Kate Heffernan
USA Guide 2024
Band 2 : Healthcare
Band 2
About
Provided by 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.
https://www.ebglaw.com/people/kate-gallin-heffernan/
Chambers Review
USA
Kate Heffernan regularly advises on issues relating to research, clinical trials and biomedical regulatory matters.
Strengths
Provided by Chambers
"We worked with her on a project that required knowledge of clinical trial issues. She provided clear advice and was proactive in guiding us."
"Kate has great expertise in this area and is very practical. She communicates well with her team and is a good point person; you can go to her and something will get done."
"Kate is great. She is very knowledgeable and thoughtful in her analysis and diplomatic in counterparty negotiations."
"We worked with her on a project that required knowledge of clinical trial issues. She provided clear advice and was proactive in guiding us."
"Kate has great expertise in this area and is very practical. She communicates well with her team and is a good point person; you can go to her and something will get done."
"Kate is great. She is very knowledgeable and thoughtful in her analysis and diplomatic in counterparty negotiations."
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