Earl Dye, PhD Genentech

Earl Dye is Director of Regulatory Policy in Genentech’s Washington, DC Regulatory Affairs Office. He has been at Genentech for twelve years and is responsible for evaluating proposed biotechnology/biologic CMC regulations, guidelines, policies and practices of US FDA. 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.

Currently, he leads a team working on accelerated CMC strategies for innovative biologic and small molecule drugs, is the Regulatory lead for a Biosimilar Readiness Team at Genentech, and is the BIO delegate to USP.

Prior to joining Genentech, Dr. Dye was the Director of the Division of Application Review and Policy in CDER’s ODE 6. 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 is a graduate of Ohio State University with a PhD in Medical Microbiology.