Holly Fernandez Lynch
Assistant Professor of Medical Ethics and Health Policy at the Hospital of the University of Pennsylvania
Assistant Faculty Director , Online Education Initiatives, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
Senior Fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania
Affiliated Faculty, Center for Technology, Innovation, and Competition, Penn Carey Law School
Antiracism, Diversity, Equity, & Inclusion (ADEI) Vice Chair, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
Department: Medical Ethics and Health Policy
Contact information
Blockley Hall, Room 1426
423 Guardian Drive
Philadelphia, PA 19104
423 Guardian Drive
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.
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.
Post-Graduate Training
Academic Fellow (Post-Doctoral Program), The Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge, MA, 2006-2007.
Academic Fellow (Post-Doctoral Program), The Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge, MA, 2011-2012.
Permanent linkAcademic Fellow (Post-Doctoral Program), The Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge, MA, 2006-2007.
Academic Fellow (Post-Doctoral Program), The Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge, MA, 2011-2012.
Description of Itmat Expertise
Research ethics and regulationIRBs
Paying research participants
Patient engagement
Biospecimen research
Informed consent
FDA oversight
Right to try
Expanded access
Challenge trials
Selected Publications
Lynch HF: Supreme Court Hearing Abortion Pill Case. Scripps News Live March 2024 Notes: https://video.snapstream.net/Play/7u0n6PNc4F9nZE4X4uFTqk?accessToken=f7f95bj5drm9.Lynch HF: "A dilemma in ALS, the first MASH drug, & why gene therapy is hard" STAT The Readout Loud (podcast) 2024 Notes: https://www.statnews.com/2024/03/14/readout-loud-podcast-als-amylyx-mash-gene-therapy-sickle-cell/
Lynch HF, Kesselheim AS: Viewpoint: FDA in the Crosshairs: Science, Politics, and Abortion (invited, peer reviewed). JAMA In press 2024 Notes: With interview: https://edhub.ama-assn.org/jn-learning/audio-player/18866351.
Etkin J, Ross J, Lynch HF, Mooghali M, Ramachandran R: Public Comment - FDA-2023-D-2318: Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. FDA Public Docket December 2023 Notes: https://www.regulations.gov/comment/FDA-2023-D-2318-0018.
Lynch HF, Ramachandran R (with signatories): Expert Letter to Congressional Sponsors re: The Promising Pathway Act Congressional Record December 2023 Notes: https://doctorsforamerica.org/wp-content/uploads/2023/12/Congress-Letter-Promising-Pathway-Act-12.04.23-FINAL.pdf.
Lynch HF, Kearns L, Moch K, Caplan AL: What’s the Worst That Could Happen? A Toothless FDA. Health Affairs Forefront November 2023 Notes: https://www.healthaffairs.org/content/forefront/s-worst-could-happen-toothless-fda.
Lynch HF: "Miracle Drugs, Million Dollar Price Tags" "playing god?" (podcast, hosted by Johns Hopkins Berman Institute of Bioethics) November 2023.
Lynch HF: “Life in the Fast Lane: Navigating Accelerated Drug Approval” MedPage Today, Instagram Live October 2023.
Lynch HF: "Do IRBs Do More Good Than Harm?" Bio(un)ethical (podcast) October 2023 Notes: https://www.biounethical.com/episodes/episode/79e72cf4/4-holly-fernandez-lynch-do-irbs-do-more-good-than-harm.
Anderson EE, Johnson A, Lynch HF: Inclusive, Engaged, and Accountable Institutional Review Boards. Accountability in Research Page: 1-9, Jun 2023.