Hello and welcome to Bighorn Veterinary Consulting, LLC! I am Michael D. Piontkowski, D.V.M., president and owner of the company.
The mission of Bighorn Veterinary Consulting, LLC is to assist animal health companies in the design, conduct and reporting of pivotal clinical and non-clinical efficacy and safety studies for the licensure and registration of veterinary biological products; and to assist start-up companies, independent research organizations and universities in initial clinical research and potential transfer of new ideas and veterinary biological products to the marketplace.
I have over five years of experience in companion animal practice and over 24 years of experience in the animal health industry. This industry experience encompasses working in both a small and large animal health company environment. I have extensive experience licensing both small and large animal veterinary biological products, and a proven track record of acceptance of licensing packages with USDA’s Center for Veterinary Biologics and European Medicines Agency. This experience includes a strong background in conducting GLP and GCP studies.
I pride myself on ethical conduct, attention to detail, organization and rapid turnaround of studies. I have extensive experience designing, conducting and reporting the following types of biological studies:
- Minimum Immunizing Dose
- Duration of Immunity
- Onset of Immunity
- Lack of Interference
- Maternal Antibody
- Backpassage – Reversion to Virulence
- Overdose and Repeat Dose Safety
- Lactation and Gestational Safety
- Non-Target Animal Safety
- Field Safety Trials
My extensive knowledge of USDA’s Center for Veterinary Biologics and European Medicines Agency licensing requirements can assist animal health companies in the design, conduct and reporting of pivotal studies to license and register modified live, avirulent live, vectored, killed and toxoid veterinary biological products. I have access to numerous contract research organizations and field investigators to conduct studies; I can serve as Study Investigator, Monitor/Director for a study; or I can assist companies with in-house studies.
In addition to working with licensed biological companies, I enjoy the opportunity to work with start-up companies, independent research organizations and universities. I can assist these entities in the development of data packages that would be applicable to presenting new ideas and products to licensed companies or guide a new company through the start-up process to licensure.
For further information or to discuss your project, please contact me at email@example.com or 785-249-5250.