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CDER Public Workshop: Regulatory Perspectives on Otic & Vestibular Toxicity...

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FDA White Oak Campus

10903 New Hampshire Ave.

Building 31 - Great Room A

Silver Spring, MD 20903

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About the Workshop

The Food and Drug Administration is announcing the following public workshop entitled "Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.

The purpose of the public meeting/public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential end-points that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This session will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular end-points.

The public workshop will be held on August 21, 2018 from 9:00 AM until 12:00 PM.

Workshop Location

The public workshop will be held in the White Oak Great Room at the FDA Headquarters, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to

https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

Additional Details

This meeting will be accessible both in-person and through webcast.

Webcast Link

The link to the webcast is available at https://collaboration.fda.gov/ovtw/.

Meeting Agenda

This session will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular end-points.

9:00 - 9:05 | Introduction by Meeting Chairs

Dr. Deepa Rao, BVSc, MS, PhD, DABT, DACVP

Division of Psychiatry Products, Center for Drug Evaluation and Research, FDA

Dr. Christopher D. Toscano, PhD, DABT

Division of Neurologic Products, Center for Drug Evaluation and Research, FDA

9:05 - 9:25 | Otic and Vestibular Toxicity in Drug and Device Development: A Clinical Regulatory Perspective

Dr. Heather Fitter, MD

Division of Neurology Products, Center for Drug Evaluation and Research, FDA

Dr. Srinivas “Nandu” Nandkumar, PhD

Ear, Nose, and Throat Devices Branch, Center for Devices and Radiological Health, FDA

9:25 – 9:45 | Otic and Vestibular Toxicity in Drug and Device Development: A Nonclinical Regulatory Perspective

Dr. Christopher D. Toscano, PhD, DABT

Division of Neurologic Products, Center for Drug Evaluation and Research, FDA

9:45 – 10:05 | End-points in Human Clinical Trials: Clinical Evaluation of Vestibular and Auditory Function

Dr. Daniel Gold, D.O.

The John Hopkins University School of Medicine

10:05 – 10:35 | Break


10:35 – 10:55 | End-points in Animal Toxicology Studies: Part 1, Neurological Evaluation of Vestibular and Auditory Function

Dr. Jessica Barker, DVM, MS, ACVIM (Neurology)

Bush Veterinary Neurology Service

10:55 – 11:15 | End-points in Animal Toxicology Studies: Part 2, Otic and Vestibular Histopathology

Dr. Kenneth Schafer, DVM, PhD, DACVP

VetPath Services, Inc.

11:15 – 11:35 | End-points in Animal Toxicology Studies: Part 3, Otic and Vestibular Electrophysiological Measurements

Dr. Tracy Fitzgerald, PhD, CCC-A

National Institute on Deafness and Other Communication Disorders

11:35 – 11:40 | Bringing it all Together

Dr. Deepa Rao, BVSc, MS, PhD, DABT, DACVP

Division of Psychiatry Products, Center for Drug Evaluation and Research, FDA


11:40 – 12:00 | Panel Discussion with Audience

Moderated by Drs. Chris Toscano and Deepa Rao

Panelists: All speakers

Dr. Amy Ellis, PhD

Division of Anti-Infective Products, Center for Drug Evaluation and Research, FDA

Dr. Lea Cranford, DVM

Office of New Animal Drug Evaluation, Center for Veterinary Medicine, FDA

Dr. Anjum Khan, MD

Ear, Nose, and Throat Devices Branch, Center for Devices and Radiological Health, FDA

Dr. Ting Zhang, PhD

Ear, Nose, and Throat Devices Branch, Center for Devices and Radiological Health, FDA

Short Biographies of Speakers

Dr. Deepa B. Rao currently serves as a senior nonclinical reviewer within the Division of Psychiatry Products, Center of Drug Evaluation and Research, FDA. Dr. Rao received her veterinary medical degree in 1992, an MS in 1995, and a PhD in Pharmaceutical Sciences in 2000. Her doctoral dissertation work was conducted in an auditory toxicology laboratory at the University of Oklahoma – Health Sciences Center, and focused on the effects of combined exposures to noise and chemicals in animal models. Data from these studies were subsequently identified as key papers to develop risk assessments for mixed exposures involving noise in human occupational settings. Dr. Rao is certified by the American Board of Toxicology (2005) and the American College of Veterinary Pathologists (2011). Her work experience in the areas of drug and chemical toxicity evaluation include several publications, invited reviews, book chapters, and invited speaker presentations in auditory toxicology and neuropathology. Dr. Rao remains an active serving member to the Society of Toxicologic Pathology and the American College of Toxicology.

Dr. Christopher D. Toscano received a B.S. in Biology (1995) from Manhattan College in The Bronx, NY, an M.S. in Toxicology (1999) from St. John’s University in Queens, NY, and a Ph.D. in Toxicology (2004) from the Department of Environmental Health Sciences in the Bloomberg School of Public Health at The Johns Hopkins University in Baltimore, MD. His Masters and Ph.D. theses focused on the molecular mechanisms of the neurotoxicity of lead. As a Postdoctoral Fellow in the Brain Physiology and Metabolism Section of the National Institute on Aging at the National Institutes of Health (2004-2008), Dr. Toscano assessed the involvement of cyclooxygenase in models of central nervous system neurotoxicity. Dr. Toscano became a Diplomate of the American Board of Toxicology just prior to joining the Division of Neurology Products in the Office of New Drugs at the Center for Drug Evaluation and Research in 2008. As a Pharmacologist in the Division of Neurology Products, he is currently involved in the review of nonclinical studies performed to support the development of therapeutics to treat neurological diseases.

Dr. Heather Fitter obtained her medical degree at George Washington University School of Medicine. She then completed her Neurology Residency and Stroke Fellowship at Georgetown University Hospital. Dr. Fitter practiced General Neurology at Kaiser Permanente and worked in the Stroke unit at Holy Cross Hospital for several years before coming to the FDA. She has been at the FDA for 10 years, initially as a Clinical Reviewer for the Division of Neurology Products, and for the past 3 years, as a Clinical Team Leader. Her areas of interest include Hearing Disorders, Migraine, Stroke, Traumatic Brain Disorder and Multiple Sclerosis.

Dr. Srinivas “Nandu” Nandkumar is the Branch Chief for the Ear, Nose and Throat Devices (ENT) Branch in the Division of Ophthalmic and Ear, Nose and Throat Devices within the Center for Devices and Radiological Health at the FDA. Dr. Nandkumar received his PhD in electrical engineering specializing in digital speech processing from Duke University, and then worked in the speech technology area in the telecommunications industry. At the FDA, he has worked as an engineering reviewer in the ENT Branch with a focus on implantable hearing devices before his current position as Branch Chief.

Dr. Daniel R. Gold is an Assistant Professor of Neurology, Ophthalmology, Otolaryngology - Head & Neck Surgery, Neurosurgery, and Emergency Medicine at The Johns Hopkins University School of Medicine. Dr. Gold is a neurologist with fellowship training in neuro-ophthalmology at the University of Pennsylvania and additional training in neuro-vestibular disorders at Johns Hopkins where he serves as the director of the Ocular Motor & Vestibular Oto-Neurology Fellowship within the Division of Neuro-Visual and Vestibular Disorders. Dr. Gold maintains an active clinical practice, seeing patients with vestibular and neuro-ophthalmic conditions. He is also heavily involved in the education of residents and fellows, giving frequent lectures on topics related to his subspecialty expertise in addition to leading neuro-ophthalmology/ocular motor bedside teaching rounds. Dr. Gold has received awards for resident teaching and clinical excellence (both within the Johns Hopkins neurology department), a merit award for outstanding educational contributions to the Neuro-Ophthalmology Virtual Education Library (through the North American Neuro-Ophthalmology Society – via an ocular motor/vestibular collection https://novel.utah.edu/Gold/), and, for the Best Consulting Physician at Johns Hopkins Hospital in 2018.

Dr. Jessica Barker received her undergraduate degree from Oberlin College, and then her Master of Science and Doctor of Veterinary Medicine concurrently at the University of Wisconsin in Madison. After completing her DVM and MS in 2008, Dr. Barker completed a one-year Rotating Internship in Small Animal Medicine and Surgery at the University of Illinois at Urbana-Champaign, and went on to complete the Neurology & Neurosurgery Residency program at the Cummings School of Veterinary Medicine at Tufts University. She is currently a staff neurologist and member of the medical committee at Bush Veterinary Neurology Service, primarily practicing in Springfield, VA.

Dr. Kenneth Schafer received his D.V.M. in 1991 and his Ph.D. in Veterinary Pathobiology in 1998, both from Purdue University. The thesis work for his PhD was performed at Lovelace Respiratory Research Institute in Albuquerque, NM. Dr. Schafer has been engaged in toxicologic pathology for about 20 years at Wyeth Research, Lilly Research Laboratories, and Vet Path Services. He is the past Secretary/Treasurer and past President of the Society of Toxicologic Pathology (STP), and served as chair of the STP’s Scientific and Regulatory Policy Committee. Dr. Schafer has an interest in ocular and otic pathology and has co-authored 4 book chapters on these topics with three more chapters currently in press. He has been a member of the American College of Veterinary Pathologists since 1996. At Vet Path Services, Dr. Schafer provides GLP-compliant contract histopathology and consulting services to pharmaceutical, animal health, medical device, and chemical companies worldwide.

Dr. Tracy Fitzgerald has been the Director of the Mouse Auditory Testing Core at the National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) for the past seven years. Dr. Fitzgerald received an M.S. and Ph.D. in Audiology from Syracuse University. She completed her Clinical Fellowship Year in Audiology at the Medical University of South Carolina and her post-doc in the lab of Dr. Carolina Abdala at the Children’s Auditory Research and Evaluation (CARE) Center, part of the former House Ear Institute in Los Angeles, CA. Dr. Fitzgerald was an Assistant Professor in the Department of Hearing and Speech Sciences at the University of Maryland-College Park prior to joining the NIH in 2011.


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FDA White Oak Campus

10903 New Hampshire Ave.

Building 31 - Great Room A

Silver Spring, MD 20903

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