Sunday, November 13, 2022

  • Best Practices When Conducting Nonclinical Studies at Various Test Sites

    • 12:00 Noon–12:55 PM
    • Summit 8

    Presented by: ToxPlus Monitoring, LLC

    Best practices for interactions between sponsors, nonclinical study sites, and study monitors will be presented and discussed. The keys to successful interactions that lead to successful study outcomes and the pitfalls that can hamper successful outcomes will be presented. The audience will be invited to share their experiences as well.

  • In Vivo and Histological Analysis of Focal Chorioretinal Defects in Dutch Belted Rabbits

    • 12:00 Noon–12:55 PM
    • Summit 6

    Presented by: Altasciences

    The rabbit is a common nonclincial research species. However, during baseline ophthalmic examinations some ocular findings can be observed that require the exclusion of the animal from study. This presentation provides in vivo and histological characterization of the microarchitecture changes of these findings.

  • Ocular Toxicity Studies: Technical Considerations and Pathology Reporting Expectations

    • 12:00 Noon–12:55 PM
    • Summit 7

    Presented by: StageBio

    Ocular toxicity studies have unique features that require specific technical considerations and pathology reporting expectations. Technical considerations to be discussed include species selection, anatomic differences, and necropsy and histology techniques. Pathology reporting expectations to be discussed include basic report components, interpretation of findings, adversity determination, and ophthalmic examination correlates.

  • Tuesday, November 15, 2022

  • Computational Approaches for Assessing Carcinogenic Potency of Untested Nitrosamines

    • 12:00 Noon–12:55 PM
    • Summit 6

    Presented by: MultiCASE Inc.

    This approach utilizes a local similarity method to objectively calculate the most relevant surrogates for data-poor N-nitrosamines (NAs) in support of expert decision making. Case studies will be used to demonstrate the usefulness of this approach in real risk-assessment context through determining the appropriate TD50 based on surrogate analysis.

  • Strategic In Silico: Creating Powerful New Scientific Insights

    • 12:00 Noon–12:55 PM
    • Summit 7

    Presented by: Instem

    Join industry thought leaders to hear how in silico solutions that assess drug target and chemical safety can be strategically deployed throughout pharmaceutical discovery and development, as well as in regulatory submissions. Learn how they support the optimization of pharmaceutical projects and the assessment of impurities, degradants, leachables, metabolites, and synthetic intermediates.

  • Best Practices for ICH E14/S7B for Nonclinical and Clinical Strategies—A Q&A Panel

    • 12:00 Noon–12:55 PM
    • Summit 8

    Presented by: Charles River

    As CRL is actively involved in the application of the Q&As for drug developers, this session will provide an interactive forum to discuss how the in vitro hERG and in vivo QT assays will be conducted, interpreted and reported.

  • Planning for a Successful IND Submission

    • 12:00 Noon–12:55 PM
    • Summit 9

    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. Come learn more about taking the proper steps to having a successful IND submission.

  • Wednesday, November 16, 2022

  • SEND: An Ever-Evolving Landscape

    • 12:00 Noon–12:55 PM
    • Summit 6

    Presented by: Labcorp Drug Development

    March 15, 2023 is the next effective date for the US FDA’s SEND reporting expectation. New requirements include SEND for developmental and reproductive toxicology embryo-fetal development (DART EFD) studies, SEND for submissions to US FDA CBER, and the define.xml v2.1 upgrade. Technical rejection criteria (TRC) were also recently implemented for existing standards.

  • 3D Liver Spheroids as Industrial Drug Development Tool

    • 12:00 Noon–12:55 PM
    • Summit 7

    Presented by: InSphero Inc

    3D liver spheroids are the smallest functional unit of the liver. It is a pragmatic micro physiological system (MPS) shown to have an increasingly high impact on pharmaceutical discovery and safety evaluations. Applications are disease-modelling, predictive and translational toxicology, and investigation of specific clinical-relevant DILI mechanisms.

  • Translational Advancement: Predicting and Overcoming Hurdles in Drug Discovery with Primary Human Tissue and Cellular Models

    • 12:00 Noon–12:55 PM
    • Summit 8

    Presented by: AnaBios Corporation

    Limitless models exist for drug discovery. This session will provide an overview across cardiovascular, neuronal, hepatic, and respiratory organ systems and use a combination of published literature and case studies to demonstrate the utility of primary human cells and tissue models to predict toxicity and advance the best molecules.

  • Applications of 3D Organoid Cultures in Drug Discovery

    • 12:00 Noon–12:55 PM
    • Summit 9

    Presented by: STEMCELL Technologies Inc.

    Join us for a discussion on applications of organoid cultures in drug discovery. This session will focus on various systems and assays employing human and mouse 3D organoid cultures in vitro. We will also explore how the CRO division of STEMCELL Technologies can help you evaluate potential toxic effects of candidate therapeutics in the intestinal system.

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