Cilcare and CBSET will contribute to a dedicated symposium on otic and vestibular toxicity at the American College of Toxicology (ACT) 2026 Annual Meeting in San Antonio, Texas, bringing together experts from the pharmaceutical, toxicology and regulatory communities, including the U.S. FDA.

Do You Hear What I Hear?

Evaluating Otic and Vestibular Toxicity in Clinical Development

Taking place on November 18, 2026, the symposium will raise awareness of the importance of evaluating ototoxicity during drug development — an area that remains challenging and is not routinely assessed prospectively, despite its potential impact on hearing, balance and quality of life.

Co-chaired by Donald Hodges (CBSET) and Seth Koelher (Regeneron), the symposium will explore the challenges of identifying, characterizing and managing otic and vestibular toxicity across drug development, from preclinical assessment to clinical and regulatory considerations.

The program will explore two complementary case studies: a clinical post-marketing observation of hearing loss associated with a monoclonal antibody (Amgen), and the nonclinical safety evaluation supporting a first-in-human AAV gene therapy for genetic hearing loss (Regeneron).

Discussions will cover the translational relevance of animal, genetic and ex vivo models, functional hearing endpoints, otic histopathology, local drug exposure and the specific challenges of assessing cochlear toxicity.

Representing Cilcare, Bettina M. Cockroft, MD, JD, MBA, Chief Medical Officer, will present “Integrated Preclinical Approaches for Assessing Ototoxicity,” highlighting the value of combining complementary models and endpoints to support robust otic safety assessment.

The symposium will also feature a regulatory perspective from Noah Druckenbrod of the U.S. FDA, followed by a panel discussion bringing together the participating experts.

Advancing awareness of auditory safety

ACT 2026 provides an important opportunity to bring ototoxicity into a broader drug development conversation and foster dialogue between industry, toxicology and regulatory experts on how otic and vestibular safety can be more systematically evaluated.

Cilcare looks forward to contributing to this important discussion alongside its CBSET partner and fellow experts from across the healthcare and regulatory ecosystem.

ACT 2026 | Symposium S14
📍 San Antonio, Texas
📅 November 18, 2026
🕘 9:00 AM–12:00 PM CT