and cytotoxicity endpoints. Correlation of gene expression data, metabolic activity, and cytotoxicity endpoints over concentration and time can provide an effective approach to explore mode of action pathways. We will discuss our research using these tools including the EPA’s ToxCast 320 chemical library (320 chemicals, ~350,000 data points).

Zebrafish: A Predictive Model for Assessing Safety and Toxicity
Monday, March 16, 12:15 PM–1:15 PM
Presented by: Phylonix

Zebrafish are increasingly used as an alternative model for assessing compound safety and toxicity. Numerous studies show >70% correlation with results in mammals. In this workshop, we will describe methods for assessing drug effects on major organs as well as several disease models for high throughput screening.

Embryology of Nonhuman Primates: Principles for Understanding Developmental Toxicology Study Designs Supporting Regulatory Submissions
Monday, March 16, 1:30 PM–2:30 PM
Presented by: SNBL USA

Preclinical toxicology professionals often oversee programs requiring reproductive toxicology assessments. Currently, many regulatory-mandated teratology studies are conducted using the nonhuman primate (NHP) model. Embryofetal developmental milestones dictate the types of parameters to monitor: mid-first trimester is the period of organogenesis; 2nd trimester involves organ/body remodeling; and 3rd trimester is the period of accelerated growth. Understanding classical NHP embryology will help professionals appreciate overall NHP reproductive biology and the precautions necessary to institute during study design and conduct.

Immunologic Considerations for the Support of Biologic Therapeutics and Other Innovative Immunomodulators— Preclinical and Development Commitments
Monday, March 16, 1:30 PM–2:30 PM
Presented by: MPI Research

This presentation will highlight immunologic characterizations required to enable successful IND registry of biologics including ligand binding assays for immunogenicity, PK/TK and other safety considerations to maximize clinical therapeutic investments.

Practical Approaches to Dosing Route Challenges in Non-Clinical Research
Monday, March 16, 1:30 PM–2:30 PM
Presented by: LAB Research Inc.

There are many biological molecules that are unsuitable for oral administration, and with the development of drugs that are targeted for delivery to specific sites in humans, there is an increasing need to develop animal models to facilitate pharmacological and non-clinical toxicological research. We present a selection of such models.

Characterizing On-Target and Potential Side Effects from Drug Targets Derived from Known Pathway and/or Protein Networks Using an Integrative Knowledge-Rich Approach
Monday, March 16, 2:45 PM–3:45 PM
Presented by: Ariadne

Find out how an integrative framework for organizing, analyzing and visualizing external and internal published findings can support research critical decision making and experimental designs throughout the drug development pipeline. The session will highlight how knowledge extracted from literature resources can be used to further elucidate knowledge on existing drugs/drug candidates and to find potentially novel biological relationships including potential side effects.

Dynamic Real-Time, Label-Free Cellular Analysis
Monday, March 16, 2:45 PM–3:45 PM
Presented by: Roche Applied Science

Join us to learn about a revolutionary impedance-based technology which enables dynamic real-time, label-free cell-based analysis. The presentation will show how dynamic real-time data facilitates discovery not possible with end-point analysis, focuses assay development, and can improve compound attrition rates.

HepaRG®: A Human Hepatic Cell Line with Unique Features
Monday, March 16, 2:45 PM–3:45 PM
Presented by: Biopredic International

HepaRG® is a bipotent cell line that gives rise simultaneously to hepatocytes and cholangiocytes. The hepatocytes are equipped with CYPs 1A, 2B, 2C, 2E, 3A, with drug transporters and with PXR and CAR in the same range of levels found in normal cultured hepatocytes. This cell line is now popular for CYP inductions studies, and begins to show its usefulness in the Comet and micronucleus assays, detection of reactive metabolites, cholestasis studies, and hepatoxicity prediction.

Tuesday

Ion Channel Panels in Safety Assessment
Tuesday, March 17, 8:30 AM–9:30 AM
Presented by: ChanTest Corp.

Drug-induced ion channel dysfunction may result in diverse adverse reactions. ChanTest provides toxicity screening, secondary confirmatory screening, and selectivity profiling using Human Ion Channel Panels™ and automated patch clamp methods. ChanTest channel panels in combination with conventional methods facilitate decision-making in drug development.

Making Sense Out of Multiple Safety Attributes in Multiple Data Formats
Tuesday, March 17, 8:30 AM–9:30 AM
Presented by: Rosetta Biosoftware

As the ability to measure multiple safety attributes from preclinical, metabolomics, genetics, and transcriptomics data improves, the work to assimilate and interpret these data increases. This workshop describes how to use Rosetta Biosoftware technology in collaboration with the Predictive Safety Testing Consortium (PSTC) led by C-PATH to address these challenges.

Systems Toxicology Data Analysis Solutions from GeneGo
Tuesday, March 17, 8:30 AM–9:30 AM
Presented by: GeneGo Inc.

GeneGo’s MetaDiscovery platform is a powerful suite of tools and molecular databases for the analysis of high content systems biology data. This session will demonstrate the power of the approach in predictive and mechanistic toxicology. Current capabilities of the system and upcoming enhancements for safety assessment will be presented.

All You Ever Wanted to Know About an IND—But Were Afraid to Ask
Tuesday, March 17, 9:45 AM–10:45 AM
Presented by: Ricerca Biosciences, LLC

Ricerca focuses on the integration of the IP to IND pathway by managing both chemistry and toxicology simultaneously. Some case studies will be presented to provide early-stage biotech with a high level overview of the challenges they can expect to meet as they progress their development.

Global Management of Rodent Colony Genetics
Tuesday, March 17, 9:45 AM–10:45 AM
Presented by: Charles River

Purposeful global management of rodent animal colonies is critical to minimize the effect of genetic variation on research results. Processes employed differ based on colony objectives, species/stock/strain characteristics and desired outcomes. As scientific discovery accelerates, effective management of these key research colonies takes on increased importance.

The Use of Metabolomics Data in Toxicology
Tuesday, March 17, 9:45 AM–10:45 AM
Presented by: BASF SE

BASF has developed a large metabolomics data base (MetaMap™Tox) using data rich agro chemicals and drugs. Metabolite patterns established are indicative of different toxicological modes of action and can be used for early recognition of toxicity for new chemicals. Using blood samples, the information can be obtained from routine studies.

Metabolomics: A Novel Tool for Understanding the Early-Stage Mechanistic Underpinnings of Drug Action and Safety
Tuesday, March 17, 11:00 AM–12:00 NOON
Presented by: Metabolon, Inc.

With increased regulatory scrutiny, understanding the mechanistic underpinnings of drug action and safety has become paramount. Earlier information on potential drug safety issues is required before deciding which compounds to take into the clinic. Global biochemical profiling provides unparallel insight into the mechanistic action of drugs. The simultaneous analysis of hundreds of biochemicals enables the identification of both on-target and off-target effects. Many changes are seen within hours of dosing, providing earlystage indication of safety issues.

Neural, Mesenchymal, and Hematopoietic Toxicity Testing Using In Vitro Stem Cell Assays
Tuesday, March 17, 11:00 AM–12:00 NOON
Presented by: Stemcell Technologies Inc.

This session will highlight in vitro assay systems designed to quantify and assess neural, mesenchymal, and hematopoietic stem and progenitor cell populations from primary cell sources. The presentation will elaborate on how these assay systems can be used to evaluate compound toxicity.

Proposed Cardiac Safety Assessment: Overall Strategy from Non-Clinical to Clinical Phases
Tuesday, March 17, 11:00 AM–12:00 NOON
Presented by: Ina Research Inc.

INA will present its latest data from non-clinical (proarrhythmia model, atrioventricular block monkey) and clinical studies (thorough QT studies assessing ethnic and gender differences) in compliance with ICH-S7B/E14 guidelines for evaluating QT prolongation and TdP. An overall strategy for cardiac safety assessment from nonclinical to clinical will also be presented.

Non-Invasive Blood Pressure Measurements on Large Animals
Tuesday, March 17, 12:15 PM–1:15 PM
Presented by: emka TECHNOLOGIES

emka TECHNOLOGIES will present its recent developments in non-invasive blood pressure measurements on large animals.

Profiling Environmental Chemicals in the Cellular Stress Pathway Using Quantitative High-Throughput Screening
Tuesday, March 17, 12:15 PM–1:15 PM
Presented by: Promega Corporation

The NIH Chemical Genomics Center (NCGC) has developed in vitro assays utilizing quantitative high-throughput screening (qHTS), where concentration response curves for several thousand compounds are quickly and efficiently produced in cell-based 384- and 1536-well format. These assays identified compound-induced stimulation of the antioxidant response element (ArE) cellular stress pathways, glutathione levels, and cytotoxicity.

Using Genomic Approaches to Accelerating Toxicology Decisions
Tuesday, March 17, 12:15 PM–1:15 PM
Presented by: Affymetrix

Discover biomarkers, understand mechanisms of toxicity, and identify relationship between patient genetic diversity and response to treatment. Comprehensive pre-clinical portfolio spans rodents, canine, monkey, and human arrays. Complete solutions include ToxFX™ Analysis Suite, enabling you to rapidly understand compound safety through matching the toxicity of your compound against Iconix Toxicogenomics database.

Environmental Health and Toxicology Program Resources
Tuesday, March 17, 1:30 PM–2:30 PM
Presented by: National Library of Medicine

The National Library of Medicine will present an overview of the Environmental Health and Toxicology Program resources. Resources include TOXNET, databases on toxicology, hazardous chemicals, environmental health, and toxic releases. Search techniques will be demonstrated highlighting the Dietary Supplements Labels Database and the Drug Information Portal.

NTP Criteria for Hazard Identification on Non-Cancer Studies
Tuesday, March 17, 1:30 PM–2:30 PM
Presented by: National Toxicology Program (NTP)

The National Toxicology Program (NTP) uses specific criteria to describe the strength of the evidence for conclusions for substances tested in its cancer bioassay. The program has now developed similar criteria for reaching conclusions from NTP immunotoxicology, reproductive toxicology, and developmental toxicology studies that will be presented at this session.

Regulatory and Scientific Issues that Impact the Development of Biotherapeutics
Tuesday, March 17, 1:30 PM–2:30 PM
Presented by: Covance

The preclinical development of a biotherapeutic requires the consideration of many factors that relate to the scientific and regulatory challenges faced. Of critical importance are the areas of manufacturing, characterization and purification, preclinical study design and selection of the relevant toxicology species, assay development and immunogenicity testing. Learn more about the critical considerations that will contribute to the success of your biotherapeutic development program.

A Novel In Vitro Method to Assess Skin Sensitization
Tuesday, March 17, 2:45 PM–3:45 PM
Presented by: CeeTox, Inc.

The session will describe a novel in vitro method that identifies test articles as skin sensitizers and predicts LLNA EC3 values as sensitizer classes. Details of the models and preliminary data sets will be presented. The alternative method may reduce animal testing and can support REACH and EU Amendment 7.

Integration of a Small Molecule R&D and Manufacturing Organization with Toxicology
Tuesday, March 17, 2:45 PM–3:45 PM
Presented by: WuXi AppTec

Integration of two separate organizations always presents challenges. Combining the assets of a Chinese based small molecule R&D and manufacturing company and a U.S. based medical device testing and biological manufacturing company has been not only a learning experience but has resulted in an organization with unmatched resources and potential.

Software-As-a-Service in Preclinical: Remote Hosting of Data Systems—Are Laboratories Ready for This?
Tuesday, March 17, 2:45 PM–3:45 PM
Presented by: Instem

This presentation will explore issues around the growing demand for affordable alternatives to traditional on-site data collection and analysis software in preclinical laboratories. As appetites for Web-based systems increase, do vendors and laboratories really understand issues related to regulatory guideline impact, data security and access requirements, qualification and validation, and requirements for peak performance?

Wednesday

Cellular Systems Biology (CSB™) for Discovery Toxicology
Wednesday, March 18, 9:45 AM–10:45 AM
Presented by: Cellumen, Inc.

Cellular Systems Biology (CSB™) is a powerful new paradigm for both Discovery Toxicology and Predictive Toxicology. CSB Toxicity Profiling enables the simultaneous determination of dose-response relationships for multiple mechanisms of toxicity over several exposure times and produces a classifier with high precision (96.6%) for predicting the safety risk of unknown compounds.

Preclinical Studies in China: From Animal Supply to Regulatory Submission
Wednesday, March 18, 9:45 AM–10:45 AM
Presented by: Charles River

Pharmaceutical companies and CROs continue to make solid progress in their Asian R&D operations and relationships. Charles River will present its experience in the operation and regulation of its preclinical facility in Shanghai, together with the ongoing development of its Research Models and Services group in this region. In addition, the experience of two multinational pharmaceutical companies that are performing and managing R&D activities in China will be presented.

Strategic Study Design—Biopharmaceuticals and Beyond
Wednesday, March 18, 9:45 AM–10:45 AM
Presented by: Huntingdon Life Sciences

Safety assessment in clinical and preclinical studies is evolving in part due to the increased understanding of mechanism of action as seen with biopharmaceuticals. Evaluation of drug action (pharmacodynamics) is paramount for selection of an appropriate species and design of nonclinical studies. In addition to the traditional approach (i.e., pathology and clinical pathology) evaluation should include product-specific markers of activity and safety and be replicated throughout the entire drug development process so that Chemistry, Manufacturing, and Control (CMC), nonclinical and clinical, do not exist in isolation.

In Vitro Evaluation of Human Drug Toxicity: Organ Specificity and Metabolism-based Toxicity
Wednesday, March 18, 11:00 AM–12:00 NOON
Presented by: ADMET Group

In vitro assays for hepatotoxicity, nephrotoxicity, neurotoxicity, and pulmonary toxicity using primary cell cultures either as single cell types or Integrated Discrete Multiple Organ Co-cultures (IdMOC) and an assay for metabolism-based hepatotoxicity will be presented. These assays are useful in early phases of drug development for drug candidate selection.

Creating an Appropriate Tox Species Justification Data Set
Wednesday, March 18, 11:00 AM–12:00 NOON
Presented by: LAB Research Inc.

Preclinical development of biotechnology-derived therapeutics requires that toxicology testing be conducted in a relevant test species. The why’s and how’s of creating an appropriate tox species justification data set will be discussed. Specific examples of thorough and successful data sets will be provided.

Multiplexed Assays Qualified for Toxicology Biomarker Profiling
Wednesday, March 18, 11:00 AM–12:00 NOON
Presented by: Meso Scale Discovery

Meso Scale Discovery has developed multiplex panels of novel biomarkers for muscle injury, kidney damage and vasculitis that overcome the limitations of traditional clinical chemistries. The challenges of multiplex biomarker assay development will be discussed as well as method for assay qualification for use in preclinical studies.

Drug Discovery: The Interface of Safety and Efficacy Evaluations in Lead Optimization
Wednesday, March 18, 12:15 PM–1:15 PM
Presented by: Covance

Lead optimization identifies lead candidates for further development. The challenges involve coordinating disciplines, such as receptor occupancy; imaging technology in vivo pharmacology models; and early evaluations of safety in toxicology studies. Applying this approach across all therapeutic areas of interest allows for the optimization of candidate molecules for safety and efficacy. The effective use of currently available tools should increase the probability of technical success and ultimately decrease the cost of drug development.

Simple-to-Use Image Analysis System for Accurately Assessing Cell Concentration & Viability of Primary Hepatocytes
Wednesday, March 18, 12:15 PM–1:15 PM
Presented by: Nexcelom Bioscience

Reliable concentration & viability data of primary Hepatocytes is critical for accurate analysis of compound toxicity in vitro. Due to Hepatocyte’s variable morphology, fragile nature and tendency to clump, manual counting is time consuming and varies from operator-to-operator. Learn about how our new technology accurately generates this data in less than 30 seconds with only 20uL of sample.

Cardiovascular Radiotelemetry and its Role in Reducing Animal Usage: How to Minimize Your Animal Use and Maximize Your Data
Wednesday, March 18, 1:30 PM–2:30 PM
Presented by: Data Integrated Scientific Systems (D.I.S.S.)

It is imperative to study nonclinical doses and pharmacological time-courses simulating what novel pharmaceuticals may do in human studies, and to rapidly report the maximal data set from a minimum number of animals. Cardiovascular radiotelemetry has evolved as an industry best practice to achieve these outcomes.

Multiparameter Flow Cytometric Cytotoxicity Screening with HyperCyt®
Wednesday, March 18, 1:30 PM–2:30 PM
Presented by: IntelliCyt Corporation

Many cytotoxicity assays have been validated for flow cytometry, but until now have not been used in screening because of constraints in commercial flow cytometers sample handling capabilities. HyperCyt is a hardware and software solution that enables flow cytometers to rapidly perform screening in 96 and 384 well microplates.

DNA Damage, PARP Activation, and DNA Repair
Wednesday, March 18, 1:30 PM–2:30 PM
Presented by: Trevigen

The Comet Assay monitors strand breaks in damaged DNA. Activation of PARP 1 in response to single strand breaks is a requisite step prior to DNA repair. Using Trevigen’s PARP Pharmacodynamic assay and its Comet ES system we explore the relationship between DNA damage, PARP activation, and DNA repair.