Presented by: Certara
This session will cover the value, process, and systems associated with gaining access to data from live nonclinical studies for real-time data analysis and visualization. Scientific benefits and logistics of working with CROs to set up data pipelines and software for advanced analytics and data visualizations for monitoring ongoing studies will be discussed.
Presented by: Altasciences
Limitations when using juvenile monkeys in research include identifying the relevant human equivalent age, lower blood volumes, difficulty with blood sampling, intravenous catheter placement, and use of sedatives—anesthetic medications require more monitoring. Data across age groups has been used to show that using older animals is a feasible option.
Presented by: Inotiv
Lipid nanoparticles are widely used as carriers to deliver multiple types of therapeutics. Many formulations for parenteral delivery contain cationic components with proprietary information that require additional safety evaluation, including genotoxicity. Inotiv has extensive experience with the modified genetox safety assessment requirements for this type of drug delivery product.
Presented by: Lovelace Biomedical Research Institute
How should you consider intranasal drug delivery in your nonclinical study? This event will review different methods to be considered in a range of different nonclinical species.
Presented by: ATCC
Toxicologists are challenged by the lack of cell models that are physiologically relevant, reliable, and consistent between experiments. Here, we will discuss ATCC’s immortalized primary cells, which exhibit the growth and reproducibility of continuous cells, and the in vivo biologies of primary cells.
Presented by: Marshall BioResources
This two-part session reviews basic and advanced biomarkers used in toxicology studies with Göttingen Minipigs® and a range of biological matrices and discusses adeno-associated virus seroprevalence results from testing serum samples from Göttingen Minipigs® for neutralization antibodies (NAb) and total antibodies (TAb) against AAV1, 2, 6, and 9 serotypes.
Presented by: Labcorp
Radiopharmaceutical development is changing the face of the oncology therapeutic arsenal. This session will review the recent history of regulatory requirements, core elements of study design, including technical considerations required to manage the radioisotopes being deployed, and investment and merger news, and provide insight into practical experiences managing these programs.
Presented by: Simulations Plus, Inc.
Learn how advances in modeling and simulation tools can enable structure-based safety assessment, and increase throughput, and power use of QST earlier in small molecule development. Attendees will see examples of the ADMET Predictor® to DILIsym® machine learning workflow and hear about high-impact safety applications that saved sponsors time and money.
Presented by: Xybion Digital
ML algorithms can predict how drugs will behave in the human body, including their (ADME) properties, as well as potential toxicity. At the other end of the spectrum, large language model supported Generative AI systems can enable intelligent querying of study databases thereby helping in treatment prediction for specific endpoints.
Presented by: BioAgilytix
Bioanalysis for investigational therapeutics, including pharmacokinetics, immunogenicity, and biomarkers, is a critical part of drug development. Preclinical assay design can significantly impact the timeline and cost of later phases. Here, we provide strategies to proactively address the preclinical to clinical transition including critical reagent generation, matrix changes, and phase-appropriate regulatory standards.
Presented by: Scantox Group
Improving blood sample collection techniques will reduce stress response in minipigs, leading to improved data quality and increased animal welfare. Recent advances and implemented methods will be showcased and discussed.
Presented by: Virscio
Virscio will present application of the African green monkey (AGM) to preclinical safety and efficacy evaluation in IND-enabling studies conducted at Virscio’s St. Kitts facility, highlighting scientific, animal welfare, regulatory, and clinical value associated with the use of this Old World NHP species relative to other test systems.
Presented by: STEMCELL Technologies Inc
Predictive, human, and patient-representative in vitro models are needed to reliably predict toxicity liabilities and address associated risks. In this session, we will demonstrate the application and value of using intestinal and hepatic organoid and organoid-derived systems in toxicity assays.
Presented by: Lhasa Limited
Join us to evaluate the toxicological risks posed by two major impurity categories: nitrosamines and extractables and leachables. Discover how the Lhasa carcinogenic potency categorization approach (CPCA) functionality can support your impurity assessment, and how to determine compound-relevant limits for these impurity types using a transparent in silico read-across workflow.
Presented by: Charles River
Lessons learned and best practices for gene therapy development will be discussed. Key areas that will be addressed include animal serology and screening, supporting laboratory assays for dose formulation and biodistribution, dosing strategies, in vivo study design, immunosuppression, germline transmission studies in juvenile animals, histopathology, and molecular pathology.
Presented by: WuXi AppTec
Discover how partnering with a multi-site laboratory can optimize your study outcomes. We’ll explore the benefits, including enhanced data diversity, faster timelines, and better resource allocation, all designed to drive your research to success. Learn how multi-site capabilities can give your projects a strategic edge.
Presented by: InSphero Inc
Presentation of the 3D InSight™ Liver microtissue platform, a versatile, scalable, and industry-compatible in vitro system, and of its uses for predictive, investigative, and translational hepatotoxicity assessment applications.
Presented by: Ellegaard Göttingen Minipigs A/S
Göttingen Minipigs carrying a mini-repertoire of human genes for the immunoglobulin heavy chains γ1 and γ4 and the immunoglobulin light chain κ have shown tolerance to IgG1κ-isotype monoclonal antibodies and can bridge the gap between animals and humans in safety testing of therapeutical antibodies as an alternative to nonhuman primates.
Presented by: Toxys
We will present case studies of different NAMs for genotoxicity, developmental- and mechanistic toxicity, and how they have been used in (regulatory) settings. These assays are applied for compound screening, follow-up testing, and potency ranking, and are used in weight-of-evidence and adverse outcome pathway approaches.
Presented by: Sinclair Bio Resources
This session will review circumstances when the Sinclair Nanopig is a suitable model for toxicology testing. The presentation will demonstrate when the Nanopig can be considered a superior model to NHP and canine, and when it is a relevant alternative model to mitigate NHP and canine supply challenges.
Presented by: Instem
The ICH S1B (R1) WoE Addendum explains how the two-year rat carcinogenicity test can be negated, if it does not add value, in lieu of a comprehensive WoE dossier. Using a structured, standardized, and machine-readable SEND package, data can be interrogated to provide evidence for specific S1B guideline factors.
Presented by: AmplifyBio
As more cell and gene therapies advance in development, toxicology assessment of these therapies is evolving to encompass new testing strategies and embrace new endpoints to assess potential physiological changes. We will discuss integrating new testing strategies and endpoints, including immune responses and imaging, with traditional study designs and assessments.
Presented by: MultiCASE, Inc.
This session covers risk assessment within the QSAR Flex N-nitrosamine evaluation suite. Topics include nitrosamine formation potential of APIs and synthesis routes, the latest updates to the carcinogenic potency categorization approach (CPCA) framework, and advanced surrogate and NDSRI search analysis for application of expert review.
