This discussion will review classification of drugs, devices and biologics, Phase I-IV trials, what is required for 510K substantial equivalence (many bone grafts are in this category) regulatory pathways, safety of commonly used drugs and devices in dentistry, particularly in dental implantology and GBR/GTR. We will also discuss how to get involved in meaningful research, higher on the evidence pyramid, and participate in Industry supported studies.
Susan Cutler DMD is currently Vice President of Medical Affairs, working on research in skin viruses and skin cancer. She has 12 years of pharmaceutical industry experience focused principally on Medical Affairs, R & D and Pharmacovigilance. She is the former Director of Oral Care Clinical Research and Scientific Communications at Colgate-Palmolive where she led a team of global scientists to develop early in development technologies to assess potential for clinical benefit. Prior to that role, Susan was Director of Medical and Clinical Affairs and Pharmacovigilance US at Almirall LLC. Susan also held positions as Senior Director of Medical Affairs at Valeant Pharmaceuticals and prior to that, practiced Periodontics and Implantology for 17 years in Philadelphia. Susan has led clinical development activities related to new drugs and devices for the treatment of periodontal disease and peri-implantitis as well as R & D efforts for FDA approval of medical devices in dentistry and dermatology. She has worked on mergers and acquisitions, drug and medical device development and launches as well as strategic planning and scientific communications. She received her BA in English from Villanova University, her dental degree and post-doctoral degree in Periodontics from the University of Pennsylvania.