12^th Asian Biologics and Biosimilars Congress

Kurt R Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing and

orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues and defi ning periods of exclusivity. He as the Co-Founder and primary author of Hyman, Phelps & McNamara’s FDA law blog, often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. He has also co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements; Pharmaceutical, Biotechnology and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI’s Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.