EMILY MARDEN is counsel in Sidley’s Food and Drug Regulatory group. Emily trained in the life sciences, and has a deep understanding of the emerging science shaping therapeutic products, agriculture, foods and dietary supplements. Emily’s practice focuses on regulatory and strategic questions at the cutting edge, including:
- Regenerative Medicine: clinical study, approval, and competitive issues associated with regenerative medicine (including gene therapy, cell therapy, and Public Health Service Act (PHSA) Section 361 products);
- Complex Drugs and Biological Products: approval and competitive issues associated with complex drugs (e.g., non-biological complex drugs, peptides) and biological products
- Genomics, and Synthetic Biology: governance and international policy associated with genomics, gene editing, and synthetic biology in agriculture, food, drugs, and biological products;
- Regulatory Exclusivity: regulatory and strategic issues associated with Hatch-Waxman (New Chemical Entity, New Clinical Study, 180-day) and other (Orphan, Paediatric, Biological Product) exclusivities; and
- Innovations in Food and Dietary Supplements: developments including novel and alternative ingredients as well as proteins using microbial, animal cell-based, and plant technologies.
In addition to her regulatory practice, Emily directs research on genomics and innovation in agriculture at the University of British Columbia. Her current research focuses on the intersection of legal frameworks governing access and use of genetic resources with research. She also publishes and speaks widely on interrelated issues of policy, regulation and innovation. Emily received degrees in Biology and the History of Science from Harvard University and she received her J.D. from the New York University School of Law.