Navigating Regulatory Affairs: Pathways and Challenges  The Innovation Gateway Lunch & Learn in January will feature Dr. Iris Marklein, an Assistant Professor of Practice and Regulatory Affairs Advisor in the UGA College of Engineering, College of Pharmacy and Innovation Gateway. Iris’ overall role is to provide regulatory support to faculty, UGA-based startups and UGA initiatives in biomanufacturing, and to provide regulatory education. Iris’ background is in regenerative medicine and regulatory affairs. After receiving her PhD from the University of Pennsylvania, she joined the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA), where she gained experience in navigating the regulatory framework for medical devices and also reviewed multiple device submission types, including Q-submissions, Investigational Device Exemption (IDE) applications, and 510(k) Premarket Notifications. Iris then moved to the Center for Biologics Evaluation and Research (CBER) within FDA and was able to expand her existing knowledge of medical device regulations and work on other types of products, including biologics and combination products. Most recently, Iris served as Device and Combination Products Team Lead in CBER, gaining even more exposure to a wide range of products and the complex regulatory challenges faced by novel, cross-cutting technologies. During the...