Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania. A lawyer and bioethicist by training, her scholarly work focuses on the ethics and regulation of research with human subjects and related issues, including access to investigational therapies outside clinical trials before they have been approved by the FDA. She is the founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), which aims to understand, evaluate, and improve IRB quality and effectiveness. During the COVID-19 pandemic, she has focused on FDA policy, drug and vaccine development, ethical conduct of research and allocation of scarce investigational products.