Earl Dye is Director of Technical Regulatory Policy in Genentech’s Washington, DC Regulatory Affairs Office, and is the FDA Liaison for a Roche Global Technical Regulatory Policy Group. He has been at Genentech for nine years and is responsible for evaluating proposed biotechnology/biologic CMC regulations, guidelines, policies and practices of US FDA and other federal government agencies. In this role he is responsible for developing strategic relationships with FDA, BIO, USP and other interested parties to shape the outcome of final guidance. Dr. Dye is also actively involved in training technical staff on new and existing guidance, and working with staff and project teams to provide technical and regulatory advice on submissions to ensure they address Genentech/Roche needs and potential health authority concerns.
Prior to joining Genentech Dr. Dye was the Director of the Division of Application Review and Policy in CDER’s ODE 6, and was responsible for managing the review of BLA’s, supplements, and IND’s for therapeutic biologic proteins. He joined the FDA in 1992, and became a regulatory expert for therapeutic biologics, participated in foreign and domestic inspections of licensed manufacturers, and was actively involved in developing policy for review of therapeutic proteins. Dr. Dye graduated from Ohio State University with a PhD in Medical Microbiology in 1978, and was a staff scientist at the Trudeau Institute where he directed a laboratory investigating cellular mechanisms of antitumor resistance.