Kate Gallin Heffernan

Partner
T: (617) 274-2858
  • New York University School of Law (J.D., 2000), magna cum laude; Order of the Coif
  • Georgetown University (B.A., 1996), magna cum laude; Phi Beta Kappa

Highlights

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"...exceptional advice on clinical trials."
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ACADEMIC & CLINICAL RESEARCH BLOG
Commentary from the Academic and Clinical Research Group
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Ranked in Chambers USA: America's Leading Lawyers for Business

Biography

Kate advises academic medical centers, hospitals, physician groups, universities and other research organizations and stakeholders on issues related to human subjects protection, research compliance and misconduct, research affiliations and contracting, investigator and institutional conflicts of interest, the creation of data, genomic, and tissue research repositories and downstream uses of stored materials, FDA requirements for clinical investigations, research involving human embryonic stem cells and induced pluripotent cells, multi-site global trials, and the privacy of research subjects’ information. In addition to her research-focused practice, Kate also has extensive experience advising clients on legal issues related to assisted reproductive technologies and other general patient care issues, including clinical informed consent and the protection of sensitive health information, as well as organ donation and transplantation. Kate’s prior experience advising from both outside and within the institutional setting has given her an appreciation of the hurdles 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 biomedical research, and her writings have appeared in, among others, the Journal of Medical Ethics, Transplantation, Journal of the American Medical Association, Cell Stem Cell, The Hastings Center publication IRB: Ethics and Human Research, and BNA Medical Research Law & Policy Report, of which she is a member of the Editorial Advisory Board. She is involved with policy and thought development on the national and international scene, for example serving as a member on an expert panel appointed by the Organ Donation Alliance in collaboration with the Health Resources and Services Administration that was charged with creating an ethical framework for the conduct and oversight of organ donor management trials, co-designing the legal track sessions for the Advancing Ethical Research Conference, an internationally attended conference jointly sponsored by Public Responsibility in Medicine & Research (PRIM&R) and Boston University, and serving 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 also serves on the Institutional Review Board of South Shore Hospital in Weymouth, Massachusetts.

Prior to joining Verrill Dana, Kate 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 Partners HealthCare System, which encompasses Massachusetts General Hospital and Brigham and Women’s Hospital, among others. Prior to that she practiced in the health care group of Ropes & Gray LLP.

When not pursuing her work, Kate enjoys time golfing with her husband Matt, whom she met in college. Kate is an avid runner and fitness enthusiast, and although she ran in the 2013 Boston Marathon (her first marathon), she mostly trains just to keep up with her three young boys. Kate enjoys writing for fun, and she and Matt continue to participate (unsuccessfully) in The New Yorker cartoon caption contest. Kate won bragging rights when her proposed caption for a bioethics cartoon won first prize in a contest sponsored by The Hastings Center’s Bioethics Forum in 2011.

Education

  • New York University School of Law (J.D., 2000), magna cum laude; Order of the Coif
  • Georgetown University (B.A., 1996), magna cum laude; Phi Beta Kappa

Clerkships

  • Hon. Dennis Jacobs, U.S. Court of Appeals for the Second Circuit

Bar Admissions

  • Massachusetts, 2001
  • New York, 2001

Honors

Recognized in Chambers USA: America's Leading Lawyers for Business 
    under Health Care