Expert Details
Biomaterials: Biocompatibility, Pathology, Devices
ID: 722927
North Carolina, USA
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.
Education
Year | Degree | Subject | Institution |
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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 |
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Years: 2004 to Present | Employer: Undisclosed | Title: Owner | Department: |
Responsibilities:As owner of Employer, Expert provides consultation to pharmaceutical, biomaterial, academic, and goverment agencies. |
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Years | Employer | Title | Department |
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. |
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Years | Employer | Title | Department |
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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He has over 40 publications and two patents. |
Additional Experience
Training / Seminars |
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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 |
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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 |
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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
animal disease model, animal model development, biomedical device, bone conduction, cardiovascular disease, drug development, drug screening, fiber-reinforced composite structure toxicity, histopathology, musculoskeletal disease, pathogenesis, pathology, pharmaceutical research, rat, rat pathology, veterinary disease, veterinary pathology, animal drug testing, animal study, animal model, animal research, cartilage disease, Spanish language translation, gynecologic oncology, bone cancer, bone disease, bioethics, clinical diagnostics, drug product approval, mycobacterial disease, neuropathology, necrosis, autopsy, veterinary computed tomography, polymer drug-delivery method, clinical toxicology, clinical pathology, molecular pathology, animal health, pathogenic bacterium, controlled-release drug delivery technology, disease, drug dosage form development, drug delivery, stenosis, animal behavior, fibrosis, drug regulation, animal breeding, pharmaceutical drug, reproductive system disease, animal, veterinary parasitology, veterinary infectious disease, skin disease, respiratory disease, pathogen, nervous system disease, infectious disease, endocrine disease, dermatopathology, bacterial disease, animal science