When academic medical centers, hospitals, universities, research institutes, start-up biotechnology companies, and other research stakeholders need advice on a comprehensive range of issues affecting biomedical research, they turn to attorney Kate Gallin Heffernan.
Kate counsels clients on issues related to the following:
- Human subjects protection
- Research noncompliance and misconduct proceedings
- Research affiliations and contracting
- Investigator and institutional conflicts of interest
- Repositories for data, genomic, and tissue research and the downstream uses of stored materials
- FDA requirements for clinical investigations
- Treatment with investigational products pursuant to FDA's expanded access program and "Right to Try" laws
- Research involving human embryonic stem cells and induced pluripotent cells
- Multi-site global trials
- Privacy of research subjects' information
In addition to her research-focused practice, Kate advises clients on general patient care issues, including clinical informed consent and the protection of sensitive health information, as well as organ donation and transplantation.
Clients benefit from Kate’s prior experience advising from inside the institutional setting, which has given her insight into the hurdles that health care organizations face, not only in analyzing and understanding the complex regulatory scheme in which they pursue their mission but also in developing and implementing solutions that work.
Kate is a frequent speaker and author on many issues related to the legal and ethical issues raised by academic and clinical research, and her writings have appeared in, among other places, the Journal of Clinical Oncology, the Journal of Medical Ethics, Transplantation, the Journal of the American Medical Association, Cell Stem Cell, The Hastings Center Report, IRB: Ethics and Human Research, BNA Medical Research Law & Policy Report, and Bloomberg Law's Pharmaceutical and Life Sciences News.
Kate is involved with policy and thought development on the national and international scene. Serving on a panel appointed to advise the Health Resources and Services Administration, she contributed to a proposed ethical framework for the conduct and oversight of organ donor intervention trials. The framework was subsequently endorsed in the National Academies of Sciences, Engineering, and Medicine’s report Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation, for which she served as an invited reviewer. The Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the Secretary of the U.S. Department of Health and Human Services on challenging issues related to human subjects research, invited Kate to present to SACHRP on this topic in July 2019.
Kate serves as a member of the planning committee for the Advancing Ethical Research Conference, an internationally attended conference jointly sponsored by Public Responsibility in Medicine & Research (PRIM&R) and Boston University, at which she is a regular faculty member. She has also served as a member of several working groups of the Multi-Regional Clinical Trials Center at Harvard University's Global Health Institute, an interdisciplinary group of academics, health care providers, and industry convened to recommend concrete solutions for challenging ethical issues in international research. Kate has an enduring interest in bioethics, pursuing advanced study in June 2009 through a fellowship in medical ethics at Harvard Medical School, Division of Medical Ethics. She served on the Institutional Review Board of South Shore Hospital in Weymouth, Massachusetts, for several years.
Kate is Managing Shareholder of Epstein Becker Green’s Boston office. Before joining Epstein Becker Green, Kate was a partner, and served as the chair of the Academic and Clinical Research Group and vice chair of the Health Care & Life Sciences Group, at a New England regional law firm. She previously operated her own practice as the founder of KGH Advisors LLC, after having worked in the Research and Technology division of the Office of the General Counsel at a not-for-profit, integrated health care system in Massachusetts. Prior to that, she practiced in the health care group of an international law firm.
- Academic and Clinical Research
- Corporate Compliance Program Development, Implementation, and Effectiveness
- FDA Inspections and Enforcement
- Federal Research Grants: Compliance, Investigations & Enforcement
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Industry Research and Clinical Trials
- Life Sciences
- Privacy, Cybersecurity & Data Asset Management
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Kate has been listed in Chambers USA: America's Leading Lawyers for Business in the Massachusetts—Healthcare category (2017-2023), selected by her peers for inclusion in The Best Lawyers in America© in the field of Health Care Law (2021 to 2024), and included on the 2018 New England Super Lawyers list in the area of Health Care.
- New York University School of Law (J.D., magna cum laude, 2000)
- Order of the Coif
- Georgetown University (B.A., magna cum laude, 1996)
- Phi Beta Kappa
- New York
- AHLA Academic Medical Centers and Teaching Hospitals Institute
- PRIM&R's 2019 Advancing Ethical Research Conference