Exhibitor-Hosted Session

Monday | Tuesday | Wednesday

Monday

3D Human Liver Spheroids: Moving Towards Meaningful In Vitro Assays

Room Please select available room

Monday, March 15, 3:00 PM to 4:00 PM

Presented by: Corning Life Sciences

Human liver spheroids are a more physiologically relevant tool for drug safety assessment and disease modeling. Corning® HepGo™ Assay-ready 3D Liver Spheroid Kit has been developed to provide researchers with an easy access to this tool. We’d like to facilitate a conversation on using liver spheroids for in vitro assays.

Consideration of Immunology and Immunotoxicology Endpoints in Drug Early Development

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Monday, March 15, 3:00 PM to 4:00 PM

Presented by: Covance

Immune system safety assessment is a critical and complex area in pre-clinical development.  We will provide an overview, from basic concepts and science, to advanced investigative approaches. We will review example data from assays such as Cytokine Release, Receptor Occupancy, and core assays critical to regulatory approval in this space.

Enormous Toxicological Risk Assessments: The New Reality of Chemical Characterization of Medical Devices

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Monday, March 15, 3:00 PM to 4:00 PM

Presented by: WuXi AppTec Medical Device Testing

Based on the recently published requirements and recommendations of ISO 10993-18:2020: Chemical characterization of medical device materials within a risk management process, and regulatory expectations for chemical characterization of devices, have an outcome often of very large numbers of chemicals that need to be assessed in the toxicological risk assessment.

Ferret Models for Vaccine and Antiviral Drug Development

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Monday, March 15, 3:00 PM to 4:00 PM

Presented by: Marshall BioResources

Ferrets remain the primary model for the development of influenza vaccines and antiviral therapies. Ferret studies have also helped model SARS-CoV-2 transmission and pathogenesis, and can support the development of antiviral treatments and vaccines. This session will explore the ferret as a model for vaccine and antiviral drug development.

Hot Topics in Computational Toxicology: New Developments that Support Regulatory Submissions

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Monday, March 15, 3:00 PM to 4:00 PM

Presented by: Leadscope - An Instem Company

This session considers how the latest developments in computational toxicology address critical regulatory and industrial use cases. We will discuss how N-Nitrosamine structure-activity relationships support carcinogenic potency categories, as well as how (Q)SAR models can be used for classification and labeling, the assessment of drug-drug interactions and skin sensitization.

In Vitro ADMET Technologies for the Evaluation of Hepatic and Enteric Drug Metabolism, Drug-Drug Interactions, Toxicity, and Pharmacology

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Monday, March 15, 3:00 PM to 4:00 PM

Presented by: In Vitro ADMET Laboratories Inc.

Novel technologies with applications in drug development will be presented:  999Elite™ single donor and pooled donor human hepatocytes with prolonged culture durations; cryopreserved enterocytes, cryopreserved intestinal mucosa with robust enteric drug metabolizing enzyme activities; permeabilized (MetMax™) hepatocytes and enterocytes with robust metabolic activities applicable as exogenous metabolic activation of protoxicants.   

Phenotypic Quantification of Liver Fibrosis in a Human 3D In Vitro NASH Platform

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Monday, March 22, 9:00 AM to 10:00 AM

Presented by: InSphero Inc

Human 3D in vitro models can be powerful tools for single and combinatorial drug screening. Our robust NASH discovery platform is engineered to recapitulate progression of steatosis, inflammation, and fibrosis in patients. We’ll discuss biopharma applications and present a new quantitative approach for assessing effects of NASH drugs on fibrosis.

Underexposed Topics in Endocrine Disruption Testing: Thyroid Modalities, Nontarget In Vitro Assays and Mode of Action Analysis

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Monday, March 22, 9:00 AM to 10:00 AM

Presented by: Charles River and Syngenta

This session will focus on aspects of endocrine disruption testing that are new or have not received much attention. Developments in in vitro assays for thyroid testing and non-mammalian testing will be highlighted and examined. Use of mode of action studies will illustrate how to determine relevance to human health. 

Tuesday

An Integrated Approach to Cardiac Safety and CiPA

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Tuesday, March 16, 9:00 AM to 10:00 AM

Presented by: ApconiX Ltd

We describe the importance and benefits of an integrated approach to in vitro cardiac safety testing and the CiPA paradigm. We show how the combination of high-throughput and rapid automated ion channel testing, and more complex models of cardiac safety, inform decision making during drug discovery. 

In Vitro Skin Sensitization Testing for Qualitative and Quantitative Potency Assessment Using GARD™

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Tuesday, March 16, 9:00 AM to 10:00 AM

Presented by: SenzaGen

GARD™skin Dose-Response is a novel in vitro test for quantitative potency assessment of chemicals based on genomics and machine-learning technology. The assay provides an estimated threshold concentration for a test substance to induce skin sensitizing effects. The readout can be extrapolated to:

• LLNA EC3 value
• Human potency category
• GHS/CLP classification

More than Monkey Business: Trends for non-human primates (NHPs) use in Drug Development; Origins, Supplies, Alternatives, and 3R's

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Tuesday, March 16, 9:00 AM to 10:00 AM

Presented by: WuXi AppTec

Learn more about the current trends in conducting and planning for NHP studies.  By attending this presentation, you will learn about the differences in NHP strains and origins, current resource limitations age and sexual maturity requirements, and the possible alternatives.  Furthermore, the continued effort in 3R will also be discussed.  

Pathology V 2.0: Digital is Here

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Tuesday, March 16, 9:00 AM to 10:00 AM

Presented by: Charles River

Study and peer review pathologist assessments are critical for study reporting and development decision making. The COVID pandemic has complicated the peer review workflow and accelerated the adoption of digital alternatives. We’ll review the use and qualification of digitized whole slide images as an alternate to traditional glass slide review.  

Today's SEND Challenges: How to Overcome Them and Realize Tomorrow's R&D Opportunities

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Tuesday, March 16, 9:00 AM to 10:00 AM

Presented by: Instem

By working with customers from discovery through to regulatory approval we are uniquely positioned to see the reality and potential for SEND. We will review the common challenges of SEND, give practical advice on overcoming them, and then discuss the opportunities arising from the standardization of nonclinical data.

HTS and Cell-Based Phenotypic Screening to Identify Potential Cardiac and Cardiovascular Liabilities

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Tuesday, March 16, 3:00 PM to 4:00 PM

Presented by: Eurofins Discovery

Compound attrition due to cardiac or cardiovascular safety/toxicity remains a drug development concern. Advances in HTS ion channel electrophysiology and cell-based testing enable comprehensive assessments of proarrhythmic potential and cardiotoxicity. Augmented by human phenotypic approaches, this allows for early/efficient drug discovery screening of candidates to dial out cardiac/cardiovascular liabilities.  

iPSC-CM Maturation: Improving Predictivity in High-throughput 2D & 3D Models

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Tuesday, March 16, 3:00 PM to 4:00 PM

Presented by: Curi Bio

We present scalable bioengineering methods that are implementable in a cell-, instrument-, and assay-agnostic manner to improve maturity and predictivity of iPSC-CM based assays. We will discuss how these strategies are deployed in both 2D and 3D model systems for high-throughput assessment of drug effects on metabolism, electrophysiology, and contractility.

It's all the Genes! Using Transcriptomics Combined With Cellular Imaging to Derisk DILI

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Tuesday, March 16, 3:00 PM to 4:00 PM

Presented by: Cyprotex

The presentation covers cutting-edge research using a combined transcriptomic and cellular imaging approach to improve DILI prediction and provide better mechanistic understanding of toxicological pathways. With over 1000 compounds assessed in 2D and 3D cellular models a DILI database was created that can be mined with data from developmental drugs.

Leveraging the Power of High Content Screening with StratoMineR for the Development of RAPIDtox, an Ethnically-Diverse, Predictive Liver Toxicity Platform

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Tuesday, March 23, 9:00 AM to 10:00 AM

Presented by: Core Life Analytics

Cytochroma’s rapid phenotypic screening and intelligent prediction of toxicity, coupled with automated animal-free production, facilitates the identification of safer, novel compounds faster and more efficiently. StratoMineR, a web-based high content data analytics platform, enabled Cytochroma to accelerate the development and validation of RAPIDtox, its ethnically-diverse iPSC-derived liver toxicity screening platform.

SEND: The Benefits Behind the Scenes

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Tuesday, March 23, 9:00 AM to 10:00 AM

Presented by: Evotec, Inc.

SEND, an implementation of the CDISC Study Data Tabulation Model, provides a framework for the standardized, electronic representation of individual animal study data. SEND poses several other advantages that go beyond regulatory requirements. This session will take you through real experiences of these benefits for toxicology and safety pharmacology studies.

Strategies to Evaluate the Risk of UGT-Mediated Drug-Drug Interactions

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Tuesday, March 23, 9:00 AM to 10:00 AM

Presented by: Charles River

This session will discuss assays and strategies to employ UDP-glucuronosyltransferase (UGT) assays for characterization, induction, and inhibition studies.  We will present our improved strategy comparing the potential induction of cytochrome P450 (CYP) and UGT between different species using enzyme activity and mRNA analysis as endpoints.

Novel Chemoinformatics Platform ChemTunes·ToxGPS® and Its Public Version COSMOS Next Generation

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Tuesday, March 23, 4:00 PM to 5:00 PM

Presented by: Molecular Networks Altamira, MN-AM

MN-AM presents an innovative chemoinformatics approach to estimate NOAEL confidence bounds for a target based on experimental NOAEL of compounds selected based on mode-of-action categories and analog quality (structure- and property-based similarity). The new COSMOS Next Generation public data and knowledgebase system will also be presented in this session.

Wednesday

A Highly Quantitative In Vitro Method for Mechanistic Genotoxicity Screening

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: Miltenyi Biotec

Information about the mode-of-action of genotoxic compounds can be vital for both screening and regulatory applications. Learn how the right early stage, mechanism based in vitro assays can not only speed up the compound development pipeline, but also reduce animal testing requirements, saving time, money, and effort.

New Drug Safety Initiative: The X-Species DILI Validation Consortium

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: InSphero Inc

Using animal models to predict human DILI has known issues and high failure rates. This consortium brings together representatives from biopharma to compare drug effects in regulatory animal models and human 3D in vitro liver models, and recapitulate in vivo findings in animals by specific DILI mechanisms to improve translation.

Novel Gottingen Minipig Model of Heart Failure with Preserved Ejection Fraction (HFpEF)

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: Marshall BioResources and Ellegaard Gottingen Minipigs

A lack of large-animal models of heart failure with preserved ejection fraction (HFpEF) recapitulating this comorbid-laden syndrome led to the inability to tease out mechanistic insights and test novel therapeutic strategies. This presentation will describe the development of a Gottingen minipig model integrating multiple comorbid determinants of HFpEF. 

Preclinical Testing: Advice for the Smaller Drug Developer

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: WuXi AppTec

Whether you are a smaller drug development company or a big global pharmaceutical organization, the preclinical development process presents many logistical challenges. Drug developers of all sizes have the potential to make breakthroughs, so don’t let the shift from discovery research to regulated safety assessment slow down the progress.

Revolutionizing Target Safety Assessment: Technology Advancements and COVID-19 Target Case Study

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: Instem

In a pandemic-dominated year, coronavirus-related scientific publications escalated. Instem engaged big-data analytics to stay ahead of the data surge. Biological target safety remains immensely important to the pharmaceutical industry. Here, we demonstrate our R&D advancements, including innovative infographics and dynamic data visualizations, using the ACE2 receptor as an example target.

Targeted Delivery Considerations for Administrations of Gene Therapies to the Central Nervous System

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Wednesday, March 17, 9:00 AM to 10:00 AM

Presented by: Charles River

Gene therapies involving targeted delivery routes of administration require many considerations for successful preclinical development.  This session will review the complexities of targeted administration including MRI-guided delivery.  The session will also review the regulatory perspectives supporting study designs and the specialized study logistics, techniques and endpoints unique to these programs.   

3D Organoids for Disease Modeling and In Vitro Toxicity Assessment by High-Content Imaging

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Wednesday, March 17, 3:00 PM to 4:00 PM

Presented by: Molecular Devices

Organoid models increasingly gained popularity in biologic research and toxicity evaluation allowing to recapitulate complexity of real tissues. To model in vivo human lungs, we‘ve cultured primary human lung epithelial cells in matrigel, with growth factors that promote formation of 3D structures recapitulating morphological and functional characteristics of the airway.

Assessment of Chemical Effects on Developmental Neurotoxicity Using High-Content Screening

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Wednesday, March 17, 3:00 PM to 4:00 PM

Presented by: Thermo Fisher Scientific

Neurite outgrowth, one of the cellular processes that defines the nervous system, is also an indicator of neuronal health.  The large volumes of compounds that require neurotoxicology evaluation is a bottleneck for safety assessment.  This session will explore leveraging High-Content Screening technology as a scalable method for characterizing cellular neurotoxicology. 

How to be More Predictive: Microphysiological Systems for Humanized Drug Assessment

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Wednesday, March 17, 3:00 PM to 4:00 PM

Presented by: CN Bio Innovations

Predicting drug toxicity remains a challenge due to limitations of standard pre-clinical models. Microphysiological Systems (MPS) can improve translatability of in vitro results by creating human-relevant, 3D cell culture models. We’ll discuss a pharma perspective on toxicological applications for single and multi-organ MPS, routes to wider adoption and regulatory acceptance. 

Serum Biomarkers for Predicting COVID-19 Disease Severity

Room Please select available room

Wednesday, March 17, 3:00 PM to 4:00 PM

Presented by: Alfa Wassermann Diagnostic Technologies

A review of published data and clinical guidance on the use of serum biomarkers for early identification of COVID-19 severity.  These biomarkers are valuable in prioritizing hospital admission and resources, in addition to evaluating potential surrogate markers for vaccine and therapeutic research studies.

Reducing Fish Numbers in BCF and BMF Studies by Applying The One Dose Approach

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Wednesday, March 24, 9:00 AM to 10:00 AM

Presented by: Covance, Inc.

Fish bioconcentration/biomagnification studies determine whether substances have potential to bioaccumulate and bio-magnify throughout different trophic levels. Increasing requirements result in the use of significant numbers of fish. However, there is now the option to test on one concentration and control only to decrease the numbers by one third.