About

Holly Fernandez Lynch JD, MBE is an Associate Professor of Medical Ethics and Health Policy at the Hospital of the University of Pennsylvania. She is also a Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania and an affiliated faculty member at the Center for Technology, Innovation, and Competition at Penn Carey Law School. She serves as Associate Faculty Director for Online Education Initiatives in the Department of Medical Ethics and Health Policy and is the Opportunity and Engagement Vice Chair in the same department at the Perelman School of Medicine. Her educational background includes a BA in Health and Societies from the University of Pennsylvania, a JD from the University of Pennsylvania Law School, and an MBE in Bioethics from the University of Pennsylvania School of Medicine. Her research focuses on medical ethics, health policy, and regulatory issues related to drug development and personalized medicine, with numerous publications addressing FDA pathways, psychedelic medicines, and bioethics.

Research topics

• Political Science
• Engineering ethics
• Engineering
• Public relations
• Law
• Pathology
• Sociology
• Medicine
• Business
• Computer Science
• Virology
• Psychology
• Philosophy
• Environmental ethics
• Finance
• Social psychology
• Accounting
• Psychiatry
• Economics
• Biology

Selected publications

• Institutional Review Board Obligations Regarding Study Funding Sufficiency

  Ethics & Human Research · 2026-03-01

  articleOpen access1st authorCorresponding

  Given their obligations to ensure ethical research, we argue that institutional review boards (IRBs) bear a responsibility to minimize the possibility that proposed clinical studies will terminate early for insufficient funding. Underfunded studies raise several ethical concerns, including potentially failing to satisfy the social value requirement for research, the possibility of leaving study participants worse off, and exposing participants to the "completion misconception," thereby impairing adequate informed consent. Although the practice is not currently typical, IRBs should confirm funding sufficiency before approving a study, ideally working with institutional offices or other experts skilled in budget review. In most cases, IRBs should withhold approval from studies lacking full funding at the point of review. In exceptional cases, however, an IRB may approve an important but underfunded study if the researcher discloses funding insufficiency and termination risk to prospective participants, does not leave participants worse off, has a clear funding plan, and follows checkpoints for securing funding within a reasonable timeframe. Even with IRB attention to study budgets at the point of approval, subsequent events outside an IRB's control may cause a study to lose its originally promised funding. To minimize these cases and their impact, IRBs can encourage institutions to buttress their funding agreements, seek sponsor certifications, require notification of material funding changes, and support investigators through contingency planning and communication with participants.

  PublisherDOI

• Advancing FDA New Approach Methodologies from animal models through digital twins

  npj Digital Medicine · 2026-04-15

  articleOpen access

  In April 2025, the U.S. Food and Drug Administration announced immediate steps toward replacing animal testing for drug evaluation with New Approach Methodologies (NAMs)-modern laboratory techniques mimicking human tissues. However, significant gaps exist between current regulatory frameworks and these technologies' promise. We argue that specific comprehensive regulatory reforms will improve transition to human-relevant drug-evaluation methodologies, laying groundwork for digital twins, in silico trials, and transformative advances in precision medicine.

  PublisherOA PDFDOI

• The arrival of digital twins and in silico trials in drug development

  Nature Medicine · 2026-04-27

  article
  PublisherDOI

• The Food and Drug Administration's role in supporting therapeutic development to address unmet needs: the National Academies report and beyond

  Health Affairs Scholar · 2026-01-01

  articleOpen accessSenior author

  Despite substantial progress, many serious diseases continue to lack safe and effective therapies. Building on a recent National Academies consensus study report that offers several recommendations to better align investments in therapeutic development with unmet needs, in this commentary, we focus on the Food and Drug Administration's role in advancing this goal. Historically, FDA has encouraged investment where market incentives fall short, undertaken efforts to address broad scientific challenges, and administered programs to expedite development and review of drugs targeting unmet needs. Under the second Trump administration, FDA has launched several initiatives that continue these key themes, although some have been controversial, primarily due to concerns about resource sufficiency and the potential for political interference. Regarding other domains addressed by the National Academies report, FDA has recently given mixed signals on its commitment to upholding rigorous approval standards; paid limited attention to noted gaps, including improving rigorous postmarket evidence generation and validating the surrogate markers often used to support product approval; and failed to ensure adequate financial and human resources to support the agency's critical work. Engagement with the National Academies report's recommendations can help ensure that FDA continues to advance progress toward addressing unmet medical needs.

  PublisherDOI

• The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2)

  Forefront Group · 2026-01-23

  dataset1st authorCorresponding

  In part 2 of this article, we note that FDA’s new “plausible mechanism pathway” holds great promise for facilitating the future development of truly individualized treatments. However, we address important questions about how the approach will work in practice, as well as concern about how it might be extended beyond narrowly defined cases.

  PublisherDOI

• US Institutional Review Board Perspectives Regarding Psychedelic Research

  Psychedelic Medicine · 2026-04-23

  articleSenior author

  Background: Institutional review boards (IRBs) are gatekeepers of psychedelic research, deciding whether and under what conditions it may proceed. Yet IRB understanding, attitudes, perspectives, and concerns regarding psychedelics and psychedelic research have not previously been studied. These factors are important to assessing whether US IRBs are likely to be over- or underprotective of psychedelic research participants and to helping psychedelic investigators address key IRB concerns. Methods: A total of 529 current IRB chairs were invited to participate in an electronic survey conducted in October–November 2024. The sample included chairs at US organizations affiliated with psychedelic studies registered on ClinicalTrials.gov, the top 100 NIH-funded organizations, and organizations in states with more and less favorable psychedelic policies; IRB chairs affiliated with the Department of Veterans Affairs and two commercial IRBs were also included. Survey domains included psychedelic experience, understanding and attitudes about psychedelics, confidence reviewing psychedelic protocols, concern about aspects of psychedelic administration research compared to other research, views on risks associated with psychedelic administration research, perspectives on participant protections, and resource needs. Results: Overall, 212 IRB chairs completed at least 80% of the survey (42.7% response rate), a third of whom (34.9%) reported professional experience with psychedelics. Participants often reported lacking knowledge about psychedelic risks/benefits (35–51%) and selected neutral responses to questions examining their attitudes about psychedelics (35–47%). Most (61–78%) reported similar confidence reviewing psychedelic and nonpsychedelic protocols. Many IRB chairs (33–53%) reported heightened concern about psychedelic administration research, including legal, employment, and other social risks, expectations of benefit leading to bias, participant safety, consent challenges, and inclusion of vulnerable populations; about half (47.2%) reported heightened institutional risk compared to other research. Most agreed with requiring extensive monitoring of psychedelic administration sessions (82.9%) but expressed wide-ranging views on other protections. Conclusions: Rather than reflecting a broadly conservative approach to psychedelic research, IRB chairs often expressed a neutral attitude toward psychedelics alongside some uncertainty, while noting concerns that align with unsettled issues in the field. Gaps in IRB knowledge regarding psychedelic risks/benefits can be addressed in research protocols, while the field must continue to work toward consensus on best practices for participant protection.

  PublisherDOI

• The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)

  Forefront Group · 2026-01-22

  dataset1st authorCorresponding

  In part 1 of this article, we describe FDA’s broadly flexible approach to meeting challenges in rare disease drug development and summarize FDA’s initial, limited policy efforts to address them. We then outline the approach that Baby KJ’s doctors are now pursuing.

  PublisherDOI

• A Framework for Assessing the Permissibility of Academic Leaders’ Outside Activities

  Milbank Quarterly · 2025-06-04

  articleOpen access

  Policy Points Many have urged academic institutions to rethink conflict of interest policies governing leaders' outside activities, which pose not only individual conflicts for leaders themselves but institutional conflicts for their academic employers. Although the American Association of Medical Colleges and Association of American Universities have provided guidance on managing such conflicts, neither offer a structured approach for determining when and under what conditions it is appropriate for a leader to engage in specific outside activities. To address this gap, this article develops a decision-making framework that institutional oversight bodies can use to assess the permissibility of academic leaders' proposed outside activities.

  PublisherOA PDFDOI

• Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval

  Health Affairs Scholar · 2025-09-13

  articleOpen access1st authorCorresponding

  Introduction: Concerns about completing postmarketing requirements (PMRs) following accelerated approval (AA) of new drugs have been well documented. However, there has been little examination of specific barriers and facilitators to timely, rigorous PMRs (eg, blinded, randomized trials in the approved population) from the perspective of key stakeholders. Methods: To understand these factors, especially for cancer and rare diseases, we interviewed 56 regulators, industry executives, patient advocates, and payers. Results: Stakeholders focused on predictable PMR barriers and, except for payers, offered weak solutions, including those that would trade rigor for feasibility (eg, avoiding randomization, conducting PMRs outside approved indications), could raise other concerns (eg, conducting PMRs abroad), or are likely to fall short (eg, patient education). Stakeholders supported requiring that confirmatory studies begin before AA but were unsure how to retain rigor thereafter, emphasized tradeoffs, and sought rare disease exceptions. Although regulators and payers supported payment reforms for AA drugs, all stakeholder groups questioned practicability. Conclusion: Stakeholders recognize PMR shortcomings but prioritize flexibility, raising questions about AA's foundations and suggesting that further documenting poor rigor is unlikely to change policy. Beyond recent reforms, future efforts should emphasize confirming benefit for rare disease AAs, encouraging PMR rigor, and exploring AA payment reform.

  PublisherOA PDFDOI

• Mapping the Landscape of Medical Venture Philanthropy

  AJOB Empirical Bioethics · 2025-10-02

  article

  BACKGROUND: A number of patient organizations have recently embraced venture philanthropy, a model of patient advocacy that purports to use practices from venture capitalism in pursuit of philanthropic goals. However, a clear understanding of what venture philanthropy entails and what these organizations do remains elusive, hindering efforts to assess ethical implications of the model's growth. METHODS: We conducted a qualitative content analysis of self-reported profiles of 130 organizations in an affinity network promoting principles of venture philanthropy. We analyzed organizations' research goals, funding strategies, activities, and patient engagement efforts. RESULTS: Despite finding substantial variation in age, revenue, and disease focus, we identified shared assumptions and approaches that represent defining characteristics of venture philanthropy. First, organizations consistently present facilitating the development of new therapies as the most urgent need for patients. Second, organizations participate in financing and managing research across the development pipeline, rather than focusing on basic research as many patient organizations historically have done. Third, organizations seek to position themselves within established research and drug development networks, fostering collaborative relationships with key stakeholders, including pharmaceutical companies. We also find that some of the most transformative practices associated with venture philanthropy, such as direct investment in for-profit companies, remain relatively uncommon. CONCLUSIONS: Venture philanthropy represents an evolution in the ambitions and activities of patient organizations, with organizations becoming more fully enmeshed in the drug development process. Our findings raise ethical questions about how patient organizations conceptualize and advance patient interests and about tradeoffs inherent to the venture philanthropy model.

  PublisherDOI

Frequent coauthors

• I. Glenn Cohen

  Harvard University

  45 shared

• Emily A. Largent

  University of Pennsylvania

  41 shared

• Steven Joffe

  University of Pennsylvania

  25 shared

• Barbara E. Bierer

  Harvard University

  22 shared

• Alison Bateman-House

  New York University

  20 shared

• Suzanne M. Rivera

  University of Pennsylvania

  17 shared

• Urs Gasser

  11 shared

• Effy Vayena

  11 shared

Labs

• Medical Ethics and Health PolicyPI

Education

• B.A., Health and Societies

  University of Pennsylvania College of Arts and Sciences

  2003

• Other, Bioethics

  University of Pennsylvania School of Medicine

  2006

• Other

  University of Pennsylvania Law School

  2006