In collaboration with our French partner CILcare, we are pleased to present a webinar hosted by the American College of Toxicology. We are also thrilled to announce the participation of the FDA!
Ototoxicity resulting in inner ear damage is a leading cause of acquired hearing loss worldwide. About 1 billion people around the world are at risk of avoidable hearing loss according to the World Health Organization. This could be minimized or avoided by early testing hearing functions in the preclinical phase.
While the assessment of ototoxicity is defined for otic drug products, current guidance for human drug development does not specifically mention the assessment of auditory structure & function. Except for otic formulations, the nonclinical assessment for ototoxicity of drug candidates in general toxicology studies is limited. Unfortunately, this has resulted in more than 200 ototoxic marketed medications.
This webinar, presented by experts in the field, will provide a look into ototoxicity assessment from early-stage screening to GLP studies and will address current guidelines and recommendations to successfully build your dossier. It will help you learn:
- Why it is important to run ototoxicity assessments in the early phase and what models are available models for use in screening, with an emphasis on cochlear explants
- What the animal models are, as well as the sensitive and specific techniques to assess ototoxicity, in GLP and non-GLP preclinical studies that can provide reliable safety data, with a focus on:
- ABR measurements: reproducibility, throughput, data management
- Histology assessment with cochleogram
- What the current regulatory guidelines for non-clinical safety auditory assessment are
Talking Tox Webinars are available to ACT Annual Meeting registrants. If you are not already registered for the Annual Meeting you may:
If you have previously registered you may access the virtual platform here, and search by date in the Agenda for our webinar on January 20th. Additionally, webinars will be available on-demand to registered attendees through February 15, 2022.
About the presenters:
Dr. Christopher D. Toscano is a nonclinical reviewer of the Office of New Drugs Center for Drug Evaluation and Research at the US Food & Drug Administration (FDA). The Office of New Drugs’s public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of New Drug and Investigational New Drug applications (NDA/IND), and to determine if candidate drugs are safe and effective.
Aurore Marie serves as Global Head, R&D Operations Management and Board Member at CILcare. She has a brilliant track-record of preclinical auditory studies management both in French & US facilities. She worked as Principal Investigator on GLP ototoxicity and general toxicity studies over the past three years, giving her a strong knowledge in the hearing field and electrophysiology measurements.
Dr. John Keating is the Director of Pathology at CBSET. He worked for several years in small animal veterinary practice, anatomic pathology training and academia, during which he collaborated and published extensively alongside colleagues in clinical veterinary medicine and basic sciences. He has a broad background in physiology and gross and histologic pathology in a variety of mammalian and non-mammalian, domestic and non-domestic species. At CBSET, he focuses on evaluating tissue responses related to novel biomedical devices and techniques, including inner ear diseases.