CILcare and CBSET – Providing GLP Preclinical Services for Auditory Safety
Clinical data confirms that many therapeutic compounds, including those targeting indications unrelated to hearing and otic disorders, should be tested for auditory safety. Ototoxicity and associated auditory pathology may affect millions of patients taking medications, potentially contributing to diminished quality of life.
Additionally, several promising drugs and devices are currently in development for improving the lives of 360 million people suffering from hearing loss, the majority of which are suffering from conditions for which regulatory agencies recognize no efficacious therapy. To meet these challenges, the auditory specialists at CILcare and the Boston-based GLP-compliant CRO CBSET, Inc. have created a strategic alliance to offer drug and device developers cutting-edge preclinical services for the evaluation of auditory functions in a regulated GLP environment.
How to evaluate auditory safety ?
FDA guidance documents specify auditory safety evaluation utilizing two methodologies* :
In vivo assessment : measure of Auditory Brainstem Responses (ABR)
Auditory Brainstem Responses (ABR)are electric potentials recorded from scalp electrodes. This non-invasive method allows to determine auditory response threshold. It is translational between rodents and human, and is commonly used for screening newborns.
Ex vivo assessment : cytocochleogram
The cytocochleogram allows histopathological assessment of ototoxic damage on inner hair cells and outer hair cells of the cochlea, with anatomical localization corresponding to predicable patterns of functional deficits.
*Source: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.
Guidance for industry and Review Staff – Oct 2015 – FDA
Fortify your IND application
CILcare and CBSET combine scientific excellence in otology with experienced, GLP-compliant, preclinical experience to reduce risk in your regulatory filings. From general toxicology studies to surgical services, our team has the capability to customize a full preclinical program in line with your IND approach and project milestones. The collaboration between CILcare and CBSET creates a highly experienced team offering complex transtympanic and intracochlear drug delivery methods which limit systemic exposure and provide robust, reproducible data in support of your ototoxicity or auditory function program.