George A. O'Brien

Partner/FDA Regulatory at Mayer Brown LLP

Speaker

George O'Brien is an FDA Regulatory partner in Mayer Brown's Washington DC office. He works with life sciences companies of all sizes to assist them in developing and marketing innovative products that are regulated by the US Food and Drug Administration, including drugs and biologics, medical devices, drug-device combination products, CBD and botanical products, medical foods and dietary supplements.

George has deep experience providing regulatory advice to pharmaceutical and biotech companies on lifecycle management issues, including regulatory exclusivities and FDA-facing patent issues. He is a leading expert on orphan drug matters, including orphan designation and exclusivity, and has successfully advocated on behalf of clients to FDA on matters related to prevalence, orphan subsets, and clinical superiority. George also regularly advises pharmaceutical and biotechnology companies on pediatric study and pediatric exclusivity issues arising under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

George regularly works with life sciences clients on FDA-facing patent issues. As part of this practice, he routinely assists clients on the submission of patent information to FDA’s Orange Book and Purple Book. George also works closely with his IP colleagues throughout the entire Hatch-Waxman litigation process to ensure that intellectual property protections and regulatory strategies are aligned throughout a product’s lifecycle.