Kelly Hoy

Biography

Kelly Hoy has over twenty years of diverse experience in the drug development industry. She joined the Diffusion team in February 2004 to coordinate the writing, assembling, and filing of the Company’s Investigational New Drug (IND) Applications following all federal guidelines and receiving Food and Drug Administration (FDA) approval. She serves as the main point of contact for the FDA to facilitate activities that satisfy their needs to move the Company’s clinical program forward. In addition to managing the two INDs she has successfully submitted and received approval for two Orphan Drug Designations. Kelly has continued to increase her role and responsibilities and in addition to her regulatory role she has assumed the role of Senior Project Manager for Diffusion manufacturing and clinical trials. She serves an integral role in overseeing the manufacturing process as the first point of contact with contracted manufacturing vendors ensuring all operational aspects meet the projected scope of work, budget and timeline. She ensures the conduct of clinical studies are carried out by the project team, including assigned contactors, in accordance with the company’s Standard Operating Procedures, Good Clinical Practices, and ICH guidelines to fulfill all federal and local regulations. Managing multiple site projects includes maintaining tracking tools; analyzing, evaluating, and reporting on study progress to ensure conduct is according to company’s timelines and needs.  

Research Interest

pharmaceutical