Talking Tox Webinars

Presented by: Altasciences

Determination of adversity in nonclinical toxicity studies is a complex evaluation, exclusively based on professional opinions. NOAEL is commonly used to describe the outcome of a toxicity study and to communicate relevant risk to physicians and regulators. Examples will cover situations where overt toxicity, exaggerated pharmacology, and changes in various markers of toxicity are observed, in the context of other safety endpoints.

Presented by: ATCC

hTERT-immortalized primary cells exhibit the growth characteristics of continuous cell lines with physiological attributes of primary cells. Here, ATCC scientists discuss using hTERT-immortalized respiratory, skin, and kidney models in toxicological assays and present data demonstrating that they provide tissue-relevant results and reproducibility for any cell-based toxicity assay.

Presented by: Charles River

As we gain more experience in the CNS ASO administration field, we are beginning to see unexpected scenarios arising despite using “well-understood” oligonucleotide backbones. Discussions will be centered on study designs, unexpected findings, and regulatory insight to consider when navigating those murky waters, including particular considerations for N=1 programs.

Presented by: Marshall BioResources

Regulations for testing medicines and nutritional substances prior to human use are in a state of constant evolution, presently with a huge focus on pediatric use. There has been increased interest in and acceptance of the use of minipigs as a nonrodent species in toxicology and safety assessment for children.

Presented by: Eurofins Regulatory Science Services

Regulatory agencies, including the US FDA and EU EMA, have developed detailed guidance on how pharmaceutical products should be assessed for possible adverse environmental effects. The Environmental Risk Assessment (ERA) is required as part of the regulatory submission and marketing authorization for human and veterinary drugs. This course covers ERA testing and submission guidelines.

Presented by: Instem

By working with customers from discovery through to regulatory approval, we are uniquely positioned to see the reality and potential for SEND. We will review the common challenges of SEND, give practical advice on overcoming these challenges, and discuss the opportunities arising from the standardization of nonclinical data.

Presented by: Stemcell Technologies Inc.

Join us for a discussion on the applications of immune cells as well as PSC-derived cardiomyocytes in the drug discovery process. This session will focus on the use of various in vitro cell-based assays to evaluate therapy’s effect on highly relevant human cells in vitro. Additionally, we will explore how the Contract Assay Services division of STEMCELL Technologies can help you evaluate the potential toxic effects of your candidate therapeutics, including small molecule compounds and biologics.

Presented by: WuXi AppTec

Learn more about the current trends in conducting and planning for NHP studies. By attending this presentation, you will learn about the differences in NHP strains and origins, current resource limitations, age and sexual maturity requirements, and the possible alternatives. Furthermore, the continued effort in the 3Rs will also be discussed.

Presented by: Cyprotex

The presentation will cover the latest 2D and 3D screening approaches in the field of neurotoxicity with an evaluation of MEA and 3D brain models and how these compare with existing technologies such as neurite outgrowth. Future direction in the use of transcriptomics will also be discussed.

Presented by: Instem

After completing several hundred Target Safety Assessments for our global clients, Instem is uniquely positioned to understand the challenges and opportunities associated with target modulation. We will present how augmented intelligence and advanced data mining technologies are now helping toxicologists make faster drug target decisions, while sharing insights on future trends.

Presented by: MultiCASE

Nitrosamines pose varying degrees of cancer risk in the environment, in food, and as impurities in drugs. However, it is a difficult task to determine potency of untested nitrosamines. Lack of adequate in vivo and in vitro carcinogenicity assay data is certainly a major challenge, but at the same time, carcinogenicity risk of nitrosamines is considered to be related to their mutagenicity, metabolic profile, and physicochemical properties. Therefore, computational approaches are becoming a potential technique to relate structural features with carcinogenic potency.

Presented by: Sinclair Research

Several different miniature swine models are commonly used as a second species in nonclinical research. This presentation will focus on the scientific rationale for miniature swine model selection, special considerations for toxicology and pharmacology study parameters, and comparative data of commonly used miniature swine strains.

Presented by: Instem

This session will outline recent developments in computational toxicology at Instem to support regulatory submissions, classification and labeling, and various R&D activities. This will include a review of recent updates to support the assessment of N-nitrosamine potency classes based on an extensive industry collaboration.

Presented by: Product Safety Labs

An overview of the challenges to performing toxicity assessments for electronic cigarettes from the standpoint of in vivo exposure will be presented, ranging from model selection to atmosphere generation and pathology and molecular biology endpoints used to determine potential product toxicity and inform regulatory decision-making.

Presented by: Toxys

Toxys has developed ToxTracker and ReproTracker, in vitro cell-based assays for chemical safety assessment with a focus on understanding the mode of action (MoA) of toxic compounds. In this session, we will address the latest developments and applications of these novel tools for the fields of genotoxicity and developmental toxicity.

Presented by: Lovelace Biomedical

The use of cell therapies has emerged as a powerful therapeutic approach with the potential to treat and even cure numerous diseases. This webinar will cover development of a successful preclinical safety program to support entry of a cell therapy into the clinic. This process requires a nimble approach where “one size” does not fit all and should be purpose-fit to the specific cell therapy approach.

Presented by: CBSET

Ototoxicity resulting in inner ear damage is a common form of hearing loss. Current guidance for human drug development does not request auditory assessment, which has resulted in more than 200 ototoxic marketed medications. This webinar will provide a look into ototoxicity evaluation from screening to GLP studies with FDA guidelines.