In the current medtech landscape, investors, and ultimately payers (insurance companies, hospitals and patients), require medical innovation that provides value – reducing health care costs through better clinical outcomes and/or reduced procedure costs. This means product development decisions need to be thoughtful of 1) the overall cost for developing a product and its ultimate release, as well as, 2) the value it brings.
Appropriately aligning your product development efforts, including your preclinical testing, can make your team more efficient and ultimately increase the likelihood of a successful product. For over a decade, we have taken time to listen to you and to understand the product development plan, intended market, and the value proposition for your investigational therapy or device. Our objective is to ask the right questions in order to choose a refined preclinical model with high translational fidelity. This approach has delivered answers in the context of the intended clinical indication of your technology. Together, we have successfully moved numerous new therapies to market; and we have failed, but failing at the preclinical stage is a whole lot better than later in clinical trials.
The Preclinical Service Core at the University of Pennsylvania School of Veterinary Medicine (Penn Vet) is focused on non-clinical and clinical (VICH-GL9) translation. Leveraging the multi-disciplinary specialties at Penn Vet, PRS & CORL provide a refined platform of successful translation using experimental and naturally-occurring disease models. We partner with pharmaceutical and medical-device companies, government agencies, and academic institutions to meet a broad range of R&D needs.
Specialties: Preclinical study design and execution from proof-of-concept to pivotal trials compliant with the United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 and VICH-GL9. Bioskills training and prototype testing.