Jamie Austin, Program Coordinator, Lecturer
Dr. Jamie Austin is a faculty member and coordinator for the MS in Biotechnology program, including the Regenerative and Stem Cell Technologies concentration. Dr. Austin brings a unique and practical perspective to this role stemming from her experiences as an alumna and former lecturer/program coordinator within the Regulatory Science program at the Johns Hopkins University, a regulatory leader at various companies, and consultant. Her recent work with navigating the regulatory framework for novelgene therapy and stem cell products, such as autologous hematopoietic stem cell gene therapies and helper-dependent adenovirus gene therapies, is especially relevant for the cutting-edge curriculum in the Regenerative and Stem Cell Technologies concentration.
Prior to coming back to Johns Hopkins as a full-time faculty member, Dr. Austin worked as a Director of Regulatory Affairs in the pharmaceutical and biotechnology industry. Her regulatory expertise spans small molecule pharmaceuticals, biologics/biosimilars, advanced therapies, medical devices, and combination products in various therapeutic areas. She remains Regulatory Affairs Certified (by the Regulatory Affairs Professional Society) in both US and Canadian regulatory affairs.
Dr. Austin earned her B.S. in Chemical Engineering from the University of Notre Dame and M.S. in Bioscience Regulatory Affairs from the Johns Hopkins University. Her Ph.D. in Pharmaceutical Sciences was earned from the University of Michigan, where she studied the biological aspects of the Human Immunodeficiency Virus (HIV) with a thesis entitled, Antiretroviral Therapy: New Mechanistic and Therapeutic Insights for HIV Single-Entity and Combination Drug Products.
Dr. Austin has developed and/or taught Introduction to Regulatory Affairs, Biological Processes in Regulatory Affairs, Regenerative Medicine: Bench to Bedside, and Stem Cell Culture Lab Methods.