Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
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.
Maddox, Hargott & Caruso - expert in class action litigation involving toxic effects of a flea and tick treatment on dogs
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
|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|
|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.|
|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.|
|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.|
|Training / Seminars|
|Educational courses in pharmacology, veterinary pathology, and surgery.|
|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.|