Expertise: Vaccines, therapeutic proteins, biologics, CMC issues, regulatory strategy

Dr. Egan offers over 30 years of experience with biologics, including 28 years at FDA. At FDA, Dr. Egan served in various director-level positions in the Office of Vaccines Research and Review for more than 10 years, as Chief of the Biophysics Laboratory, as Associate Director for Research for the Office of Vaccines Research and Review (OVRR), as Deputy Director, OVRR, and as Acting Director, OVRR. At OVRR, Dr. Egan had oversight responsibility for vaccine regulation in the United States; he also represented OVRR to various national and international agencies, including the World Health Organization and various National Control Agencies, and to various Congressional bodies. As Associate Director for Research, Dr. Egan was responsible for overseeing the research programs within OVRR.

Dr. Egan's research experience within FDA includes 13 years as the Chief for OVRR’s Biophysics Laboratory. There, he brought various physical chemical methods to OVRR for the study of vaccines and other biological macromolecules, primarily the polysaccharide-based vaccines. These methods included NMR spectroscopy, laser light scattering, and computational chemistry.

Dr. Egan is an author or co-author of more than 100 scientific articles, primarily in the study of bio-macromolecular structure. Dr. Egan is a member of many professional organizations, including the American Chemical Society and the International Society for Biologicals, where he now serves as Vice-chair of the Human Vaccines Committee; Dr. Egan is also a member of the U.S. Pharmacopoeia’s Vaccines and Virology Expert Working Group.

Dr. Egan received his Ph.D. in Chemistry from Princeton University and was a post-doctoral fellow in the Division of Physical Chemistry of the Lund Institute of Technology (Sweden).