Holly Fernandez Lynch is Assistant Professor of Medical Ethics and Law at the University of Pennsylvania. She pursues conceptual and empirical scholarship regarding various gatekeeping issues in health care, including those arising in the context of clinical research ethics and regulation, institutional study prioritization, access to investigational medicines outside clinical trials, and FDA pharmaceutical policy, especially early approval standards for diseases with unmet treatment needs. As founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (www.aereo.org), Professor Fernandez Lynch is leading a collaborative effort to understand, evaluate, and improve IRB quality and effectiveness. She is also currently leading work funded by Arnold Ventures to understand stakeholder perspectives on FDA’s exercise of regulatory flexibility in new drug approvals and challenges raised by life-cycle regulation and post-market studies.
Professor Fernandez Lynch serves on the boards of Public Responsibility in Medicine & Research (PRIM&R) and the American Society for Law, Medicine, and Ethics (ALSME). She is a National Academy of Medicine Emerging Leader in Health and Medicine, an elected fellow of the Hastings Center, and the inaugural recipient of the Baruch A. Brody Award and Lecture in Bioethics. Professor Fernandez Lynch served as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019. She was previously Executive Director of the Petrie-Flom Center at Harvard Law School, a private practice attorney focused on pharmaceuticals regulation, and a bioethicist at NIH’s Division of AIDS and President Obama’s Commission for the Study of Bioethical Issues. She attended college at Penn, was a Levy Scholar in Law and Bioethics at Penn Law, and earned a Master of Bioethics also from Penn.
Bioethics & Drug Regulation