Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process, “Using Artificial Intelligence &
Dalia Deak is an associate in the firm's Chambers top-ranked Food, Drug, and Device Practice Group. Dalia draws on her scientific training and years of public health and policy experience to provide strategic and regulatory advice to emerging and leading biotechnology, pharmaceutical, digital health, and medical device companies. She leverages her experience to understand clients’ specific and enterprise-level needs and advises on a broad range of complex regulatory, compliance, and policy matters at the intersection of science, strategy, public health, and law.
A lawyer with scientific training and public health and policy experience, Dalia advises emerging and leading companies on regulatory and strategic matters. Her focus is primarily on matters affecting biotechnology, pharmaceutical, digital health, and medical device products.
Dalia has assisted clients with top-priority issues, like conducting due diligence for FDA-regulated products and companies, responding to clinical holds, and providing advice on advertising and promotion, prevention of healthcare fraud and abuse, and the design and conduct of clinical trials. In doing so, she leverages the valuable in-house experience she gained while on secondment at a biopharmaceutical company to understand the enterprise and stakeholders and translate legal advice into actionable steps that are responsive to the business.
Prior to joining the Food, Drug, and Device practice group, Dalia was a member of the Patent Litigation practice group where she focused on representing clients in pharmaceutical patent litigation. She also maintains an active pro bono practice at Covington, with a particular focus on asylum, reproductive justice, and criminal justice matters.
Before attending law school, Dalia received her M.P.H from the Harvard T.H. Chan School of Public Health, during which she worked as a Research Trainee at Brigham and Women’s Hospital. At Brigham, she researched drug repurposing and U.S. Food & Drug Administration law and policy. Prior to graduate school, Dalia was a research assistant at The Brookings Institution researching drug and device innovation, safety, and evidence issues. She co-authored a report for the U.S. Food & Drug Administration on effective implementation of Unique Device Identifiers (UDIs).
While in law school, Dalia interned for the Honorable Indira Talwani of the U.S. District Court of the District of Massachusetts. She also served as a Health Law Fellow at the Georgetown University O’Neill Institute for National & Global Health Law, where she researched pandemics, international health law, and intellectual property. Dalia was also active in a number of clinics, including Harvard’s Center for Health Law & Policy Innovation and the Immigration and Refugee Advocacy Clinic.
Dalia has published her research in peer-reviewed journals, publicly-available reports, and health law blogs.