Expert in Biomaterials: Biocompatibility, Pathology, Devices
Expert ID: 722927
North Carolina, USA
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous large animal models of musculoskeletal disease. As faculty member at major university’s comparative medicine research center he used, developed, further characterized, refined, and validated several animal species for animal research. He has participated in the grant review process for the U.S. government, pharmaceutical companies, and the U.S. Army, and has assisted in the Spanish translation of "The Guide for the Care and Use of Laboratory Animals" for the National Academy of Sciences. In addition, he has received grants from the National Institutes of Health, National Centers of Research Resources, and National Institute of Arthritis and Musculoskeletal diseases. As an industry and private consultant he has had the opportunity to be involved in research projects that have required regulatory protocols, standard operating procedures, and Good Laboratory Practices (GLP) for auditing review. These projects have been for several pharmaceutical, biotechnology, and device companies. His role for each has been broad and has depended on need; but has ranged from basic experimental design, animal model selection and number, randomization, drug delivery, pharmacokinetics, implant and device efficacy testing, to regulatory toxicology for FDA approval of drugs or devices. The experiences have also allowed him to understand animal model endpoint evaluation tools that include biostatistical analyses, clinical chemistry and hematology, histopathology, histomorphometric analysis, immunohistochemistry, and molecular pathology. Lastly, his years of experience allows him to conduct surgical, chemical, genetic, and/or transgenic animal experimentation, and he has conducted necropsies (animal autopsies) on almost every single animal species available for research, including mice, rats, pigs, non-human primates, sheep, and cattle. Examples of recent work includes the evaluation of biomedical devices, implants, and cements with or without molecules or cells for cartilage repair, bone conduction, fracture repair, cardiovascular disease and new stent technology, pharmaceutical drug development and testing, nutraceutical toxicity and efficacy, and the prevention and treatment of metastatic breast and uterine cancer.
As a pathologist, Expert has provided consultation for anatomic histopathology and evaluation of clinical and post-mortem data; on-site necropsy support for the evaluation of gross tissue changes; worked with multidisciplinary teams, either in the initial scientific development (discovery) or the pre-clinical evaluation (regulatory safety and/or efficacy); and conducted peer review of pathology data reports provided by other laboratories.He has provided animal model development assistance; study design recommendations and advice for safety, toxicology, and efficacy; GLP and non-GLP animal studies; assisted with the evaluation, review, and preparation of study protocols; and provided sponsors with a written pathology report to be presented to FDA agencies or as part of the application packages.Expert has served as an expert witness or company sponsor at the FDA.
He has served as an expert witness for litigation and civil cases that required pathology and veterinary expetise.
Expert may consult nationally and internationally, and is also local to the following cities:
Charlotte, North Carolina - Raleigh, North Carolina - Greensboro, North Carolina - Durham, North Carolina - Winston Salem, North Carolina - Cary, North Carolina - High Point, North Carolina - Gastonia, North Carolina - Concord, North Carolina - Roanoke, Virginia