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 (PSOM), University of Pennsylvania. She co-chairs the PSOM Research Ethics and Policy Series (REPS) and serves as Assistant Faculty Director of Online Educational Initiatives in the Department, where she helps lead the Master of Health Care Innovation. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.

A lawyer and bioethicist by training, Professor Fernandez Lynch’s scholarly work focuses on clinical research ethics, access to investigational medicines outside clinical trials, Food and Drug Administration (FDA) policy, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), human infection challenge studies, research risks to bystanders, research with biospecimens, the use of social media in research settings, and patient-engaged research. During the COVID-19 pandemic, Professor Fernandez Lynch published extensively on drug and vaccine development and authorization, ethical conduct of research, allocation of scarce investigational products, challenge studies, and political influence on FDA.

Prior to joining Penn, Professor Fernandez Lynch was the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School (2012-2017) and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She worked as an attorney in private practice focused on pharmaceuticals regulation at Hogan & Hartson, LLP, as a bioethicist at the NIH’s Division of AIDS, and as a senior policy and research analyst with President Obama’s Commission for the Study of Bioethical Issues. Professor Fernandez Lynch attended college at Penn, was a Levy Scholar in Law and Bioethics at Penn Law, and earned a Master of Bioethics also from Penn.