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Catherine Gatza

Vice President, Regulatory Affairs


Dr. Gatza joined Premier Consulting in 2013 and brings a strong scientific background to her position, Vice President, Regulatory Strategy. She is responsible for leading multidisciplinary teams in developing overall drug development program strategy, reviewing and preparing regulatory documentation, including pre-IND meeting packages, INDs, NDAs, and other applications for submission to regulatory agencies. Her work includes development of regulatory strategy, research, data analysis, and leading interactions with FDA.

Prior to joining Premier Consulting, Dr. Gatza was a postdoctoral fellow at Duke University Medical Center, in Durham, N.C., where she studied the role of the type III TGF-beta receptor in breast and colon cancer. Dr. Gatza received a B.S. in Biology from Virginia Tech and a Ph.D. in Cell and Molecular Biology from Baylor College of Medicine in Houston, Texas. During her graduate work, Dr. Gatza studied the role of the tumor suppressor p53 in the regulation of aging as well as mammary gland development. As a postdoctoral fellow and graduate student, Dr. Gatza was responsible for developing, designing, and implementing experimental protocols, writing grants and manuscripts, and reviewing papers.

Dr. Gatza received several awards and authored 15 peer-reviewed publications, including eight as first author, as well as book chapters and reviews during her postdoctoral fellowship and graduate education. She received a Susan G. Komen Foundation postdoctoral fellowship and a Ruth L. Kirschstein National Research Service Award (NRSA) postdoctoral fellowship. She was awarded a Ruth L. Kirschstein NRSA Viral Oncology Training Grant in support of her graduate work and an AstraZeneca Scholar-in-Training award to attend the annual meeting of the American Association for Cancer Research. Dr. Gatza also completed a Duke Translational Medicine Institute Regulatory Affairs Internship. Dr. Gatza has presented her work at multiple national conferences, including as an invited mini-symposium speaker at the American Association for Cancer Research annual meeting.