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.
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.
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.
Presented by: Sinclair Bio Resources, LLC
The Sinclair miniature swine (SMS) was downsized through selective breeding using genetic markers over the last 10 years and a revised feeding regimen. The data resulting from this successful endeavor will be reviewed. The downsized SMS is an attractive alternative to canine as a non-rodent species in drug safety assessment.
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.
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.
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.
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.
Presented by: Labcorp
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.
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.
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.
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.
