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Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday


A Typical Timeline for your Biologics Toxicology Program

Room 217B

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: WuXi AppTec

This session will address what a standard program for a biologic will look like. Preclinical studies for biologics are customized for each product and designed to generate meaningful results through the performance of a thorough scientific and regulatory-compliant program. 


Releasing the Immune System Brakes: The Importance of Modeling Effects in Nonclinical Safety Studies

Room 217A

Monday, March 12, 9:00 AM to 10:00 AM

Presented by: Envigo

Checkpoint inhibitors release the immune system’s biological control mechanisms, increasing anti-tumor activity.  As these products enter the clinic, increasingly in combination with other drugs, it is essential to understand potential risks.  Design of appropriate nonclinical studies, interpretation of results, and translation to the clinic are critical to understanding potential impact.


New Regulatory Drivers for Agrochemical Testing

Room 217B

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Charles River

New data requirements have been set for European agrochemical Regulations 283/2013 and 284/2013. Affecting such studies as in vitro metabolism, toxicokinetics, phototoxicity, immunotoxicity, and others, the requirements have shifted the agrochemical framework toward a more pharma-based development process.


A New Telemetry-Based System for Assessing Cardiovascular Function in Large Animals-Part II, Pharmacological Validation by M.Markert, Boehringer Ingelheim

Room 217A

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: TSE Systems

A first pharmacological evaluation of a newly-developed total implant telemetry system for cardiovascular, electrophysiological, and body temperature measurement. It is intended to be used for drug candidate safety pharmacological evaluations.


Implementation of Liquid Chromatography-Mass Spectrometric Workflows for the Quantitation of Large Molecule Biotherapeutics

Room 217C

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Altasciences Clinical Research

This session will outline workflows implemented using immunocapture-liquid chromatography mass spectrometry assays, high-resolution mass spectrometry, nano and micro flow chromatographic separation, and microsampling to expedite bioanalysis of large molecule biotherapeutics, including monoclonal antibodies, fusion proteins and peptides. Case studies highlighting scientific considerations and regulatory challenges will be presented. 


Skin Sensitization: What Place Does In Silico Have within a Defined Approach?

Room 217D

Monday, March 12, 10:30 AM to 11:30 AM

Presented by: Lhasa Limited

Testing strategies incorporating in silico predictions can provide additional value by considering factors such as metabolism, lipophilicity, and chemical reactivity. Lhasa Limited will describe a defined approach integrating Derek Nexus with non-animal assays to reliably predict skin sensitization and will compare its performance to both human and animal data.


Evolution of 3D Tissue Models for Toxicology and Disease Modeling

Room 217D

Monday, March 12, 12:00 PM to 1:00 PM

Presented by: Bio-Techne

This session will present the history of in vitro models for toxicology, drug screening, and disease modeling. It will emphasize culture methods, advantages, and disadvantages of current 3D models. It will introduce MimEX™ Tissue Model Systems, a platform to generate sustainable, accessible, and physiologically-relevant 3D organ tissue on a 2D surface.

 


Leveraging Genetic Diversity to Reduce Clinical Attrition: A Novel Approach to In Vitro Safety and Toxicity Testing

Room 217C

Monday, March 12, 12:00 PM to 1:00 PM

Presented by: Coyne Scientific, LLC

Coyne Scientific, a biotech services company, invites you to discover how using hiPSC-derived cardiomyocytes obtained from a cohort of genetically-diversified individuals (rather than a single individual) can significantly improve the assessment of cardiac toxicity of pharmaceuticals within a target population and potentially reduce attrition of compounds in clinical development.


Neurotox and Cardiac Safety Assessment: Case Studies Employing iPS Cell Lines and Next-Generation MEA Technology

Room 217A

Monday, March 12, 12:00 PM to 1:00 PM

Presented by: Axion BioSystems and Cellular Dynamics International, a FUJIFILM company

Discover the predictive power of iCell Cardiomyocytes2 and iCell GlutaNeurons with the Maestro Pro multiwell MEA platform.  Experts in the field will present case studies on optimization of neuronal/astrocyte co-culture for neurotoxicology (HESI NeuTox) and incorporation of the local extracellular action potential (LEAP) signal for cardiac safety (CiPA).


Tools for Streamlining QSAR/PBPK/QST Modeling and Simulation

Room 217B

Monday, March 12, 12:00 PM to 1:00 PM

Presented by: Simulations Plus, Inc.

Simulations Plus and DILIsym Services have partnered to combine top-ranked, easy-to-use software (GastroPlus™, ADMET Predictor™, and DILIsym®) to streamline QSAR/PBPK/QST modeling and simulation in animals and humans, following administration around the body, and predict exposure/safety characterization of compounds in preclinical and clinical development. In this session, case studies will be presented demonstrating the integrated workflow to support research activities and regulatory submissions. Lunch will be provided.


Can Pharmacokinetic Modelling Keep Up with Risk Assessment in the 21st Century?

Room 217C

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: ScitoVation

This session will explore current issues and future challenges associated with the increased requirement for rapid pharmacokinetic modelling associated with Tox21, the Lautenberg Chemical Safety Act, and animal welfare concerns.  It will feature panel discussions with audience participation to discuss issues such as modelling platforms, model evaluation, and modeler training.


Immunopharmacology and Immunotoxicology in Minipigs in Support of Nonclinical Drug Development

Room 217B

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: Sinclair Research Center

This session will describe how to develop, validate, and implement the different assays needed to support immunotoxicoloy investigations in minipigs. The design of special immunotoxicity studies for different breed of minipigs (Yucatan, Hanford, Sinclair, and Göttingen) and the collection and interpretation of immunotoxicology data in minipigs will be discussed.


Novel MetMax Hepatocytes and Enterocytes for the Evaluation Drug Metabolism, Drug-Drug Interactions, and Metabolism-Dependent Toxicity

Room 217A

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: InVitro ADMET Laboratories

MetMax™ hepatocytes and enterocytes are permeabilized cells supplemented with metabolic cofactors that have complete metabolizing enzyme pathways but can be stored and used like cell free fractions.  Applications include metabolism, drug-drug interactions, and as exogenous metabolic activating systems for in vitro toxicity assays involving target cells incompetent in xenobiotic metabolism.


Validation of 3D Human Liver Microtissues for Enhanced DILI Prediction and Investigation of Mechanisms of Hepatotoxicity

Room 217D

Monday, March 12, 1:30 PM to 2:30 PM

Presented by: InSphero Inc.

3D microtissues have emerged as promising tools to assess mechanisms of hepatotoxicity, as they demonstrate enhanced liver phenotype and function. This session will present the most comprehensive evaluation by pharma to date, demonstrating their utility for enhanced DILI prediction, as well as application examples for studying mechanistic aspects of hepatotoxicity.


Strategies for Successful PreIND and IND Submissions for the Toxicologist

Room 217D

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: ToxStrategies

Preparing PreINDs and INDs can be challenging. ToxStrategies consultants will provide strategic scientific and regulatory advice on preparing PreIND and subsequent IND submissions. Insights on the PreIND/IND process, addressing what nonclinical data to include, how to prepare concise nonclinical summaries, and how to avoid submission delays will be presented.


What Can In Vitro Toxicology Learn from Genetic Toxicology for Regulatory Acceptance?

Room 217C

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: Charles River and Toxys

Acceptance of in vitro toxicology models has been slower or difficult to adopt, despite formal validation and OECD test guidelines. What can in vitro toxicology learn from the genetic toxicology experience for the acceptance of these models and replacement of their, usually, acute tests?  


Genetic Diversity for Patient Specific Safety Assessments: Future of Toxicology?

Room 217A

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: Nanion Technologies

One speaker will present cardiotoxicity investigations of iPS-derived cells with optogenetic stimulation for efficient risk evaluation. A second will discusse in vitro methodologies investigating the use of adjuvant chemotherapy to prevent tumor recurrence. A third, by Coyne Scientific, will describe the use of a cohort of genetically-diverse iPS cardiomyocytes to assess toxicity.


High-Throughput Transcriptomics: Addressing the Human Risk Assessment Challenges of Chemical Coverage, Metabolism, and Population Variation

Room 217B

Monday, March 12, 3:00 PM to 4:00 PM

Presented by: BioSpyder Technologies

In vitro approaches to chemical risk assessment are being more widely used for evaluating mechanisms of action and estimating effect doses. Several challenges remain before wide acceptance in regulatory settings. This session will cover topics such as coverage in chemical and biological space, lack of metabolic capacity, and understanding of population variability.



Tuesday


A Novel 3D Microtissue-Based Platform for Studying Liver Fibrosis

Room 217D

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: InSphero Inc.

This session will share the characterization of a 3D Human Liver Fibrosis Model as a novel tool to study liver fibrosis, suitable for high-throughput efficacy testing of anti-fibrotic drugs. The disease model consists of only primary cell material for more physiologically-relevant screening hits.


Advanced Therapy Medicinal Products -The Good, the Bad, and the Unknown

Room 217C

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: Envigo

The nonclinical safety assessment of advanced therapies (cell and gene therapies) requires additional investigations beyond what is expected for traditional therapeutics. Frequently, the use of non-standard toxicology models, such immunodeficient rodent strains, is required to obtain crucial information on potential toxicities and inform clinical study design. 


Are Your Regulatory Submission Timelines at Risk?

Room 217B

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: PDS Life Sciences

The SEND (Standard for Exchange of Nonclinical Data) requirements have begun to roll out.  The data standardization schema presents both challenges and opportunities for the toxicology community.  This session will present the latest updates to the SEND requirements and the current best practices to comply with them for toxicologists.


TSCA Reform: Use of New Tools and Technology for Prioritization and Chemical Risk Evaluation

Room 217A

Tuesday, March 13, 9:00 AM to 10:00 AM

Presented by: ToxStrategies, Inc.

This session will provide an overview of chemical prioritization and risk evaluations under TSCA as amended by the Lautenberg Chemical Safety Act. It will focus on new analytical tools, technologies, and databases that can be used for prioritization and testing of new chemicals and for risk evaluation of existing chemicals. 


Quantitative Methods for Monitoring Thyroid Hormones in Late Fetal and Early Neonatal Rat Specimens

Room 217C

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Charles River

During thyroid development in the late stages of gestation, serum concentrations of T3 and T4 can be well below the limits of detection using conventional assays. An HPLC/MS/MS method has been validated to secure accurate data during early development to meet EPA and OECD guidelines expectations. 


Achieve Higher Quality Data and Enable Multiplexing Options by Adopting Real-Time In Vitro Cytotoxicity Assays in 2D/3D Cultures

Room 217A

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Promega Corporation

Real-time assay methods have been developed enabling kinetic measurement of live, dead, and apoptotic cells repeatedly from the same sample using a plate reader. The methods simplify and reveal how time and dose affect cytotoxicity in 2D or 3D models and enable downstream applications with the same samples.


Quantitation of Oligonucleotides Using a Hybridization Method in Various Tissues and Species for Accurate Pharmacology and Toxicology Evaluations

Room 217D

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Altasciences Clinical Research

Antisense oligonucleotides (ASOs) are widely used for silencing gene expression leading to promising treatment of rare diseases. This session will be an introduction to concepts and techniques in support of ASOs quantitation in blood and various tissue samples. Case studies highlighting scientific considerations and regulatory challenges will be presented.


Three-Dimensional (3D) Cultures of HepaRG Cell Models Physiologically-Relevant Drug Metabolism, Drug-Induced Liver Injury, and Hepatic Signaling Pathways

Room 217B

Tuesday, March 13, 10:30 AM to 11:30 AM

Presented by: Lonza

Prediction of liver injury and toxicological mechanisms remain focal points to pharmacological and environmental toxicology research. In this presentation, the development and application of organotypic in vitro liver models (e.g., 3D) will be described, including their utility to predict liver injury and characterize physiologically-relevant transcriptomic perturbations reflective of human outcomes.


Development of Real-Time Cardiotoxicity and Hepaotoxicity Assays Using Human iPSC-Derived Cells

Room 217B

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: ACEA Biosciences

Human iPSC-derived cells provide a relevant model system for screening and assessment of potential toxicities associated with pharmaceutical and environmental compounds. In this session the utility of real-time cell-based assay using matured iPSC-cardiomyocytes and iPSC-hepatocytes for risk assessment of pharmaceutical and environmental hazardous compounds will be discussed.


Let the Machine Do the Work: Using Automation for High-Throughput In Vitro Toxicity Assays

Room 217C

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: Miltenyi Biotec Inc.

Fast and standardized flow cytometry workflows overcome the limitations of microscopic analysis, providing both reproducible and reliable high content toxicology information. This session will present Litron Laboratories multiplexed DNA damage assay for MOA detection and the Institute for In Vitro Sciences efforts with flow cytometry and the human Cell Line Activation Test (h-CLAT).


Solving Target Safety Assessment Challenges

Room 217D

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: Instem

Companies are under enormous pressure to quickly produce high-quality target risk assessments to make drug development decisions. KnowledgeScan (KS) Target Safety Assessment (TSA) is revolutionizing this area. Hear how Instem clients are improving quality, reducing costs, getting faster results and gaining value by engaging in TSA projects with Instem.

 


Telemetry and Data Production : Looking Beyond the Requirements

Room 217A

Tuesday, March 13, 12:00 PM to 1:00 PM

Presented by: emka TECHNOLOGIES Inc.

Telemetry produces unprecedented volumes of recordings from which powerful software derives even larger volumes of results. This session will present the challenges and possible solutions for intelligent data analysis and handling big data:  how to speed up analysis and processing, to report efficiently, and to mine information from various sources of historical data.
 


Ames Test Strain Profile: Implications for Mutagenicity Predictions and ICH M7

Room 217D

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Lhasa Limited

Recent discussions around the bacterial strains used for the Ames test may impact both the development of in silico models (e.g. training sets) and the interpretation of predictions. These topics will be discussed and new features in Sarah Nexus to assist with expert review will be demonstrated.


Bioanalysis and Toxicology Challenges with Antibody Drug Conjugates (ADC)

Room 217C

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Intertek

Avoid preclinical testing failure by understanding the complex bioanalytical and toxicology challenges associated with Antibody Drug Conjugates (ADC) drug development and unique ways to overcome them. ADCs are new compounds compared to others, but they also face challenges in the immunogenicity assays requirements and increasing bioanalysis assay complexity.


Standard for Exchange of Nonclinical Data (SEND): What is it and Why is it Mandated by the FDA?

Room 217B

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: WuXi AppTec

During this session we will be discussion what SEND is and why it is mandated by the FDA. 

 


Cardio quickPredict: A New Way to Evaluate the Cardiotoxicity Potential of Compounds

Room 217A

Tuesday, March 13, 1:30 PM to 2:30 PM

Presented by: Stemina Biomarker Discovery, Inc.

Stemina has developed a new cardiotoxicity assay, Cardio quickPredict, which predicts the cardiotoxicity potential of a compound based on changes in human iPSC-derived cardiomyocyte metabolism and viability and indicates whether the cardiotoxicity profile is consistent with functional or structural toxicity.  This session will cover assay development, performance, and application.



Wednesday


What is Needed in your IND Submission?

Room 217B

Wednesday, March 14, 9:00 AM to 10:00 AM

Presented by: WuXi AppTec

During this session a consultant will define what a standard IND submission includes and why this is standard for your program. 


From Nose to Tail: Nonclinical Safety Assessment Success Factors in Rats

Room 217A

Wednesday, March 14, 9:00 AM to 10:00 AM

Presented by: Envigo

The rat has been used extensively in nonclinical safety assessment for many years.  Rat strain and diet selection for long-term studies are important in mitigating age-related pathologies. Managing body weight, maintaining proper organ function, and avoiding non-nutrient confounders can impact animal welfare and should be considered when designing studies. 


Classic, Modern, and Innovative Uses of Electron Microscopy in a GLP Environment

Room 217C

Wednesday, March 14, 10:30 AM to 11:30 AM

Presented by: Charles River

Electron Microscopy (EM) has evolved as generations of scientists have pushed the boundaries of its classical application to answer novel scientific questions. Experience demonstrates that electron microscopy can be successfully utilized in a GLP regulatory environment for a variety of important applications in discovery, safety assessment, and manufacturing.


Designed-For-Purpose: Complex Liver Cell Cultures for Improving In Vitro Hepatotoxicity Testing

Room 217B

Wednesday, March 14, 10:30 AM to 11:30 AM

Presented by: Lonza

Lonza, in collaboration with ScitoVation, will present 2D and 3D hepatotoxicity models that can recapitulate in vivo liver phenotypes. These models combine primary hepatocytes and liver non-parenchymal cells to improve hepatocyte viability, phenotype, and response to chemicals.  Maximizing improvements to phenotypic relevance while minimizing culture complexity will be discussed.


Ensuring SEND Success Beyond Regulatory Compliance

Room 217A

Wednesday, March 14, 4:30 PM to 5:30 PM

Presented by: Instem

SEND - is it simply a standard, or are there more commercial factors that organizations are overlooking? Join us for this informative session where we will be discussing how to exploit the standard beyond simply being compliant. During this time attendees will also receive the latest SEND updates.