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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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.
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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.