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December 7, 2012
What’d You Say? Understanding Nonclinical Auditory Safety Evaluations |
Speakers for this Event: 
Matthew Abernathy, MS, Associate Scientist, MPI Research 
Rachel Tapp, BS, LATG, Study Director, MPI Research |
Auditory safety evaluations are recommended for any drug that is administered into the middle ear or is expected to come in contact with the middle or inner ear tissues. In addition to otically administered compounds, some classes of systemically administered drugs should also be considered for evaluation.
Auditory safety evaluations require executing a specialized set of functions to obtain the appropriate measures to definitively characterize the auditory safety of drugs. Evaluating ototoxicity as part of the overall safety program is an area of unmet need within nonclinical research. In efforts to meet this need, MPI Research has taken steps to develop and validate the procedures required to perform these study types under Good Laboratory Practices.
This presentation will explore requisite study designs and detail the procedures routinely employed in support of scientific and regulatory best practices in assessing auditory safety.
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This conference would be of interest to pharmaceutical, biotechnology, medical device companies who deal in:
- Clinical Safety
- Clinical Research
- Pharmacology
- Toxicology
- Principal Research
- Research Investigation
- Drug Development
- Regulatory Affairs
This webinar would also be of interest to the following individuals:
- Scientists
- Researchers
- Directors
- Laboratory Professionals
- Study Coordinators
- Study Monitors
- Consultants
- Managers
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Matthew Abernathy, MS, Associate Scientist, MPI Research
Matthew Abernathy is a scientist in the Safety Pharmacology and Neurobehavioral Sciences Department at MPI Research. As a scientist, he is responsible for developing predictive models of toxicity and also integrating new methods of data collection to adequately assess drug safety. Before joining MPI Research in 2005, he worked as a surgical research technician at Borgess Research Institute. Mr. Abernathy obtained his Master’s degree in biological sciences from Western Michigan University in 2009.
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Rachel Tapp, BS, LATG, Study Director, MPI Research
Rachel Tapp is a Study Director in the Safety Pharmacology and Neurobehavioral Sciences Department at MPI Research. In this role, she is responsible for ensuring high-level performance of contracted safety pharmacology and neurobehavioral studies for both regulatory and non-regulatory needs of Sponsors. Before joining MPI Research in 2003, she worked as a field research technician at the National Audubon Society and as a laboratory assistant in the Aquatic Toxicology Laboratory at Michigan State University. Ms. Tapp obtained her BS in zoology from Michigan State University in East Lansing, Michigan, and is LATG certified through the American Association of Laboratory Animal Science.
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| OUR XTALKS PARTNER FOR THIS EVENT |
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With global headquarters in Mattawan, Michigan, MPI Research is a preclinical, contract research organization that provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Responsiveness, scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. |
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