Kate Heffernan

Practice Areas

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 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. She also counsels clients in FDA requirements for clinical investigations and treatment with investigational products pursuant to FDA’s expanded access program and “Right to Try” laws.

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.

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