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Kelly Hoy began working in the drug development industry in 1988 beginning with a clinical trials office within the Department of Neurosurgery at the University of Virginia. She assisted the University in the process of selling the clinical trials office to INC Research, a private corporation, in 1998 and transitioning the employees from a State institution to a private institution. At INC Research, Mrs. Hoy participated in US and international regulatory filings, including INDs, BLAs and NDAs, and was responsible for corresponding with the FDA, ensuring all amendments and documents were submitted in an acceptable and timely manner. Prior to joining the Company in 2004, Mrs. Hoy was employed by PRA International, Inc. and participated in their first electronic NDA submission. As Diffusion’s Regulatory Filings Director, she manages the Company’s regulatory documentation and filing processes, including documentation collection and storage, coordination of writing, managing deadlines, assembly, and submission of Diffusion’s inaugural IND. Additionally, she assists in the planning and tracking of all preclinical and clinical processes and documentations. Mrs. Hoy has been instrumental in developing Diffusion’s Standard Operating Procedures for both the discovery and development aspects of the company while also managing the daily facility operations. | 