“The ear is the only major organ that is not included on FDA’s list of recommended tissues to test for toxicity as part of an IND or NDA regulatory submission,” said Jeremy Turner, PhD, Founder and Chief Scientific Officer of Turner Scientific. “Since approximately one-third of all FDA approved drugs are associated with hearing loss or tinnitus as possible side effects, the potential for ototoxicity is both well-documented and not adequately addressed. Evaluating such potential damage to hearing represents a large unmet need of both patients and drug developers.”
“Through this partnership with Turner Scientific, Sinclair Research now offers sponsors the ability to perform GLP ototoxicity studies and evaluate efficacy of otic drugs in improving hearing and preventing hearing loss, reducing the risks and severity of tinnitus, and improving vestibular dysfunction,” said Guy Bouchard, DVM, President of Sinclair Research. “Additionally, all of our GLP auditory efficacy and ototoxicity study data will be collected in Xybion’s Pristima® Suite™, our preferred nonclinical software platform.”
About Sinclair Research
Sinclair Research Center, a preclinical contract research organization (CRO), offers animal efficacy models, IND-enabling and specialty toxicology services and compliant research capabilities to support biopharmaceutical, animal health and medical device development programs. Sinclair is experienced in all research models and the undisputed experts in miniature swine. With more than 50 years’ experience, Sinclair has emerged as a leader in diabetes, dermal, otic and animal health research services with streamlined quality systems supporting both VICH and GLP compliant studies and SEND reporting with no backlog.
About Turner Scientific
Turner Scientific, a leading preclinical contract research organization specializing in hearing research, provides non-GLP and GLP research services to advance sponsor compounds and devices toward IND/IDE approval and clinical trials. Turner Scientific serves a wide variety of biotechnology companies and pharmaceutical sponsors by evaluating therapeutic efficacy of new compounds, and by assessing the potential for ototoxicity, hearing loss, development of tinnitus, and balance/vestibular disorders. Turner Scientific provides niche expertise, unmatched study design and execution, data analysis, specialty report writing, and sponsor communication by hearing research experts.