Expert Details

Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine

Expert ID: 711642 Michigan, USA

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Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal systems. Expert also has experience with issues affecting the practical aspects of veterinary medicine. Currently, he works in the role of a house-call and relief veterinarian. In the relief role, he works with approximately 16 separate veterinary clinics throughout Michigan filling in for vacation relief and scheduled days off for practitioners.

Expert has experience in Animal Health through preventive medicine training and experience as a practicing veterinarian. He also has previous work experience in animal health research with Pfizer Animal Health.

He has utilized both his veterinary and biomedical engineering backgrounds to perform animal research for a number of years. He is skilled at medical device and animal health pharmaceutical research. He has studied cardiovascular, soft-tissue, and orthopedic medical devices. He has also been on teams developing agents for controlling the pain of osteoarthritis in canines, and an anti-coccidial in poultry.

Expert has background with both GLP and non-GLP medical device study evaluation. He managed the preclinical area of this evaluation process, which included developing protocols, writing reports, assisting with site and animal model selection, identifying associated services, and securing quotations.

He has evaluated medical devices such as peripheral vascular stents, intravenous filters, urethral stents, percutaneous devices, ophthalmic sutures, skin staples, and adhesion prevention products. He has also tested catheters with biomedical instrumentation technology for measuring blood pO2, pCO2, temperature, and pH for market use in premature infants. Expert has also tested both drug-eluting and bare stents in the carotids, renal, iliac, superficial femoral, mesenteric and gastric arteries.

Expert was involved with a $3 million renovation of an animal facility. He handled the identification and purchase of major capital surgical equipment plus instrumentation needed for the operating room. Examples of these purchases include a fluoroscope, surgical table lights, anesthesia machines, surgery tables, and various instrumentation for cardiovascular and soft-tissue surgery.

Expert has a vast amount of experience with both large and small laboratory animals, to include pigs, mini-pigs, sheep, dogs, rabbits, and rats. He has interfaced with both AAALAC and the USDA on maintaining the standards of care. He managed an animal facility for approximately ten years along with implanting the medical devices in these animals.

Expert has worked as a study director/project manager for a number of years, designing and writing preclinical protocols to match the requirements of multidisciplinary core teams. He has worked with IACUCs to approve both GLP and non-GLP protocols for animal studies. Expert has written the required data capture forms with each protocol.

Expert has interfaced with regulatory colleagues in the submission of GLP/Pivotal studies to the FDA. He coordinated the preclinical requirements of these submissions in GLP/Pivotal studies. He is well versed in the Quality Assurance process required to approve the studies for submission. Expert has managed an AAALAC accredited animal facility maintaining their guidelines. He prepared this facility for inspections with continuation of accreditation. Expert has continuously maintained the federal regulations outlined by the USDA for animal facilities while managing the facility. He has directly handled the random inspections for a number of years.

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Expert may consult nationally and internationally, and is also local to the following cities: Detroit, Michigan - Warren, Michigan - Flint, Michigan - Sterling Heights, Michigan - Lansing, Michigan - Ann Arbor, Michigan - Livonia, Michigan - Dearborn, Michigan - Westland, Michigan - Toledo, Ohio

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Education

Year Degree Subject Institution
Year: 1984 Degree: MS Subject: Bioengineering Institution: University of Utah
Year: 1981 Degree: DVM Subject: Veterinary Medicine Institution: Michigan State University
Year: 1979 Degree: BS Subject: Mechanical Engineering with Biomedical Option (actual BS degree in Veterinary Science) Institution: Michigan State University

Work History

Years Employer Title Department Responsibilities
Years: 2010 to Present Employer: Undisclosed Title: Owner & Principal Department: Responsibilities: Work as a house call and relief veterinarian servicing the needs of dogs and cats for preventative and geriatric medicine and private at-home euthanasia.
Years: 2007 to 2011 Employer: Undisclosed Title: Program Director Department: Veterinary Technology Responsibilities: Expert directs a Veterinary Technology program with 75% administration and 25% teaching responsibilities. He oversees the budget of the Program and all aspects of management reporting to the Dean of Health Sciences.
Years: 2004 to 2004 Employer: Argosy University Title: Undisclosed Department: Veterinary Technician Department Responsibilities: Expert taught anesthesia and surgery to senior veterinary technician students.
Years: 2001 to 2004 Employer: Boston Scientific Corporation Title: Department: Preclinical Responsibilities: Expert managed preclinical peripheral vascular research projects to meet goals of teams, departments, and company. He interfaced with cross-functional core teams to arrange both GLP and non-GLP preclinical studies. He developed protocols, wrote reports, assisted with site and animal model selection, identified associated services, and secured quotations. He also managed associate research scientists.
Years: 1987 to 2000 Employer: Pfizer, Inc. Title: Department: Animal Health/Medical Devices/Hospital Products Group Responsibilities: Expert was the study director of clinical and non-clinical studies (both pivotal and non-pivotal) in the Animal Health Group. He directed pharmaceutical studies of both canine osteoarthritis and poultry feed agents. He was key in test for FDA approval of Rimadyl. He was the manager of the animal testing facility and sterilization laboratory with a budget of $1.6 million in the Medical Devices Division. He performed in a dual role as a veterinary surgeon and study director, interfacing with medical device staff. He provided team leadership for medical device safety and efficacy testing. He maintained GLP study records, animal health and husbandry standards as specified in the SOPs, USDA standards, and the AAALAC guidelines. He was a member of the IACUC with the responsibility of coordination meetings and writing Animal Care and Use Procedures. He also managed three techinicians.
Years: 1985 to 1987 Employer: Undisclosed Title: Sr. Veterinary Surgeon/Scientist Department: Responsibilities: Expert directed research projects related to wound healing. He designed animal models for biomechanical testing and evaluated surgical mechanical staplers. He also provided product training to sales personnel.

International Experience

Years Country / Region Summary
Years: 2000 to 2000 Country / Region: Canada/Calgary, Alberta Summary: Expert was the study director in multi-center study visiting veterinary clinics in Calgary, Alberta. In this capacity, he discussed results with practitioners and gathered data for clinical study of canine osteoarthritis pharmaceutical.

Career Accomplishments

Associations / Societies
Expert is a member of the following associations: Academy of Surgical Research (founding member); American Veterinary Medical Association; American Association of Industrial Veterinarians, Michigan Veterinary Medical Association, Southeast Michigan Veterinary Medical Association, Rochester Chamber of Commerce
Licenses / Certifications
DVM License - States of Michigan and Utah; Controlled Substance License - State of Michigan; DEA License - United States; Microsurgery certification
Awards / Recognition
Expert received Andreas von Recum award from the Academy of Surgical Research and the "I Care Award" from a respected college.
Publications and Patents Summary
Expert has seven publications: book chapter on biomaterials, book chapter on biomechanical testing, master's thesis, and three journal articles.

Additional Experience

Training / Seminars
Educational courses in pharmacology, veterinary pathology, and surgery.
Vendor Selection
He has experience in sourcing and purchasing the following types of equipment: flouroscopes, operating room equipment, animal runs and animal caging.
Other Relevant Experience
Expert has performed microsurgery for device implantation in GLP studies.

Fields of Expertise

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