Presented by: Altasciences
As gene therapy treatments become more prevalent, properly prescreening nonhuman primates (NHP) for single nucleotide polymorphisms (SNPs) and anti-adeno-associated virus (AAV) antibodies becomes increasingly important. While SNPs can be rare, incidence rates of AAV-neutralizing antibodies in NHP colonies can be widely varied, based on several factors, and seroconversion can also be a concern. This review evaluates potential prescreening strategies to ensure quality nonclinical studies.
Presented by: Charles River
Enjoy fast and fun poster presentations by students, postdocs, and new investigators who have a chance to win up to $500! The rules of this contest are simple: one PowerPoint slide, and two minutes to deliver a presentation to attendees and a panel of judges. All are invited to attend and support the future stars of toxicology
Presented by: Southern Research
Oncolytic viruses (OVs) represent a new therapeutic strategy for cancer treatment, given their inherent cytotoxicity and tumor cell selectivity. Since the first observation in early clinical studies whereby viral infection coincided with tumor regression, several genetically modified OVs have been developed, the first being US FDA approved for clinical use in 2015. Considerations when evaluating nonclinical safety of OVs are discussed.
Presented by: WuXi AppTec
When submitting data to the US FDA, they prefer an ACVP pathologist. CROs based in China are hiring ACVP pathologists based in the US and using the services of a pathology provider when required. This session highlights the practice of toxicologic pathology as it relates to studies based in China and discusses how this is achieved with quality, efficiency, comparable timelines, and attentive customer service.
Presented by: EPL, Inc.
Light microscopic evaluation of the central nervous system remains a key endpoint in neurotoxicity assessment. This session will present the most recent guidelines for sampling and evaluating the brain and spinal cord in general toxicity studies. We will explore the significance of these subsites to neurologic function and toxicity.
Presented by: MilliporeSigma
In this session, an integrated testing strategy for genotoxic impurities under ICH M7 with known and unknown molecular structures will be discussed. For known structures, in silico analysis can be performed followed by standard or miniatured genetox assays. For impurities with unknown structures, a novel technology, Crystal-Do, can be used.
Presented by: Sinclair Research Center, LLC
The minipig is considered to be the best animal model to understand drug effects in human skin. The Hanford and G.ttingen minipigs have been used for accepted regulatory submissions. Sinclair Research is developing a white Sinclair lineage, which may provide another alternative when choosing a model for dermal research.
Presented by: Instem
The deployment of automated technologies to enhance production/analytical processes does not eliminate the need for skilled human intervention. This session draws upon our experience with the SEND standard and the curation of scientific source materials for regulatory and decision-making purposes—specifically, Target Safety Assessments—to explore opportunities and barriers to leveraging data sources for commercial advantage in drug R&D.
Presented by: SEKISUI XenoTech
In vitro ADME and drug-drug interaction investigations are early activities in the drug development process that are critical for framing downstream decision-making. This session will provide insights at a high level related to regulatory drivers, investigatory objectives, and practical concerns for such studies that are relevant to interested general toxicologists.