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Dr. Brauer is responsible for the development and implementation of regulatory strategies for the Company's diagnostic and therapeutic products. Dr. Brauer has more than 15 years of experience in regulatory affairs, specializing in the preclinical and clinical development of new medical products and meeting regulatory requirements in a time-efficient manner. Prior to joining Panacea, Dr. Brauer managed a consulting firm specializing in regulatory affairs and served as Vice President of Regulatory Affairs at TransMedics, Inc.
As a consultant for over 12 years, Dr. Brauer assisted manufacturers in analyzing and developing regulatory strategies for new products, and in understanding how the U.S. Food and Drug Administration regulations and policies apply to new products. She prepared or aided in the preparation of regulatory submissions, developed clinical protocols, and presented findings at Advisory Panel Meetings. She provided services to a range of clients from small businesses specializing in the development of one product to large international corporations.
Dr. Brauer worked for the U.S. Food and Drug Administration for 5 years as a scientific reviewer in the Office of Device Evaluation where she was responsible for the analysis and evaluation of 510(k), PMA and IDE applications. She was responsible for the presentation of agency findings at Advisory Panel Meetings, development of guidance documents, and ongoing post-market surveillance activities. Dr. Brauer worked extensively on the development of new products for cervical and breast cancer screening while at FDA. She was a member of the CDRH's Toxicology Risk Assessment Committee, CDRH's Ad Hoc Committee to Improve Science in CDRH, and the Advancement of FDA Science Committee.
Dr. Brauer earned a BA in biology at the University of Delaware, an MS in microbiology at the University of Virginia, and PhD in women's health and research methods at the University of Maryland. She is a frequent speaker at professional meetings on regulatory affairs and the U.S. Food and Drug Administration's requirements for product development and approval. | 