Designing in Vivo Models to Help Translate Biomaterials Technologies Toward Clinical Practice
Friday, November 15, 2013 – ( 2:00 pm to 3:00 pm )
Location: Babbio 310, Stevens Institute of Technology
Dr. Thomas Schaer
University of Pennsylvania School of Veterinary Medicine
Scientific discoveries for improvement of human health must be translated into practical applications. Such discoveries typically begin at "the bench" with basic research, then progress to the clinical level. In particular, the field of musculoskeletal research (orthopaedics) can look back on a long and productive history of cross-fertilization between veterinary and human surgeons resulting in the development of innovative therapies for their patients. Pre-clinical studies using animal models continue to play a very important role in the evaluation of efficacy and safety of new medical devices before their use in human clinical studies. This seminar provides practical insight into the design, execution and analytical methodologies of pre-clinical large animal studies. In addition the increasing complexity of regulatory scrutiny at the preclinical level is being discussed.
Dr. Thomas Schaer is the Director of the Comparative Orthopaedic Research Laboratory in the Department of Clinical Studies at the University Of Pennsylvania School Of Veterinary Medicine. Dr. Schaer trained in both human and veterinary medicine, and completed an internship, residency and lectureship in large animal/equine surgery. He is a member of the UPENN Veterinary Care Advisory Board as well as the UPENN IACUC. His primary interests are in clinical orthopedic trauma, joints, spine, and CMF with a particular interest in the application of novel materials for functional restoration of the musculoskeletal system. His academic background combined with his surgical training has allowed Dr. Schaer to pursue translational research with direct application to patient care. He has been involved in the successful translation of many technologies that are currently used in clinical practice. Some of the recent efforts are in the field of injectable technologies for hardware augmentation in long bone trauma, anti-infective device coatings and new strategies for joint resurfacing. Pathophysiology around device-centered biofilm formation recently triggered interest in the various tissue microbiomes and their shifts. This has led to the exploration of causation for pathogen initiated / exacerbated degeneration of musculoskeletal tissues (i.e. arthritides) through large animal models. Dr. Schaer is experienced in developing pivotal trials through discussions with cross-functional groups in the orthopedic biotech arena and his lab has functioned as a (GLP) Testing Facility, designing, executing and managing studies to match the requirements of multidisciplinary core teams. He has interfaced with regulatory colleagues in the submission of GLP (21CFR58 & 21CFR11)/pivotal studies to the USFDA. Since the inception and implementation of his research program in 2005, Dr. Schaer has trained numerous fellows, residents, veterinary students and pre-vet students in translational orthopedic research and has raised over US$10 million in research funding through the biotech industry and foundations. He is a consulting surgeon with various industry-led ventures in orthopedic trauma, spine and sports medicine.