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Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday


In Vitro Platforms for Derisking Nephrotoxicity

Room Room 337

Monday, March 11, 9:00 AM to 10:00 AM

Presented by: SOLVO Biotechnology

The aProximate™ proximal tubule cell model was utilized to assess 30 mechanistically-distinct pharmaceuticals for nephrotoxicity with measurement of clinically-relevant biomarkers (KIM-1, NGAL, Clusterin) employed alongside non-specific cytotoxicity end-points (ATP depletion, LDH leakage, TEER). The results show that aProximate™ cells are a promising in vitro tool for nephrotoxicity safety assessment.


Hematology and Biochemistry Background Data in Juvenile Sprague Dawley Rats at 4, 7, and 21 Days of Age

Room Room 338

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

Presented by: ITR Laboratories Canada Inc

Our laboratory published background hematology and biochemistry data from naive pups at 4, 7, and 21 days of age. A number of pups were used to generate the data. We will discuss the difference in some of these parameters from 4 days of age until shortly before weaning.


ICH M7 Perception: Unifying Knowledge from Predictions to Purging

Room Room 337

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

Presented by: Lhasa Limited

Multiple approaches exist for addressing potentially mutagenic impurities (PMIs) under ICH M7. This session will demonstrate how purge argumentation, (Q)SAR predictions and data can all be used to qualify PMIs and importantly how knowledge gained can be retained and easily applied to future projects.


The Application of hTERT-Immortalized Primary Cells in Toxicological Assays

Room Room 339

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

Presented by: ATCC

hTERT-immortalized primary cells exhibit the growth characteristics of continuous cell lines while providing the physiological attributes of primary cells. Our experts will discuss the characteristics of respiratory, ocular, cardiovascular, skin, reproductive, and kidney hTERT-immortalized primary cells, as well as the utility of these versatile cells in various toxicological assays.


The Expanded Role of Flow Cytometry in PK/PD Studies in Nonhuman Primates – What Can We Learn Early within Biotherapeutic Drug Development Programs?

Room Room 340

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

Presented by: Charles River

Flow cytometry quantitation of biotherapeutics and receptor binding assessments has become an integral tool in supporting investigative toxicology, preclinical and clinical programs. Comprehensive PK/PD studies in nonhuman primates provide valuable information used to design nonclinical and clinical programs. We will present an overview of pharmacology and pharmacodynamic capabilities in nonhuman primates, strategies for implementing these end points on studies, and options for expediting reporting of key data. 


Game Changing – The Latest Developments in the Machine Learning/PBPK/QST Modeling Space

Room Room 337

Monday, March 11, 12:00 PM to 1:00 PM

Presented by: Simulations Plus, Inc.

With the evolving partnership between Simulations Plus and DILIsym Services, and several recent grant awards, we’re excited to share the latest developments in our top-ranked, streamlined software – GastroPlus™, ADMET Predictor™, and DILIsym® – for simplifying the complex processes required to predict risk assessment and develop safe therapies. Join us for lunch!


Nonclinical Development Considerations for Cell and Gene Therapies

Room Room 340

Monday, March 11, 12:00 PM to 1:00 PM

Presented by: Covance

Regenerative therapies have recently undergone some spectacular clinical successes and offer great potential to significantly redefine medical treatments. In this session, we will highlight some of the nonclinical development studies and analytical tools supporting a cell or gene product for an IND/IMPD submission and beyond.


Scalable 3D In Vitro Technology for Predictive DILI Screening and Mechanistic Hepatotoxicity Testing

Room Room 339

Monday, March 11, 12:00 PM to 1:00 PM

Presented by: InSphero Inc.

A comprehensive evaluation of clinical compounds in 3D liver co-cultures consisting of primary hepatocytes and Kupffer cells for improved DILI prediction compared to standard 2D hepatocyte culture will be presented. Data on functional characterization of 3D liver co-cultures in 384-well plates suitable for high-throughput screening will also be shared.  


The Utility of Electrical Field Stimulation for Functional Maturation of hiPSC-CM & Assessment if Inotropic Compounds

Room Room 338

Monday, March 11, 12:00 PM to 1:00 PM

Presented by: ACEA Biosciences, Inc.

One of the biggest gaps to full utilization of hiPSC-CM is their inherent maturation status. We discuss the launch of a high-throughput instrument that uses electrical conditioning to achieve fully-functional mature cardiomyocytes, used to assess excitation-contraction coupling and more. We discuss how the system can provide incisive multi-parametric and predictive information for safety assessment, drug discovery and disease modeling.


Discover Hidden Relationships in your Toxicological Studies with IPA and 50,000 Curated Datasets

Room 340

Monday, March 11, 1:30 PM to 2:30 PM

Presented by: QIAGEN

Learn how to discover the hidden upstream drivers and downstream outcomes in your toxicogenomics datasets, based on up or down regulation of genes, proteins, or metabolites. Understand how those results compare to ~50,000 pre-analyzed omics datasets from human, mouse, and rat. These approaches can help you explain the causes and effects in your studies so you can generate hypotheses to develop better drugs, biomarkers, and more.


Derisk Your Drug Pipeline – Screen out Drug-induced Mitochondrial Toxicity in the Early Stages of Drug Development

Room Room 337

Monday, March 11, 1:30 PM to 2:30 PM

Presented by: Agilent Technologies

Dr. Karen Tilmant will share how real-time cell-based bioenergetics for mitochondrial toxicity can be part of the battery of safety screening assays. This talk assesses the Seahorse XF platform as a tool for screening mitochondrial dysfunction and presents a workflow with reference to a panel of mitotoxic drugs. The work was performed by UCB Pharma (Belgium) and was supported by the MIP-DILI consortium (Innovative Medicines Initiative).


Developing High Content and MEA Assays for Toxicology Prediction using Organ Specific Cellular Subtypes

Room Room 338

Monday, March 11, 1:30 PM to 2:30 PM

Presented by: Cyprotex

The session will provide an overview of the latest cell-based technologies available for predicting human safety. Strategies for assessing organ-specific toxicity using iPSC-derived cells, electrophysiology, 2D and 3D models and high content imaging will be presented with case studies on how these techniques have been used to understand clinical liabilities.


Strategies and Innovations for Addressing the Requirements of Proposition 65 and Other Consumer Product Regulations

Room Room 339

Monday, March 11, 1:30 PM to 2:30 PM

Presented by: Gradient

The session provides guidance and case studies related to both proactive (e.g., company initiated) and reactive (e.g., responding to regulatory requirements) chemical product safety programs. Speakers will address changes under California's Proposition 65, as well as the growing number of product disclosure regulations in the U.S.  Discussion includes some of the challenges that have been observed in applying risk and exposure assessment strategies in this context.


Embracing Translation at the National Toxicology Program: A Strategic Realignment

Room Room 340

Monday, March 11, 3:00 PM to 4:00 PM

Presented by: National Institute of Environmental Health Sciences

The National Toxicology Program (NTP) continuously builds on its history of relevance, excellence, and impact. In 2018, NIEHS’ NTP Division initiated an effort to refine its portfolio and approaches to evolve the way toxicology is applied to public health issues. This session will provide information about NTP’s realignment toward translational toxicology.


In Vitro Hepatic and Enteric Systems for Drug Metabolism, Toxicology, and Pharmacology

Room Room 337

Monday, March 11, 3:00 PM to 4:00 PM

Presented by: In Vitro ADMET Laboratories Inc.

Novel in vitro experimental systems for the evaluation of hepatic and enteric drug metabolism, toxicity and pharmacology to aid drug development will be discussed. The novel systems include human and animal 999Elite™ plateable cryopreserved hepatocytes, MetMax™ permeabilized hepatocytes and enterocytes, and cryopreserved intestinal mucosa. 

 


Suggested Guidance for Drug Submission and Timelines

Room Room 339

Monday, March 11, 3:00 PM to 4:00 PM

Presented by: WuXi AppTec

Whether you are working on an advanced biologic or an innovative small molecule drug, you need someone you can rely on to use its proven expertise to develop a study that meets your specific needs. WuXi AppTec will discuss their suggested guidance for drug submission and timelines.


Working with Weird and Wonderful Viral Vectors - How to Combine Animal Husbandry and Study Design to Ensure Success

Room Room 338

Monday, March 11, 3:00 PM to 4:00 PM

Presented by: Envigo

Specific considerations are required when assessing safety of viral products.  However, with an increasing move to utilization of species that are natural pathogens of toxicology species, standard approaches to handling and containment are insufficient.  Creative and adaptable approaches are required to enable assessment of such products without jeopardizing unrelated studies.



Tuesday


Endocrine Disrupter (ED) Testing in the European Union (EU) - from ‘Conceptual Framework’ to Reality

Room Room 338

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

Presented by: Envigo

The European Union (EU) is finally emerging from the shadow of proactive US EPA testing-based approaches embodied in the EDSP Tier 1 battery and development of the EDSP21 Dashboard. The OECD ‘Conceptual Framework’ has now come of age with ED assessment for agrochemical AI’s coming into force from 10 November 2018.


ICCVAM Update on Implementing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States

Room Room 337

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

Presented by: National Institute of Environmental Health Sciences

In 2018, ICCVAM published a strategic roadmap to guide U.S. federal agencies and stakeholders seeking to adopt new approaches to safety and risk assessment that improve human relevance and replace or reduce the use of animals. This session will provide an update on implementation activities within federal agencies.


SEND (Standard for Exchange of Nonclinical Data) Past, Present and Future; and What it Means for Toxicologists

Room Room 339

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

Presented by: PDS LIfe Sciences Inc

Provide a SEND update on what has happened to date, including latest information provided by the FDA to the SEND community.  The most pressing issue is the implementation of SENDIG v3.1 in March 2019. Further discussion on new requirements compared to the SENDIG v3.0.


Auditory Safety in Toxicology: Discussions on Current Trends

Room Room 340

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

Presented by: Charles River and Vet Path Services (VPS)

Evaluation of sensory systems in toxicity studies has historically been only a priority for directly administered compounds and those in classes of risk.  We will discuss the necessary considerations for compounds that may be in a class of risk for ototoxicity, those directly administered to the ear, those targeting the ear, and considerations for future screening and inclusion of these specialty system evaluations in standard toxicity studies.  


Factors to Consider for Developing In Vitro Cytotoxicity Assays to Replace Animal Testing

Room Room 338

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

Presented by: Promega Corporation

There are many options for measuring cytotoxicity in vitro as an alternative to animal testing. Critical factors to consider during alternative assay development include predictivity and reproducibility of the cell model, detection sensitivity, selecting endpoint versus real-time kinetic assay methods, and the ability to multiplex more than one orthogonal endpoint.


Global IND Submission: What are the Benefits and Why Should it be Considered?

Room Room 339

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

Presented by: WuXi AppTec

This session will provide the details of why a global IND submission should be considered and will also highlight the many benefits that will come from it. Also, during this session, we will highlight what all is needed for a Global IND Submission.


Using In Silico Tools to Increase Confidence in Defined Approaches for Skin Sensitization

Room Room 337

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

Presented by: Lhasa Limited

In silico tools are a valuable complement to defined approaches as they can consider chemical reactivity, metabolism, and lipophilicity, often outside the domain of in chemico/in vitro assays. Lhasa Limited will illustrate, using case studies, how confidence in skin sensitization predictions increases when using all three (in silico/in chemico/in vitro).


A Graph is Worth a Thousand Data Points

Room Room 340

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

Presented by: Covance

The reporting of nonclinical studies has evolved from hand-generated tables to electronic PDFs. Concomitantly, data standardization has been demystified through SEND to compile and present nonclinical data differently than the study report. Scientists are realizing the benefit that the SEND format provides to reviewing and analyzing endpoints flexibly.


Recent Advances in ECG analysis for ProArrhythmia Risk Assessment: The need to Read Between the Lines

Room Room 337

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

Presented by: emka TECHNOLOGIES, Inc.

In recent years, FDA has characterized innovative ECG analysis methods for proarrhythmia assessments in clinical trials. ECG is a cornerstone of cardiac safety monitoring in toxicology and safety pharmacology. The session will compare well established ECG analysis methods used in toxicology with novel strategies that may offer lower false positive rates. Critical success factors in the analysis of pre-clinical ECGs will also be discussed.


A Scalable, 3D In Vitro Drug Discovery Platform for NASH and Fibrosis

Room Room 339

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

Presented by: InSphero Inc.

Characterization and applications of 3D microtissue models for screening and efficacy testing of anti-NASH and anti-fibrotic drugs will be discussed. These advanced human disease models contain the relevant primary liver cell types involved in disease initiation and progression, and incorporate key pathophysiological aspects, such as inflammation and scarring. 


Case Studies: Using Primary Cells and Media to Create Physiologically Relevant Models

Room Room 338

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

Presented by: Lonza

Understanding ADMET of new drugs is a key element of drug discovery. In vitro systems such as culturing primary human cells to mimic human in vivo environment are becoming increasingly important for decision making in the drug development pipeline. Lonza offers a large selection of primary human cells and advanced cell culture systems suitable for ADMET research. Toxicity-related applications as supported by various customer studies will be discussed.    


Identify Functional and Structural Cardiotoxicants with the Biomarker-Based Cardio quickPredict Assay

Room Room 337

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

Presented by: Stemina Biomarker Discovery, Inc.

Preclinical cardiac safety evaluations are heavily focused on electrophysiological assessment and often fail to identify structural cardiotoxicants. Stemina’s Cardio quickPredict assay accurately identifies compounds that elicit both structural and/or functional cardiotoxic effects. We will discuss how the assay can be used for early cardiac safety assessment.


Pre-IND Research Opportunities to Accelerate Rare/Orphan Disease Trials

Room Room 340

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

Presented by: Charles River

Approval and clinical efficacy of AAV-based gene therapies, as well as the advent of CRISPR, promise many new therapies that might reverse monogenic disease, and possibly modify many other diseases including cancers, neurodegenerative, cardiovascular, and autoimmune disease. Many of these diseases are inherited or start in utero from naturally occurring mutations, so the key target population for therapy is young infants. How do we accelerate entry into these trials, before significant or irretrievable loss of abilities has occurred?


Using the Göttingen Minipigs - Why, When, How?

Room Room 337

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

Presented by: Ellegaard Göttingen Minipigs A/S and Marshall BioResouces

In this session the reasons for selecting Göttingen Minipigs for preclinical studies will be reviewed. The aim is to provide background knowledge for non-rodent species selection. Several illustrative examples of its use will also be given. The session celebrates the 50 years anniversary of Göttingen Minipigs.



Wednesday


Demystifying Juvenile Toxicology Study Designs for Regulatory Success

Room Room 338

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

Presented by: Envigo

Recognizing that children are not just miniature adults is the first step to understanding juvenile toxicity studies. During this session we will explore a range of key considerations, from age of the target pediatric population to regulatory expectations for CNS and when to include developmental neurotoxicity or reproductive performance evaluations.


Case Studies and Challenges of Risk Assessments using Physical and/or Chemical Information Per ISO 10993 Part 1

Room Room 339

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

Presented by: WuXi AppTec

In this session, we will outline case studies that show challenges for risk assessment due to incomplete and/or limited chemical characterization. Case studies will demonstrate how risk assessment is affected when limited existing chemical characterization is provided, when compounds are not identified, and an example of a risk assessment with a complete chemical characterization.


Molecular Imaging in Preclinical Drug Development

Room Room 340

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

Presented by: Charles River and Université de Sherbrooke

Current in vivo imaging modalities offer unique sensitivity, specificity, and resolution to longitudinally evaluate drug metabolism, efficacy endpoints, physiological, pathological and molecular changes, and off-target effects. Morphological and functional imaging methods are becoming an integral part of drug development as early and translational biomarkers in drug discovery and safety assessment.