Lynda Sutton is the chief regulatory officer for CATO SMS, currently serving as the FDA agent for multiple sponsors for IND and post-marketing products, including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions and ensures that regulatory requirements for the approval and launch of new products are satisfied.
Sutton has over 40 years of experience in the drug development industry. She has led teams from pre-IND to marketing approval for a variety of products including biologics, drugs, and drug/device combination products. Since cofounding CATO Research in 1988, 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. Sutton has provided interpretation, guidance, and advice on regulatory issues; facilitated regulatory interactions on behalf of sponsors; and assisted with the development of regulatory strategies. She has served as the primary regulatory contact for more than 100 sponsors over the last 32 years. As the regulatory agent, she is responsible for developing and coordinating meeting strategies, attending regulatory agency meetings, and serving as the moderator at these meetings. In addition, Sutton has cofounded nine other companies and participates as a member of the board of directors for several of these companies. She has special expertise in the development of biological products, including stem cell therapy, gene therapy, blood products, and vaccines, and in the development of oncology, infectious disease, and neuropharmacology agents.
Sutton’s education included achieving salutatorian of her high school and obtaining a leadership scholarship to Troy State University where she obtained a double major in biology and chemistry.