Our services

CILcare offers comprehensive R&D services dedicated to ear disorders. Based on our extensive experience and scientific excellence of hearing functions, we provide customized studies to meet our Sponsor’s goals in bringing emerging therapies to the market.

Pharmacokinetics

Pharmacokinetics

Efficacy studies

Efficacystudies

GLP toxicology studies

Consulting

Consulting

Pharmacokinetics

Whatever the route of administration, the drug candidate in hearing loss or tinnitus has to reach its target, the inner ear, at the desired concentration. CILcare’s PK studies allow to assess the bioavailability of the candidate in the inner ear, to determine its kinetic profile, and to estimate the best time-point and concentration for dosing in a following efficacy study.

 

  • Route of administration: local (transtympanic, intrabullar, intracochlear, round window niche) and systemic (PO, IP, IV, SC)
  • Samplings: perilymph, tympanic bulla, CSF, different brain structures, plasma
  • Bioanalysis

Efficacy studies

CILcare provides a broad range of in vivo validated pharmacological models to assess hearing loss, tinnitus, and ear inflammation. With its state-of-the-art facility and using the most advanced instrumentation and technology, CILcare offers you customized studies to best address your requirements.

Models:

  • Age-related hearing loss
  • Noise-induced hearing loss
  • Salicylate-induced tinnitus
  • Noise-induced tinnitus
  • Drug-induced ototoxicity
  • Inflammation & otitis

 

Technological platform:

  • Electrophysiology & Electroacoustic: ABR, DPOAE, CAP
  • Behavioral assessment to detect tinnitus: GPIAS
  • Anxiety & memory tests
  • Imaging MRI
  • Otoscopic evaluation
  • Histology
  • Cytocochleogram
  • Bioanalysis
  • Biochemistry (protein analysis) & molecular biology (RNA analysis)

Magnification image of inner hair cell of a SAMP8 mouse cochlea
(Scanning electron microscopy)

GLP toxicology studies

Services provided in partnership with CBSET

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* :

1/ 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.

2/ 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.

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.

 

Consulting

From discovery to market authorization, CILcare guides life sciences industries and academics in the development of novel therapies and medical devices for ear disorders. Our decades of industrial experience including discovery, regulatory, and clinical development, give us great capabilities to speed up your product’s R&D cycle time.

Benefit from a recognized and passionate research team of experts in otology to:

  • Write clinical protocols
  • Build R&D strategy plans from discovery to market
  • Support in the due diligence process for licencing molecules of interest
  • Work on regulatory submissions (constitution of regulatory dossiers, CE marking for medical devices)