Michelle Frazier, PhD Coherus BioSciences
Dr. Frazier has 18-plus years of experience in the biotechnology Regulatory Affairs field. She has worked in both Industry and as a Regulator at the US FDA. Michelle is currently employed at Coherus BioSciences, a biosimilars company, where she is responsible for a global portfolio of biosimilars that span early development to commercial products. Michelle has worked in both small and large companies. She has built and led teams that provided overall Regulatory Strategy for early to late stage clinical development programs as well as commercial programs.
Michelle’s experience and success in the biopharmaceutical industry was influenced by her tenure at the Food and Drug Administration, where she was a Review Biologist and Acting Team Leader in the Division of Monoclonal Antibodies, Office of Biotechnology Products at CDER.
Michelle is an Associate Director for CASSS (California Separation Science Society) where she has been a strong advocate for the development of Industry/Health Authority forms that emphasize strategic rapid product development for both large and small companies as well as strategic content and dossier preparation to ensure successful submissions.
Michelle earned her bachelor’s degree in Microbiology from Washington State University and her Ph.D. in Cell Biology, Neurobiology & Anatomy from Loyola University Chicago. She has post-doctoral research training in cell biology, immunology and inflammation.
Michelle’s experience and success in the biopharmaceutical industry was influenced by her tenure at the Food and Drug Administration, where she was a Review Biologist and Acting Team Leader in the Division of Monoclonal Antibodies, Office of Biotechnology Products at CDER.
Michelle is an Associate Director for CASSS (California Separation Science Society) where she has been a strong advocate for the development of Industry/Health Authority forms that emphasize strategic rapid product development for both large and small companies as well as strategic content and dossier preparation to ensure successful submissions.
Michelle earned her bachelor’s degree in Microbiology from Washington State University and her Ph.D. in Cell Biology, Neurobiology & Anatomy from Loyola University Chicago. She has post-doctoral research training in cell biology, immunology and inflammation.