Presented by: Evotec
This session will let you dive into the realm of preclinical formulation and toxicology studies, where you will explore the intricate interplay between formulation, systemic exposure, and toxicology, and uncover the vital insights they provide for drug development. Enabling formulations are designed based on physiochemical properties, taking safety and tolerability of excipients into consideration.
Presented by: Altasciences
Minipigs have been used for decades to support pharmaceuticals and medical device development. The development of the next-generation Sinclair Nanopig™ may assist in mitigating supply constraints of other nonrodent species, and allow for routine consideration of the minipig as a nonrodent species for nonclinical (bio)pharmaceuticals development.
Presented by: Ellegaard
Göttingen Minipigs are a valuable alternative to non-human primates in many areas of biomedical research including proof of concept studies and in the safety testing of drugs. Göttingen Minipigs humanized with IgG can further bridge the gap between animals and humans in the safety testing of therapeutical antibodies.
Presented by: InSphero
Hepatic spheroids as micro-physiological system recapitulate important features of an in vivo liver. The physiological relevance of this model makes it a valuable in vitro tool for pharmaceutical discovery and safety evaluation. In addition, their scalability, cost-efficiency and standardized production makes hepatic spheroids a reliable and industry-compatible liver model.
Presented by: Inotiv
Molecular pathology can help us better understand the mechanisms of toxicity, identify target cell populations, and define mechanisms of action in toxicity studies. This session will highlight how molecular pathology can assist toxicologists in investigative studies, and demonstrate how the pathologist can be leveraged in study design and the interpretation of these techniques.
Presented by: Cyprotex
Using multiple assay platforms and transcriptomics, Cyprotex has developed a comprehensive group of assays for predicting organ specific toxicity and has supplemented these with Evotecs industry leading PanHunter software for the analysis of pathway activation and machine learning for prediction.
Presented by: Charles River
Integrated toxicology elevates the standard approach to lead optimization studies, combining technology around automation and robust data collection with CRL’s scientific expertise. This powerful combination shapes a webbed infrastructure to support sharing of data. Our predictive science modeling provides information to improve decision making, shorten delivery times, and reduce use of animals.
Presented by: Lovelace Biomedical
Setting up successful cell and gene therapy toxicology programs typically requires multiple different bioanalytical assays. Understanding which assay is the most appropriate, what level of regulatory compliance is required, and how the assays are fit for purpose is critical to a successful toxicology program. This session will evaluate a wide range of assays from biomarkers to PK/TK to ADA and their appropriate application within toxicology programs.
Presented by: Altis Biosystems
Dr. Bill Thelin, CSO, will share characterization and qualification of our newly released RepliGut StemTox Assay. The StemTox Assay utilizes primary human intestinal stem cells in a complex culture system paradigm that accurately predicts effects of drugs on stem cell proliferation and epithelial barrier disruption commonly associated with clinical diarrhea.
Presented by: AmplifyBio
Dose administration in a preclinical laboratory has unique challenges related to species and route. The nature of the compound to be administered can provide additional challenges. The experienced staff at AmplifyBio have accepted these challenges and values the triumphs achieved. Our session will outline some of our case studies.
Presented by: Instem
We will present the latest intelligence surrounding translational safety assessment, including an illustration of the recently revised ICH S1B guideline. A demonstration of how clinical and preclinical data, together with evidence from literature and database searches, can be collated and reviewed in a defined workflow, then extrapolated to gain scientific insight.
Presented by: Labcorp
Neurological disorders are immensely challenging to treat due to the blood-brain barrier. Adeno-associated virus (AAV) gene therapy can potentially treat diverse monogenic neurological disorders. A direct, stereotaxic dosing of AAV gene therapy can safely and effectively deliver DNA payload into defined structures in the brain.
Presented by: Toxys
DART is one of the large systemic toxicity areas not yet covered by accepted in vitro methods, remaining one of the most animal intensive areas of regulatory toxicology. This session aims to foster animal-free methods and provide context for the results of alternative assays to facilitate further regulatory decision making.
Presented by: WuXi AppTec
This seminar will cover development of gene therapy products using adeno-associated virus-based studies. We will also focus on considerations for the conduct of these studies, pulling on experience gained in the conduct of these studies. We will look at the study designs, in-life conduct, and clinical and anatomic pathology endpoints.
Presented by: VJO Canada
Translation of inhalation toxicology study results to human clinical trials comes with important differences in how human dose calculations are viewed by the FDA. Safe starting doses are typically straightforward; determination of the maximum allowable inhalation doses for human trials differs from the approach used for drugs delivered systemically.
Presented by: Sinclair BioResources
Pigs can be a pharmacologically relevant species for drug development more often than realized. Pigs have similarities in metabolic profile and target reactivity for many drug classes administered via a variety of methods, including some large molecules. This session will present new data and provide justification for considering pig models.
