Expert Details

Expert in Biomaterials: Biocompatibility, Pathology, Devices

Expert ID: 722927 North Carolina, USA

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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

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Education

Year Degree Subject Institution
Year: 1983 Degree: DVM Subject: Veterinary Medicine Institution: Kansas State University
Year: 1986 Degree: PhD Subject: Pathology (Veterinary) Institution: Kansas State University
Year: 1992 Degree: Board Certified Subject: Veterinary Pathology Institution: American College of Veterinary Pathology

Work History

Years Employer Title Department Responsibilities
Years: 2004 to Present Employer: Undisclosed Title: Owner Department: Responsibilities: As owner of JayoPath, Expert provides consultation to pharmaceutical, biomaterial, academic, and goverment agencies.
Years: 1998 to 2004 Employer: Charles River Laboratories Title: Senior Pathologist Department: Ohio Division Responsibilities: He was Director of a North Carolina Pathology Division that was connected with the Ohio Division. He provided pathology services for clients seeking toxicologic, efficacy, and safety evaluations.
Years: 1986 to 1998 Employer: Wake Forest University School of Medicine Title: Associate Professor Department: Comparative Medicine/Pathology Responsibilities: Expert was Director of post-doctoral training, NIH RO-1 Grant Principal Investigator, and pharmaceutical company Grant Investigator.

Government Experience

Years Agency Role Description
Years: 2005 to 2005 Agency: NCRR-NIH Role: Reviewer and Member Description: Expert was a member of the NCRR-NIH Study Group, Comparative Medicine Review Committee, SEPA (Science Education Partnership Award), July 2005
Years: 2004 to 2004 Agency: NIAMS-NIH Role: Reviewer and Member Description: He was a member of the NIAMS-NIH Special Study Group, October, 2004.
Years: 2004 to 2004 Agency: NCRR-NIH Role: Reviewer and Member Description: Expert was a member of the NCRR-NIH Study Group, Comparative Medicine Review Committee, SEPA (Science Education Partnership Award), June 2004.
Years: 1998 to 2000 Agency: NCRR-NIH Role: Reviewer and Member Description: He was a Permanent Member of the National Center for Research Resources (NCRR) – National Institutes of Health (NIH), Study Group, Comparative Medicine Review Committee, 1998-2000.

International Experience

Years Country / Region Summary
Years: 1995 to 1995 Country / Region: Bogor, Indonesia Summary: Expert was a visiting professor providing pathology training and continuing education courses at the Institut Pertanian Bogor.
Years: 1998 to 1998 Country / Region: Bogor, Indonesia Summary: He was a visiting professor providing pathology training and continuing education courses at the Institut Pertanian Bogor.
Years: 1997 to 1997 Country / Region: Milan, Italy Summary: Expert visited the Pharmacia facility to provide guidance and consultation in bone and cartilage ongoing studies.
Years: 1997 to 1997 Country / Region: Zurich, Switzerland Summary: He was a visiting professor providing pathology training and continuing education courses at the University of Zurich Veterinary School.

Career Accomplishments

Associations / Societies
Expert’s professional memberships are with: Society of Toxicologic Pathology (2001 to present); Orthopaedic Research Society (2001 to present); American College of Veterinary Pathologists (1992 to present); Colegio Médicos Veterinarios de Puerto Rico (1983 to present); Kansas Veterinary Medical Association (1983 to present).
Licenses / Certifications
He is a Diplomate of the American College of Veterinary Pathology (1992); is licensed in Veterinary Medicine, State of Kansas (1983) and is licensed in Veterinary Medicine, Commonwealth of Puerto Rico (1983).
Professional Appointments
Expert is President of the non-profit Student Emergency Relief Association, Inc. (2004 to present); and Advisory Board Member, Bennett Partners, LLC (2003 to present).
Awards / Recognition
He is a member of the NCRR-NIH Study Group, Comparative Medicine Review Committee, SEPA (Science Education Partnership Award), July 2005; member of the NIAMS-NIH Special Study Group, October, 2004; member of the NCRR-NIH Study Group, Comparative Medicine Review Committee, SEPA (Science Education Partnership Award), June 2004; and editorial board member, The Infectious Disease Review Journal, 1999-2001.
Medical / Professional
Expert was an NIH Fellow, Department of Comparative Medicine, Bowman Gray School of Medicine of Wake Forest University, Winston-Salem, North Carolina, 1986-1987.
Publications and Patents Summary
He has over 40 publications and two patents.

Additional Experience

Training / Seminars
Expert is able to provide basic pathology lectures designed to assist sponsors in the understanding of: histotechnology, histopathology, and in vivo biodevice evaluation.
Other Relevant Experience
Expert has participated in the development of several drug and device formulations presented to the FDA.

He would be able to evaluate results from animal pre-clinical studies conducted as part of any FDA application.


As part of his advisory role to Bennett Partners LLC, Expert is able to coordinate executive board member instrument evaluations and analyses.

Language Skills

Language Proficiency
Spanish Expert is fluent in Spanish, his first language.
Italian Expert is capable of communicating with Italian researchers (he can speak and read the language).

Fields of Expertise

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