Lynda Sutton

Biography

Ms. Sutton has more than 25 years of experience in the drug development industry, specializing in the development of regulatory strategies for drugs and biologics. She has coordinated activities in various disciplines (e.g., toxicology, pharmacology, pharmacokinetics, analytical and pharmaceutical development, and clinical research). Ms. Sutton has been involved in the development of new clinical entities; has overseen the preparation of FDA pre-meeting submissions; and has ensured that regulatory requirements necessary for the approval and launch of new products have been satisfied. Since cofounding Cato Research in 1988, Ms. Sutton has served as project leader or project advisor on numerous project teams. In this capacity, she has been responsible for the strategic planning of full development programs for both drugs and biologics in a variety of therapeutic areas. In her current position, Ms. Sutton provides interpretation, guidance, and advice on regulatory issues; oversees the preparation of regulatory submissions; reviews documents that will be submitted to regulatory agencies; initiates and facilitates FDA interactions on behalf of sponsors; and assists with the development of regulatory strategies. She has served as the primary regulatory contact for more than 100 sponsors over the last 10 years. As the primary regulatory contact at Cato Research, she develops and coordinates strategies for regulatory agency meetings, and serves as the moderator at these meetings. In addition, Ms. Sutton has cofounded several small biotechnology companies and serves as a member of the board of directors for several companies. She has expertise in the development of biological products, with emphasis on gene therapy and blood products, and in the development of oncological, anti-infective, and neuropharmacological products. Ms. Sutton has more than 25 years of experience in the drug development industry, specializing in the development of regulatory strategies for drugs and biologics. She has coordinated activities in various disciplines (e.g., toxicology, pharmacology, pharmacokinetics, analytical and pharmaceutical development, and clinical research). Ms. Sutton has been involved in the development of new clinical entities; has overseen the preparation of FDA pre-meeting submissions; and has ensured that regulatory requirements necessary for the approval and launch of new products have been satisfied. Since cofounding Cato Research in 1988, Ms. Sutton has served as project leader or project advisor on numerous project teams. In this capacity, she has been responsible for the strategic planning of full development programs for both drugs and biologics in a variety of therapeutic areas. In her current position, Ms. Sutton provides interpretation, guidance, and advice on regulatory issues; oversees the preparation of regulatory submissions; reviews documents that will be submitted to regulatory agencies; initiates and facilitates FDA interactions on behalf of sponsors; and assists with the development of regulatory strategies. She has served as the primary regulatory contact for more than 100 sponsors over the last 10 years. As the primary regulatory contact at Cato Research, she develops and coordinates strategies for regulatory agency meetings, and serves as the moderator at these meetings. In addition, Ms. Sutton has cofounded several small biotechnology companies and serves as a member of the board of directors for several companies. She has expertise in the development of biological products, with emphasis on gene therapy and blood products, and in the development of oncological, anti-infective, and neuropharmacological products.

Research Interest

Regulatory Affairs