I am a 1988 graduate of the University of Pennsylvania Veterinary Teaching Hospital.
After a year in private practice near Washington D.C., I joined the National Institutes of Health Veterinary Program as a Public Health Service (PHS) veterinary officer. My positions at NIH included nearly 8 years for the central veterinary program animal critical care and surgery area within The Office of Research Services and two years at the National Institutes of Neurologic Diseases and Stroke in the role of clinical veterinarian.
I followed on the NIH experience with 14 years at the US Food and Drug Administration in leadership and review roles; for four years at The Center for Veterinary Medicine (CVM), then principally at the Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular Devices where I was the lead preclinical expert for a decade.
I simultaneously maintained my clinical skills by weekend and after-hour moonlighting in busy metropolitan area veterinary hospitals.
I retired from federal service in 2015 at the rank of Captain and founded CPSRC, LLC, a niche preclinical consulting firm in Washington D.C. In my first three years of business, I signed contracts with 63 companies. About 1/3 of my clients come from affiliations and relationships with full-service consulting firms while the remainder are word of mouth referrals. I have been involved in numerous negotiations with FDA across a spectrum of devices principally cardiovascular and neurovascular but also more recently general surgical and urogenital. The work ranges from writing protocols for CRO bid to answering deficiencies issued to a sponsor by FDA, stitching together information from multiple animal studies into a single cogent preclinical argument for the preclinical section of a regulatory submission, developing a preclinical test plan, and doing gap analysis for presentation to FDA to demonstrate gaps between non-GLP and GLP studies and presenting this to FDA. Leveraging large animal studies to replace rodent biocompatibility studies is also a specialty. This helps companies refine and reduce overall animal use and preclinical costs.
I am the author of more than three dozen peer-reviewed papers ranging from biomedical research models to ethics of animal use in biomedical research and Agency guidance on animal models for medical devices, several book chapters on animal care and use and animal drug safety, and agency guidance related to food and drug topics. I am also the recipient of a continuous stream of USPHS veterinary awards including the prestigious Veterinarian of the Year Award.
Dr. Hampshire’s exemplary background in regulatory testing brings yet another level of expertise in the area of FDA-guided animal trials as she leads the team from Innovative Medicine Partners and GCMI in the development of clinical animal trial protocols.