Business
Coya Therapeutics Strengthens its Management Team with the Appointment of Dr. Michelle Frazier as Senior Vice President of Regulatory Affairs
Dr. Frazier brings over 20 years of strong regulatory expertise since her tenure at the FDA followed by a successful career in the pharmaceutical industry.
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":"\n\nDr. Frazier brings over 20 years of strong regulatory expertise since her tenure at the FDA followed by a successful career in the pharmaceutical industry.\n\n\n\nDr. Frazier spent 7 years at the FDA, where she was a team lead reviewing over 60 new molecular entities, overseeing multiple biologic license applications, including the first anti-angiogenic monoclonal antibody approved for cancer therapy. In turn, she was recognized multiple times for her leadership and excellence.\n\n\n\nSubsequent to FDA, Dr. Frazier has demonstrated a proven track record for overseeing and guiding successful global regulatory strategies at prestigious bio pharmaceutical companies for numerous biologic drug products leading to FDA approval of multiple biologic license applications and supplements, including Udenyca® (pegfilgrastim-cbqv biosimilar), and Blincyto®, the first bispecific monoclonal antibody product. As part of her career, Dr. Frazier has also provided strategic advice to multiple biotechnology companies.\n\n\n\nDr. Frazier received a B.S in Microbiology from Washington State University and a Ph.D. In Cell Biology from Loyola University.\n\n\n\n HOUSTON--(BUSINESS WIRE)--\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the appointment of Dr. Michelle Frazier, Ph.D. to Coya’s management team as Senior Vice President of Regulatory Affairs. Dr. Frazier will leverage her regulatory and CMC expertise to guide and oversee all of Coya’s regulatory submissions including the upcoming IND submission for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS).\n\n\n“Dr. Frazier has proven time and again that she has the expertise and ability to take biologics across the finish line to FDA approval. She has overseen the entire regulatory and submission process for biologic drugs from start to finish at multiple organizations and I am confident she will do the same for Coya. Her deep understanding of FDA requirements and practices makes her a strong addition to our growing organization,” stated Howard H. Berman, Ph.D., CEO of Coya Therapeutics.\n\n\nDr. Frazier commented: “Coya is developing highly promising multimodal Treg therapies for the treatment of neurodegenerative diseases of high unmet need. I look...