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.
Stewart Suzanne, Barr Stephanie, Engiles Julie, Hickok Noreen J, Shapiro Irving M, Richardson Dean W, Parvizi Javad, Schaer Thomas P Vancomycin-modified implant surface inhibits biofilm formation and supports bone-healing in an infected osteotomy model in sheep: a proof-of-concept study. The Journal of bone and joint surgery. American volume 94: 1406-15, 2012.Showalter Brent L, Beckstein Jesse C, Martin John T, Beattie Elizabeth E, Espinoza Orías Alejandro A, Schaer Thomas P, Vresilovic Edward J, Elliott Dawn M Comparison of animal discs used in disc research to human lumbar disc: torsion mechanics and collagen content. Spine 37: E900-7, 2012.Schaer Thomas P, Stewart Suzanne, Hsu Bryan B, Klibanov Alexander M Hydrophobic polycationic coatings that inhibit biofilms and support bone healing during infection. Biomaterials 33: 1245-54, 2012.Gasiorowski Janik C, Richardson Dean W, Boston Raymond C, Schaer Thomas P Influence of a resilient, hard-carbon thin film on drilling efficiency and thermogenesis. Veterinary surgery : VS 40: 875-80, 2011.Jasmin Bambi H, Boston Ray C, Modesto Rolf B, Schaer Thomas P Perioperative ruminal pH changes in domestic sheep (Ovis aries) housed in a biomedical research setting. Journal of the American Association for Laboratory Animal Science : JAALAS 50: 27-32, 2011.Ahern Benjamin J, Schaer Thomas P, Terkhorn Shawn P, Jackson Karen V, Mason Nicola J, Hankenson Kurt D Evaluation of equine peripheral blood apheresis product, bone marrow, and adipose tissue as sources of mesenchymal stem cells and their differentation potential. American journal of veterinary research 72: 127-33, 2011.Risbud Makarand V, Schaer Thomas P, Shapiro Irving M Toward an understanding of the role of notochordal cells in the adult intervertebral disc: from discord to accord. Developmental dynamics : an official publication of the American Association of Anatomists 239: 2141-8, 2010.Ahern Benjamin J, Richardson Dean W, Boston Raymond C, Schaer Thomas P Orthopedic infections in equine long bone fractures and arthrodeses treated by internal fixation: 192 cases (1990-2006). Veterinary surgery : VS 39: 588-93, 2010.Ahern Benjamin J, Harten Robert D, Gruskin Elliott A, Schaer Thomas P Evaluation of a fiber reinforced drillable bone cement for screw augmentation in a sheep model--mechanical testing. Clinical and translational science 3: 112-5, 2010.Ahern Benjamin J, Soma Lawrance R, Boston Raymond C, Schaer Thomas P Comparison of the analgesic properties of transdermally administered fentanyl and intramuscularly administered buprenorphine during and following experimental orthopedic surgery in sheep. American journal of veterinary research 70: 418-22, 2009.
BS SAMD, Davos/Switzerland, 1986VMD (Veterinary Medicine) University of Pennsylvania School of Veterinary Medicine, 1996