Tom Schaer is the Director, Translational Orthopaedic Research & Preclinical Studies, University of Pennsylvania School of Veterinary Medicine New Bolton Center.
We can help you get across the Valley of Death!
In the current medtech landscape, investors, and ultimately payors (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 and 2) the value it brings.
Appropriately aligning your product development efforts, including your preclinical testing, can make your team more efficient and increase the likelihood of a successful product. For over a decade I 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. I have learnt to ask the right questions for choosing 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, and failing at the preclinical stage is a whole lot better than later in clinical trials.
Specialties: Preclinical translational research and service core. Preclinical study consulting, 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. Bioskills training and protoype testing.