Exhibitor Hosted Sessions

Monday

Development of a Fully Human Monoclonal Antibody for the Treatment of Inflammatory Disease
Room 100

Monday, March 12, 9:15 AM–10:15 AM

Presented by: Huntingdon Life Sciences

Monoclonal antibodies are in development to treat a wide range of diseases. One such therapeutic area is that of inflammatory disease. Performing nonclinical studies to assess the safety of these therapies is a very important aspect of the development program. Studies highlight the need for strong focus upon disease biology.

Developmental Toxicity Testing of Preventive Vaccines
Room 101

Monday, March 12, 9:15 AM–10:15 AM

Presented by: MPI Research

Vaccination is the primary means of preventing pandemic disease outbreak. The concern for vaccine safety has received increasing attention from the medical community and the public. Toxicity assessments for preventive vaccines can be conducted either in dedicated stand-alone toxicity studies or combination safety/immunogenicity studies with toxicity.

The Use of Human HepatoPac™, an In Vitro Microliver Platform, for Predictive Toxicology
Room 105

Monday, March 12, 9:15 AM–10:15 AM

Presented by: Hepregen, Corp.

Current in vitro platforms to assess hepatotoxicty have been poor predictors of in vivo performance. The use of HepatoPac™, a novel and highly predictive in vitro microliver platform that remains functional for several weeks, will be presented for a variety of “extended-horizon” toxicology applications including chronic toxicity and drug-drug interactions.

Safeguarding Rodent Toxicology Study Results—Auditing Animal Biosecurity Programs
Room 100

Monday, March 12, 10:30 AM–11:30 AM

Presented by: Harlan Laboratories, Inc.

Periodic review of an animal biosecurity program will help minimize the chance of a microbial pathogen outbreak and subsequent alteration of study results. After auditing our United States rodent production sites, lessons were learned about the biosecurity auditing process that can help other institutions review their own programs.

Regulated Laboratory Sciences for Toxicologists
Room 101

Monday, March 12, 10:30 AM–11:30 AM

Presented by: Charles River

Successful GLP compliant toxicology programs are reliant upon appropriate and well-timed communication. Toxicologists and Study Directors often work with Scientists from multiple laboratory-based disciplines. This session is designed to provide a brief overview of Laboratory Sciences and focus on the unique regulatory and logistical requirements of each discipline.

Juvenile Preclinical Safety Evaluations of Biopharmaceuticals: Combining Data from Repeat Dose General and Pre/Postnatal Toxicology Studies
Room 105

Monday, March 12, 10:30 AM–11:30 AM

Presented by: SNBL USA, Ltd.

To maximize data use and minimize additional animal experiments, preclinical/clinical date may be re-evaluated for pediatric testing proposals. The challenge is identifying relevant data from different studies. This presentation discusses how to determine which data are relevant to the experimental goals with focus on nonhuman primate (NHP) study data.

In Vitro Approaches to Assess the Enzyme-Suppressing Effects of Biologics
Room 100

Monday, March 12, 11:45 AM–12:45 PM

Presented by: XenoTech

In vitro assays to assess small molecule drug-drug interactions are well established; however, the conduct of drug-drug interaction in vitro studies with biologic-based drugs is not clearly understood. Approaches to evaluate these interactions will be discussed, and a novel in vitro human test system to predict their potential will be introduced.

Translating MiRNA Discovery in Bio Fluids into Robust Clinical Biomarkers
Room 105

Monday, March 12, 11:45 AM–12:45 PM

Presented by: Exiqon

Discovery and clinical application of microRNA biomarkers in biofluids. Presentation of Exiqon’s highly sensitive LNATM-based microRNA qPCR system to detect microRNAs in challenging clinical material. Considerations for transforming biomarket discovery results into robust assay development. Case studies of miRNA biomarkers into bio fluids.

US EPA and L’Oreal Partner to Test Chemicals in Cosmetic Products
Room 101

Monday, March 12, 11:45 AM–12:45 PM

Presented by: US EPA

US EPA is collaborating with the L’Oreal Cosmetic Company to determine if its chemical toxicity forecaster (ToxCast) tool can be used as an alternative to chemical toxicity tests using animals. L’Oreal is providing US EPA $1.2 million, 20 chemicals founds in their cosmetic products and access to previously conducted animal toxicity data.

Cryopreserved HepaRG™ Cells, Cryopreserved Kupffer Cells in Co-Culture, and Primary Human Hepatocytes as Emerging In Vitro Models for Predictive Toxicology
Room 101

Monday, March 12, 1:00 PM–2:00 PM

Presented by: Life Technologies

In this session we will describe several hepatic model systems including: 1) cryopreserved HepaRG™ cells (metabolically competent alternatives to primary hepatocytes), 2) Primary hepatocytes and next-generation toxicology approaches, 3) Cryopreserved Kupffer cell co-cultures with hepatocytes as inflammatory models for the liver.

Enhanced Early Nonclinical Cardiac Risk Assessment
Room 100

Monday, March 12, 1:00 PM–2:00 PM

Presented by: Chantest Corporation

False positives and false negatives are known in hERG in vitro assays. Chantest founder Dr. Arthur Brown explains a new collaboration with the US FDA designed to improve predicivity, in particular early in drug discovery at the lead selection stage.

Trancsriptomics Tools for Genotoxicity Testing: Mechanistic Insights
Room 105

Monday, March 12, 1:00 PM–2:00 PM

Presented by: Agilent Technologies

The development of mechanism-based approaches for genotoxicity testing is an important undertaking and a prerequisite for the development of better, more rapid identification of genotoxic vs non genotoxic compounds. Two transcriptomics-based mechanisms studies will be presented by leading toxicologists, including the development of guidelines for biomarker qualification.

Application of Ultrasensitive Immunoassay Technology for Pre-Clinical Toxicity Testing
Room 100

Monday, March 12, 2:15 PM–3:15 PM

Presented by: Singulex

Drug safety and toxicity testing often requires precise monitoring of biomarker response, but analytical methods capable of providing the requisite sensitivity and dynamic range are lacking. The talk presents an ultrasensitive immunoassay technology and how it improves biomarker utility in pre-clinical/clinical testing.

CNS Characterization and Assessment of Innovative Efficacy Animal Research Models: Parkinson’s Disease
Room 101

Monday, March 12, 2:15 PM–3:15 PM

Presented by: WIL Research

The assessment of neurodegenerative animal models often includes neuropathology, behavior, and biochemical analysis. These assays are important for both neuroscience research and efficacy testing of potential clinical therapies. This session will discuss the CNS animal model disease program methodology and data at WIL Research as it relates to Parkinson’s Disease.

Targeted Protein Biomarker Quantitation by LC-MS/MS
Room 105

Monday, March 12, 2:15 PM–3:15 PM

Presented by: Tandem Labs

Peptide and protein molecules can serve as therapeutic drugs or biomarkers. Quantitative analysis of these molecules is required for monitoring pharmacokinetic profiles of peptide drugs or drug response in the body for protein biomarkers. This presentation will examine the challenges of peptide and protein analysis as well as relevant bioanalytical practices.

An Introduction to the NTP DrugMatrix and ToxFX Toxicogenomic Database and Analysis Tools
Room 105

Monday, March 12, 3:30 PM–4:30 PM

Presented by: National Toxicology Program

DrugMatrix and its automated reporting system, ToxFX, represent the scientific communities’ largest, freely available toxicogenomic reference database and informatics system. Based on rat organ toxicogenomic profiles for 638 compounds, DrugMatrix allows an investigator to formulate a comprehensive picture of a compound's potential for toxicity with greater efficiency than traditional methods.

Metabolism-Dependent Toxicity Evaluation Using Human Hepatocytes and IdMOC
Room 101

Monday, March 12, 3:30 PM–4:30 PM

Presented by: In Vitro ADMET Laboratories

In vitro approaches for metabolism-dependent xenobiotic toxicity will be described, including the use of metabolic inhibitors with primary human hepatocyte cultures for in vitro metabolic-dependent hepatotocity, and the Integrated Discrete Multiple Organ Co-culture for the evaluation of hepatic metabolite toxicity on nonhepatic organs.

Understanding the New ICH S2(R1) Genotoxicity Guideline and the Advantages of Automated Methods
Room 100

Monday, March 12, 3:30 PM–4:30 PM

Presented by: Litron Laboratories

ICH S2(R1) was signed in November 2011. This session will focus on how Litron technologies address: 1) the requirement to score more cells for in vivo micronucleus studies, 2) acceptance of rat blood for simpler integration into general toxicology studies, and 3) the new role for In Vitro Micronucleus testing.

Tuesday

Development Challenges for Antibody Drug Conjugates (ADCs)
Room 101

Tuesday, March 13, 8:30 AM–9:30 AM

Presented by: MPI Research

ADCs combine the targeting potential of mAbs with the pharmacology of small molecules. These are significant challenges in the development of ADCs such as lot variation as well as the need to simultaneously determine safety margins for intact ADC, drug free mAb, and small molecules that are released in vivo.

Human Induced Pluripotent Stem Cell Technology in Predictive and Mechanism-Based Drug Discovery and Toxicity Testing Using Photometric-Based Assays
Room 105

Tuesday, March 13, 8:30 AM–9:30 AM

Presented by: Promega Corporation

Human iPSC-technology and photometric assays provide rapid and predictive assessments of viability/toxicity and ADME properties during drug development. This tutorial will highlight recent developments in human iPSC-derived cell types from CDI and reporter assays from Promega while demonstrating the advantages of these technologies in accurate assessment of drug-induced cellular responses.

Pathology Peer Review: Who, What, When, Where, Why, and How
Room 100

Tuesday, March 13, 8:30 AM–9:30 AM

Presented by: Vet Path Services

This presentation will cover pathology peer review in the industrial, GLP setting, with discussions of who does a peer review, what the peer review achieves, when it is performed, why should a peer review be done, and how a pathologist goes about a peer review. It will highlight current common practices in the current regulatory environment.

Current Strategies for Juvenile Preclinical Services
Room 101

Tuesday, March 13, 9:45 AM–10:45 AM

Presented by: Charles River

Since issuance of the pediatric rule 14 years ago, we have conducted over 300 juvenile toxicity studies in rodent and nonrodent animals for numerous therapeutics (large and small molecule) and chemicals. This seminar will cover what we have learned, current global regulatory expectations and program designs including species, dose routes and evaluation.

Experience Results: Lessons Learned Developing New Anticancer Drugs and Biotherapeutics
Room 105

Tuesday, March 13, 9:45 AM–10:45 AM

Presented by: Accelera Srl

Case stories from the direct experience of safety assessment for different drug development programs, including some marketed products, are represented with special emphasis on anticancer drugs and biotherapeutics. Challenges, key issues, and lessons learned are described in the context of scientific and regulatory requirements.

Developing a Novel Gene Therapy Product for the Treatment of Rare X-Linked Disease
Room 100

Tuesday, March 13, 9:45 AM–10:45 AM

Presented by: Huntingdon Life Sciences

Safety assessment of gene therapy products is a complex business with multiple safety risks. Standard paradigms do not exist and approaches must be designed on a case by case basis. A case study will be discussed which highlights considerations for a gene therapy to treat an x-linked disease.

Best Practices for Assessing Functional CV Endpoints in Repeat Dose Tox Studies
Room 105

Tuesday, March 13, 11:00 AM–12:00 Noon

Presented by: Data Sciences International

Experienced cardiovascular physiologist and histopathologist will present data from recent studies. In the drug development context, utilization of current methodologies in tox studies and best practices for assessing CV risk will be discussed.

Innovative Models and Techniques for the Investigation of Nanotoxicity
Room 100

Tuesday, March 13, 11:00 AM–12:00 Noon

Presented by: Fraunhofer ITEM

The session will focus on the state of the art and future of in vivo inhalation tests, innovative in vitro and ex vivo models as significant tools in inhalation toxicology and sensitive methods to detect lung damage potentially induced by nanoparticles including carbonanotubes.

Searching for Drug Safety, Efficacy, and Performance: Scientific and Regulatory Perspectives
Room 101

Tuesday, March 13, 11:00 AM–12:00 Noon

Presented by: PointCross Life Sciences

Nonclinical scientists and regulatory reviewers are increasingly confronted with the need to assess safety, efficacy and performance of drug candidates across study data, reports, chemical structures, and other artifacts. This session focuses on practical ways to search and navigate disparate information from the perspective of R&D and US FDA reviewers.

Advancing the Science of Stem Cells in Toxicology
Room 105

Tuesday, March 13, 12:15 PM–1:15 PM

Presented by: Integrated Laboratory Systems, Inc.

This presentation will compare stem cells to traditional in vivo and in vitro models for their relative utility in evaluating the toxicity of pharmaceuticals, chemicals, and personal care products. Specific emphasis will be placed on the advantages of stem cell-based platforms for assessing reproductive and developmental toxicity, neurotoxicity, and cardiotoxicity.

Dermal Drug Development
Room 100

Tuesday, March 13, 12:15 PM–1:15 PM

Presented by: CiToxLAB

The session will present the toxicology studies to support the development of a dermal drug, covering early screening assays, IND-enabling package, and full development. In addition the session will cover the skin histology in laboratory animals and issues relating to broken skin and wound healing.

Preliminary Characterization of the Aryl Hydrocarbon Receptor Knockout Rat Shows Significant Cross-Species Differences Compared with the Mouse
Room 101

Tuesday, March 13, 12:15 PM–1:15 PM

Presented by: SAGE Labs

Advances in genetic engineering have enabled the generation of targeted knockout rats. We will discuss the technology used to develop Mdr1a, Bcrp, and Mrp2 drug transporter knockouts. Data from these models demonstrate they may serve as more relevant and specific tools for the elucidation of compound efflux and DMPK studies.

New Capabilities of Noninvasive Telemetry Used for Cardiovascular Respiration and CNS Assessments
Room 105

Tuesday, March 13, 1:30 PM–2:30 PM

Presented by: emka TECHNOLOGIES INC.

The presentation will explain how the new features of emka TECHNOLOGIES’ latest generation of noninvasive telemetry and associated software allow for a significant increase in power and efficiency of preclinical investigations. The focus will be on blood pressure and respiration analysis, subject specific QT correction and arrhythmia detection, and EEG signal collection and use in sleep or epilepsy studies.

The Key Role of Experience in Toxicological Study Design and Data Interpretation
Room 101

Tuesday, March 13, 1:30 PM–2:30 PM

Presented by: RTC—Research Toxicology Centre S.p.A.

RTC senior science experts in different areas of Toxicology will share some special cases for which practical experience played an important role during preclinical development. In fact, for an effective translational approach, it is important to define appropriate study designs and apply a critical interpretation of equivocal results.

Utility of Primary Stem Cell Colony Assays in Drug Development
Room 100

Tuesday, March 13, 1:30 PM–2:30 PM

Presented by: STEMCELL Technologies, Inc.

A potential side effect of anticancer and come novel inhibitor drugs is damage to stem cells including those of the hematopoietic (blood) system. Impairment of 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.

Knowledge-Driven Multi-Omics Integration for Pathways of Toxicology (PoT) Research: Policy and Technology Drivers
Room 105

Tuesday, March 13, 2:45 PM–3:45 PM

Presented by: Agilent Technologies

The use of transcriptomics tools for toxicology research is nearly a decade old. Recent advances in other complimentary -omics domains offer the possibility of mapping the various Pathways of Toxicity (PoT). The regulatory, scientific and technological drivers of current PoT research will be explored by two leading toxicologists.

Modular Approaches for Pharmaceutical Lead Optimization
Room 101

Tuesday, March 13, 2:45 PM–3:45 PM

Presented by: WIL Research

Lead optimization has become an important strategy in candidate selection to increase the probability of successful commercialization. In this seminar we will present how a core battery of in vitro and in vivo assays like automated hERG and rapid PK screening can be tailored to address the specific end-points of concern.

Routine 3D Cell-Based Toxicology Assays for Compound De-Risking
Room 100

Tuesday, March 13, 2:45 PM–3:45 PM

Presented by: InSphero AG

3D hepatocyte cell models (spheroids) offer significant advantages for toxicology testing: higher functionality, longer functional life time, integration of non-parenchymal cells and more. InSphero will illustrate, using examples from recent collaborations, various approaches for exploiting 3D models in toxicology using laboratory automation and reliable, proven off-the-shelf biochemical assays.

Wednesday

Advances in High Throughput, Nontargeted Cell-Based Screens for Toxicity and Genotoxicity Assessment
Room 105

Wednesday, March 14, 8:30 AM–9:30 AM

Presented by: Thermo Fisher Scientific

We will discuss the development of automated, non-targeted cell-based assays for endocrine disruption, developmental neurotoxicity, and genotoxicity. Utilizing image cyrometry technology, we have developed panels of assays with wide applicability in the regulatory testing of food, environmental and consumer products. Case studies will be presented.

Image-Based Cytometry for Cell Viability and Cell-Based Assays
Room 100

Wednesday, March 14, 8:30 AM–9:30 AM

Presented by: Nexcelom Bioscience

This session will present image-based cytometry for cell viability (including fragile hepatocytes) and cell-based assays with 20ul of sample. It will review the advantages of image-based cytometry and present comparative data to flow cyrometry for apoptosis, cell cycle, ABC transporter assays, mitochondrial membrane potential, and other cell-based assays.

Toxicokinetic Evaluation in the Virtual Animal
Room 101

Wednesday, March 14, 8:30 AM–9:30 AM

Presented by: MPI Research

Routinely generated in vitro ADME data can be used as prior knowledge to develop PBPK models in virtual animals (rat, dog, mouse) using the Simcyp Simulator. Optimisation of toxicokinetic/safety pharmacology studies can be undertaken focusing upon systemic xenobiotic concentrations rather than dose alone and reducing the need for iterative in vivo.

Beyond Antibodies: Characterization of the Cellular Immune Response to Keyhole Limpet
Room 101

Wednesday, March 14, 9:45 AM–10:45 AM

Presented by: Charles River

Production of antigen-specific antibodies is the principal readout in the T-cell dependent antibody response assay. However, generation of specific antibodies requires participation of antigen-presenting cells, T and B lymphocytes. Given this has not been well characterized, we will provide an overview of what is known about the cell mediated immune response in the TDAR.

Predicting Safety, Prophylactic and Therapeutic Efficacy in an African Green Monkey RSV Model Dosed via Continuous Infusion
Room 100

Wednesday, March 14, 9:45 AM–10:45 AM

Presented by: Huntingdon Life Sciences

RSV is an important unmet medical need in newborns. The development of an intravenous anti-RSV drug from target selection through proof of concept in the African Green Monkey RSV model is discussed. The development program start was impacted by surgical issues which were successfully mitigated by an HLS surgical team.

JRF Launches Endocrine Disruption Screening Tests & ADME Studies and Services
Room 100

Wednesday, March 14, 11:00 AM–12:00 PM

Presented by: JRF Global

JRF has undertaken development and validation of all the in vivo endocrine disruptor screening tests which are significant to assess the potential of test items to disrupt the delicate balance of the endocrine system in rats. The oral and dermal ADME test validation proves the capability of evaluation of the ADME aspects of the test compounds at JRF.

Kidney Toxicity Biomarkers: Applications for Drug Safety and Kidney Disease
Room 101

Wednesday, March 14, 11:00 AM–12:00 PM

Presented by: Myriad RBM

Myriad RBM’s Rat Kidney MAP got its start as the primary quantitative protein biomarker testing platform for the PSTC nephrotoxicity working group’s successful submission and qualification of 7 biomarkers for use in preclinical safety studies. Selected examples of rat and human kidney MAP applications will be presented in addition to a sneak preview of upcoming canine specific kidney assays.

Introduction to the nCounter® System: A Digital, Amplification-Free Platform for mRNA and miRNA Quantification
Room 105

Wednesday, March 14, 2:00 PM–3:00 PM

Nanostring Technologies, Inc.

This session will present a unique technology that enables the quantitative detection of hundreds of nucleic acids within a single tube in less than 15-minutes bench-time. We will discuss how the system is utilized for toxicogenomics, biomarker discovery, pathway analysis, and validating data obtained from other technologies.

Predictive Platform for In Vitro Early Safety Assessment
Room 101

Wednesday, March 14, 2:00 PM–3:00 PM

Presented by: Enzo Life Sciences

A predictive platform for in vitro early safety assessment, consisting of live cell assays and focused compound libraries, will be discussed. The described workflows provide rapid and quantitative high-throughput read-outs of drug- or toxic agent-induced live cell response, offering throughput advantages over conventional methods based upon fluorescence microscopy or flow cytometry.

Nanotechnology: US-EU Cooperative Research Opportunities
Room 100

Wednesday, March 14, 2:45 PM–3:45 PM

Presented by: US EPA

In March, US National Nanotechnology Initiative Agencies and the European Commission held a joint Workshop to promote cooperation in environmental, health, and safety research. This session will summarize US and EU Nanotechnology research programs, and seek to establish US-EU Communities of Research in defined areas.