Accueil / Communiqués / Sinclair Research and Turner Scientific Announce Exclusive Partnership to Offer GLP Ototoxicity Testing Services

Sinclair Research and Turner Scientific Announce Exclusive Partnership to Offer GLP Ototoxicity Testing Services

Monday, March 11th 2019 at 12:00pm UTC

COLUMBIA, Mo.–(BUSINESS WIRE)– Sinclair
Research
, a leading provider of nonclinical services, and Turner
Scientific, an industry leader specializing in nonclinical hearing
research, have formed an exclusive partnership to offer GLP
auditory testing
to evaluate efficacy and detect and define
potential ototoxicity of compounds and devices progressing toward
IND/IDE approval and clinical trials.

“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.

Contacts

George Kerrick, 573 387-4400
communications@sinclairresearch.com

Source: Sinclair Research


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