Catherine Gatza, Ph.D. 

Catherine Gatza, Ph.D., is an experienced regulatory strategist with over 11 years of experience in both consulting and the Sponsor side of the pharmaceutical industry. Dr. Gatza is skilled in the development of strategic and streamlined drug development programs across multiple therapeutic areas, with a specialization in 505(b)(2) applications. She has led the development of regulatory strategy for small, mid-,and large pharmaceutical companies, from early-stage proof-of-concept to NDA submissions and approvals, as well as post-approval support for small molecules, biologics, fixed dose combination, and drug-device combination products. She is experienced in preparation, oversight, and review of regulatory documentation for client and FDA submissions including feasibility and strategic assessments, labeling, INDs, NDAs, ANDAs, EUAs, Type A, B, C, and D meetings, annual reports, pediatric study plans, orphan drug designations, Fast Track and Breakthrough therapy designations, and others, in addition to leading meetings with regulatory agencies. She has extensive experience in leading multidisciplinary teams to support drug development programs.  

Dr. Gatza has worked across multiple therapeutic areas including oncology, cardiovascular disease, gastroenterology, metabolic diseases, neurology, dermatology, reproductive health, and infectious diseases, including rare diseases. Dr. Gatza has participated in over 45 FDA meetings and been involved in submissions across 13 FDA Divisions, as well as the Office of Generic Drugs and the Office of Orphan Product Development.  

Dr. Gatza has a PhD in Cell and Molecular Biology from Baylor College of Medicine and completed a postdoctoral fellowship in breast and colon cancer at Duke University Medical Center.