Holly Fernandez Lynch JD, MBE
Associate Professor of Medical Ethics and Health Policy at the Hospital of the University of Pennsylvania
Senior Fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania
Affiliated Faculty, Center for Technology, Innovation, and Competition, Penn Carey Law School
Associate Faculty Director, Online Education Initiatives, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
Faculty Search Advisor, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
Opportunity and Engagement Vice Chair, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
Department: Medical Ethics and Health Policy
Contact information
3600 Civic Center Boulevard
Philadelphia, PA 19104
Philadelphia, PA 19104
Office: 215-746-7327
Links
A resource for locating diverse, underrepresented bioethics scholars
Public website for the Advancing Effective Research Ethics Oversight (AEREO) Consortium
A resource for locating diverse, underrepresented bioethics scholars
Public website for the Advancing Effective Research Ethics Oversight (AEREO) Consortium
Education:
BA (Health and Societies)
University of Pennsylvania College of Arts and Sciences, 2003.
JD (Law)
University of Pennsylvania Law School, 2006.
MBE (Bioethics)
University of Pennsylvania School of Medicine, 2006.
Permanent linkBA (Health and Societies)
University of Pennsylvania College of Arts and Sciences, 2003.
JD (Law)
University of Pennsylvania Law School, 2006.
MBE (Bioethics)
University of Pennsylvania School of Medicine, 2006.
Selected Publications
Lynch HF: How Do Clinical Trials Work, and Who Can Participate? NPR: Science Friday May 2026 Notes: https://www.sciencefriday.com/segments/how-clinical-trials-work/Lynch HF, Ramachandran R, Sachs R, Zettler PJ, Joffe S: Public Comment: FDA-2026-D-1256 - "Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause" FDA Public Docket April 2026.
Lynch HF, Ramachandran R, Sachs R, Joffe S, Zettler PJ : The Promise and Perils of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1). Health Affairs Forefront January 2026 Notes: www.healthaffairs.org/content/forefront/promise-and-perils-fda-s-new-plausible-mechanism-pathway-part-1
Lynch HF: "Fewer Drugs, More Chaos: One Year Under the New FDA" Endpoints News Post-Hoc Live (podcast) January 2026 Notes: https://www.youtube.com/watch?v=1NXX14EXa6I.
Mast J: “FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns" STAT News January 2026 Notes: Full length interview, https://www.statnews.com/2026/01/26/fda-makary-prasad-crispr-gene-editing-concerns-baby-kj/
Lynch HF, Ramachandran R, Sachs R, Joffe S, Zettler PJ: The Promise and Perils of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2). Health Affairs Forefront January 2026 Notes: https://www.healthaffairs.org/content/forefront/promise-and-perils-fda-s-new-plausible-mechanism-pathway-part-2.
Lynch HF, Hu XP, Bateman-House A: Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty. Journal of Law, Medicine, and Ethics 54(1): 60-68, 2026.
Hu X, Robertson C, Bateman-House A, Lynch HF: Balancing Scientific Uncertainty and Demand for Psychedelic Medicines (chapter). Law and Policy of Psychedelic Medicine. Cohen IG, Marks M, McGuire AL (eds.). Cambridge University Press, In press 2026.
Dhruva SS, Dusetzina SB, Phillips KA, Lynch HF: FDA’s Role in Supporting Therapeutic Development to Address Unmet Needs: The National Academies Report and Beyond. Health Affairs Scholar 4(1): qxag013, 2026 Notes: Peer reviewed.
Neitzke-Spruill L, Robinson JO, Purcell A, Sisti D, McGuire AL, Lynch HF : Investigators’ Experiences with IRB Oversight of Psychedelic Research. Ethics & Human Research Online first 2026.