Marlee P. Gallant is an associate in the health care and life sciences practice.
Practice & Background
Ms. Gallant received her J.D. in May 2014 from Loyola University Chicago School of Law where she was managing editor of the Loyola University Chicago Law Journal. Ms. Gallant was awarded a fellowship by Loyola’s Beazley Institute for Health Law and Policy and earned a Certificate in Health Law. She was also a fellow of the Loyola Institute for Consumer Antitrust Studies.
During law school, Ms. Gallant was a judicial intern for a magistrate judge in the U.S. District Court for the Northern District of Illinois and a legal intern at the American Medical Association, headquartered in Chicago, IL. Ms. Gallant was a member of Akin Gump Strauss Hauer & Feld LLP’s 2013 summer associate class.
- Engaging the Food and Drug Administration (FDA) on development of cybersecurity standards on behalf of a medical device cybersecurity company
- Advising a health technology company on the application of FDA device regulations to its products
- Advising a biomedical company on FDA classification of a combination product
- Producing global, U.S. and U.K. compliance handbooks for a pharmaceutical company based in India
- Advising a dialysis company on regulatory issues impacting its business
- Advocating before Congress and federal agencies to obtain Medicare coverage for comprehensive genomic profiling tests
- Engaging stakeholders (patients and physicians) to educate the FDA and federal policymakers on issues relating to osteoarthritis.
- panelist, “Understanding and Applying Ethics and Confidentiality Rules in the MLP Context,” webinar hosted by the National Center for Medical-Legal Partnerships (July 9, 2015)